A prospective multicenter parallel-controlled trial of TIVOLI biodegradable-polymer-based @entity3446 -eluting stent compared to ENDEAVOR zotarolimus-eluting stent for the treatment of XXXX : 8-month angiographic and 2-year clinical follow-up results.

@entity1 @entity583 @entity75 @entity256 @entity3446 @entity7050 @entity299 @entity453 @entity204 @entity715
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 @entity3446 -eluting coronary stent with biodegradable coating containing @entity3446 and @entity7050 ( @entity7050 ) polymer. The present study sought to evaluate the effectiveness and safety of the TIVOLI biodegradable-polymer-based @entity3446 -eluting stent in treating @entity1 with @entity453 . METHODS: A prospective, multicenter clinical trial comparing TIVOLI biodegradable coated @entity3446 -eluting stent with ENDEAVOR zotarolimus-eluting stent was conducted in 324 @entity1 (TIVOLI group: 168 @entity1 ; ENDEAVOR group: 156 @entity1 ) 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 @entity453 (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 @entity299 ( @entity204 , @entity583 , or @entity75 revascularization) and stent @entity715 . 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 @entity75 revascularization (4.2% vs. 9.6%, P = 0.0495) at 2 years. The two-year major adverse @entity299 (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 @entity256 at 8 months and @entity75 revascularization (TLR) at 2 years. The MACE rate at 2 years was comparable in both groups.
