David E Kandzari1, Jacques J Koolen2, Gheorghe Doros3, Joseph J Massaro4, Hector M Garcia-Garcia5, Johan Bennett6, Ariel Roguin7, Elie G Gharib8, Donald E Cutlip9, Ron Waksman5. 1. Piedmont Heart Institute, Atlanta, Georgia. Electronic address: david.kandzari@piedmont.org. 2. Catharina Hospital, Eindhoven, the Netherlands. 3. Department of Biostatistics and Epidemiology, Boston University School of Public Health, Baim Institute for Clinical Research, Boston, Massachusetts. 4. Department of Biostatistics and Epidemiology, Boston University School of Public Health, Boston, Massachusetts. 5. Division of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC. 6. Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium. 7. Department of Cardiology, Rambam Medical Center, Haifa, Israel. 8. Charleston Area Medical Center, Charleston, West Virginia. 9. Beth Israel Deaconess Medical Center, Baim Institute for Clinical Research, Boston, Massachusetts.
Abstract
BACKGROUND: Coronary drug-eluting stent development has introduced new metal alloys, changes in stent architecture, and bioresorbable polymers. Whether these advancements improve long-term clinical safety and efficacy has been inconsistent in prior studies. OBJECTIVES: The authors sought to compare late-term clinical outcomes among patients treated with anultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP SES) and a thin strut (81 μm) durable polymer everolimus-eluting stent (DP EES) in a large randomized trial. METHODS: BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the 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 V) was an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Analysis of pre-specified 2-year clinical outcomes was performed. RESULTS: Among 1,334 patients randomized to treatment withBP SES (n = 884) or DP EES (n = 450), the 2-year TLF rate was 7.5% for BP SES and 11.9% for DP EES (-4.33% treatment difference; 95% confidence interval: -8.16% to -0.91%; p = 0.015), driven by differences in target vessel myocardial infarction (MI) (5.3% vs. 9.5%; p = 0.01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%; p = 0.04). Rates of cardiac death or MI were 7.0% versus 10.4% for BP SES and DP EES, respectively (p = 0.047). Late/very late definite stent thrombosis was statistically lower for BP SES compared with DP EES (0.1% vs. 1.0%; p = 0.045). CONCLUSIONS: In a large randomized trial, significant differences in both TLF and target vessel-related MI persisted through 2 years, favoring treatment with BP SES over DP EES. Significantly lower cumulative target lesion revascularization and late/very late stent thrombosis were also observed with BP SES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946).
RCT Entities:
BACKGROUND: Coronary drug-eluting stent development has introduced new metal alloys, changes in stent architecture, and bioresorbable polymers. Whether these advancements improve long-term clinical safety and efficacy has been inconsistent in prior studies. OBJECTIVES: The authors sought to compare late-term clinical outcomes among patients treated with an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP SES) and a thin strut (81 μm) durable polymer everolimus-eluting stent (DP EES) in a large randomized trial. METHODS: BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the 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 V) was an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Analysis of pre-specified 2-year clinical outcomes was performed. RESULTS: Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 2-year TLF rate was 7.5% for BP SES and 11.9% for DP EES (-4.33% treatment difference; 95% confidence interval: -8.16% to -0.91%; p = 0.015), driven by differences in target vessel myocardial infarction (MI) (5.3% vs. 9.5%; p = 0.01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%; p = 0.04). Rates of cardiac death or MI were 7.0% versus 10.4% for BP SES and DP EES, respectively (p = 0.047). Late/very late definite stent thrombosis was statistically lower for BP SES compared with DP EES (0.1% vs. 1.0%; p = 0.045). CONCLUSIONS: In a large randomized trial, significant differences in both TLF and target vessel-related MI persisted through 2 years, favoring treatment with BP SES over DP EES. Significantly lower cumulative target lesion revascularization and late/very late stent thrombosis were also observed with BP SES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946).
Authors: Robert Michael Nechwatal; Kurt Bestehorn; Florian Leuschner; Andreas Hagendorff; Manju Guha; Axel Schlitt Journal: Herz Date: 2020-04-20 Impact factor: 1.443
Authors: Selina Vlieger; Gian B Danzi; Floris Kauer; Rohit M Oemrawsingh; Sinisa Stojkovic; Alexander J J IJsselmuiden; Helen Routledge; Peep Laanmets; Marco Roffi; Ole Fröbert; Pascual Baello; Adrian Wlodarczak; Angel Puentes; Jawed Polad; David Hildick-Smith Journal: Coron Artery Dis Date: 2021-08-01 Impact factor: 1.439