Two-year clinical outcomes after paclitaxel-eluting stent or brachytherapy treatment for bare metal stent restenosis: the TAXUS V ISR trial.
OBJECTIVE
This study sought to investigate the 2-year outcomes of patients treated with the paclitaxel-eluting TAXUS((R)) stent (PES) or vascular brachytherapy (VBT), the previous 'gold standard therapy', for bare metal stent in-stent restenosis (ISR).


RESULTS
In the TAXUS V-ISR trial, 396 patients with bare metal stent ISR referred for percutaneous coronary intervention were prospectively randomized to either PES or beta source VBT. The present analysis reports 24-month clinical outcomes from that study. Between 9 and 24 months, ischaemia-driven target lesion revascularization tended to be required less frequently with assignment to PES compared to VBT (5.3 vs. 10.3%, P = .07). As a result, ischaemia-driven target lesion revascularization at 24 months was significantly reduced with PES compared with VBT (10.1 vs. 21.6%, P = 0.003), as was ischaemia-driven target vessel revascularization (18.1 vs. 27.5%, P = .03). There were no significant differences between the two groups with regard to death, myocardial infarction, or target vessel thrombosis either between 12 and 24 months, or cumulative to 24 months.


CONCLUSIONS
Freedom from clinical restenosis at 2 years is significantly enhanced after PES placement compared with VBT for bare metal stent ISR, with similar rates of death, myocardial infarction, and target vessel thrombosis.
Department of Cardiovascular Medicine, Cleveland Clinic, 9500 Euclid Avenue, F25, Cleveland, OH 44195, USA. elliss@ccf.org
Stephen G
SG
Ellis
Charles D
CD
O'Shaughnessy
Steven L
SL
Martin
Kenneth
K
Kent
Thomas
T
McGarry
Mark A
MA
Turco
Dean J
DJ
Kereiakes
Jeffrey J
JJ
Popma
Mark
M
Friedman
Joerg
J
Koglin
Gregg W
GW
Stone
D000368:Aged; D001918:Brachytherapy; D023903:Coronary Restenosis / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D017239:Paclitaxel / Q000008:administration & dosage*; D012307:Risk Factors; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage*
D050257:Tubulin Modulators; D017239:Paclitaxel