Impact of Insulin-Treated Compared to Non-Insulin-Treated Diabetes Mellitus on Outcome of Percutaneous Coronary Intervention with Drug-Coated Balloons versus Drug-Eluting Stents in De Novo Coronary Artery Disease: The Randomized BASKET-SMALL 2 Trial

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Julia Seeger - , Medical Campus Lake Constance (Author)
  • Jochen Wöhrle - , Medical Campus Lake Constance (Author)
  • Bruno Scheller - , University Hospital of Saarland (Author)
  • Ahmed Farah - , University Hospital Knappschaftskrankenhaus Bochum GmbH (Author)
  • Marc-Alexander Ohlow - , SRH Wald-Klinikum Gera (Author)
  • Norman Mangner - , Department of Internal Medicine and Cardiology (at Dresden Heart Centre), TUD Dresden University of Technology (Author)
  • Sven Möbius-Winkler - , Jena University Hospital (Author)
  • Daniel Weilenmann - , Cantonal Hospital St. Gallen (Author)
  • Georg Stachel - , University Hospital Olomouc (Author)
  • Gregor Leibundgut - , Cantonal Hospital Baselland (Author)
  • Peter Rickenbacher - , University of Basel (Author)
  • Marco Cattaneo - , University of Basel (Author)
  • Nicole Gilgen - , University of Basel (Author)
  • Christoph Kaiser - , University of Basel (Author)
  • Raban Jeger - , University Hospital Basel (Author)
  • On Behalf Of The Basket-Small Investigators - (Author)

Abstract

BACKGROUND: We evaluated the outcome of PCI of de novo stenosis with drug-coated balloons (DCB) versus drug-eluting stents (DES) in patients with insulin-treated diabetes mellitus (ITDM) versus non-insulin-treated diabetes mellitus (NITDM).

METHODS: Patients were randomized in the BASKET-SMALL 2 trial to DCB or DES and followed over 3 years for MACE (cardiac death, non-fatal myocardial infarction [MI], and target vessel revascularization [TVR]). Outcome in the diabetic subgroup (n = 252) was analyzed with respect to ITDM or NITDM.

RESULTS: In NITDM patients (n = 157), rates of MACE (16.7% vs. 21.9%, hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.29-1.58, p = 0.37), death, non-fatal MI, and TVR (8.4% vs. 14.5%, HR 0.30, 95% CI 0.09-1.03, p = 0.057) were similar between DCB and DES. In ITDM patients (n = 95), rates of MACE (DCB 23.4% vs. DES 22.7%, HR 1.12, 95% CI 0.46-2.74, p = 0.81), death, non-fatal MI, and TVR (10.1% vs. 15.7%, HR 0.64, 95% CI 0.18-2.27, p = 0.49) were similar between DCB and DES. TVR was significantly lower with DCB versus DES in all diabetic patients (HR 0.41, 95% CI 0.18-0.95, p = 0.038).

CONCLUSIONS: DCB compared to DES for treatment of de novo coronary lesions in diabetic patients was associated with similar rates of MACE and numerically lower need for TVR both for ITDM and NITDM patients.

Details

Original languageEnglish
Article number119
JournalJournal of cardiovascular development and disease
Volume10
Issue number3
Publication statusPublished - 13 Mar 2023
Peer-reviewedYes

External IDs

PubMedCentral PMC10057565
Scopus 85151338390

Keywords

Sustainable Development Goals