Trial DesignRationale and design of the Statins Evaluation in Coronary procedUres and REvascularization: The SECURE-PCI Trial
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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Steven R. Bailey, MD, served as guest editor for this article.
RCT# NCT01448642.