MedicalResearch.com Interview with:
Professor Christopher P. Cannon MD
Executive Director, Cardiometabolic Trials, Baim Institute
Cardiologist Brigham and Women’s Hospital
Baim Institute for Clinical Research
Columbia University College of Physicians and Surgeons
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The trial explored whether a dual therapy approach of anticoagulation and P2Y12 antagonist – without aspirin – in non-valvular atrial fibrillation (AF) patients following percutaneous coronary intervention (PCI) and stent placement would be as safe, and still efficacious, as the current standard treatment – triple therapy. For more detailed background on the study, readers may want to review the first paragraph of the article in the New England Journal of Medicine.
Results showed significantly lower rates of major or clinically relevant non-major bleeding events for dual therapy with dabigatran, when compared to triple therapy with warfarin.
In the study, the risk for the primary safety endpoint (time to major or clinically relevant non-major bleeding event) was 48 percent lower for dabigatran 110 mg dual therapy and 28 percent lower for dabigatran 150 mg dual therapy (relative difference), with similar rates of overall thromboembolic events.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: For physicians treating patients with atrial fibrillation who have undergone PCI with stent placement, the “dual therapy” approach using full dose anticoagulation with dabigatran – with a P2Y12 antagonist and without aspirin – could reduce bleeding by 25-50% with similar rates of overall thromboembolic events. This opens up new approaches to managing these patients.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: There are two ongoing studies, each with a different novel oral anticoagulant (NOAC), which will provide additional information on those agents as part of a dual therapy approach. One trial is a 2×2 factorial design, which shows how much of the benefit of reduced bleeding relates to stopping the aspirin versus using the NOAC instead of warfarin. From our study, we found that the dominant part of the benefit is likely due to the removal of aspirin. However, some of the benefit is due to the NOAC since there are differences by dose as well as a very low intracranial hemorrhage (ICH) rate.
MedicalResearch.com: Is there anything else you would like to add?
Response: As many as 30 percent of people with AF have coronary artery disease that may require PCI with stenting. PCI, also known as angioplasty, is a medical intervention where stents may be used when widening arteries of the heart in patients with coronary artery disease. This intervention is conducted to restore or improve blood flow to the heart muscle.
This study was funded by Amgen, Arisaph, Boehringer-Ingelheim (BI), Bristol-Myers Squibb (BMS), Daiichi Sankyo, Janssen, Merck, and Takeda. In addition, I have received consulting fees from Alnylam, Amgen, Amarin, Arisaph, Astra Zeneca, BI, BMS, Eisai, GlaxoSmithKline, Kowa, Lipimedix, Merck, Pfizer, Regeneron, Sanofi and Takeda.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
August 27, 2017DOI: 10.1056/NEJMoa1708454
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.