Abstract | AIMS: 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. METHODS AND 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). CONCLUSION: 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.
|
Authors | Yoshinobu Onuma, Patrick W Serruys, Neville Kukreja, Susan Veldhof, Julie Doostzadeh, Sherry Cao, Gregg W Stone, SPIRIT II and III Investigators |
Journal | European heart journal
(Eur Heart J)
Vol. 31
Issue 9
Pg. 1071-8
(May 2010)
ISSN: 1522-9645 [Electronic] England |
PMID | 20118171
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Tubulin Modulators
- Everolimus
- Paclitaxel
- Sirolimus
|
Topics |
- Aged
- Cell Proliferation
(drug effects)
- Coronary Restenosis
(mortality, prevention & control)
- Drug-Eluting Stents
- Everolimus
- Female
- Follow-Up Studies
- Graft Occlusion, Vascular
(etiology)
- Humans
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Paclitaxel
(administration & dosage)
- Sirolimus
(administration & dosage, analogs & derivatives)
- Treatment Outcome
- Tubulin Modulators
(administration & dosage)
|