A novel NanoCoated Coronary Stent (NCS) failed to meet noninferiority criteria to a drug eluting stent, new trial results from Transcatheter Cardiovascular Therapeutics (TCT) 2020 suggested.
Researchers for the COBRA PzF Stenting to REDUCE Duration of Triple Therapy (COBRA-REDUCE) trial, seeking to evaluate the efficacy of a polymer polyzene F-coated stent with very short duration of triple therapy in patients on oral anticoagulation medication who underwent coronary stenting, was a multicenter, prospective, parallel-group study that included 996 patients at high bleeding risk due to requirement for oral anticoagulation. Patients were randomly assigned to either the COBRA-PzF stent plus two weeks of dual antiplatelet therapy (Group A; n=495), or an FDA-approved drug-eluting stent followed by guideline-recommended antiplatelet therapy for three to six months (Group B; n=501). The co-primary endpoints of the study were BARC ≥2 bleeding beyond two weeks or after hospital discharge (whichever is later), and a thrombo-embolic composite endpoint of death, myocardial infarction, definite or probably stent thrombosis or ischemic stroke.
According to the study results, baseline characteristics were balanced between study groups. Mean age of the patient population was 74.4 years. The COBRA stent did not lower BARC bleeding after 14 days compared with the drug-eluting stent, and the small difference between the two stents was not statistically significant. The superiority threshold was also not met, with the two stents also performing similarly for the co-primary endpoint of thrombotic complications (difference, 2.5%; P=0.061).
“Treatment with COBRA PzF stent was safe with ST rates considerably lower than those seen in earlier trials with high-bleeding-risk patients despite dual antiplatelet therapy duration of only 14 days,” the researchers said in a presentation. “Ongoing follow-up and planned analysis of secondary outcomes at 12 months is awaited in order to assess comparative efficacy of the treatment arms in relation to the study devices. Analyses of bleeding events according to medication compliance, oral anticoagulation dose and number of ATR high bleeding risk criteria will permit examination of interaction between treatment effect, anticoagulation intensity and baseline bleeding risk.”
Byrne R. Randomized Trial of COBRA PzF Stenting to REDUCE Duration of Triple Therapy (COBRA-REDUCE). Presented at TCT 2020.