Polymer-free sirolimus-eluting versus polymer-based paclitaxel-eluting stents: an individual patient data analysis of randomized trials.
OBJECTIVE
The angiographic and clinical efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents remain a matter of debate. We sought to investigate angiographic and clinical measures of efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents.


METHODS
Patient data from the randomized intracoronary stenting and angiographic restenosis-test equivalence between the 2 drug-eluting stents (ISAR-TEST) clinical trial and the LIPSIA Yukon clinical trial (randomized comparison of a polymer-free sirolimus-eluting stent vs a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus) were pooled. The angiographic (primary) endpoint was in-stent late lumen loss at 6 months to 9 months. The clinical (secondary) endpoints were death or myocardial infarction, cardiac death or myocardial infarction, target lesion revascularization, and myocardial infarction.


RESULTS
A total of 686 patients (polymer-free sirolimus-eluting stents, n=345 vs polymer-based paclitaxel-eluting stents, n=341) and 751 lesions (polymer-free sirolimus-eluting stents, n=383 vs polymer-based paclitaxel-eluting stents, n=368) were included in the study. Control angiography (606 lesions, 80.6%) showed comparable in-stent late lumen loss for polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents (0.53 [0.59] mm vs 0.46 [0.57] mm; P=.15). Median follow-up was 34.8 months. Polymer-free sirolimus-eluting stents and polymer-based paclitaxel-eluting stents were associated with comparable risk of death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0.49-2.80; P=.71), cardiac death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0.72-1.89; P=.50), target lesion revascularization (relative risk=0.98; 95% confidence interval, 0.65-1.47; P=.93), and myocardial infarction (relative risk=1.79; 95% confidence interval, 0.85-3.76; P=.12).


CONCLUSIONS
In this pooled analysis, polymer-free sirolimus-eluting stents were comparable to polymer-based paclitaxel-eluting stents with respect to both angiographic and clinical efficacy.
Deutsches Herzzentrum, Technische Universität, München, Germany.
Salvatore
S
Cassese
Department of Internal Medicine/Cardiology, University of Leipzig-Heart Center, Leipzig, Germany.
Steffen
S
Desch
Deutsches Herzzentrum, Technische Universität, München, Germany. Electronic address: kastrati@dhm.mhn.de.
Adnan
A
Kastrati
Deutsches Herzzentrum, Technische Universität, München, Germany.
Robert A
RA
Byrne
Deutsches Herzzentrum, Technische Universität, München, Germany.
Lamin
L
King
Deutsches Herzzentrum, Technische Universität, München, Germany.
Tomohisa
T
Tada
Department of Cardiology, Zentralklinik Bad Berka, Bad Berka, Germany.
Bernward
B
Lauer
Deutsches Herzzentrum, Technische Universität, München, Germany; 1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, München, Germany.
Albert
A
Schömig
Department of Internal Medicine/Cardiology, University of Leipzig-Heart Center, Leipzig, Germany.
Holger
H
Thiele
Deutsches Herzzentrum, Technische Universität, München, Germany.
Jürgen
J
Pache
D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000627:therapeutic use*; D003327:Coronary Disease / Q000628:therapy*; D054855:Drug-Eluting Stents; D023381:Endpoint Determination; D005260:Female; D006083:Graft Occlusion, Vascular / Q000453:epidemiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use*; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage* / Q000627:therapeutic use*; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus