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[ESC/WCC2006]FRISC II研究—中高危NSTE-ACS患者接受早期血运重建治疗更能获益
周玉杰 刘宇扬
[2006/9/4 0:00:00]
全文（共1页）
在9月4日的WCC-2006会议上，Dr.bo lagerqvist教授公布了FRISC-II（Fragmin and Fast Revascularization During Instability in Coronary Artery Disease Trial）研究结果。FRISC-II试验旨在探讨非ST段抬高急性冠脉综合征患者选择早期干预治疗或保守治疗这两种不同治疗策略对于患者死亡或心肌梗塞发生情况的影响。
FRISC-II临床试验资料主要来源于斯堪的那维亚半岛五年随访的结果，该研究共入选了2457例非ST段抬高急性冠脉综合征患者随机分入早期干预组或保守治疗组，本项研究依据以下标准：年龄＞65岁，男性，糖尿病，陈旧心肌梗塞，ST段压低，肌钙蛋白升高(>0.03 ug/L)，C-反应蛋白及白介素-6的升高水平将患者归为中高危组。早期干预组五年死亡和/或心梗的发生率明显低于保守治疗组(19.9 %vs. 24.5 %,RR 0.81; 95% CI 0.69 - 0.95; p=0.009);但五年死亡率早期干预组与保守治疗组无明显差异 (9.7%vs.10.1%,RR 0.95; CI 0.75 - 1.21; p=0.693)；心肌梗塞发生率在早期干预组低于保守治疗组12.9 %vs.17.7 %,RR 0.73; 95% CI 0.60 - 0.89; p=0.002)。
进一步研究发现：男性、非吸烟人士或两个及两个以上危险因素的患者更能从早期干预治疗中获益，具有这些危险因素的病人其死亡及心肌梗塞发生率更低 (21.2%vs.28.1%,RR 0.75¸95% CI 0.64-0.89) 。
FRISC-II试验五年随访的结果显示：对于中高危的非ST段抬高急性冠脉综合征患者，早期干预治疗可以使患者持续获益。
FRISC-II
In the FRISC-II trial 2457 patients with non-ST-elevation acute coronary syndrome were randomised to an early invasive or a non-invasive strategy. Risk stratification was performed based on the following risk indicators at randomization: age>65, male gender, diabetes mellitus, previous myocardial infarction, ST-segment depression, troponin elevation (>0.03 ug/L) and elevation of C-reactive protein or Il-6.
At 5 years there was a difference in the primary composite of death and/or myocardial infarction 217 (19.9 %) in the invasive versus 270 (24.5 %) in the noninvasive group (RR 0.81; 95% CI 0.69 - 0.95; p=0.009). The 5-year mortality was 117 (9.7%) versus (RR 0.95; CI 0.75 - 1.21; p=0.693) and the rate of myocardial infarction 141 (12.9 %) versus 195 (17.7 %) (RR 0.73; 95% CI 0.60 - 0.89; p=0.002) in the respective invasive and noninvasive groups.
The benefit of the invasive strategy was confined to males, non-smokers or the group with 2 or more risk indicators where the rate of death and myocardial infarction was 182 (21.2%) versus 240 (28.1%) (RR 0.75¸95% CI 0.64-0.89) and mortality 99 (10.5%) versus 112 (12.0%) (RR 0.87¸95% CI 0.68-1.13).
Conclusion The 5 years outcome of the FRISC-2 trial indicates a sustained benefit of an early invasive strategy in moderate to high risk non-ST-elevation acute coronary syndrome.
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