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经皮冠状动脉腔内血管成形术(PTCA)干预的改善是否影响长期预后?美国国立心肺血液研究所PTCA注册研究的经验。

Has improvement in PTCA intervention affected long-term prognosis? The NHLBI PTCA Registry experience.

作者信息

Detre K, Yeh W, Kelsey S, Williams D, Desvigne-Nickens P, Holmes D, Bourassa M, King S, Faxon D, Kent K

机构信息

University of Pittsburgh, PA 15261, USA.

出版信息

Circulation. 1995 Jun 15;91(12):2868-75. doi: 10.1161/01.cir.91.12.2868.

Abstract

BACKGROUND

The NHLBI Percutaneous Transluminal Coronary Angioplasty (PTCA) Registry followed 1345 consecutive patients with first PTCA between 1977 and 1981 (registry 1) and 2136 consecutive patients with PTCA between 1985 and 1986 (registry 2). Changes in patient selection and in immediate and 1-year outcome are presented. This report extends to 5 years the comparison of the effects of early and more recent management with PTCA.

METHODS AND RESULTS

Sixteen participating centers entered consecutive patients who had angioplasty for the first time between 1977 and 1981 and between 1985 and 1986. Patients with recent myocardial infarction (MI) were excluded. Vessel disease was defined according to the Coronary Artery Surgery Study. Successful dilatation required > or = 20% reduction in luminal narrowing and < 50% lumen diameter stenosis after intervention. Routine annual follow-up was conducted by telephone interview. The product-limit method was used to estimate freedom from untoward events, Cox regression analysis to model relative risk and adjusted relative risk of events between the two registries, and logistic regression when the exact time of outcome (such as recurrence of symptoms) was not known. Long-term event rates were computed by vessel disease for all patients and for the cohort of patients with initially successful PTCA. After adjustment for extent of disease, diabetes, prior bypass surgery (CABG), hypertension, age, and sex, the 5-year risk of death was similar in the two registry cohorts. However, rates of MI, CABG, and a combined outcome measure of death, MI, and/or CABG were significantly lower in the registry 2 cohort both for all patients and for patients who were initially treated successfully. Use of repeated PTCA was higher, and freedom from symptoms without adverse events was significantly better in the latter cohort.

CONCLUSIONS

Compared with registry 1, the management of the registry 2 cohort resulted in lower 5-year morbid event rates and reduced CABG operations. Mortality rates remained similar. When symptomatic status was considered in combination with events, a significantly better outcome was seen overall and in the initially successful cohort. In registry 2, repeated PTCA was used with much greater frequency early after the initial procedure.

摘要

背景

美国国立心肺血液研究所经皮腔内冠状动脉成形术(PTCA)注册研究随访了1977年至1981年间连续的1345例首次接受PTCA的患者(注册研究1)以及1985年至1986年间连续的2136例接受PTCA的患者(注册研究2)。报告了患者选择以及即刻和1年结局的变化。本报告将早期和近期PTCA治疗效果的比较延长至5年。

方法与结果

16个参与中心纳入了1977年至1981年以及1985年至1986年间首次接受血管成形术的连续患者。近期发生心肌梗死(MI)的患者被排除。血管疾病根据冠状动脉外科研究进行定义。成功的扩张要求干预后管腔狭窄减少≥20%且管腔直径狭窄<50%。通过电话访谈进行常规年度随访。采用乘积限法估计无不良事件的自由度,采用Cox回归分析对两个注册研究之间事件的相对风险和调整后的相对风险进行建模,当结局的确切时间(如症状复发)未知时采用逻辑回归。针对所有患者以及最初PTCA成功的患者队列,按血管疾病计算长期事件发生率。在对疾病程度、糖尿病、既往搭桥手术(CABG)、高血压、年龄和性别进行调整后,两个注册研究队列的5年死亡风险相似。然而,注册研究2队列中所有患者以及最初治疗成功的患者的MI、CABG发生率以及死亡、MI和/或CABG的综合结局指标均显著较低。后一组中重复PTCA的使用频率更高,且无症状且无不良事件的自由度显著更好。

结论

与注册研究1相比,注册研究2队列的治疗导致5年发病事件率降低且CABG手术减少。死亡率保持相似。当将症状状态与事件结合考虑时,总体以及最初成功的队列中均观察到明显更好的结局。在注册研究2中,首次手术后早期重复PTCA的使用频率更高。

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