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冠状动脉疾病治疗方法的持续演变。冠状动脉成形术时代的初步结果。

Continuing evolution of therapy for coronary artery disease. Initial results from the era of coronary angioplasty.

作者信息

Mark D B, Nelson C L, Califf R M, Harrell F E, Lee K L, Jones R H, Fortin D F, Stack R S, Glower D D, Smith L R

机构信息

Department of Medicine, Duke University Medical Center, Durham, NC 27710.

出版信息

Circulation. 1994 May;89(5):2015-25. doi: 10.1161/01.cir.89.5.2015.

Abstract

BACKGROUND

Survival after coronary artery bypass graft surgery (CABG) and medical therapy in patients with coronary artery disease (CAD) has been studied in both randomized trials and observational treatment comparisons. Over the past decade, the use of coronary angioplasty (PTCA) has increased dramatically, without guidance from either randomized trials or prospective observational comparisons. The purpose of this study was to describe the survival experience of a large prospective cohort of CAD patients treated with medicine, PTCA, or CABG.

METHODS AND RESULTS

The study was designed as a prospective nonrandomized treatment comparison in the setting of an academic medical center (tertiary care). Subjects were 9263 patients with symptomatic CAD referred for cardiac catheterization (1984 through 1990). Patients with prior PTCA or CABG, valvular or congenital disease, nonischemic cardiomyopathy, or significant (> or = 75%) left main disease were excluded. Baseline clinical, laboratory, and catheterization data were collected prospectively in the Duke Cardiovascular Disease Databank. All patients were contacted at 6 months, 1 year, and annually thereafter (follow-up 97% complete). Cardiovascular death was the primary end point. Of this cohort, 2788 patients were treated with PTCA (2626 within 60 days) and 3422 with CABG (3080 within 60 days). Repeat or crossover revascularization procedures were counted as part of the initial treatment strategy. Kaplan-Meier survival curves (both unadjusted and adjusted for all known imbalances in baseline prognostic factors) were used to examine absolute survival differences, and treatment pair hazard ratios from the Cox model were used to summarize average relative survival benefits. For the latter, a 13-level CAD prognostic index was used to examine the relation between survival and revascularization as a function of CAD severity. The effects of revascularization on survival depended on the extent of CAD. For the least severe forms of CAD (ie, one-vessel disease), there were no survival advantages out to 5 years for revascularization over medical therapy. For intermediate levels of CAD (ie, two-vessel disease), revascularization was associated with higher survival rates than medical therapy. For less severe forms of two-vessel disease, PTCA had a small advantage over CABG, whereas for the most severe form of two-vessel disease (with a critical lesion of the proximal left anterior descending artery), CABG was superior. For the most severe forms of CAD (ie, three-vessel disease), CABG provided a consistent survival advantage over medicine. PTCA appeared prognostically equivalent to medicine in these patients, but the number of PTCA patients in this subgroup was low.

CONCLUSIONS

In this first large-scale, prospective observational treatment comparison of PTCA, CABG, and medicine, we confirmed the previously reported survival advantages for CABG over medical therapy for three-vessel disease and severe two-vessel disease. For less severe CAD, the primary treatment choices are between medicine and PTCA. In these patients, there is a trend for a relative survival advantage with PTCA, although absolute survival differences were modest. In this setting, treatment decisions should be based not only on survival differences but also on symptom relief, quality of life outcomes, and patient preferences.

摘要

背景

在随机试验和观察性治疗比较中,均对冠状动脉疾病(CAD)患者接受冠状动脉旁路移植术(CABG)后的生存率及药物治疗情况进行了研究。在过去十年中,冠状动脉血管成形术(PTCA)的应用急剧增加,且缺乏随机试验或前瞻性观察性比较的指导。本研究的目的是描述接受药物治疗、PTCA或CABG的大量CAD患者前瞻性队列的生存情况。

方法与结果

本研究设计为在学术医疗中心(三级医疗)进行的前瞻性非随机治疗比较。研究对象为9263例因症状性CAD接受心脏导管检查的患者(1984年至1990年)。排除曾接受PTCA或CABG、瓣膜或先天性疾病、非缺血性心肌病或严重(≥75%)左主干病变的患者。在杜克心血管疾病数据库中前瞻性收集基线临床、实验室和导管检查数据。所有患者在6个月、1年及此后每年进行随访(随访完成率97%)。心血管死亡为主要终点。在该队列中,2788例患者接受PTCA治疗(2626例在60天内),3422例接受CABG治疗(3080例在60天内)。重复或交叉血运重建程序被视为初始治疗策略的一部分。采用Kaplan-Meier生存曲线(未调整及针对基线预后因素的所有已知不平衡进行调整)来检验绝对生存差异,并使用Cox模型的治疗组风险比来总结平均相对生存获益。对于后者,采用13级CAD预后指数来检验生存与血运重建之间的关系,该关系是CAD严重程度的函数。血运重建对生存的影响取决于CAD的程度。对于CAD最不严重的形式(即单支血管病变),在长达5年的时间里,血运重建相对于药物治疗并无生存优势。对于中等程度的CAD(即双支血管病变),血运重建与高于药物治疗的生存率相关。对于双支血管病变不太严重的形式,PTCA比CABG有微小优势,而对于双支血管病变最严重的形式(左前降支近端有临界病变),CABG更具优势。对于CAD最严重的形式(即三支血管病变),CABG相对于药物治疗具有持续的生存优势。在这些患者中,PTCA在预后方面似乎与药物治疗相当,但该亚组中接受PTCA治疗的患者数量较少。

结论

在这项首次针对PTCA、CABG和药物治疗的大规模前瞻性观察性治疗比较中,我们证实了先前报道的CABG相对于药物治疗在三支血管病变和严重双支血管病变中的生存优势。对于不太严重的CAD,主要治疗选择在药物治疗和PTCA之间。在这些患者中,尽管绝对生存差异不大,但PTCA有相对生存优势的趋势。在此情况下,治疗决策不仅应基于生存差异,还应基于症状缓解、生活质量结果和患者偏好。

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