BIORESOLVE-ISR Study Compares Use of BVS With DCB and EES for Coronary ISR
February 5, 2018—Elisabetta Moscarella, MD, et al published 1-year follow-up results from the BIORESOLVE-ISR study in Catheterization and Cardiovascular Interventions. The study's objective is to compare the 1-year outcomes between bioresorbable vascular scaffolds (BVSs), drug-coated balloons (DCBs), and everolimus-eluting stents (EES) for treating coronary in-stent restenosis (ISR).
As summarized in Catheterization and Cardiovascular Interventions, the investigators retrospectively analyzed all ISR lesions treated via BVS, DCB, and EES from January 2012 to December 2014. A total of 548 lesions (498 patients) were included in the analysis. Applying propensity score matching, 93 lesions treated with BVSs were compared with 93 lesions treated with DCBs and 100 lesions treated with BVSs were compared to 100 lesions treated with EESs.
The investigators reported that at 1-year follow-up, the incidence of device-oriented cardiovascular events (DOCEs) and its components (cardiac death, ischemia-driven target lesion revascularization [ID-TLR], and target vessel myocardial infarction [TV-MI]) did not significantly differ.
For BVS and DCB, the results were:
- DOCE: 10.9% vs 11.8%; hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.33–2.52; P = .86
- Cardiac death: 2.2% vs 1.2%; HR, 1.74; 95% CI, 0.16–18.8; P = .65
- ID-TLR: 8.9% vs 10.7%; HR, 0.81; 95% CI, 0.27–2.48; P = .71
- TV-MI: 3.3% vs 1.2%; HR, 2.39; 95% CI, 0.27–21.32; P = .43
For BVS and EES, the results were:
- DOCE: 10.1% vs 5.2%; HR, 1.81; 95% CI, 0.63–5.25; P = .27
- Cardiac death: 3.0% vs 1.1%; HR, 2.83; 95% CI, 0.29–27.4; P = .37
- ID-TLR: 7.2% vs 4.2%; HR, 1.57; 95% CI, 0.47–5.23; P = .46
- TV-MI: 3.1% vs 0%
At 1-year follow-up, the use of a BVS as an ISR treatment was associated with a higher, even if not significant, DOCE rate compared with the EES and a similar rate compared to DCB, concluded the investigators in Catheterization and Cardiovascular Interventions.