Serban Puricel1, Florim Cuculi2, Melissa Weissner3, Axel Schmermund4, Peiman Jamshidi2, Tobias Nyffenegger2, Harald Binder5, Holger Eggebrecht4, Thomas Münzel3, Stephane Cook1, Tommaso Gori6. 1. Department of Cardiology, University & Hospital Fribourg, Fribourg, Switzerland. 2. Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland. 3. Zentrum für Kardiologie, University Hospital Mainz, Mainz, Germany, and German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Mainz, Germany. 4. Cardioangiologisches Centrum Bethanien, Frankfurt am Main, Germany. 5. Institute of Medical Biostatistics, Epidemiology and Informatics, University Hospital Mainz, Mainz, Germany. 6. 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.
Abstract
BACKGROUND: Recent reports suggest an elevated incidence of bioresorbable vascular scaffold (BVS) thrombosis (scaffold thrombosis [ScT]). OBJECTIVES: 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).
RCT Entities:
BACKGROUND: Recent reports suggest an elevated incidence of bioresorbable vascular scaffold (BVS) thrombosis (scaffold thrombosis [ScT]). OBJECTIVES: 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: Daisuke Nakamura; Guilherme F Attizzani; Setsu Nishino; Kentaro Tanaka; Mohamad Soud; Gabriel T Pereira; Milana Leygerman; Anas Fares; Audrey Schnell; Marco A Costa; Andrejs Erglis; Hiram G Bezerra Journal: Int J Cardiovasc Imaging Date: 2017-06-08 Impact factor: 2.357
Authors: Gregg W Stone; Takeshi Kimura; Runlin Gao; Dean J Kereiakes; Stephen G Ellis; Yoshinobu Onuma; Bernard Chevalier; Charles Simonton; Ovidiu Dressler; Aaron Crowley; Ziad A Ali; Patrick W Serruys Journal: JAMA Cardiol Date: 2019-12-01 Impact factor: 14.676