Medicines Company Drug Finally Gets Nod From FDA Advisory Panel

On Wednesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-2-1 to recommend approval of cangrelor during PCI to reduce the risk of periprocedural thrombotic events such as MI, stent thrombosis, and ischemia driven revascularization. … Click here to read the full post on Forbes.  …

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FDA Grants Premarket Approval To AbioMed Heart Pump

The FDA said today that it had approved Abiomed’s Impella 2.5 System. According to the company it is is the first hemodynamic support device to gain FDA premarket approval for use during high risk PCI procedures. The miniature blood pump is designed for temporary use in patients with severe symptomatic coronary artery disease and diminished (but stable) heart…

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FDA Approves New Noninvasive FFR Technology

The FDA said today that it had granted approval to a novel technology that noninvasively measures fractional flow reserve (FFR) using data obtained from a CT scan of the heart…. … Click here to read the full post on Forbes.  …

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Study Raises Questions About Transfusions In PCI Patients

A very large observational study raises important questions about the role of transfusions in PCI patients in the US. In a study published in JAMA, researchers from Duke and Yale analyzed data from more than 2.25 million percutaneous coronary intervention (PCI) procedures at more than 1,400 hospitals. The data came from the CathPCI Registry, a large ongoing study…

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FDA Advisory Panel Recommends Against Approval Of Cangrelor

The FDA’s Cardiovascular and Renal Drugs Advisory Committee today recommended against the approval of cangrelor, the investigational new antiplatelet drug from the Medicines Company. In a 7-2 vote the panel first rejected an indication  for the reduction of thrombotic cardiovascular events including stent thrombosis in patients undergoing PCI. The panel also voted unanimously to reject a second indication… … Click…

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FDA Reviewers Deliver Split Opinion On The Medicines Company’s Cangrelor

FDA reviewers presented two dramatically different views of The Medicines Company’s investigational new drug cangrelor. One reviewer says the drug should not be approved without a new trial and even states that the CHAMPION trials “were conducted unethically” and should not be approved “on that fact alone.”  But two other reviewers recommend approval. … Click here to read…

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Both Overuse And Underuse Explain Disparities In Heart Procedures

A new study finds that groups who have often been found to receive less medical care– non-whites, women, and people without private insurance or who are from urban and rural areas– are less likely to undergo coronary revascularization. But the same study finds that this disparity may be in no small part due to the fact…

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Fibrinolysis May Benefit Late-Arriving STEMI Patients

Although primary PCI has emerged as the best treatment for STEMI, most patients don’t receive this treatment within the early time frame when it is known to be most beneficial. Delay in presentation is one important factor. Another is that most patients don’t arrive at a PCI-capable hospital and cannot be transferred fast enough to a…

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Cangrelor During PCI May Reduce Ischemic Events

In the Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) trial, the intravenous platelet inhibitor cangrelor was tested for its effect on ischemic events associated with PCI. Cangrelor is a potent, fast-acting and reversible  agent. Results of the trial were presented at the ACC in San Francisco and published simultaneously in…

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Are Most People With Complex Coronary Disease Getting The Best Treatment?

The relative value of PCI (stents) and bypass surgery for the treatment of people with blocked coronary arteries has been a topic of intense interest and debate for more than a generation now. Over time, the less invasive and more patient-friendly (and less scary) PCI has become the more popular procedure, but the surgeons (who…

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Are Cardiologists Worried About Being Accused Of Unnecessary PCI?

In the last week two cases highlighted, yet again, the continuing shift in standards regarding PCI. In his interventional cardiology blog on CardioExchange, Rick Lange asks cardiologists: Could You Be Accused of Doing Unnecessary PCI? “Public confidence is eroding as the number of reports of physician suspensions and monetary penalties for unnecessary PCIs grow. Accordingly, patients…

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Ohio Hospital And Cardiology Group Pay $4.4 Million To Settle Charges Over Unnecessary PCIs

In 2006, Reed Abelson in the New York Times reported that the PCI rate in Elyria, Ohio was four times the national average. Now, six-and-a-half years later, the local hospital and cardiology group have agreed to pay $4.4 million to settle US allegations “that the hospital and the physicians “performed angioplasty and stent placement procedures on patients who had heart disease…

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CABG Highly Cost Effective In Diabetics With Multivessel Disease

In November the main results of the FREEDOM trial showed that diabetics with multivessel disease do better with CABG than PCI. Now the findings of the trial’s cost-effectiveness study, published online in Circulation, demonstrate that CABG is also highly cost-effective when compared with PCI. Elizabeth Magnuson and colleagues  found that although CABG initially cost nearly $9,000 more…

