New Study Lends Support For Alternative Heart Attack Treatment Strategy Reply

It is generally agreed that the best treatment for heart attack patients is to immediately reperfuse the blocked artery with a stent. But many people live in areas where this strategy, known as primary PCI, is not available within the time frame when it produces the greatest benefit. Previous studies have found good short term outcomes in patients who receive a pharmaco-invasive strategy, in which patients first receive fibrinolytic therapy including a clot-busting drug and then later undergo angiography. Now long-term results from a large real-world study show that this strategy may be an acceptable alternative for some patients when immediate primary PCI is not available.

In a paper published in Circulation, French researchers report the 5 year mortality findings from nearly 1,500 STEMI patients enrolled in the 2005 cohort of FAST-MI (The French Registry on Acute ST-Elevation and Non–ST-Elevation Myocardial Infarction).

Click here to read the full post on Forbes.

 

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High-Sensitivity Troponin Test Could Identify Low Risk Chest Pain Patients In The ED Reply

Approximately 15-20 million people in Europe and the United States go to the emergency department every year with chest pain. Many can be discharged early if they are not having an acute coronary syndrome. A large new single-center observational study, presented at the American College of Cardiology meeting in Washington, DC and published simultaneously in the Journal of the American College of Cardiology, provides fresh evidence that high-sensitivity cardiac troponin T (hs-cTnT) may be useful in helping identify chest pain patients in the emergency department who do not need to be admitted to the hospital.

Click here to read the full post on Forbes.

 

FDA Once Again Rejects New Indication For Rivaroxaban Reply

The third time wasn’t the charm. The FDA today turned turned down– for the third time– the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke or death. In addition, the FDA– for the second time– turned down the sNDA for rivaroxaban in the same population for the reduction of stent thrombosis.

Click here to read the full post on Forbes.

 

Surviving A Heart Attack: Location And Time Make A Big Difference Reply

Two studies published this week offer fresh evidence that your life may depend on where and when you have a heart attack.

1. Heart attack patients in the United Kingdom are more likely to die than heart attack patients in Sweden, according to a study published in the Lancet.

2. Heart attack patients are more likely to die if they reach the hospital at night or on the weekends, according to a study published in the BMJ.

… 

Click here to read the full post on Forbes.

 

FDA Panel Once Again Rejects New Indication For Rivaroxaban Reply

The FDA’s Cardiovascular and Renal Drugs Advisory Committee once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (rivaroxaban). The nearly unanimous vote (10-0, with 1 abstention) was in line with a highly negative review from FDA staff members.

Click here to read the full post on Forbes.

 

English: Logo of the band Rejected Español: Lo...
(Photo credit: Wikipedia)

 

FDA Advisory Panel Votes In Favor Of Approval For Merck’s Vorapaxar Reply

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar, Merck’s novel thrombin receptor antagonist. The “roller coaster ride” cliché might have been invented for this drug, which was the subject of tremendous early hopes followed by major disappointments and, finally, a subsequent revival.

Click here to read the entire post on Forbes.

 

English: The Kraken roller coaster ride at Sea...

(Photo credit: Wikipedia) 

 

 

 

Rivaroxaban Faces Uphill Battle At FDA Advisory Panel Reply

The third time may not be the charm. Twice before the FDA has turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (rivaroxaban). On Thursday the Cardiovascular and Renal Drugs Advisory Committee will take up the sNDA yet again, but FDA review documents posted today suggest that the company will again face an uphill battle.

Click here to read the full post on Forbes.

 

Stone wall of an English barn

 

Merck’s Vorapaxar Gets Positive FDA Review Reply

A few years ago a novel antiplatelet agent from Merck seemed all but dead. Vorapaxar, a thrombin receptor antagonist, was widely thought to have no future after unacceptably high serious bleeding rates were found in two large clinical trials studying the drug in a wide variety of acute and chronic cardiovascular patients. But hopes for the drug resurfaced with a new analysis of one of those trials, the TRA2P trial. Now the FDA appears willing to give the drug a renewed lease on life.

