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血流储备分数指导下的完全血运重建改善 ST 段抬高型心肌梗死合并严重非罪犯病变患者的预后:DANAMI 3-PRIMULTI 子研究(ST 段抬高型心肌梗死合并多支血管病变患者的直接经皮冠状动脉介入治疗:仅治疗罪犯病变还是完全血运重建)

Fractional Flow Reserve-Guided Complete Revascularization Improves the Prognosis in Patients With ST-Segment-Elevation Myocardial Infarction and Severe Nonculprit Disease: A DANAMI 3-PRIMULTI Substudy (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization).

作者信息

Lønborg Jacob, Engstrøm Thomas, Kelbæk Henning, Helqvist Steffen, Kløvgaard Lene, Holmvang Lene, Pedersen Frants, Jørgensen Erik, Saunamäki Kari, Clemmensen Peter, De Backer Ole, Ravkilde Jan, Tilsted Hans-Henrik, Villadsen Anton Boel, Aarøe Jens, Jensen Svend Eggert, Raungaard Bent, Køber Lars, Høfsten Dan Eik

机构信息

From the Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark (J.L., T.E., S.H., L. Kløvgaard, L.H., F.P., E.J., K.S., O.D.B., H.-H.T., L. Køber, D.E.H.); Department of Cardiology, Roskilde Hospital, Denmark (H.K.); Department of Cardiology, Nykoebing Falster Hospital, Denmark (P.C.); and Department of Cardiology, Aalborg University Hospital, Denmark (J.R., A.B.V., J.A., S.E.J., B.R.).

出版信息

Circ Cardiovasc Interv. 2017 Apr;10(4). doi: 10.1161/CIRCINTERVENTIONS.116.004460.

Abstract

BACKGROUND

The impact of disease severity on the outcome after complete revascularization in patients with ST-segment-elevation myocardial infarction and multivessel disease is uncertain. The objective of this post hoc study was to evaluate the impact of number of diseased vessel, lesion location, and severity of the noninfarct-related stenosis on the effect of fractional flow reserve-guided complete revascularization.

METHODS AND RESULTS

In the DANAMI-3-PRIMULTI study (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization), we randomized 627 ST-segment-elevation myocardial infarction patients to fractional flow reserve-guided complete revascularization or infarct-related percutaneous coronary intervention only. In patients with 3-vessel disease, fractional flow reserve-guided complete revascularization reduced the primary end point (all-cause mortality, reinfarction, and ischemia-driven revascularization; hazard ratio [HR], 0.33; 95% confidence interval [CI], 0.17-0.64; =0.001), with no significant effect in patients with 2-vessel disease (HR, 0.77; 95% CI, 0.47-1.26; =0.29; for interaction =0.046). A similar effect was observed in patients with diameter stenosis ≥90% of noninfarct-related arteries (HR, 0.32; 95% CI, 0.18-0.62; =0.001), but not in patients with less severe lesions (HR, 0.72; 95% CI, 0.44-1.19; =0.21; for interaction =0.06). The effect was most pronounced in patients with 3-vessel disease and noninfarct-related stenoses ≥90%, and in this subgroup, there was a nonsignificant reduction in the end point of mortality and reinfarction (HR, 0.32; 95% CI, 0.08-1.32; =0.09). Proximal versus distal location did not influence the benefit from complete revascularization.

CONCLUSIONS

The benefit from fractional flow reserve-guided complete revascularization in ST-segment-elevation myocardial infarction patients with multivessel disease was dependent on the presence of 3-vessel disease and noninfarct diameter stenosis ≥90% and was particularly pronounced in patients with both of these angiographic characteristics.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01960933.

摘要

背景

疾病严重程度对ST段抬高型心肌梗死合并多支血管病变患者完全血运重建后预后的影响尚不确定。这项事后分析研究的目的是评估病变血管数量、病变位置以及非梗死相关狭窄的严重程度对血流储备分数引导下完全血运重建效果的影响。

方法与结果

在DANAMI-3-PRIMULTI研究(ST段抬高型心肌梗死合并多支血管病变患者的直接经皮冠状动脉介入治疗:仅处理罪犯病变还是完全血运重建)中,我们将627例ST段抬高型心肌梗死患者随机分为血流储备分数引导下的完全血运重建组或仅进行梗死相关经皮冠状动脉介入治疗组。在三支血管病变患者中,血流储备分数引导下的完全血运重建降低了主要终点事件(全因死亡率、再梗死和缺血驱动的血运重建;风险比[HR],0.33;95%置信区间[CI],0.17 - 0.64;P = 0.001),而在两支血管病变患者中无显著效果(HR,0.77;95% CI,0.47 - 1.26;P = 0.29;交互作用P = 0.046)。在非梗死相关动脉直径狭窄≥90%的患者中观察到类似效果(HR,0.32;95% CI,0.18 - 0.62;P = 0.001),但在病变较轻的患者中未观察到(HR,0.72;95% CI,0.44 - 1.19;P = 0.21;交互作用P = 0.06)。这种效果在三支血管病变且非梗死相关狭窄≥90%的患者中最为明显,在该亚组中,死亡率和再梗死终点有非显著降低(HR,0.32;95% CI,0.08 - 1.32;P = 0.09)。近端与远端位置不影响完全血运重建的获益。

结论

血流储备分数引导下的完全血运重建对ST段抬高型心肌梗死合并多支血管病变患者的获益取决于三支血管病变的存在以及非梗死直径狭窄≥90%,并且在具有这两种血管造影特征的患者中尤为明显。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT01960933。

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