Primary stenting of totally occluded native coronary arteries II (PRISON II) - A randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions
Primary stenting of totally occluded native coronary arteries II (PRISON II) - A randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions
复制标题
DOI：
10.1161/circulationaha.106.613588
复制
发表时间：
2006-08-29
期刊：
影响因子：
37.8
通讯作者：
Mast, E. Gijs
中科院分区：
文献类型：
--
作者：
Suttorp, Maarten J.;Laarman, Gert J.;Mast, E. Gijs
与裸金属支架相比，西罗莫司洗脱支架显著降低了再狭窄的风险。然而，目前尚不清楚裸金属和西罗莫司洗脱支架在完全冠状动脉闭塞患者中的有效性是否存在差异。方法和结果-在一项前瞻性、随机、单盲、2中心试验中，我们招募了200例完全冠状动脉闭塞患者：一半（n = 100）被随机分配接受裸金属BxVelocity支架，另一半（n = 100）接受西罗莫司洗脱Cypher支架。主要终点为6个月随访时血管造影二次节段内再狭窄率。次要终点是6个月随访时主要不良心脏事件、靶血管衰竭、二元支架内再狭窄率、支架内和节段内最小管腔直径、直径狭窄百分比和晚期管腔丢失的复合终点。西罗莫司支架组的支架内二次再狭窄率为7%，明显低于裸金属支架组的36%（P < 0.001）。西罗莫司支架组的节段内二次再狭窄率为11%，裸金属支架组为41%（P < 0.0001），西罗莫司组靶病变血运重建率为4%，裸金属支架组为19%（P < 0.001）。接受药物洗脱支架的患者也有显着较低的靶血管血运重建率，靶血管失败，和所有主要不良心脏事件.Conclusions-In患者总冠状动脉闭塞，西罗莫司洗脱支架的使用是上级裸金属支架血管造影二元再狭窄显着减少，导致在显着减少需要靶病变和靶血管血运重建。
Background-Sirolimus-eluting stents markedly reduce the risk of restenosis compared with bare metal stents. However, it is not known whether there are differences in effectiveness between bare metal and sirolimus-eluting stents in patients with total coronary occlusions.Methods and Results-In a prospective, randomized, single-blind, 2-center trial, we enrolled 200 patients with total coronary occlusions: Half (n = 100) were randomly assigned to receive bare metal BxVelocity stents and half (n = 100) to receive sirolimus-eluting Cypher stents. The primary end point was angiographic binary in-segment restenosis rate at 6-month follow-up. Secondary end points were a composite of major adverse cardiac events, target vessel failure, binary in-stent restenosis rate, in-stent and in-segment minimal lumen diameter, percent diameter stenosis, and late luminal loss at 6-month follow-up. The sirolimus stent group showed a significantly lower in-stent binary restenosis rate of 7% compared with 36% in the bare metal stent group (P < 0.001). The in-segment binary restenosis rate was 11% in the group receiving a sirolimus stent versus 41% in the bare metal stent group (P < 0.0001), resulting in a target lesion revascularization rate of 4% in the sirolimus group versus 19% in the bare metal group (P < 0.001). Patients who received the drug-eluting stent also had significantly lower rates of target vessel revascularization, target vessel failure, and all major adverse cardiac events.Conclusions-In patients with total coronary occlusions, use of the sirolimus-eluting stents are superior to the bare metal stents with significant reduction in angiographic binary restenosis, resulting in significantly less need for target lesion and target vessel revascularization.