The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Diabetes and Outcomes following Guided De-Escalation of Antiplatelet Treatment in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention: A Prespecified Analysis from the Randomized TROPICAL-ACS Trial

EuroIntervention 2019; just accepted article published in April 2019. DOI: 10.4244/EIJ-D-18-01077

1. Ludwig-Maximilians University, Department of Cardiology, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Munich Heart Alliance, Munich, Germany; 2. Ludwig-Maximilians University, Department of Cardiology, Munich, Germany; 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; Clinic for Internal Medicine, University of Rostock, Germany; 9. Ernst-Moritz-Arndt University, Division for Internal Medicine, Greifswald, Germany; 10. Ludwig-Maximilians University, Department of Cardiology, Munich, Germany; 11. Ludwig-Maximilians University, Department of Cardiology, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Munich Heart Alliance, Munich, Germany; 12. University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany; 13. Ludwig-Maximilians University, Department of Cardiology, Munich, Germant; DZHK (German Center for Cardiovascular Research), Munich Heart Alliance, Munich, Germany, GERMANY; 14. University Hospital of Tübingen, Department of Cardiology, Tübingen, Germany; 15. Wilhelminen Hospital Vienna, Austria; 16. University of Szeged, First Department of Internal Medicine, Szeged, Hungary; 17. Petz Aladár County Teaching Hospital, Department of Cardiology, Győr, Hungary; 18. Medical University of Warsaw, 1st Department of Cardiology, Warsaw, Poland; 19. Department of Cardiology, Klinikum Neuperlach, Germany; 20. Ludwig-Maximilians University, Department of Cardiology, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Munich Heart Alliance, Munich, Germany; 21. Ludwig-Maximilians University, Department of Cardiology, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Munich Heart Alliance, Munich, Germany
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Background: A guided de-escalation of P2Y12 inhibitor treatment is considered as 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 aims of this study was to compare the outcomes of platelet function testing (PFT) guided de-escalation of dual antiplatelet treatment (DAPT) in ACS patients with and without diabetes mellitus.

Methods and results: TROPICAL-ACS trial randomized 2610 biomarker-positive ACS patients 1:1 to either standard treatment with prasugrel for 12 months (control group) or to 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 1-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=2083, 79.8%), the 1-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 treatment effects of guided DAPT de-escalation, our results suggest that this approach might be safe and effective in non-diabetic patients, whilst further investigation is definitely warranted in diabetic patients.

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