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Randomized Controlled Trial
. 2018 Apr 3;319(13):1331-1340.
doi: 10.1001/jama.2018.2444.

Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial

Otavio Berwanger  1 , Eliana Vieira Santucci  1 , Pedro Gabriel Melo de Barros E Silva  1   2 , Isabella de Andrade Jesuíno  1 , Lucas Petri Damiani  1 , Lilian Mazza Barbosa  2 , Renato Hideo Nakagawa Santos  1 , Ligia Nasi Laranjeira  1 , Flávia de Mattos Egydio  2 , Juliana Aparecida Borges de Oliveira  1 , Frederico Toledo Campo Dall Orto  3 , Pedro Beraldo de Andrade  4 , Igor Ribeiro de Castro Bienert  5 , Carlos Eduardo Bosso  6 , José Armando Mangione  7 , Carisi Anne Polanczyk  8 , Amanda Guerra de Moraes Rego Sousa  9 , Renato Abdala Karam Kalil  10 , Luciano de Moura Santos  11 , Andrei Carvalho Sposito  12 , Rafael Luiz Rech  13 , Antônio Carlos Sobral Sousa  14 , Felipe Baldissera  15 , Bruno Ramos Nascimento  16 , Roberto Rocha Corrêa Veiga Giraldez  17 , Alexandre Biasi Cavalcanti  1 , Sabrina Bernardez Pereira  1 , Luiz Alberto Mattos  18 , Luciana Vidal Armaganijan  2 , Hélio Penna Guimarães  1 , José Eduardo Moraes Rego Sousa  1 , John Hunter Alexander  19 , Christopher Bull Granger  19 , Renato Delascio Lopes  2   19 ; SECURE-PCI Investigators
Affiliations
Randomized Controlled Trial

Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial

Otavio Berwanger et al. JAMA. .

Erratum in

  • Error in Figure.
    [No authors listed] [No authors listed] JAMA. 2018 Sep 4;320(9):938. doi: 10.1001/jama.2018.11635. JAMA. 2018. PMID: 30193257 Free PMC article. No abstract available.

Abstract

Importance: The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain.

Objective: To 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 participants: Multicenter, 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.

Interventions: Patients 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 measures: The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days.

Results: Among 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 relevance: Among 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 registration: clinicaltrials.gov Identifier: NCT01448642.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Berwanger reports receipt of grants and/or personal fees from AstraZeneca, Amgen, Bayer, Novo Nordisk, Boehringer Ingelheim, Roche Diagnostics, and Sanofi. Dr Alexander reports receipt of grants and/or personal fees from AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, CryoLife, CSL Behring, Janssen Pharmaceuticals, Merck, the National Institutes of Health, the US Food and Drug Administration, Novo Nordisk Pharmaceuticals, Pfizer, Portola Pharmaceuticals, Tenax Therapeutics, the VA Cooperative Studies Program, VoluMetrix, Zafgen, Sanofi, Cempra, and Vasoprep Surgical. Dr Granger reports receipt of grants and/or personal fees from Pfizer, Abbvie, Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, the US Food and Drug Administration, Gilead Scientific, GlaxoSmithKline, Janssen, Medscape, Medtronic, Medtronic Foundation, Merck, the National Institutes of Health, Novartis Pharmaceuticals, Rho Pharmaceuticals, Sirtex, and Verseon. Dr Lopes reports receipt of grants and/or personal fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Medtronic, Merck, Pfizer, and Portola. No other disclosures are reported.

Figures

Figure 1.
Figure 1.. Flow of Participants Through the Statins Evaluation in Coronary Procedures and Revascularization Trial
PCI indicates percutaneous coronary intervention. Considering the pragmatic nature of the study, not all sites collected complete and detailed information of patients who would be eligible but not randomized because of lack of adequate time to obtain informed consent. Patients who were lost to 30-day follow-up or withdrew consent were censored at hospital discharge in the time-to-event analysis.
Figure 2.
Figure 2.. Cumulative Incidence of the Primary Outcome
HR indicates hazard ratio; NSTEMI, non–ST-segment elevation myocardial infarction; STEMI, ST-segment elevation myocardial infarction. The combined primary outcome of major adverse cardiovascular events (MACE) included all-cause mortality, acute myocardial infarction, stroke, and unplanned coronary revascularization occurrence in all patients. Panels B-D show primary outcome occurrence in patients who underwent percutaneous coronary intervention (PCI) and in patients who did not undergo PCI. There were 4 patients (2 in each group) for whom information regarding PCI could not be obtained. These patients were not included in the subgroup analyses (PCI and no PCI subgroups). P=.04 for interaction between PCI and non-PCI and P=.13 for interaction between groups in panels C and D.
Figure 3.
Figure 3.. Subgroup Analysis of the Primary Outcome
NSTEMI indicates non–ST-segment elevation myocardial infarction; STEMI, ST-segment elevation myocardial infarction. Size of the data markers indicates size of hazard ratios. P values were calculated by interaction parameters in the Cox regression model. aAmong patients undergoing PCI, 2643 (98%) received a stent.
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