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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Late Stent Recoil of the Bioabsorbable Everolimus-Eluting Coronary Stent and its Relationship With Plaque Morphology

Shuzou Tanimoto, MD^_*, Nico Bruining, PhD^_*,_*, Ron T. van Domburg, PhD^_*, David Rotger, BSc, Petia Radeva, PhD, Jurgen M. Ligthart, BSc^_* and Patrick W. Serruys, MD, PhD, FACC^_*

^_* Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
Computer Vision Center, Autonomous University of Barcelona, Bellaterra, Spain

Manuscript received June 1, 2007; revised manuscript received August 8, 2008, accepted August 18, 2008.

^_* Reprint requests and correspondence: Dr. Nico Bruining, Erasmus Medical Center, P.O. Box 1738, 3000 DR, Rotterdam, the Netherlands (Email: n.Bruining{at}erasmusmc.nl).

Objectives: This study sought to evaluate late recoil of a novel bioabsorbable everolimus-eluting coronary stent (BVS), which is composed of a poly-L-lactic acid backbone, coated with a bioabsorbable polymer containing everolimus.

Background: Little is known about the mechanical behavior of bioabsorbable polymer stents after deployment in diseased human coronary arteries.

Methods: The study population consisted of 16 patients, who were treated with elective BVS implantation for single de novo native coronary artery lesions and were followed at 6 months. All patients underwent an intravascular ultrasound examination at post-procedure and follow-up. A total of 484 paired cross-sectional areas (CSAs) were acquired and analyzed. Late absolute stent recoil was defined as stent area at post-procedure (X) – stent area at follow-up (Y). Late percent stent recoil was defined as (X – Y)/X x 100. In each CSA, plaque morphology was assessed qualitatively and classified as calcific, fibronecrotic, or fibrocellular plaque.

Results: Late absolute and percent recoil of the BVS was 0.65 ± 1.71 mm² (95% confidence interval [CI]: 0.49 to 0.80 mm²) and 7.60 ± 23.3% (95% CI: 5.52% to 9.68%). Calcified plaques resulted in significantly less late recoil (0.20 ± 1.54 mm² and 1.97 ± 22.2%) than fibronecrotic plaques (1.03 ± 2.12 mm² and 12.4 ± 28.0%, p = 0.001 and p = 0.001, respectively) or fibrocellular plaque (0.74 ± 1.48 mm² and 8.90 ± 19.8%, p = 0.001 and p = 0.001, respectively).

Conclusions: The BVS shrank in size during the follow-up period. The lesion morphology of stented segments might affect the degree of late recoil of the BVS. (ABSORB Everolimus Eluting Coronary Stent System First in Man Clinical Investigation; NCT00300131)

Key Words: bioabsorbable • coronary artery disease • recoil • stents

Abbreviations and Acronyms   AS = acoustic shadowing   BVS = bioabsorbable everolimus-eluting coronary stent   CI = confidence interval   CSA = cross-sectional area   ECG = electrocardiogram   IVUS = intravascular ultrasound   PLLA = poly-L-lactic acid   QCA = quantitative coronary angiography

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