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Coronary In-Stent Restenosis SABRE Trial: 1-Year Outcomes
Study Questions:
What is the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR)?
Methods:
SABRE was a prospective, single-arm feasibility study at nine European centers, where 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months were reported, along with 12-month clinical follow-up. The primary safety endpoint was target lesion failure (TLF) at 30 days, a composite of cardiac death, target vessel myocardial infarction (MI), and clinically driven TLR. Frequency data were analyzed using Chi-square or Fisher’s exact test, depending on minimal attribute count; p values < 0.05 were considered to be statistically significant.
Results:
Procedural success in the intent-to-treat (ITT) population was 100%. The primary safety endpoint was TLF (cardiac death, target vessel MI, and clinically-driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm, n = 47). Secondary 6-month endpoints included binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per protocol (PP) population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the ITT group were 12.2% TLF and 14.3% MACE and, for the PP population, 2.8% TLF and 2.8% MACE.
Conclusions:
The authors concluded that this first-in-human study showed excellent procedural success for the sirolimus-eluting angioplasty balloon.
Perspective:
This single-arm pilot study reports that the use of a microporous balloon to deliver sirolimus nanoparticles to the vessel wall was both feasible and safe and may represent a new approach to treatment of ISR. These promising findings need to be evaluated further in appropriately powered clinical trials with an active comparator arm and hard clinical endpoints.
Keywords: Angiography, Angioplasty, Balloon, Constriction, Pathologic, Coronary Restenosis, Myocardial Infarction, Myocardial Revascularization, Nanoparticles, Sirolimus, Stents
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