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荷兰当前的经皮冠状动脉腔内血管成形术(PTCA)实践及临床结果:药物洗脱支架时代之前的现实情况

Current PTCA practice and clinical outcomes in The Netherlands: the real world in the pre-drug-eluting stent era.

作者信息

Agema Willem R P, Monraats Pascalle S, Zwinderman Aeilko H, De Winter Robbert J, Tio René A, Doevendans Pieter A F M, Waltenberger Johannes, De Maat Moniek P M, Frants Rune R, Atsma Douwe E, Van Der Laarse Arnoud, Van Der Wall Ernst E, Jukema J Wouter

机构信息

Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.

出版信息

Eur Heart J. 2004 Jul;25(13):1163-70. doi: 10.1016/j.ehj.2004.05.006.

Abstract

AIMS

To document the practice of interventional cardiology and the clinical restenosis rate, as well as the risk factors for clinical restenosis in an unselected population of patients in daily practice and to provide a perspective for the need of new devices such as drug-eluting stents.

METHODS AND RESULTS

A total of 3177 consecutive patients, who underwent successful percutaneous transluminal coronary angioplasty (PTCA) in the Netherlands, were included. Patients with acute myocardial infarction were excluded. The pre-defined end-point of clinical restenosis was defined as cardiac death, myocardial infarction and revascularisation of the target vessel. Follow-up (9.6 months, IQR 3.9) was complete in 3146 (99.3%) patients with a mean age of 62.1+/-10.7 years. Of them 896 (28.5%) were female, 459 (14.6%) had diabetes and 1459 (46.4%) had multi-vessel disease. Most patients (2105, 66.9%) were treated for stable angina. Of all patients, 819 (26.0%) were treated for multiple lesions, 2340 (74.4%) underwent stenting and 820 (26.1%) received glycoprotein IIb/IIIa inhibitors. All stented patients received life-long aspirin and ticlopidin/clopidogrel during at least 1 month after the procedure. Target vessel revascularisation during follow-up by either coronary artery by-pass grafting (CABG) or PTCA was necessary in 304 patients (9.7%). Thirty-three (1.1%) patients died of cardiac disease and 22 (0.7%) patients suffered from myocardial infarction (MI) attributable to the originally treated vessel. Overall, the need for revascularisation, or the incidence of cardiac death or MI occurred in 346 patients (11.0%), at 9 and 12 months these event-rates were 10.2% and 12.0%, respectively. Diabetes, hypertension, peripheral vessel disease, multi-vessel disease and treatment of type C lesions prevailed as independent risk factors for clinical restenosis. Longer stents and smaller minimal stent diameter were risk factors for in-stent stenosis.

CONCLUSION

In this unselected series of consecutive patients treated for stable and unstable angina in everyday clinical practice in the pre-drug-eluting stent era, clinical restenosis after 9 and 12 months follow-up of the patients occurred in 10.2% and 12.0%, respectively. The risk varies from 8.3% to 17.6% depending on the number of risk factors. A proper selection of patients that benefit from new devices warranted, since the vast majority are well-treated with standard techniques and proper assignment of expensive new devices is obviously of importance for overall health care.

摘要

目的

记录日常临床实践中未选择的患者群体中心脏介入治疗的实际情况、临床再狭窄率以及临床再狭窄的危险因素,并为药物洗脱支架等新器械的需求提供参考。

方法与结果

纳入了在荷兰连续接受成功经皮冠状动脉腔内血管成形术(PTCA)的3177例患者。排除急性心肌梗死患者。临床再狭窄的预定义终点为心源性死亡、心肌梗死和靶血管血运重建。3146例(99.3%)患者完成随访(9.6个月,四分位间距3.9),平均年龄62.1±10.7岁。其中896例(28.5%)为女性,459例(14.6%)患有糖尿病,1459例(46.4%)有多支血管病变。大多数患者(2105例,66.9%)因稳定型心绞痛接受治疗。所有患者中,819例(26.0%)因多处病变接受治疗,2340例(74.4%)接受了支架置入,820例(26.1%)接受了糖蛋白IIb/IIIa抑制剂治疗。所有置入支架的患者在术后至少1个月内接受终身阿司匹林和噻氯匹定/氯吡格雷治疗。随访期间,304例患者(9.7%)因靶血管血运重建而需要进行冠状动脉旁路移植术(CABG)或PTCA。33例(1.1%)患者死于心脏病,22例(0.7%)患者因原治疗血管发生心肌梗死(MI)。总体而言,346例患者(11.0%)需要进行血运重建,或发生心源性死亡或MI,在9个月和12个月时这些事件发生率分别为10.2%和12.0%。糖尿病、高血压、外周血管疾病、多支血管病变和C型病变的治疗是临床再狭窄的独立危险因素。较长的支架和较小的最小支架直径是支架内狭窄的危险因素。

结论

在药物洗脱支架时代之前的日常临床实践中,对这一系列连续的未选择的稳定型和不稳定型心绞痛患者进行治疗,患者在9个月和12个月随访后的临床再狭窄率分别为10.2%和12.0%。根据危险因素的数量,风险在8.3%至17.6%之间变化。鉴于绝大多数患者采用标准技术治疗效果良好,因此有必要正确选择能从新器械中获益的患者,显然合理分配昂贵的新器械对整体医疗保健至关重要。

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