Evaluation Studies – ABC CARDIOL

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Downstream Change of the Primary Endpoint in the ISCHEMIA Trial: the Elephant in the Room

Luis Cláudio Lemos Correia et al. Anis Rassi Junior

Modification of the Trial Protocol

Recently we learned that the protocol of the ISCHEMIA trial published on ClinicalTrials.gov had a major modification in January 2018, only 11 months before the estimated completion of this 7-year trial. The primary endpoint was changed from the composite of cardiovascular death or nonfatal MI (2012 version) to a 5-component endpoint that also includes resuscitated cardiac arrest, hospitalization for unstable angina and hospitalization for heart failure (January 2018 version).^,

Then, in February 2018, the full version of the 2012 ISCHEMIA protocol was published on ClinicalTrials.gov. This version of the protocol stated that if the incidence of the primary endpoint pooled across randomized groups is lower than expected, an independent advisory panel can decide to extend the follow-up period or change the primary endpoint.

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Quality of life in hypertensive patients and concurrent validity of Minichal-Brazil

Ana Carolina Melchiors et al. Cassyano Januário Correr Roberto Pontarolo Felipe de Oliveira de Souza Santos Rodrigo Augusto de Paula e Souza

BACKGROUND: Health-Related Quality of Life Questionnaires (HRQOL) are humanistic outcome measure instruments both in clinical and in pharmacoeconomic studies. However, they should have their psychometric parameters evaluated so as to reflect the individual subjective assessment of quality of life. OBJECTIVES: To describe the quality of life profile of hypertensive patients and to assess the concurrent validity of the Minichal-Brazil instrument by comparing it to the generic World Health Organization’s (WHO) assessment instrument known as WHOQOL-Bref. METHODS: A total of 191 adult patients (72.8% females) with hypertension were interviewed. Approximately one third of these patients had their hypertension controlled. The mean HRQOL as measured by the total Minichal score was 69.7 (SD = 19.2; 95%CI from 66.9 to 72.4); the “mental status” domain and “somatic manifestations” domain scores were 69.1 (95%CI from 66.1 to 72.2), and 69.9 (95%CI from 66.5 to 73.2), respectively. The means for the WHOQOL-Bref instrument were: in the “physical” domain = 61.5 (95%CI from 59.0 to 64.1); in the “psychological” domain = 65.7 (95%CI from 63.2 to 68.2); in the “social” domain = 72.3 (95%CI from 70.0 to 74.5); and in the “environment” domain = 59.7 (95%CI from 57.7 to 61.7). RESULTS: Minichal significantly correlated (p<0.001) with WHOQOL-Bref as regards all its domains, except for the "environment" domain, which did not correlate with the "somatic manifestations" domain. CONCLUSION: Minichal-Brazil proved to be a useful tool in the assessment of HRQOL in hypertensive patients.

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Unsupported valvuloplasty for degenerative mitral regurgitation: long-term results

Alexsandra L. Balbinot et al. Renato A. K. Kalil Paulo R. Prates João Ricardo M. Sant'Anna … Orlando C. Wender Guaracy Fernandes Teixeira Filho Rogério S. Abrahão Ivo A. Nesralla

BACKGROUND: The advantages of valve repair for treatment of degenerative mitral regurgitation are well established. The procedure is associated with low mortality and morbidity rates, and low indices of reoperation, thromboembolic events and endocarditis have been reported. In most series, annuloplasty rings are implanted, but some institutions give preference to unsupported valvuloplasty. OBJECTIVE: To assess the clinical outcome of patients submitted to unsupported valvuloplasty for degenerative mitral regurgitation. METHODS: Between January 1980 and January 2003, 116 patients were submitted to the procedure. A total of 62 (53.4%) were men, and mean age was 47.2 ± 16.5 years. The procedures included: Wooler annuloplasty (65.5%), unilateral annuloplasty (15.5%), quadrangular resection of the posterior leaflet (35.3%), anterior chordal shortening (20.7%), posterior chordal shortening (6.9%), and calcium debridement (0.9%). Mean follow-up was 6.5 ± 5.1 years, and the longest follow-up was 24 years. RESULTS: Mortality was 0.86% (1 pt) early and 6.03% (7 pt) late. Actuarial survival was 85.3% in 20 years. Most patients (55.2%) presented preoperative NYHA functional class III, whereas class I was more frequent in the postoperative period (66.4%). Thromboembolic complications were observed in 4 patients (3.4%), and no correlation was seen with atrial fibrillation. Freedom from thromboembolic events was 94.8%, and similar results were observed for bacterial endocarditis. Survival free from reoperation was 79%, and 53% at 5 and 10 years, respectively. CONCLUSION: Unsupported valvuloplasty is effective and safe for treatment of degenerative mitral regurgitation, representing an adequate therapeutic alternative for selected cases.

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Downstream Change of the Primary Endpoint in the ISCHEMIA Trial: the Elephant in the Room

Modification of the Trial Protocol

Quality of life in hypertensive patients and concurrent validity of Minichal-Brazil

Unsupported valvuloplasty for degenerative mitral regurgitation: long-term results

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Electronic Document Format (ABNT)

Electronic Document Format (APA)

Electronic Document Format (ISO)

Electronic Document Format (Vancouver)

Electronic Document Format (ABNT)

Electronic Document Format (APA)

Electronic Document Format (ISO)