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Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Mehilli, Julinda Kastrati, Adnan Wessely, Rainer Dibra, Alban Hausleiter, Jörg Jaschke, Birgit Dirschinger, Josef Schoemig, Albert |
| Copyright Year | 2006 |
| Abstract | BACKGROUND Although drug-eluting stents (DESs) constitute a major achievement in preventing restenosis, concerns remain regarding the increased inflammatory and thrombogenic responses associated with the polymers used. Recently, we showed that a nonpolymer on-site coating with rapamycin not only is feasible and safe but also leads to a dose-dependent reduction in restenosis. METHODS AND RESULTS To assess whether polymer-free stents coated on-site with 2% rapamycin solution are inferior to polymer-based paclitaxel-eluting stents for the prevention of restenosis, we randomly assigned a total of 450 patients with de novo lesions in native coronary vessels, excluding the left main trunk, to either the polymer-free, rapamycin-coated Yukon DES (rapamycin stent) or the polymer-based, paclitaxel-eluting Taxus stent (paclitaxel stent). The primary end point was in-stent late lumen loss. Secondary end points were angiographic restenosis and target lesion revascularization. The study was designed to test the noninferiority of the rapamycin stent compared with the paclitaxel stent with respect to late lumen loss according to a noninferiority margin of 0.13 mm. Follow-up angiography was completed in 81% of the patients. The mean difference in in-stent late lumen loss between the rapamycin-stent group and the paclitaxel-stent group was 0.002 mm, and the upper limit of the 1-sided 95% confidence interval was 0.10 mm (P=0.02 from test for noninferiority). No significant differences were observed regarding angiographic restenosis rates (14.2% with the rapamycin stent and 15.5% with the paclitaxel stent) and target lesion revascularization rates due to restenosis (9.3% in both groups). CONCLUSIONS The polymer-free, rapamycin-coated stent has an antirestenotic effect that is not inferior to that observed with the polymer-based paclitaxel-eluting stent. |
| Starting Page | 353 |
| Ending Page | 360 |
| Page Count | 8 |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | http://www.sficv.com/images/files/nonpolymerstent.pdf |
| Alternate Webpage(s) | http://circ.ahajournals.org/content/circulationaha/113/2/273.full.pdf?download=true |
| PubMed reference number | 16391155v1 |
| Volume Number | 113 |
| Issue Number | 2 |
| Journal | Circulation |
| Language | English |
| Access Restriction | Open |
| Subject Keyword | Blood Vessel Confidence Intervals Coronary Vessels Diethylstilbestrol Drug-Eluting Stents Hearing Loss, High-Frequency Neoplasm Metastasis Paclitaxel Patients PersonNameUse - assigned Polymers Sensorineural Hearing Loss (disorder) Sirolimus Stent Device Component Stent, device Structure of lumen of body system Taxus angiogram restenosis revascularization |
| Content Type | Text |
| Resource Type | Article |
