In a Hot Line session yesterday, Professor Valentin Fuster (Centro Nacional de Investigaciones Cardiovasculares (CNIC) - Madrid, Spain, and Mount Sinai Health System - New York, USA) presented results from the SECURE trial, the first randomised trial to investigate the effects of a polypill on recurrent CV events in post-MI patients.
This multicentre trial enrolled patients who had experienced a type 1 MI within the previous 6 months. Eligibility included age over 75 years or age over 65 years with one or more risk factors: diabetes mellitus or previous treatment with antihyperglycaemic agents, mild-to-moderate renal dysfunction, prior MI before the index event, coronary revascularisation or stroke. Patients were randomised 1:1 to receive either a polypill – containing aspirin (100 mg), ramipril (2.5, 5 or 10 mg) and atorvastatin (20 or 40 mg) – or usual care (administered at the discretion of the treating physician). The primary composite endpoint was death from CV causes, non-fatal MI, stroke and urgent revascularisation.
Among the 2,499 patients randomised, the average age was 76 years; 31% were women, 78% had hypertension, 57% had diabetes and 51% had a history of smoking.
During a median follow-up of 36 months, the primary outcome was significantly less frequent in patients receiving the polypill (9.5%) compared with usual care (12.7%) (hazard ratio [HR] 0.76; 95% CI 0.60 to 0.96; p<0.001 for non-inferiority and p=0.02 for superiority).
While all components of the primary endpoint contributed to the treatment effect, the main driver was CV death, which occurred in 3.9% and 5.8% of patients in the polypill and usual care groups, respectively (HR 0.67; 95% CI 0.47 to 0.97; p=0.03). Treatment effects were similar across prespecified subgroups of country, age, sex, diabetes, chronic kidney disease and prior revascularisation.
There was also a 30% reduction in the risk of the key secondary endpoint of CV death, non-fatal MI and stroke, with rates of 8.2% and 11.7% in the polypill and usual care groups, respectively (HR 0.70; 95% CI 0.54 to 0.90; p=0.005). All-cause mortality was similar between the two groups (HR 0.97; 95% CI 0.75 to 1.25). Levels of treatment adherence, classified according to the Morisky Medication Adherence Scale, were higher in the polypill group than in the usual care group, with no differences in safety outcomes.
Commenting on the results, Prof. Fuster says, “The findings suggest that a polypill could become an integral part of strategies to prevent CV events in post-infarction patients. By simplifying treatment and improving adherence, this approach has the potential to reduce the risk of recurrent disease and CV death on a global scale.”