Coronary interventions

Diabetes and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients undergoing percutaneous coronary intervention: a pre-specified analysis from the randomised TROPICAL-ACS trial

EuroIntervention 2019;15:e513-e521. DOI: 10.4244/EIJ-D-18-01077

Ralph Hein
Ralph Hein1,2, MD; Lisa Gross1,2, MD; Dániel Aradi3, MD; Johannes Rieber4, MD; Martin Hadamitzky5, MD; Béla Merkely6, MD; Zenon Huczek7, MD; Hüseyin Ince8,9, MD; Astrid Hummel10, MD; Monika Baylacher1, MD; Steffen Massberg1,2, MD; Dietmar Trenk11, MD; Dirk Sibbing1,2, MD
1. Ludwig-Maximilians University, Department of Cardiology, Munich, Germany; 2. DZHK (German Centre for Cardiovascular Research), Munich Heart Alliance, Munich, Germany; 3. Semmelweis University, Heart Centre Balatonfüred and Heart and Vascular Centre, Budapest, Hungary; 4. Klinikum Bogenhausen, Munich, Germany; 5. German Heart Center of Munich, Department of Radiology, Munich, Germany; 6. Semmelweis University, Heart and Vascular Centre, Budapest, Hungary; 7. Medical University of Warsaw, 1st Department of Cardiology, Warsaw, Poland; 8. Vivantes Klinikum Am Urban and im Friedrichshain, Department of Cardiology, Berlin, Germany; 9. Clinic for Internal Medicine, University of Rostock, Rostock, Germany; 10. Ernst-Moritz-Arndt University, Division for Internal Medicine, Greifswald, Germany; 11. University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany

Aims: A guided de-escalation of P2Y12 inhibitor treatment is considered an alternative treatment strategy in ACS patients undergoing PCI. However, the safety and efficacy of this strategy may differ in diabetic vs non-diabetic patients. The aim of this study was to compare the outcomes of platelet function testing (PFT)-guided de-escalation of dual antiplatelet therapy (DAPT) in ACS patients with and without diabetes mellitus.

Methods and results: The TROPICAL-ACS trial randomised 2,610 biomarker-positive ACS patients 1:1 to either standard treatment with prasugrel for 12 months (control group) or PFT-guided DAPT de-escalation. The association and interaction of diabetes on clinical endpoints across treatment groups and on platelet reactivity was investigated. In diabetic patients (n=527, 20.2%), the overall event rates were high and the one-year incidence of the primary endpoint (cardiovascular death, myocardial infarction, stroke or bleeding ≥grade 2) did not differ between guided de-escalation and control group patients (12.5% vs 10.8%; HR 1.17, 95% CI: 0.71–1.93, p=0.55). In non-diabetic patients (n=2,083, 79.8%), the one-year incidence of the primary endpoint was lower in the guided de-escalation vs control group (6.1% vs 8.5%; HR 0.71, 95% CI: 0.52–0.99, p=0.04, pint=0.10). Diabetic patients showed higher platelet reactivity levels in both control (=on prasugrel, p=0.01) and guided de-escalation group (=on clopidogrel, p=0.005) patients.

Conclusions: Although diabetic status did not significantly interfere with the treatment effects of guided DAPT de-escalation, our results suggest that this approach might be safe and effective in non-diabetic patients. Further investigation is definitely warranted in diabetic patients.

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