Corrado Tamburino1, Piera Capranzano1, Tommaso Gori2, Azeem Latib3, Maciej Lesiak4, Holger Nef5, Giuseppe Caramanno6, Christopher Naber7, Julinda Mehilli8, Carlo Di Mario9, Manel Sabaté10, Thomas Münzel2, Antonio Colombo3, Aleksander Araszkiewicz4, Jens Wiebe6, Salvatore Geraci6, Christoph Jensen7, Alessio Mattesini9, Salvatore Brugaletta10, Davide Capodanno11. 1. Dipartimento Cardio-Toraco-Vasculare, Ferrarotto Hospital, University of Catania, Catania, Italy. 2. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz, University Medical Center, Mainz, Germany. 3. EMO-GVM Centro Cuore and San Raffaele Hospitals, Milan, Italy. 4. Department of Cardiology, University of Medical Sciences, Poznan, Poland. 5. Medizinische Klinik I, Department of Cardiology, University of Giessen, Giessen, Germany. 6. San Giovanni di Dio Hospital, Agrigento, Italy. 7. Klinik für Kardiologie und Angiologie, ElisabethKrankenhaus, Essen, Germany. 8. Munich University Clinic, Ludwig-Maximilians University and Munich Heart Alliance at DZHK, Munich, Germany. 9. National Institute of Health Research Cardiovascular BRU, Royal Brompton Hospital & Imperial College, London, United Kingdom. 10. Department of Cardiology, Thorax Institute, Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain. 11. Dipartimento Cardio-Toraco-Vasculare, Ferrarotto Hospital, University of Catania, Catania, Italy. Electronic address: dcapodanno@gmail.com.
Abstract
OBJECTIVES: The purpose of this study was to compare the 1-year outcomes of the ABSORB everolimus-eluting bioresorbable scaffold (BRS) (Abbott Vascular, Santa Clara, California) and the XIENCE everolimus-eluting stent (EES) (Abbott Vascular) in patients undergoing percutaneous coronary intervention. BACKGROUND: Randomized studies of the ABSORB BRS have been performed in selected patient and lesion scenarios. The available registries of the ABSORB BRS reflect real-world practice more closely compared with randomized studies, but most of them are limited by the small sample size and the lack of comparative outcomes versus second-generation drug-eluting stents. METHODS: A total of 1,189 consecutive patients treated with ABSORB BRS from the GHOST-EU (Gauging coronary Healing with bioresorbable Scaffolding plaTforms in EUrope) registry and 5,034 patients treated with XIENCE EES from the XIENCE V USA registry were analyzed. Clinical outcomes were compared with the use of propensity-score matching techniques and reported as Kaplan-Meier estimates and absolute risk difference (D) with 95% confidence intervals (CIs). The primary endpoint was a device-oriented composite endpoint, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 1-year follow-up. RESULTS: After propensity score matching was performed for the entire population (N = 6,223), there were 905 matched pairs of patients. In the matched cohort (N = 1,810), there was no significant difference between ABSORB BRS and XIENCE EES in the risk of device-oriented composite endpoint at 1 year (5.8% vs. 7.6%, D = -1.8 [95% CI: -4.1 to 0.5]; p = 0.12). Cardiac death was less likely to occur in the ABSORB BRS group (0.7% vs. 1.9%, D = -1.2 [95% CI: -2.2 to 0.2]; p = 0.03), and a trend toward a reduction in myocardial infarction was noted with ABSORB BRS compared with XIENCE EES (2.4% vs. 4.0%, D = -1.6 [95% CI: -3.2 to 0.0]; p = 0.07). Conversely, no differences in ischemia-driven target lesion revascularization (4.6% vs. 3.5%, D = 1.1 [95% CI: -0.7 to 2.9]; p = 0.22) and definite or probable device thrombosis (1.8% vs. 1.1%, D = 0.7 [95% CI: -0.4 to 1.8]; p = 0.23) were detected between ABSORB BRS and XIENCE EES. CONCLUSIONS: In a contemporary large cohort of patients undergoing percutaneous coronary intervention with ABSORB BRS, the combined rate of ischemic events at 1 year was low and nonsignificantly different compared with matched patients treated with XIENCE EES.
