Objective To evaluate the efficacy and safety of a novel biodegradable poly ( trimethylene carbonate-co-D, L-Iactide) ( PTDLA) polymer coated paclitaxel-eluting stent in preventing vascular in-stent restenosis in porcine model. Methods Twenty-seven pigs were randomly divided into three groups. Bare metal stent ( BMS) , or polymercoated-only stent ( POLY) . or polymer-based paclitaxel-eluting stents ( PACL) , was randomly implanted in left and right femoral artery of each pig (2 same stents in each pig) . Three pigs in each group were sacrificed for histomorphometric and histopathological analysis after 1. or 3. or 6 months of follow up. Results Fifty-four stents were implanted and all pigs survived. All stented arteries were patent without in-stent thrombosis, malapposition or other related events. At 1 month,compared to BMS and POLY group, pigs in PACL group had the lowest level of intimal thickness [ (133 ±26) μm vs.(280 ±54) μm and ( 284 ±46 ) μm, respectively, P ＜ 0. 05 ] and largest histological residual luminal area [ ( 3. 92 ±0. 32) mm2 vs. ( 2. 86 ± 0. 24) mm2 and ( 2. 78 ± 0. 22) mm2 , respectively, P ＜ 0. 05 ] . At 3 months, neointimal proliferation occurred in all three groups. Pigs in PACL group still had the least neointimal thickness [ ( 190 ±21) μm vs.(374 ±40) μm and (334 ±30) μm, respectively, P ＜ 0. 01 ] and largest luminal area [ (3. 68 ±0. 30) mm2 vs. (2. 40 ±0. 20) mm2 and (2. 55 ±0. 23) mm2 , respectively, P ＜ 0. 01 ] as compared to those in BMS and POLY group. But at 6 months, all pigs in three groups showed similar neointimal thickness [ (328 ±28) μm in PACL group vs. (440 ±45 ) μm in BMS group, and (408 ±39) μm in POLY group, respectively, P =0. 13] and luminal area [ (2. 83 ±0. 25) mm2 vs.(2. 17 ±0. 23) mm2 and ( 2. 30 ± 0. 18) mm2 , respectively, P = 0. 12] . Inflammatory and injury scores were similar among three groups at all study time. Conclusions The present study shows favorable vascular safety and efficacy of PTDLA coated paclitaxel-eluting stents in preventing in-stent neointima proliferation and preserving lumen area at 1 and 3 months in porcine model.%目的 评价生物可降解聚乳酸聚碳酸酯共聚物(PTDLA)涂层紫杉醇洗脱支架预防小型猪血管支架内冉狭窄的有效性与安全性.方法 27只小型猪以体质量编号随机分人裸支架(BMS)组、单纯PTDLA涂层支架(POLY)组和PTDLA涂层紫杉醇洗脱支架(PACL)组.各组均包括1、3个月和6个月观察终点的小型猪各3只.每只小型猪于双侧股动脉各置入同种支架1枚.至观察终点,复查血管造影并处死取材,通过组织病理形态学观察内膜增生及炎症情况.结果 共54枚支架成功置入27只小型猪股动脉,术后均健康存活.术后即刻及处死前血管造影示各相关动脉均通畅,无支架内血栓、移位及其他并发症.1个月时,3组中PACI,组内膜厚度最小[(133±26)μm比(280±54)μm和(284±46)μm,P＜0.05];管腔面积最大[(3.92±0.32)mm2比(2.86±0.24)mm2和(2.78±0.22)mm2,P＜0.05].3个月时,3组反映内膜增生的各项指标均加重,仍以PACL组内膜厚度最小[(190±21)μm比(374±40)μm和(334±30)μm,P＜0.01],管腔面积最大[(3.68±O.30)mm2比(2.40±0.20)mm2和(2.55±0.23)mm2,P ＜0.01].6个月时,3组内膜增生均进一步加重,PACL组内膜厚度最小,但3组间差异无统计学意义[(328±28)μm比(440±45)μm和(408±39)μm,P=0.13];剩余管腔面积最大,但差异亦无统计学意义[(2.83±0.25)mm2比(2.17±0.23)mm2和(2.30±0.18)mm2,P=0.12].结论 采用可降解PTDLA涂层的紫杉醇洗脱支架可以安全有效地抑制健康小型猪血管支架置入术后1个月和3个月时的内膜增生,保持管腔面积,预防血管支架内再狭窄.
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