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?

In the recent RE-DUAL PCI trial [ ] 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.