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JACC Cardiovasc Interv. 2014 Jan;7(1):89-99. doi: 10.1016/j.jcin.2013.07.007. Epub 2013 Oct 16.

A next-generation bioresorbable coronary scaffold system: from bench to first clinical evaluation: 6- and 12-month clinical and multimodality imaging results.

Author information

1
Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium. Electronic address: stefan.verheye@gmail.com.
2
Mercy Angiography Unit, Auckland, New Zealand; Auckland City Hospital, Auckland, New Zealand.
3
Auckland City Hospital, Auckland, New Zealand.
4
Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium.
5
Cardiovascular Research Center, Sao Paulo, Brazil.
6
Elixir Medical Corporation, Sunnyvale, California.

Abstract

OBJECTIVES:

This study sought to perform clinical and imaging assessments of the DESolve Bioresorbable Coronary Scaffold (BCS).

BACKGROUND:

BCS, which is drug eluting, may have potential advantages compared with conventional metallic drug-eluting stents. The DESolve system, designed to provide vessel support and neointimal suppression, combines a poly-l-lactic acid-based scaffold with the antiproliferative myolimus.

METHODS:

The DESolve First-in-Man (a non-randomized, consecutive enrollment evaluation of the DESolve myolimus eluting bioresorbable coronary stent in the treatment of patients with de novo native coronary artery lesions) trial was a prospective multicenter study enrolling 16 patients eligible for treatment. The principal safety endpoint was a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization. The principal imaging endpoint was in-scaffold late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 6 months. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging was performed at baseline and 6 months; multislice computed tomography (MSCT) was performed at 12 months.

RESULTS:

Acute procedural success was achieved in 15 of 15 patients receiving a study scaffold. At 12 months, there was no scaffold thrombosis and no major adverse cardiac events directly attributable to the scaffold. At 6 months, in-scaffold LLL (by QCA) was 0.19 ± 0.19 mm; neointimal volume (by IVUS) was 7.19 ± 3.56%, with no evidence of scaffold recoil or late malapposition. Findings were confirmed with OCT and showed uniform, thin neointimal coverage (0.12 ± 0.04 mm). At 12 months, MSCT demonstrated excellent vessel patency.

CONCLUSIONS:

This study demonstrated the feasibility and efficacy of the DESolve BCS. Results showing low in-scaffold LLL, low % neointimal volume at 6 months, no chronic recoil, and maintenance of lumen patency at 12 months prompt further study. (DESolve First-in-Man; EudraCT number 2011-000027-32).

KEYWORDS:

%DS; BCS; CK; DES; IVUS; LLL; MACE; MI; MSCT; OCT; PLLA; QCA; TLR; bioresorbable coronary scaffold; coronary disease; creatine kinase; drug-eluting; drug-eluting stent(s); imaging; intravascular ultrasound; late lumen loss; major adverse cardiac event(s); multislice computed tomography; myocardial infarction; optical coherence tomography; percent diameter stenosis; poly-l-lactic acid; quantitative coronary angiography; scaffold; stent(s); target lesion revascularization

PMID:
24139932
DOI:
10.1016/j.jcin.2013.07.007
[Indexed for MEDLINE]
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