Randomized Trial of COBRA Polyzene F (PzF) Stenting to Reduce the Duration of Triple Therapy: The COBRA-REDUCE Trial
Authors' conclusion
In patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention, treatment with the COBRA PzF stent plus 14 days of DAPT was not superior with respect to bleeding events and was not noninferior with respect to thromboembolic events at 6 months compared with treatment with standard Food and Drug Administration-approved drug-eluting stent plus 3 to 6 months of DAPT.
Study context
- Population
- Patients with an indication for OAC undergoing PCI
- Participants
- 996 patients
- Comparison
- COBRA PzF stent + 14 days DAPT vs new-generation DES + 3 or 6 months DAPT
- Primary endpoint
- Coprimary: BARC type ≥2 bleeding beyond 14 days (or after discharge) until 6 months; composite of all-cause death, MI, definite or probable stent thrombosis or ischemic stroke
- Follow-up
- 6 months
Methodological detailsnon-inferiority
- Non-inferiority
Primary result
As reported in the abstract
COBRA PzF
- Bleeding
- 37 of 475 (7.8%)
- Thromboembolic
- 37 of 492 (7.5%)
Control
- Bleeding
- 47 of 482 (9.8%)
- Thromboembolic
- 24 of 490 (4.9%)
Bleeding
COBRA PzF37 of 475 (7.8%)
Control47 of 482 (9.8%)
Thromboembolic
COBRA PzF37 of 492 (7.5%)
Control24 of 490 (4.9%)
COBRA PzF vs ControlDifference (95% CI)P value
Bleeding; superiority not shown
−2.0(−5.6 to 1.6)
P = 0.14Non-inferiority margin 5 as printed, not drawn
- Thromboembolic; upper limit of 1-sided 95% CI 5.2%; non-inferiority margin 5%; noninferiority not shown
- difference 2.6 %; P for non-inferiority = 0.07
Original publication
Randomized Trial of COBRA PzF Stenting to Reduce the Duration of Triple Therapy: The COBRA-REDUCE Trial. Circ Cardiovasc Interv. Published 15 October 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →