Why is this study important?

• Polyzene-F (PzF) coated stent, which is the first in a new category of non-drug-eluting, nanocoated stents. 
• Previous data, including 9-month clinical and angiographic outcomes of the PzF Shield Trial assessing the device’s safety and efficacy in the treatment of de novo coronary artery lesions, which concluded that performance goals had been met with target vessel failure occurred 11.5% (33) of the 287 patients who completed the primary endpoint analysis.

What question was this study supposed to answer?  

• Cobra PzF stenting with just 14 days of dual antiplatelet therapy (DAPT) would provide superior bleeding outcomes in patients undergoing coronary intervention who are receiving oral anticoagulation (with or without dose reduction), versus 3 to 6 months to DAPT after stenting with a “standard” U.S. Food & Drug Administration-approved DES (e.g., Xience/Promus, Resolute or Synergy) in those with an indication for chronic oral anticoagulation.

What did the study show?

• Of 996 patients enrolled, 495 patients given Cobra PzF plus 14 days DAPT and 501 given a standard DES stent with 3 to 6 months DAPT
• The randomized, open-label, active-controlled, assessor-blinded trial also set out to prove non-inferiority versus outcomes in the composite of death, myocardial infarction (MI), stent thrombosis and ischemic stroke.
• The COBRA-REDUCE trial missed its primary endpoint, after the Cobra PzF NanoCoated coronary stent (NCS) with 14-day-dual antiplatelet therapy (DAPT) failed to reduce bleeding versus standard drug-eluting stents (DES) and longer DAPT regimens at 6 months. The study treatment also missed its thrombotic event non-inferiority co-primary endpoint compared with the standard DES therapy at 6 months and its 12-month composite thromboembolic secondary outcome measure. the significantly higher rate of Cobra PzF patients experiencing the 12-month thromboembolic endpoint was “driven mainly by an increase in the rate of ischemia driven target lesion revascularization.
• While the results do not support a routine use of Cobra PzF stenting with 14 days DAPT in patients receiving oral anticoagulation, the investigational device may benefit selected patients at high bleeding risk or in whom an early interruption of DAPT is likely.

All authors: M. Chadi Alraies, MD, MPH