Arq Bras Cardiol abc Arquivos Brasileiros de Cardiologia Arq. Bras. Cardiol. 0066-782X 1678-4170 Sociedade Brasileira de Cardiologia - SBC F6YwnGsLQZY8rvDWTxtfp4c S0066-782X2016000500373 S0066-782X2016005009101 10.5935/abc.20160043 Original Articles First- Versus Second-Generation Drug-Eluting Stents in Acute Coronary Syndromes (Katowice-Zabrze Registry) Kawecki Damian 1 Morawiec Beata 1 Dola Janusz 1 Wanha Wojciech 2 Smolka Grzegorz 2 Pluta Aleksandra 2 Marcinkiewicz Kamil 2 Ochała Andrzej 2 Nowalany-Kozielska Ewa 1 Wojakowski Wojciech 2 Zabrze Medical University of Silesia 2nd Department of Cardiology Katowice Poland 2nd Department of Cardiology - Zabrze Medical University of Silesia, Katowice -Poland Medical University of Silesia 3rd Division of Cardiology Katowice Poland 3rd Division of Cardiology - Katowice-Ochojec - Medical University of Silesia, Katowice - Poland University of Silesia Mailing Address: Damian Kawecki, 2nd Department of Cardiology, Zabrze. Medical University of Silesia, Katowice. M. Skłodowskiej-Curie Str. 10, Postal Code 41-800, Zabrze - Poland. E-mail: d.kawecki@interia.pl

Author contributions

Conception and design of the research: Kawecki D, Ochała A, Wojakowski W; Acquisition of data: Morawiec B, Dola J, Wanha W, Smołka G, Pluta A, Marcinkiewicz K; Analysis and interpretation of the data: Kawecki D, Morawiec B, Dola J, Wanha W, Smołka G, Pluta A, Marcinkiewicz K, Ochała A; Statistical analysis: Kawecki D, Morawiec B, Wanha W, Pluta A, Marcinkiewicz; Writing of the manuscript: Kawecki D, Morawiec B, Ochała A, Nowalany-Kozielska E, Wojakowski W; Critical revision of the manuscript for intellectual content: Kawecki D, Smołka G, Ochała A, Nowalany-Kozielska E, Wojakowski W.

Potential Conflict of Interest

No potential conflict of interest relevant to this article was reported.

 05 04 2016 5 2016 106 05 373 381 25 06 2015 04 01 2016 06 01 2016 This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Background:

There are sparse data on the performance of different types of drug-eluting stents (DES) in acute and real-life setting.

 Objective:

The aim of the study was to compare the safety and efficacy of first- versus second-generation DES in patients with acute coronary syndromes (ACS).

 Methods:

This all-comer registry enrolled consecutive patients diagnosed with ACS and treated with percutaneous coronary intervention with the implantation of first- or second-generation DES in one-year follow-up. The primary efficacy endpoint was defined as major adverse cardiac and cerebrovascular event (MACCE), a composite of all-cause death, nonfatal myocardial infarction, target-vessel revascularization and stroke. The primary safety outcome was definite stent thrombosis (ST) at one year.

 Results:

From the total of 1916 patients enrolled into the registry, 1328 patients were diagnosed with ACS. Of them, 426 were treated with first- and 902 with second-generation DES. There was no significant difference in the incidence of MACCE between two types of DES at one year. The rate of acute and subacute ST was higher in first- vs. second-generation DES (1.6% vs. 0.1%, p < 0.001, and 1.2% vs. 0.2%, p = 0.025, respectively), but there was no difference regarding late ST (0.7% vs. 0.2%, respectively, p = 0.18) and gastrointestinal bleeding (2.1% vs. 1.1%, p = 0.21). In Cox regression, first-generation DES was an independent predictor for cumulative ST (HR 3.29 [1.30-8.31], p = 0.01).

 Conclusions:

In an all-comer registry of ACS, the one-year rate of MACCE was comparable in groups treated with first- and second-generation DES. The use of first-generation DES was associated with higher rates of acute and subacute ST and was an independent predictor of cumulative ST.

Keywords: Acute Coronary Syndrome Drug-Eluting Stents Thrombosis Percutaneous Coronary Intervention Introduction

Drug-eluting stents (DES) were successfully introduced into clinical practice for percutaneous coronary interventions (PCI) as a response to high rate of restenosis associated with bare-metal stents (BMS).1,2 Pooled analyses from randomized studies with paclitaxel-eluting and sirolimus-eluting stents showed similar mortality and myocardial infarction (MI) rates, but less repeat revascularization in comparison to BMS.3 Older DES platforms, with relatively thick struts and durable polymers were however associated with late and very late stent thrombosis (ST).4,5

Current evidence shows that newer stent platforms with thinner struts, more biocompatible polymer and limus drugs provide better efficacy in terms of reduced thrombogenicity in preclinical studies as well as clinical safety (ST).6,7 Such stents are regarded as second-generation DES.

Both randomized trials and large registries have consistently shown improved safety and efficacy across patients subgroups, including acute coronary syndromes (ACS) and stable coronary artery disease (CAD).8 Stent thrombosis however, despite its slow rate, remains the main concern associated with the implantations of DES, especially in patients with high risk for bleeding, bad drug compliance and ACS due to the high mortality of this complication.9

The use of DES in ACS was initially off-label, however current guidelines indicate that DES should be preferred over BMS also in ACS including ST-segment elevation acute myocardial infarction (STEMI) based on randomized trials.10-13 The majority of studies that compared first- and second-generation DES patients with ACS consisted only a fraction of studied populations.8,14-16 In recent years a few studies comparing both generations of DES in acute setting were published.17,18 Nonetheless, these data are sparse and require further evaluation.

We therefore aimed to compare the safety and efficacy of first-generation vs. second-generation DES in all-comer ACS population in one-year follow-up.

 Methods Study design

The investigator-initiated all-comer Katowice-Zabrze Registry involved consecutive patients treated with PCI with implantation of DES. The enrollment was conducted in two tertiary high volume (together 5500 PCI/year) cardiac centers (Upper Silesian Medical Center in Katowice and 2nd Department of Cardiology, Zabrze) from January, 1st 2009 to December, 31st 2010. The aim of this ongoing registry is to compare the first and second generations of DES in unrestricted population of patients. Within the registry population, the inclusion criterion was the diagnosis of ACS treated with PCI with the implantation of either first- or second-generation DES. ACS was defined according to the current guidelines as unstable angina (UA), non-ST-elevation MI (NSTEMI) or STEMI.19-21 In coronary angiography, the basic angiographic characteristics were recorded: location of the lesion, severity of stenosis, AHA/ACC lesion type, thrombus, calcifications. In every patient, excluding those after coronary artery bypass grafting (CABG), the SYNTAX score was assessed. Stents were chosen out of first-generation DES durable polymer based or second-generation DES, according to the operator's decision. In case of the implantation of more than one stent in one patient, the DES implanted to culprit lesion or to more severe stenosis was considered as the index procedure. Dual antiplatelet therapy (acetylsalicylic acid and P2Y12 subtype of ADP receptor inhibitors) was prescribed for up to 12 months after the procedure in each patient. Baseline clinical, angiographic and procedure related data were retrospectively collected from medical records.

 Coronary stenting

Stents for implantation were chosen from first-generation DES durable polymer based [Paclitaxel-eluting stents (PES) (Taxus, Boston Scientific Corporation, Maple Grove, MN, USA) or Sirolimus-eluting stent (SES) (Cypher, Cordis, USA)] or second-generation DES [Everolimus-eluting stent (EES) (Promus, Boston Scientific Corporation; Xience, Xience Prime, Abbott Vascular, Santa Clara, CA, USA), Zotarolimus-eluting stent (ZES) (Endeavor, Resolute, Medtronic, Minneapolis, MN, USA), and Biolimus-eluting stent (BES) (Biolimus A9, Biosensors International, Switzerland)].

 Antiplatelet and antithrombotic regimen

All patients were treated according to guidelines for ACS and received a loading dose of aspirin and ADP-receptor inhibitor prior, during or directly after PCI, and a bolus of unfractionated heparin prior to PCI. IIb/IIIa receptor inhibitor was administered according to operator's decision. Following the procedure, patients were prescribed aspirin, 75 mg daily, lifelong, and clopidogrel, 75 mg daily, for up to 12 months, which was modified in patients who required anticoagulation therapy for other reasons.

 Follow-up

Patients were followed up at one year. All information was obtained from medical records of enrolling centers. If no information was available, phone contact was attempted. In case of phone contact failure, information on clinical endpoints was obtained from National Health Care System.

