摘要
目的:急性心肌梗死已成为危害人类健康的主要疾病之一,近年来发展的易化经皮冠状动脉介入术(Facilitated Percutaneous Coronary Intervention,FPCI)为治疗急性心肌梗死的研究开辟了新的道路。为探讨FPCI治疗急性心肌梗死的可行性,本研究通过与直接PCI比较,观察FPCI手术成功率、住院治疗期间的出血事件、对治疗不同部位心肌梗死患者左室重构的影响,并于术后随访1年,记录心源性死亡,心功能不全等主要不良心脏事件,观察FPCI对治疗急性心肌梗死患者远期预后的影响。为临床开展FPCI治疗急性心肌梗死提供可行性依据。
方法:选择2005年3月-2006年3月于我院住院治疗的142例首次急性心肌梗死患者,患者入选标准:(1)缺血性胸痛持续≥30min,舌下含服硝酸甘油症状不缓解;(2)心电图ST段在2个或2个以上相邻导联有弓背样抬高,肢体导联≥0.1mV,胸导联≥0.2mv; (3)心肌酶峰值超过正常上限2倍并具有动态演变过程;(4)距发病时间在6小时之内,发病后6-12小时,心电图ST段抬高明显伴有或不伴有严重胸痛者; (5)年龄<75岁。除外标准包括陈旧性心肌梗死、合并严重心功能不全、半年内脑出血、缺血性脑卒中、消化道溃疡、难以控制的高血压病及有出血倾向、造影剂过敏者、不同意介入治疗、冠状动脉造影(Coronary Arteriography, CAG)提示左主干病变等的患者。所有患者于急诊120即给予吸氧,镇静,止痛等基本治疗,并予术前拜阿司匹林300mg嚼服,硫酸氯吡格雷300mg顿服。其中易化PCI组67例,包括男性47例,女性20例,平均年龄62.5±9.3岁。入院后于急诊先行溶栓治疗,普通肝素5000u静脉注射,小剂量重组织型纤溶酶原激活剂(rt-PA)29mg(8mg静脉注射,21mg以0.5mg/min静点),后行CAG检查,明确病变。直接PCI组75例,包括男性54例,女性21例,平均年龄60.7±9.6岁,不予溶栓,接受直接CAG检查。根据梗死部位的不同将直接PCI组与易化PCI组进行亚组分组。FPCI组中急性前壁和/或侧壁心肌梗死患者39例,急性下壁和/或右室、正后壁心肌梗死组28例,直接PCI组分别为42例,33例。CAG提示梗死相关动脉(Infarction Related Artery ,IRA)狭窄>70%,则行PCI术。术后给予低分子肝素5000u,1/12h,皮下注射,连用5-7天。冠状动脉造影提示长病变等复杂病变、术中出现慢/无血流情况时,给予输注糖蛋白IIb/IIIa受体拮抗剂,欣维宁(国产盐酸替罗非班氯化钠注射液),起始推注剂量为10ug/kg,在3分钟内推注完毕,而后以0.15ug/kg/min的速率维持滴注,联合普通肝素以600-1000u/h维持泵入至术后36h,每6小时测定1次活化部分凝血活酶时间(Activated Partial Thromboplastin Time,aPTT),以调整欣维宁及肝素用量,使aPTT延长至正常对照的1.5-2.0倍(50-70s)。停止抗凝药物泵入后,待aPTT小于40s,行动脉鞘管拔除。手术成功标准为IRA残余狭窄<20%且获得TIMI 3级血流,同时住院期间无主要临床并发症(如死亡、急性心肌梗死、急诊冠状动脉搭桥术)发生。所有病例均在术后口服拜阿司匹林300mg,1月后减量至100mg,硫酸氯吡格雷75mg,口服9个月,如能耐受延长至12个月。无禁忌症时,均常规给予口服硝酸酯类,他汀类、血管紧张素转换酶抑制剂、β-受体阻滞剂等药物。分析两组间性别、年龄、发病危险因素、从症状发作到入院时间,入院到球囊扩张时间等的差异,观察IRA术前TIMI(Thrombolysis In Myocardial Infarction)血流灌注情况及住院期间出血率等并发症。所有患者术后1周及8周采用美国惠普2500型彩超仪行心脏超声检查,记录比较左室舒张末期容积指数(Left Ventricular End Diastolic Volume Index,LVEDVI)、左室收缩末期容积指数(Left Ventricular End Systolic Volume Index,LVESVI)、左室射血分数(Left Ventricular Ejection Fraction,LVEF),以评价两种治疗对心功能及左室重构(Left Ventricular Remolding,LVRM)情况的影响。两组分别于PCI术后8周使用Siemens Diacam ICDN单探头核素心肌显像仪,配平行孔低能通用型准直器,行99mTc-MIBI静息心肌灌注显像。采用半定量节段评分法计算平均缺血积分(Mean Ischemic Scores,MIS)及心肌梗死面积。术后随访12个月,记录心源性死亡,靶血管再次血运重建,心功能不全等主要心脏不良事件的发生情况。将FPCI组与直接PCI组患者的心室功能,心肌梗死面积及预后情况进行比较。同时亚组之间亦进行上述指标的比较,观察FPCI对治疗不同梗死部位心肌梗死患者的左室重构及远期预后的影响。
