药物洗脱支架与金属裸支架内血栓发生率比较

Comparison of Drug-Eluting Stents and Bare-Metal Stents on Stent Thrombosis

目的:了解置入药物洗脱支架(DES)患者在经皮冠状动脉(冠脉)介入治疗(PCI)术后各期支架血栓(ST)的发生情况,并与置入金属裸支架(BMS)患者进行比较,探讨影响支架血栓发生的危险因素。方法:连续入选2001-07至2002-06和2003-07至2005-06期间接受PCI并置入支架的所有患者,共入选3893例。随访至少2年。根据所使用支架分为DES组(n=2930,至少置入1枚DES)和BMS组(n=963,单纯置入BMS)。记录所有患者住院期和随访期内临床资料,并根据美国和欧洲学者组成的学术研究联盟(ARC)正式发表的支架血栓定义判定支架血栓事件。结果:与BMS组相比,DES组患者的平均年龄较大,而白细胞数、甘油三脂水平和空腹血糖水平较低,既往有冠脉血运重建病史者较多,但吸烟、糖尿病和ST段抬高型心肌梗死(STEMI)发生率较低;在DES组患者的冠脉病变中,多支病变、开口病变、前降支(LAD)近段病变和左主干(LM)病变发生率较高,但慢性完全闭塞性(CTO)病变所占的发生率较低,造影成功率及完全血运重建率均较高,差异均有统计学意义(P均<0.05～0.001)。两组患者PCI术后无论在住院期还是之后的随访期内,所有的不良心脑血管事件发生率均无显著差异,而支架血栓发生率在急性期、亚急性期、晚期和晚晚期均无差异(P均>0.05)。Cox回归分析结果提示,DES组患者发生支架血栓的危险因素为:氯吡格雷疗程短和冠脉多支病变(P均<0.001);而BMS组患者发生支架血栓的危险因素为:血清肌酐值升高和合并高血压(P均<0.05)。结论:尽管DES时代患者的病变更为复杂,所置入的DES数更多,但支架血栓的发生率并不比BMS时代更高。但术后双联抗血小板治疗的疗程过短和冠脉多支病变是支架血栓发生的危险因素,应引起重视。

Objective ： To evaluate the rates of stent thrombosis （ST） after drug-eluting stents （DES） or bare-metal stents （BMS） implantation in PCI, and to determine the risk factors of ST. Methods：A total of 3893 consecutive patients treated with PCI and stents implantation were involved in this study from July 2001 to June 2002,and from July 2003 to June 2005 who admitted in our hospital. The patients were followed up for at least 2 years after PCI. All of the clinical, angiographic and interventional treatment character were recorded. ST was adjudicated by the definition of Dublin from Academic Research Consortium. All patients were divided into 2 groups： DES group（ n = 2 930 ,the patients were treated with at least one DES） and BMS group（ n = 963 ,the patients were treated with only BMS）. The rates of main adverse cardiac and cerebral event （MACCE） in hospital and during the follow-up, and the rate of acute ST, sub-acute ST,late ST and very late ST between the 2 groups were compared respectively. Results：In DES group,2 930 （75.3 % ） patients had the higher mean age,lower mean white blood cell, lower serum triglyceride and fasting blood sugar level（ all P 〈 0. 05）, more patients had the history of revascularization.,less but some patients had ST elevated myocardial infarction, and there were smokers. In BMS group,963 （24. 7% ） patients had more muhivessel disease, ostial disease, LAD proximal disease and LM disease, but less CTO disease, more completely revascularization and higher achievement ratio for angiography（ all P 〈 0. 05 ）. There were no significant differences between 2 groups in MACCE during hospitalization and after being discharged（all P 〉0. 05）. And the rates of acute ST（0. 1% vs. 0. 1% ） ,subacute ST（0. 4% vs. 0. 6% ） ,late ST （0. 5% vs. 0. 8% ） and very late ST（0. 3% vs. 0. 3% ） between 2 groups were no significant differences（all P 〉0.05）. Cox regression revealed, decurtation of clopidogrel therapy （ OR = 4. 532 ; 95 % CI = 0. 079-0. 732 ;P 〈 0. 001 ） and multivessel disease （ OR = 2. 711 ; 95% CI = 1. 851-3. 970 ; P 〈 0. 001 ） were the independent predictors of ST in DES group patients. Meanwhile, serum creatinine（ OR = 14. 235 ; 95% CI = 1. 358-149. 257 ; P = 0. 027 ） and hypertension （ OR = 9.935 ; CI = 1. 142-86.467 ; P = 0. 038 ） were the independent predictors of ST in BMS group patients. Conclusion： In DES era, the ST rates were no more than that in BMS era, though there were more complex coronary artery diseases. Decurtation of clopidogrel therapy and multivessel disease were the risk factors of ST after DES implantation and it should be recognized.