Randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the diabetes and sirolimus-eluting stent (DIABETES) trial.
BACKGROUND
Outcomes after percutaneous coronary interventions in diabetic patients are shadowed by the increased rate of recurrence compared with nondiabetic patients.


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.
Sabaté
Manel
M
The Cardiovascular Institute, San Carlos University Hospital, Madrid, Spain. manelsabate@telefonica.net
Jiménez-Quevedo
Pilar
P
Angiolillo
Dominick J
DJ
Gómez-Hospital
Joan Antoni
JA
Alfonso
Fernando
F
Hernández-Antolín
Rosana
R
Goicolea
Javier
J
Bañuelos
Camino
C
Escaned
Javier
J
Moreno
Raúl
R
Fernández
Cristina
C
Fernández-Avilés
Francisco
F
Macaya
Carlos
C
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000900:Anti-Bacterial Agents; D023903:Coronary Restenosis / Q000453:epidemiology; D023921:Coronary Stenosis / Q000628:therapy*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003925:Diabetic Angiopathies / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020123:Sirolimus; D015607:Stents
D000900:Anti-Bacterial Agents; D020123:Sirolimus