Salem Mohamed, Rotevatn Svein, Nordrehaug Jan Erik
Department of Heart Disease, Haukeland University Hospital, Bergen, Norway.
Coron Artery Dis. 2006 May;17(4):385-90. doi: 10.1097/00019501-200606000-00010.
The usefulness and safety of percutaneous myocardial laser therapy in selected patients have been identified in previous 1-year randomized trial reports, including that from a double-blind, sham-controlled trial we independently conducted. We aimed to determine whether the 1-year effects are maintained through a long-term, longitudinal follow-up.
Patients (n=77) with chronic, stable, medically refractory angina (class III or IV) not amenable to conventional revascularization and with evidence of reversible ischemia, ejection fraction > or =25%, and myocardial wall thickness > or =8 mm were treated with percutaneous myocardial laser. After the 1-year follow-up and disclosure of all randomized assignments as prespecified in the respective study protocol, patients were followed up longitudinally for a mean of 3 years for angina class, left ventricular ejection fraction, medication usage, and adverse events.
No procedural mortality, myocardial infarction, or cerebral embolism occurred. Pericardiocentesis was required in two patients (2.6%). Cardiac event-free survival was 88% at 1 year and 66% at late follow-up. Mean Canadian Cardiovascular Society angina class was significantly improved from baseline (3.2+/-0.4) at 1 year (2.2+/-1.1, P<0.001) and at a mean of 3 years (1.9+/-1.2, P<0.001). Nitrate usage was significantly reduced at late follow-up; however, ejection fraction did not change over time. In a multivariate analysis, angina improvement at 1 year was found to be a significant independent predictor of both survival and angina improvement at late follow-up.
We conclude that percutaneous myocardial laser therapy in selected patients with severe, medically refractory angina not treatable with conventional revascularization induces significant and sustained symptomatic benefit.
在既往1年的随机试验报告中，已证实经皮心肌激光治疗在特定患者中的有效性和安全性，包括我们独立开展的一项双盲、假手术对照试验。我们旨在通过长期纵向随访确定1年的疗效是否得以维持。
对77例慢性、稳定性、药物治疗无效的心绞痛患者（Ⅲ或Ⅳ级）进行经皮心肌激光治疗，这些患者不宜接受传统血运重建治疗，且有可逆性心肌缺血的证据，射血分数≥25%，心肌壁厚度≥8 mm。在1年随访并按照各自研究方案预先规定披露所有随机分组情况后，对患者进行平均3年的纵向随访，观察心绞痛分级、左心室射血分数、药物使用情况及不良事件。
未发生手术死亡、心肌梗死或脑栓塞。2例患者（2.6%）需要进行心包穿刺。1年时无心脏事件生存率为88%，后期随访时为66%。加拿大心血管学会心绞痛平均分级在1年时（2.2±1.1，P<0.001）和平均3年时（1.9±1.2，P<0.001）较基线（3.2±0.4）均有显著改善。后期随访时硝酸酯类药物使用显著减少；然而，射血分数未随时间变化。在多变量分析中，发现1年时心绞痛改善是后期随访生存率和心绞痛改善的显著独立预测因素。
我们得出结论，对于不宜接受传统血运重建治疗的严重、药物治疗无效的心绞痛患者，经皮心肌激光治疗可带来显著且持续的症状改善。
