PMID- 29216999 OWN - NLM STAT- MEDLINE DCOM- 20180730 LR - 20190127 IS - 1876-7605 (Electronic) IS - 1936-8798 (Linking) VI - 10 IP - 23 DP - 2017 Dec 11 TI - Characteristics, Predictors, and Mechanisms of Thrombosis in Coronary Bioresorbable Scaffolds: Differences Between Early and Late Events. PG - 2363-2371 LID - S1936-8798(17)31716-8 [pii] LID - 10.1016/j.jcin.2017.08.020 [doi] AB - OBJECTIVES: The study sought to investigate the incidence, characteristics, predictors, and possible mechanisms of early and 3-year coronary scaffold thrombosis (ScT). BACKGROUND: An increased incidence of both early and late ScT has been shown in randomized trials. METHODS: Consecutive patients were enrolled in a single-center registry. Quantitative coronary angiography was performed. Incidence and predictors of ScT were assessed with Kaplan-Meier and Cox regression analyses. RESULTS: A total of 657 patients (63 +/- 12 years of age, 79% men, 21% diabetic, 64% acute coronary syndrome) who received 925 coronary bioresorbable scaffolds (BRS) (Abbott Vascular, Santa Clara, California) between May 2012 and January 2015 were enrolled. Clinical and procedural characteristics and outcome data at 1,076 (interquartile range: 762 to 1,206) days (3-year follow-up rate 93%) were collected. Twenty-eight ScTs were recorded: 14 early (Kaplan-Meier estimate: 2.2%), 5 late (Kaplan-Meier estimate: 0.9%), and 9 very late (Kaplan-Meier estimate: 1.7%). The incidence of ScT followed a U-shaped curve with highest incidence at the extremes of the distributions of reference vessel diameter (RVD) and the ratio of BRS nominal diameter to RVD. At quantitative coronary angiography, RVD (hazard ratio [HR]: 0.14; 95% confidence interval [CI]: 0.04 to 0.49) and BRS oversizing (ratio of BRS nominal diameter to RVD >1.15; HR: 107.40; 95% CI: 9.20 to 1,261.30) emerged as potent predictors of early ScT. RVD (HR: 9.55; 95% CI: 3.90 to 23.42) and BRS undersizing (ratio of BRS nominal diameter to RVD <0.85; HR: 0.0004; 95% CI: 0.0000 to 0.0400) predicted late or very late ScT (all p < 0.0001). The incidence of both early and late or very late ScT were lower ( approximately 80% reduction) when an optimal implantation technique was used. The most important factor appeared to be vessel and BRS sizing. CONCLUSIONS: Different mechanisms underlie early and late ScT: although incomplete BRS deployment was a predictor of the former, the latter was associated with large vessel size and BRS undersizing. However, both phenomena are significantly less frequent with an optimized implantation technique. (Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry [MICAT]; NCT02180178). CI - Copyright (c) 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. FAU - Gori, Tommaso AU - Gori T AD - Zentrum fur Kardiologie, University Hospital Mainz, Mainz, Germany; German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Germany. Electronic address: tommaso.gori@unimedizin-mainz.de. FAU - Weissner, Melissa AU - Weissner M AD - Zentrum fur Kardiologie, University Hospital Mainz, Mainz, Germany; German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Germany. FAU - Gonner, Svenja AU - Gonner S AD - Zentrum fur Kardiologie, University Hospital Mainz, Mainz, Germany; German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Germany. FAU - Wendling, Franziska AU - Wendling F AD - Zentrum fur Kardiologie, University Hospital Mainz, Mainz, Germany; German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Germany. FAU - Ullrich, Helen AU - Ullrich H AD - Zentrum fur Kardiologie, University Hospital Mainz, Mainz, Germany; German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Germany. FAU - Ellis, Stephen AU - Ellis S AD - Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. FAU - Anadol, Remzi AU - Anadol R AD - Zentrum fur Kardiologie, University Hospital Mainz, Mainz, Germany; German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Germany. FAU - Polimeni, Alberto AU - Polimeni A AD - Zentrum fur Kardiologie, University Hospital Mainz, Mainz, Germany; German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Germany. FAU - Munzel, Thomas AU - Munzel T AD - Zentrum fur Kardiologie, University Hospital Mainz, Mainz, Germany; German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Germany. LA - eng SI - ClinicalTrials.gov/NCT02180178 PT - Comparative Study PT - Journal Article PL - United States TA - JACC Cardiovasc Interv JT - JACC. Cardiovascular interventions JID - 101467004 SB - IM CIN - JACC Cardiovasc Interv. 2017 Dec 11;10(23):2372-2374. PMID: 29217000 MH - *Absorbable Implants MH - Aged MH - Coronary Angiography MH - Coronary Thrombosis/diagnostic imaging/*epidemiology/mortality MH - Female MH - Germany/epidemiology MH - Humans MH - Incidence MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - Percutaneous Coronary Intervention/*adverse effects/*instrumentation MH - Proportional Hazards Models MH - Prosthesis Design MH - Registries MH - Risk Factors MH - ST Elevation Myocardial Infarction/epidemiology MH - Time Factors MH - Treatment Outcome OTO - NOTNLM OT - bioresorbable scaffold OT - stent thrombosis EDAT- 2017/12/09 06:00 MHDA- 2018/07/31 06:00 CRDT- 2017/12/09 06:00 PHST- 2017/06/27 00:00 [received] PHST- 2017/08/11 00:00 [revised] PHST- 2017/08/14 00:00 [accepted] PHST- 2017/12/09 06:00 [entrez] PHST- 2017/12/09 06:00 [pubmed] PHST- 2018/07/31 06:00 [medline] AID - S1936-8798(17)31716-8 [pii] AID - 10.1016/j.jcin.2017.08.020 [doi] PST - ppublish SO - JACC Cardiovasc Interv. 2017 Dec 11;10(23):2363-2371. doi: 10.1016/j.jcin.2017.08.020.