Key result
Sirolimus-eluting stents show no benefit over paclitaxel-eluting stents for 3-year MACE in diabetic patients.
Why the study?
Does sirolimus-eluting stent implantation reduce major adverse cardiovascular events compared to paclitaxel-eluting stent implantation in diabetic patients with de novo coronary lesions?
RCT (n=169)
randomly assigned
Yes
Does sirolimus-eluting stent implantation reduce major adverse cardiovascular events compared to paclitaxel-eluting stent implantation in diabetic patients with de novo coronary lesions?
Absolute Event Rate: 5.9% vs 9.5%
p-value: p=0.374
Sirolimus-eluting stents and paclitaxel-eluting stents show similar rates of MACE and stent thrombosis at three years in diabetic patients, with insulin treatment being a strong independent predictor of adverse outcomes.
Either stent is acceptable for diabetic patients; extends RCT evidence of long-term equivalence between these platforms.
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.
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Hong et al. (2009) conducted an RCT in Diabetic patients with de novo coronary lesions (n=169). Sirolimus-eluting stent (SES) vs. Paclitaxel-eluting stent (PES) was evaluated on major adverse cardiovascular event (MACE) (death, nonfatal myocardial infarction, target lesion revascularization) (p=0.374). Sirolimus-eluting stents resulted in similar rates of major adverse cardiovascular events compared to paclitaxel-eluting stents at 3 years in diabetic patients (5.9% vs 9.5%, P=0.374).
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