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What is the significance, if any, of the increased incidence of stent thrombosis with dual therapy of dabigatran 110mg twice daily and clopidogrel in the RE-DUAL PCI trial?

Published:December 22, 2017DOI:https://doi.org/10.1016/j.ejim.2017.12.009
      In the recent RE-DUAL PCI trial [
      • Cannon C.P.
      • Bhatt D.L.
      • Oldgren J.
      • Lip G.Y.H.
      • Ellis S.G.
      • Kimura T.
      • et al.
      RE-DUAL PCI Steering Committee and Investigators. Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation.
      ] where dual therapy of dabigatran, at the dose of both 110 and 150 mg twice daily, and clopidogrel was compared with conventional triple therapy of warfarin, aspirin, and clopidogrel in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with stent (PCI), the occurrence of major adverse ischemic events, including death or thromboembolic events, or unplanned revascularization, was comparable with dual (110 and 150 mg twice daily doses of dabigatran combined) and triple therapy (Fig. 1). The occurrence of individual thromboembolic endpoints, including all-cause death, stroke, unplanned revascularization, myocardial infarction and stent thrombosis, which was examined separately for the two doses of dabigatran and compared with corresponding patients on triple therapy, was also comparable (Table 1). The absolute incidence of stent thrombosis with dual therapy of dabigatran 110 mg twice daily however, was approximately two-fold higher than with corresponding triple therapy (Table 1). When discussing this finding, it is often said that it might represent a signal of insufficient protection against stent thrombosis of dual therapy (where only one antiplatelet agent is given) as compared to triple therapy (where standard dual antiplatelet therapy is given). This may indeed be the case, but may also be the case for the opposite.
      Fig. 1
      Fig. 1Trend of Kaplan-Meier curves of the probability of the efficacy end-point of death or thromboembolic event, or unplanned revascularization, with dual therapy of combined dabigatran 110 and 150 mg twice daily and clopidogrel vs. triple therapy of warfarin, aspirin, and clopidogrel
      [
      • Cannon C.P.
      • Bhatt D.L.
      • Oldgren J.
      • Lip G.Y.H.
      • Ellis S.G.
      • Kimura T.
      • et al.
      RE-DUAL PCI Steering Committee and Investigators. Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation.
      ]
      . HR: hazard ratio; CI: confidence intervals.
      Table 1Individual efficacy end-points in the various treatment arms of the RE-DUAl PCI trial
      • Cannon C.P.
      • Bhatt D.L.
      • Oldgren J.
      • Lip G.Y.H.
      • Ellis S.G.
      • Kimura T.
      • et al.
      RE-DUAL PCI Steering Committee and Investigators. Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation.
      .
      DT dabigatran 110 mg TT DT dabigatran 110 mg vs. TT p value DT dabigatran 150 mg TT DT dabigatran 150 mg vs. TT p value
      n = 981 n = 981 HR (95% CI) n = 763 n = 764 HR (95% CI)
      n (%) n (%) n (%) n (%)
      All-cause death 55 (5.6) 48 (4.9) 1.12 (0.76–1.65) 0.56 30 (3.9) 35 (4.6) 0.83 (0.51–1.34) 0.44
      Stroke 17 (1.7) 13 (1.3) 1.30 (0.63–2.67) 0.48 9 (1.2) 8 (1.0) 1.09 (0.42–2.83) 0.85
      Unplanned revascularization 76 (7.7) 69 (7.0) 1.09 (0.79–1.51) 0.61 51 (6.7) 52 (6.8) 0.96 (0.65–1.41) 0.83
      Myocardial infarction 44 (4.5) 29 (3.0) 1.51 (0.94–2.41) 0.09 26 (3.4) 22 (2.9) 1.16 (0.66–2.04) 0.61
      Stent thrombosis 15 (1.5) 8 (0.8) 1.86 (0.79–4.40) 0.15 7 (0.9) 7 (0.9) 0.99 (0.35–2.81) 0.98
      DT = dual therapy; TT = triple therapy; HR = hazard ratio; CI = confidence intervals.

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      References

        • Cannon C.P.
        • Bhatt D.L.
        • Oldgren J.
        • Lip G.Y.H.
        • Ellis S.G.
        • Kimura T.
        • et al.
        RE-DUAL PCI Steering Committee and Investigators. Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation.
        N Engl J Med. Aug 27 2017; https://doi.org/10.1056/NEJMoa1708454
        • Rubboli A.
        Superior safety of dual therapy with dabigatran and clopidogrel vs. triple therapy with warfarin, aspirin and clopidogrel in the RE-DUAL PCI trial: what is key, the strategy or the drug?.
        Eur J Intern Med. Oct 3 2017; 46 (pii: S0953-6205(17)30409-0): e40-e41