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Missouri Board Issues Emergency Suspension Of Cardiologist Accused Of Implanting Unnecessary Stents

A Missouri cardiologist who has been accused of unnecessarily implanting stents in six patients has been temporarily barred from seeing patients. The Missouri State Board of Registration for the Healing Arts, which licenses physicians and investigates and disciplines physicians in cases of accused misconduct, issued an emergency suspension of the cardiologist’s license to practice, according to…

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2012 In Review: A Bad Year For Conventional Wisdom

This was a really grim year for anyone who thought we had things pretty well figured out. Time and again conventional wisdom was thrown out the window. 2012 forced the cardiology community to reconsider what it thought it knew about HDL cholesterol, platelet function tests, aspirin resistance, triple therapy, IABP, and more. One device company,…

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FREEDOM Lends Strong Support To CABG For Diabetics With Multivessel Disease

Editor’s note: The embargo on FREEDOM was lifted early after a press release was published by mistake.) Diabetics with multivessel disease do better with CABG than PCI, according to FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease), a large NIH-sponsored study presented at the American Heart Assocation in Los…

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PCI Utilization Lower In States With Public Reporting Of Outcomes

In patients with acute MI, utilization of percutaneous coronary intervention (PCI) is lower in states that publicly report outcomes data, according to a new study published in JAMA. Despite the difference in utilization, however, there was no difference in mortality between reporting and nonreporting states. Karen Joynt and colleagues used Medicare data to analyze PCI utilization and mortality…

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FAME 2: Can FFR Save PCI From Medical Therapy?

Two sharply divergent views have developed about the value of fractional flow reserve (FFR) in PCI. FFR advocates think the new technology can help identify ischemic lesions that will benefit from PCI, thereby helping to salvage or enhance the reputation of PCI. FFR skeptics think that optimal medical therapy is still the preferred option for most…

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Guest Post: Is It The Right Time To Introduce Real Supervision Into Medical Practice?

Editor’s Note: Dr. Schloss, the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH, originally submitted the following post as a comment on my previous post in which I compared HCA to Barclays and JP Morgan. I’d be very eager to hear responses from other physicians about this subject. Is It The Right Time To…

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Why HCA Is Like Barclays And JP Morgan

Earlier this week the New York Times reported on a pattern of seriously deficient cardiac care at a number of hospitals owned by HCA. Understandably, the most common reaction is simple disgust over more bad cardiology behavior. After the Mark Midei case, after subsequent and even worse cases in Maryland, Pennsylvania, and elsewhere, the easy thing is to…

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NY Times: HCA Concealed Significant Problems At Lucrative Cardiac Centers

Despite numerous internal reviews that turned up a widespread pattern of unnecessary cardiology procedures being performed at many of its hospitals, the giant HCA corporation did little to rein in the problem or to inform regulators, payers, or patients about the problem, according to an investigative report in the New York Times by Reed Abelson and…

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Drug-Eluting Stents Often Used In Patients At Low Risk Of Restenosis

The chief advantage of drug-eluting stents (DES) over bare-metal stents is that they significantly reduce the risk of restenosis. The chief disadvantages of DES are their greater cost and the requirement for prolonged dual antiplatelet therapy after DES implantation. In a study published in Archives of Internal Medicine,  Amit Amin and colleagues analyzed data from 1.5…

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No Benefit Found For Exercise Echocardiography In Asymptomatic Patients Following CABG Or PCI

Routine exercise echocardiography in asymptomatic patients after revascularization does not lead to better outcomes, according to a new study published in Archives of Internal Medicine. Although guidelines generally discourage the practice, post-revascularization stress tests are still commonly performed. Serge Harb and colleagues performed exercise echocardiography on 2,105 patients following CABG surgery or PCI and followed…

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Revascularization In New York State: High Questionable Rates For PCI But Not CABG

A large study looking at real world usage of elective coronary artery bypass surgery (CABG) and stenting (PCI) in New York State finds that nearly two-thirds of PCI procedures have inappropriate or uncertain indications. By contrast, 90% of CABG procedures were deemed appropriate and 1.1% inappropriate. In a paper published in the Journal of the…

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Meta-Analysis Compares Drug-Eluting and Bare-Metal Stents for Primary Angioplasty

A new meta-analysis comparing drug-eluting stents (DES) and bare-metal stents (BMS) in patients with myocardial infarction has provoked opposing take-away messages from an author of the study and an editorialist. The authors emphasize the reduction in target-vessel revascularization (TVR) associated with DES, but the editorialist focuses on several potential DES weaknesses suggested by the study….

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