Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 1021-1027 |
| Number of pages | 7 |
| Journal | Catheterization and Cardiovascular Interventions |
| Volume | 92 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - 2018 |
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A multicenter post-marketing evaluation of the Elixir DESolve®Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study. / Nef, H; Wiebe, J; Boeder, N; Dörr, O; Bauer, T; Hauptmann, KE; Latib, A; Colombo, A; Fischer, D; Rudolph, T; Foin, N; Richardt, G; Hamm, C.
In: Catheterization and Cardiovascular Interventions, Vol. 92, No. 6, 2018, p. 1021-1027.Research output: Contribution to journal › Article
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TY - JOUR
T1 - A multicenter post-marketing evaluation of the Elixir DESolve®Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study
AU - Nef, H
AU - Wiebe, J
AU - Boeder, N
AU - Dörr, O
AU - Bauer, T
AU - Hauptmann, KE
AU - Latib, A
AU - Colombo, A
AU - Fischer, D
AU - Rudolph, T
AU - Foin, N
AU - Richardt, G
AU - Hamm, C
PY - 2018
Y1 - 2018
N2 - Objectives: To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease. Background: The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. Methods: One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. Results: The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54±0.44 mm, with a reduction in % diameter stenosis from 61.00±11.29 to 12.69±0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. Conclusions: Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed. © 2018 Wiley Periodicals, Inc.
AB - Objectives: To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease. Background: The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. Methods: One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. Results: The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54±0.44 mm, with a reduction in % diameter stenosis from 61.00±11.29 to 12.69±0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. Conclusions: Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed. © 2018 Wiley Periodicals, Inc.
U2 - 10.1002/ccd.27550
DO - 10.1002/ccd.27550
M3 - Article
VL - 92
SP - 1021
EP - 1027
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
SN - 1522-1946
IS - 6
ER -