Author + information
- Received September 1, 2015
- Revision received November 23, 2015
- Accepted December 1, 2015
- Published online March 1, 2016.
- Serban Puricel, MDa,
- Florim Cuculi, MDb,
- Melissa Weissner, MTAc,
- Axel Schmermund, MDd,
- Peiman Jamshidi, MDb,
- Tobias Nyffenegger, MDb,
- Harald Binder, PhDe,
- Holger Eggebrecht, MDd,
- Thomas Münzel, MDc,
- Stephane Cook, MDa and
- Tommaso Gori, Dott Med Chir, PhDc,∗ ()
- aDepartment of Cardiology, University & Hospital Fribourg, Fribourg, Switzerland
- bDepartment of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
- cZentrum für Kardiologie, University Hospital Mainz, Mainz, Germany, and German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Mainz, Germany
- dCardioangiologisches Centrum Bethanien, Frankfurt am Main, Germany
- eInstitute of Medical Biostatistics, Epidemiology and Informatics, University Hospital Mainz, Mainz, Germany
- ↵∗Reprint requests and correspondence:
Dr. Tommaso Gori, Zentrum für Kardiologie, University Medical Center Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany.
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)
Dr. Cuculi has received lecture fees from Abbott Vascular; and has received unrestricted grants from Abbott Vascular and SIS Medical. Drs. Schmermund has received speakers’ fees and travel expenses from Abbott Vascular. Dr. Eggebrecht has received unrestricted research grants from Abbott Vascular. Drs. Münzel and Cook have received speakers’ fees from Abbott Vascular. Drs. Münzel and Gori receive funding from the Center for Translational Vascular Biology, Mainz. Dr. Gori has received speakers’ honoraria from Abbott Vascular and St. Jude Medical. Abbott Vascular had no role in any phase of this research. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Puricel and Cuculi as well as Drs. Cook and Gori contributed equally to the study.
- Received September 1, 2015.
- Revision received November 23, 2015.
- Accepted December 1, 2015.
- American College of Cardiology Foundation