The primary efficacy endpoint was a composite major adverse cardiac and cerebrovascular events (MACCE) including all-cause death, non-fatal MI, target-vessel revascularization (TVR), and stroke.

The secondary endpoints were individual components of the primary endpoint: all-cause death, MI, TVR, stroke, as well as CABG. The safety of DES was defined as definite ST (acute, subacute, late and cumulative) and gastrointestinal bleeding rate at one year. MI was defined according to the universal definition.19 TVR, definite ST, acute, subacute and late ST were defined according to the definitions of endpoints for clinical trials.22 Gastrointestinal bleeding was considered an endpoint if fulfilled criteria of type 3 or type 5 bleeding, according to proposed definitions.23

Informed consent was obtained from each patient and the study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in a priori approval by the Ethical Committee of the Medical University of Silesia (No. KNW/0022/KB/59/11).

 Statistics

Variables were checked for normality of distribution with Shapiro-Wilks test. Continuous variables are presented as mean ± SD or median (25th, 75th percentile) and were compared with Student t test or Mann-Whitney test. Categorical variables are presented as percentages and were compared with chi-square test. The Kaplan-Meier survival curves were constructed to describe the incidence of endpoints over time. The assessment of influence of parameters significantly statistically different between groups on endpoints was conducted with univariate Cox analysis. Multivariate Cox regression model was used to identify risk factor for safety and efficacy endpoints and included all variables statistically significant in univariate analysis. All tests were two-tailed and the value of p < 0.05 was considered significant. Analysis was performed with Statistica software, version 10PL (StatSoft Inc., Tulsa, OK, USA) and GraphPad Prism, version 6.00 (GraphPad, La Jolla, California, USA).

 Results

A total of 8284 PCI were performed during analyzed period. Of them, 6368 patients who received BMS (6177 patients) or underwent balloon angioplasty (191 patients) were excluded. Out of remaining 1916 patients who underwent PCI with the implantation of DES, 588 patients had stable CAD and were excluded from the analysis. Remaining 1328 patients were diagnosed with ACS (including 131 STEMI, 285 NSTEMI, and 912 UA patients) and subjected to the current analysis. Of them, 426 were treated with first-generation DES (391 PES, 35 SES) and 902 with second-generation DES (90 BES, 483 EES, 329 ZES). The distribution of initial diagnosis in both groups is presented in Table 1.

Clinical characteristics.
Characteristic First-generation DES (n = 426) Second-generation DES (n = 902) P value
Male sex 255 (60) 590 (65) 0.05
Age (years) 64 ± 9.4 63.2 ± 10.4 0.17
BMI (kg/m2) 29.3 ± 4.9 28.8 ± 4.7 0.26
Obesity 103 (24) 198 (22) 0.37
Renal insufficiency 75 (18) 171 (19) 0.56
Ejection fraction (%) 50 (42;55) 54 (45;60) 0.03
Diabetes mellitus 171 (40) 331 (37) 0.23
Hypertension 360 (85) 790 (88) 0.12
Dyslipidemia 278 (65) 575 (64) 0.59
Smoker 99 (23) 212 (24) 0.92
Familial history of CAD 133 (31) 317 (35) 0.16
Prior AMI 179 (42) 439 (49) 0.02
Prior PCI 220 (52) 478 (53) 0.65
Prior CABG 90 (21) 225 (25) 0.13
Carotid atherosclerosis 19 (4) 57 (6) 0.17
PAD 51 (12) 105 (12) 0.86
Initial diagnosis
Unstable Angina 265 (62) 647 (71) < 0.001
NSTEMI 109 (26) 176 (20) 0.01
STEMI 52 (12) 79 (9) 0.05

Data are presented as n (%), median (25th and 75th interquartile) or mean±SD. DES: drug eluting stent; BMI: body mass index; CAD: coronary artery disease; AMI:acute myocardial infarction; PCI: percutaneous coronary intervention; CABG: coronary artery bypass grafting; PAD: peripheral artery disease; NSTEMI: non-ST-segmentelevation myocardial infarction; STEMI: ST-segment elevation myocardial infarction.

Both groups had similar baseline profile (Table 1). Comparable rates of cardiovascular risk factors were observed. Patients who received a second-generation DES had higher incidence of prior acute MI than patients with first-generation DES (49% vs. 42%, p = 0.02). Patients' history of coronary interventions did not differ significantly between groups.

Angiographic and procedural characteristics are depicted in Table 2. No differences regarding treated vessel were found between groups. Higher SYNTAX score was observed in first-generation than in second-generation DES (median 17 vs. 13 points, p < 0.001). Thrombus and calcifications were more commonly found in first-generation DES (p < 0.001 and p < 0.001, respectively). Temporal distribution of the implantation of both types of DES during studied period is presented in Figure 1. First-generation DES were implanted more frequently after predilation and with lower mean inflation pressure than second-generation DES (p = 0.002 and p < 0.001, respectively). Procedures did not differ regarding length and diameter of the stent, as well as total number of stents per lesion. Angiographic outcome of the procedure was equal, and TIMI 3 flow was achieved in 98% of cases in both groups (p = 0.48). Regarding antithrombotic and antiplatelet treatment, IIb/IIIa receptor inhibitors were administered in 7% and 6% of cases in first- and second-generation DES, respectively (p = 0.62). Aspirin was prescribed in 99% and 98% of patients in first- and second-generation DES group, respectively (p = 0.23). Patients received oral anticoagulation with equal frequency (6%) in both groups (p = 0.8). Among them, in 3 patients from first-generation DES group (0.7%) and in 1 patient from second-generation DES group (0.1%), aspirin was discontinued after 3-6 months (p = 0.19).

Angiographic and procedural characteristics.
Characteristic First-generation DES (n = 426) Second-generation DES (n = 902) P value
Culprit vessel
LM 40 (9) 59 (7) 0.07
LAD 216 (51) 442 (49) 0.56
Cx 69 (16) 158 (18) 0.55
RCA 78 (18) 186 (21) 0.32
SVG 21 (5) 49 (5) 0.7
AG 2 (0.5) 8 (1) 0.41
SYNTAX score 17 (10;28) 13 (7;22) < 0.001
Thrombus 30 (7) 26 (3) 0.001
Ostial lesion 74 (18) 128 (15) 0.25
Restenosis 72 (17) 144 (16) 0.67
Calcifications 56 (13) 36 (4) < 0.001
Stenosis severity (%) 86.8 87.4 0.78
No DES per lesion 1 (1;1) 1 (1;1) 0.15
Length DES per lesion (mm) 22 (15;29) 22.5 (15;28) 0.57
Stent diameter (mm) 3.03 ± 0.48 3.07 ± 0.47 0.55
Predilation 222 (53) 368 (44) 0.002
Maximal inflation pressure (atm) 16 ± 4 17 ± 4 < 0.001
TIMI 3 flow 419 (98) 881 (98) 0.48
GPIIb/IIIa inhibitors 28 (7) 53 (6) 0.62

Data are presented as n (%), median (25th and 75th interquartile) or mean±SD. DES: drug eluting stent; LM: left main; LAD: left anterior descending artery; Cx:circumflexartery; RCA: right coronary artery; SVG: saphenous graft; AG: arterial graft; TIMI: thrombosis in myocardial infarction.

Temporal distribution of the number of first- and second-generation DES implanted during studied period. DES: drug-eluting stent.

Endpoints

There was no significant difference in the incidence of the primary and secondary efficacy endpoints between first- and second-generation DES at one year (Table 3). The Kaplan-Meier curves for the incidence of MACCE are presented in Figure 2 with no significant difference between groups. In univariate Cox regression model, the predictors of the incidence of MACCE were left ventricular ejection fraction, history of acute MI, SYNTAX score and predilation (Table 4). After adjustment in multivariate analysis only the history of acute MI was a statistically significant predictor of MACCE (HR 1.39, CI 1.04-1.84, p=0.03) (Table 5).

Clinical outcomes at one year.
Characteristic First-generation DES (n = 426) Second-generation DES (n = 902) P value
Stent thrombosis (ST)
Acute ST 7 (1.6) 1 (0.1) < 0.001
Subacute ST 5 (1.2) 2 (0.2) 0.025
Late ST 3 (0.7) 2 (0.2) 0.18
Cumulative ST 15 (3.5) 5 (0.6) < 0.001
Primary endpoint
MACCE 80 (19) 135 (15) 0.078
Secondary endpoint
Death 19 (4.5) 39 (4.3) 0.91
AMI 31 (7.2) 43 (4.8) 0.06
TVR 51 (12) 90 (10) 0.27
Stroke 6 (1.4) 5 (0.6) 0.11
CABG 12 (2.8) 12 (1.3) 0.06
Gastrointestinal bleeding 9 (2.1) 10 (1.1) 0.15

Data are presented as n (%). DES: drug eluting stent; ST: stent thrombosis; MACCE: major adverse cardiac and cerebrovascular events; AMI: acute myocardialinfarction; TVR: target vessel revascularization; CABG: coronary artery bypass grafting.

Incidence of MACCE at 1 year. MACCE: major adverse cardiac and cerebrovascular events; DES: drug-eluting stents.

Univariate Cox proportional hazard model for the incidence of MACCE and ST.
Characteristic p value HR HR CI p value HR HR CI
MACCE Cumulative stent thrombosis
First-generation DES 0.07 1.29 0.98-1.7 < 0.001 4.61 1.88-11.31
Sex (male) 0.38 1.13 0.86-1.5 0.36 1.53 0.6-3.91
Prior AMI 0.005 1.46 1.12-1.94 0.34 0.66 0.27-1.56
LVEF 0.04 0.99 0.98-0.999 0.04 0.97 0.94-0.998
SYNTAX Score 0.02 1.02 1.0-1.03 < 0.001 1.06 1.03-1.09
Thrombus 0.99 1.0 0.53-1.89 < 0.001 6.99 2.57-18.97
Calcifications 0.79 1.08 0.61-1.94 0.22 2.13 0.63-7.24
Predilation 0.009 1.44 1.09-1.91 0.03 2.83 1.1-7.28
Max inflation pressure 0.52 0.98 0.94-1.03 0.02 0.83 0.72-0.97

DES: drug eluting stent; AMI: acute myocardial infarction; LVEF: left ventricular ejection fraction; CI: confidence interval.

 Multivariate Cox proportional hazard model for the incidence of MACCE.
Characteristic p value HR HR CI
MACCE
Prior AMI 0.03 1.38 1.04-1.84
LVEF 0.65 0.98 0.98-1.01
SYNTAX Score 0.38 1.01 0.99-1.02
Predilatation 0.05 1.34 1.0-1.79

DES: drug eluting stent; AMI: acute myocardial infarction; LVEF: left ventricular ejection fraction; CI: confidence interval.

Regarding the safety profile, the rate of acute and subacute ST was significantly higher in first- than in second-generation DES (1.6% vs. 0.1%, p < 0.001 and 1.2% vs. 0.2%, p = 0.025, respectively) (Figure 3). There was no significant difference between first- and second-generation DES in the occurrence of late ST (0.7% vs. 0.2%, respectively, p = 0.18) and gastrointestinal bleeding (2.1% vs 1.1%, respectively, p = 0.21). Cox regression model for the incidence of cumulative ST revealed that, among other parameters, the first generation of DES was an independent predictor in univariate analysis (HR 4.61, CI 1.88-11.31, p < 0.001) (Table 4).

Stent thrombosis (ST) rates. ST: stent thrombosis; DES: drug-eluting stents.

Discussion

The Katowice-Zabrze registry shows that, in patients with ACS treated with PCI, the use of second-generation DES might be associated with better safety profile, and lower rate of acute and subacute ST at one year. There was, however, no difference in favor of second-generation DES as to the overall MACCE rate.

Similar observations for the population of ACS have been published previously,18,24 suggesting that, for the treatment of STEMI, all (first- and second-generation) DES show similar results, notwithstanding higher late lumen loss, restenosis and thrombosis rates for first-generation DES. It seems that the PCI in ACS is similarly efficient regardless of the type of eluting drug.

Of note, the rates of MACCE in our population were higher than those presented earlier by different groups.17,25 This could be explained by the differences in the profile of the population with more or less restricted criteria of enrollment (exclusion of the implantation of DES due to ST or patients in cardiogenic shock, with renal insufficiency or with suboptimal outcome of the index procedure). Lower overall endpoint rate for patients with ACS and lower incidence of MACCE for first-generation DES than in our study was also reported in a pooled analysis of 4 randomized trials.7 The reason for this could be different profile of the population with higher rates of risk factors (diabetes mellitus, arterial hypertension, prior acute MI and prior PCI), more complex lesions (more left anterior descending and left main coronary arteries as the indexed procedure, longer lesion, higher diameter of stenosis) than in our cohort.

Finally, high rates of endpoints in our study could be explained in a comparison of the trial with the most consistent inclusion criteria with ours, i.e. the SORT OUT-III trial.16 The SORT OUT was a randomized trial with a great fraction of non-randomized patients, thus not undergoing the analysis. Better risk profile than presented here had implication in lower rates of endpoints in the studied population. Our study is an analysis of an all-comer, unrestricted and independent use of DES in real-life ACS population, thus its outcomes could reflect real clinical practice and could be directly applied into patient care.

All-comer Swedish SCAAR Registry with more than 94000 patients showed that second-generation DES have 62% less risk of ST than BMS and 43% less than first-generation DES, which is consistent with our data. In large SCAAR population there was also reduction of mortality in favor of second-generation DES.8 The observations were confirmed by network meta-analysis by Palmerini et al., showing in pooled analysis of 49 randomized clinical trials with 50,844 patients a consistent reduction of ST with new generation DES in comparison to first-generation DES and BMS.26

Regarding the safety of DES, ST is the most serious and often fatal form of target-vessel failure. Nevertheless, the percentage of TVR of thrombotic origin reported here is low. Presented results confirm significantly higher occurrence of the thromboembolic complication in short-term follow-up after implantation of first-generation DES. These facts are not surprising, considering the majority of previously published data.8,27,28 Higher rates of acute and subacute ST were observed despite no difference in post-procedural angiographic characteristics, and no difference in the administration of standard in-hospital dual antiplatelet therapy. Higher rates of ST in first- than second-generation DES could be explained by significantly higher CAD burden in this group as measured by the SYNTAX score, although classifying patients in both groups as low risk with median score < 22.

It is an interesting observation that only rates of acute and subacute ST were significantly different between first- and second-generation DES and the cumulative ST rate was driven by early ST events. Several differences in stent design might be attributable for these differences, namely impaired strut endothelialization in first-generation stents related to higher strut thickness, less biocompatible polymer coating (polyolefin derivative in Taxus and PEVA + PBMA copolymer in Cypher) causing peri-strut inflammatory response, polymer structural defect after deployment as well as paclitaxel which may cause delayed endothelial recovery. New generation EES were shown to be less susceptible to inflammatory response and thrombosis.29 Of course the optimization of the procedure with proper stent sizing and deployment is equally important, especially in patients with ACS and high thrombotic burden.30

These differences were not reflected in the clinical follow-up, with similar rates of MACCE in both groups. According to the publications in this field,31,32 the major concern accompanying the implantation of DES is very late ST. Lack of the routine angiographic follow-up and the observational period restricted to one year in the present study limit the possibilities for deeper understanding of clinical significance of the two major in-stent complications, ST and restenosis, and their interaction over time. It is known that ST in BMS occurs entirely due to restenosis.33 The thrombotic origin of TVR in DES is a derivative of several factors,34 such as the characteristics of the lesion specific for ACS.

Limitations

The study is retrospective and observational in nature, thus saddled with obvious limitations. Lack of random allocation to receive either first- or second-generation DES resulted in disproportion of the type of ACS in each group and, despite equal STEMI rates regarded as the strongest factor for ST, might have affected the results. The safety endpoint was defined as definite ST. This could underestimate real incidence of ST in follow-up. However, according to Cutlip et al.,22 the quality of data, which were received from the follow-up of this retrospective registry, had to be taken into account. In case of acute MI occurrence in the follow-up, there was no possibility of checking if there was documented acute ischemia in the territory of the implanted stent. In cases where coronary angiography was accessible, it was verified and classified as definite ST if applicable. Finally, one of the most prone conditions to the development of ST is incomplete strut apposition. No routine use of an intracoronary imaging technique after stent placement, reflecting retrospective nature of the study, does not render precise indication of operator- or stent-related cause of stent failure.

 Conclusions

In this all-comer registry of ACS patients, the 12-month MACCE rate was comparable in groups treated with first- and second-generation DES. The use of first-generation DES, as an independent predictor of cumulative ST, was associated with higher rates of acute and subacute ST, but similar rate of late ST and gastrointestinal bleeding when compared with the use of second-generation DES.

