Shkolnik Evgeny, Burneikaite Greta, Celutkiene Jelena, Scherbak Mikhail, Zuoziene Gitana, Petrauskiene Birute, Trush Ekaterina, Laucevicius Aleksandras, Vasyuk Yury
Centre of Cardiology and Angiology, Vilnius University Hospital, Santaros Klinikos; Vilnius-Lithuania.
Anatol J Cardiol. 2018 Feb;19(2):100-109. doi: 10.14744/AnatolJCardiol.2017.8023.
Despite revascularization and optimal medical treatment (OMT), patients with angina often have a reduced quality of life due to inadequate relief from symptoms. Recent studies have shown that the application of shock waves may reduce angina symptoms and improve quality of life, exercise capacity, and myocardial perfusion due to the stimulation of angiogenesis. However, there is limited evidence due to small, single-arm, single-center studies of low to moderate quality. The purpose of this study is to evaluate the impact of cardiac shock wave therapy (CSWT) on exercise tolerance and angina symptoms in patients with coronary artery disease and objective evidence of myocardial ischemia who cannot undergo traditional revascularization and experience angina despite OMT in comparison to sham procedure.
We designed a randomized, triple-blind, placebo-controlled, multicentre trial (NCT02339454) to assess the efficacy of CSWT in addition to OMT in patients with stable angina and myocardial ischemia documented by exercise treadmill test (ETT). All patients were treated with stable doses of standard medical treatment 4 weeks before screening. An increase in the total exercise duration on ETT by ≥90 s from the baseline at the end of the study was set as the primary endpoint. Secondary endpoints included angina class, Seattle angina questionnaire scores, symptoms, and ECG changes during stress test. Patients underwent nine sessions of CSWT or corresponding sham procedure applied to all segments of the left ventricle, within 9 weeks. Endpoint assessments were performed at 6-month follow-up. The imaging substudies assessed the potential of CSWT to reduce stress-induced myocardial ischemia detected by dobutamine stress echocardiography, cardiac single-photon emission computed tomography, and cardiac magnetic resonance imaging.
At two centers, 72 of the 323 screened patients were randomized in two groups (ratio 1:1): active treatment and placebo control. Study patients were predominantly males (70.8%); the mean age of the patients was 68.4±8.3 years. Of these, 44 patients had angina Canadian Cardiovascular Society class III, and 66.7% of the patients had a history of myocardial infarction.
Using sham applicators, blinding study participants, investigators, and endpoints assessors to the study data as well as centralized randomization ensures rigorous methodology and low risk of bias in this large randomized controlled CSWT study.
尽管进行了血运重建和最佳药物治疗（OMT），但心绞痛患者的症状缓解不足，生活质量常常降低。最近的研究表明，由于冲击波刺激血管生成，其应用可能会减轻心绞痛症状，改善生活质量、运动能力和心肌灌注。然而，由于低至中等质量的小型单臂单中心研究，证据有限。本研究的目的是评估心脏冲击波疗法（CSWT）对冠状动脉疾病且有心肌缺血客观证据、无法进行传统血运重建且尽管接受OMT仍有心绞痛的患者的运动耐量和心绞痛症状的影响，并与假手术进行比较。
我们设计了一项随机、三盲、安慰剂对照、多中心试验（NCT02339454），以评估CSWT联合OMT对运动平板试验（ETT）记录的稳定型心绞痛和心肌缺血患者的疗效。所有患者在筛查前4周接受稳定剂量的标准药物治疗。研究结束时ETT总运动持续时间较基线增加≥90秒被设定为主要终点。次要终点包括心绞痛分级、西雅图心绞痛问卷评分、症状以及应激试验期间的心电图变化。患者在9周内接受9次CSWT或相应的假手术，应用于左心室的所有节段。在6个月随访时进行终点评估。影像学亚研究评估了CSWT减轻多巴酚丁胺负荷超声心动图、心脏单光子发射计算机断层扫描和心脏磁共振成像检测到的应激性心肌缺血的潜力。
在两个中心，323例筛查患者中的72例被随机分为两组（比例1:1）：积极治疗组和安慰剂对照组。研究患者以男性为主（70.8%）；患者的平均年龄为68.4±8.3岁。其中，44例患者为加拿大心血管学会III级心绞痛，66.7%的患者有心肌梗死病史。
在这项大型随机对照CSWT研究中，使用假治疗器，使研究参与者、研究者和终点评估者对研究数据不知情，以及集中随机化确保了严谨的方法和低偏倚风险。