结果:1.FPCI与直接PCI患者从症状发作到入院时间比较无统计学意义,[(7.1±3.5)h vs(6.9±4.2)h ,P > 0. 05 ]。从入院到球囊扩张时间[(82.4±9.7)min vs (80.6±10.3)min,P > 0. 05],无显著差别,FPCI组入院至开始静脉溶栓时间为(23.7±6.4)min。2.CAG显示在PCI前,FPCI组IRA TIMI 3级血流者明显多于直接PCI组(32.8% vs 2.7% , P <0. 05),两组相比有统计学意义。3. FPCI与直接PCI组住院期间并发症结果:两组患者住院期间均无颅内出血并发症出现,易化PCI组牙龈出血,泌尿系出血,穿刺部位等出血事件8例(11.9%),直接PCI组8例(10.7%),无显著差别。两组患者住院期间均无急诊冠脉搭桥术发生。易化PCI组1例亚急性血栓形成,支架内再闭塞后死亡,3例因梗死面积较大,心力衰竭死亡。直接PCI组亚急性支架内闭塞事件2例,1例死亡、1例抢救成功,因梗死面积较大,心力衰竭死亡4例。手术成功率易化PCI组66例(98.5%),直接PCI组73例(97.3%),无显著差别,P>0.05。4.FPCI与直接PCI组心肌梗死面积检测结果:8周时直接PCI组静息心肌灌注显像MIS为(13.42±2.53)分,心肌梗死面积为(20.34±5.61)%,易化PCI组MIS为(12.20±2.82)分,心肌梗死面积为(19.73±5.24)%,两组相比易化PCI组相对直接PCI组有减小梗死面积的趋势,但P>0.05,无显著差别。FPCI与直接PCI组左室功能检测结果:8周时易化PCI组LVEDVI为(63.1±8.2)ml/m2、LVESVI为(35.6±9.3)ml/m2、LVEF为(54.5±7.9)%,直接PCI组LVEDVI为(64.6±7.0)ml/m2、LVESVI为(36.5±7.6)ml/m2、LVEF为(53.5±6.6)%,两组之间比较无显著差别,P>0.05。5.亚组心肌梗死面积及左室功能结果:前壁和/或侧壁心肌梗死患者的心肌梗死面积易化PCI亚组较直接PCI亚组小,[(20.21±3.24)% vs(22.25±4.35)%,P <0. 05],有统计学意义。下壁和/或右室、正后壁心肌梗死患者心肌梗死面积为[(15.27±2.65)% vs(15.69±3.84)%, P>0.05],无显著差别。8周时,前壁和/或侧壁心肌梗死患者LVEF在易化PCI亚组高于直接PCI亚组[(56.9±8.5) % vs (50.5±5.6) % ,P < 0. 05 ] ,两组相比有统计学意义,而下壁和/或右室、正后壁心肌梗死患者LVEF[ (58.9±7.5) % vs (59.2±7.8) % ,P > 0. 05 ],无显著差别。6.术后随访12个月主要心脏不良事件发生情况:心源性死亡易化PCI组2例,直接PCI组4例;心功能分级易化PCI组心功能I级43例(76.8%),心功能II-IV级13例(23.2%),直接PCI组心功能I级38例(61.3%),心功能II-IV级24例(38.7%),无显著差别。前壁和/或侧壁心肌梗死组易化PCI亚组心功能I级26例(72.2%),心功能II-IV级10例(27.8%),直接PCI亚组心功能I级19例(48.7%),心功能II-IV级20例(51.3%),两组比较P < 0. 05,有显著差别。
结论:1易化PCI与直接PCI治疗急性心肌梗死比较手术成功率相当,出血等并发症并未增加,安全有效。
2前壁和/或侧壁急性心肌梗死患者接受易化PCI治疗较直接PCI进一步减小心肌梗死面积,更有利于改善左室重构。
3前壁和/或侧壁急性心肌梗死患者接受易化PCI治疗更有利于保护左室功能,提高生活质量,改善远期预后。
Objective: Acute Myocardial Infarction has become one of the serious disease to human health.In recent years , Facilitated Percutaneous Coronary Intervention has emerged as a new method for AMI.In order to explore the feasibility of FPCI,in this study ,We contrasted facilitated PCI with primary PCI from the effect on the success rate of PCI, hemorrhage event of two groups after PCI in hospital and left ventricular remolding between different position of AMI. Then we followed up the clinical event of two groups in 1 year and observed the prognosis.Provided FPCI ,a more rational strategy of perfusion treatment for AMI patients.