Erratum

Consider correct and use to citation the author’s name Wojciech Wanha to the article “First- Versus Second- Generation Drug‑Eluting Stents in Acute Coronary Syndromes (Katowice -Zabrze Registry)”.

Sources of Funding

There were no external funding sources for this study.

Study Association

This study is not associated with any thesis or dissertation work.

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Kolandaivelu K Swaminathan R Gibson WJ Kolachalama VB Nguyen-Ehrenreich KL Giddings VL Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings Circulation 2011 123 13 1400 1409 7 Planer D, Smits PC, Kereiakes DJ, Kedhi E, Fahy M, Xu K, et al. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials. J Am Coll Cardiol Cardiovasc Interv. 2011;4(10):1104-15. Planer D Smits PC Kereiakes DJ Kedhi E Fahy M Xu K Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials J Am Coll Cardiol Cardiovasc Interv 2011 4 10 1104 1115 8 Sarno G, Lagerqvist B, Fröbert O, Nilsson J, Olivecrona G, Omerovic E, et al. Lower risk of stent thrombosis and restenosis with unrestricted use of 'new-generation' drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J. 2012;33(5):606-13. Sarno G Lagerqvist B Fröbert O Nilsson J Olivecrona G Omerovic E Lower risk of stent thrombosis and restenosis with unrestricted use of 'new-generation' drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR) Eur Heart J 2012 33 5 606 613 9 Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med. 2007;356(10):1020-9. Mauri L Hsieh WH Massaro JM Ho KK D'Agostino R Cutlip DE Stent thrombosis in randomized clinical trials of drug-eluting stents N Engl J Med 2007 356 10 1020 1029 10 Valgimigli M, Percoco G, Malagutti P, Campo G, Frrari F, Barbieri D, et al; STRATEGY Investigators. Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial. JAMA. 2005;293(17):2109-17. Valgimigli M Percoco G Malagutti P Campo G Frrari F Barbieri D STRATEGY Investigators Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial JAMA 2005 293 17 2109 2117 11 Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrie D, et al; TYPHOON Investigators. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med. 2006;355(11):1093-104. Spaulding C Henry P Teiger E Beatt K Bramucci E Carrie D TYPHOON Investigators Sirolimus-eluting versus uncoated stents in acute myocardial infarction N Engl J Med 2006 355 11 1093 1104 12 Stone G, Lansky A, Pocock S, Gersh BJ, Dangas G, Wong SC, et al; HORIZONS-AMI Trial Investigators. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med. 2009;360(19):1946-59. Stone G Lansky A Pocock S Gersh BJ Dangas G Wong SC HORIZONS-AMI Trial Investigators Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction N Engl J Med 2009 360 19 1946 1959 13 Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, et al. Meta-analysis of randomized trials on drug-eluting stents vs bare-metal stents in patients with acute myocardial infarction. Eur Heart J. 2007;28(22):2706-13. Kastrati A Dibra A Spaulding C Laarman GJ Menichelli M Valgimigli M Meta-analysis of randomized trials on drug-eluting stents vs bare-metal stents in patients with acute myocardial infarction Eur Heart J 2007 28 22 2706 2713 14. Rasmussen K, Maeng M, Kaltoft A, Thayssen P, Kelbaek H, Tilsted HH, et al; SORT OUT III study group. Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial. Lancet. 2010;375(9720):1090-9. Rasmussen K Maeng M Kaltoft A Thayssen P Kelbaek H Tilsted HH SORT OUT III study group Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial Lancet 2010 375 9720 1090 1099 15 Park DW, Kim YH, Yun SC, Kang SJ, Lee SW, Lee CW, et al. Comparison of zotarolimus-eluting stents with sirolimus- and paclitaxel-eluting stents for coronary revascularization: the ZEST (comparison of the efficacy and safety of zotarolimus-eluting stent with sirolimus-eluting and paclitaxel-eluting stent for coronary lesions) randomized trial. J Am Coll Cardiol. 2010;56(15):1187-95. Park DW Kim YH Yun SC Kang SJ Lee SW Lee CW Comparison of zotarolimus-eluting stents with sirolimus- and paclitaxel-eluting stents for coronary revascularization: the ZEST (comparison of the efficacy and safety of zotarolimus-eluting stent with sirolimus-eluting and paclitaxel-eluting stent for coronary lesions) randomized trial J Am Coll Cardiol 2010 56 15 1187 1195 16 Thim T, Maeng M, Kaltoft A, Jensen LO, Tilsted HH, Hansen PR, et al. Zotarolimus-eluting vs. sirolimus-eluting coronary stents in patients with and without acute coronary syndromes: a SORT OUT III substudy. Eur J Clin Invest. 2012;42(10):1047-54. Thim T Maeng M Kaltoft A Jensen LO Tilsted HH Hansen PR Zotarolimus-eluting vs. sirolimus-eluting coronary stents in patients with and without acute coronary syndromes: a SORT OUT III substudy Eur J Clin Invest 2012 42 10 1047 1054 17 Garg A, Brodie BR, Stuckey TD, Garberich RF, Tobbia P, Hansen C, et al. New generation drug-eluting stents for ST-Elevation myocardial infarction: a new paradigm for safety. Catheter Cardiovasc Interv. 2014;84(6):955-62. Garg A Brodie BR Stuckey TD Garberich RF Tobbia P Hansen C New generation drug-eluting stents for ST-Elevation myocardial infarction: a new paradigm for safety Catheter Cardiovasc Interv 2014 84 6 955 962 18 Lee CW, Park DW, Lee SH, Kim YH, Hong MK, Kim JJ, et al; ZEST-AMI Investigators. Comparison of the efficacy and safety of zotarolimus-, sirolimus-, and paclitaxel-eluting stents in patients with ST-elevation myocardial infarction. Am J Cardiol. 2009;104(10):1370-6. Lee CW Park DW Lee SH Kim YH Hong MK Kim JJ ZEST-AMI Investigators Comparison of the efficacy and safety of zotarolimus-, sirolimus-, and paclitaxel-eluting stents in patients with ST-elevation myocardial infarction Am J Cardiol 2009 104 10 1370 1376 19 Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, et al; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012;33(20):2551-67. Thygesen K Alpert JS Jaffe AS Simoons ML Chaitman BR White HD Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction ESC Committee for Practice Guidelines Third universal definition of myocardial infarction Eur Heart J 2012 33 20 2551 2567 20 Steg PG, James SK, Atar D, Badano LP, Blömstrom-Lundqvist C, Borger MA, et al. Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC). ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012;33(20):2569-619. Steg PG James SK Atar D Badano LP Blömstrom-Lundqvist C Borger MA Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation Eur Heart J 2012 33 20 2569 2619 21 Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, et al; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011;32(23):2999-3054. Hamm CW Bassand JP Agewall S Bax J Boersma E Bueno H ESC Committee for Practice Guidelines ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC) Eur Heart J 2011 32 23 2999 3054 22 Cutlip DE , Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344-51. Cutlip DE Windecker S Mehran R Boam A Cohen DJ van Es GA Academic Research Consortium Clinical end points in coronary stent trials: a case for standardized definitions Circulation 2007 115 17 2344 2351 23 Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123(23):2736-47. Mehran R Rao SV Bhatt DL Gibson CM Caixeta A Eikelboom J Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium Circulation 2011 123 23 2736 2747 24 Wang L, Zang W, Xie D, Ji W, Pan Y, Li Z, et al. Drug-eluting stents for acute coronary syndrome: a meta-analysis of randomized controlled trials. PLoS One. 2013;8(9):e72895. Wang L Zang W Xie D Ji W Pan Y Li Z Drug-eluting stents for acute coronary syndrome: a meta-analysis of randomized controlled trials PLoS One 2013 8 9 e72895 25 Choi CU, Rha SW, Chen KY, Li YJ, Poddar KL, Jin Z, et al. Lack of clinical benefit of improved angiographic results with sirolimus-eluting stents compared with paclitaxel and zotarolimus-eluting stents in patients with acute myocardial infarction undergoing percutaneous coronary intervention. Circ J 2009;73(12):2229-35. Choi CU Rha SW Chen KY Li YJ Poddar KL Jin Z Lack of clinical benefit of improved angiographic results with sirolimus-eluting stents compared with paclitaxel and zotarolimus-eluting stents in patients with acute myocardial infarction undergoing percutaneous coronary intervention Circ J 2009 73 12 2229 2235 26 Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D'Ascenzo F, et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012;379(9824):1393-402. Palmerini T Biondi-Zoccai G Della Riva D Stettler C Sangiorgi D D'Ascenzo F Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis Lancet 2012 379 9824 1393 1402 27 Li Y, Torguson R, Syed AI, Ben-Dor I, Collons SD, Maluenda G, et al. Effect of drug-eluting stents on frequency of repeat revascularization in patients with unstable angina pectoris or non-ST-elevation myocardial infarction. Am J Cardiol . 2009;104(12):1654-9. Li Y Torguson R Syed AI Ben-Dor I Collons SD Maluenda G Effect of drug-eluting stents on frequency of repeat revascularization in patients with unstable angina pectoris or non-ST-elevation myocardial infarction Am J Cardiol 2009 104 12 1654 1659 28 De la Torre H, Alfonso F, Gimeno F, Diarte JA, Lopez-Palop R, Perez de Prado A, et al.; ESTROFA-2 Study Group. Thrombosis of second generation Drug Eluting Stents in real practice. Results from the multicenter Spanish registry ESTROFA-2. JACC Cardiovasc Interv. 2010;3(9):911-9. De la Torre H Alfonso F Gimeno F Diarte JA Lopez-Palop R Perez de Prado A ESTROFA-2 Study Group Thrombosis of second generation Drug Eluting Stents in real practice. Results from the multicenter Spanish registry ESTROFA-2 JACC Cardiovasc Interv 2010 3 9 911 919 29 Otsuka F, Vorpahl M, Nakano M, Foerst J, Newell JB, Sakakura K, et al. Pathology of second-generation everolimus-eluting stents versus first-generation sirolimus- and paclitaxel-eluting stents in humans. Circulation. 2014;129(2):211-23. Otsuka F Vorpahl M Nakano M Foerst J Newell JB Sakakura K Pathology of second-generation everolimus-eluting stents versus first-generation sirolimus- and paclitaxel-eluting stents in humans Circulation 2014 129 2 211 223 30 Nakano M, Yahagi K, Otsuka F, Sakakura K, Finn AV, Kutys R, et al. Causes of early stent thrombosis in patients presenting with acute coronary syndrome: an ex vivo human autopsy study. J Am Coll Cardiol. 2014;63(23):2510-20. Nakano M Yahagi K Otsuka F Sakakura K Finn AV Kutys R Causes of early stent thrombosis in patients presenting with acute coronary syndrome: an ex vivo human autopsy study J Am Coll Cardiol 2014 63 23 2510 2520 31 Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, et al. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007;369(9562):667-78. Daemen J Wenaweser P Tsuchida K Abrecht L Vaina S Morger C Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study Lancet 2007 369 9562 667 678 32 Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, et al; BASKET-LATE Investigators. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 2006;48(12):2584-91. Pfisterer M Brunner-La Rocca HP Buser PT Rickenbacher P Hunziker P Mueller C BASKET-LATE Investigators Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents J Am Coll Cardiol 2006 48 12 2584 2591 33 Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006;48(1):193-202. Joner M Finn AV Farb A Mont EK Kolodgie FD Ladich E Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk J Am Coll Cardiol 2006 48 1 193 202 34 Townsend J, Rideout P, Steinberg DH. Everolimus-eluting stents in interventional cardiology. Vasc Health Risk Manag. 2012;8:393-404. Townsend J Rideout P Steinberg DH Everolimus-eluting stents in interventional cardiology Vasc Health Risk Manag 2012 8 393 404 Stents Farmacológicos de Primeira Versus Segunda Geração na Síndrome Coronariana Aguda (Registro Katowice-Zabrze) Kawecki Damian 1 Morawiec Beata 1 Dola Janusz 1 Wanha Wojciech 2 Smolka Grzegorz 2 Pluta Aleksandra 2 Marcinkiewicz Kamil 2 Ochała Andrzej 2 Nowalany-Kozielska Ewa 1 Wojakowski Wojciech 2 Poland 2nd Department of Cardiology - Zabrze Medical University of Silesia, Katowice - Polônia Poland 3rd Division of Cardiology - Katowice-Ochojec - Medical University of Silesia, Katowice - Polônia Correspondência: Damian Kawecki, 2nd Department of Cardiology, Zabrze. Medical University of Silesia, Katowice. M. Skłodowskiej-Curie Str. 10, Postal Code 41-800, Zabrze – Polônia. E-mail: d.kawecki@interia.pl

