1、体外反搏对冠心病体外反搏对冠心病 近远期临床疗效的研究近远期临床疗效的研究马马 虹虹 教授教授 中国中国 广州市广州市 中山大学附属第一医院中山大学附属第一医院心血管医学部体外反搏中心心血管医学部体外反搏中心研研 究究 背背 景景 尽管体外反搏疗法对冠心病近期临床疗效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碍了该疗法在冠心病治疗领域中的更广泛应用应用2研研 究究 目目 的的 评价体外反搏疗法对冠心病患者的近期疗评价体外反
2、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效和远期临床心血管事件发生率的影响3研研 究究 对对 象象病病 例例 来来 源源 本研究是一项前瞻性、分层随机、开放的药物对本研究是一项前瞻性、分层随机、开放的药物对照试验照试验 于于19961996年年3 3月月2222日在我院开始进行，从入组日在我院开始进行，从入组3 3个月个月后开始随访，随访至后开始随访，随访至20062006年年4 4月月2727日日4研研 究究 设设 计计观察指标观察指标 3 3个月、个月、6 6个月、个月、1212个月时心绞痛发作频率个月时心绞痛发作频率 心血管联合终点事件：冠心病死亡、非致命性心肌梗心血
3、管联合终点事件：冠心病死亡、非致命性心肌梗死、脑卒中死、脑卒中 次要心血管事件：心绞痛住院、次要心血管事件：心绞痛住院、冠脉血管重建术冠脉血管重建术5研研 究究 对对 象象纳纳 入入 标标 准准 冠状动脉造影显示冠脉主要分支有一处以上冠状动脉造影显示冠脉主要分支有一处以上7070的狭窄的狭窄或闭塞性病变，或狭窄或闭塞性病变，或狭窄5050伴有胸痛及或心肌缺血表伴有胸痛及或心肌缺血表现，或现，或 急性心肌梗死后急性心肌梗死后3 3个月伴有胸痛及或心肌缺血表现，或个月伴有胸痛及或心肌缺血表现，或 冠心病冠心病PCIPCI术后患者术后患者(预防再狭窄预防再狭窄)6研研 究究 对对 象象排排 除除 标
4、标 准准急性心肌梗死急性心肌梗死1212周之内，或周之内，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，或重静脉曲张、深静脉栓塞，或进展性恶性疾病进展性恶性疾病(如肿瘤如肿瘤)或预后差
5、的严重疾病，或或预后差的严重疾病，或随机分组时收缩压随机分组时收缩压180mmHg180mmHg或舒张压或舒张压100mmHg100mmHg ，或，或影响反搏治疗的严重心律失常，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一年内曾接受过体外反搏治疗 7干干 预预 措措 施施 在标准的冠心病药物治疗基础上，患者随在标准的冠心病药物治疗基础上，患者随机分为药物组机分为药物组(n=125)(n=125)，药物，药物+体外反搏组体外反搏组(n=130)(n=130)体外反搏：每天体外反搏：每天1 1小时，每周反搏小时，每周反搏6 6天休息天休息1 1天，共天，共3636天天8受试者入组
6、随访流程图255255例例药物组药物组125125例例药物反博组药物反博组130130例例评估主要终点事件评估主要终点事件随机随机随机随机中位随访时间中位随访时间92个月个月9统计学方法统计学方法 使用使用SASSAS统计软件包估计主要心血管事件的统计软件包估计主要心血管事件的风险比。风险比。全部数据资料由中山大学公共卫生学院统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。计学教研室进行统计分析。10结结 果果 -基线特征基线特征反搏组反搏组(n=133)药物组药物组(n=124)P值值年龄年龄60.6759.720.36男性男性103970.75血压血压129.81/80.28
7、129.72/78.970.96体重指数体重指数23.63723.620.96心功能分级心功能分级I/II/III/IV74/55/0/089/29/2/00.08既往心梗既往心梗/心绞痛病史心绞痛病史58/12265/1050.24既往既往PCI史史10130.4511结结 果果 -基线特征基线特征反搏组反搏组(n=133)药物组药物组(n=124)P值值高甘油三酯血症高甘油三酯血症44510.25高胆固醇血症高胆固醇血症35340.96高血压病高血压病68520.08糖尿病史糖尿病史14200.22吸烟史吸烟史48540.3012结结 果果 -基线特征基线特征反搏组反搏组(n=133)药物
8、组药物组(n=124)P值值硝酸酯类硝酸酯类96850.30-受体阻滞剂受体阻滞剂70680.93ACEI83820.77钙拮抗剂钙拮抗剂47480.71抗心律失常药物抗心律失常药物690.38阿司匹林阿司匹林97990.38他汀类他汀类110.98地高辛地高辛460.48其他抗凝药其他抗凝药62720.1113药物组(n=125)随访三个月、六个月、十随访三个月、六个月、十二个月时心绞痛发作频率二个月时心绞痛发作频率反搏组(n=130)3个月个月6个月个月12个月个月P=0.0001P=0.0002P=0.000114P=0.00098P=0.052P=0.24P=0.01515P=0.47
9、P=0.0416结结 论论 冠心病患者给予标准药物治疗的同时应用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、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卒中发生的联合终点17谢谢大家！谢谢大家！1819The Short-term and Long-term Effect of EECP on Coronary Heart DiseaseProf.Ma Hong M.D.The 1st Affiliated Hos
10、pital of Sun Yat-Sen UniversityEECP Center of Cardiovascular Medicine20BackgroundsBackgrounds Although Enhanced External Although Enhanced External Counterpulsation(EECP)has been Counterpulsation(EECP)has been applied in the clinical settings and applied in the clinical settings and its short-term t
11、herapeutic benefit its short-term therapeutic benefit documented,data of its long-term documented,data of its long-term effect on cardiovascular events is effect on cardiovascular events is lacking.Broader application of EECP lacking.Broader application of EECP for is therefore hindered.for is there
12、fore hindered.2121ObjectivesObjectives To investigate the short-term and To investigate the short-term and long-term effect of EECP on coronary long-term effect of EECP on coronary heart disease(CHD)patients.heart disease(CHD)patients.2222SubjectsSubjects This is a prospective,randomized,open-This i
13、s a prospective,randomized,open-label,medical Rx-controlled triallabel,medical Rx-controlled trial Initiated in our center from Mar.22Initiated in our center from Mar.22ndnd 1996;follow-up begins 3 mo after 1996;follow-up begins 3 mo after inclusion;last follow-up Apr.27inclusion;last follow-up Apr.
