Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes.

Abstract

BACKGROUND:

The first generation of the bioresorbable everolimus drug-eluting vascular scaffold showed signs of shrinkage at 6 months, which largely contributed to late luminal loss. Nevertheless, late luminal loss was less than that observed with bare metal stents. To maintain the mechanical integrity of the device up to 6 months, the scaffold design and manufacturing process of its polymer were modified.

METHODS AND RESULTS:

Quantitative coronary angiography, intravascular ultrasound with analysis of radiofrequency backscattering, and as an optional assessment, optical coherence tomography (OCT) were performed at baseline and at a 6-month follow-up. Forty-five patients successfully received a single bioresorbable everolimus drug-eluting vascular scaffold. One patient had postprocedural release of myocardial enzyme without Q-wave occurrence; 1 patient with OCT-diagnosed disruption of the scaffold caused by excessive postdilatation was treated 1 month later with a metallic drug-eluting stent. At follow-up, 3 patients declined recatheterization, 42 patients had quantitative coronary angiography, 37 had quantitative intravascular ultrasound, and 25 had OCT. Quantitative coronary angiography disclosed 1 edge restenosis (1 of 42; in-segment binary restenosis, 2.4%). At variance with the ultrasonic changes seen with the first generation of bioresorbable everolimus drug-eluting vascular scaffold at 6 months, the backscattering of the polymeric struts did not decrease over time, the scaffold area was reduced by only 2.0% with intravascular ultrasound, and no change was noted with OCT. On an intention-to-treat basis, the late lumen loss amounted to 0.19±0.18 mm with a limited relative decrease in minimal luminal area of 5.4% on intravascular ultrasound. OCT showed at follow-up that 96.8% of the struts were covered and that malapposition of at least 1 strut, initially observed in 12 scaffolds, was detected at follow-up in only 3 scaffolds. Mean neointimal growth measured by OCT between and on top of the polymeric struts equaled 1.25 mm(2), or 16.6% of the scaffold area.

CONCLUSION:

Modified manufacturing process of the polymer and geometric changes in the polymeric platform have substantially improved the medium-term performance of this new generation of drug-eluting scaffold to become comparable to those of current drug eluting stents.

CLINICAL TRIAL REGISTRATION:

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

• Authors: Patrick W Serruys, Yoshinobu Onuma, John A Ormiston, Bernard de Bruyne, Evelyn Regar, Dariusz Dudek, Leif Thuesen, Pieter C Smits, Bernard Chevalier, Dougal McClean, Jacques Koolen, Stephan Windecker, Robert Whitbourn, Ian Meredith, Cécile Dorange, Susan Veldhof, Karine Miquel-Hebert, Richard Rapoza, Hector M García-García
• Journal: Circulation (Circulation) Vol. 122 Issue 22 Pg. 2301-12 (Nov 30 2010) ISSN: 1524-4539 [Electronic] United States
• PMID: 21098436 (Publication Type: Evaluation Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Polymers
• Everolimus
• Sirolimus

Topics

• Absorbable Implants
• Aged
• Coronary Angiography
• Coronary Stenosis (diagnostic imaging, pathology, therapy)
• Coronary Vessels (diagnostic imaging, pathology)
• Drug-Eluting Stents
• Everolimus
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Polymers
• Retrospective Studies
• Sirolimus (analogs & derivatives)
• Time Factors
• Tissue Scaffolds
• Tomography, Optical Coherence (methods)
• Treatment Outcome
• Ultrasonography