Contribuição dos autores

Concepção e desenho da pesquisa: Kawecki D, Ochała A, Wojakowski W. Obtenção de dados: Morawiec B, Dola J, Wanha W, Smołka G, Pluta A, Marcinkiewicz K; Análise e interpretação dos dados: Kawecki D, Morawiec B, Dola J, Wanha W, Smołka G, Pluta A, Marcinkiewicz K, Ochała A; Análise estatística: Kawecki D, Morawiec B, Wanha W, Pluta A, Marcinkiewicz K; Redação do manuscrito: Kawecki D, Morawiec B, Ochała A, Nowalany-Kozielska E, Wojakowski W; Revisão crítica do manuscrito quanto ao conteúdo intelectual importante: Kawecki D, Smołka G, Ochała A, Nowalany-Kozielska E, Wojakowski W.

Potencial conflito de interesse

Declaro não haver conflito de interesses pertinentes.

 Resumo Fundamento:

Os dados sobre o desempenho dos diferentes tipos de stents farmacológicos (SF) no cenário agudo e da vida real são escassos.

 Objetivo:

Comparar a segurança e a eficácia dos SF de primeira e de segunda geração em pacientes com síndrome coronariana aguda (SCA).

 Métodos:

Este registro arrolou pacientes consecutivos com diagnóstico de SCA e tratados com intervenção coronariana percutânea e implantação de SF de primeira ou segunda geração em seguimento de 1 ano. O desfecho primário 'eficácia' foi definido como eventos cardíacos adversos maiores (ECAM), um composto de morte por todas as causas, infarto do miocárdio não fatal, revascularização de vaso-alvo e acidente vascular encefálico. O desfecho primário 'segurança' foi trombose de stent (TS) definitiva em 1 ano.

 Resultados:

Do total de 1.916 pacientes arrolados, 1.328 foram diagnosticados com SCA. Desses, 426 foram tratados com SF de primeira geração e 902, com SF de segunda geração. Não houve diferença significativa na incidência de ECAM entre os dois tipos de SF em 1 ano. A taxa de TS aguda e subaguda foi maior com SF de primeira geração do que com os de segunda geração (1,6% vs. 0,1%, p < 0,001; e 1,2% vs. 0,2%, p = 0,025, respectivamente), mas não houve diferença para TS tardia (0,7% vs. 0,2%, respectivamente, p = 0,18) nem para sangramento gastrointestinal (2,1% vs.1,1%, p = 0,21). Na regressão de Cox, o SF de primeira geração foi preditor independente para TS cumulativa [HR 3,29 (1,30-8,31); p = 0,01].

 Conclusões:

No registro de SCA, a taxa de ECAM em 1 ano foi comparável nos grupos tratados com SF de primeira e de segunda geração. O uso de SF de primeira geração associou-se a maiores taxas de TS aguda e subaguda, sendo um preditor independente para TS cumulativa.

 Palavras-chave: Síndrome Coronariana Aguda Stents Farmacológicos Trombose Intervenção Coronária Percutânea Introdução

Os stents farmacológicos (SF) foram introduzidos com sucesso na prática clínica para intervenções coronarianas percutâneas (ICP) em resposta à alta taxa de re-estenose associada com os stents convencionais (SC).1,2 Análises de estudos randomizados com SF liberadores de paclitaxel e sirolimo mostraram taxas similares de mortalidade e de infarto do miocárdio (IM), mas menos repetição de revascularização em comparação aos SC.3 Plataformas mais antigas de SF, com estrutura relativamente grossa e polímeros duráveis associaram-se, no entanto, a trombose de stent (TS) tardia e muito tardia.4,5

Atualmente há evidência de que plataformas mais novas de stents com estruturas mais finas, polímeros mais biocompatíveis e os fármacos "-limo" fornecem melhor eficácia em termos de menor trombogenicidade, assim como segurança clínica (TS), em estudos pré-clínicos.6,7 Tais stents são considerados SF de segunda geração.

