First-in-Human Evaluation of a Bioabsorbable Polymer–Coated Sirolimus-Eluting Stent
| Autor: | Guilherme F. Attizzani, Robert Whitbourn, Dennis Donohoe, John A. Ormiston, Jim Stewart, Mark Webster, Peter J. Fitzgerald, David E. Kandzari, Charlene Knape, Alexandra J. Lansky, Mathias Vrolix, William Wijns |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
medicine.diagnostic_test business.industry Unstable angina medicine.medical_treatment Percutaneous coronary intervention Stent equipment and supplies medicine.disease Surgery Coronary arteries Coronary artery disease medicine.anatomical_structure Intravascular ultrasound Angiography medicine cardiovascular diseases Myocardial infarction business Cardiology and Cardiovascular Medicine |
| Zdroj: | JACC: Cardiovascular Interventions. 6(10):1026-1034 |
| ISSN: | 1936-8798 |
| DOI: | 10.1016/j.jcin.2013.05.013 |
| Popis: | Objectives This first-in-human multicenter study sought to examine prospectively the safety and efficacy of a new, cobalt chromium thin-strut, coronary absorbable polymer–coated, sirolimus-eluting stent. Background Bioabsorbable polymers on drug-eluting stents may lower the long-term risks of inflammation, delayed healing, and adverse events. Methods We enrolled patients with symptomatic coronary artery disease with stable or unstable angina pectoris and >50% diameter stenosis, amenable to coverage with a ≤23-mm long stent in a vessel 2.5 to 3.5 mm in diameter. All patients received dual antiplatelet therapy after implantation. Patients, in groups of 10, underwent repeat angiography, intravascular ultrasound, and optical coherence tomography at 4, 6, or 8 months, and all patients were seen or contacted at 18 months of follow-up. Results The median (range) in-stent late lumen loss (LLL) was 0.03 mm (−0.22 to 0.21 mm), 0.10 mm (−0.03 to 1.2 mm), and 0.08 mm (−0.01 to 0.28 mm), at 4, 6, and 8 months, respectively. At 18 months, the median in-stent LLL was 0.08 mm (−0.30 to 0.46 mm). On optical coherence tomography, the proportion of uncovered stent struts decreased from a median of 7.3% (range 0.4% to 46.3%) at 4 months to 0% (range: 0% to 3.4%) at 18 months. The percentage of neointimal volume obstruction by intravascular ultrasound increased from a median of 5.3% to 9.1% between 4 and 6 months and remained nearly unchanged thereafter through 18 months of follow-up. The only recorded major adverse cardiac event was a myocardial infarction. Conclusions At 18 months of follow-up, this absorbable polymer–coated, cobalt chromium sirolimus-eluting stent was associated with a low and stable in-stent LLL, complete strut coverage, and no stent thrombosis. (First-In-Human Trial of the MiStent Drug-Eluting Stent [DES] in Coronary Artery Disease [DESSOLVE-I]; NCT01247428 ) |
| Databáze: | OpenAIRE |
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