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Percutaneous transmyocardial laser revascularization: overview of US clinical trials.

机译:经皮经心肌激光血运重建:美国临床试验概述。

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Data from four surgical trials of laser transmyocardial revascularization (TMR) show pain reductions of at least two classes occurred among 25-76% of patients, significantly greater than with optimal medical therapy. The safety and feasibility of percutaneous TMR (PTMR) was proved in multiple uncontrolled registry studies. With PTMR in two randomized trials enrolling about 550 patients, improvements were found among 45% and 66% of patients as compared with 13% for best medical therapy. Other encouraging observations included significant improvements in exercise time (85 and 100 seconds) as compared with minimal or negative results for medical therapy, consistent overall exercise time improvements for PTMR, and overall patient perceptions of anginal stability and global health. Peri-procedural mortality is low and ranged from 0% to 0.6%. Some skepticism remains about the procedures, arising from failure in most cases to show improvements with SPECT imaging and lack of conclusive insights into the mechanism of action. A randomized 'blinded' study is underway to establish a definitive therapeutic value for catheter-based TMR. Nonetheless, preliminary clinical data seem promising for catheter-based TMR for obtaining symptomatic improvement in patients with chronic refractory ischemic coronary syndromes. Copyright 2000 Harcourt Publishers Ltd.
机译:来自四次激光跨心肌血运重建术(TMR)的外科试验数据表明,在25%至76%的患者中,至少有两种疼痛减轻的程度明显高于最佳药物疗法。多次非对照注册表研究证明了经皮TMR(PTMR)的安全性和可行性。在两项随机试验中,PTMR招募了约550名患者,其中45%和66%的患者发现了改善,而最佳药物治疗则为13%。其他令人鼓舞的观察结果包括:与药物治疗的最低或阴性结果相比,运动时间有了显着改善(85和100秒); PTMR的总体运动时间得到了持续的改善;患者对心绞痛稳定性和整体健康的总体看法也得到了改善。围手术期死亡率低,范围从0%到0.6%。对该程序仍有一些怀疑,这是由于在大多数情况下未能通过SPECT成像显示出改善,并且对作用机理缺乏结论性见解。一项随机的“盲”研究正在进行中,以确立基于导管的TMR的确切治疗价值。尽管如此,基于导管的TMR可以改善慢性难治性缺血性冠状动脉综合征患者的症状,初步临床数据似乎很有希望。版权所有2000 Harcourt Publishers Ltd.

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