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SECURE-PCI: MACE not affected by statin loading dose in planned PCI, questions remain
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ORLANDO, Fla. — Patients with ACS who had planned revascularization with PCI and received a periprocedural loading dose of atorvastatin did not experience a reduction in MACE at 30 days, according to results of the randomized controlled SECURE-PCI trial.
However, researchers observed a reduction in 30-day MACE among patients who underwent PCI as planned, as compared with those who did not undergo PCI, Otavio Berwanger, MD, PhD, cardiologist and clinical epidemiologist at the Brazilian Clinical Research Institute, Sao Paulo, said during his presentation at the American College of Cardiology Scientific Session.
At 30 days, the primary endpoint of MACE, defined as a composite of all-cause mortality, MI, stroke and unplanned revascularization, occurred in fewer patients assigned atorvastatin group vs. placebo, but the difference did not reach statistical significance (6.2% vs. 7.1%; HR = 0.88; 95% CI, 0.69-1.11; P = .27).
Nevertheless, among patients who underwent PCI, as opposed to CABG or use of medical management only, the rate of 30-day MACE was 6% of the atorvastatin group vs. 8.2% in the placebo group (HR = 0.72; 95% CI, 0.54-0.96; P = .02). In this subgroup of patients, the reduction in MACE with atorvastatin was statistically significant, Berwanger noted, which was primarily driven by a 32% risk reduction in total MI.
SECURE-PCI was a double blind, randomized, placebo-controlled trial conducted at 53 sites in Brazil. The researchers randomly assigned 4,191 patients with ACS — including STEMI (24.8%), non-STEMI (60.7%) and unstable angina (14.5%) — who had planned invasive management from April 2012 to October 2017 to receive a loading dose of atorvastatin (n = 2,087) or placebo (n = 2,104).
Patients assigned to the intervention group received 80 mg of atorvastatin before the procedure and 80 mg at 24 hours after the procedure. All patients in the intervention and placebo groups continued on atorvastatin 40 mg for 30 days thereafter.
Of all patients, 64.7% underwent PCI, 8% underwent CABG and 27.3% received exclusive medical management. Time from hospital admission to PCI was less than 48 hours and the majority of patients received drug administration between 2 and 12 hours.
Baseline characteristics were comparable between the two groups, with men representing the majority of patients and a mean age of 62 years.
Follow-up was 30 days.
In terms of secondary endpoints, point estimates tended to favor atorvastatin, according to Berwanger. However, he noted there were no significant differences between study groups in the rates of death, CV death, MI, unplanned revascularization, stroke or stent thrombosis.
Additionally, in other prespecified subgroup analyses based on sex, age, type of ACS, previous statin use and type of stent used, the researchers found no significant differences in the primary outcome.
When the researchers analyzed adverse events, they found no cases of hepatic failure, and three cases of rhabdomyolysis in the placebo group vs. none in the atorvastatin group.
“Among patients with ACS and planned invasive management — in a pragmatic population — periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days,” Berwanger said. “We need to be strict and consider the trial to be negative, so the findings do not support the routine use of a loading dose of atorvastatin. However, among patients undergoing PCI, loading doses of atorvastatin seem to improve clinical periprocedural outcomes and might be an attractive treatment strategy for patients with acute coronary syndromes.” – by Melissa Foster
References:
Berwanger O, et al. Joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; March 10-12, 2018; Orlando, Fla.
Berwanger O, et al. JAMA. 2018;doi:10.1001/jama.2018.2444.
Disclosure: Berwanger reports he has received grants and/or personal fees from AstraZeneca, Amgen, Bayer, Novo Nordisk, Boehringer Ingelheim, Roche Diagnostics and Sanofi. Please see the full study for all other authors’ relevant financial disclosures.