Clinical and intravascular imaging outcomes at 1 and 2 years after implantation of absorb everolimus eluting bioresorbable vascular scaffolds in small vessels. Late lumen enlargement: does bioresorption matter with small vessel size? Insight from the ABSORB cohort B trial

• Published in: Heart (British Cardiac Society) Vol. 99; no. 2; pp. 98 - 105
• Main Authors: Diletti, Roberto, Farooq, Vasim, Girasis, Chrysafios, Bourantas, Christos, Onuma, Yoshinobu, Heo, Jung Ho, Gogas, Bill D, van Geuns, Robert-Jan, Regar, Evelyn, de Bruyne, Bernard, Dudek, Dariusz, Thuesen, Leif, Chevalier, Bernard, McClean, Dougal, Windecker, Stephan, Whitbourn, Robert J, Smits, Pieter, Koolen, Jacques, Meredith, Ian, Li, Xiaolin, Miquel-Hebert, Karine, Veldhof, Susan, Garcia-Garcia, Hector M, Ormiston, John A, Serruys, Patrick W
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd and British Cardiovascular Society 01.01.2013; BMJ Publishing Group; BMJ Publishing Group LTD
• Subjects: Absorbable Implants; Adolescent; Adult; Aged; Biological and medical sciences; Blood clots; Cardiology. Vascular system; Clinical outcomes; Coronary Angiography; Coronary Artery Disease; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - surgery; Coronary vessels; Coronary Vessels - diagnostic imaging; Coronary Vessels - surgery; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Heart attacks; Humans; Immunosuppressive Agents - pharmacology; Male; Medical imaging; Medical sciences; Middle Aged; Prospective Studies; Prosthesis Design; Sirolimus - analogs & derivatives; Sirolimus - pharmacology; Stents; Time Factors; Tissue Scaffolds; Treatment Outcome; Ultrasonography, Interventional - methods; Veins & arteries; Young Adult; California; Late; Prognosis; Size; Blood vessel; Medical imagery; Implantation; Circulatory system; Immunosuppressive agent; Cardiology; Everolimus
• ISSN: 1355-6037; 1468-201X
• DOI: 10.1136/heartjnl-2012-302598

Background The long-term results after second generation everolimus eluting bioresorbable vascular scaffold (Absorb BVS) placement in small vessels are unknown. Therefore, we investigated the impact of vessel size on long-term outcomes, after Absorb BVS implantation. Methods In ABSORB Cohort B Trial, out of the total study population (101 patients), 45 patients were assigned to undergo 6-month and 2-year angiographic follow-up (Cohort B1) and 56 patients to have angiographic follow-up at 1-year (Cohort B2). The pre-reference vessel diameter (RVD) was <2.5 mm (small-vessel group) in 41 patients (41 lesions) and ≥2.5 mm (large-vessel group) in 60 patients (61 lesions). Outcomes were compared according to pre-RVD. Results At 2-year angiographic follow-up no differences in late lumen loss (0.29±0.16 mm vs 0.25±0.22 mm, p=0.4391), and in-segment binary restenosis (5.3% vs 5.3% p=1.0000) were demonstrated between groups. In the small-vessel group, intravascular ultrasound analysis showed a significant increase in vessel area (12.25±3.47 mm2 vs 13.09±3.38 mm2 p=0.0015), scaffold area (5.76±0.96 mm2 vs 6.41±1.30 mm2 p=0.0008) and lumen area (5.71±0.98 mm2 vs 6.20±1.27 mm2 p=0.0155) between 6-months and 2-year follow-up. No differences in plaque composition were reported between groups at either time point. At 2-year clinical follow-up, no differences in ischaemia-driven major adverse cardiac events (7.3% vs 10.2%, p=0.7335), myocardial infarction (4.9% vs 1.7%, p=0.5662) or ischaemia-driven target lesion revascularisation (2.4% vs 8.5%, p=0.3962) were reported between small and large vessels. No deaths or scaffold thrombosis were observed. Conclusions Similar clinical and angiographic outcomes at 2-year follow-up were reported in small and large vessel groups. A significant late lumen enlargement and positive vessel remodelling were observed in small vessels.