Here’s a completely personal review of the past year in cardiology. Please write a comment if you strongly agree, disagree, or think something is missing.
Drug of the Year: Rivaroxaban (Xarelto)– Despite a highly negative review from FDA reviewers, rivaroxaban gained FDA approval for the coveted stroke prevention in AF indication. The drug was approved earlier in the year for VTE prevention after surgery. The biggest surprise, though, was rivaroxaban’s success in ACS in the ATLAS ACS TIMI 51 trial, which may well have an important impact on the field for years to come.
- Rivaroxaban (Xarelto) Gains First FDA Approval for DVT Prevention
- FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)
- The Rivaroxaban FDA Panel and Large Pragmatic Trials
- Live Blog– FDA Advisory Panel on Rivaroxaban (Xarelto)
- Rivaroxaban Meets Primary Endpoint in ATLAS ACS TIMI 51
- FDA Approves Rivaroxaban for Stroke Prevention in AF
- ATLAS ACS 2-TIMI 51: Rivaroxaban Beneficial in Low-Risk ACS Population
Device of the Year: Sapien Transcatheter Heart Valve– TAVI entered the marketplace this year. It will take another few years before its full impact is completely understood.
Drug of the Year Runnerup: Apixaban (Eliquis)— For a while it looked like apixaban might be the drug of the year, and certainly the ARISTOTLE trial was the most highly praised trial of the year. But unlike rivaroxaban, apixaban was unable to thread the needle and succeed in ACS, as evidenced by the APPRAISE-2 trial.
- APPRAISE-2 Dashes Hope of Adding Anticoagulant to Antiplatelet Therapy in ACS
- ARISTOTLE Study Finds the Golden Mean of Anticoagulation
- Apixaban Better Than Aspirin for Stroke Prevention in AF Patients Unable to Take Warfarin
- Apixaban (Eliquis) Meets Primary Endpoint in ARISTOTLE
- ADOPT Fails to Support Extended Oral Anticoagulation with Apixabanin High Risk Post-Discharge Patients
- Sanofi-Aventis To Inform Doctors About Liver Transplants in 2 Patients Taking Multaq (Dronedarone)
Drug Dog of the Year: Dronedarone (Multaq)— It was not a good year for dronedarone. The year started off with warnings about liver toxicity (as first reported here on CardioBrief) and the news didn’t get much better as the year progressed:
- FDA Warns About Severe Liver Injury Associated with Multaq (Dronedarone)
- Dronedarone (Multaq) Study for Permanent AF Stopped Early
- Dronedarone (Multaq) Gets Another Drubbing in Europe
- Easy Come, Easy Go? ESC To Review Dronedarone’s Role in AF Guidelines
- FDA Adds New Warnings to Dronedarone (Multaq) Label
- PALLAS: Poor Results for Dronedarone in Permanent AF
Year’s biggest disappointment: Vorapaxer, Merck’s thrombin receptor antagonist–
- TRACER: Novel Antiplatelet Vorapaxar Runs Into Trouble in ACS
- Merck’s Thrombin Receptor Antagonist Suffers Major Setback
Ticagrelor (Brilinta) gained FDA approval this year and will continue to be a major story, but there wasn’t much major new information about the drug this year:
Major conflict-of-interest stories– As part of its Dollars for Docs series, Pro Publica shed light on the relationship between industry and cardiology medical societies. CardioBrief took a hard look at the National Lipid Association. The New York Times examined the ties with cardiologists of one company, Biotronik. And there was much more:
- $50K: The Price For A VIP Dinner For 2 With The Cleveland Clinic CEO
- Financial Ties Bind Medical Societies To Drug and Device Makers (Pro Publica)
- Part 1: The National Lipid Association and the FH Guidelines
- National Lipid Association Expert Panel Has Many Deep Ties To Industry
- Ray of Light for the Physician Payment Sunshine Act
- CardioBrief Poll: Should the ACC Train Industry Reps?
- GRAVITAS Published: Who Gets To Weigh In On the Results?
- PROTECT II: Who Will Protect Us From The Protectors?