Tanto estudos randomizados quanto grandes registros mostraram consistentemente melhores segurança e eficácia em subgrupos de pacientes, incluindo aqueles com síndrome coronariana aguda (SCA) e doença arterial coronariana (DAC) estável.8 A despeito de sua baixa frequência, a TS, no entanto, permanece a principal preocupação associada à implantação de SF, em especial em pacientes com alto risco de sangramento, baixa adesão à medicação e SCA, devido à alta mortalidade dessa complicação.9

No início, o uso do SF na SCA foi "off-label", mas as diretrizes atuais indicam que o SF deve ser preferido em lugar do SC também na SCA, incluindo o infarto agudo do miocárdio com supradesnível do segmento ST (IAMCSST), com base em ensaios randomizados.10-13 Na maioria dos estudos que compara a primeira e a segunda geração de SF, os pacientes com SCA constituem apenas uma fração das populações estudadas.8,14-16 Recentemente, alguns estudos comparando as duas gerações de SF em quadros agudos foram publicados.17,18 No entanto, tais dados são escassos e aguardam avaliação adicional.

Este estudo, portanto, visou a comparar a segurança e a eficácia da primeira vs. a segunda geração de SF em uma população com SCA em seguimento de 1 ano.

 Métodos Delineamento do estudo

O registro Katowice-Zabrze envolveu pacientes consecutivos tratados com ICP e implantação de SF. O arrolamento foi conduzido em dois centros terciários de cardiologia de grande volume, num total de 5.500 ICP/ano (Upper Silesian Medical Center, em Katowice, e 2º Departamento de Cardiologia, em Zabrze), de 1 de janeiro de 2009 a 31 de dezembro de 2010. Este registro ainda em andamento teve por objetivo comparar a primeira e a segunda geração de SF em uma população irrestrita de pacientes. Para a população do registro, o critério de inclusão foi o diagnóstico de SCA tratada com ICP e implantação de SF de primeira ou segunda geração. A SCA foi definida de acordo com as diretrizes atuais como angina instável (AI), infarto agudo do miocárdio sem supradesnível do segmento ST (IAMSSST) ou IAMCSST.19-21 Na angiografia coronariana, registraram-se as características angiográficas básicas: localização da lesão, gravidade da estenose, tipo de lesão segundo AHA/ACC, trombo, calcificações. Avaliou-se o SYNTAX escore de todos os pacientes, exceto após cirurgia de revascularização do miocárdio (CRM). Os stents foram escolhidos pelo operador entre SF de primeira-geração com polímero durável ou SF de segunda geração. Se mais de um stent foi implantado em um paciente, o SF implantado na lesão culpada ou na estenose mais grave foi considerado o procedimento-índice. A terapia antiagregante plaquetária dupla (ácido acetilsalicílico e inibidor de receptor de ADP do subtipo P2Y12) foi prescrita por até 12 meses após o procedimento em cada paciente. Dados basais clínicos, angiográficos e procedurais foram retrospectivamente coletados dos prontuários médicos.

 Implantação de stent coronariano

Os stents para implantação foram escolhidos entre SF de primeira e de segunda geração, a saber: SF de primeira geração com base de polímero durável [SF liberador de paclitaxel (SFP) (Taxus, Boston Scientific Corporation, Maple Grove, MN, EUA) ou SF liberador de sirolimo (SFS) (Cypher, Cordis, EUA)]; SF de segunda geração [SF liberador de everolimo (SFE) (Promus, Boston Scientific Corporation; Xience, Xience Prime, Abbott Vascular, Santa Clara, CA, EUA), SF liberador de zotarolimo (SFZ) (Endeavor, Resolute, Medtronic, Minneapolis, MN, EUA) e SF liberador de biolimo (SFB) (Biolimus A9, Biosensors International, Suíça)].

 Regime antiagregante plaquetário e antitrombótico

Todos os pacientes foram tratados de acordo com as diretrizes para SCA, tendo recebido uma dose de ataque de ácido acetilsalicílico e inibidor de receptor de ADP antes, durante ou logo depois da ICP, e um bolus de heparina não fracionada antes da ICP. O inibidor do receptor glicoproteína IIb/IIIa foi administrado de acordo com a decisão do operador. Após o procedimento, os pacientes receberam prescrição de ácido acetilsalicílico, 75 mg ao dia, por toda a vida, e clopidogrel, 75 mg ao dia, por até 12 meses, modificado nos pacientes que necessitaram de anticoagulação por outros motivos.

 Seguimento

Os pacientes foram acompanhados por 1 ano. Toda a informação foi obtida dos prontuários médicos nos centros de arrolamento. Quando a informação não estava disponível, tentou-se contato telefônico. Quando não houve sucesso, a informação sobre os desfechos clínicos foi obtida no Sistema Nacional de Atenção à Saúde.

O desfecho primário 'eficácia' foi um composto de eventos cardíacos adversos maiores (ECAM), que incluíram morte por todas as causas, IM não fatal, revascularização do vaso-alvo (RVA) e acidente vascular encefálico.

Os desfechos secundários foram componentes individuais do desfecho primário: morte por todas as causas, IM, RVA, acidente vascular encefálico e CRM. A segurança do SF foi definida como TS definitiva (aguda, subaguda, tardia e cumulativa) e taxa de sangramento gastrointestinal em 1 ano. Para o IM, adotou-se a definição universal.19 A RVA e a TS definitiva (aguda, subaguda e tardia) foram definidas de acordo com as definições dos desfechos para ensaios clínicos.22 O sangramento gastrointestinal foi considerado desfecho se atendesse aos critérios de sangramento do tipo 3 ou tipo 5, de acordo com as definições propostas.23

Todos os pacientes assinaram o termo de consentimento livre e esclarecido. O protocolo do estudo estava em conformidade com a Declaração de Helsinki de 1975, tendo sido aprovado pelo Comitê de Ética em Pesquisa da Medical University of Silesia (No. KNW/0022/KB/59/11).

 Análise estatística

A normalidade da distribuição das variáveis foi checada com o teste de Shapiro-Wilks. As variáveis contínuas foram apresentadas como média ± desvio padrão ou mediana (percentis 25 e 75), sendo comparadas com o teste t de Student ou teste de Mann-Whitney. As variáveis categóricas foram apresentadas como porcentagens, sendo comparadas usando-se o teste do qui-quadrado. As curvas de sobrevida de Kaplan-Meier foram construídas para descrever a incidência dos desfechos ao longo do tempo. A influência nos desfechos dos parâmetros significativamente diferentes entre os grupos foi avaliada com análise univariada de Cox. Usou-se o modelo de regressão multivariada de Cox para identificar o fator de risco para os desfechos 'segurança' e 'eficácia', tendo sido incluídas todas as variáveis estatisticamente significativas na análise univariada. Todos os testes foram bicaudais, adotando-se como significativo o valor de p < 0,05. A análise foi realizada com os programas Statistica, versão 10PL (StatSoft Inc., Tulsa, OK, EUA), e GraphPad Prism, versão 6.00 (GraphPad, La Jolla, California, EUA).

 Resultados

Um total de 8.284 ICP foi realizado durante o período analisado. Foram excluídos do estudo, 6.368 pacientes (6.177 que receberam SC e 191 que foram submetidos a angioplastia com balão). Dos 1.916 pacientes restantes submetidos à ICP com implantação de SF, 588 tinham DAC estável, sendo excluídos da análise. Os 1.328 pacientes restantes receberam o diagnóstico de SCA (incluindo 131 IAMCSST, 285 IAMSSST e 912 AI) e participaram deste estudo. Desses 1.328 pacientes, 426 foram tratados com SF de primeira geração (391 SFP, 35 SFS) e 902 com SF de segunda geração (90 SFB, 483 SFE, 329 SFZ). A Tabela 1 apresenta a distribuição do diagnóstico final nos dois grupos.

Características clínicas
Características SF de primeira geração (n = 426) SF de segunda geração (n = 902) Valor de p
Sexo masculino 255 (60) 590 (65) 0,05
Idade (anos) 64 ± 9,4 63,2 ± 10,4 0,17
IMC (kg/m2) 29,3 ± 4,9 28,8 ± 4,7 0,26
Obesidade 103 (24) 198 (22) 0,37
Insuficiência renal 75 (18) 171 (19) 0,56
Fração de ejeção (%) 50 (42;55) 54 (45;60) 0,03
Diabetes mellitus 171 (40) 331 (37) 0,23
Hipertensão 360 (85) 790 (88) 0,12
Dislipidemia 278 (65) 575 (64) 0,59
Fumantes 99 (23) 212 (24) 0,92
História familiar de DAC 133 (31) 317 (35) 0,16
IAM prévio 179 (42) 439 (49) 0,02
ICP prévia 220 (52) 478 (53) 0,65
CRM prévia 90 (21) 225 (25) 0,13
Aterosclerose carotídea 19 (4) 57 (6) 0,17
DAP 51 (12) 105 (12) 0,86
Diagnóstico inicial
Angina instável 265 (62) 647 (71) < 0,001
IAMSSST 109 (26) 176 (20) 0,01
IAMCSST 52 (12) 79 (9) 0,05

Dados apresentados como n (%) ou média ± DP. SF: stent farmacológico; IMC: índice de massa corporal; CAD: doença arterial coronariana; IAM: infarto agudo do miocárdio; ICP: intervenção coronariana percutânea; CRM: cirurgia de revascularização do miocárdio; DAP: doença arterial periférica; IAMSSST: infarto agudo do miocárdio sem supradesnível do segmento ST; IAMCSST: infarto agudo do miocárdio com supradesnível do segmento ST.

