Journal Article

Rationale and design of the Statins Evaluation in Coronary procedUres and REvascularization: The SECURE-PCI Trial

Berwanger, Otavio, Pereira, Sabrina Bernardez, Alexander, John H., Borges de Oliveira, Juliana A., Cavalcanti, Alexandre Biasi, Kalil, Renato, Rech, Rafael L., Guimarães, Hélio Penna, de Andrade Jesuíno, Isabella, Baldissera, Felipe, Nascimento, Bruno Ramos, Giraldez, Roberto R., Armaganijan, Luciana Vidal, Sousa, José Eduardo, de Moura Santos, Luciano, Laranjeira, Ligia N., Mangione, José, de Andrade, Pedro Beraldo, Bosso, Carlos Eduardo, Granger, Christopher B., Santucci, Eliana Vieira, Sousa, Antonio Carlos Sobral, Dall Orto, Frederico Toledo Campo, Polanczyk, Carisi Anne, Sposito, Andrei C., Sousa, Amanda, de Castro Bienert, Igor Ribeiro, de Barros e Silva, Pedro G.M., Lopes, Renato D., Damiani, Lucas Petri, Mattos, Luiz Alberto

2018

Overview

Previous evidence suggests that acute treatment with statins reduce atherosclerotic complications, including periprocedural myocardial infarction, but currently, there are no large, adequately powered studies to define the effects of early, high-dose statins in patients with acute coronary syndrome (ACS) and planned invasive management. The main goal of Statins Evaluation in Coronary procedUres and REvascularization (SECURE-PCI) Trial is to determine whether the early use of a loading dose of 80 mg of atorvastatin before an intended percutaneous coronary intervention followed by an additional dose of 80 mg 24 hours after the procedure will be able to reduce the rates of major cardiovascular events at 30 days in patients with an ACS. The SECURE-PCI study is a pragmatic, multicenter, double-blind, placebo-controlled randomized trial planned to enroll around 4,200 patients in 58 different sites in Brazil. The primary outcome is the rate of major cardiovascular events at 30 days defined as a composite of all-cause mortality, nonfatal acute myocardial infarction, nonfatal stroke, and coronary revascularization. The SECURE PCI is a large randomized trial testing a strategy of early, high-dose statin in patients with ACS and will provide important information about the acute treatment of this patient population.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Acute Coronary Syndrome - diagnostic imaging / Acute Coronary Syndrome - drug therapy / Acute Coronary Syndrome - mortality / Acute Coronary Syndrome - surgery / Acute coronary syndromes / Aged / Angina pectoris / Anticholesteremic Agents - therapeutic use / Arteriosclerosis / Atherosclerosis / Atorvastatin / Atorvastatin - therapeutic use / Biomarkers / Brazil / Cardiovascular disease / Cerebral infarction / Clinical trials / Complications / Dose-Response Relationship, Drug / Double-Blind Method / Drug Administration Schedule / Drug therapy / Evaluation / Female / Health risk assessment / Heart attacks / Humans / Kaplan-Meier Estimate / Male / Meta-analysis / Middle Aged / Mortality / Multicenter Studies as Topic / Myocardial infarction / Myocardial Revascularization - methods / Myocardial Revascularization - mortality / Patients / Percutaneous Coronary Intervention - methods / Percutaneous Coronary Intervention - mortality / Postoperative Care - methods / Pragmatic Clinical Trials as Topic / Preoperative Care - methods / Prognosis / Proportional Hazards Models / Randomized Controlled Trials as Topic / Risk Assessment / Statins / Studies / Survival Rate / Treatment Outcome