Key result
PFT-guided DAPT de-escalation did not significantly affect the 1-year primary endpoint in diabetic ACS patients (12.5% vs 10.8%; HR 1.17, P=0.55) but reduced it in non-diabetics (6.1% vs 8.5%; HR 0.71).
Why the study?
Guided de-escalation of P2Y12 inhibitor treatment is an alternative strategy in ACS patients undergoing PCI, but safety and efficacy may differ in diabetic versus non-diabetic patients.
Does PFT-guided de-escalation of DAPT improve clinical outcomes in ACS patients undergoing PCI, and does this effect differ by diabetes status?
RCT (n=2,610)
1:1
Does PFT-guided de-escalation of DAPT improve clinical outcomes in ACS patients undergoing PCI, and does this effect differ by diabetes status?
Hazard Ratio: 1.17 (95% CI 0.71–1.93)
Absolute Event Rate: 12.5% vs 10.8%
p-value: p=0.55
PFT-guided DAPT de-escalation appears safe and effective in non-diabetic ACS patients, but its benefit in diabetic patients remains uncertain due to higher platelet reactivity and event rates.
Guided DAPT de-escalation shows no benefit in diabetics; leaves open its role in this high-risk subgroup.
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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Hein et al. (2019) conducted an RCT in Acute coronary syndrome (n=2,610). Platelet function testing (PFT)-guided de-escalation of dual antiplatelet therapy (DAPT) vs. Standard treatment with prasugrel was evaluated on cardiovascular death, myocardial infarction, stroke or bleeding ≥grade 2 (HR 1.17, 95% CI 0.71-1.93, p=0.55). PFT-guided DAPT de-escalation did not significantly affect the 1-year primary endpoint in diabetic ACS patients (12.5% vs 10.8%; HR 1.17, P=0.55) but reduced it in non-diabetics (6.1% vs 8.5%; HR 0.71).
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