Möllmann Helge, Elsässer Albrecht, Nef Holger, Schneider Steffen, Nienaber Christoph A, Richardt Gert, Weber Michael, Kelm Malte, Levenson Benny, Bonzel Tassilo, Tebbe Ulrich, Sabin Georg, Pfannebecker Thomas, Senges Jochen, Hamm Christian W
Department of Cardiology, Kerckhoff Heart Centre, Bad Nauheim, Germany.
Clin Res Cardiol. 2008 Jul;97(7):432-40. doi: 10.1007/s00392-008-0646-9. Epub 2008 Mar 3.
Drug-eluting stents have been reported to effectively reduce in-stent restenosis (ISR). However, the effectiveness and safety have yet been investigated only in small trials or case series. The aim of this prospective large scale registry was to show that treatment of ISR with sirolimus eluting stents (SES) is safe, effective and feasible in daily routine.
The German Cypher registry prospectively enrolled 6,555 patients undergoing implantation with SES for various indications, including 1,533 patients treated for ISR. Follow-up data (median 6.6 months) of this cohort was available for 1,531 patients (99.8%). Of these patients 75.8% were male. Of these patients 36.5% (n = 552) presented with acute coronary syndromes. In total, 1,932 SES were used with successful implantation in 98.9%. MI during hospitalization was observed in 0.7% (n = 11) while in-hospital mortality was only 0.1% (n = 2). MACE-rate at follow-up was 13.8% (n = 211) including a mortality of 1.3% (n = 20) and MI in 1.9% (n = 29). Total revascularization procedures including CABG (1.7%) were necessary in 12.3% (n = 186). Target vessel revascularization (TVR) rate was 9.3% (n = 139) and thus similar to patients with de novo lesions (8.1%, P = 0.69). Ten patients (0.65%) suffered from subacute stent thrombosis Vs. 0.24% observed in patients with de novo lesions (P = 0.03).
This large registry confirms that treatment of ISR with sirolimus-eluting-stents is effective and save with good clinical results at index procedure and follow-up. TVR was not different from de novo lesions.
据报道，药物洗脱支架可有效降低支架内再狭窄（ISR）。然而，其有效性和安全性仅在小型试验或病例系列中得到研究。这项前瞻性大规模注册研究的目的是表明，在日常临床中，使用西罗莫司洗脱支架（SES）治疗ISR是安全、有效且可行的。
德国Cypher注册研究前瞻性纳入了6555例因各种适应证接受SES植入的患者，其中1533例为ISR患者。该队列的随访数据（中位时间6.6个月）可用于1531例患者（99.8%）。这些患者中75.8%为男性。其中36.5%（n = 552）表现为急性冠状动脉综合征。总共使用了1932枚SES，成功植入率为98.9%。住院期间心肌梗死发生率为0.7%（n = 11），住院死亡率仅为0.1%（n = 2）。随访时主要不良心血管事件（MACE）发生率为13.8%（n = 211），包括死亡率1.3%（n = 20）和心肌梗死发生率1.9%（n = 29）。12.3%（n = 186）的患者需要进行包括冠状动脉旁路移植术（CABG，1.7%）在内的完全血运重建手术。靶血管血运重建（TVR）率为9.3%（n = 139），与初发病变患者相似（8.1%，P = 0.69）。10例患者（0.65%）发生亚急性支架血栓形成，而初发病变患者中观察到的发生率为0.24%（P = 0.03）。
这项大型注册研究证实，使用西罗莫司洗脱支架治疗ISR是有效的，且在首次手术及随访时临床效果良好，安全性高。TVR与初发病变无差异。