- ACC CEO Jack Lewin Provides The Argument Against Industry Money
- ProPublica Investigates Heart Check America
- An Embargo Becomes A Public Relations Tool
- More Questions Raised About Biotronik’s Relationships With Cardiologists
Dumbing Down the News– As usual, the media did its best to dumb down the news. Here are just a few examples.
- WebMD: the 800 Pound Gorilla in the Room
- CNN Documentary Promises Screening and Vegan Diet CanEliminate Heart Attacks
- CNN, ABC, and NBC Dumb Down the News About CV Screening
- Taking Medical Advice From Peggy Fleming?
Scientific Misconduct and Retractions– I remain shocked that the scientific community continues to ignore the implications of the growing number of cases of scientific misconduct and article retractions.
- Guest Post: Retraction Reveals Downfall of Company Where Ron Waksman Consulted
- Ron Waksman Paper on Novel CAD Test Retracted
- Scientific Fraud Found In Wayne Alexander’s Research Group At Emory
- Archives Decides At Last Minute Not to Publish a Scheduled Paper
- New Concerns Raised About Withdrawn Archives Meditation Paper
- Very Little New Light Shed on the Archives Meditation Paper Fiasco
- Montreal Heart Institute Researcher Fired After Investigation of Retracted Papers
- Prominent Dutch Cardiovascular Researcher Fired for Scientific Misconduct
- More Details Emerge About the Dutch Research Scandal
- ESC May Re-Examine Guidelines in Wake of Poldermans Dismissal
- Investigation in Poldermans Case Expands to Leiden University Medical Center
Mark Midei, Stents, and Device Overuse– Was 2011 the beginning of the end of the device overuse problem or the end of the beginning?
- NCDR Study in JAMA: Only Half of Nonacute PCIs Deemed Appropriate
- Maryland Revokes Mark Midei’s Medical License
- CMS Tightening the Screws on Unnecessary Procedures in Florida and 10 Other States
- New Study Finds Wide Variation Among Hospitals in Diagnostic Yield for Angiography
- Financial Incentives Increase Utilization of Stress Tests
- Significant Declines Observed in Cardiovascular Procedures Performed in Hospitals
- Going Beyond COURAGE: NHLBI Funds the ISCHEMIA Study
Statins, Generic Atorvastatin, and Niacin– Generic atorvastatin, AIM-HIGH, cholesterol testing for children, and a warning about high dose simvastatin:
- One More Thought About Lipitor
- Generic Atorvastatin Hits the Market
- NHLBI Stops the AIM-HIGH Trial of Niacin
- National Lipid Association: AIM-HIGH Results “Disappointing” But Prescribing Practices Should Not Change
- AIM-HIGH: No Benefit for Niacin on Top of Statins
- Experts Clash Over Interpretation and Value of AIM-HIGH
- SATURN Regression Trial: Gorilla Statin and Statin KingBattle to a Draw
- Controversy Over Cholesterol Testing for Children
- NEJM: FDA Officials Explain the New Simvastatin Label
- FDA Recommends Limiting Usage of High Dose Simvastatin
At Long Last:
- 22 Years Later, Study Shows Life-Prolonging Effect of Antihypertensive Therapy
- Long Term Followup of HPS Shows Extended Benefits of Statins
- STICH Illuminates CABG In Heart Failure, Finally
Editorials and Comments:
- Letter From Jail: A Cautionary Tale
- The Pen Is Mightier Than the Scold
- Industry & Medicine: It’s Complicated
- US Senate Unanimously Endorses Campaign Against Atrial Fibrillation
- The Voice of the Patient: Time To Bring Out the Muzzle?
- Less May Be More, But Stents Are Neither Good Nor Bad
RIP:
Great compilation, Larry! Not sure I’ve seen a nicer summary of events in 2011.
All the best to you in 2012!
Following Larry is like having a journalistic army watching the whole field of cardiology. Many thanks and happy new year!
Wes, SMFleet– thanks so much for your nice comments. Happy New Year!
Agree with Wes! This is spectacular.