Click here to read the full story on Forbes.

 

Massive Heart Attack Or Massive Journalistic Irresponsibility? 2

A great lesson in how not to report about heart attacks in the general media, from Gary Schwitzer, health journalism watchdog:

Journalists: don’t use the term “massive” heart attack if you don’t know what you’re talking about

 Very quickly, the term “massive heart attack” started going viral among Minnesota news organizations and on Twitter and Facebook.

Two and a half hours later, Rybak was tweeting from the hospital: “My cardiac surprise/Gave me quite a start/But it proves this politician/Has a great big heart.”

“His former spokesman, John Stiles, described the heart attack as “serious,’’ but said Rybak will be released in several days.”

“Massive heart attack” is a vague, frightening, dangerous term to be throwing around in the absence of evidence. I know how I reacted when I read the news yesterday; many other readers’ comments showed that they thought Rybak was dead or dying imminently.

Read the entire post at HealthNewsReview.Org.

 

Cardiology in 2013: Like A Wrecking Ball 1

Perhaps I’m being overdramatic but I think  the best metaphor for the year in cardiology is Miley Cyrus on the wrecking ball.

The Guidelines Wrecking Ball: Like Hannah Montana guidelines are supposed to be boring and reliable.  But in 2013 the guidelines were more like Miley Cyrus. Like a wrecking ball, the NIH abandoned its long-entrenched and highly influential role in producing cholesterol and hypertension guidelines. Then the new ACC/AHA guidelines came along, abandoning tradition and targets and adopting a whole new approach. But the controversy didn’t go away. One easy prediction for 2014: we’ll see more debate about guidelines.

Click here to read the full post on Forbes.

Wrecking Ball

The New Guidelines

Miley Cyrus- Note: Cropped from larger image

The Old Guidelines

Possible New Lease On Life For Two Cardiology Drugs From Merck And J&J Reply

Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and Renal Drugs Advisory Committee suggests that the companies have made progress resolving earlier problems.

Merck’s new drug application for vorapaxar (Zontivity is the proposed trade name) will be discussed on January 15 for the proposed indication of reduction of atherothrombotic events in patients with a history of myocardial infarction (MI).

On January 16 the panel will discuss the supplemental new drug application for J&J’s Xarelto (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients in the first 90 days after suffering acute coronary syndrome.

Click here to read the full story on Forbes.

English: Logo of the .

Little Difference In Chest Pain Between Men And Women 1

In recent years the medical community has grown increasingly concerned that women with heart attacks may be less likely to receive prompt and effective treatment. The difference between the sexes in the presentation of symptoms is thought to be a major barrier to better treatment for women. But now a new study published in JAMA Internal Medicine finds that a key aspect of these differences– the description of chest pain in the emergency department– may not play as big a role as previously suspected.

Click here to read the full post on Forbes.

 

JAMA Int Med

FDA Removes Restrictions On Avandia Reply

In a remarkable climax to a long-running drama, the FDA today lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug has been the subject of  intense criticism and controversy since the 2007 publication of the famous Nissen meta-analsysis that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death.

The FDA said its actions were “consistent with the recommendations of expert advisory committees.” In June of this year an FDA panel reviewed re-adjudicated data from the RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes) trial and concluded that the trial had not found an elevated risk of heart attack or death associated with rosiglitazone.

Click here to read the full post on Forbes.

 

TACT Substudy Suggests Possible Strong Benefit for Chelation in Diabetics Reply

One year ago the results of the TACT trial were published in JAMA, sparking an enormous controversy over the propriety of publishing a trial suggesting that chelation therapy might be beneficial in people with cardiovascular disease. Chelation therapy has long been a staple of alternative medicine, but until the publication of TACT it had received no credit whatsoever in mainstream medicine. TACT was supported by the NIH as part of an initiaitve to test the scientific basis of alternative medical therapies.

