SMART: The microstent's ability to limit restenosis trial.
In this randomized, prospective, multicenter trial (n = 661) of patients with de novo or restenotic coronary lesions, 330 patients received the MicroStent(R) II (MSII), and 331 received the Palmaz-Schatz (PS) stent. The short-term procedural success rates were 94.4% and 95.7%, respectively (P = 0.47). The 30-day cumulative incidence of major adverse events [death, myocardial infarction, CVA, target lesion revascularization (TLR)] was 6.4% for the MSII and 4.5% for the PS stent (P = 0.31). The in-stent binary restenosis rate at 6 months was 25.2% for the MSII and 22.1% for the PS stent (P = 0.636). Using Kaplan-Meier estimates, the incidence of clinically driven TLR was 8.9% for the MSII and 9.2% for the PS stent at 180 days; at 270 days, it was 12.8% and 12.1%, respectively (P = 0.83). MSII and the PS stents were comparable with respect to short-term procedural success, complications, and late clinical and angiographic restenosis.
Phoenix Heart Center, Arizona 85016, USA. phoenixheart@earthlink.net
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R
Heuser
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Lopez
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Kuntz
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Reduto
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Badger
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Coleman
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Whitlow
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LA
Iannone
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Safian
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Yeung
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Moses
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012008:Recurrence; D015607:Stents