Randomised comparison of a bioresorbable everolimuseluting scaffold with a metallic everolimus-eluting stent for ischaemic heart disease caused by de novo native coronary artery lesions: The 2-year clinical outcomes of the ABSORB II trial

EuroIntervention

Volumn 12, Issue 9, 2016, Pages 1102-1107

  Chevalier, Bernard ^a   Onuma, Yoshinobu ^b   Van Boven, Ad J ^c   Piek, Jan J ^d   Sabaté, Manel ^e   Helqvist, Steffen ^f   Baumbach, Andreas ^g   Smits, Pieter C ^h   Kumar, Ravindra ⁱ   Wasungu, Luc ⁱ   Serruys, Patrick W ^j  

^a INSTITUT CARDIOVASCULAIRE PARIS SUD   (France)

^b ERASMUS MEDICAL CENTER   (Netherlands)

^c MEDICAL CENTER LEEUWARDEN   (Netherlands)

^d ACADEMIC MEDICAL CENTER   (Netherlands)

^e UNIVERSITY OF BARCELONA   (Spain)

^f UNIVERSITY OF COPENHAGEN   (Denmark)

^g The Bristol Heart Institute Hospital   (United Kingdom)

^h Maasstad Hospital   (Netherlands)

ⁱ ABBOTT VASCULAR   (United States)

^j IMPERIAL COLLEGE LONDON   (United Kingdom)

more..

Author keywords

Bioresorbable scaffold; Everolimus; Metallic stent; Randomised trial

Indexed keywords

ADULT; ARTICLE; BIORESORBABLE SCAFFOLD; CARDIOVASCULAR MORTALITY; CONTROLLED STUDY; CORONARY ARTERY DISEASE; CORONARY ARTERY LESION; CORONARY ARTERY RECANALIZATION; DEVICE SAFETY; EVEROLIMUS ELUTING CORONARY STENT; EVEROLIMUS ELUTING SCAFFOLD; FEMALE; HEART INFARCTION; HUMAN; INCIDENCE; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MALE; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; STENT THROMBOSIS; TARGET LESION REVASCULARIZATION; TARGET VESSEL REVASCULARIZATION; TREATMENT OUTCOME; AGED; BIODEGRADABLE IMPLANT; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; COMPLICATION; DRUG ELUTING STENT; GRAFT OCCLUSION, VASCULAR; HEART MUSCLE REVASCULARIZATION; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; MYOCARDIAL INFARCTION; MYOCARDIAL ISCHEMIA; PERCUTANEOUS CORONARY INTERVENTION; POSTOPERATIVE COMPLICATIONS; SINGLE BLIND PROCEDURE; THROMBOSIS; TISSUE SCAFFOLD; UTILIZATION;

ANTINEOPLASTIC AGENT; EVEROLIMUS;

ABSORBABLE IMPLANTS; AGED; ANTINEOPLASTIC AGENTS; CARDIOVASCULAR DISEASES; CORONARY ARTERY DISEASE; DRUG-ELUTING STENTS; EVEROLIMUS; FEMALE; GRAFT OCCLUSION, VASCULAR; HUMANS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; MYOCARDIAL ISCHEMIA; MYOCARDIAL REVASCULARIZATION; PERCUTANEOUS CORONARY INTERVENTION; POSTOPERATIVE COMPLICATIONS; SINGLE-BLIND METHOD; THROMBOSIS; TISSUE SCAFFOLDS; TREATMENT OUTCOME;

EID: 84994609154     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJY16M08_01     Document Type: Article

References (11)

1. Onuma Y, Dudek D, Thuesen L, Webster M, Nieman K, Garcia-Garcia HM, Ormiston JA, Serruys PW. Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB cohort A trial. JACC Cardiovasc Interv. 2013;6:999-1009.
2. Serruys PW, Ormiston J, van Geuns RJ, de Bruyne B, Dudek D, Christiansen E, Chevalier B, Smits P, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Wasungu L, Ediebah D, Veldhof S, Onuma Y. A Polylactide Bioresorbable Scaffold Eluting Everolimus for Treatment of Coronary Stenosis: 5-Year Follow-Up. J Am Coll Cardiol. 2016;67:766-76.
3. Diletti R, Serruys PW, Farooq V, Sudhir K, Dorange C, Miquel-Hebert K, Veldhof S, Rapoza R, Onuma Y, Garcia-Garcia HM, Chevalier B. ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vas-cular scaffold system against the XIENCE everolimus-eluting coro-nary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design. Am Heart J. 2012;164:654-63.
4. Serruys PW, Chevalier B, Dudek D, Cequier A, Carrie D, Iniguez A, Dominici M, van der Schaaf RJ, Haude M, Wasungu L, Veldhof S, Peng L, Staehr P, Grundeken MJ, Ishibashi Y, Garcia-Garcia HM, Onuma Y. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015;385:43-54.
5. Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015;373:1905-15.
6. Gao R, Yang Y, Han Y, Huo Y, Chen J, Yu B, Su X, Li L, Kuo HC, Ying SW, Cheong WF, Zhang Y, Xu B, Popma JJ, Stone GW. Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease: ABSORB China Trial. J Am Coll Cardiol. 2015;66:2298-309.
7. Kimura T, Kozuma K, Tanabe K, Nakamura S, Yamane M, Muramatsu T, Saito S, Yajima J, Hagiwara N, Mitsudo K, Popma JJ, Serruys PW, Onuma Y, Ying S, Cao S, Staehr P, Cheong WF, Kusano H, Stone GW; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015;36:3332-42.
8. Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016;387:1277-89.
9. Puricel S, Cuculi F, Weissner M, Schmermund A, Jamshidi P, Nyffenegger T, Binder H, Eggebrecht H, Munzel T, Cook S, Gori T. Bioresorbable Coronary Scaffold Thrombosis: Multicenter Comprehensive Analysis of Clinical Presentation, Mechanisms, and Predictors. J Am Coll Cardiol. 2016;67:921-31.
10. Karanasos A, Van Mieghem N, van Ditzhuijzen N, Felix C, Daemen J, Autar A, Onuma Y, Kurata M, Diletti R, Valgimigli M, Kauer F, van Beusekom H, de Jaegere P, Zijlstra F, van Geuns RJ, Regar E. Angiographic and optical coherence tomography insights into bioresorbable scaffold thrombosis: single-center experience. Circ Cardiovasc Interv. 2015;8(5).
11. Otsuka F, Pacheco E, Perkins LE, Lane JP, Wang Q, Kamberi M, Frie M, Wang J, Sakakura K, Yahagi K, Ladich E, Rapoza RJ, Kolodgie FD, Virmani R. Long-term safety of an everolimus-eluting bioresorbable vascular scaffold and the cobalt-chromium XIENCE V stent in a porcine coronary artery model. Circ Cardiovasc Interv. 2014;7:330-42.