Os dois grupos apresentavam perfis basais similares (Tabela 1) e taxas comparáveis de fatores de risco cardiovascular. Os pacientes que receberam SF de segunda geração apresentaram maior incidência de infarto agudo do miocárdio prévio do que aqueles que receberam SF de primeira geração (49% vs. 42%, p = 0,02). A história de intervenções coronarianas não diferiu significativamente entre os grupos.

A Tabela 2 apresenta as características angiográficas e procedurais. Não houve diferença quanto ao vaso tratado entre os grupos. Observou-se SYNTAX escore mais alto nos pacientes com SF de primeira geração do que nos de segunda geração (mediana, 17 vs. 13 pontos, p < 0,001). Trombos e calcificações foram mais comuns nos pacientes com SF de primeira geração (p < 0,001 e p < 0,001, respectivamente). A Figura 1 apresenta a distribuição temporal da implantação dos dois tipos de SF durante o período estudado. Os SF de primeira geração foram implantados mais frequentemente após pré-dilatação e com pressão de insuflação média mais baixa do que os de segunda geração (p = 0,002 e p < 0,001, respectivamente). Os procedimentos não diferiram quanto ao comprimento e ao diâmetro do stent, nem quanto ao número total de stents por lesão. O desfecho angiográfico do procedimento foi igual, sendo fluxo TIMI 3 alcançado em 98% dos casos nos dois grupos (p = 0,48). Quanto ao tratamento antitrombótico e antiagregante plaquetário, inibidores do receptor glicoproteína IIb/IIIa foram administrados em 7% e 6% dos casos de SF de primeira e de segunda geração, respectivamente (p = 0,62). Ácido acetilsalicílico foi prescrito para 99% e 98% dos pacientes dos grupos com SF de primeira e de segunda geração, respectivamente (p = 0,23). Os dois grupos receberam anticoagulação oral com igual frequência (6%; p = 0,8). Em 3 pacientes do grupo de SF de primeira geração (0,7%) e 1 paciente do grupo de SF de segunda geração (0,1%), o ácido acetilsalicílico foi descontinuado após 3-6 meses (p = 0,19).

Características angiográficas e procedurais.
Características SF de primeira geração (n = 426) SF de segunda geração (n = 902) Valor de p
Vaso culpado
TC 40 (9) 59 (7) 0,07
DAE 216 (51) 442 (49) 0,56
Cx 69 (16) 158 (18) 0,55
CD 78 (18) 186 (21) 0,32
ES 21 (5) 49 (5) 0,7
EA 2 (0,5) 8 (1) 0,41
SYNTAX escore 17 (10;28) 13 (7;22) < 0,001
Trombo 30 (7) 26 (3) 0,001
Lesão ostial 74 (18) 128 (15) 0,25
Re-estenose 72 (17) 144 (16) 0,67
Calcificações 56 (13) 36 (4) < 0,001
Gravidade da estenose (%) 86,8 87,4 0,78
Número de SF por lesão 1 (1;1) 1 (1;1) 0,15
Comprimento do SF por lesão (mm) 22 (15;29) 22,5 (15;28) 0,57
Diâmetro do stent (mm) 3,03 ± 0,48 3,07 ± 0,47 0,55
Pré-dilatação 222 (53) 368 (44) 0,002
Pressão máxima de insuflação (atm) 16 ± 4 17 ± 4 < 0,001
Fluxo TIMI 3 419 (98) 881 (98) 0,48
Inibidores GPIIb/IIIa 28 (7) 53 (6) 0,62

Dados apresentados como n (%) ou média ± DP.SF: stent farmacológico; TC: tronco de coronária esquerda; DAE: artéria coronária descendente anterior esquerda; Cx: artéria coronária circunflexa; CD: artéria coronária direita; ES: enxerto de safena; EA: enxerto arterial; TIMI: thrombosis in myocardial infarction

Distribuição temporal do número de SF de primeira e de segunda geração implantados durante o período estudado. DES: drug-eluting stent.

Desfechos

Não houve diferença significativa na incidência dos desfechos primário e secundário 'eficácia' entre os SF de primeira e segunda geração em 1 ano (Tabela 3). A Figura 2 apresenta as curvas de Kaplan-Meier para incidência de ECAM, sem diferença significativa entre os grupos. No modelo de regressão univariada de Cox, os preditores de ECAM foram fração de ejeção ventricular esquerda, história de infarto agudo do miocárdio, SYNTAX escore e pré-dilatação (Tabela 4). Após ajuste na análise multivariada, apenas a história de infarto agudo do miocárdio foi um preditor estatisticamente significativo de ECAM (HR 1,39; IC: 1,04-1,84; p = 0,03) (Tabela 5).

Desfechos clínicos em 1 ano.
Características Primeira geração SF (n = 426) Segunda geração SF (n = 902) Valor de p
TS
TS aguda 7 (1,6) 1 (0,1) < 0,001
TS subaguda 5 (1,2) 2 (0,2) 0,025
TS tardia 3 (0,7) 2 (0,2) 0,18
TS cumulativa 15 (3,5) 5 (0,6) < 0,001
Desfecho primário
ECAM 80 (19) 135 (15) 0,078
Desfecho secundário
Morte 19 (4,5) 39 (4,3) 0,91
IAM 31 (7,2) 43 (4,8) 0,06
RVA 51 (12) 90 (10) 0,27
Acidente vascular encefálico 6 (1,4) 5 (0,6) 0,11
CRM 12 (2,8) 12 (1,3) 0,06
Sangramento gastrointestinal 9 (2,1) 10 (1,1) 0,15

Dados apresentados como n (%). SF: stent farmacológico; TS: trombose de stent; ECAM: eventos cardíacos adversos maiores; IAM: infarto agudo do miocárdio; RVA: revascularização de vaso-alvo; CRM: cirurgia de revascularização do miocárdio.

 Modelo univariado de riscos proporcionais de Cox para incidência de eventos cardíacos adversos maiores (ECAM) e de trombose de <italic>stent</italic> (TS)
Características Valor de p HR HR IC Valor de p HR HR IC
ECAM TS cumulativa
SF de primeira geração 0,07 1,29 0,98-1,7 < 0,001 4,61 1,88-11,31
Sexo masculino 0,38 1,13 0,86-1,5 0,36 1,53 0,6-3,91
IAM prévio 0,005 1,46 1,12-1,94 0,34 0,66 0,27-1,56
FEVE 0,04 0,99 0,98-0,999 0,04 0,97 0,94-0,998
SYNTAX escore 0,02 1,02 1,0-1,03 < 0,001 1,06 1,03-1,09
Trombo 0,99 1,0 0,53-1,89 < 0,001 6,99 2,57-18,97
Calcificações 0,79 1,08 0,61-1,94 0,22 2,13 0,63-7,24
Pré-dilatação 0,009 1,44 1,09-1,91 0,03 2,83 1,1-7,28
Pressão de insuflação máxima 0,52 0,98 0,94-1,03 0,02 0,83 0,72-0,97

SF: stent farmacológico; IAM: infarto agudo do miocárdio; FEVE: fração de ejeção ventricular esquerda; IC: intervalo de confiança.

Incidência de ECAM em 1 ano. ECAM: eventos cardíacos adversos maiores; SCA: síndrome coronariana aguda; SF: stents farmacológicos.

Modelo multivariado de riscos proporcionais de Cox para incidência de eventos cardíacos adversos maiores (ECAM)
Características Valor de p HR HR IC
ECAM
IAM prévio 0.03 1.38 1.04-1.84
FEVE 0.65 0.98 0.98-1.01
SYNTAX escore 0.38 1.01 0.99-1.02
Pré-dilatação 0.05 1.34 1.0-1.79

SF: stent farmacológico; IAM: infarto agudo do miocárdio; FEVE: fração de ejeção ventricular esquerda; IC: intervalo de confiança.

