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Background <p>Atherosclerotic cardiovascular disease (ASCVD) represents the primary cause of morbidity and mortality among cases with diabetes.</p> Purpose <p>To determine whether a strategy of ticagrelor monotherapy initiated after 3 months of dual antiplatelet treatment (DAPT) modifies the rate of major adverse cardiovascular effect (MACE) as the primary endpoint and bleeding events as the secondary endpoint, relative to a 12-month regimen of ticagrelor-based DAPT in diabetic cases with acute coronary syndrome (ACS) treated by Percutaneous coronary intervention (PCI).</p> Methods <p>This randomized, open-label study included 400 diabetic patients with acute coronary syndrome (STEMI or NSTEMI) treated with PCI. Patients were randomly assigned to receive ticagrelor monotherapy after 3 months of DAPT or to continue ticagrelor plus aspirin for 12 months. The primary endpoint was major adverse cardiovascular events (MACE), and the secondary endpoint was bleeding events.</p> Results <p>Hemoglobin level after three month was substantially higher in group 1, the mean ± SD was 12.97 ± 1.7&#xa0;g/dl while group 2 was 12.6 ± 1.47&#xa0;g/dl (<i>p</i> = 0.02). Platelet count did not differ markedly between groups. Similarly, the incidence of complications—mortality, chest pain, bleeding, ICH, ischemic stroke, recurrent MI, and repeated PCI—showed no significant variation between them. There was no significant difference in the incidence of MACE between the two groups during 12 months of follow-up. Ticagrelor monotherapy was associated with a lower incidence of overall bleeding events, mainly driven by reductions in mild bleeding, while rates of moderate or severe bleeding were comparable between groups.</p> Conclusions <p>Switching to ticagrelor monotherapy after 3 months of DAPT results in a significant reduction in bleeding events among diabetic cases with ACS undergoing PCI, while maintaining a comparable safety profile regarding complications.</p> Trial registration <p>Pan African Clinical Trials Registry (PACTR202511832264697) Date of registration 24 November 2025.</p>

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Evaluation of safety and affection of variable duration of dual antiplatelet therapy using aspirin plus ticagrelor after successful percutaneous coronary intervention for diabetic patients with acute coronary syndrome

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  • 发表日期：

    2026年3月27日

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  • Nour Eldeen Mahmoud Shabaan Ibrahim,
  • Mohamed Tarek Mounir Zaki,
  • Khaled Ahmed Fouad Abdel Magid,
  • Khaled Ahmed Fouad,
  • Mina Magued Abdalla Iskandar

摘要

Background

Atherosclerotic cardiovascular disease (ASCVD) represents the primary cause of morbidity and mortality among cases with diabetes.

Purpose

To determine whether a strategy of ticagrelor monotherapy initiated after 3 months of dual antiplatelet treatment (DAPT) modifies the rate of major adverse cardiovascular effect (MACE) as the primary endpoint and bleeding events as the secondary endpoint, relative to a 12-month regimen of ticagrelor-based DAPT in diabetic cases with acute coronary syndrome (ACS) treated by Percutaneous coronary intervention (PCI).

Methods

This randomized, open-label study included 400 diabetic patients with acute coronary syndrome (STEMI or NSTEMI) treated with PCI. Patients were randomly assigned to receive ticagrelor monotherapy after 3 months of DAPT or to continue ticagrelor plus aspirin for 12 months. The primary endpoint was major adverse cardiovascular events (MACE), and the secondary endpoint was bleeding events.

Results

Hemoglobin level after three month was substantially higher in group 1, the mean ± SD was 12.97 ± 1.7 g/dl while group 2 was 12.6 ± 1.47 g/dl (p = 0.02). Platelet count did not differ markedly between groups. Similarly, the incidence of complications—mortality, chest pain, bleeding, ICH, ischemic stroke, recurrent MI, and repeated PCI—showed no significant variation between them. There was no significant difference in the incidence of MACE between the two groups during 12 months of follow-up. Ticagrelor monotherapy was associated with a lower incidence of overall bleeding events, mainly driven by reductions in mild bleeding, while rates of moderate or severe bleeding were comparable between groups.

Conclusions

Switching to ticagrelor monotherapy after 3 months of DAPT results in a significant reduction in bleeding events among diabetic cases with ACS undergoing PCI, while maintaining a comparable safety profile regarding complications.

Trial registration

Pan African Clinical Trials Registry (PACTR202511832264697) Date of registration 24 November 2025.