• Otavio Berwanger, Eliana Vieira Santucci, de Barros E SilvaPedro Gabriel MeloPGMResearch Institute-Heart Hospital, São Paulo, Brazil.Brazilian Clinical Research Institute, São Paulo, Brazil., Isabella de Andrade Jesuíno, Lucas Petri Damiani, Lilian Mazza Barbosa, Renato Hideo Nakagawa Santos, Ligia Nasi Laranjeira, Flávia de Mattos Egydio, Juliana Aparecida Borges de Oliveira, Frederico Toledo Campo Dall Orto, Beraldo de AndradePedroPSanta Casa de Marília, Marília, Brazil., Igor Ribeiro de Castro Bienert, Carlos Eduardo Bosso, José Armando Mangione, Carisi Anne Polanczyk, SousaAmanda Guerra de Moraes RegoAGMRInstituto Dante Pazzanese de Cardiologia, São Paulo, Brazil., KalilRenato Abdala KaramRAKInstituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil., Luciano de Moura Santos, Andrei Carvalho Sposito, Rafael Luiz Rech, SousaAntônio Carlos SobralACSHospital São Lucas, Aracaju, Brazil., Felipe Baldissera, Bruno Ramos Nascimento, Roberto Rocha Corrêa Veiga Giraldez, Alexandre Biasi Cavalcanti, Sabrina Bernardez Pereira, Luiz Alberto Mattos, Luciana Vidal Armaganijan, Hélio Penna Guimarães, José Eduardo Moraes Rego Sousa, John Hunter Alexander, Christopher Bull Granger, Renato Delascio Lopes, and SECURE-PCI Investigators.
• Research Institute-Heart Hospital, São Paulo, Brazil.
• JAMA. 2018 Apr 3; 319 (13): 1331-1340.

ImportanceThe effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain.ObjectiveTo determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management.Design, Setting, And ParticipantsMulticenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017.InterventionsPatients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication.Main Outcomes And MeasuresThe primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days.ResultsAmong the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group.Conclusions And RelevanceAmong patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management.Trial Registrationclinicaltrials.gov Identifier: NCT01448642.

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