Key result
Absorb bioresorbable vascular scaffold yields 0% MACE at one month in observational cohort.
Why the study?
The clinical outcomes of Absorb everolimus-eluting bioresorbable vascular scaffold in longer lesions and smaller vessels without mandatory IVUS imaging were not well established.
Cohort (n=88)
Yes
Treatment with the Absorb everolimus-eluting bioresorbable vascular scaffold in longer lesions and smaller vessels without obligatory IVUS use is safe and efficacious at one month.
Short-term procedural success holds with extended Absorb BVS criteria sans mandatory IVUS; leaves open long-term safety versus stents in broader lesions.
AIMS: The clinical outcome of patients treated with the everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) in the ABSORB Cohort A and B studies using mandatory intravascular ultrasound (IVUS) imaging showed encouraging results. The ABSORB EXTEND study aimed to include longer lesions, allow overlap and did not oblige IVUS imaging. We assessed the procedural and short-term clinical outcomes in a cohort including these extended criteria. METHODS AND RESULTS: Patients included in three study cohorts (ABSORB Cohort A, Cohort B and EXTEND) at two centres in Rotterdam were systematically followed for major adverse cardiac events (MACE). Clinical data were obtained for 88 patients (mean age 61.2 years, 73% male) with a total of 92 lesions. Lesion length was significantly longer in the ABSORB EXTEND cohort 11.34±4.01 mm (9.20±2.66 mm; p<0.01) and the reference vessel diameter was smaller 2.53±0.34 mm (2.87±0.38 mm; p<0.001) compared to previous cohorts. Predilatation was performed with a balloon diameter of 2.5±0.3 mm and inflated to a maximum pressure of 12.6±3.2 atm. The scaffold was successfully implanted in 90 of the 92 lesions (97.8%) with a maximum pressure of 14.1±2.8 atm. Post-dilatation was performed in 55% of the patients (53% EXTEND vs. 56% Cohort A and B; p=0.7). The acute gain was 1.21±0.37 mm. Absolute recoil was 0.16±0.20 mm with percentage acute recoil of 5.60±6.60%. At one month, none of the patients had a MACE. CONCLUSIONS: This study, which constitutes the largest combined study cohort of patients treated with the Absorb BVS in Rotterdam, shows that treatment of longer lesions and smaller vessels without obligatory IVUS use is safe and efficacious at one month.
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Şimşek et al. (2014) conducted a cohort in Coronary artery disease (n=88). Absorb everolimus-eluting bioresorbable vascular scaffold was evaluated on Major adverse cardiac events (MACE). Treatment with the Absorb everolimus-eluting bioresorbable vascular scaffold resulted in 0% major adverse cardiac events at one month.
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