Abstract:
BACKGROUND:Outcomes after percutaneous coronary interventions in diabetic patients are shadowed by the increased rate of recurrence compared with nondiabetic patients. METHODS AND RESULTS:We conducted a multicenter, randomized trial to demonstrate the efficacy of sirolimus-eluting stents compared with standard stents to prevent restenosis in diabetic patients with de novo lesions in native coronary arteries. The primary end point of the trial was in-segment late lumen loss as assessed by quantitative coronary angiography at 9-month follow-up. The trial was stratified by diabetes treatment status. One hundred sixty patients were randomized to sirolimus-eluting stents (80 patients; 111 lesions) or standard stent implantation (80 patients; 110 lesions). On average, reference diameter was 2.34+/-0.6 mm, lesion length was 15.0+/-8 mm, and 13.1% of lesions were chronic total occlusions. In-segment late lumen loss was reduced from 0.47+/-0.5 mm for standard stents to 0.06+/-0.4 mm for sirolimus stents (P<0.001). Target-lesion revascularization and major adverse cardiac event rates were significantly lower in the sirolimus group (31.3% versus 7.3% and 36.3% versus 11.3%, respectively; both P<0.001). Non-insulin- and insulin-requiring patients demonstrated similar reductions in angiographic and clinical parameters of restenosis after sirolimus-eluting stent implantation. During the 9-month follow-up, stent thrombosis occurred in 2 patients after standard stent implantation. Conversely, this phenomenon was not seen in the sirolimus stent group. CONCLUSIONS:This randomized trial demonstrated that sirolimus stent implantation is safe and efficacious in reducing both angiographic and clinical parameters of restenosis compared with standard stents in diabetic patients with de novo coronary stenoses.
journal_name
Circulationjournal_title
Circulationauthors
Sabaté M,Jiménez-Quevedo P,Angiolillo DJ,Gómez-Hospital JA,Alfonso F,Hernández-Antolín R,Goicolea J,Bañuelos C,Escaned J,Moreno R,Fernández C,Fernández-Avilés F,Macaya C,DIABETES Investigators.doi
10.1161/CIRCULATIONAHA.105.562421subject
Has Abstractpub_date
2005-10-04 00:00:00pages
2175-83issue
14eissn
0009-7322issn
1524-4539pii
112/14/2175journal_volume
112pub_type
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