1. Drug-Eluting Balloons and Drug-Eluting Stents in Diabetic Patients Undergoing Percutaneous Coronary Intervention Due to Restenosis-DM-Dragon Registry.
- Author
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Niezgoda P, Kasprzak M, Kubica J, Kuźma Ł, Januszek R, Iwańczyk S, Tomasiewicz B, Bil J, Kowalewski M, Jaguszewski M, Wybraniec M, Reczuch K, Dobrzycki S, Bartuś S, Lesiak M, Gąsior M, Wolny R, Witkowski A, Gil R, Cortese B, D'Ascenzo F, Wojakowski W, and Wańha W
- 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.
- Published
- 2024
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