de Muinck E D, den Heijer P, van Dijk R B, Crijns H J, Hillege H J, Twisk S P, Lie K I
Department of Cardiology, Groningen University Hospital, The Netherlands.
Am J Cardiol. 1994 Nov 15;74(10):1002-5. doi: 10.1016/0002-9149(94)90848-6.
Efficacy and major clinical end points were compared in 61 patients treated with a Stack autoperfusion balloon versus 36 patients who received a Palmaz-Schatz stent for acute or threatened closure during coronary angioplasty. The groups were comparable regarding baseline clinical characteristics. Procedural success was achieved in 43 patients (70%) treated with an autoperfusion balloon versus 34 patients (94%) who received a stent (p < 0.02). Emergency bypass surgery was performed in 13 patients (21%) with the autoperfusion balloon versus none of the patients with a stent (p < 0.001). In the stent group, 3 patients (8%) died (p < 0.05); 2 deaths were caused by thrombotic reclosure, and 1 patient died after unsuccessful stent delivery. Subacute reclosure during hospitalization occurred in none of the patients with autoperfusion versus 8 patients with the stent (22%) (p < 0.0002). Therefore, the number of patients with successful stent implantation at discharge decreased to 26 (72%). At 3-month follow-up in all patients with a successful intervention, reclosure or angiographic restenosis (> 50%) occurred in 13 patients with autoperfusion (30%) versus 3 patients with stents (12%) (p = NS). There was no difference in event-free survival during follow-up. Thus, both interventions were equally successful in the treatment of acute and threatened closure. More emergency surgery was performed in the autoperfusion balloon group, whereas a higher subacute reclosure rate was seen in the stent group. At 3-month follow-up, there were no significant differences regarding reclosure, restenosis, and event-free survival.
在冠状动脉血管成形术期间，对61例使用Stack自动灌注球囊治疗的患者与36例接受Palmaz-Schatz支架治疗急性或濒临闭塞的患者的疗效和主要临床终点进行了比较。两组在基线临床特征方面具有可比性。43例（70%）接受自动灌注球囊治疗的患者手术成功，而接受支架治疗的34例患者（94%）手术成功（p<0.02）。13例（21%）接受自动灌注球囊治疗的患者接受了急诊搭桥手术，而接受支架治疗的患者无一例接受急诊搭桥手术（p<0.001）。在支架组中，3例患者（8%）死亡（p<0.05）；2例死亡由血栓性再闭塞引起，1例患者在支架植入失败后死亡。接受自动灌注治疗的患者住院期间均未发生亚急性再闭塞，而接受支架治疗的患者中有8例（22%）发生亚急性再闭塞（p<0.0002）。因此，出院时成功植入支架的患者数量降至26例（72%）。在所有成功干预的患者中，随访3个月时，13例接受自动灌注治疗的患者（30%）发生再闭塞或血管造影再狭窄（>50%），而接受支架治疗的患者中有3例（12%）发生再闭塞或血管造影再狭窄（p=无显著性差异）。随访期间无事件生存率无差异。因此，两种干预措施在治疗急性和濒临闭塞方面同样成功。自动灌注球囊组进行的急诊手术更多，而支架组的亚急性再闭塞率更高。随访3个月时，在再闭塞、再狭窄和无事件生存率方面无显著差异。
