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

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)

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.

References:

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;Aug 26:[Epub ahead of print].

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

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Cardiac Surgery and Arrhythmias, Interventions and ACS, Interventions and Coronary Artery Disease

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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