Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial.
OBJECTIVE
Although 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.


RESULTS
This 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, P(non-inferiority) 0.005; relative risk = 0.96 (95% confidence interval, 0.78-1.17), P(superiority) = 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.


CONCLUSIONS
A 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. The trial was registered at ClinicalTrials.gov (identifier: NCT00598676).
Byrne
Robert A
RA
ISAResearch Center, Deutsches Herzzentrum, Technische Universität, Lazarettstrasse 36, 80636 Munich, Germany. byrne@dhm.mhn.de
Kastrati
Adnan
A
Kufner
Sebastian
S
Massberg
Steffen
S
Birkmeier
K Anette
KA
Laugwitz
Karl-Ludwig
KL
Schulz
Stefanie
S
Pache
Jürgen
J
Fusaro
Massimiliano
M
Seyfarth
Melchior
M
Schömig
Albert
A
Mehilli
Julinda
J
D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D023903:Coronary Restenosis / Q000517:prevention & control*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006083:Graft Occlusion, Vascular / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000209:etiology; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage*; D055815:Young Adult
D050257:Tubulin Modulators; D000068338:Everolimus; D020123:Sirolimus