Author + information
- Received September 8, 2017
- Revision received November 28, 2017
- Accepted November 29, 2017
- Published online April 2, 2018.
- Stephen G. Ellis, MDa,∗ (, )
- Tommaso Gori, MD, PhDb,
- Patrick W. Serruys, MD, PhDc,
- Holger Nef, MDd,
- Giuseppe Steffenino, MDe,
- Salvatore Brugaletta, MD, PhDf,
- Thomas Munzel, MDb,
- Cordula Feliz, MDc,
- Götz Schmidt, MDd,
- Manel Sabaté, MD, PhDf,
- Yoshinobu Onuma, MDc,
- R.J. van Geuns, MDc,
- Run-Lin Gao, MDg,
- Maurizio Menichelli, MDh,
- Dean J. Kereiakes, MDi,
- Gregg W. Stone, MDj,
- Luca Testa, MDk,
- Takeshi Kimura, MDl and
- Alexandre Abizaid, MDm
- aCleveland Clinic, Cleveland, Ohio
- bKardiologie I, Universitatsmedizin Mainz and DZHK Standort Rhein-Main, Germany
- cCardiovascular Science Division of the National Heart and Lung Institute (NHLI), Faculty of Medicine, Imperial College, London, United Kingdom
- dUKGM Universitatsklinikum Giessen, Giessen, Germany
- eASO S. Croce, Cuneo, Italy
- fHospital Clinic, Institut Clinic Cardiovascular, Barcelona, Spain
- gFuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- hDivision of Cardiology, Spaziani Hospital, Frosinone, Italy
- iThe Christ Hospital Heart and Vascular Center and The Lindner Research Center, Cincinnati, Ohio
- jColumbia University Medical Center, NewYork-Presbyterian Hospital, New York, New York
- kIRCCS Policlinico San Donato Department of Cardiology, Milan, Italy
- lDepartment of Cardiovascular Medicine at Kyoto University, Kyoto, Japan
- mInstituto Dante Pazzanese de Cardiologa-Fundacão, São Paulo, Brazil
- ↵∗Address for correspondence:
Dr. Stephen G. Ellis, Cleveland Clinic, 9500 Euclid Avenue, J2-3, Cleveland, Ohio 44195.
Objectives The aim of this study was to identify independent correlates of very late scaffold thrombosis (VLST) from an analysis of consecutively treated patients from 15 multicenter studies.
Background Recent analyses suggest an increased risk for VLST with the Absorb Bioresorbable Vascular Scaffold compared with drug-eluting stents, but insights as to correlates of risk are limited.
Methods A total of 55 patients were identified with scaffold thrombosis. They were matched 2:1 with control subjects selected randomly from patients without thrombosis from the same study. Quantitative coronary angiography was available for 96.4% of patients. Multiple logistic and Cox regression analysis were used to identify significant independent outcome correlates from 6 pre-specified characteristics.
Results Patients had scaffold thrombosis at a median of 20 months (interquartile range: 17 to 27 months). Control subjects were followed for 36 months (interquartile range: 24 to 38 months). For the combined groups, reference vessel diameter (RVD) was 2.84 ± 0.50 mm, scaffold length was 26 ± 16 mm, and post-dilatation was performed in 56%. Univariate correlates of thrombosis were smaller nominal scaffold/RVD ratio (linear p = 0.001; ratio <1.18:1; odds ratio: 7.5; p = 0.002) and larger RVD (linear p = 0.001; >2.72 mm; odds ratio: 3.4; p = 0.001). Post-dilatation at ≥16 atm, post-dilatation balloon/scaffold ratio, final percentage stenosis, and dual antiplatelet therapy were not correlated with VLST. Only scaffold/RVD ratio remained a significant independent correlate of VLST (p = 0.001), as smaller ratio was correlated with RVD (p < 0.001). Post hoc analysis of 8 other potential covariates revealed no other correlates of outcome.
Conclusions In the present analysis, the largest to date of its type, relative scaffold undersizing was the strongest determinant of VLST. Given current understanding of “scaffold dismantling,” this finding likely has ramifications for all bioresorbable scaffolds.
Dr. Ellis is a consultant for Abbott Vascular. Dr. Gori has received speaking honoraria (<$10,000) from Abbott Vascular. Dr. Serruys is a consultant for Abbott Vascular. Dr. Munzel has received speaking honoraria from Abbott Vascular. Dr. Sabaté is a consultant for Abbott Vascular. Dr. van Geuns has received speaking honoraria from Abbott Vascular; and the Thoraxcenter, Erasmus Medical Center, has received a research grant from Abbott Vascular. Dr. Kimura has received a research grant from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 8, 2017.
- Revision received November 28, 2017.
- Accepted November 29, 2017.