Author + information
- Received April 25, 2017
- Revision received June 19, 2017
- Accepted July 12, 2017
- Published online September 18, 2017.
- Alberto Polimeni, MDa,b,
- Melissa Weissnera,
- Katharina Schochlowa,
- Helen Ullricha,
- Ciro Indolfi, MDb,
- Jouke Dijkstrac,
- Remzi Anadola,
- Thomas Münzel, MDa and
- Tommaso Gori, MD, PhDa,∗ ()
- aKardiologie I, Zentrum für Kardiologie, University Medical Center Mainz and Deutsches Zentrum für Herz und Kreislauf Forschung, Standort Rhein-Main, Germany
- bDivision of Cardiology, Department of Medical and Surgical Sciences, “Magna Graecia” University, Catanzaro, Italy
- cDivision of Image Processing, Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands
- ↵∗Address for correspondence:
Dr. Tommaso Gori, Kardiologie I, Zentrum für Kardiologie, University Medical Center Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany.
Objectives The aim of this study was to describe the incidence and clinical characteristics, including intracoronary imaging features, of clinical restenosis in bioresorbable coronary scaffolds (BRS). Further, the authors searched for clinical and procedural predictors of scaffold restenosis (ScR) and report on the clinical outcomes after treatment of ScR in a cohort of consecutive all-comer patients.
Background Data from randomized controlled trials demonstrate a higher rate of target lesion failure in patients treated with BRS as compared with those treated with metal drug-eluting stents. Although in-scaffold thrombosis has been thoroughly investigated, there are little data available on the incidence and characteristics of ScR.
Methods A total of 657 consecutive patients (age 63 ± 12 years, 79% men, 21% diabetics, 67% acute coronary syndrome) who received a total of 883 BRS for the treatment of coronary artery stenoses between May 2012 and January 2015 were enrolled in a retrospective registry.
Results During the median follow-up of 1,076 days (interquartile range: 762 to 1,206 days), a total of 49 cases of ScR were found in 41 patients (Kaplan-Meier incidence: 2.4%, 6.0%, and 9.0% at 12-, 24-, and 36-month follow-up, respectively). ScR presented as stable angina or as incidental finding in 73% of the cases. The angiographic pattern was complex (type II to IV) in 55% of the ScR lesions. The neointima was homogeneous with high signal intensity in all but 3 cases at optical coherence tomography. Prior revascularization (hazard ratio [HR]: 2.7; 95% confidence interval [CI]: 1.5 to 5.1; p = 0.002), diabetes (HR: 2.9; 95%CI: 1.5 to 5.4; p = 0.001), lesion types B2 or C (HR: 2.8; 95% CI: 1.5 to 5.4; p = 0.002), and implantation technique (HR: 0.3; 95% CI: 0.1 to 0.6; p = 0.001) emerged as independent predictors of ScR. Oversizing (HR: 6.29; 95% CI: 2.4 to 16.4), undersizing (HR: 5.15; 95% CI: 1.99 to 13.30), and a residual stenosis >27% (HR: 8.9; 95% CI: 3.6 to 21.8) were associated with an increased ScR risk.
Conclusions The 3-year incidence of ScR was similar to that observed in similar settings with newer-generation drug-eluting stents. It is often associated with a benign presentation and a complex angiographic pattern. Predictors of ScR match those of metallic stent restenosis, and the implantation technique used at index appears to play an important role.
Dr. Gori has received DZHK (German Center for Cardiac and Cardiovascular Research) funding for research. Dr. Münzel has received funding from the Center for Translational Vascular Biology, Mainz. Dr. Polimeni is a fellow of the European Association of Percutaneous Coronary Interventions. Drs. Indolfi, Münzel, and Gori have received speaker fees 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.
- Received April 25, 2017.
- Revision received June 19, 2017.
- Accepted July 12, 2017.
- 2017 American College of Cardiology Foundation