Randomized controlled trials as topic

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Original Article

Hydroxychloroquine for Non-Hospitalized COVID-19 Patients: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Rosa Lucchetta et al. Jessica Y. Matuoka Haliton Alves de Oliveira Junior Gustavo Oliveira … Alexandre Biasi Cavalcanti Luciano Azevedo Otavio Berwanger Renato Delascio Lopes Regis Goulart Rosa Viviane Cordeiro Veiga Álvaro Avezum

Abstract

Background:

Previous systematic reviews have identified no benefit of hydroxychloroquine and chloroquine in non-hospitalized COVID-19 patients. After publication of these reviews, the results of COPE, the largest randomized trial conducted to date, became available.

Objectives:

To conduct a systematic review and meta-analyses of randomized clinical trials (RCTs) to synthesize the evidence on the efficacy and safety of hydroxychloroquine and chloroquine for non-hospitalized COVID-19 patients compared to placebo or standard of care.

Methods:

Searches were conducted in PubMed, Embase, The Cochrane Library, and ClinicalTrials.gov complemented by manual search. Pairwise meta-analyses, risk of bias, and evidence certainty assessments were conducted, including optimal information size analysis (OIS). A level of significance of 0.05 was adopted in the meta-analysis. PROSPERO: CRD42021265427.

Results:

Eight RCTs with 3,219 participants were included. COVID-19 hospitalization and any adverse events rates were not significantly different between hydroxychloroquine (5.6% and 35.1%) and control (7.4% and 20.4%) (risk ratio, RR, 0.77, 95% confidence interval, CI, 0.57-1.04, I²: 0%; RR 1.78, 95%-CI 0.90; 3.52, I²: 93%, respectively). The OIS (7,880) was not reached for COVID-19 hospitalization, independently of the simulation for anticipated event rate and RR reduction estimate.

Conclusion:

Evidence of very low certainty showed lack of benefit with hydroxychloroquine in preventing COVID-19 hospitalizations. Despite being the systematic review with the largest number of participants included, the OIS, considering pre-vaccination response to infection, has not yet been reached.

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IJCS

Original Article

Drug-eluting stents Versus Coronary Artery Bypass Grafting in Multivessel Disease and Left Main Obstruction: Meta-analysis of Randomized Clinical Trials

Pedro José Negreiros de Andrade et al. Hermano Alexandre Lima Rocha João Luiz de Alencar Araripe Falcão Antonio Thomaz de Andrade Breno de Alencar Araripe Falcão

Abstract

Background:

The choice between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) remains controversial.

Objective:

To conduct a meta-analysis of randomized studies comparing drug-eluting stents (DES) and CABG in multivessel disease or obstruction of the left main coronary artery.

Method:

Electronic databases were searched systematically to evaluate results of randomized trials comparing PCI with DES versus CABG in multivessel disease and obstruction of the left main coronary artery. Ten studies were identified.

Results:

In the aggregated results (n = 9268), mortality at 30 days and incidence of stroke favored PCI (0.8% versus 1.5%, p = 0.005; 0.4% versus 1.5%, p < 0.0001, respectively). There was no difference in mortality at 1 year (3.4% versus 3.5%, p = 0.50). The late mortality favored CABG (10.1% versus 8.5%, p = 0.01). In patients with diabetes derived from four studies (n = 3830), late mortality favored CABG (12.5% versus 9.7%, p < 0.0001). In six studies of left main coronary artery obstruction (n = 4700), the incidence of stroke favored PCI (0.3% versus 1.5%, p < 0.001) and there was no difference in mortality at 30 days (0.8% versus 1.3%, p = 0.15), mortality at 1 year, or late mortality (8.1% versus 8.1%). The subgroups with high SYNTAX score and diabetes were those influencing most strongly and adversely the PCI results.

Conclusion:

When compared with PCI, CABG was superior in regards to late mortality and inferior in regards to 30-day mortality and incidence of stroke. Diabetes and SYNTAX score strongly impacted the results.

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ABC

Artigo Original

Angioplasty guided by intravascular ultrasound: meta-analysis of randomized clinical trials

José Albuquerque de Figueiredo Neto et al. Iara Antonia Lustosa Nogueira Mabel Fernandes Figueiro Anna Maria Buehler Otavio Berwanger

BACKGROUND: The impact of intravascular ultrasound (IVUS) use on stenting has shown inconclusive results. OBJECTIVE: Systematic review and meta-analysis of the impact of IVUS on stenting regarding the clinical and angiographic evolution. METHODS: A search was performed in Medline/Pubmed, CENTRAL, Embase, Lilacs, Scopus and Web of Science databases. It included randomized clinical trials (RCTs) that evaluated the implantation of stents guided by IVUS, compared with those using angiography alone (ANGIO). The minimum follow-up duration was six months and the following outcomes were assessed: thrombosis, mortality, myocardial infarction, percutaneous and surgical revascularization, major adverse cardiovascular events (MACE) and restenosis. The binary outcomes were presented considering the number of events in each group; the estimates were generated by a random effects model, considering Mantel-Haenszel statistics as weighting agent and magnitude of effect for the relative risk (RR) with its respective 95% confidence interval (95%CI). Higgins I² test was used to quantify the consistency between the results of each study. RESULTS: A total of 2,689 articles were evaluated, including 8 RCTs. There was a 27% reduction in angiographic restenosis (RR: 0.73, 95% CI: 0.54-0.97, I² = 51%) and statistically significant reduction in the rates of percutaneous revascularization and overall (RR: 0.88; 95% CI: 0.51 to 1.53, I² = 61%, RR: 0.73, 95% CI: 0.54 to 0.99, I² = 55%), with no statistical difference in surgical revascularization (RR: 0.95, 95% CI: 0.52-1.74, I² = 0%) in favor of IVUS vs. ANGIO. There were no differences regarding the other outcomes in the comparison between the two strategies. CONCLUSION: Angioplasty with stenting guided by IVUS decreases the rates of restenosis and revascularization, with no impact on MACE, acute myocardial infarction, mortality or thrombosis outcomes.

