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冠状动脉血管成形术与冠状动脉搭桥手术:心绞痛随机干预治疗(RITA)试验。

Coronary angioplasty versus coronary artery bypass surgery: the Randomized Intervention Treatment of Angina (RITA) trial.

出版信息

Lancet. 1993 Mar 6;341(8845):573-80.

PMID:8094826
Abstract

The Randomised Intervention Treatment of Angina (RITA) trial is comparing the long-term effects of percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass surgery (CABG) in patients with one, two, or three diseased coronary arteries in whom equivalent revascularisation was deemed achievable by either procedure. This first report is for a mean 2.5 years' follow-up on the 1011 patients randomised. 59% had grade 3 or 4 angina, 59% had experienced angina at rest, and 55% had two or more diseased coronary arteries. The intended procedure was done in 98% of patients. In 97% of CABG patients all intended vessels were grafted. Dilatation of all treatment vessels was attempted in 87% of PTCA patients with an angiographic success rate per vessel of 87% (90% excluding occluded vessels). There have been 34 deaths (18 CABG, 16 PTCA) and the pre-defined combined primary event of death or definite myocardial infarction shows no evidence of a treatment difference (43 CABG, 50 PTCA; relative risk 0.88 [95% confidence interval 0.59-1.29]). 4% of PTCA patients required emergency CABG before discharge and a further 15% had CABG during follow-up. Within 2 years of randomisation 38% and 11% of the PTCA and CABG groups, respectively, required revascularisation procedure(s) or had a primary event (p < 0.001) and repeat coronary arteriography during follow-up was four times more common in PTCA than in CABG patients (31% vs 7%, p < 0.001). The prevalence of angina during follow-up was higher in the PTCA group (eg, 32% vs 11% at 6 months) but this difference became less marked after 2 years (31% vs 22%). Anti-anginal drugs were prescribed more frequently for PTCA patients. At 1 month CABG patients were less physically active, with greater coronary related unemployment and lower mean exercise times than the PTCA patients. Thereafter employment status, breathlessness, and physical activity improved, with no significant differences between the two treatment groups. At 1 year mean exercise times had increased by 3 min for both groups. These interim findings indicate that recovery after CABG, the more invasive procedure, takes longer than after PTCA. However, CABG leads to less risk of angina and fewer additional diagnostic and therapeutic interventions in the first 2 years than PTCA. So far, there is no significant difference in risk of death or myocardial infarction, and follow-up continues to at least five years.

摘要

心绞痛随机干预治疗(RITA)试验正在比较经皮腔内冠状动脉成形术(PTCA)和冠状动脉搭桥术(CABG)对一、二或三支冠状动脉病变患者的长期影响,这两种手术均被认为可实现同等程度的血运重建。本首次报告是对1011例随机分组患者平均2.5年的随访结果。59%的患者有3或4级心绞痛,59%的患者曾有静息性心绞痛,55%的患者有两支或更多支冠状动脉病变。98%的患者接受了预期手术。97%的CABG患者所有预期血管均进行了搭桥。87%的PTCA患者尝试对所有治疗血管进行扩张,每支血管的血管造影成功率为87%(不包括闭塞血管时为90%)。已发生34例死亡(18例CABG,16例PTCA),预先定义的死亡或明确心肌梗死这一联合主要事件未显示出治疗差异(43例CABG,50例PTCA;相对风险0.88[95%置信区间0.59 - 1.29])。4%的PTCA患者在出院前需要急诊CABG,另有15%的患者在随访期间接受了CABG。随机分组后2年内,PTCA组和CABG组分别有38%和11%的患者需要进行血运重建手术或发生主要事件(p<0.001),随访期间PTCA患者重复冠状动脉造影的频率是CABG患者的4倍(31%对7%,p<0.001)。随访期间PTCA组心绞痛的发生率较高(如6个月时为32%对11%),但2年后这种差异变得不那么明显(31%对22%)。PTCA患者使用抗心绞痛药物的频率更高。术后1个月时,CABG患者的身体活动较少,与冠状动脉相关的失业率较高,平均运动时间低于PTCA患者。此后,就业状况、呼吸困难和身体活动情况均有所改善,两个治疗组之间无显著差异。1年时两组的平均运动时间均增加了3分钟。这些中期结果表明,作为侵入性更强的手术,CABG术后的恢复时间比PTCA术后更长。然而,CABG在最初2年内导致心绞痛的风险更低,额外的诊断和治疗干预也比PTCA更少。到目前为止,死亡或心肌梗死风险无显著差异,随访将持续至少5年。

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