PDF(Pubmed)
Abstract：
Background: The rate of in-stent restenosis (ISR) is decreasing; however, it is still a challenge for contemporary invasive cardiologists. Therapeutic methods, including drug-eluting balloons (DEBs), intravascular lithotripsy, excimer laser coronary atherectomy, and imaging-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES), have been implemented. Patients with diabetes mellitus (DM) are burdened with a higher risk of ISR than the general population. Aims: DM-Dragon is aimed at evaluating the clinical outcomes of ISR treatment with DEBs vs. DES, focusing on patients with co-existing diabetes mellitus. Methods: The DM-Dragon registry is a retrospective study comprising data from nine high-volume PCI centers in Poland. A total of 1117 patients, of whom 473 individuals had DM and were treated with PCI due to ISR, were included. After propensity-score matching (PSM), 198 pairs were created for further analysis. The primary outcome of the study was target lesion revascularization (TLR). Results: In DM patients after PSM, TLR occurred in 21 (10.61%) vs. 20 (10.1%) in non-diabetic patients, p = 0.8690. Rates of target vessel revascularization (TVR), target vessel myocardial infarction, device-oriented composite endpoint (DOCE), and cardiac death did not differ significantly. Among diabetic patients, the risk of all-cause mortality was significantly lower in the DEB group (2.78% vs. 11.11%, HR 3.67 (95% confidence interval, CI) [1.01-13.3), p = 0.0483). Conclusions: PCI with DEBs is almost as effective as DES implantation in DM patients treated for ISR. In DM-Dragon, the rate of all-cause death was significantly lower in patients treated with DEBs. Further large-scale, randomized clinical trials would be needed to support these findings.
摘要：
背景：支架内再狭窄（ISR）的发生率正在下降；然而，对于当代侵入性心脏病专家来说，这仍然是一个挑战。治疗方法,包括药物洗脱球囊（DEB），血管内碎石术,准分子激光冠状动脉粥样斑块切除术,和使用药物洗脱支架（DES）的影像引导经皮冠状动脉介入治疗（PCI），已经实施了。糖尿病（DM）患者的ISR风险高于普通人群。目的：DM-Dragon旨在评估DEB与ISR治疗的临床结果DES,重点关注并存糖尿病患者。方法：DM-Dragon注册是一项回顾性研究，包括来自波兰9个高容量PCI中心的数据。共有1117名患者，其中473人患有DM，并因ISR接受PCI治疗，包括在内。在倾向得分匹配(PSM)之后，创建198对用于进一步分析。该研究的主要结果是靶病变血运重建（TLR）。结果：在PSM后的DM患者中，TLR发生在21（10.61%）与20（10.1％）在非糖尿病患者中，p=0.8690。目标血管血运重建(TVR)率靶血管心肌梗死,面向设备的复合端点(DOCE)，和心脏死亡没有显著差异。在糖尿病患者中，DEB组的全因死亡率风险显著降低(2.78%vs.11.11%，HR3.67(95%置信区间，CI)[1.01-13.3)，p=0.0483)。结论：在接受ISR治疗的DM患者中，采用DEB的PCI几乎与DES植入一样有效。在DM-Dragon,在接受DEB治疗的患者中,全因死亡率显著降低.进一步大规模,需要随机临床试验来支持这些发现.