14、27thth 2006 20062323DesignDesignOutcomes:Outcomes:Angina frequencies 3 months,6 months and 12 Angina frequencies 3 months,6 months and 12 months after randomization,respectivelymonths after randomization,respectively Composite Primary Cardiovascular Endpoints:Composite Primary Cardiovascular Endpoin
15、ts:Cardiac death,Non-fatal MI,StrokeCardiac death,Non-fatal MI,Stroke Secondary Endpoints:Hospitalization due to Secondary Endpoints:Hospitalization due to Angina,Coronary Revasc.Angina,Coronary Revasc.2424Inclusion CriteriaInclusion Criteria One or more One or more 70%70%stenotic or occlusive lesio
16、ns on stenotic or occlusive lesions on major branches during angiography,or one or more major branches during angiography,or one or more 50%stenotic or occlusive lesions with50%stenotic or occlusive lesions with chest pain chest pain and/or myocardial ischemia,ORand/or myocardial ischemia,OR 3 month
17、s after MI with residual chest pain and/or 3 months after MI with residual chest pain and/or myocardial ischemia,ORmyocardial ischemia,OR Post-PCI patients(for prevention of restenosis)Post-PCI patients(for prevention of restenosis)2525Exclusion CriteriaExclusion Criteria12 weeks after MI,OR12 weeks
18、 after MI,ORSignificant aortic regurgitation,aneurysm,or dissection,ORSignificant aortic regurgitation,aneurysm,or dissection,ORCoronary fistula or aneurysm,ORCoronary fistula or aneurysm,ORSymptomatic CHF,ORSymptomatic CHF,ORValvular heart disease,congenital heart disease,Valvular heart disease,con
19、genital heart disease,cardiomyopathy with significant hemodynamic compromise,ORcardiomyopathy with significant hemodynamic compromise,ORHistory of hemorrhagic stroke within 6 month,bleeding History of hemorrhagic stroke within 6 month,bleeding diathesis,local infection,phlebitis,varicoses,DVT of the
20、 diathesis,local infection,phlebitis,varicoses,DVT of the lower extremities,ORlower extremities,ORProgressive malignant diseases(e.g.cancer),ORProgressive malignant diseases(e.g.cancer),ORSBP SBP 180mmHg180mmHg or DBP or DBP 100mmHg,OR100mmHg,ORSevere arrhythmias that affects EECP implementation,ORS
21、evere arrhythmias that affects EECP implementation,ORPrevious EECP treatment within 1 yearPrevious EECP treatment within 1 year2626InterventionIntervention On top of standard pharmacological On top of standard pharmacological therapy,patients were randomized therapy,patients were randomized into Med
22、ical groupinto Medical group (n=125)and(n=125)and Medical+EECP group(n=130).Medical+EECP group(n=130).EECP protocol:1 hour daily,6 times EECP protocol:1 hour daily,6 times a week,with a total of 36 hoursa week,with a total of 36 hours2727Flow Chart of Patient Registration28N=255Med N=125Med+EECP N=1
23、30Observation ofPredetermined EventsRandomizedMedium F-U Time 92 moRandomized28Statistical AnalysisStatistical Analysis SAS software was applied for hazard SAS software was applied for hazard ratios of major cardiac events.ratios of major cardiac events.All data was analyzed by the Dept.of Medical S
24、tatistics,Academy of Public Health,Sun Yat-Sen University2929Results Baseline Results Baseline CharacteristicsCharacteristics30Med+EECP(n=133)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
25、/Angina58/12265/1050.24Prior CABG10130.4530Results Baseline Results Baseline CharacteristicsCharacteristics31Med+EECP(n=133)Med(n=124)PValueTG44510.25Chol35340.96Hypertension68520.08Diabetes14200.22Smoking48540.3031Results Baseline Results Baseline CharacteristicsCharacteristics32Med+EECP(n=133)Med(
26、n=124)PValueNitrates96850.30Beta blockers70680.93ACEI83820.77CCB47480.71Anti-arrhythmics690.38Aspirin97990.38Statins110.98Digoxin460.48Other Anticoagulants62720.113233Med(n=125)AnginaFrequencyDuring 3mo,6mo,&12mo follow-upMed+EECP(n=130)3 mo6 mo12 moP=0.0001P=0.0002P=0.00013334P=0.00098P=0.052P=0.24
27、P=0.0153435P=0.47P=0.0435ConclusionConclusion EECP,when applied in addition to EECP,when applied in addition to standard medical therapy for the standard medical therapy for the treatment of patients with stable treatment of patients with stable coronary disease patients,coronary disease patients,si
28、gnificantly improves angina significantly improves angina frequency at 3 month,6 month and 12 frequency at 3 month,6 month and 12 months of follow-up,and months of follow-up,and significantly reduces long-term significantly reduces long-term composite endpoints of cardiac death,composite endpoints of cardiac death,non-fatal MI and stroke.non-fatal MI and stroke.3636Thank you!Thank you!3737
