ESC 2022: SECURE trial finds “polypill” results in lower risk of cardiovascular events compared to usual care

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Valentin Fuster pictured at ESC 2022 in Barcelona

Use of a ‘polypill’ after myocardial infarction (MI)—an all-in-one pill containing an antiplatelet, lipid lowering medication, and a blood pressure lowering and vascular stabilising drug—was found to be more effective at reducing the risk of major adverse cardiovascular events than when patients were asked to take the medications separately.

This is according to findings of the SECURE trial, presented during a hot line trial session at the 2022 congress of the European Society of Cardiology (ESC; 26 – 29 August, Barcelona, Spain) and published simultaneously in The New England Journal of Medicine. Valentin Fuster (Centro Nacional de Investigaciones Cardiovasculares [CNIC], Madrid, Spain and Mount Sinai Health System, New York, USA) delivered the findings of the trial, in which patients were randomised to receive either the three-in-one pill containing aspirin, rampiril, and astorvastatin, or usual care.

During a press conference in which he previewed the results of the trial, Fuster described adherence to medication following MI as a “huge issue” and commented that use of a polypill containing all three required treatments could make it simpler for patients to adhere to their medication.

Researchers previously demonstrated that prescription of their polypill improved treatment adherence among patients recovering after MI, in the FOCUS study, published in the Journal of the American College of Cardiology (JACC).

The CNIC team then launched the SECURE study, an international randomised clinical trial, to determine whether the improved treatment adherence with the polypill translated into a reduction in cardiovascular events. The polypill analysed in the study contains aspirin (100 mg), the angiotensin-converting enzyme inhibitor ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg).

The trial randomised 2,499 patients within six months of MI to receive either the polypill or usual care, with a primary composite endpoint of death from cardiovascular causes, non-fatal MI, stroke, or urgent revascularisation. The Morisky Medication Adherence Scale was used to classify adherence as low, medium or high.

Fuster reported that the average age of participants was 76 years, while 31% were women, 77.9% had hypertension, 57.4% had diabetes, and 51.3% had a history of smoking.

Describing the results as “striking”, Fuster detailed that during a median follow up of three years, the primary composite endpoint occurred in 118 (9.5%) patients in the polypill group and 156 (12.7%) in the usual care group (hazard ratio [HR] 0.76; 95% confidence interval [CI] 0.60–0.96; p<0.001 for non- inferiority, p=0.02 for superiority).

All four components of the primary endpoint contributed to the observed treatment effect, but the most notable contributor was cardiovascular death, which occurred in 48 (3.9%) patients in the polypill group and 71 (5.8%) in the usual care group (HR 0.67; 95% CI 0.47–0.97; p=0.03). Treatment effects for the primary outcome were similar in pre-specified subgroups (country, age, sex, diabetes, chronic kidney disease, and prior revascularisation).

Regarding secondary endpoints, the key secondary endpoint of cardiovascular death, non-fatal MI, or stroke occurred in 101 (8.2%) patients in the polypill group and 144 (11.7%) in the usual care group (HR 0.70; 95% CI 0.54–0.90; p=0.005). All-cause mortality was similar in both groups (HR 0.97; 95% CI 0.75–1.25).

Importantly, patients in the polypill group had higher levels of adherence compared with those in the usual care group, Fuster said.

“A treatment strategy based on a polypill containing aspirin, astorvastatin, and rampiril, led to fewer recurrent cardiovascular events following MI, presumably due to improved adherence,” Fuster said in the concluding remarks of his press conference presentation. “Use of a cardiovascular polypill as a substitute approach, could be an integral part of a global strategy to improve secondary prevention,” he added.


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