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.
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.
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%
- 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
- 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
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)
- 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)
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.
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.
Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Atherosclerotic Disease (CAD/PAD), 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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