Megaly Michael, Ali Abdelrahman, Abraham Bishoy, Khalil Charl, Zordok Magdi, Shaker Marco, Tawadros Mariam, Hennawy Bassam S, Elbadawi Ayman, Omer Mohamed, Saad Marwan
Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA; Department of Cardiovascular Medicine, Hennepin Healthcare, Minneapolis, MN, USA.
Department of Medicine, Mercy Hospital and Medical Center, Chicago, IL, USA.
Cardiovasc Revasc Med. 2020 Jan;21(1):78-85. doi: 10.1016/j.carrev.2019.03.001. Epub 2019 Mar 13.
Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains associated with inferior clinical outcomes and an increased risk of restenosis compared with non-diabetics even in the era of drug-eluting stents (DES). The outcomes with drug-coated balloons (DCBs) in diabetic patients have received limited study.
We performed a meta-analysis of all studies published between January 2000 and January 2019 reporting the outcomes with DCB vs. DES after PCI of de-novo coronary lesions in diabetic patients. Outcomes included major adverse cardiovascular events (MACE), target lesion revascularization (TLR), binary restenosis by quantitative coronary angiography (QCA), and late lumen loss (LLL).
Three studies with 378 patients (440 lesions) were included in the meta-analysis. During 17.3 ± 11.3 months follow-up, DCB were associated with a similar risk of MACE (OR: 0.63, 95% CI [0.36, 1.12], p = 0.11), TLR (OR: 0.51, 95% CI [0.25, 1.06] p = 0.07), binary restenosis (OR: 0.42, 95% CI [0.09, 1.92], p = 0.26), and LLL (mean difference: -0.13 mm, 95% CI [-0.41, 0.14], p = 0.34) compared with DES.
In diabetic patients with de-novo coronary lesions undergoing PCI, DCBs are associated with similar outcomes compared with first-generation DES, with a signal toward potential benefit in lowering target lesion revascularization. Further randomized studies are needed to compare the newer-generation DCBs and DES in this setting.
即使在药物洗脱支架（DES）时代，糖尿病（DM）患者的经皮冠状动脉介入治疗（PCI）与非糖尿病患者相比，临床结局仍较差，再狭窄风险增加。药物涂层球囊（DCB）在糖尿病患者中的疗效研究有限。
我们对2000年1月至2019年1月发表的所有研究进行了荟萃分析，这些研究报告了糖尿病患者原发性冠状动脉病变PCI后DCB与DES的疗效。结局指标包括主要不良心血管事件（MACE）、靶病变血运重建（TLR）、定量冠状动脉造影（QCA）评估的二元再狭窄以及晚期管腔丢失（LLL）。
荟萃分析纳入了3项研究，共378例患者（440处病变）。在17.3±11.3个月的随访期间，与DES相比，DCB发生MACE的风险相似（OR：0.63，95%CI[0.36，1.12]，p = 0.11），TLR风险相似（OR：0.51，95%CI[0.25，1.06]，p = 0.07），二元再狭窄风险相似（OR：0.42，95%CI[0.09，1.92]，p = 0.26），LLL相似（平均差异：-0.13 mm，95%CI[-0.41，0.14]，p = 0.34）。
在接受PCI的糖尿病原发性冠状动脉病变患者中，与第一代DES相比，DCB的疗效相似，在降低靶病变血运重建方面有潜在获益的趋势。需要进一步的随机研究来比较新一代DCB和DES在这种情况下的疗效。
