摘要
Background Available drug-eluting stents （DES） have achieved great success in reducing restenosis rates. Recently,investigators have demonstrated that the durable polymer carrier plays a significant role in DES-related hypersensitive reaction and delays vessel healing. TIVOLI stent is a novel sirolimus-eluting coronary stent with biodegradable coating containing sirolimus and polylactic-co-glycolic acid （PLGA） polymer. The present study sought to evaluate the effectiveness and safety of the TIVOLI biodegradable-polymer-based sirolimus-eluting stent in treating patients with coronary artery disease.Methods A prospective, multicenter clinical trial comparing TIVOLI biodegradable coated sirolimus-eluting stent with ENDEAVOR zotarolimus-eluting stent was conducted in 324 patients （TIVOLI group： 168 patients; ENDEAVOR group：156 patients） at 12 centers in China to demonstrate the non-inferiority of in-stent late loss with TIVOLI stent compared to ENDEAVOR stent in subjects with a maximum of two de novo native coronary artery lesions （lesion length ≤40 mm,reference vessel diameter 2.25-4.00 mm）. The primary end point was angiographic in-stent late loss at 8-month. The secondary end points were clinical outcomes at 2 years,including major adverse cardiac events （cardiac death,myocardial infarction, or target-lesion revascularization） and stent thrombosis.Results Angiographic late lumen loss at 8 months in the TIVOLI group was superior to the ENDEAVOR group （in-stent （0.25±0.33） mm vs. （0.57±0.55） mm, diff （95% CI）-0.23 （-0.32, -0.14）, P 〈0.0001; in-segment （0.25±-0.33） mm vs. （0.42±-0.55） mm, diff （95% CI） -0.13 （-0.23, -0.02）,P=0.0083）. The rate of in-stent binary restenosis at 8 months was reduced from 8.6% in the ENDEAVOR group to 2.9% in the TIVOLI group （P=0.0229）. Compared to ENDEAVOR stent, TIVOLI stent resulted in a significant reduction in target-lesion revascularization （4.2% vs. 9.6%, P=0.0495） at 2 years. The two-year major adverse cardiac events （MACE） rate was lower for the TIVOLI group, but not significantly different （6.6% vs. 10.9%, P=0.1630）.Conclusions TIVOLI was superior to ENDEAVOR stent with respect to late lumen loss at 8 months, and it yielded both lower rates of angiographic binary restenosis at 8 months and target lesion revascularization （TLR） at 2 years.The MACE rate at 2 years was comparable in both groups.
Background Available drug-eluting stents （DES） have achieved great success in reducing restenosis rates. Recently,investigators have demonstrated that the durable polymer carrier plays a significant role in DES-related hypersensitive reaction and delays vessel healing. TIVOLI stent is a novel sirolimus-eluting coronary stent with biodegradable coating containing sirolimus and polylactic-co-glycolic acid （PLGA） polymer. The present study sought to evaluate the effectiveness and safety of the TIVOLI biodegradable-polymer-based sirolimus-eluting stent in treating patients with coronary artery disease.Methods A prospective, multicenter clinical trial comparing TIVOLI biodegradable coated sirolimus-eluting stent with ENDEAVOR zotarolimus-eluting stent was conducted in 324 patients （TIVOLI group： 168 patients; ENDEAVOR group：156 patients） at 12 centers in China to demonstrate the non-inferiority of in-stent late loss with TIVOLI stent compared to ENDEAVOR stent in subjects with a maximum of two de novo native coronary artery lesions （lesion length ≤40 mm,reference vessel diameter 2.25-4.00 mm）. The primary end point was angiographic in-stent late loss at 8-month. The secondary end points were clinical outcomes at 2 years,including major adverse cardiac events （cardiac death,myocardial infarction, or target-lesion revascularization） and stent thrombosis.Results Angiographic late lumen loss at 8 months in the TIVOLI group was superior to the ENDEAVOR group （in-stent （0.25±0.33） mm vs. （0.57±0.55） mm, diff （95% CI）-0.23 （-0.32, -0.14）, P 〈0.0001; in-segment （0.25±-0.33） mm vs. （0.42±-0.55） mm, diff （95% CI） -0.13 （-0.23, -0.02）,P=0.0083）. The rate of in-stent binary restenosis at 8 months was reduced from 8.6% in the ENDEAVOR group to 2.9% in the TIVOLI group （P=0.0229）. Compared to ENDEAVOR stent, TIVOLI stent resulted in a significant reduction in target-lesion revascularization （4.2% vs. 9.6%, P=0.0495） at 2 years. The two-year major adverse cardiac events （MACE） rate was lower for the TIVOLI group, but not significantly different （6.6% vs. 10.9%, P=0.1630）.Conclusions TIVOLI was superior to ENDEAVOR stent with respect to late lumen loss at 8 months, and it yielded both lower rates of angiographic binary restenosis at 8 months and target lesion revascularization （TLR） at 2 years.The MACE rate at 2 years was comparable in both groups.
