体外反搏对冠心病近远期临床疗效的研究参考课件

1、体外反搏对冠心病 近远期临床疗效的研究马 虹 教授 中国 广州市 中山大学附属第一医院心血管医学部体外反搏中心体外反搏对冠心病 近远期临床疗效的研究马 虹 教授研 究 背 景尽管体外反搏疗法对冠心病近期临床疗效的作用已被确立并在临床上被应用，但是缺乏其对远期心血管事件影响的资料，阻碍了该疗法在冠心病治疗领域中的更广泛应用2研 究 背 景尽管体外反搏疗法对冠心病近期临床疗效的作研 究 目 的评价体外反搏疗法对冠心病患者的近期疗效和远期临床心血管事件发生率的影响3研 究 目 的评价体外反搏疗法对冠心病患者的近期疗效和研 究 对 象病 例 来 源 本研究是一项前瞻性、分层随机、开放的药物对照试验 于

2、1996年3月22日在我院开始进行，从入组3个月后开始随访，随访至2006年4月27日4研 究 对 象病 例 来 源 本研究是一项前瞻性、分研 究 设 计观察指标3个月、6个月、12个月时心绞痛发作频率心血管联合终点事件：冠心病死亡、非致命性心肌梗死、脑卒中次要心血管事件：心绞痛住院、 冠脉血管重建术5研 究 设 计观察指标5研 究 对 象纳 入 标 准冠状动脉造影显示冠脉主要分支有一处以上70的狭窄或闭塞性病变，或狭窄50伴有胸痛及或心肌缺血表现，或急性心肌梗死后3个月伴有胸痛及或心肌缺血表现，或冠心病PCI术后患者(预防再狭窄) 6研 究 对 象纳 入 标 准冠状动脉造影显示冠脉主要研 究

3、 对 象排 除 标 准急性心肌梗死12周之内，或显著的主动脉瓣关闭不全，主动脉瘤及夹层动脉瘤，或冠状动脉瘘或严重的冠状动脉瘤，或有症状的充血性心力衰竭，或心瓣膜病、先心病、心肌病伴明显的血流动力学障碍，或脑出血半年内，出血性疾病或明确的出血倾向，下肢感染、静脉炎、严重静脉曲张、深静脉栓塞，或进展性恶性疾病(如肿瘤)或预后差的严重疾病，或随机分组时收缩压180mmHg或舒张压100mmHg ，或影响反搏治疗的严重心律失常，或 一年内曾接受过体外反搏治疗 7研 究 对 象排 除 标 准急性心肌梗死12周之内，干 预 措 施在标准的冠心病药物治疗基础上，患者随机分为药物组(n=125)，药物+体外反

4、搏组(n=130)体外反搏：每天1小时，每周反搏6天休息1天，共36天8干 预 措 施在标准的冠心病药物治疗基础上，患者随机分受试者入组随访流程图255例药物组125例药物反博组130例评估主要终点事件随机随机中位随访时间92个月9受试者入组随访流程图255例药物组125例药物反博组130统计学方法 使用SAS统计软件包估计主要心血管事件的风险比。 全部数据资料由中山大学公共卫生学院统计学教研室进行统计分析。10统计学方法 使用SAS统计软件包估计主要心血管事件结 果 - 基线特征反搏组(n=133)药物组(n=124)P值年龄60.6759.720.36男性103970.75血压129.81

5、/80.28129.72/78.970.96体重指数23.63723.620.96心功能分级I/II/III/IV74/55/0/089/29/2/00.08既往心梗/心绞痛病史58/12265/1050.24既往PCI史10130.4511结 果 - 基线特征反搏组(n=133)药物组(n=124结 果 - 基线特征反搏组(n=133)药物组(n=124)P值高甘油三酯血症44510.25高胆固醇血症35340.96高血压病68520.08糖尿病史14200.22吸烟史48540.3012结 果 - 基线特征反搏组(n=133)药物组(n=124结 果 - 基线特征反搏组(n=133)药物组

6、(n=124)P值硝酸酯类96850.30-受体阻滞剂70680.93ACEI83820.77钙拮抗剂47480.71抗心律失常药物690.38阿司匹林97990.38他汀类110.98地高辛460.48其他抗凝药62720.1113结 果 - 基线特征反搏组(n=133)药物组(n=124药物组(n=125)随访三个月、六个月、十二个月时心绞痛发作频率反搏组(n=130)3个月6个月12个月P = 0.0001P = 0.0002P = 0.000114药物组(n=125)随访三个月、六个月、十二个月时心绞痛发作P = 0.00098P = 0.052P = 0.24P = 0.01515P

