Suttorp Maarten J, Laarman Gert J, Rahel Braim M, Kelder Johannes C, Bosschaert Mike A R, Kiemeneij Ferdinand, Ten Berg Jur M, Bal Egbert T, Rensing Benno J, Eefting Frank D, Mast E Gijs
Department of Interventional Cardiology, St Antonius Hospital Nieuwegein, Koekoekslaan 1, 3435 CM Nieuwegein, The Netherlands.
Circulation. 2006 Aug 29;114(9):921-8. doi: 10.1161/CIRCULATIONAHA.106.613588. Epub 2006 Aug 14.
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.
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.
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.
与裸金属支架相比，西罗莫司洗脱支架显著降低了再狭窄风险。然而，对于完全冠状动脉闭塞患者，裸金属支架和西罗莫司洗脱支架在有效性上是否存在差异尚不清楚。
在一项前瞻性、随机、单盲、2中心试验中，我们纳入了200例完全冠状动脉闭塞患者：其中一半（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。主要终点是6个月随访时血管造影的节段内二元再狭窄率。次要终点包括主要不良心脏事件、靶血管失败、支架内二元再狭窄率、支架内和节段内最小管腔直径、直径狭窄百分比以及6个月随访时的晚期管腔丢失的复合终点。西罗莫司支架组的支架内二元再狭窄率显著低于裸金属支架组，分别为7%和36%（P < 0.001）。接受西罗莫司支架组的节段内二元再狭窄率为11%，而裸金属支架组为41%（P < 0.0001），导致西罗莫司组的靶病变血运重建率为4%，裸金属组为19%（P < 0.001）。接受药物洗脱支架的患者在靶血管血运重建、靶血管失败和所有主要不良心脏事件的发生率也显著更低。
在完全冠状动脉闭塞患者中，使用西罗莫司洗脱支架优于裸金属支架，血管造影二元再狭窄显著降低，导致靶病变和靶血管血运重建的需求显著减少。