Quanto ao perfil de segurança, a taxa de TS aguda e subaguda foi significativamente mais alta nos SF de primeira do que naqueles de segunda geração (1,6% vs. 0,1%, p < 0,001 e 1,2% vs. 0,2%, p = 0,025, respectivamente) (Figura 3). Não houve diferença significativa entre os SF de primeira e de segunda geração quanto à ocorrência de TS tardia (0,7% vs. 0,2%, respectivamente, p = 0,18) e nem quanto ao sangramento gastrointestinal (2,1% vs. 1,1%, respectivamente, p = 0,21). O modelo de regressão de Cox para a incidência de TS cumulativa revelou que, entre outros parâmetros, o SF de primeira geração foi um preditor independente na análise univariada (HR 4,61; IC: 1,88-11,31; p < 0,001) (Tabela 4).

Taxas de trombose de stent (TS). TS: trombose de stent; SF: stents farmacológicos.

Discussão

O registro Katowice-Zabrze mostra que, em pacientes com SCA tratados com ICP, o uso de SF de segunda geração pode estar associado com melhor perfil de segurança e taxa mais baixa de TS aguda e subaguda em 1 ano. Entretanto, o SF de segunda geração não melhorou a taxa global de ECAM em comparação ao SF de primeira geração.

Observações similares para a população com SCA foram publicadas,18,24 sugerindo que, para o tratamento de IAMCSST, todos os SF (primeira e segunda geração) mostram resultados semelhantes, a despeito das taxas mais elevadas de perda tardia de lúmen, re-estenose e trombose dos SF de primeira geração. Parece que a ICP na SCA tem eficiência similar, a despeito do tipo do fármaco de revestimento do stent.

É importante notar que as taxas de ECAM na nossa população foram mais altas do que as relatadas em diferentes estudos.17,25 Isso pode ser explicado pelas diferenças no perfil da população com mais ou menos critérios de restrição no arrolamento (exclusão da implantação de SF devido a TS ou pacientes em choque cardiogênico, com insuficiência renal ou com desfecho subótimo do procedimento-índice). Uma taxa mais baixa de desfecho global para pacientes com SCA e menor incidência de ECAM para SF de primeira geração do que a do nosso estudo foi relatada em uma análise que agrupou 4 ensaios randomizados.7 A razão para isso poderia ser o perfil diferente da população com mais fatores de risco (diabetes mellitus, hipertensão arterial, infarto agudo do miocárdio prévio e ICP prévia) e lesões mais complexas (artéria coronária descendente anterior esquerda e tronco de coronária esquerda como procedimento-índice, lesão mais extensa, maior diâmetro da estenose) do que na nossa coorte.

Finalmente, as altas taxas dos desfechos no nosso estudo poderiam ser explicadas comparando-o com um estudo com critérios de inclusão mais consistentes, o SORT OUT-III.16 O SORT OUT foi um estudo randomizado com uma grande parte de pacientes não randomizados, que, portanto, não foram analisados. Um melhor perfil de risco do que o apresentado aqui implicou em baixas taxas de desfecho na população estudada. Nosso estudo é uma análise, em uma população com SCA, de uso irrestrito e independente de SF; seus desfechos, portanto, poderiam refletir a prática clínica real e ser diretamente aplicados nos cuidados aos pacientes.

O registro sueco SCAAR, com mais de 94.000 pacientes, mostrou que os SF de segunda geração apresentam 62% menos risco de TS do que os SC, e 43% menos do que os SF de primeira geração, achados consistentes com os nossos. Na grande população do SCAAR, houve uma redução de mortalidade com o uso de SF de segunda geração.8 As observações foram confirmadas pela meta-análise de Palmerini et al., mostrando, em uma análise que agrupou 49 estudos clínicos randomizados com 50.844 pacientes, uma consistente redução de TS com SF da nova geração em comparação com os SF de primeira geração e os SC.26

No que concerne à segurança do SF, a TS é a forma mais grave e frequentemente fatal de comprometimento do vaso-alvo. No entanto, a porcentagem de RVA de origem trombótica aqui relatada é baixa. Os resultados apresentados confirmam a ocorrência significativamente maior de complicação tromboembólica no seguimento de curto prazo após a implantação de SF de primeira geração. Tais fatos não surpreendem, considerando-se a maioria dos dados já publicada.8,27,28 Taxas mais altas de TS aguda e subaguda foram observadas a despeito da inexistência de diferença nas características angiográficas pós-procedurais e na administração de terapia antiagregante plaquetária dupla padronizada intra-hospitalar. As maiores taxas de TS com os SF de primeira do que com os de segunda geração poderiam ser explicadas pela significativamente maior carga de DAC nesse grupo, como indicado pelo SYNTAX escore, apesar de os pacientes nos dois grupos terem sido classificados como de baixo risco (mediana do escore < 22).

É importante notar que apenas as taxas de TS aguda e subaguda diferiram significativamente entre os SF de primeira e de segunda geração, sendo a taxa de TS cumulativa influenciada pelos eventos de TS precoces. Tais diferenças podem ser atribuídas aos diferentes designs dos stents, em especial o comprometimento da endotelização da estrutura nos SF de primeira geração relacionado à maior espessura da estrutura e ao menor revestimento com polímero biocompatível (derivado de poliolefina no Taxus e copolímero PEVA+PBMA no Cypher), causando resposta inflamatória em torno da estrutura, defeito estrutural no polímero após liberação do stent, e ainda ao paclitaxel, que pode retardar a recuperação endotelial. A nova geração do SFE mostrou-se menos suscetível a resposta inflamatória e trombose.29 A otimização do procedimento com adequação do tamanho e da liberação do stent é igualmente importante, em especial em pacientes com SCA e alta carga trombótica.30

Tais diferenças não se refletiram no seguimento clínico, que mostrou taxas similares de ECAM nos dois grupos. De acordo com publicações na área,31,32 a maior preocupação da implantação de SF é a TS muito tardia. A falta de acompanhamento angiográfico rotineiro e a restrição do período de observação a 1 ano no presente estudo limitaram as possibilidades para uma compreensão mais profunda do significado clínico das duas principais complicações no stent, TS e re-estenose, e suas interações ao longo do tempo. Sabe-se que a TS no SC deve-se inteiramente à re-estenose.33 A origem trombótica da RVA no SF deriva de vários fatores,34 tal como as características da lesão específicas para SCA.

Limitações

Este foi um estudo retrospectivo e observacional, tendo, portanto, limitações óbvias. A falta de alocação aleatória para a implantação de SF de primeira ou de segunda geração resultou em uma desproporção no tipo de SCA em cada grupo, e, a despeito das taxas iguais de IAMCSST, considerado o mais forte fator para TS, deve ter afetado os resultados. O desfecho 'segurança' foi definido como TS definitiva. Isso pode ter subestimado a real incidência de TS no seguimento. Entretanto, de acordo com Cutlip et al.,22 a qualidade dos dados, que foram obtidos através do seguimento deste registro retrospectivo, tinha que ser considerada. Quando ocorreu infarto agudo do miocárdio no seguimento, não foi possível checar a existência de isquemia aguda documentada no território do stent implantado. Nos casos em que a angiografia coronariana era acessível, aquela foi verificada e, quando aplicável, classificada como TS definitiva. Por fim, uma das condições mais favoráveis ao desenvolvimento de TS é a incompleta aposição da estrutura. Como a técnica de imagem intracoronariana não foi usada rotineiramente após a implantação do stent, refletindo a natureza retrospectiva do estudo, não há precisa indicação das causas de insucesso relacionadas ao operador ou ao stent.

 Conclusões

Neste registro de pacientes com SCA, a taxa de ECAM em 12 meses foi comparável nos grupos tratados com SF de primeira e de segunda geração. O uso de SF de primeira geração, como preditor independente de TS cumulativa, associou-se com taxas mais altas de TS aguda e subaguda, mas taxas similares de TS tardia e de sangramento gastrointestinal, quando comparado ao uso de SF de segunda geração.

Errata

Considerar correto e utilizar para citação o nome do autor Wojciech Wanha para o artigo “Stents Farmacológicos de Primeira Versus Segunda Geração na Síndrome Coronariana Aguda (Registro Katowice- Zabrze)”.

Fontes de financiamento

O presente estudo não teve fontes de financiamento externas.

Vinculação acadêmica

Não há vinculação deste estudo a programas de pós-graduação.