Comparison of three-year clinical outcomes between sirolimus-versus paclitaxel-eluting stents in diabetic patients: prospective randomized multicenter trial.
BACKGROUND
Three-year follow-up of major adverse cardiovascular event (MACE) (death, nonfatal myocardial infarction, target lesion revascularization) and the predictors of MACEs in diabetic patients after sirolimus-eluting stent (SES) or paclitaxel-eluting stent (PES) implantation have not been reported.


METHODS
Diabetic patients with de novo coronary lesions (169 patients with 190 lesions) were randomly assigned prospectively to either SES or PES.


RESULTS
Baseline characteristics were similar between the two groups. The rates of MACEs [5.9% (n = 5) in the SES vs. 9.5% (n = 8) in the PES Group, P = 0.374] and definite stent thrombosis [1.2% (n = 1) in the SES vs. 3.6% (n = 3) in the PES Group, P = 0.368] were similar in the two groups during the three-year follow-up. Multivariate logistic analysis showed that insulin treatment was the only independent predictor of MACE [odds ratio (OR) 8.60, 95% confidence interval (CI) 3.25-22.76, P < 0.001] and target vessel revascularization (TVR) (OR 9.50, 95% CI 3.07-29.44, P < 0.001) during the three-year follow-up.


CONCLUSIONS
The rates of MACEs, TVR, and stent thrombosis during the three-year follow-up were similar in the SES and PES Groups. Insulin treatment was a main predictor of MACEs and TVR during the three-year follow-up after either SES or PES implantation.
Hong
Soon Jun
SJ
Department of Cardiology, Korea University Anam Hospital, Seoul, Korea.
Kim
Moo Hyun
MH
Cha
Kwang Soo
KS
Park
Hun Sik
HS
Chae
Shung Chull
SC
Hur
Seung Ho
SH
Gwon
Hyeon Cheol
HC
Bae
Jang Ho
JH
Lim
Do-Sun
DS
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D048909:Diabetes Complications / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin / Q000627:therapeutic use; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D016017:Odds Ratio; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011474:Prosthesis Design; D056910:Republic of Korea; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage*; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D007004:Hypoglycemic Agents; D007328:Insulin; D017239:Paclitaxel; D020123:Sirolimus