Peter Munk Cardiac Centre and the Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Ontario, Canada.
Albany Medical College, Albany, New York.
J Am Coll Cardiol. 2019 Feb 5;73(4):400-411. doi: 10.1016/j.jacc.2018.11.044.
The optimal coronary revascularization strategy in patients with stable ischemic heart disease (SIHD) who have type 2 diabetes (T2DM) and chronic kidney disease (CKD) remains unclear.
This patient-level pooled analysis sought to compare outcomes of 3 large, federally-funded randomized trials in SIHD patients with T2DM and CKD (COURAGE [Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation], BARI 2D [Bypass Angioplasty Revascularization Investigation 2 Diabetes], and FREEDOM [Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multi-vessel Disease]).
The primary endpoint was the composite of major adverse cardiovascular or cerebrovascular events (MACCE) including all-cause death, myocardial infarction (MI), or stroke adjusted for trial and randomization strategy.
Of the 4,953 patients with available estimated glomerular filtration rate (eGFR) at baseline, 1,058 had CKD (21.4%). CKD patients were more likely to be older, be female, and have a history of heart failure. CKD subjects were more likely to experience a MACCE (adjusted hazard ratio [HR]: 1.48; 95% confidence interval [CI]: 1.28 to 1.71; p = 0.0001) during a median 4.5-year follow-up. Both mild (eGFR 45 to 60 ml/min/1.73 m) and moderate to severe (eGFR <45 ml/min/1.73 m) CKD predicted MACCE (adjusted HRs: 1.25 and 2.26, respectively). For patients without CKD, coronary artery bypass graft (CABG) surgery combined with optimal medical therapy (OMT) was associated with lower MACCE rates compared with percutaneous coronary intervention (PCI) + OMT (adjusted HR: 0.69; 95% CI: 0.55 to 0.86; p = 0.001). For the comparison of CABG + OMT versus PCI + OMT in the CKD group, there was only a statistically significant difference in subsequent revascularization rates (HR: 0.25; 95% CI: 0.15 to 0.41; p = 0.0001) but not in MACCE rates.
Among SIHD patients with T2DM and no CKD, CABG + OMT significantly reduced MACCE compared with PCI + OMT. In subjects with CKD, there was a nonsignificant trend toward a better MACCE outcome with CABG and a significant reduction in subsequent revascularization.
患有 2 型糖尿病(T2DM)和慢性肾脏病(CKD)的稳定型缺血性心脏病(SIHD)患者的最佳冠状动脉血运重建策略仍不清楚。
本患者水平的汇总分析旨在比较 COURAGE(血管重建和强化药物评估的临床结果)、BARI 2D(糖尿病 2 型血管旁路研究)和 FREEDOM(糖尿病患者多血管疾病的未来血运重建评估:最佳多血管疾病管理)这 3 项大型联邦资助的随机试验中 T2DM 和 CKD 合并 SIHD 患者的结局。
主要终点是包括全因死亡、心肌梗死(MI)或卒中在内的主要不良心血管或脑血管事件(MACCE)的复合终点,根据试验和随机化策略进行调整。
在基线时可获得估计肾小球滤过率(eGFR)的 4953 例患者中,1058 例患有 CKD(21.4%)。CKD 患者更可能年龄较大、女性和有心力衰竭病史。CKD 患者在中位 4.5 年的随访期间更可能发生 MACCE(调整后的危险比 [HR]:1.48;95%置信区间 [CI]:1.28 至 1.71;p<0.0001)。轻度(eGFR 45 至 60 ml/min/1.73 m)和中重度 CKD(eGFR<45 ml/min/1.73 m)均预测 MACCE(调整后的 HRs:1.25 和 2.26)。对于没有 CKD 的患者,冠状动脉旁路移植术(CABG)联合最佳药物治疗(OMT)与经皮冠状动脉介入治疗(PCI)+OMT 相比,MACCE 发生率较低(调整后的 HR:0.69;95%CI:0.55 至 0.86;p=0.001)。对于 CKD 组中 CABG+OMT 与 PCI+OMT 的比较,仅在随后的血运重建率方面存在统计学显著差异(HR:0.25;95%CI:0.15 至 0.41;p=0.0001),而在 MACCE 发生率方面没有差异。
在无 CKD 的 T2DM 和 SIHD 患者中,CABG+OMT 与 PCI+OMT 相比,MACCE 显著降低。在 CKD 患者中,CABG 有更好的 MACCE 结局趋势,随后的血运重建明显减少。