Methods: From March 2005 to March 2006,one hundred and fourty-two patients with primary AMI were divided into two group, All patients had persistent angina for more than 30 minutes ,ST-segment elevation of at least 0.1 mV in two or more extremity leads or at least 0.2 mV in two or more pre-cordial leads and the cardiac enzyme peak beyond two folds of normal range,the presence of symptoms for <6h, or<12h but ST-segment keep elevation and has chest pain,age<75years. Patients with the history of old myocardial infarction, severe heart failure,haemorrhagic stroke、ischaemic stroke< 6 months, peptic ulcer, uncontrolled hypertension, with hypersensitivity to rapamycin,disagree to CAG, IRA was left main vessel were all excluded.FPCI group 67 cases,average age was(62.5±9.3) year,47male,20 female. and primary PCI group75 cases. average age was(60.7±9.6)year,54 male,21 female .All the patients first received basic therapy,for example, oxygenate, calm,then 300mg of aspirine and 300mg of Clopidogrel Sulfate Tablets. The primary PCI group were under angiography without thrombolysis,while the FPCI group were under an intravenous drip of 5000u heparin ,followed by 29mg rt-PA(intravenous bolus of 8mg recombined rt-PA,then followed by 21mg).When there was the phenomenon of no-reflow, long disease vessel ,the Tirofiban Hydrochloride and Sodium Chloride Injection (intravenous bolus of 10ug/kg in three minies, then followed by 21mg 0.15ug/kg/min), and heparin was administered at the dose of 600-1000u/h for 36 hours,the APTT was measured for 1/6h,the APTT value was set at 50-70s.The residual stenosis of IRA>70% were implanted with stents. The standard of success is residual stenosis of IRA <20% and TIMI 3 flow. All patients were received routine medications of PCI, Beta-blocker, ACEa-Inhibitors etal.we collected clinical information detailed including:year, sex, risk factors,the mean interval from onset to PCI and thecomplications and mortality in-hospital. According to the different location of myocardial infarction , 142 patients were divided into anterior AMI and inferior AMI subgroups,At one week and eight weeks after PCI, Echocardiography was applied to observe the changes of parameters of Left Ventricular End Diastolic Volume Index、Left Ventricular End Systolic Volume Index、Left Ventricular Ejection Fraction.The Mean Ischemic Scores and myocardial infarction area were measured by 99mTc– MIBI eight weeks after PCI.The follow-up period was 12 months,observed the cardiac dysfunction, death due to primary cardiac cause et al. Compared the left ventricular remolding and prognosis between two groups.At the same time, also compared the left ventricular remolding and prognosis between subgroups groups.
Results: 1. There was not significant differences about the mean interval from onset to the hospital between facilitated PCI group and primary PCI group [(7.1±3.5)h vs (6.9±4.2) h , P>0.05]; from arrival at hospital to first balloon inflation [(82.4±9.7)min vs (80.6±10.3)min,P>0.05],the time arrival at hospital to admitted to ethrombolytic was(23.7±6.4)min. 2.At the CAG the patients with TIMI 3 flow were more in the facilitated PCI group(32.8%vs2.7%,P<0.05);3.The haemorrhage event were similar in two groups, [(11.9%)vs(10.7%), P>0.05].4. At eight weeks after PCI in facilitated PCI the area of myocardial infarction was similar to primary PCI, [(19.73±5.24)%, vs(20.34±5.61)%,p>0.05].At eight weeks after PCI in FPCI the LVEDVI,LVESVI ,LVEF ,was (63.1±8.2)ml/m2, (35.6±9.3)ml/m2, (54.5±7.9)%,in primary PCI group LVEDVI, LVESVI, LVEF was(64.6±7.0)ml/m2,(36.5±7.6)ml/m2,(53.5±6.6) %, there were of no significant differences between the two groups.5.The area of the anterior myocardial infarction was smaller in the facilitated PCI subgroups, [(20.21±3.24)% vs(22.25±4.35)%,P<0.05], but there were of no statistical differences in inferior AMI[(15.27±2.65)% vs(15.69±3.84)%,P>0.05]; After eight weeks of PCI, The LVEF of the anterior myocardial infarction was higher in the facilitated PCI group[ (56.9±8.5) % vs (50.5±5.6) % , P<0.05 ]; there were of no statistical differences in inferior AMI, LVEF[(58.9±7.5)% vs (59.2±7.8)%, P>0.05]. 6. The follow-up period was 12 months ,the heart function in anterior myocardial infarction of facilitated PCI NYHA I was 72.2%, NYHA II-IV was 27.8%, the anterior myocardial infarction in primary PCI group NYHA I was 48.7%, NYHA II-IV was 51.3%,P<0.05,there were of statistical differences in anterior AMI.
Conclusions: 1 In the success rate of PCI and haemorrhage event, there were of no difference between the FPCI and Primary PCI.
2 The facilitated PCI has the benefit on smaller anterior myocardial infarction area,better left Ventricular function and left ventricular remolding.
3 The anterior myocardial infarction in facilitated PCI group has fewer cardiac dysfunction, the prognosis is better.
引文
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