ESC 2017 - Barcelona

RE-DUAL PCI: Dual Antithrombotic Therapy with Dabigatran after Percutaneous Coronary Intervention in Patients with Atrial Fibrillation

Presented at the ESC congress 2017 by: Christopher P Cannon (Boston, MA, USA)

Background

About 20-30% of patients with atrial fibrillation (AF) who take continuous oral anticoagulation for stroke prevention, have concomitant coronary disease and may need percutane coronaire interventie (PCI) with stent placement. The combination of potent antithrombotic treatment in current standard or care, triple therapy with warfarin and two thrombocyte aggregation inhibitors, has been associated with high rates of major bleeding in these patients.

RE-DUAL PCI tested another treatment strategy: dual therapy with dabigatran etexilate without aspirin in patients with non-valvular AF after PCI and placing of a stent, in comparison with standard of care based on warfarin and two thrombocyte aggregation inhibitors, among which aspirin (plus clopidogrel or ticagrelor). 2725 Adult patients who underwent PCI with stent placement (elective or due to acute coronary syndrome) were randomized in RE-DUAL PCI, at 414 locations in over 41 countries worldwide. RE-DUAL PCI was a non-inferiority study of 30 months.

Main results

• Incidence of the primary endpoint (time to major or clinically relevant non-major bleeding: 15.4% for dual therapy with dabigatran 110 mg as compared with 26.9% with triple therapy with warfarin (48% lower risk).
• Incidence of the primary endpoint was 20.2% for dual therapy with dabigatran 150 mg as compared with 25.7% for triple therapy with warfarin (28%) lower risk).
• Both groups on dual therapy with dabigatran also showed lower rates of major bleedings (when analyzed separately, both according to the definitions of major bleeding according to ISTH and TIMI) and the total number of bleedings.
• The most important secondary endpoint (composite of death, myocardial infarction, CVA, systemic embolism and unplanned revascularization) was comparable between treatment groups: 13.7% for the combination of the two groups with dual therapy as compared twith 13.4% for triple therapy.

Conclusion

Dual therpay with the NOAC dabigatran was associated with fewer major or clinically relevant non-major bleedings as compared with triple therapy based on warfarin and two platelet inhibitors, among which aspirin. Dual versus triple therapy did not affect the number of total thrombo-embolic events.

- Our reporting is based on the information provided in a press release of Boehringer Ingelheim after the ESC congress -