First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study.

Abstract

BACKGROUND:

Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confirm the absence of late restenosis or unfavorable imaging outcomes.

METHODS AND RESULTS:

The ABSORB trial is a multicenter single-arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm(2) on optical coherence tomography and 0.17±0.26 mm(2) on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm(2) on intravascular ultrasound, P=0.003 and 0.77±1.33 m(2) on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis.

CONCLUSIONS:

This serial analysis of the second generation of the everolimus-eluting bioresorbable vascular scaffold confirmed, at medium term, the safety and efficacy of the new device.

CLINICAL TRIAL REGISTRATION:

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.

• Authors: John A Ormiston, Patrick W Serruys, Yoshinobu Onuma, Robert-Jan van Geuns, Bernard de Bruyne, Dariusz Dudek, Leif Thuesen, Pieter C Smits, Bernard Chevalier, Dougal McClean, Jacques Koolen, Stephan Windecker, Robert Whitbourn, Ian Meredith, Cecile Dorange, Susan Veldhof, Karine Miquel Hebert, Richard Rapoza, Hector M Garcia-Garcia
• Journal: Circulation. Cardiovascular interventions (Circ Cardiovasc Interv) Vol. 5 Issue 5 Pg. 620-32 (Oct 2012) ISSN: 1941-7632 [Electronic] United States
• PMID: 23048057 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Cardiovascular Agents
• Coated Materials, Biocompatible
• Everolimus
• Sirolimus

Topics

• Absorbable Implants
• Aged
• Angioplasty, Balloon, Coronary (adverse effects, instrumentation)
• Australia
• Cardiovascular Agents (administration & dosage)
• Coated Materials, Biocompatible
• Coronary Angiography
• Coronary Artery Disease (diagnosis, physiopathology, therapy)
• Coronary Restenosis (diagnosis, etiology)
• Coronary Thrombosis (diagnosis, etiology)
• Coronary Vessels (diagnostic imaging, pathology, physiopathology)
• Diagnostic Imaging (methods)
• Drug-Eluting Stents
• Europe
• Everolimus
• Female
• Humans
• Male
• Middle Aged
• Neointima
• New Zealand
• Predictive Value of Tests
• Prosthesis Design
• Risk Factors
• Sirolimus (administration & dosage, analogs & derivatives)
• Time Factors
• Tissue Scaffolds
• Tomography, Optical Coherence
• Treatment Outcome
• Ultrasonography, Interventional