The JAMA paper reported positive results for the prespecified subgroup of patients who had diabetes at the start of the trial. Now a new paper, presented at the American Heart Association Scientific Sessions and published online in Circulation: Cardiovascular Quality and Outcomes, focuses on this important subgroup, and provides even stronger evidence for a possible benefit for chelation in patients with diabetes. The authors speculate that ethylene diamine tetra-acetic acid (EDTA) chelation might have an effect on metal-catalyzed oxidation reactions in the development of advanced glycation end-products, which appear to play a central role in diabetic complications.

The primary endpoint of the main trial – the composite of death, MI, stroke, coronary revascularization, or hospitalization for angina – was significantly lowered from 30% in the placebo group to 26% in the chelation group (HR 0.82, 0.69-0.99, p=0.035).

Click here to read the full post on Forbes.

 

EUROMAX Meets Primary Endpoint But Editorialist Raises Questions Reply

When started during transport to the hospital during a heart attack, bivalirudin (Angiox, Medicines Company) improves clinical outcomes and reduces major bleeding, though at the cost of a small but significant risk in stent thrombosis. The results of the European Ambulance Acute Coronary Syndrome (ACS) Angiography) Trial (EUROMAX) were presented today by Phillippe Gabriel Steg at the TCT conference in San Francisco and published simultaneously in the New England Journal of Medicine.

Click here to read the full post on Forbes.

 

 

 

Flu Vaccine May Help Prevent Cardiovascular Events Reply

A new meta-analysis published in JAMA offers the best evidence yet that the flu vaccine may help prevent cardiovascular events.

Jacob  Udell and colleagues analyzed data from 5 published clinical trials in which 6,469 patients were randomized. People who received the flu vaccine had a significantly lower risk of cardiovascular events. The protective effect was largely restricted to people who had had a recent acute coronary syndrome (ACS). Cardiovascular events occurred in 2.9% of people in the vaccination group versus 4.7% of controls (RR 0.64, CI 0.48-0.86, p = .003).

Click here to read the full post on Forbes.

 

Younger Women With Acute Coronary Syndromes Less Likely To Have Classic Chest Pain Reply

Younger women with an acute coronary syndrome are slightly less likely than men to present with the classic symptom of chest pain, according to a new study published in JAMA Internal Medicine. In recent years there has been a growing understanding that women with ACS are less likely to have chest pain and, partly as a result, often fail to receive a correct diagnosis in the emergency department. However, there has only been limited data on whether this pattern is also true for younger women.

Nadia Khan and colleagues prospectively analyzed data from more than 1,000 ACS patients 55 years of age or younger– 30% of whom were women– participating in the GENESIS PRAXY study.  When compared with older cohorts in previous studies, patients in the study were more likely to have chest pain, but even in these younger patients women were less likely to have chest pain than men…

Click here to read the full story on Forbes.

 

 

Clear! CPR in the Hospital Is Not Always Good for the Patient Reply

On TV it always seems clear and simple. A patient in the hospital goes into cardiac arrest and the medical team springs into action. After a few tense moments of furious activity, and only after all seems lost, the patient is successfully revived. A few scenes later the smiling and now fully healthy patient thanks the doctor and returns to his or her life as a professional athlete, parent of young children, or criminal mastermind.

Medical professionals know that in real life this is rarely the way it goes. Most patients who undergo cardiopulmonary resuscitation (CPR) are old, frail, and very sick. Many will die and many who survive CPR will die anyway before leaving the hospital. And many survivors will have severe neurological problems.

Now a physician states in JAMA Internal Medicine that hospitals need to change the way they view CPR.

Click here to read the full story on Forbes.

 

Too Much Emphasis on Door-to-Balloon Time? Reply

One of the great medical advances in recent years has been the improved treatment of acute myocardial infarction. As the enormous benefits of earlier reperfusion became evident, medical systems in many parts of the world aimed to treat increasing numbers of patients in a shorter time frame. The door-to-balloon (D2B) time as a performance measure has emerged as a key part of this initiative. Now a study published in the New England Journal of Medicine finds that in-hospital mortality for acute MI patients receiving PCI has not fallen despite improvements in the D2B time. But some experts fear this finding may be misinterpreted, as it more accurately reflects a growing and changing population receiving PCI than any shortcomings in the D2B initiative.

