Stenting with the COBRA PzF Stent with short-duration (14 days) dual antiplatelet therapy (DAPT) did not reduce bleeding compared with drug-eluting stents (DES) and standard DAPT (3-6 months) in patients undergoing PCI for acute or chronic coronary syndromes and receiving oral anticoagulation, said researchers presenting the COBRA-REDUCE trial Oct. 17 during TCT 2020. Additionally, noninferiority criteria were not met in terms of thrombotic events.

The study, led by Robert A. Byrne, MB Bch, PhD, et al., enrolled 996 patients across 59 sites in Europe and Asia between February 2016 and May 2020. Patients were randomized to receive either the COBRA stent (N=481) or DES (N=501). Clinical follow-up occurred at six months in 97.6% of patients in the COBRA group and 96.6% of patients in the DES control group.

Overall results showed the primary endpoint of BARC 2-5 bleeding occurred in 7.5% of patients in the COBRA/short DAPT group at 14 days compared with 8.9% in the DES/standard DAPT group at three to six months. In addition, there were no significant differences across secondary bleeding endpoints between the two groups. The co-primary endpoint of a thrombotic composite of death, myocardial infarction, stroke, stent thrombosis and ischemic stroke occurred in 7.7% of those in the COBRA/short DAPT group compared with 5.2% in the DES/standard DAPT group, failing to show noninferiority.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: TCT20, Transcatheter Cardiovascular Therapeutics, Percutaneous Coronary Intervention, Stents

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