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A randomised study of dabigatran in elective percutaneous coronary intervention in stable coronary artery disease
Pascal Vranckx1, Freek W A Verheugt, Moniek P de Maat
1Department of Cardiac Intensive Care & Interventional Cardiology, Hartcentrum, Hasselt, Belgium.
Insights
Dabigatran may not sufficiently prevent coagulation activation during percutaneous coronary intervention (PCI). This study found increased markers of coagulation in patients on dabigatran compared to unfractionated heparin (UFH), suggesting potential risks.
Area of Science:
- Cardiology
- Pharmacology
- Thrombosis
Background:
- Patients on long-term dabigatran therapy may require percutaneous coronary intervention (PCI).
- Assessing coagulation activation during PCI in patients on dabigatran is crucial for procedural safety.
- Standard anticoagulation protocols may need adjustment for patients on novel oral anticoagulants.
Purpose of the Study:
- To investigate coagulation activation during elective PCI in patients treated with dabigatran.
- To determine if dabigatran suppresses coagulation activation without additional heparin.
- To compare dabigatran's effect against unfractionated heparin (UFH) during PCI.
Main Methods:
- Phase IIa, exploratory, randomized, open-label, multicenter study.
- 50 stable patients undergoing elective PCI, on dual antiplatelet therapy (DAPT).
- Randomization to dabigatran (110 mg or 150 mg BID) or unfractionated heparin (UFH) control.
Main Results:
- Significant increases in prothrombin fragment 1+2 (F1+2) and thrombin-antithrombin (TAT) complexes observed in dabigatran group post-PCI.
- No significant increase in F1+2 and TAT complexes in the UFH control group.
- 12.5% of dabigatran patients required bail-out anticoagulation, with four experiencing procedural myocardial infarction (MI); one UFH patient had stent thrombosis.
Conclusions:
- Dabigatran (110 mg or 150 mg BID) may not provide adequate anticoagulation during PCI.
- Coagulation activation markers were elevated in patients treated with dabigatran during PCI.
- Further investigation is warranted to optimize anticoagulation strategies for dabigatran users undergoing PCI.
Aims:
Patients receiving long-term anticoagulant treatment with dabigatran may need to undergo a percutaneous coronary intervention (PCI). We studied markers of coagulation activation during elective PCI in patients using dabigatran in order to investigate whether coagulation activation upon balloon inflation and stenting is suppressed by dabigatran without additional heparin treatment.
Methods And Results:
This phase IIa, exploratory, multicentre, randomised, open-label study included 50 stable patients having an elective PCI. Patients on standard dual antiplatelet therapy (DAPT) were randomised (2:2:1) to either pre-procedural dabigatran 110 mg BID (n=19) or 150 mg BID (n=21), as compared to standard intraprocedural unfractionated heparin (UFH) (n=10). Following PCI, a significant increase in the levels of prothrombin fragment 1+2 (F1+2) in the combined dabigatran group was observed compared to the level just before the start of PCI (159.1 [1.4] pmol/l; geometric mean [gSD]). Levels at 0.5, 1.0, 1.5 and 2 hrs after the start of PCI ranged from 193.5 (1.4) to 270.6 pmol/l (1.7); (p-value for paired analysis=0.015, 0.022, 0.2342, 0.0379, respectively). Also, thrombin-antithrombin (TAT) complexes were increased significantly in the combined dabigatran group compared to pre-PCI levels (4.2 [2.2] ug/l). Levels ranged from 5.2 (2.5) to 8.5 (2.3) (p=0.0497, 0.0343, 0.005 and 0.1628, respectively). In contrast, in the control group of patients treated with UFH, no increase was observed in F1+2 and TAT complexes during PCI. Five out of 40 (12.5%) patients required bail-out anticoagulation in the dabigatran group, of whom four experienced a procedural myocardial infarction (MI), versus one out of 10 in the UFH group, who had a stent thrombosis without MI prior to the study-PCI. One minor access-site bleeding occurred in the dabigatran group.
Conclusions:
Dabigatran treatment (110 mg or 150 mg BID) may not provide sufficient anticoagulation during PCI. EudraCT. No: 2007-007536-25.
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