title: Bioresorbable Coronary Scaffold Thrombosis: Multicenter Comprehensive Analysis of Clinical Presentation, Mechanisms, and Predictors.
abstract: BACKGROUND
  Recent reports suggest an elevated incidence of bioresorbable vascular scaffold (BVS) thrombosis (scaffold thrombosis [ScT]).
  
  
  OBJECTIVE
  This study investigated occurrence rates, clinical and angiographic characteristics, and possible mechanisms of ScT in all-comer patients undergoing BVS implantation at 2 German and 2 Swiss hospitals.
  
  
  METHODS
  A total of 1,305 consecutive patients (mean age 64 years, 78% male) who received 1,870 BVS (mean 1.4 ± 0.8 BVS/patient) were enrolled. Clinical/procedural characteristics, mortality, and ScT data at 485 days (range 312 to 652 days) were examined.
  
  
  RESULTS
  ScT occurred in 42 patients. The incidence of probable and definite ScT was 1.8% at 30 days and 3.0% at 12 months, without differences among centers (p = 0.60). A total of 22 (52%) ScTs presented as ST-segment elevation myocardial infarction and 6 (17%) as sudden cardiac death. In multivariable analysis, ostial lesions (p = 0.049) and impaired left ventricular ejection fraction (p = 0.019) were independently associated with ScT. Nine (21%) of the ScTs occurred in patients who had suspended dual antiplatelet therapy, in 6 cases prematurely. Lower post-procedural minimum lumen and reference vessel diameters were hallmarks of ScT (all p < 0.0001). The risk of ScT appeared to rapidly increase for post-procedural minimum lumen diameters below 2.4 mm (for the 2.5- to 3.0-mm BVS) and 2.8 mm (for the 3.5-mm BVS). When a BVS-specific implantation strategy was implemented, 12-month ScT rates fell from 3.3% to 1.0%, an effect that remained significant when adjusted for multivariable propensity score (p = 0.012; hazard ratio: 0.19; 95% confidence interval: 0.05 to 0.70).
  
  
  CONCLUSIONS
  The 12-month incidence of ScT reached 3% and could be significantly reduced when an optimized implantation strategy was employed. (retrospective multicentric registry and Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry [MICAT]; NCT02180178).
authors.affiliation: Department of Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.
authors.forename: Serban
authors.initials: S
authors.lastname: Puricel
authors.affiliation: Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.
authors.forename: Florim
authors.initials: F
authors.lastname: Cuculi
authors.affiliation: Zentrum für Kardiologie, University Hospital Mainz, Mainz, Germany, and German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Mainz, Germany.
authors.forename: Melissa
authors.initials: M
authors.lastname: Weissner
authors.affiliation: Cardioangiologisches Centrum Bethanien, Frankfurt am Main, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Schmermund
authors.affiliation: Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.
authors.forename: Peiman
authors.initials: P
authors.lastname: Jamshidi
authors.affiliation: Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.
authors.forename: Tobias
authors.initials: T
authors.lastname: Nyffenegger
authors.affiliation: Institute of Medical Biostatistics, Epidemiology and Informatics, University Hospital Mainz, Mainz, Germany.
authors.forename: Harald
authors.initials: H
authors.lastname: Binder
authors.affiliation: Cardioangiologisches Centrum Bethanien, Frankfurt am Main, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Eggebrecht
authors.affiliation: Zentrum für Kardiologie, University Hospital Mainz, Mainz, Germany, and German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Mainz, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Münzel
authors.affiliation: Department of Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.
authors.forename: Stephane
authors.initials: S
authors.lastname: Cook
authors.affiliation: Zentrum für Kardiologie, University Hospital Mainz, Mainz, Germany, and German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Mainz, Germany. Electronic address: tommaso.gori@unimedizin-mainz.de.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Gori
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects*; D054058:Acute Coronary Syndrome / Q000601:surgery*; D000368:Aged; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D005260:Female; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006083:Graft Occlusion, Vascular / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011474:Prosthesis Design; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D013557:Switzerland / Q000453:epidemiology; D013997:Time Factors; D054457:Tissue Scaffolds / Q000009:adverse effects*
keywords: bioresorbable scaffold; stent thrombosis