Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk - Bioflow-DAPT

Aug 25, 2023
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
Biotronik
Date Presented:
08/25/2023
Date Published:
08/25/2023
Date Updated:
08/25/2023
Original Posted Date:
08/25/2023
References

Contribution To Literature:

The Bioflow-DAPT trial showed that among patients with high bleeding risk undergoing PCI and receiving DAPT for 1 month post-PCI, Orsiro Mission (biodegradable polymer SES) implantation is noninferior to Resolute Onyx (durable polymer ZES) at 1 year for cardiovascular outcomes.

Description:

The goal of the trial was to compare the safety and efficacy of 1 month of dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) with either the Resolute Onyx stent or with the Orsiro Mission stent among patients at high bleeding risk.

Study Design

Eligible patients were randomized in a 1:1 fashion to either Resolute Onyx drug-eluting stent (DES) (durable polymer zotarolimus-eluting stent [ZES]) (n = 979) or Orsiro Mission (biodegradable polymer sirolimus-eluting stent [SES]) (n = 969). Patients received DAPT for 1 month. At the 1-month follow-up visit, eligibility for discontinuation of DAPT was reassessed by investigators. Patients who were adherent to treatment and free from recurrent events were eligible for treatment discontinuation and received a prescription for either aspirin or a P2Y12 inhibitor (P2Y12i) monotherapy at the discretion of the treating physician. If they had an indication for an oral anticoagulant (OAC) alone, triple therapy (OAC + P2Y12i + aspirin) was continued for 1 month and then tapered to either single antiplatelet therapy (SAPT) (P2Y12i or aspirin) or OAC after 1 month.

  • Total number of enrollees: 1,948
  • Duration of follow-up: 1 years
  • Mean patient age: 76 years
  • Percentage female: 32%

Inclusion criteria:

Fulfilled one or more criteria for high bleeding risk:

  • ≥75 years of age
  • Moderate or severe chronic kidney disease or failure
  • Advanced liver disease
  • Cancer diagnosed or treated within the previous 12 months or actively treated
  • Anemia with hemoglobin <11.0 g/dL or requiring transfusion within 4 weeks before randomization
  • Baseline thrombocytopenia
  • History of stroke, previous intracerebral hemorrhage, or presence of a brain arteriovenous malformation
  • History of hospitalization for bleeding within previous 12 months
  • Chronic clinically significant bleeding diathesis
  • Clinical indication for chronic or lifelong OAC
  • Clinical indication for chronic steroid or oral nonsteroidal anti-inflammatory drug(s) other than aspirin
  • Nondeferrable major surgery on DAPT
  • Recent major surgery or major trauma within 30 days before PCI
  • PRECISE DAPT score ≥25
  • Eligible for 1 month of DAPT after the procedure
  • Age ≥18 years

Other salient features/characteristics:

  • Acute coronary syndrome (ACS): 20%
  • Need for OAC: 35%
  • Multivessel PCI: 20%; mean number of stents/patient: 1.7
  • 53.5%% met ≥2 high bleeding risk criteria
  • SAPT use at ≥2 months: 94%, at 12 months: 93%

Principal Findings:

The primary safety outcome, cardiac death/myocardial infarction (MI)/stent thrombosis for Orsiro Mission vs. Resolute Onyx, was: 3.5% vs. 3.4% (p for noninferiority < 0.0001).

  • Cardiac death: 1.7% vs. 2.0%
  • MI (Academic Research Consortium [ARC] 2): 1.2% vs. 1.1%
  • Definite or probable stent thrombosis: 0.8% vs. 0.5% (early [within 30 days] stent thrombosis: 0.5% vs. 0.1%)

The primary safety outcome, cardiac death/MI (using 3rd universal definition of MI)/stent thrombosis for Orsiro Mission vs. Resolute Onyx, was: 6.6% vs. 6.3%.

Secondary outcomes for Orsiro vs. Onyx:

  • BARC 3 or 5 bleeding: 3.5% vs. 3.8% (p > 0.05)
  • Stroke: 1.0% vs. 0.7%
  • Target lesion revascularization: 4.2% vs. 4.8%
  • All-cause mortality: 4.5% vs. 3.9%

Interpretation:

The results of this trial indicate that among patients with high bleeding risk undergoing PCI and receiving DAPT for 1-month post-PCI, Orsiro Mission (biodegradable polymer SES) implantation is noninferior to Resolute Onyx (durable polymer ZES) at 1 year for cardiovascular outcomes. This trial adds to the literature on shorter duration DAPT among patients undergoing PCI and high bleeding risk. This also suggests that the shorter duration is feasible with both durable and biodegradable polymer-based DES.

One limitation of this trial is its open-label design. The decision to continue aspirin or a P2Y12 inhibitor after 30 days of DAPT was at the discretion of physicians. Event rates in this trial were lower than those noted in ONYX ONE, which enrolled a similar high bleeding risk population but with a larger proportion presenting with ACS (~50% vs. ~20%).

References:

Valgimigli M, Wlodarczak A, Tölg R, et al., on behalf of the Bioflow-DAPT Investigators. Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial. Circulation 2023;148:989-99.

Presented by Dr. Marco Valgimigli at the European Society of Cardiology Congress, Amsterdam, Netherlands, August 25, 2023.

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Interventions and ACS

Keywords: Acute Coronary Syndrome, Drug-Eluting Stents, ESC23, ESC Congress, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Stents


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