Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation 

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

Dr. Cannon

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.

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COMPASS Study Finds Rivaroxaban -XARELTO® – Plus Aspirin Reduces Adverse Events in Patients With Heart Disease or PAD

MedicalResearch.com Interview with:

John Eikelboom MBBS Associate Professor, Division of Hematology & Thromboembolism Department of Medicine Canada Research Chair in Cardiovascular Medicine Canadian Institutes for Health Research McMaster University

Dr. Eikelboom

John Eikelboom MBBS
Associate Professor, Division of Hematology & Thromboembolism
Department of Medicine
Canada Research Chair in Cardiovascular Medicine
Canadian Institutes for Health Research
McMaster University

MedicalResearch.com: What is the background for this study?

Response: Cardiovascular disease affects 1 in 25 persons around the world and a total of more than 300 million individuals. Thrombus formation at the site of a ruptured atherosclerotic plaque is the commonest mechanism of myocardial infarction and ischemic stroke in patients with cardiovascular disease. Aspirin is effective for the prevention of these complications but reduces the risk by only 19% during long term therapy.

Rivaroxaban has previously been tested in the ATLAS ACS-2 TIMI 51 trial at doses of 2.5 mg twice daily or 5 mg twice daily on top of background antiplatelet therapy and has been shown to reduce major adverse cardiovascular events as well as mortality. We tested these same doses of rivaroxaban for the prevention of cardiovascular death, stroke or myocardial infarction in patients with stable cardiovascular disease.

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Duration of Dual Anti-Platelet Therapy After Cardiac Stenting Needs To Be Personalized

MedicalResearch.com Interview with:
Abhishek Sharma MD and

Division of Cardiovascular Medicine State University
New York Downstate Medical Center
Dr.Sahil Agarwal M.B.B.S., M.D.
Division of Cardiology
St. Luke’s University Health Network
Bethlehem, Pennsylvania

MedicalResearch.com: What is the background for this study? 

Response: Prior randomized control trials (RCTs) and meta-analysis of these trials which have attempted to compare differences in outcomes between strategies of short (S) (3-6 months) and longer (L) (12-30 months) durations of dual anti-platelet therapy (DAPT) after drug eluting stents (DES) implantation have reported conflicting results. In general, the events rates in these studies were small, affecting statistical power. To overcome this limitation, we conducted an updated meta-analysis to compare the efficacy and safety of strategies of S-DAPT versus L-DAPT strategy after DES implantation by restricting inclusion to randomized studies with follow-up durations of 24 months or longer.

The current meta-analysis is the first to compare outcomes between S-DAPT and L-DAPT in a meta-analysis restricted to trials with patient follow-up of 24 months or longer. We found no significant difference in the rates of mortality or of stent thrombosis with S-DAPT or L-DAPT. S-DAPT was associated with significantly lower risk of major bleeding but slightly higher risk of future myocardial infarctions.

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Comparison of NOACs with Warfarin In Atrial Fibrillation Patients With Single Stroke Risk Factor

MedicalResearch.com Interview with:

Gregory Y. H. Lip, MD Professor of Cardiovascular Medicine University of Birmingham, UK; Adjunct Professor of Cardiovascular Sciences, Thrombosis Research Unit, Aalborg University, Denmark National Institute for Health Research (NIHR) Senior Investigator. Visiting Professor of Haemostasis Thrombosis & Vascular Sciences, Aston University, Birmingham, UK Visiting Professor of Cardiology, University of Belgrade, Serbia; Visiting Professor, University of Leeds, UK Honorary Professor, Chinese PLA Medical School, Beijing, China; Honorary Professor, Nanjing Medical University, Nanjing, China; Visiting Professor, National Yang-Ming University, Taipei, Taiwan Institute of Cardiovascular Sciences City Hospital Birmingham England UK

Dr. Lip

Gregory Y. H. Lip, MD
Professor of Cardiovascular Medicine
University of Birmingham
Adjunct Professor of Cardiovascular Sciences, Thrombosis Research Unit, Aalborg University, Denmark
National Institute for Health Research (NIHR) Senior Investigator.
Visiting Professor of Haemostasis Thrombosis & Vascular Sciences, Aston University, Birmingham, UK
Institute of Cardiovascular Sciences
City Hospital
Birmingham England UK

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The randomized clinical trials comparing non-Vitamin K antagonist oral anticoagulants (NOACs) vs warfarin largely focused on recruitment of high risk atrial fibrillation(AF) patients with >2 stroke risk factors, with only the trials testing dabigatran or apixaban including a minority of patients with 1 stroke risk factor.