Using the CathPCI Registry of the National Cardiovascular Data Registry, Daniel Menees and colleagues analyzed data from almost 100,000 hospital admissions for primary PCI between July 2005 and June 2009.

Click here to read the full story on Forbes.

 

New Test Could Speed Heart Attack Treatment In The Emergency Department Reply

Only 1 in 10 patients with acute chest pain in the emergency department turn out to have an actual heart attack (myocardial infarction), yet many are not released from the hospital until after 6-12 hours of cardiac monitoring and multiple ECG and troponin tests. The search for a test that can rule out MI early in the process has proved elusive.

The Biomarkers in Cardiology-8 (BIC-8) trial, presented at the European Society of Cardiology meeting in Amsterdam, was designed to determine the utility of the combination of troponin and copeptin testing. Copeptin is a marker of severe hemodynamic stress. After an acute MI copeptin levels increase rapidly. In earlier observational studies the combination test was found to have a negative predictive value of 99%.

902 patients with suspected ACS who were troponin negative were randomized to standard treatment or an experimental strategy in which patients with a negative  copeptin test were discharged early. At 30 days there were no significant differences in the rate of major adverse cardiovascular events between the two groups:

Click here to read the full post on Forbes.

 

A Disruptive TASTE of the Future? Getting the Best of Randomized Trials AND Observational Studies Reply

A new study  from Scandanavia may influence the treatment of acute myocardial infarction. But it also may end up having a much bigger impact on the entire field of medicine by pointing the way to an entirely new way of performing randomized clinical trials rapidly and inexpensively. One expert said the trial design may represent “a new paradigm,” and for once the use of the p-word may actually be appropriate.

Thrombus aspiration for ST-segment elevation myocardial infarction (STEMI) has been kicking around for a long time, but its utility has never been definitively evaluated. The procedure uses a dedicated catheter to suck the clot out of the vessel prior to stent implantation. In an accompanying editorial, Robert Byrne and Adnan Kastrati write that thrombus extraction “is an intuitively attractive strategy and one that is simple to carry out.”

The  Scandanavian study has its origins in an earlier study, TAPAS, which found an unexpected benefit on mortality at one year for thrombus aspiration, though the trial was not designed to assess mortality. On the basis of TAPAS, thrombus aspiration was given a level IIA endorsement in both European and U.S. guidelines.

TASTE (Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia) was presented at the European Society of Cardiology meeting in Amsterdam and published simultaneously in the New England Journal of MedicineThe investigator-initiated randomized trial was performed as part of the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), which in this case included 1 center each in Iceland and Denmark. After obtaining consent, patients were randomized through “an online randomization module within the SCAAR database.”

A total of 7244 STEMI patients were randomized, representing a striking 60% of all STEMI patients referred for PCI in Sweden and Iceland during the study period. All-cause mortality at 30 days was not significantly different between the two groups:

  • 2.8% in the thrombus aspiration group versus 3% of the PCI-only group (hazard ratio 0.94, CI 0.72-1.22, p=0.63)

A similar result was observed in the per-protocol analysis.

There were no significant differences in the rate of rehospitalization due to reinfarction, stent thrombosis, target-lesion revascularization, target-vessel revascularization, neurological complications, or other clinical outcomes, though there were trends in favor of thrombus aspiration in hospitalization for MI and stent thrombosis. The results were consistent across all major subgroups.

In their editorial, Byrne and Kastrati hold out hope that thrombus aspiration may turn out to be beneficial. They predict that “many interventional cardiologists will continue to perform thrombus aspiration for now,” based on hints of efficacy and the lack of any safety issues found in the trial.

Furthermore, they write, 30-day followup may not be long enough to detect a benefit, since the benefit in the TAPAS trial only emerged at 1 year. They urge the TASTE investigators to report the 12-month findings of their trial, and note that another large-scale randomized trial is nearing completion. “For now,” however, “the hope that this simple, easy-to-use, intuitively attractive technology could save the lives of patients presenting with myocardial infarction remains an unmet aspiration.”

