胰岛素治疗与非胰岛素治疗的糖尿病对初发冠状动脉疾病中药物涂层球囊与药物洗脱支架经皮冠状动脉介入治疗结局的影响：随机BASKET-SMALL 2试验
Impact of Insulin-Treated Compared to Non-Insulin-Treated Diabetes Mellitus on Outcome of Percutaneous Coronary Intervention with Drug-Coated Balloons versus Drug-Eluting Stents in De Novo Coronary Artery Disease: The Randomized BASKET-SMALL 2 Trial.
作者信息
Seeger Julia, Wöhrle Jochen, Scheller Bruno, Farah Ahmed, Ohlow Marc-Alexander, Mangner Norman, Möbius-Winkler Sven, Weilenmann Daniel, Stachel Georg, Leibundgut Gregor, Rickenbacher Peter, Cattaneo Marco, Gilgen Nicole, Kaiser Christoph, Jeger Raban
机构信息
Medical Campus Lake Constance, Department of Cardiology and Intensive Care, 88048 Friedrichshafen, Germany.
Clinical and Experimental Interventional Cardiology, University of Saarland, 66421 Homburg, Germany.
出版信息
J Cardiovasc Dev Dis. 2023 Mar 13;10(3):119. doi: 10.3390/jcdd10030119.
BACKGROUND
We evaluated the outcome of PCI of de novo stenosis with drug-coated balloons (DCB) versus drug-eluting stents (DES) in patients with insulin-treated diabetes mellitus (ITDM) versus non-insulin-treated diabetes mellitus (NITDM).
METHODS
Patients were randomized in the BASKET-SMALL 2 trial to DCB or DES and followed over 3 years for MACE (cardiac death, non-fatal myocardial infarction [MI], and target vessel revascularization [TVR]). Outcome in the diabetic subgroup ( = 252) was analyzed with respect to ITDM or NITDM.
RESULTS
In NITDM patients ( = 157), rates of MACE (16.7% vs. 21.9%, hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.29-1.58, = 0.37), death, non-fatal MI, and TVR (8.4% vs. 14.5%, HR 0.30, 95% CI 0.09-1.03, = 0.057) were similar between DCB and DES. In ITDM patients ( = 95), rates of MACE (DCB 23.4% vs. DES 22.7%, HR 1.12, 95% CI 0.46-2.74, = 0.81), death, non-fatal MI, and TVR (10.1% vs. 15.7%, HR 0.64, 95% CI 0.18-2.27, = 0.49) were similar between DCB and DES. TVR was significantly lower with DCB versus DES in all diabetic patients (HR 0.41, 95% CI 0.18-0.95, = 0.038).
CONCLUSIONS
DCB compared to DES for treatment of de novo coronary lesions in diabetic patients was associated with similar rates of MACE and numerically lower need for TVR both for ITDM and NITDM patients.
背景
我们评估了药物涂层球囊（DCB）与药物洗脱支架（DES）治疗初发狭窄的疗效，比较了胰岛素治疗的糖尿病（ITDM）患者和非胰岛素治疗的糖尿病（NITDM）患者的情况。
方法
在BASKET-SMALL 2试验中，患者被随机分为接受DCB或DES治疗，并随访3年以观察主要不良心血管事件（MACE，包括心源性死亡、非致死性心肌梗死[MI]和靶血管血运重建[TVR]）。对糖尿病亚组（n = 252）的患者，根据是否接受胰岛素治疗进行分析。
结果
在NITDM患者（n = 157）中，DCB组与DES组的MACE发生率（16.7%对21.9%，风险比[HR] 0.68，95%置信区间[CI] 0.29 - 1.58，P = 0.37）、死亡、非致死性MI及TVR发生率（8.4%对14.5%，HR 0.30，95% CI 0.09 - 1.03，P = 0.057）相似。在ITDM患者（n = 95）中，DCB组与DES组的MACE发生率（DCB组23.4%对DES组22.7%，HR 1.12，95% CI 0.46 - 2.74，P = 0.81）、死亡、非致死性MI及TVR发生率（10.1%对15.7%，HR 0.64，95% CI 0.18 - 2.27，P = 0.49）相似。在所有糖尿病患者中，DCB组的TVR显著低于DES组（HR 0.41，95% CI 0.18 - 0.95，P = 0.038）。
结论
对于糖尿病患者初发冠状动脉病变的治疗，与DES相比，DCB治疗的MACE发生率相似，且ITDM和NITDM患者的TVR需求在数值上更低。
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