Despite this, regulatory approvals of all NOACs have been for stroke prevention in AF patients with ≥1 stroke risk factors. No difference between NOACs compared to warfarin in risk of ischemic stroke/systemic embolism, was seen but for ‘any bleeding’, this was lower for apixaban and dabigatran compared to warfarin.

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Patients With Paroxysmal Atrial Fibrillation Less Likely To Receive Anticoagulants

MedicalResearch.com Interview with:

Dr Nicola Adderley BA, MSci (Cantab), MA, MPhil, PhD Institute of Applied Health Research Research Fellow University of Birmingham

Dr. Adderley

Dr Nicola Adderley BA, MSci (Cantab), MA, MPhil, PhD
Institute of Applied Health Research
Research Fellow
University of Birmingham

MedicalResearch.com: What is the background for this study?

Response: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and a major global public health problem. It is associated with a five-fold increase in risk of stroke.

There are three types of AF – paroxysmal, persistent or permanent. In paroxysmal AF, episodes come and go, and usually stop without any treatment. With persistent AF episodes can last for periods of more than seven days and are treated with medication or a medical procedure called cardioversion. In permanent AF, the irregular heartbeat is present all the time and cardioversion has failed to restore a normal heart rhythm.

All patients with AF, including paroxysmal AF, are at an increased risk of stroke. UK guidelines recommend anticoagulant treatment, such as the blood-thinning drug warfarin, for patients with all types of AF in order to reduce the risk of stroke.

Our study aimed to determine whether patients with paroxysmal AF are less likely to be treated with anticoagulants than patients with persistent or permanent AF and to investigate trends in treatment between 2000 and 2015.

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Anticoagulation With Bivalirudin vs Heparin for STEMI treated with PCI: Pros and Cons of Each

MedicalResearch.com Interview with:

Dr. Ion S. Jovin, MD, ScD Associate Professor of Medicine at Virginia Commonwealth University Pauley Heart Center Director of the Cardiac Catheterization Laboratories and Site Director of the VCU Interventional Cardiology Fellowship Program at  McGuire V.A. Medical Center Visiting Assistant Professor in the Department of Surgery/Cardiothoracic Surgery Yale University, New Haven, CT

Dr. Jovin


Dr. Ion S. Jovin, MD, ScD

Associate Professor of Medicine at Virginia Commonwealth University Pauley Heart Center
Director of the Cardiac Catheterization Laboratories and
Site Director of the VCU Interventional Cardiology Fellowship Program at
McGuire V.A. Medical Center
Visiting Assistant Professor in the Department of Surgery/Cardiothoracic Surgery
Yale University, New Haven, CT

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There is still uncertainty regarding the best anticoagulant for patients with acute ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI) and especially PCI done via radial (as opposed to femoral) access. Our study compared outcomes of patients with STEMI treated with PCI done via radial access in the NCDR database who received one of the two main anticoagulants: bivalirudin and heparin. There is a large degree of variation in the use of the two anticoagulants in PCI and in primary PCI both within the United States but also in the world.

We did not find a statistically significant difference between the outcomes of the two groups of patients, but we also found that a significant number of patients in both the heparin and in the bivalirudin group were also treated with additional medicines that inhibit platelet activation (glycoprotein IIb/IIIa inhibitors).

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Dabigatran is Associated With a Lower Risk of Osteoporotic Fractures Compared to Warfarin

MedicalResearch.com Interview with:
Wallis CY Lau BSc

Centre for Safe Medication Practice and Research
Department of Pharmacology and Pharmacy
Li Ka Shing Faculty of Medicine
The University of Hong Kong

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Warfarin is a vitamin K antagonist (VKA) oral anticoagulant used for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF), a common heart rhythm disorder. It works by interfering with vitamin K-dependent reactions in the process of blood clot formation. As these reactions also play a role in bone mineralization, there is concern that warfarin use may be linked with osteoporotic fracture. Despite the concerns for fracture risk, warfarin had been an inevitable treatment choice for over 50 years as there were no other alternatives available.

Dabigatran is the first non-VKA oral anticoagulant (NOAC) approved for use in patients with NVAF. Recently, an animal study reported that use of dabigatran is associated with a better bone safety profile compared to warfarin in rats, suggesting a potential for a lower risk of osteoporotic fractures over warfarin. However, the actual risk of osteoporotic fractures with dabigatran use in human remains unclear. Therefore, we conducted a population-based cohort study to compare the risk of osteoporotic fractures in patients with NVAF treated with dabigatran and warfarin.

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High risks of mortality following bleeding and ischemic events occurring 1 year after coronary stenting

MedicalResearch.com Interview with:

Eric A. Secemsky, MD, MSc Interventional Cardiology Fellow Massachusetts General Hospital Harvard Medical School Baim Institute for Clinical Research

Dr. Eric Secemsky

Eric A. Secemsky, MD, MSc
Interventional Cardiology Fellow
Massachusetts General Hospital Harvard Medical School
Baim Institute for Clinical Research 

MedicalResearch.com: What is the background for this study?  What are the main findings?

Response: We know from previous trials that continuing dual antiplatelet therapy longer than 12 months after coronary stenting decreases ischemic events, including spontaneous myocardial infarction and stent thrombosis. However, extending dual antiplatelet therapy is also associated with some increase in bleeding risk. For instance, in the DAPT Study, more than 25,600 patients were enrolled and received both aspirin and a thienopyridine antiplatelet drug (clopidogrel or prasugrel) for one year after stenting. Of these patients, 11,648 participants who had followed the study protocol and had no serious cardiovascular or bleeding events during that first year were then randomized to either continue with dual therapy or to receive aspirin plus a placebo for another 18 months. The overall findings of the DAPT study were that, compared with switching to aspirin only after one year, continuing dual antiplatelet therapy for a total of 30 months led to a 1.6 percent reduction in major adverse cardiovascular and cerebrovascular events – a composite of death, myocardial infarction, stent thrombosis and ischemic stroke – and a 0.9 percent increase in moderate to severe bleeding events.

The prognosis following early ischemic and bleeding events has previously been well described. However, data for events occurring beyond 1 year after PCI are limited. As such, we sought to assess the cumulative incidence of death following ischemic and bleeding events occurring among patients in the DAPT Study beyond 1 year after coronary stenting.

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Appropriate Anticoagulation Underutilized in Atrial fibrillation

MedicalResearch.com Interview with:
Dr. Ying Xian
 MD PhD
Department of Neurology,
Duke Clinical Research Institute
Duke University Medical Center
Durham, North Carolina

MedicalResearch.com: What is the background for this study?

Response: Atrial fibrillation (AF) is the most common arrhythmia. AF increases the risk for stroke and accounts for 10% to 15% of all ischemic strokes. While the burden of AF-related stroke is high, AF is a potentially treatable risk factor. Numerous studies have demonstrated that vitamin K antagonists, such as warfarin, or non-vitamin K antagonist oral anticoagulants (NOACs), reduce the risk of ischemic stroke. Based on these data, current guidelines recommend adjusted-dose warfarin or NOACs over aspirin for stroke prevention in high-risk patients with Atrial fibrillation.

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Stopping Warfarin in Dementia Patients with Atrial Fib Associated With Increased Risk of Stroke and Death

MedicalResearch.com Interview with:

Ariela Orkaby, MD, MPH Geriatrics & Preventive Cardiology Associate Epidemiologist Division of Aging, Brigham and Women's Hospital Instructor in Medicine, Harvard Medical School

Dr. Ariela Orkaby

Ariela Orkaby, MD, MPH
Geriatrics & Preventive Cardiology
Associate Epidemiologist
Division of Aging, Brigham and Women’s Hospital
Instructor in Medicine, Harvard Medical School

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Atrial Fibrillation is a common heart rhythm that affects 1 in 25 adults over age 60 and 1 in 10 adults over age 80. The feared consequence of atrial fibrillation is stroke, leading to the prescription of blood thinning medications (anticoagulants such as warfarin) to prevent strokes. However, there is an underutilization of these life-saving medications in older adults, and particularly in those who have dementia. In part, this is due to a lack of research and inclusion of older adults with dementia in prior studies.

In this study, we used clinical Veterans Administration data, linked to Medicare, to follow 2,572 individuals over age 65 who had atrial fibrillation and until a diagnosis of dementia. The average age was 80 years, and 99% were male. We found that only 16% remained on warfarin. We used statistical methods to account for reasons why a patient would or would not be treated with warfarin and found that those who continued to take warfarin had a significantly lower risk of stroke (HR 0.74, 95% Confidence interval 0.54- 0.99, p=0.47) and death (HR 0.72, 95% CI 0.60-0.87, p<0.01) compared to those who did not continue to take warfarin, without an increased risk of bleeding.

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