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PROHLÍŽENÍ ABSTRAKTA

THE SECURE STUDY, A TRIAL WITH SIGNIFICANT CONTRIBUTION FROM THE CZECH REPUBLIC.
Tématický okruh: okruh
Typ: Ústní sdělení - lékařské , Číslo v programu: 81
Etický kodex:
Podpora výzkumu / granty: Funded by the European Union, Horizon 2020; SECURE ClinicalTrials.gov number, NCT02596126; EudraCT number, 2015 -002868-17.
Lubanda J.1, Linhart A.1

1 II. interní klinika kardiologie a angiologie, Všeobecná Fakultní Nemocnice a 1.LFUK, Praha


Backgrounds:
A polypill with key medications associated with improved outcomes (aspirin, ACE inhibitor, and statin) has been proposed as a simple approach to the secondary prevention of cardiovascular (CV) death and complications after myocardial infarction (MI). This strategy was tested in the SECURE trial which results were recently presented. The Czech Republic was a part of the consortium of 11 European research institutions conducting the trial.

METHODS: patients with MI within the previous 6 months were assigned to a polypill-based strategy or usual care. The polypill  arm consisted of aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg). The primary composite outcome was CV death, nonfatal type 1 MI, nonfatal ischemic stroke, or urgent revascularization. The secondary end point was a composite of previous except urgent revascularisation.

RESULTS: 2499 patients were followed for a median of 36 months. The Czech Republic enrolled 174 subjects in the trial from 9 participating centers. A primary-outcome event occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229  patients (12.7%) in the usual-care group (HR, 0.76; 95% CI; P = 0.02). The secondary-outcome occured in 8.2% in the polypill group and 11.7% in the usual-care group (HR, 0.70; 95% CI, P = 0.005). Medication adherence was higher in the polypill group. Comparison of the Czech cohort to other countries did not show significant difference in all prespecified outcomes.
CONCLUSIONS: Treatment with a polypill after MI resulted in a significantly lower risk of major adverse CV events. We are happy that the Czech Republic was an active part of this trial and was able to significantly contribute to its positive results.

Ref.: Castellano JM et al. Polypill Strategy in Secondary Cardiovascular Prevention. NEngl J Med. 2022 Sep 15;387(11):967-977.