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裸金属支架与药物洗脱支架再狭窄率的对比研究。

A comparative study of restenosis rates in bare metal and drug-eluting stents.

作者信息

Mohan Shilpi, Dhall Anil

机构信息

Department of Cardiology, Army Hospital (Research and Referral), and Indian Council of Medical Research, New Delhi, India.

出版信息

Int J Angiol. 2010 Summer;19(2):e66-72. doi: 10.1055/s-0031-1278368.

Abstract

BACKGROUND

Various studies have been performed throughout the world on the rate of restenosis using bare metal stents (BMS) and drug-eluting stents (DES). The prohibitive costs associated with DES generally dictate the type of stent used, especially in developing countries. Therefore, there was a need for a study to assess the effect of various risk factors on restenosis in BMS and DES in the Indian context. A study was performed in the premier institution of the Indian Armed Forces, the Army Hospital (Research and Referral), New Delhi, India, under the aegis of the Indian Council of Medical Research (New Delhi). The profile of patients in the armed forces is inherently diverse in terms of demography, ethnicity, genetics, etc, which reflects the diverse and varied nature of the population in India.

METHODS AND RESULTS

A total of 130 patients were included in the present study. Follow-up after stent implantation was scheduled for six to nine months following the procedure to assess symptoms, drug compliance, and treadmill test and coronary angiography results, and to ascertain the incidence of restenosis. However, only 80 patients returned for follow-up and, therefore, the final analysis was based on these patients. They were segregated into BMS (n=41) and DES (n=39) groups. Restenosis occurred in 29 patients (36.3%). Nine of 39 patients with DES (23.1%) and 20 of 41 patients with BMS (48.8%) developed restenosis. There was a statistically significant relationship between restenosis and female sex, clinical presentation before intervention and at the time of follow-up evaluation (unstable angina), hypertension, positive stress test and compliance with medical therapy (P<0.05). No statistically significant relationship was observed between restenosis and age, diabetes, smoking, obesity and diet (P>0.05).

CONCLUSIONS

DES appear to reduce the restenosis rate and clinical end points, and appear to be more cost effective than BMS. Patient-related factors (eg, sex, hypertension and unstable angina) are important variables that affect the restenosis rate. Noninvasive stress testing had high positive and negative predictive values. Therefore, based on the present study, noninvasive stress testing is suggested before routine angiography at follow-up, which will reduce the need for repeat coronary angiography.

摘要

背景

世界各地已针对使用裸金属支架(BMS)和药物洗脱支架(DES)的再狭窄率开展了多项研究。DES相关的高昂成本通常决定了所使用支架的类型,尤其是在发展中国家。因此,有必要开展一项研究,以评估在印度背景下各种风险因素对BMS和DES再狭窄的影响。在印度医学研究理事会(新德里)的支持下,于印度新德里的印度武装部队主要机构陆军医院(研究与转诊)开展了一项研究。武装部队患者在人口统计学、种族、遗传学等方面本质上具有多样性,这反映了印度人口的多样化性质。

方法与结果

本研究共纳入130例患者。支架植入术后计划在术后6至9个月进行随访,以评估症状、药物依从性、平板运动试验和冠状动脉造影结果,并确定再狭窄的发生率。然而,只有80例患者返回进行随访,因此最终分析基于这些患者。他们被分为BMS组(n = 41)和DES组(n = 39)。29例患者(36.3%)发生再狭窄。39例DES患者中有9例(23.1%)发生再狭窄,41例BMS患者中有20例(48.8%)发生再狭窄。再狭窄与女性性别、干预前及随访评估时的临床表现(不稳定型心绞痛)、高血压、运动试验阳性及药物治疗依从性之间存在统计学显著关系(P<0.05)。再狭窄与年龄、糖尿病、吸烟、肥胖和饮食之间未观察到统计学显著关系(P>0.05)。

结论

DES似乎可降低再狭窄率和临床终点事件,且似乎比BMS更具成本效益。患者相关因素(如性别、高血压和不稳定型心绞痛)是影响再狭窄率的重要变量。无创运动试验具有较高的阳性和阴性预测价值。因此,基于本研究,建议在随访时进行常规血管造影前先进行无创运动试验,这将减少重复冠状动脉造影的需求。

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