A New Paradigm?

But the sweetest part of TASTE may be that the investigators were able to conduct a rapid and low-cost trial utilizing a new model, “a registry-based randomized clinical trial,” by incorporating the trial within the already existing framework of SCAAR: “The data were monitored and adjudicated as part of the regular registry validation; we did not perform separate, dedicated monitoring and adjudication of the data for the TASTE trial.”

In an accompanying Perspective, Michael Lauer and Ralph D’Agostino, Sr. ask whether randomized registry trials may be “the next disruptive technology in clinical research.” Current trials are expensive and “too complex and difficult to apply.” The usual alternative, traditional observational studies utilizing registries, “lack the rigor of randomization.”

TASTE, they write, represents “a new paradigm… that can potentially release us from the circular (and expensive) trap of the randomized-versus-registry debate.”

“The TASTE investigators designed a large-scale trial to answer an important clinical question and carried it out at remarkably low cost by building on the platform of an already-existing high-quality observational registry. With this clever design, which leveraged clinical information that was already being gathered for the registry and for other preexisting databases, the investigators were able to quickly identify potential participants, to enroll thousands of patients in little time…, to avoid filling out long case-report forms, to obtain accurate follow-up with minimal effort, and to report their findings, all for less than the amount of a typical modular R01 grant…”

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American Heart Association Announces Late-Breaking Clinical Trials Reply

AHA 2013 logoThere are still a few days left in August and the European Society of Cardiology meeting doesn’t start until this weekend in Amsterdam. Nevertheless, the American Heart Association has released the list of late-breaking clinical trials for the annual meeting in November.

Late-Breaking Clinical Trials 1: Acute Cardiovascular and Cerebrovascular Care

  • Sunday, Nov 17, 2013, 4:00 PM – 5:19 PM

Moderators:

  • Lance Becker, Philadelphia, PA
  • Stephen Bernard, Melbourne, Australia

4:00 PM: Nitrites in Acute Myocardial Infarction

  • Nishat Siddiqi, Univ of Aberdeen, Aberdeen, United Kingdom
  • Discussant: Kenneth Bloch, Boston, MA

4:13 PM: Blood Pressure Reduction Among Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial

  • Jiang He, Tulane Univ, New Orleans, LA
  • Discussant: Cathy A Sila, Cleveland, OH

4:35 PM: Randomized Clinical Trial of Pre-hospital Induction of Mild Hypothermia in Out-of-Hospital Cardiac Arrest Patients Using a Rapid Infusion of 4oC Normal Saline

  • Francis Kim, Univ of Washington, Seattle, WA
  •  Discussant: Maaret Castrén, Stockholm, Sweden

4:57 PM: Target Temperature Management 33°C versus 36°C after Out-of-hospital Cardiac Arrest, a Randomized, Parallel Group, Assessor Blinded Clinical Trial

  • Niklas Nielsen, Helsingborg Hosp, Lund Univ, Helsingborg, Sweden
  •  Discussant: Benjamin S Abella, Philadelphia, PA

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Late-Breaking Clinical Trials 2: Prevention: From Schools to Countries

  • Monday, Nov 18, 2013, 9:00 AM -10:28 AM

Moderators:

  • Donna K Arnett, Birmingham, AL
  • Lynne Braun, Chicago, IL

9:00 AM: Promotion of Cardiovascular Health in Preschool Children: 36-month Cohort Follow-up

  • Jaime Céspedes, Fundación CardioInfantil Insto de Cardiología, Bogotá, Colombia
  • Discussant: Gerard R Martin, Washington, DC

9:22 AM: Randomized Trial of Social Network Lifestyle Intervention for Obesity: MICROCLINIC Intervention Results and 16-Month Followup

  • Eric L Ding, Harvard Sch of Public Health, Boston, MA
  • Discussant: Lawrence J Appel, Baltimore, MD

9:44 AM:  Multifaceted Intervention to Improve Medication Adherence and Secondary Prevention Measures (Medication Study) After Acute Coronary Syndrome Hospital Discharge

