Verdoia Monica, Nardin Matteo, Rognoni Andrea, Cortese Bernardo
Division of Cardiology, ASL, Biella, Italy.
Department of Internal Medicine, Spedali Civili, Brescia, Italy.
Catheter Cardiovasc Interv. 2024 Dec;104(7):1423-1433. doi: 10.1002/ccd.31257. Epub 2024 Oct 28.
Despite the improvements in drug eluting stents (DES) technology, suboptimal results have been observed in certain higher-risk subsets of patients, as in diabetes mellitus (DM). Drug-coated balloons (DCB) could represent an alternative to DES in complex populations and anatomies, as in DM.
The present meta-analysis aimed at assessing the role of DCBs in patients with diabetes mellitus.
Studies comparing DCB versus percutaneous coronary revascularization (PCI) with/without DES for PCI in high-risk populations (>30% DM) were included. The primary efficacy endpoint was overall mortality, secondary endpoints were myocardial infarction, target lesion revascularization (TLR), and major adverse cardiovascular events (MACE).
We included 10 studies, comprising 2026 patients. Among them, 1002 patients (49.5%) were treated with DCB and 1024 with DES implantation. Among the included studies, 6 only enrolled diabetic patients and 2 had a prevalence of diabetes of 50%. At a mean follow-up of 15.3 months, mortality rate was 3.8% (82 patients), significantly lower with DCB (3.2% vs. 4.9% with DES; odds ratio [OR] [95% confidence interval {CI}] = 0.61 [0.38, 0.97], p = 0.04 p = 0.34. A similar reduction in favor of DCB was observed for MACE (13.6% vs. 17.6%; OR [95% CI] = 0.79 [0.61, 1.04], p = 0.09, p = 0.25), while TLR was significantly reduced only in the diabetic-restricted sub-analysis.
In the present meta-analysis, we showed a significant survival benefit and an absolute reduction in MACE and TLR with a DCB-based strategy as compared to DES in high-risk patients, mostly with DM. Future large-scale randomized trials, dedicated to this population, are deserved to confirm our findings.
Complex coronary anatomies and diabetes mellitus (DM) represent the pitfall of drug eluting stents (DES), mainly due to inflammatory and thrombotic complications, which should be reduced with drug-coated balloons (DCB).
We confirmed a significant advantage of DCB versus DES in the treatment of de novo lesions in high-risk patients and mainly in DM, reducing overall mortality, MACE and target lesion revascularization.
尽管药物洗脱支架（DES）技术有所改进，但在某些高危患者亚组中，如糖尿病（DM）患者，仍观察到不理想的结果。药物涂层球囊（DCB）在复杂人群和解剖结构中，如糖尿病患者中，可能是DES的一种替代方案。
本荟萃分析旨在评估DCB在糖尿病患者中的作用。
纳入比较DCB与经皮冠状动脉血运重建术（PCI）联合/不联合DES用于高危人群（糖尿病患者>30%）PCI的研究。主要疗效终点为全因死亡率，次要终点为心肌梗死、靶病变血运重建（TLR）和主要不良心血管事件（MACE）。
我们纳入了10项研究，共2026例患者。其中，1002例患者（49.5%）接受了DCB治疗，1024例接受了DES植入。在纳入的研究中，6项仅纳入糖尿病患者，2项糖尿病患病率为50%。平均随访15.3个月时，死亡率为3.8%（82例患者），DCB治疗组显著更低（3.2% vs. DES治疗组的4.9%；优势比[OR][95%置信区间{CI}]=0.61[0.38,0.97]，p=0.04，p=0.34）。在MACE方面也观察到有利于DCB的类似降低（13.6% vs. 17.6%；OR[95%CI]=0.79[0.61,1.04]，p=0.09，p=0.25），而仅在糖尿病限制亚组分析中TLR显著降低。
在本荟萃分析中，我们表明与DES相比，基于DCB的策略在高危患者（主要是糖尿病患者）中具有显著的生存获益以及MACE和TLR的绝对降低。未来针对该人群的大规模随机试验值得开展以证实我们的发现。
复杂的冠状动脉解剖结构和糖尿病（DM）是药物洗脱支架（DES）的缺陷所在，主要是由于炎症和血栓形成并发症，而药物涂层球囊（DCB）应可减少这些并发症。
我们证实了DCB在治疗高危患者尤其是糖尿病患者的初发病变方面相对于DES具有显著优势，可降低全因死亡率、MACE和靶病变血运重建率。
