Polypill better for secondary cardiovascular prevention than physician-directed care

Reference

Castellano JM, Pocock SJ, Bhatt AJ, et al, for the SECURE Investigators. Polypill strategy in secondary cardiovascular prevention. N Engl J Med 2022;387(11):967-977.

Synopsis

This multicountry European study identified 2499 participants with a history of myocardial infarction in the past 6 months, older than 75 years, or older than 65 years with at least one risk factor (diabetes, mild to moderate kidney failure, previous myocardial infarction, previous stroke, or previous revascularization). They were randomized into 1 of 2 groups. The first group received a polypill containing aspirin (100 mg), ramipril (2.5 mg, 5 mg, or 10 mg), and atorvastatin (40 mg). The atorvastatin dose could be reduced to 20 mg at the discretion of the investigators, and the target dose for ramipril was 10 mg. The second group received usual care based on European guidelines. The average age of participants was 75 years, 69% were men, and more than 98% were white. Groups were balanced at baseline, outcomes were assessed by a committee masked to treatment group, and the analysis was by intention to treat. Participants were followed up for a median of 3 years. In the polypill group, 92% of patients received the 40-mg dose of atorvastatin; in the usual care group, 83% of patients received what was defined as a high-intensity statin. The use of aspirin was similar between groups. Most patients in the polypill group received ramipril at a 2.5-mg or 5-mg dose. The primary outcome of cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, or urgent revascularization occurred less often in the polypill group (9.5% vs 12.7%; P < .001; number needed to treat [NNT] = 31). All the components of the composite decreased similarly, including cardiovascular death (3.9% vs 5.8%; HR 0.67; 0.47 - 0.97; NNT = 53). However, you have to die of something: There was a trend toward more noncardiovascular deaths (5.4% vs 3.7%; HR = 1.42; 0.97 - 2.07) and no difference in all-cause mortality.