October 17, 2020
COBRA-REDUCE Evaluates Shorter Duration DAPT After PCI With Nano-Coated Coronary Stent
October 17, 2020—The results of the COBRA-REDUCE trial demonstrated that for patients undergoing percutaneous coronary intervention (PCI) who also require oral anticoagulation, treatment with a nanotechnology polymer-coated stent plus 14-day dual antiplatelet therapy (DAPT) did not reduce bleeding or establish noninferior outcomes for thrombotic events compared with a drug-eluting stent (DES) and standard 3- or 6-month DAPT therapy.
The data were presented by the trial's coprincipal investigator, Robert A. Byrne MB, BCh, PhD, at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020. Dr. Byrne is Director of Cardiology, Mater Private Hospital, Dublin and Chair of Cardiovascular Research, Royal College of Surgeons in Ireland.
COBRA-REDUCE was funded by CeloNova Biosciences, Inc., maker of the the non–drug-eluting Cobra polyzene-F [PzF] nanocoated coronary stent. On June 1, 2020, the company announced completion of enrollment in the trial.
According to TCT Connect, COBRA-REDUCE was a randomized, open-label, active-controlled, assessor-blinded, multicenter trial. The trial enrolled 996 patients at 59 sites in Europe and the United States between February 2016 and May 2020. Patients at high bleeding risk (HBR) due to requirement for oral anticoagulation were randomized at the time of PCI to treatment with the Cobra-PzF stent followed by a very short duration (14 days) of DAPT or an FDA-approved new-generation DES followed by guideline-recommended DAPT duration (3 or 6 months).
The primary endpoints were BARC class ≥ 2 bleeding beyond 14 days or after hospital discharge (whichever is later) at 6 months post randomization and composite of death, myocardial infarction (MI), definite/probable stent thrombosis (ST), or ischemic stroke at 6 months.
Secondary endpoints included composite endpoint of all cause death, MI, definite/probable ST, ischemia-driven TLR, or ischemic stroke; composite of cardiac death and MI; ischemia driven TLR; definite/probable ST; ischemic stroke; BARC class 3-5 bleeding; TIMI major bleeding; TIMI major or minor bleeding; and health economic utilities.
In the test group (Cobra-PzF stent with short DAPT) compared with the control group (DES with standard DAPT), the rate of bleeding was 7.5 % versus 8.9% (P = .477). The rate of the composite thrombotic endpoint was 7.7% in the test group and 5.2% in the control group (Difference +2.5%; 95% CI, 5.15%; Pnoninferiority = .061).
In the TCT Connect announcement, Dr. Byrne commented, "In patients undergoing PCI for acute or chronic coronary syndromes who are receiving oral anticoagulation with or without dose reduction, stenting with Cobra PzF stents with 14 days DAPT did not reduce BARC 2-5 bleeding and did not meet noninferiority criteria with respect to thrombotic events compared with standard DES and 3-6 months of DAPT.
Dr. Byrne noted, "Treatment with the Cobra PzF stent was safe with ST rates considerably lower than those seen in earlier trials with HBR patients despite DAPT duration of only 14 days."
Finally, Dr. Byrne advised, “Ongoing follow-up and planned analysis of secondary outcomes at 12 months is needed to assess comparative efficacy of the treatment arms in relation to the study devices. Analyses of bleeding events according to medication compliance, oral anticoagulant dose, and number of Academic Research Consortium for High Bleeding Risk criteria will permit examination of interaction between treatment effect, anticoagulation intensity and baseline bleeding risk."