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

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...

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Published in:The American heart journal 2018-04, Vol.198, p.129-134
Main Authors: Berwanger, Otavio, de Barros e Silva, Pedro G.M., Dall Orto, Frederico Toledo Campo, de Andrade, Pedro Beraldo, de Castro Bienert, Igor Ribeiro, Bosso, Carlos Eduardo, Mangione, José, Polanczyk, Carisi Anne, Sousa, Amanda, Kalil, Renato, de Moura Santos, Luciano, Sposito, Andrei C., Rech, Rafael L., Sousa, Antonio Carlos Sobral, Baldissera, Felipe, Nascimento, Bruno Ramos, de Andrade Jesuíno, Isabella, Santucci, Eliana Vieira, Damiani, Lucas Petri, Laranjeira, Ligia N., Borges de Oliveira, Juliana A., Giraldez, Roberto R., Cavalcanti, Alexandre Biasi, Pereira, Sabrina Bernardez, Mattos, Luiz Alberto, Armaganijan, Luciana Vidal, Guimarães, Hélio Penna, Sousa, José Eduardo, Alexander, John H., Granger, Christopher B., Lopes, Renato D.
Format: Article
Language:English
Subjects:
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
Evaluation
Female
Health risk assessment
Heart attacks
Humans
Kaplan-Meier Estimate
Male
Meta-analysis
Middle Aged
Mortality
Myocardial infarction
Myocardial Revascularization - methods
Myocardial Revascularization - mortality
Patients
Percutaneous Coronary Intervention - methods
Percutaneous Coronary Intervention - mortality
Postoperative Care - methods
Preoperative Care - methods
Prognosis
Proportional Hazards Models
Risk Assessment
Statins
Studies
Survival Rate
Treatment Outcome
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Summary: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.
ISSN:0002-8703
1097-6744
DOI:10.1016/j.ahj.2017.12.018