Michael Ho, VA Eastern Colorado Health Care System, Denver, CO

Discussant: Nancy Albert, Cleveland, OH

10:06 AM: China Rural Health Initiative – Sodium Reduction Study: the Effects of a Community-Based Sodium Reduction Program on 24hr Urinary Sodium and Blood Pressure in Rural China

  • Nicole Li, The George Inst for Global Health, Sydney, Australia

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Late-Breaking Clinical Trials 3: Medical and Surgical Approaches to Improving Heart Failure Outcomes

  • Monday, Nov 18, 2013, 10:45 AM -12:13 PM

Moderators:

  • Frederick A Masoudi, Aurora, CO
  • Adrian F Hernandez, Durham, NC

10:45 AM: Atrial Antitachycardia Pacing and Managed Ventricular Pacing Reduce the Endpoint Composed by Death, Cardiovascular Hospitalizations and Permanent Atrial Fibrillation Compared to Conventional Dual Chamber Pacing in Bradycardia Patients: Results of the Minerva Randomized Study

  • Giuseppe Boriani, Univ of Bologna, Policlinico S.Orsola-Malpighi, Bologna, Bologna, Italy
  • Discussant: Anthony Tang, Victoria, BC, Canada

11:07 AM: Renal Optimization Strategies Evaluation in Acute Heart Failure (ROSE AHF) Trial

  • Horng H Chen, MAYO Clinic, Rochester, MN
  • Discussant: Marco Metra, Brescia, Italy

11:29 AM: Severe Ischemic Mitral Regurgitation: Is it Better to Repair or Replace the Valve?

  • Michael A Acker, Hosp of the Univ of Pennsylvania, Philadelphia, PA
  • Discussant: Timothy J Gardner, Newark, DE

11:51 AM: Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT)

  • Marc A. Pfeffer, Brigham & Women’s Hosp, Harvard, Boston, MA
  • Discussant: Margaret M Redfield, Rochester, MN

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Late-Breaking Clinical Trials 4: Therapeutic Advances in Coronary and Peripheral Vascular Disease.

  • Monday, Nov 18, 2013, 3:45 PM – 5:13 PM

Moderators:

  • John G Harold, Washington, DC
  • Mark A Creager, Boston, MA

3:45 PM: One Year Mortality in STEMI Patients Randomized to Primary PCI or a Pharmaco-invasive Strategy. The Stream 1 Year Follow-up

  • Peter Sinnaeve, Univ of Leuven, Leuven, Belgium
  • Discussant: Harold Dauerman, Burlington, VT

4:07 PM: Secretory Phospholipase A2 Inhibition with Varespladib and Cardiovascular Events in Patients with an Acute Coronary Syndrome: Results of the VISTA-16 Study

  • Stephen Nicholls, South Australian Health and Medical Res Inst, Adelaide, Australia
  • Discussant: Philippe Gabriel Steg, Paris, France

4:29 PM: Randomized Comparison of Endovascular Revascularization Plus Supervised Exercise Therapy Versus Supervised Exercise Therapy Only in Patients With Peripheral Artery Disease and Intermittent Claudication: Results of the Endovascular Revascularization and Supervised Exercise (ERASE) Trial

  • Farzin Fakhry, Erasmus MC, Rotterdam, Netherlands
  • Discussant: Mary McDermott, Chicago, IL

4:51 PM: A Randomized Multicenter Clinical Trial of Renal Artery Stenting in Preventing Cardiovascular and Renal Events: Results of the CORAL Study

  • Christopher J Cooper, Univ of Toledo, Toledo, OH
  • Discussant: Thomas Zeller, Bad Krozingen, Germany
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Late-Breaking Clinical Trials 5: New Strategies for Atrial Fibrillation Patients: Rhythm and Thrombosis

  • Tuesday, Nov 19, 2013, 10:45 AM -12:03 PM

Moderators:

