COBRA PzF Stenting to REDUCE Duration of Triple Therapy - COBRA-REDUCE

Oct 17, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
CeloNova Biosciences
Date Presented:
10/17/2020
Date Updated:
10/17/2020
Original Posted Date:
10/17/2020
References

Contribution To Literature:

The COBRA-REDUCE trial failed to show that an experimental stent was superior to a standard stent at reducing bleeding events.

Description:

The goal of the trial was to evaluate an experimental stent compared with a standard drug-eluting stent among patients undergoing percutaneous coronary intervention (PCI). The experimental stent was impregnated with a nano coating (Polyzene-F) to promote vessel healing and shorten the duration of necessary dual antiplatelet therapy (DAPT).

Study Design

  • Randomized
  • Parallel

Patients undergoing PCI for stable and unstable ischemic heart disease were randomized to an experimental stent (n = 495) versus a standard drug-eluting stent (n = 501). In the experimental stent arm, subjects received dual antiplatelet therapy (DAPT) for 14 days. After 14 days, subjects received oral anticoagulation plus aspirin. In the control stent arm, subjects received DAPT for 3-6 months. After 6 months, subjects received oral anticoagulation plus aspirin.

  • Total number of enrollees: 996
  • Duration of follow-up: 6 months
  • Mean patient age: 77 years
  • Percentage female: 27%
  • Percentage with diabetes: 36%

Inclusion criteria:

  • Patients undergoing PCI with chronic need for oral anticoagulation

Principal Findings:

The co-primary outcome, major bleeding (BARC 2-5) at 14 days, occurred in 7.5% of the experimental stent/14-day DAPT group compared with 8.9% of the standard stent/3-6-month DAPT group (p = 0.48).

The co-primary outcome, death, myocardial infarction, stroke, or stent thrombosis at 6 months occurred in 7.7% of the experimental stent/14-day DAPT group compared with 5.2% of the standard stent/3-6-month DAPT group (p for noninferiority = 0.061).

Secondary outcomes:

Death, myocardial infarction, stroke, stent thrombosis, or ischemia-driven target lesion revascularization at 6 months occurred in 9.7% of the experimental stent/14-day DAPT group compared with 5.8% of the standard stent/3-6-month DAPT group (p = 0.023). 

Interpretation:

Among patients undergoing PCI, an experimental stent was not superior to a standard drug-eluting stent. The experimental stent was designed to allow for a shorter duration of DAPT; however, the experimental stent was not associated with a reduction in major bleeding. In addition, the experimental stent did not meet the criteria for noninferiority with regard to major adverse ischemic events.

References:

Presented by Dr. Robert Byrne at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 17, 2020.

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Anticoagulation Management and ACS, Aortic Surgery, Interventions and ACS

Keywords: Acute Coronary Syndrome, Anticoagulants, Aspirin, Drug-Eluting Stents, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Stents, Stroke, TCT20, Thrombosis, Transcatheter Cardiovascular Therapeutics


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