1. Long-Term Outcomes of Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent ― A Randomized Comparison Through 5 Years in Japan ―
- Author
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Kengo Tanabe, Hajime Kusano, Yuji Ikari, Yoshihisa Nakagawa, Ken Kozuma, Jiro Ando, Divine E. Ediebah, Yuji Hamazaki, Takayuki Okamura, and Takeshi Kimura
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,Percutaneous ,medicine.medical_treatment ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Revascularization ,Coronary Restenosis ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Japan ,Restenosis ,Risk Factors ,Internal medicine ,Absorbable Implants ,medicine ,Humans ,Single-Blind Method ,Everolimus ,Prospective Studies ,030212 general & internal medicine ,Myocardial infarction ,Aged ,business.industry ,Coronary Thrombosis ,Stent ,Cardiovascular Agents ,Drug-Eluting Stents ,General Medicine ,Middle Aged ,medicine.disease ,Thrombosis ,Treatment Outcome ,Metals ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,Mace ,medicine.drug - Abstract
Background Bioresorbable vascular scaffolds (BVS) are promising alternatives to metallic drug-eluting stents (DES) in percutaneous coronary interventions. Absorb BVS was comparable to XIENCE (DES) for patient- and device-oriented composite endpoints through 1 year post-procedure. Mid-term results showed increased rates of device-oriented events with Absorb. The objective of this study was to evaluate the long-term safety and effectiveness of Absorb BVS compared with XIENCE metallic DES when implanted in patients in Japan with de novo coronary artery lesions.Methods and Results:ABSORB Japan randomized 400 patients into either Absorb (n=266) or XIENCE (n=134) treatment arm. Through 5-year follow-up, the composite endpoints of DMR (death, myocardial infarction [MI], and all revascularization), target vessel failure (TVF), major adverse cardiac events (MACE), target lesion failure (TLF), and cardiac death/all MI were evaluated. Individual endpoints included death, MI, coronary revascularization, and scaffold/stent thrombosis. There were no significant differences in the composite or individual endpoint outcomes between the Absorb and XIENCE arms through 5 years or between 3 and 5 years. Numerically lower TVF, MACE, and all MI rates were observed for the Absorb vs. XIENCE arm after 3 years. No scaffold/stent thrombosis was reported beyond 3 years. Post-procedure imaging subgroups showed comparable event rates. Conclusions Following resorption of the scaffold, between 3 and 5 years post-procedure, the Absorb BVS performed comparably to XIENCE in all patient- and device-oriented endpoints (ClinicalTrials.gov, #NCT01844284).
- Published
- 2020