SECURE
Trial question
What is the role of cardiovascular polypill strategy in the secondary prevention of CVD?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 2466
2466 patients (765 female, 1701 male).
Inclusion criteria: elderly patients with MI within the previous 6 months.
Key exclusion criteria: receipt of oral anticoagulation; severe congestive HF; severe renal disease; severe liver impairment; significant arrhythmias.
Interventions
N=1237 polypill strategy (a single pill containing aspirin 100 mg, ramipril 2.5, 5, or 10 mg, and atorvastatin 40 mg).
N=1229 usual care (standard of care therapies according to the ESC).
Primary outcome
Composite outcome of CV death, nonfatal type 1 MI, nonfatal ischemic stroke, or urgent revascularization
9.5%
12.7%
12.7 %
9.5 %
6.3 %
3.2 %
0.0 %
Polypill
strategy
Usual
care
Significant
decrease ▼
NNT = 31
Significant decrease in composite outcome of CV death, nonfatal type 1 MI, nonfatal ischemic stroke, or urgent revascularization (9.5% vs. 12.7%; HR 0.76, 95% CI 0.6 to 0.96).
Secondary outcomes
Significant decrease in composite outcome of CV death, nonfatal type 1 MI, or nonfatal ischemic stroke (8.2% vs. 11.7%; HR 0.7, 95% CI 0.54 to 0.9).
Significant decrease in CV death (3.9% vs. 5.8%; HR 0.67, 95% CI 0.47 to 0.97).
Significant increase in patients with high adherence to medication at 2 years (74.1% vs. 63.2%; RR 1.17, 95% CI 1.1 to 1.25).
Safety outcomes
No significant differences in death from any cause, adverse events, and nonfatal serious adverse events.
Conclusion
In elderly patients with MI within the previous 6 months, polypill strategy was superior to usual care with respect to the composite outcome of CV death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization.
Reference
Jose M Castellano, Stuart J Pocock, Deepak L Bhatt et al. Polypill Strategy in Secondary Cardiovascular Prevention. N Engl J Med. 2022 Sep 15;387(11):967-977.
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