2-year clinical and angiographic outcomes from a randomized trial of polymer-free dual drug-eluting stents versus polymer-based Cypher and Endeavor [corrected] drug-eluting stents.
OBJECTIVE
In the ISAR-TEST-2 (Intracoronary Stenting and Angiographic Results: Test Efficacy of Three Limus-Eluting Stents) randomized trial, a new-generation sirolimus- and probucol-eluting stent (Dual-DES) demonstrated a 12-month efficacy that was comparable to sirolimus-eluting stents (SES) (Cypher, Cordis Corp., Warren, New Jersey) and superior to zotarolimus-eluting stents (ZES) (Endeavor, Medtronic CardioVascular, Santa Rosa, California). The aim of the current study was to investigate the comparative clinical and angiographic effectiveness of SES, Dual-DES, and ZES between 1 and 2 years.


BACKGROUND
Long-term polymer residue is implicated in adverse events associated with delayed vessel healing after drug-eluting stent therapy. The second-generation ZES utilizes an enhanced biocompatibility polymer system whereas a new-generation Dual-DES employs a polymer-free drug-release system.


METHODS
A total of 1,007 patients undergoing coronary stenting of de novo lesions in native vessels were randomized to treatment with SES (n = 335), Dual-DES (n = 333), or ZES (n = 339). Clinical follow-up was performed to 2 years. Angiographic follow-up was scheduled at 6 to 8 months and 2 years.


RESULTS
There were no significant differences between groups regarding death/myocardial infarction (SES: 10.2% vs. Dual-DES: 7.8% vs. ZES: 9.2%; p = 0.61) or definite stent thrombosis (SES: 0.9% vs. Dual-DES: 0.9% vs. ZES: 0.6%; p = 0.87). Two-year target lesion revascularization (TLR) was 10.7%, 7.7%, and 14.3% lesions in the SES, Dual-DES, and ZES groups, respectively (p = 0.009). Incident TLR between 1 and 2 years in the Dual-DES group (0.9%) was significantly lower than in the Cypher SES group (3.6%) (p = 0.009), but comparable to the Endeavor ZES group (0.7%) (p = 0.72). These findings mirrored those observed for binary restenosis.


CONCLUSIONS
At 2 years, there was no signal of a differential safety profile between the 3 stent platforms. Furthermore, the antirestenotic efficacy of both Dual-DES and ZES remained durable between 1 and 2 years, with Dual-DES maintaining an advantage over the entire 2-year period. (Intracoronary Stenting and Angiographic Results: Test Efficacy of Three Limus-Eluting Stents [ISAR-TEST-2]; NCT00332397).
Byrne
Robert A
RA
Deutsches Herzzentrum, Technische Universität, Munich, Germany. byrne@dhm.mhn.de
Kastrati
Adnan
A
Tiroch
Klaus
K
Schulz
Stefanie
S
Pache
Jürgen
J
Pinieck
Susanne
S
Massberg
Steffen
S
Seyfarth
Melchior
M
Laugwitz
Karl-Ludwig
KL
Birkmeier
Katrin A
KA
Schömig
Albert
A
Mehilli
Julinda
J
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000401:mortality / Q000473:pathology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging* / Q000401:mortality / Q000628:therapy*; D003331:Coronary Vessels / Q000187:drug effects; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011108:Polymers; D011336:Probability; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D018570:Risk Assessment; D012720:Severity of Illness Index; D020123:Sirolimus / Q000494:pharmacology; D015607:Stents; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
D011108:Polymers; D020123:Sirolimus