  • Augustus O Grant, Durham, NC
  • Keith A Fox, Edinburgh, United Kingdom

10:45 AM: RADAR-AF Trial. A Randomized Multicenter Comparison of Radiofrequency Catheter Ablation of Drivers versus Circumferential Pulmonary Vein Isolation in Patients with Atrial Fibrillation

  • Felipe Atienza, Hosp Gregorio Maranon, Madrid, Spain
  • Discussant: Mark Link, Boston, MA

11:07 AM: A Randomized Trial Comparing Genotype-Guided Dosing of Warfarin to Standard Dosing: The EU Pharmacogenetics of Anticoagulant Therapy (EU-PACT) Warfarin Study

  • Munir Pirmohamed, Univ of Liverpool, Liverpool, United Kingdom

11:17 AM: The Clarification of Optimal Anticoagulation through Genetics (COAG) Trial

  • Stephen E. Kimmel, Univ PA Sch of Med, Philadelphia, PA

11:27 AM: Discussant of EU-PACT Warfarin Study and COAG Trial: Patrick T. Ellinor, Boston, MA

11:41 AM: ENGAGE AF-TIMI 48 Primary Results

  • Robert P Giugliano, Brigham and Women’s Hosp, Boston, MA
  • Discussant: Elaine Hylek, Boston, MA

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FDA Turns Back New Indication For Rivaroxaban To Prevent Stent Thrombosis In ACS Patients Reply

Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application for rivaroxaban (Xarrelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the  general use of rivaroxaban to treat ACS patients.

Click here to read the full story on Forbes.

 

English: Logo of the .

 

 

Some Patients With Minor Stroke Or TIA May Benefit From Early Clopidogrel And Aspirin Reply

Some people with minor ischemic stroke or transit ischemic attack (TIA) may benefit from dual antiplatelet therapy with aspirin and clopidogrel, according to a large new study from China published in the New England Journal of Medicine. In the immediate period following a TIA or minor stroke people are at high risk for having a major stroke. Aspirin is known to cause a modest reduction in recurrent events. More potent antiplatelet agents like clopidogrel may also be beneficial, but have not been well studied in the early phase and may increase the risk of bleeding complications, including the conversion of an ischemic stroke into a worse hemorrhagic stroke.

Investigators in the CHANCE (Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events) trial randomized 5,170 patients within 24 hours of a minor ischemic stroke or high-risk TIA to three months of treatment with either clopidogrel and aspirin or placebo and aspirin. At 90 days the rate of stroke was 8.2% in the combination group versus 11.7% in the aspirin-alone group (hazard ratio 0.68, CI 0.57-0.81, p<0.001). There were also significant reductions…

Click here to read the full story on Forbes.

 

Rivaroxaban Gains Approval In Europe For ACS Indication Reply

Rivaroxaban (Xarelto, Bayer) has been approved in Europe for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) following an acute coronary syndrome (ACS). The drug was approved at a dose of 2.5 mg twice-daily and should be used in combination with standard antiplatelet therapy. Rivaroxaban is now the only oral anticoagulant to receive an ACS indication.

The approval is based on data from the pivotal ATLAS ACS 2-TIMI 51 trial. In the United States, where Xarelto is marketed by Johnson & Johnson, the FDA has twice rejected an ACS indication for rivaroxaban.

The new indication joins the already-approved indications for higher doses of rivaroxaban for the prevention of venous thromboembolism (VTE) in patients undergoing elective hip or knee replacement surgery, for the treatment of, (and prevention of recurrent) DVT and PE, and for stroke prevention in patients with atrial fibrillation.

“We know that thrombin levels remain elevated long after an ACS event, leaving patients at risk. In the ATLAS ACS 2-TIMI 51 study, we’ve shown that treating these patients with a low dose of rivaroxaban in combination with standard antiplatelet therapy targets both pathways of clot formation providing more complete long-term protection, including significant reduction in mortality risk,” said C. Michael Gibson, the Principal Investigator of the ATLAS ACS2-TIMI 51 trial, in a Bayer press release. “This approval marks an important shift in the way we deliver protection to patients who are at risk of a secondary atherothrombotic event.”