7、 = 0.00098P = 0.052P = 0.24P P = 0.47P = 0.0416P = 0.47P = 0.0416结 论冠心病患者给予标准药物治疗的同时应用体外反搏治疗，可显著改善随访三个月、六个月与十二个月心绞痛症状，并可显著降低远期冠心病死亡、非致死性心梗、脑卒中发生的联合终点17结 论冠心病患者给予标准药物治疗的同时应用体外反搏治疗，可谢谢大家！18谢谢大家！181919The Short-term and Long-term Effect of EECP on Coronary Heart DiseaseProf. Ma Hong M.D.The 1st Affilia

8、ted Hospital of Sun Yat-Sen UniversityEECP Center of Cardiovascular Medicine20The Short-term and Long-term EBackgroundsAlthough Enhanced External Counterpulsation (EECP) has been applied in the clinical settings and its short-term therapeutic benefit documented, data of its long-term effect on cardi

9、ovascular events is lacking. Broader application of EECP for is therefore hindered.2121BackgroundsAlthough Enhanced EObjectivesTo investigate the short-term and long-term effect of EECP on coronary heart disease (CHD) patients.2222ObjectivesTo investigate the sSubjects This is a prospective, randomi

10、zed, open-label, medical Rx-controlled trial Initiated in our center from Mar. 22nd 1996; follow-up begins 3 mo after inclusion; last follow-up Apr. 27th 20062323Subjects This is a prospectiveDesignOutcomes:Angina frequencies 3 months, 6 months and 12 months after randomization, respectivelyComposit

11、e Primary Cardiovascular Endpoints: Cardiac death, Non-fatal MI, StrokeSecondary Endpoints: Hospitalization due to Angina, Coronary Revasc.2424DesignOutcomes:2424Inclusion CriteriaOne or more 70% stenotic or occlusive lesions on major branches during angiography, or one or more 50% stenotic or occlu

12、sive lesions with chest pain and/or myocardial ischemia, OR3 months after MI with residual chest pain and/or myocardial ischemia, ORPost-PCI patients (for prevention of restenosis)2525Inclusion CriteriaOne or more Exclusion Criteria12 weeks after MI, ORSignificant aortic regurgitation, aneurysm, or

13、dissection, ORCoronary fistula or aneurysm, ORSymptomatic CHF, ORValvular heart disease, congenital heart disease, cardiomyopathy with significant hemodynamic compromise, ORHistory of hemorrhagic stroke within 6 month, bleeding diathesis, local infection, phlebitis, varicoses, DVT of the lower extre

14、mities, ORProgressive malignant diseases (e.g. cancer), ORSBP 180mmHg or DBP 100mmHg, ORSevere arrhythmias that affects EECP implementation, ORPrevious EECP treatment within 1 year2626Exclusion Criteria12 weeks aftInterventionOn top of standard pharmacological therapy, patients were randomized into

15、Medical group (n=125) and Medical + EECP group (n=130).EECP protocol: 1 hour daily, 6 times a week, with a total of 36 hours2727InterventionOn top of standardFlow Chart of Patient Registration28N=255Med N=125Med+EECP N=130Observation ofPredetermined EventsRandomizedMedium F-U Time 92 moRandomized28F

16、low Chart of Patient RegistraStatistical Analysis SAS software was applied for hazard ratios of major cardiac events. All data was analyzed by the Dept. of Medical Statistics, Academy of Public Health, Sun Yat-Sen University2929Statistical Analysis SAS Results Baseline Characteristics30Med+EECP(n=13

17、3)Med (n=124)P ValueAge60.6759.720.36Male103970.75BP129.81/80.28129.72/78.970.96BMI23.63723.620.96Cardiac Function NYHA I/II/III/IV74/55/0/089/29/2/00.08Prior MI/Angina58/12265/1050.24Prior CABG10130.4530Results Baseline CharacterisResults Baseline Characteristics31Med+EECP(n=133)Med(n=124)PValueTG4

18、4510.25Chol35340.96Hypertension68520.08Diabetes14200.22Smoking48540.3031Results Baseline CharacterisResults Baseline Characteristics32Med+EECP (n=133)Med(n=124)PValueNitrates96850.30Beta blockers70680.93ACEI83820.77CCB47480.71Anti-arrhythmics690.38Aspirin97990.38Statins110.98Digoxin460.48Other Anticoagulants62720.1132Results Baseline Characteris33Med(n=125)AnginaFrequencyDuring 3mo, 6mo, & 12mo follow-upMed+ EECP(n=130)3 m