OBJECTIVES: The purpose of this study was to compare the 1-year outcomes of the ABSORB everolimus-eluting bioresorbable scaffold (BRS) (Abbott Vascular, Santa Clara, California) and the XIENCE everolimus-eluting stent (EES) (Abbott Vascular) in patients undergoing percutaneous coronary intervention. BACKGROUND: Randomized studies of the ABSORB BRS have been performed in selected patient and lesion scenarios. The available registries of the ABSORB BRS reflect real-world practice more closely compared with randomized studies, but most of them are limited by the small sample size and the lack of comparative outcomes versus second-generation drug-eluting stents. METHODS: A total of 1,189 consecutive patients treated with ABSORB BRS from the GHOST-EU (Gauging coronary Healing with bioresorbable Scaffolding plaTforms in EUrope) registry and 5,034 patients treated with XIENCE EES from the XIENCE V USA registry were analyzed. Clinical outcomes were compared with the use of propensity-score matching techniques and reported as Kaplan-Meier estimates and absolute risk difference (D) with 95% confidence intervals (CIs). The primary endpoint was a device-oriented composite endpoint, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 1-year follow-up. RESULTS: After propensity score matching was performed for the entire population (N = 6,223), there were 905 matched pairs of patients. In the matched cohort (N = 1,810), there was no significant difference between ABSORB BRS and XIENCE EES in the risk of device-oriented composite endpoint at 1 year (5.8% vs. 7.6%, D = -1.8 [95% CI: -4.1 to 0.5]; p = 0.12). Cardiac death was less likely to occur in the ABSORB BRS group (0.7% vs. 1.9%, D = -1.2 [95% CI: -2.2 to 0.2]; p = 0.03), and a trend toward a reduction in myocardial infarction was noted with ABSORB BRS compared with XIENCE EES (2.4% vs. 4.0%, D = -1.6 [95% CI: -3.2 to 0.0]; p = 0.07). Conversely, no differences in ischemia-driven target lesion revascularization (4.6% vs. 3.5%, D = 1.1 [95% CI: -0.7 to 2.9]; p = 0.22) and definite or probable device thrombosis (1.8% vs. 1.1%, D = 0.7 [95% CI: -0.4 to 1.8]; p = 0.23) were detected between ABSORB BRS and XIENCE EES. CONCLUSIONS: In a contemporary large cohort of patients undergoing percutaneous coronary intervention with ABSORB BRS, the combined rate of ischemic events at 1 year was low and nonsignificantly different compared with matched patients treated with XIENCE EES.
Authors: Katherine Hsin-Yu Chau; Kevin F Kennedy; John C Messenger; Kirk N Garratt; Thomas M Maddox; Robert W Yeh; Ajay J Kirtane Journal: JAMA Cardiol Date: 2019-06-01 Impact factor: 14.676
Authors: B Everaert; J J Wykrzykowska; J Koolen; P van der Harst; P den Heijer; J P Henriques; R van der Schaaf; B de Smet; S H Hofma; R Diletti; A Weevers; J Hoorntje; P Smits; R J van Geuns Journal: Neth Heart J Date: 2017-07 Impact factor: 2.380
Authors: Rafael Alexandre Meneguz-Moreno; José de Ribamar Costa; Freddy Antônio Britto Moscoso; Rodolfo Staico; Luiz Fernando Leite Tanajura; Marinella Patrizia Centemero; Auréa Jacob Chaves; Andrea Claudia Leão de Sousa Abizaid; Amanda Guerra de Moraes Rego E Sousa; Alexandre Antonio Cunha Abizaid Journal: Arq Bras Cardiol Date: 2017-01-09 Impact factor: 2.000