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伴有或不伴有糖尿病的左主干病变患者经皮冠状动脉介入治疗与冠状动脉旁路移植术的比较:来自4项随机临床试验汇总分析的结果

Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Left Main Disease With and Without Diabetes: Findings From a Pooled Analysis of 4 Randomized Clinical Trials.

作者信息

Gaba Prakriti, Sabik Joseph F, Murphy Sabina A, Bellavia Andrea, O'Gara Patrick T, Smith Peter K, Serruys Patrick W, Kappetein A Pieter, Park Seung-Jung, Park Duk-Woo, Christiansen Evald H, Holm Niels R, Nielsen Per H, Sabatine Marc S, Stone Gregg W, Bergmark Brian A

机构信息

TIMI Study Group, Brigham and Women's Hospital, Boston, MA (P.G., S.A.M., A.B., M.S.S., B.A.B.).

Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (P.G., S.A.M., A.B., P.T.O., M.S.S., B.A.B.).

出版信息

Circulation. 2024 Apr 23;149(17):1328-1338. doi: 10.1161/CIRCULATIONAHA.123.065571. Epub 2024 Mar 11.

Abstract

BACKGROUND

Diabetes may be associated with differential outcomes in patients undergoing left main coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). The aim of this study was to investigate outcomes in patients with left main disease with and without diabetes randomized to PCI versus CABG.

METHODS

Individual patient data were pooled from 4 trials (SYNTAX [Synergy Between PCI With Taxus and Cardiac Surgery], PRECOMBAT [Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease], NOBLE [Nordic-Baltic-British Left Main Revascularisation Study], and EXCEL [Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization]) that randomized patients with left main disease to PCI or CABG. Patients were considered suitable for either approach. Patients were categorized by diabetes status. Kaplan-Meier event rates, Cox model hazard ratios, and interactions were assessed.

RESULTS

Among 4393 patients, 1104 (25.1%) had diabetes. Patients with diabetes experienced higher rates of 5-year death (158/1104 [Kaplan-Meier rate, 14.7%] versus 297/3289 [9.3%]; <0.001), spontaneous myocardial infarction (MI; 67/1104 [6.7%] versus 114/3289 [3.7%]; <0.001), and repeat revascularization (189/1104 [18.5%] versus 410/3289 [13.2%]; <0.001). Rates of all-cause mortality did not differ after PCI versus CABG in those with (84/563 [15.3%] versus 74/541 [14.1%]; hazard ratio, 1.11 [95% CI, 0.82-1.52]) or without (155/1634 [9.7%] versus 142/1655 [8.9%]; hazard ratio, 1.08 [95% CI, 0.86-1.36; =0.87) diabetes. Rates of stroke within 1 year were lower with PCI versus CABG in the entire population, with no heterogeneity based on diabetes status (=0.51). The 5-year rates of spontaneous MI and repeat coronary revascularization were higher after PCI regardless of diabetes status (spontaneous MI: 45/563 [8.9%] versus 22/541 [4.4%] in diabetes and 82/1634 [5.3%] versus 32/1655 [2.1%] in no diabetes, =0.47; repeat revascularization: 127/563 [24.5%] versus 62/541 [12.4%] in diabetes and 254/1634 [16.3%] versus 156/1655 [10.1%] in no diabetes, =0.18). For spontaneous MI and repeat revascularization, there were greater absolute risk differences beyond 1 year in patients with diabetes (4.9% and 9.9%) compared with those without (2.1% and 4.3%; =0.047 and 0.016).

CONCLUSIONS

In patients with left main disease considered equally suitable for PCI or CABG and with largely low to intermediate SYNTAX scores, diabetes was associated with higher rates of death and cardiovascular events through 5 years. Compared with CABG, PCI resulted in no difference in the risk of death and a lower risk of early stroke regardless of diabetes status, and a higher risk of spontaneous MI and repeat coronary revascularization, with larger late absolute excess risks in patients with diabetes.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01205776, NCT0146651, NCT00422968, and NCT00114972.

摘要

背景

糖尿病可能与接受经皮冠状动脉介入治疗(PCI)或冠状动脉旁路移植术(CABG)的左主干冠状动脉血运重建患者的不同预后相关。本研究的目的是调查随机接受PCI与CABG的合并或未合并糖尿病的左主干病变患者的预后。

方法

从4项试验(SYNTAX [紫杉醇洗脱支架PCI与心脏手术的协同作用]、PRECOMBAT [左主干冠状动脉疾病患者使用西罗莫司洗脱支架进行搭桥手术与血管成形术随机比较的首要研究]、NOBLE [北欧-波罗的海-英国左主干血运重建研究]和EXCEL [XIENCE与冠状动脉旁路手术治疗左主干血运重建有效性的评估])中汇总个体患者数据,这些试验将左主干病变患者随机分为PCI组或CABG组。患者被认为适合两种方法中的任何一种。患者按糖尿病状态分类。评估了Kaplan-Meier事件发生率、Cox模型风险比和相互作用。

结果

在4393例患者中,1104例(25.1%)患有糖尿病。糖尿病患者5年死亡率更高(158/1104 [Kaplan-Meier率,14.7%] 对297/3289 [9.3%];<0.001),自发性心肌梗死(MI)发生率更高(67/1104 [6.7%] 对114/3289 [3.7%];<0.001),再次血运重建率更高(189/1104 [18.5%] 对410/3289 [13.2%];<0.001)。在合并糖尿病(84/563 [15.3%] 对74/541 [14.1%];风险比,1.11 [95% CI,0.82 - 1.52])或未合并糖尿病(155/1634 [9.7%] 对142/1655 [8.9%];风险比,1.08 [95% CI,0.86 - 1.36;P = 0.87])的患者中,PCI与CABG后的全因死亡率无差异。在整个人口中,PCI后1年内的卒中发生率低于CABG,且基于糖尿病状态无异质性(P = 0.51)。无论糖尿病状态如何,PCI后5年的自发性MI和再次冠状动脉血运重建率均更高(自发性MI:糖尿病患者中45/563 [8.9%] 对22/541 [4.4%],非糖尿病患者中82/1634 [5.3%] 对32/1655 [2.1%],P = 0.47;再次血运重建:糖尿病患者中127/563 [24.5%] 对62/541 [12.4%],非糖尿病患者中254/1634 [16.3%] 对156/1655 [10.1%],P = 0.18)。对于自发性MI和再次血运重建,糖尿病患者1年后的绝对风险差异(4.9%和9.9%)大于非糖尿病患者(2.1%和4.3%;P = 0.047和0.016)。

结论

在认为同样适合PCI或CABG且SYNTAX评分大多为低至中度的左主干病变患者中,糖尿病与5年内更高的死亡率和心血管事件发生率相关。与CABG相比,PCI在死亡风险方面无差异,且无论糖尿病状态如何,早期卒中风险较低,而自发性MI和再次冠状动脉血运重建风险较高,但糖尿病患者后期的绝对超额风险更大。

注册

网址:https://www.clinicaltrials.gov;唯一标识符:NCT01205776、NCT0146651、NCT00422968和NCT00114972。

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