A multicenter post-marketing evaluation of the Elixir DESolve®Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study

H Nef, J Wiebe, N Boeder, O Dörr, T Bauer, KE Hauptmann, A Latib, A Colombo, D Fischer, T Rudolph, N Foin, G Richardt, C Hamm

Research output: Contribution to journalArticle

Abstract

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.
Original languageEnglish
Pages (from-to)1021-1027
Number of pages7
JournalCatheterization and Cardiovascular Interventions
Volume92
Issue number6
DOIs
Publication statusPublished - 2018

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Marketing
Equipment and Supplies
Thrombosis
Myocardial Infarction
Lactones
Coronary Artery Disease
Polymers
Pathologic Constriction
Prospective Studies
Safety
Therapeutics
poly(lactide)

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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 journalArticle

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 2018, 'A multicenter post-marketing evaluation of the Elixir DESolve®Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study', Catheterization and Cardiovascular Interventions, vol. 92, no. 6, pp. 1021-1027. https://doi.org/10.1002/ccd.27550
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. / A multicenter post-marketing evaluation of the Elixir DESolve®Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study. In: Catheterization and Cardiovascular Interventions. 2018 ; Vol. 92, No. 6. pp. 1021-1027.
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abstract = "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{\circledR} 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. {\circledC} 2018 Wiley Periodicals, Inc.",
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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 -