Randomized comparison of everolimus- and paclitaxel-eluting stents: pooled analysis of the 2-year clinical follow-up from the SPIRIT II and III trials.
OBJECTIVE
To investigate the clinical impact of the following observations in the randomized SPIRIT II and III trials: an incremental increase in in-stent neointima between 1 and 2 years with the everolimus-eluting stent (EES) but not with the paclitaxel-eluting stent (PES) in SPIRIT II; a tendency of lower stent thrombosis in EES than in PES among those who first discontinued a thienopyridine after 6 months.


RESULTS
A pooled analysis was performed using the 2-year clinical data from the SPIRIT II and III trials randomizing a total of 1302 patients with de novo coronary artery lesions either to EES or to PES. Inclusion and exclusion criteria were comparable between two trials. Major adverse cardiac event (MACE) was defined as cardiac death, myocardial infarction, or ischaemia-driven target lesion revascularization (TLR). At 2 years, MACE rates were 7.1% in EES vs. 12.3% in PES, respectively (log-rank P = 0.0014), without late increase in TLR. Among those who first discontinued a thienopyridine after 6 months, Academic Research Consortium (ARC) definite or probable stent thrombosis was 1.1% in EES vs. 1.3% in PES (P = 1.00).


CONCLUSIONS
The benefits of EES in reducing TLR were robust between 6 months and 2 years. No significant difference in the thrombosis rate among those who first stopped a thienopyridine after 6 months was observed.
Onuma
Yoshinobu
Y
Thoraxcenter, Erasmus Medical Center, Ba-583, s Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands.
Serruys
Patrick W
PW
Kukreja
Neville
N
Veldhof
Susan
S
Doostzadeh
Julie
J
Cao
Sherry
S
Stone
Gregg W
GW
D000368:Aged; D049109:Cell Proliferation / Q000187:drug effects; D023903:Coronary Restenosis / Q000401:mortality / Q000517:prevention & control*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage*
D050257:Tubulin Modulators; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus