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
- Roberto Diletti1,
- Vasim Farooq1,
- Chrysafios Girasis1,
- Christos Bourantas1,
- Yoshinobu Onuma1,
- Jung Ho Heo1,
- Bill D Gogas1,
- Robert-Jan van Geuns1,
- Evelyn Regar1,
- Bernard de Bruyne2,
- Dariusz Dudek3,
- Leif Thuesen4,
- Bernard Chevalier5,
- Dougal McClean6,
- Stephan Windecker7,
- Robert J Whitbourn8,
- Pieter Smits9,
- Jacques Koolen10,
- Ian Meredith11,
- Xiaolin Li12,
- Karine Miquel-Hebert13,
- Susan Veldhof13,
- Hector M Garcia-Garcia14,
- John A Ormiston15,
- Patrick W Serruys1
- 1Department of Interventional Cardiology, Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands
- 2Department of Interventional Cardiology, Cardiovascular Center Aalst, Aalst, Belgium
- 3Department of Cardiology, Jagiellonian University, Krakow, Poland
- 4Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, Skejby, Aarhus, Denmark
- 5Department of Cardiology, Institut Hospitalier Jacques Cartier, Massy, France
- 6Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand
- 7Department of Cardiology, Bern University Hospital, Bern, Switzerland
- 8Department of Cardiology, St Vincents Hospital, Melbourne, Fitzroy, Victoria, Australia
- 9Department of Interventional Cardiology, Maasstad Ziekenhuis Rotterdam, Rotterdam, The Netherlands
- 10Department of Interventional Cardiology, Catharina Ziekenhuis, Eindhoven, The Netherlands
- 11Department of Interventional Cardiology, Monash Medical Centre, Victoria, Australia
- 12Abbott Vascular, Santa Clara, California, USA
- 13Abbott Vascular, Diegem, Belgium
- 14Cardialysis B.V., Rotterdam, The Netherlands
- 15Department of Cardiology, Auckland City Hospital, Auckland, New Zealand
- Correspondence to Professor Patrick W Serruys, Interventional Cardiology Department, Erasmus MC, 's-Gravendijkwal 230, Rotterdam 3015 CE, The Netherlands; p.w.j.c.serruys{at}erasmusmc.nl
- Received 18 June 2012
- Revised 6 September 2012
- Accepted 19 September 2012
- Published Online First 31 October 2012
Abstract
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.
