An open label, single-centre, randomized trial of spinal cord stimulation vs. percutaneous myocardial laser revascularization in patients with refractory angina pectoris: the SPiRiT trial
An open label, single-centre, randomized trial of spinal cord stimulation vs. percutaneous myocardial laser revascularization in patients with refractory angina pectoris: the SPiRiT trial
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DOI：
10.1093/eurheartj/ehi827
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发表时间：
2006-05-01
影响因子：
39.3
通讯作者：
Schofield, PM
中科院分区：
文献类型：
--
作者：
McNab, D;Khan, SN;Schofield, PM
目的：顽固性心绞痛的发病率较高。治疗方案包括经皮激光心肌血管重建术(PMR)和脊髓刺激(SCS)。这项研究旨在比较这两种治疗方法。方法和结果加拿大心血管学会(CCS)3/4级心绞痛和可逆性血流灌注缺损者随机分为SCS组(34例)和PMR组(34例)。主要结果是比较改良Bruce方案在12个月内的锻炼跑步机时间。两组均有30名受试者完成了12个月的随访。12个月时SCS组平均总运动时间为6.38±-3.45min，PMR组为7.41+/-3.68min，SCS组为7.08+/-0.67min，PMR组为7.12+/-0.71min(95%可信限为-1.02~+2.2min，P=0.466)。两种治疗方法在无心绞痛运动能力、CCS分级和生活质量方面没有差异。SCS患者前12个月的不良事件较多，主要与心绞痛或SCS系统有关(P=0.001)。结论SCS与PMR对顽固性心绞痛的疗效差异不大。
Aims Refractory angina pectoris leads to significant morbidity. Treatment options include percutaneous myocardial laser revascularization (PMR) and spinal cord stimulation (SCS). This study was designed to compare these two treatments.Methods and results Subjects with Canadian Cardiovascular Society (CCS) class 3/4 angina and reversible perfusion defects were randomized to SCS (34) or PMR (34). The primary outcome was to compare exercise treadmill time on a modified Bruce protocol over 12 months. Thirty subjects in both groups completed 12-month follow-up. The mean total exercise time was 6.38 +/- 3.45 min in the SCS group and 7.41 +/- 3.68 min in the PMR group at baseline and 7.08 +/- 0.67 min in the SCS group and 7.12 +/- 0.71 min in the PMR group at 12 months (95% confidence limits for the difference between the groups -1.02 to +2.2 min, P=0.466). There were no differences in angina-free exercise capacity, CCS class, and quality of life between treatments. SCS patients had more adverse events in the first 12 months, mainly angina or SCS system related (P=0.001).Conclusion There was little evidence of a difference in effectiveness between SCS and PMR in patients with refractory angina.