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早期侵入性策略对不稳定型冠状动脉疾病保护作用的长期观察:FRISC-II侵入性研究的两年随访

A long-term perspective on the protective effects of an early invasive strategy in unstable coronary artery disease: two-year follow-up of the FRISC-II invasive study.

作者信息

Lagerqvist Bo, Husted Steen, Kontny Fredrik, Näslund Ulf, Ståhle Elisabeth, Swahn Eva, Wallentin Lars

机构信息

Department of Cardiology, University Hospital, Uppsala, Sweden.

出版信息

J Am Coll Cardiol. 2002 Dec 4;40(11):1902-14. doi: 10.1016/s0735-1097(02)02572-x.

DOI:10.1016/s0735-1097(02)02572-x
PMID:12475448
Abstract

OBJECTIVES

We sought to report the first and repeat events and to separate spontaneous and procedure-related events over two years in the Fast Revascularization during InStability in Coronary artery disease (FRISC-II) invasive trial.

BACKGROUND

The FRISC-II invasive trial compared the long-term effects of an early invasive versus noninvasive strategy, in terms of death and myocardial infarction (MI) and the need for repeat hospital admissions and late revascularization procedures in patients with coronary artery disease (UCAD).

METHODS

In the FRISC-II trial, 2,457 patients with UCAD were randomized to an early invasive or noninvasive strategy.

RESULTS

At 24 month follow-up, there were reductions in mortality (n = 45 [3.7%] vs. 67 [5.4%]; risk ratio 0.68 [95% confidence interval (CI) 0.47 to 0.98]; p = 0.038), MI (n = 111 [9.2%] vs. 156 [12.7%]; risk ratio 0.72 [95% CI 0.57 to 0.91]; p = 0.005), and the composite end point of death or MI (n = 146 [12.1%] vs. 200 [16.3%]; risk ratio 0.74 [95% CI 0.61 to 0.90]; p = 0.003) in the invasive compared with the noninvasive group. Procedure-related MIs were two to three times more common, but spontaneous ones were three times less common in the invasive than in the noninvasive group. After the first year, there was no difference in mortality (n = 20 [1.7%]) between the two groups and fewer MIs in the invasive group (p = 0.031).

CONCLUSIONS

In UCAD, the early invasive approach leads to a sustained reduction in mortality, cardiac morbidity, and the need for repeat hospital admissions and late revascularization procedures. Although the benefits are greatest during the first months, during the second year, cardiac morbidity is lower and the need for hospital care is less in the invasive group.

摘要

目的

我们试图在冠心病不稳定期快速血运重建(FRISC-II)侵入性试验中报告两年内首次及再次发生的事件,并区分自发事件和与操作相关的事件。

背景

FRISC-II侵入性试验比较了早期侵入性策略与非侵入性策略对冠心病(CAD)患者死亡、心肌梗死(MI)以及再次住院需求和晚期血运重建操作的长期影响。

方法

在FRISC-II试验中,2457例CAD患者被随机分为早期侵入性策略组或非侵入性策略组。

结果

在24个月的随访中,侵入性策略组与非侵入性策略组相比,死亡率降低(45例[3.7%]对67例[5.4%];风险比0.68[95%置信区间(CI)0.47至0.98];p = 0.038),MI发生率降低(111例[9.2%]对156例[12.7%];风险比0.72[95%CI 0.57至0.91];p = 0.005),死亡或MI的复合终点发生率降低(146例[12.1%]对200例[16.3%];风险比0.74[95%CI 0.61至0.90];p = 0.003)。与操作相关的MI在侵入性策略组中更为常见,是其两到三倍,但自发MI在侵入性策略组中比非侵入性策略组少三倍。第一年之后,两组之间死亡率无差异(20例[1.7%]),侵入性策略组MI较少(p = 0.031)。

结论

在CAD中,早期侵入性方法可使死亡率、心脏发病率以及再次住院需求和晚期血运重建操作持续降低。尽管在最初几个月益处最大,但在第二年,侵入性策略组心脏发病率较低,住院需求较少。

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