Author + information
- Ivan Gomez-Blazquez1,
- Victor Jimenez Diaz2,
- Saleta Fernandez-Barbeira3,
- Guillermo Bastos Fernández4,
- Antonio De Miguel Castro4,
- Jose Antonio Baz Alonso5,
- Alberto Ortiz4 and
- Andres Iñiguez5
In-stent restenosis (ISR) constitutes a main cause of percutaneous coronary treatment failure and target vessel revascularization. Currently, the use of either drug-eluting stent (DES) or drug-coated balloon is recommended in this setting. Nevertheless, ISR lesions treated with any of both options have worse results compared with treatment of de novo lesions. Everolimus-eluting bioresorbable scaffold (BRS) is a potential alternative for ISR treatment. We aim to evaluate 1-year angiographic results after everolimus-eluting BRS implantation for ISR treatment.
Prospective observational study. Consecutive patients with ISR coronary lesions treated with BRS implantation were included. Target lesion failure (TLF) was defined as composite of cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization. Quantitative coronary analysis (QCA) of angiograms was performed by external imaging core laboratory.
From June 2013 to December 2015, a total of 56 ISR lesions in 53 patients were treated with BRS implantation (mean age of 64±10 years, 26% female, 38% diabetics. Among all lesions, 43% were ISR of DES, 18% were recalcitrant ISR, 48% had diffuse ISR pattern and 70% were B2/C. Baseline reference vessel diameter by QCA was 2.47±0.58 mm. All lesions were predilated (52% of cutting balloon dilatation). Mean diameter of BRS was 3.0±0.4 mm (23% BRS had 2.5 mm nominal diameter) with mean length of 21.2±6.4 mm. Postdilatation with non-compliant balloon was performed in 86% lesions at 21±5 atmospheres. Successful PCI was achieved in 100%, with in-segment acute gain of 0.81±0.47 mm and residual diameter stenosis of 21.3±10.5%. Angiographic follow-up at 1 year was performed in 48 patients (51 lesions, 91%). In-segment late loss was 0.23±0.38 mm and diameter stenosis 28.2±14.7%. One-year TLF rate was 11.3%, 2 patients (3.8%) had cardiac death and 4 patients (7.5%) underwent target lesion revascularization for binary restenosis. Scaffold thrombosis rate was 1.9% (1 patient with probable late thrombosis).
In our study, BRS implantation for ISR treatment was safe and it was associated with favorable angiographic outcomes at 1-year follow-up.
CORONARY: Stents: Bioresorbable Vascular Scaffolds