Pohl T, Kupatt C, Steinbeck G, Boekstegers P
Department of Internal Medicine I, Grosshadern University Hospital, Munich, Germany.
Z Kardiol. 2005 Jun;94(6):405-10. doi: 10.1007/s00392-005-0253-y.
With the use of coronary stents for the treatment of coronary artery disease, in-stent restenosis became a major clinical problem. In this non-randomized study, we examined the use of stent-based delivery of sirolimus (rapamycin) for the treatment of in-stent restenosis in comparison to intracoronary beta-brachytherapy, regarding the clinical effectiveness and the angiographic results for the treatment of in-stent restenosis after 6-9 months.
Between July 2001 and May 2002, 28 patients (65+/-11 years) with instent restenosis were treated with intracoronary brachytherapy. Consecutively, between May 2002 and April 2003, 28 patients (65+/-10 years) with in-stent restenosis were treated with the implantation of a sirolimus-eluting stent (SES). Patients with in-stent restenosis treated by implantation of a SES had significantly lower incidence of in-stent restenosis (1/28 (3.6%) vs 10/28 (36%); p=0.007) and insegment restenosis (4/28 (14%) vs 14/28 (50%); p=0.013) compared to patients treated with brachytherapy. Target lesion and target vessel revascularization rate tended to be lower in the SES group (14 vs 25%) but did not yet reach statistical significance. One patient died in the group treated by implantation of a SES eight months after stenting, one patient suffered from myocardial infarction due to a subtotal in-stent restenosis after brachytherapy. Two patients after brachytherapy underwent surgical revascularization due to recurrent in-stent restenosis similar to the patient with in-stent restenosis after SES implantation.
In this study we show the feasibility and safety of the treatment of in-stent restenosis by implantation of sirolimus-eluting stents and demonstrate a lower incidence of recurrent in-stent restenosis as well as lower late luminal loss compared to treatment by intravascular brachytherapy.
随着冠状动脉支架用于治疗冠状动脉疾病，支架内再狭窄成为一个主要的临床问题。在这项非随机研究中，我们比较了采用基于支架的西罗莫司（雷帕霉素）给药治疗支架内再狭窄与冠状动脉内β射线近距离治疗，观察6至9个月后治疗支架内再狭窄的临床疗效和血管造影结果。
2001年7月至2002年5月期间，28例（65±11岁）支架内再狭窄患者接受了冠状动脉内近距离治疗。随后，在2002年5月至2003年4月期间，28例（65±10岁）支架内再狭窄患者接受了西罗莫司洗脱支架（SES）植入治疗。与接受近距离治疗的患者相比，接受SES植入治疗的支架内再狭窄患者的支架内再狭窄发生率（1/28（3.6%）对10/28（36%）；p = 0.007）和节段内再狭窄发生率（4/28（14%）对14/28（50%）；p = 0.013）显著更低。SES组的靶病变和靶血管血运重建率有降低趋势（14%对25%），但尚未达到统计学意义。SES植入治疗组有1例患者在支架置入8个月后死亡，1例接受近距离治疗的患者因支架内再狭窄不完全导致心肌梗死。2例接受近距离治疗的患者因支架内再狭窄复发接受了外科血运重建，情况与SES植入后支架内再狭窄患者相似。
在本研究中，我们展示了通过植入西罗莫司洗脱支架治疗支架内再狭窄的可行性和安全性，并证明与血管内近距离治疗相比，复发性支架内再狭窄的发生率更低，晚期管腔丢失也更低。