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ABC

Special Article

Evidence-based therapy prescription in high-cardiovascular risk patients: the REACT study

Otávio Berwanger et al. Luiz Alberto Piva e Mattos José Fernando Vilela Martin Renato Delascio Lopes … Estevão Lanna Figueiredo Daniel Magnoni Dalton Bertolim Precoma Carlos Alberto Machado Jorge Ilha Guimarães Jadelson Pinheiro de Andrade

BACKGROUND: Data on outpatient care provided to patients at high cardiovascular risk in Brazil are insufficient. OBJECTIVE: To describe the profile and document the clinical practice of outpatient care in patients at high cardiovascular risk in Brazil, regarding the prescription of evidence-based therapies. METHODS: Prospective registry that documented the ambulatory clinical practice in individuals at high cardiovascular risk, which was defined as the presence of the following factors: coronary artery disease, cerebrovascular and peripheral vascular diseases, diabetes, or those with at least three of the following factors: hypertension, smoking, dyslipidemia, age > 70 years, family history of coronary artery disease, chronic kidney disease or asymptomatic carotid artery disease. Basal characteristics were assessed and the rate of prescription of pharmacological and non-pharmacological interventions was analyzed. RESULTS: A total of 2364 consecutive patients were included, of which 52.2% were males, with a mean age of 66.0 years (± 10.1). Of these, 78.3% used antiplatelet agents, 77.0% used statins and of patients with a history of myocardial infarction, 58.0% received beta-blockers. Concomitant use of these three classes of drugs was 34%; 50.9% of hypertensive, 67% of diabetic and 25.7% of dyslipidemic patients did not achieve the goals recommended by guidelines. The main predictors of prescription therapies with proven benefit were centers with a cardiologist and history of coronary artery disease. CONCLUSION: This national and representative registry identified important gaps in the incorporation of therapies with proven benefit, offering a realistic outlook of patients at high cardiovascular risk.

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Artigo Original

Informed consent as viewed by patients participating in cardiology drug trial

Silmara Meneguin et al. Elma L. C. P. Zoboli Raquel Z. L. Domingues Moacyr R. Nobre Luiz A. M. César

BACKGROUND: In clinical tests, the Informed Consent is critical to preserve the ethics, but due to its high complexity level, it cannot be fully understood. This study assesses the Informed Consent as viewed by patients. OBJECTIVE: We addressed the issue of what do patients understand about the studies based on the IC. METHODS: We invited participants of outpatient clinical drug trials phase II, III and IV to answer a questionnaire with 29 questions, such as: why have you accepted to participate? Did you read the Informed Consent before signing it? By signing it, were you sure you have fully understood it? Eighty individuals (20 women and 60 men) showed up, from 106 patients. The variables of each question were considered as often as they appeared. The comparison of the averages among the groups was made by t tests of Student or Wilcoxon; and for associations, Chi-square or Likelihood Ratio, or Fisher’s exact test. RESULTS: Ages averaged 58.7 ± 9.3 years. Concerning their reasons to taking part in the survey, 66.2% pointed out their own benefit; 42.5%, for science’s sake; 25.0% claimed they were doing so at their doctor’s request; 50% did not understand the Informed Consent properly; and 32.9% did not read it, but signed it. Among those who were administered placebo after randomization (n = 47), 66.7% did not understand the meaning of the informed consent. A strong correlation between failure to understand the meaning of placebo with literacy level (p = 0,02) was verified, which is an evidence that the smaller is the literacy level, the smaller is the understanding level. CONCLUSION: The Informed Consent is poorly understood by patients and for some of them, trusting a doctor affected their decision in taking part in the clinical trial with drugs. Their literacy level also influenced their understanding of the term “placebo”.

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Hydroxychloroquine for Non-Hospitalized COVID-19 Patients: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Abstract

Background:

Objectives:

Methods:

Results:

Conclusion:

Drug-eluting stents Versus Coronary Artery Bypass Grafting in Multivessel Disease and Left Main Obstruction: Meta-analysis of Randomized Clinical Trials

Abstract

Background:

Objective:

Method:

Results:

Conclusion:

Angioplasty guided by intravascular ultrasound: meta-analysis of randomized clinical trials

Evidence-based therapy prescription in high-cardiovascular risk patients: the REACT study

Informed consent as viewed by patients participating in cardiology drug trial

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