冠状动脉直接支架术与常规支架术的对比研究

A comparative study of coronary stenting with or without balloon predilation

目的:与球囊预扩张后置入支架的常规支架术相比较,分析冠状动脉直接支架术的可行性、安全性及其临床疗效。方法:选择389例行冠脉介入治疗并置入金属裸支架的患者,分为A、B两组进行比较分析,其中A组187例患者的214处病变施行了直接支架术。B组202例患者的276处病变施行了预扩张置入支架术。两组患者的临床及冠脉造影特征相似,将两组的介入治疗结果相比较。结果:A组187例患者中181例成功施行直接支架术,技术成功率96.8%;6例患者换为常规支架术而顺利置入支架,介入手术成功率100%。两组患者支架置入成功率无差异,A组手术操作时间较短、球囊导管用量较少(P<0.01)、X线暴光时间较短、造影剂用量较少、手术费用较低(P<0.05)。A、B两组分别有3例(1.6%)和17例(8.4%)术中发生血管撕裂夹层(P<0.05)。术后12～36个月随访显示,A组有10例患者(5.3%)心绞痛复发,9例患者经心电图活动平板试验证实有心肌缺血复发,这19例复发患者经CAG复查示14例(7.5%)为支架内再狭窄;B组有26例患者(12.9%)心绞痛复发,6例患者活动平板试验心肌缺血复发,复查CAG显示其中20例(9.9%)为支架内再狭窄。临床随访期内A组心绞痛复发率低于B组(P<0.05)。结论:直接支架术是一种安全、有效、易行的冠脉介入治疗技术,其术中血管并发征及术后心绞痛发生率较低。

Objective To explore the clinical experience,effectiveness,and safeness of direct stenting for coronary artery disease （CAD）. Methods A total of 389 patients with CAD were assigned to receive direct bare metal stents （BMS） （214 lesions in 187 patients,Group A） or BMS with balloon predilation （276 lesions in 202 patients,Group B）. The characteristics of clinical and coronary visualization of patients in both groups were similar. Results All the BMS were implanted successfully in patients of both groups. Direct stenting failed in 6 （3.2%） patients because stents did not cross the target lesions,these 6 patients were crossed over to balloon prediliation. The technical success rate of direct stenting was 96.8%. Three patients （1.6% ） in Group A developed a distal dissection. In group B the severe dissection following predilation occurred in 17 patients （8.4%） and were treated successfully with stenting in all cases. The acute and follow-up results were satisfactory. There was no significant difference in clinical or angiographic data and stent implantation data between Group A and B. As compare to Group B,the procedure time and the number of catheters （P 0.01）,and the amount of x-ray radiations and contrast （P 0.05） used in group A was significantly less. With all patients followed up for 12-36 months after PCI,no acute or subacute thrombosis occurred. The recurrent rates of angina pectoris in Group A and B were 5.3% and 12.9% （P 0.05）. Conclusion Direct stenting without predilation can be performed safely and effectively for CAD in selected patients.