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ST 段抬高型心肌梗死患者糖尿病的长期影响:来自 EXAMINATION 随机试验的观察。

Long-term impact of diabetes in patients with ST-segment elevation myocardial infarction: Insights from the EXAMINATION randomized trial.

机构信息

Interventional Cardiology Department, Clinico San Carlos University Hospital, IdISSC, Madrid, Spain.

Interventional Cardiology Department, University Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.

出版信息

Catheter Cardiovasc Interv. 2019 Dec 1;94(7):917-925. doi: 10.1002/ccd.28194. Epub 2019 Mar 20.

Abstract

BACKGROUND

Long-term outcomes of diabetic patients suffering from ST-segment elevation myocardial infarction (STEMI) and treated with second-generation drug-eluting stent have been scarcely evaluated. The aim of this posthoc subanalysis of the EXAMINATION trial was to compare 5-year outcomes according to the presence of diabetes mellitus.

METHODS

From a total of 1,497 patients included in the trial, 258 were diabetics (n = 137, received everolimus-eluting stent (EES) and n = 121 bare-metal stent (BMS); whereas 1,239 were nondiabetics (n = 613 treated with EES and n = 626 with BMS). Patient-oriented combined endpoint (POCE) defined as all-cause death, any MI or any revascularization, and other clinical parameters were collected up to 5-years. All results were adjusted for various potential confounders.

RESULTS

At 5-years, patients with diabetes showed similar rates of POCE between diabetics treated with EES and those treated with BMS (32.8% vs. 32.2%; p = 0.88). However, rates of TLR were significantly lower in the EES group (4.4% vs. 9.9%; HR 0.52 (0.29-0.94); P = 0.03). In non-diabetics, the use of EES was associated with a significant improvement in all-clinical parameters except for MI rate: POCE: [10.0% vs. 12.6%; HR 0.78(0.62-0.98); P = 0.038], all cause death: [7.0% vs. 12.1%; HR 0.62(0.42-0.90); P = 0.014], and [TLR: 4.2 vs. 6.7; HR 0.60 (0.37-0.98); P = 0.04]. Overall, diabetics showed higher rate of POCE at 5-years (32.6% vs. 21.5% in nondiabetics HR1.45[1.03-2.04];p = 0.03) driven by increased rates of MI and the need for revascularization that occurred in coronary segments remote from target lesions [2.7% vs. 1.1%; HR: 2.27 (1.12-5.23); P = 0.02 and 14% vs. 6.2%; HR: 2.11 (1.38-3.22); P = 0.001, respectively].

CONCLUSIONS

Diabetics had worse clinical outcomes than nondiabetics after STEMI mainly due to atherosclerosis progression. At 5-years, the treatment with EES did not reduce the rate of POCE in diabetics but reduced the need for revascularization compared with BMS.

摘要

背景

患有 ST 段抬高型心肌梗死(STEMI)并接受第二代药物洗脱支架治疗的糖尿病患者的长期预后鲜有评估。EXAMINATION 试验的这一事后亚分析的目的是根据糖尿病的存在比较 5 年的结果。

方法

在试验中总共纳入了 1497 例患者,258 例为糖尿病患者(n=137,接受依维莫司洗脱支架(EES)治疗,n=121 例接受裸金属支架(BMS)治疗);1239 例为非糖尿病患者(n=613 例接受 EES 治疗,n=626 例接受 BMS 治疗)。收集了患者为中心的复合终点(POCE),定义为全因死亡、任何心肌梗死或任何血运重建以及其他临床参数,直至 5 年。所有结果均经过多种潜在混杂因素的调整。

结果

在 5 年时,糖尿病患者中 EES 治疗组和 BMS 治疗组的 POCE 发生率相似(32.8% vs. 32.2%;p=0.88)。然而,EES 组的 TLR 发生率显著降低(4.4% vs. 9.9%;HR 0.52(0.29-0.94);P=0.03)。在非糖尿病患者中,EES 的使用与所有临床参数的显著改善相关,除了心肌梗死率:POCE:[10.0% vs. 12.6%;HR 0.78(0.62-0.98);P=0.038]、全因死亡:[7.0% vs. 12.1%;HR 0.62(0.42-0.90);P=0.014]和[TLR:4.2% vs. 6.7%;HR 0.60(0.37-0.98);P=0.04]。总的来说,糖尿病患者在 5 年时 POCE 发生率更高(32.6% vs. 非糖尿病患者 21.5%,HR 1.45[1.03-2.04];p=0.03),这主要归因于心肌梗死和血运重建的发生率增加,这些发生在靶病变以外的冠状动脉节段[2.7% vs. 1.1%;HR:2.27(1.12-5.23);P=0.02]和[14% vs. 6.2%;HR:2.11(1.38-3.22);P=0.001]。

结论

糖尿病患者 STEMI 后临床结局较非糖尿病患者差,主要是由于动脉粥样硬化进展。在 5 年时,与 BMS 相比,EES 的治疗并未降低糖尿病患者 POCE 的发生率,但降低了血运重建的需求。

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