TY - JOUR
T1 - Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings
T2 - The Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial
AU - Byrne, Robert A.
AU - Kastrati, Adnan
AU - Kufner, Sebastian
AU - Massberg, Steffen
AU - Birkmeier, K. Anette
AU - Laugwitz, Karl Ludwig
AU - Schulz, Stefanie
AU - Pache, Jürgen
AU - Fusaro, Massimiliano
AU - Seyfarth, Melchior
AU - Schömig, Albert
AU - Mehilli, Julinda
N1 - Funding Information:
Study design and analysis were performed by Deutsches Herzzentrum, Munich, and was industry independent. Funding was provided in part by the Bavarian Research Foundation (BFS-ISAR Aktenzeichen AZ: 504/02 and BFS-DES Aktenzeichen AZ: 668/05).
Funding Information:
R.A.B. was supported by a Research Fellowship in Atherothrombo-sis from the European Society of Cardiology.
PY - 2009/10
Y1 - 2009/10
N2 - AimsAlthough biodegradable polymer drug-eluting stent (DES) platforms have potential to enhance long-term clinical outcomes, data concerning their efficacy are limited to date. We previously demonstrated angiographic antirestenotic efficacy with a microporous, biodegradable polymer DES. In the current study, we hypothesized that at 12 months, its clinical safety and efficacy would be non-inferior to that of permanent polymer DES.Methods and resultsThis prospective, randomized, open-label, active-controlled trial was conducted at two tertiary referral cardiology centres in Munich, Germany. Patients presenting with stable coronary disease or acute coronary syndromes undergoing DES implantation in de novo native-vessel coronary lesions were randomly assigned to treatment with biodegradable polymer DES (rapamycin-eluting; n = 1299) or permanent polymer DES (n = 1304: rapamycin-eluting, Cypher, n = 652; or everolimus-eluting, Xience, n = 652) and underwent clinical follow-up to 1 year. The primary endpoint was a composite of cardiac death, myocardial infarction (MI) related to the target vessel, or revascularization related to the target lesion (TLR). Biodegradable polymer DES was non-inferior to permanent polymer DES concerning the primary endpoint [13.8 vs. 14.4, respectively, Pnon-inferiority 0.005; relative risk = 0.96 (95 confidence interval, 0.78-1.17), Psuperiority = 0.66]. Biodegradable polymer DES in comparison with permanent polymer DES showed similar rates of cardiac death or MI related to the target vessel (6.3 vs. 6.2, P = 0.94), TLR (8.8 vs. 9.4, P = 0.58), and stent thrombosis (definite/probable: 1.0 vs. 1.5, P = 0.29). Subgroup analysis of the biodegradable polymer DES vs. individual Cypher and Xience stent arms revealed no signal of performance difference.ConclusionA biodegradable polymer rapamycin-eluting stent is non-inferior to permanent polymer-based DES in terms of clinical efficacy over 1 year. These results provide a framework for testing the potential clinical advantage of biodegradable polymer DES over the medium to long term.
AB - AimsAlthough biodegradable polymer drug-eluting stent (DES) platforms have potential to enhance long-term clinical outcomes, data concerning their efficacy are limited to date. We previously demonstrated angiographic antirestenotic efficacy with a microporous, biodegradable polymer DES. In the current study, we hypothesized that at 12 months, its clinical safety and efficacy would be non-inferior to that of permanent polymer DES.Methods and resultsThis prospective, randomized, open-label, active-controlled trial was conducted at two tertiary referral cardiology centres in Munich, Germany. Patients presenting with stable coronary disease or acute coronary syndromes undergoing DES implantation in de novo native-vessel coronary lesions were randomly assigned to treatment with biodegradable polymer DES (rapamycin-eluting; n = 1299) or permanent polymer DES (n = 1304: rapamycin-eluting, Cypher, n = 652; or everolimus-eluting, Xience, n = 652) and underwent clinical follow-up to 1 year. The primary endpoint was a composite of cardiac death, myocardial infarction (MI) related to the target vessel, or revascularization related to the target lesion (TLR). Biodegradable polymer DES was non-inferior to permanent polymer DES concerning the primary endpoint [13.8 vs. 14.4, respectively, Pnon-inferiority 0.005; relative risk = 0.96 (95 confidence interval, 0.78-1.17), Psuperiority = 0.66]. Biodegradable polymer DES in comparison with permanent polymer DES showed similar rates of cardiac death or MI related to the target vessel (6.3 vs. 6.2, P = 0.94), TLR (8.8 vs. 9.4, P = 0.58), and stent thrombosis (definite/probable: 1.0 vs. 1.5, P = 0.29). Subgroup analysis of the biodegradable polymer DES vs. individual Cypher and Xience stent arms revealed no signal of performance difference.ConclusionA biodegradable polymer rapamycin-eluting stent is non-inferior to permanent polymer-based DES in terms of clinical efficacy over 1 year. These results provide a framework for testing the potential clinical advantage of biodegradable polymer DES over the medium to long term.
KW - Biodegradable
KW - Coronary restenosis
KW - Drug-eluting stents
KW - Polymer
KW - Rapamycin
UR - http://www.scopus.com/inward/record.url?scp=73949089126&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehp352
DO - 10.1093/eurheartj/ehp352
M3 - Article
C2 - 19720642
AN - SCOPUS:73949089126
SN - 0195-668X
VL - 30
SP - 2441
EP - 2449
JO - European Heart Journal
JF - European Heart Journal
IS - 20
ER -