Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With up to Three de Novo or Restenotic Coronary Artery Lesions - BIOFLOW V

Jan 30, 2019
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Presenter/Author:
David E. Kandzari, MD, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Biotronik
Date Presented:
08/26/2017
Date Published:
12/27/2018
Date Updated:
01/30/2019
Original Posted Date:
08/26/2017
References

Contribution To Literature:

The BIOFLOW V trial showed that a bioresorbable polymer sirolimus-eluting stent was noninferior at preventing target lesion failure.

Description:

The goal of the trial was to evaluate a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent among patients undergoing coronary revascularization.

Study Design

  • Randomized
  • Parallel

Patients undergoing coronary revascularization were randomized to a bioresorbable polymer sirolimus-eluting stent (n = 884) versus a durable polymer everolimus-eluting stent (n = 450).

  • Total number of enrollees: 1,334
  • Duration of follow-up: 12 months
  • Mean patient age: 65 years
  • Percentage female: 25%
  • Percentage with diabetes: 34%
  • Percentage with acute coronary syndrome: 51%

Inclusion criteria:

  • Patients at least 18 years of age undergoing coronary revascularization for stable ischemic heart disease or unstable angina
  • One to three de novo lesions in ≤2 native target vessels
  • Lesion length ≤36 mm
  • Thrombolysis in Myocardial Infarction (TIMI) flow >1
  • Eligible for dual antiplatelet therapy

Exclusion criteria:

  • Recent ST-segment elevation MI or hemodynamically unstable acute coronary syndrome
  • Target vessel chronic total occlusion or saphenous vein graft
  • Bifurcation lesion
  • In-stent restenosis or acute stent thrombosis
  • Left ventricular ejection fraction <30%
  • Prior percutaneous coronary intervention (PCI) within 30 days for nontarget vessel or within 9 months for target vessel
  • Planned staged PCI post-procedure
  • Chronic kidney disease
  • Excessive angulation, tortuosity, or calcification

Principal Findings:

The primary outcome, incidence of target lesion failure at 12 months (cardiovascular death, MI, or ischemia-driven target lesion revascularization [TLR]), occurred in 6.2% of the bioresorbable polymer sirolimus-eluting stent versus 9.6% of the durable polymer everolimus-eluting stent group (p = 0.04). This met the prespecified margin for noninferiority. Outcomes were the same in tested subgroups.

Secondary outcomes (all for bioresorbable polymer vs. durable polymer group, respectively):

  • Cardiac death: 0.1% vs. 0.7% (p = 0.12)
  • Target vessel MI: 4.7% vs. 8.3% (p = 0.016)
  • Clinically driven TLR: 2.0% vs. 2.4% (p = 0.69)
  • Definite/probable stent thrombosis: 0.5% vs. 0.7% (p = 0.69)

Two-year outcomes:

  • Target lesion failure: 7.5% with bioresorbable polymer sirolimus-eluting stent versus 11.9% with durable polymer everolimus-eluting stent (p = 0.015)
  • Ischemia-driven TLR: 2.6% with bioresorbable polymer sirolimus-eluting stent versus 4.9% with durable polymer everolimus-eluting stent (p = 0.04)
  • Target vessel MI: 5.3% with bioresorbable polymer sirolimus-eluting stent versus 9.5% with durable polymer everolimus-eluting stent (p = 0.01)

Interpretation:

Among patients undergoing coronary revascularization, a bioresorbable polymer sirolimus-eluting stent was noninferior at preventing target lesion failure at 12 months compared with a durable polymer everolimus-eluting stent. Individual outcomes of cardiac death, target vessel MI, clinically driven TLR, or definite/probable stent thrombosis were also similar between treatment groups. Although the trial was established to evaluate for noninferiority, the bioresorbable polymer sirolimus-eluting stent appeared to be superior to the comparator device, which persisted to 2 years of follow-up.

References:

Kandzari DE, Koolen JJ, Doros G, et al., on behalf of the BIOFLOW V Investigators. Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents Versus Thin Durable Polymer Everolimus-Eluting Stents. J Am Coll Cardiol 2018;72:3287-97.

Editorial Comment: Puri R, Reed GW. Refining Coronary Stent Platforms in the Modern DES Era: Thinning, Eluting, Inhibiting, and Absorbing. J Am Coll Cardiol 2018;72:3298-3300.

Kandzari DE, Mauri L, Koolen JJ, et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularization (BIOFLOW V): a randomised trial. Lancet 2017;390:1843-52.

Presented by Dr. David E. Kandzari at the European Society of Cardiology Congress, Barcelona, Spain, August 26, 2017.

Keywords: Angina, Unstable, Acute Coronary Syndrome, Coronary Artery Disease, Drug-Eluting Stents, ESC2017, ESC Congress, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Polymers, Secondary Prevention, Sirolimus, Stents, Thrombosis


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