Patrick W Serruys1, Yuki Katagiri2, Yohei Sotomi2, Yaping Zeng3, Bernard Chevalier4, René J van der Schaaf5, Andreas Baumbach6, Pieter Smits7, Nicolas M van Mieghem3, Antonio Bartorelli8, Paul Barragan9, Anthony Gershlick10, Ran Kornowski11, Carlos Macaya12, John Ormiston13, Jonathan Hill14, Irene M Lang15, Mohaned Egred16, Jean Fajadet17, Maciej Lesiak18, Stephan Windecker19, Robert A Byrne20, Lorenz Räber19, Robert-Jan van Geuns3, Gary S Mintz21, Yoshinobu Onuma3. 1. The National Heart and Lung Institute, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com. 2. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 3. ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands. 4. Department of Interventional Cardiology, Institut Jacques Cartier, Massy, France. 5. Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands. 6. Bristol Heart Institute, Bristol, United Kingdom. 7. Maasstad Hospital, Rotterdam, the Netherlands. 8. Centro Cardiologico Monzino, University of Milan, Milan, Italy. 9. Polyclinique les Fleurs, Ollioules, France. 10. Department of Cardiology, University of Leicester, Leicester, United Kingdom; NIHR Leicester Cardiovascular Biomedical Research Centre, Leicester, United Kingdom. 11. Rabin Medical Center, Petah Tikva, Israel. 12. Hospital Clinico San Carlos, Universidad Complutense, Madrid, Spain. 13. Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. 14. King's College Hospital, London, England. 15. Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria. 16. Freeman Hospital & Newcastle University, Institute of Cellular Medicine, Newcastle upon Tyne, United Kingdom. 17. Clinique Pasteur, Toulouse, France. 18. Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland. 19. Department of Cardiology, Bern University Hospital, Bern, Switzerland. 20. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. 21. Cardiovascular Research Foundation, New York, New York.
Abstract
BACKGROUND: Although previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion. OBJECTIVES: This study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling. METHODS: In the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements. RESULTS: The relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 ± 12.6% vs. 2.9 ± 11.5%; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 ± 19.1% vs. -1.9 ± 10.5%, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index ≥0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling. CONCLUSIONS:Expansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281).
RCT Entities:
BACKGROUND: Although previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion. OBJECTIVES: This study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling. METHODS: In the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements. RESULTS: The relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 ± 12.6% vs. 2.9 ± 11.5%; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 ± 19.1% vs. -1.9 ± 10.5%, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index ≥0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling. CONCLUSIONS: Expansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281).
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