SECURE PCI: Loading Doses of Atorvastatin versus Placebo in Patients with ACS and planned revascularisation
Reported from the ACC Scientific Sessions 2018 (ACC.18) in Orlando, United States
SECURE PCI evaluated if high dose of atorvastatin used before and after PCI might reduce cardiovascular events compared to placebo.
What was the aim of this study?
SECURE PCI is another trial presented at ACC.18 and simultaneously published in JAMA evaluating if 2 doses of high dose atorvastatin (80mg) used before and after PCI followed by 40 mg maintenance dose in both groups might reduce adverse events at 30 days compared with placebo. The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. ACS patients aged ≥18 years with planned invasive management within 7 days were included. Key exclusion criteria were use of any fibrate in the 24 hours previous to the loading dose and use of any statin at a maximum dose in the 24 hours previous to the loading dose. Maximum doses of statins were considered as follows: atorvastatin, 80 mg; rosuvastatin, 40 mg; simvastatin, 80 mg; pravastatin, 40 mg; and fluvastatin, 80 mg.
What are the key results?
4,191 patients (mean age 61.8 years) were randomised to receive atorvastatin or placebo consisting of 24.8% STEMI, 60.7% NSTEMI, 14.5% unstable angina patients. 64.7% of patients had PCI, 27.3% had medical therapy. This trial failed to show benefit in terms of the primary endpoint. The event rate was 6.2% (atorvastatin) vs. 7.1% (placebo), p=0.27 with no difference in MI (HR, 0.80; 95% CI, 0.57-1.11; p =0 .18), stroke (HR, 0.92; 95% CI, 0.39-2.16; p =0 .85) or death (HR, 0.97; 95% CI, 0.69-1.35; p = 0.84) analysed individually. Interestingly there was benefit among patients who underwent PCI, MACE at 30 days occurred in 81 (6.0%) in the atorvastatin group compared with 112 (8.2%) in the placebo group (HR, 0.72; 95% CI, 0.54-0.96; p =0 .02).
My take on this trial
In a way the results of this trial are not surprising that two doses of 80mg atorvastatin around the time of the procedure did not lead to reduction in CV events. This trial does not affect clinical practice and continuing with the current guideline recommended therapy for these patients would be appropriate!