Yuki Ishibashi1, Takashi Muramatsu2, Shimpei Nakatani1, Yohei Sotomi3, Pannipa Suwannasom1, Maik J Grundeken3, Yun-Kyeong Cho1, Hector M Garcia-Garcia1, Ad J van Boven4, Jan J Piek3, Manel Sabaté5, Steffen Helqvist6, Andreas Baumbach7, Dougal McClean8, Manuel de Sousa Almeida9, Luc Wasungu10, Karine Miquel-Hebert10, Dariusz Dudek11, Bernard Chevalier12, Yoshinobu Onuma1, Patrick W Serruys13. 1. Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. 2. Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan. 3. The Heart Center, Academic Medical Center, Amsterdam, the Netherlands. 4. Medical Center Leeuwarden, Leeuwarden, the Netherlands. 5. Thorax Institute, Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. 6. Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. 7. Bristol Heart Institute, Bristol, United Kingdom. 8. Christchurch Hospital, Christchurch, New Zealand. 9. Hospital Santa Cruz, Carnaxide, Portugal. 10. Abbott Vascular, Diegem, Belgium. 11. Jagiellonian University, Krakow, Poland. 12. Institut Jacques Cartier, Massy, France. 13. International Centre for Cardiovascular Health, Imperial College, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.
Abstract
OBJECTIVES: This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation. BACKGROUND: A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periprocedural myocardial injury. METHODS: In 501 patients with stable or unstable angina randomized to either Absorb (335 patients) orEES (n = 166) in the ABSORB II trial, 3 types of CB (creatine kinase, creatine kinase-myocardial band, and troponin) were obtained before and after procedure. Per protocol, periprocedural myocardial infarction (PMI) was defined as creatine kinase rise >2× the upper limit of normal with creatine kinase-myocardial band rise. RESULTS:Incidence of side branch occlusion and any anatomic complications assessed by angiography was similar between the 2 treatment arms (side branch occlusion: Absorb: 5.3% vs. Xience: 7.6%, p = 0.07; any anatomic complication: Absorb: 16.4% vs. EES: 19.9%, p = 0.39). Fourteen patients who presented with recent myocardial infarction at entry with normalized creatine kinase-myocardial band according to the protocol were excluded for post-CB analysis. The overall compliance for CB was 97.8%. The CB rise subcategorized in 7 different ranges was comparable between the 2 treatment arms. PMI rate was numerically higher in the Absorb arm according to the per-protocol definitions, and treatment with overlapping devices was the only independent determinant of per-protocol PMI (odds ratio: 5.07, 95% confidence interval: 1.78 to 14.41, p = 0.002). CONCLUSIONS: There were no differences in the incidence of CB rise and PMI between Absorb and EES. Device overlap might be a precipitating factor of myocardial injury. (ABSORB II Randomized Clinical Trial: A Clinical Evaluation to Compare the Safety, Efficacy, and Performance of Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System Against Xience Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by De Novo Native Coronary Artery Lesions [ABSORB II]; NCT01425281).
RCT Entities:
OBJECTIVES: This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation. BACKGROUND: A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periprocedural myocardial injury. METHODS: In 501 patients with stable or unstable angina randomized to either Absorb (335 patients) or EES (n = 166) in the ABSORB II trial, 3 types of CB (creatine kinase, creatine kinase-myocardial band, and troponin) were obtained before and after procedure. Per protocol, periprocedural myocardial infarction (PMI) was defined as creatine kinase rise >2× the upper limit of normal with creatine kinase-myocardial band rise. RESULTS: Incidence of side branch occlusion and any anatomic complications assessed by angiography was similar between the 2 treatment arms (side branch occlusion: Absorb: 5.3% vs. Xience: 7.6%, p = 0.07; any anatomic complication: Absorb: 16.4% vs. EES: 19.9%, p = 0.39). Fourteen patients who presented with recent myocardial infarction at entry with normalized creatine kinase-myocardial band according to the protocol were excluded for post-CB analysis. The overall compliance for CB was 97.8%. The CB rise subcategorized in 7 different ranges was comparable between the 2 treatment arms. PMI rate was numerically higher in the Absorb arm according to the per-protocol definitions, and treatment with overlapping devices was the only independent determinant of per-protocol PMI (odds ratio: 5.07, 95% confidence interval: 1.78 to 14.41, p = 0.002). CONCLUSIONS: There were no differences in the incidence of CB rise and PMI between Absorb and EES. Device overlap might be a precipitating factor of myocardial injury. (ABSORB II Randomized Clinical Trial: A Clinical Evaluation to Compare the Safety, Efficacy, and Performance of Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System Against Xience Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by De Novo Native Coronary Artery Lesions [ABSORB II]; NCT01425281).
Authors: Heerajnarain Bulluck; Valeria Paradies; Emanuele Barbato; Andreas Baumbach; Hans Erik Bøtker; Davide Capodanno; Raffaele De Caterina; Claudio Cavallini; Sean M Davidson; Dmitriy N Feldman; Péter Ferdinandy; Sebastiano Gili; Mariann Gyöngyösi; Vijay Kunadian; Sze-Yuan Ooi; Rosalinda Madonna; Michael Marber; Roxana Mehran; Gjin Ndrepepa; Cinzia Perrino; Stefanie Schüpke; Johanne Silvain; Joost P G Sluijter; Giuseppe Tarantini; Gabor G Toth; Linda W Van Laake; Clemens von Birgelen; Michel Zeitouni; Allan S Jaffe; Kristian Thygesen; Derek J Hausenloy Journal: Eur Heart J Date: 2021-07-15 Impact factor: 29.983