Drug-Eluting Balloons and Drug-Eluting Stents in Diabetic Patients Undergoing Percutaneous Coronary Intervention Due to Restenosis-DM-Dragon Registry

Piotr Niezgoda, Michal Kasprzak, Jacek Kubica, Lukasz Kuzma, Rafal Januszek, Sylwia Iwanczyk, Brunon Tomasiewicz, Jacek Bil, Mariusz Kowalewski, Milosz Jaguszewski, Maciej Wybraniec, Krzysztof Reczuch, Slawomir Dobrzycki, Stanislaw Bartus, Maciej Lesiak, Mariusz Gasior, Rafal Wolny, Adam Witkowski, Robert Gil, Bernardo CorteseFabrizio D'Ascenzo, Wojciech Wojakowski, Wojciech Wanha

Research output: Contribution to journalArticleAcademicpeer-review

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.

Original languageEnglish
Article number4464
JournalJournal of Clinical Medicine
Volume13
Issue number15
DOIs
Publication statusPublished - 30 Jul 2024

Keywords

  • DEB
  • DES
  • diabetes mellitus
  • in-stent restenosis (ISR)
  • restenosis

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