Elsevier

American Heart Journal

Volume 198, April 2018, Pages 129-134
American Heart Journal

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

https://doi.org/10.1016/j.ahj.2017.12.018Get rights and content

Abstract

Background

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.

Objectives

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.

Design

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.

Summary

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.

Section snippets

Evidence from randomized clinical trials and meta-analysis for the use of statins in the peri-PCI setting

Previous trials17., 18., 19., 20. have shown potential benefit of a loading dose of statin in stable coronary disease and non-ST elevation ACS, including also patients on chronic statin therapy (a summary of the ARMYDA trials in 3 different scenarios is presented in Table I).

Regarding ST-elevation myocardial infarction, there is little evidence about the effect of acute statin treatment in this population. Nevertheless, a study with 171 patients has shown an improvement in coronary flow after

Study design

The Statins Evaluation in Coronary procedUres and REvascularization (SECURE-PCI) trial is an academic-led, randomized, double-blind, pragmatic, multicenter trial designed to provide reliable evidence of the risk-benefit ratio of an early strategy with high-dose statin before and after PCI in patients presenting with ACS. The SECURE-PCI Trial aims to randomize around 4,200 patients with ACS invasively managed, with PCI if appropriate, to receive 80 mg of atorvastatin or placebo before an

Discussion

The use of statins in ACS patients is well established and routinely recommended by evidence-based guidelines.3., 4. These patients should use high-intensity statin therapy which is defined as daily dose that lowers LDL-cholesterol by ≥50%.23 Thus, the current recommendation is the use of atorvastatin 40-80 mg or rosuvastatin 20-40 mg in patients at high risk for cardiovascular events including ACSs.3., 4., 23. However, there is still a debate on the benefit of a loading dose in the peri-PCI

Conclusions

The SECURE-PCI trial will test an early strategy with high-dose statin before and after PCI in patients presenting with ACS, including patients with and without ST-segment elevation and also among naive or previous users of statins. Therefore, SECURE-PCI will include the full spectrum of ACS patients intended to be treated with an invasive strategy and is designed to provide a clear answer about the efficacy of loading doses of atorvastatin pre- and post-PCI in this population.

Conflict of interests

The authors declare no conflict of interest.

Organization

Steering Committee: Otávio Berwanger (Co-chair), Renato D. Lopes (Co-chair), Pedro Gabriel M. de Barros e Silva, Luiz Alberto Mattos, Alexandre Biasi Cavalcanti, Hélio Penna Guimarães, Amanda G. M. R. Sousa, José Eduardo M. R. Sousa, Roberto Rocha C. V. Giraldez, Christopher B. Granger, John H. Alexander.

CEC Committee: Renato D. Lopes (Chair); CEC reviewers: Pedro G. M. de Barros e Silva, Luciana Vidal Armaganijan, Thiago Andrade de Macedo, Érique José Farias Peixoto de Miranda, Lucas Colombo

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  • Cited by (0)

    Steven R. Bailey, MD, served as guest editor for this article.

    RCT# NCT01448642.

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