No Value For Renal-Artery Stenting In CORAL Reply

Previous small studies have failed to find any benefit associated with renal-artery stenting, but the trials have been small and were not powered for clinical outcomes. Now, the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) trial, presented at the American Heart Association meeting and published simultaneously in the New England Journal of Medicine, offers strong and persuasive evidence that renal-artery stenting is not beneficial.

A total of 947 patients with renal-artery stenosis and either systolic hypertension, despite taking two or more antihypertensive agents, or chronic kidney disease were randomized to medical therapy plus stenting or medical therapy alone. There were no significant differences after 43 months in the primary composite endpoint of cardiovascular and renal events (death from cardiovascular or renal causes, MI, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy):

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Prolonged Dual Antiplatelet Therapy May Not Be Necessary For Second-Generation Drug-Eluting Stents Reply

The precise duration of dual antiplatelet therapy (DAPT) following implantation of a drug-eluting stent (DES) has been the subject of considerable controversy. On the one hand, prolonged therapy may help prevent late stent thrombosis, which was particularly evident in first generation DESs. On the other hand, the risk of stent thrombosis may have diminished in newer generation drug-eluting stents, and prolonged DAPT  is associated with a greater risk for bleeding complications and additional expense and management issues.

In the Optimized Duration of Clopidogrel Therapy Following Treatment With the Zotarolimus-Eluting Stent in Real-World Clinical Practice (OPTIMIZE) trial 3,119 patients with stable CAD or a history of low-risk acute ACS who received a zotarolimus-eluting stent (Endeavor, Medtronic) were randomized to either short-term (3 months) or long-term (12 months)  DAPT. The results of OPTIMIZE were presented at TCT 2013 in San Francisco and published online in JAMA.

At one year there were no significant differences between the groups. The primary endpoint– the composite of death, MI, stroke, or major bleeding– occurred in 6% of patients in the short term group versus 5.8% of patients in the long-term group (risk difference 0.17, CI -1.52 – 1.86, p = 0.002 for noninferiority). Between 3 months and 1 year there was an identical 2.6% rate of events in both groups.

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The Good, The Bad, And The Ugly: Stents In The News Reply

Three big stent stories were in the news today. You’d never know that all 3 were about the same topic.

 

The Ugly

 

The ugly side of stents is emphasized in David Armstrong’s Bloomberg News story on Mehmood Patel, the Louisiana interventional cardiologist serving a 10-year prison sentence for Medicare fraud. These days Patel “leads health-conscious inmates on a morning walk, then cracks open one of the medical journals on his prison-approved reading list. Counseling fellow convicts to keep their blood pressure down is about the extent of the doctoring done by the man who once boasted he was the busiest cardiologist in the nation.”

 

The Bad

 

Unlike Patel, Mark Midei, the poster-boy of overstenting, never faced criminal charges, but he did lose his medical license and faced an avalanche of lawsuits. Many have been settled our of court, but an important decision was reached yesterday in one very large remaining case. Jessica Anderson reports in the Baltimore Sun that a jury ruled that Midei “improperly placed three stents in the heart of a prominent businessman who didn’t need them.” The businessman is suing Midei and the former owners of his hospital, St. Joseph Medical Center, for $150 million. The businessman claims that he “lost millions of dollars after scaling back his career” after “Midei falsely led him to believe that he had serious coronary artery disease requiring stents.”

 

The Good

 

But it’s not all bad news for stents. In the New Yorker‘s Elements blog, cardiology fellow Lisa Rosenbaum adopts a much more nuanced view of stents. She writes that “stories about cardiologists behaving badly validate the conviction, common among both policymakers and the public, that misaligned financial incentives drive doctors to do things that they shouldn’t.”

 

But, she argues, the conservative view, based largely on the well known COURAGE trial, that medical therapy is just as good as a stent, “is a colossal oversimplification.”

 

Successful conservative management, however, depends on seeing patients regularly, so that you can titrate their medications and make sure that their cardiovascular risk factors are controlled. But Sun Kim didn’t come back.

 

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The Good, the Bad and the Ugly is a well-known...

 

Study Supports Loosening Guidelines for Surgery After Stent Implantation Reply

According to current guidelines, noncardiac surgery should be delayed for six weeks after bare-metal stent (BMS) implantation and for one year after drug-eluting stent (DES) implantation, though there is little good evidence to support these recommendations. Stent thrombosis caused by discontinuation of antiplatelet therapy in order to lower the risk of bleeding during surgery is the biggest concern. Now, a new study published in JAMA suggests that the guidelines may be over strict and that delays recommended after DES implantation are longer than warranted.

Mary T. Hawn and colleagues analyzed data from nearly 125,000 VA patients who received a stent between 2000 and 2010. Within this group more than 28,000 (22.5%) had a noncardiac operation within 2 years…

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Questions About President George W. Bush’s Stent Reply

Former President George W. Bush received a stent today at Texas Health Presbyterian Hospital. Here is the statement from Bush’s office:

During President George W. Bush’s annual physical examination at the Cooper Clinic in Dallas yesterday, a blockage was discovered in an artery in his heart. At the recommendation of his doctors, President Bush agreed to have a stent placed to open the blockage. The procedure was performed successfully this morning, without complication, at Texas Health Presbyterian Hospital. President Bush is in high spirits, eager to return home tomorrow and resume his normal schedule on Thursday. He is grateful to the skilled medical professionals who have cared for him. He thanks his family, friends, and fellow citizens for their prayers and well wishes. And he encourages us all to get our regular check-ups.

As someone who has followed the intense debate and discussion that has occurred in the cardiology community in the last few years about precisely this sort of case, I’m wondering about a number of issues raised here:

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G.W. Bush on a bike

 

 

A CME Program Begs The Question: Promotion Or Education? Reply

In recent years defenders of commercially-supported continuing medical education (CME) have claimed that the industry has cleaned up its act and that CME programs today are largely free of the abuses that were so common not so long ago. Perhaps. But there are still plenty of examples of programs that violate the fundamental principle that medical education should be completely separate from commercial interests.

A striking example is a recent email I received from TCTMD, the online arm of the Cardiovascular Research Foundation (CRF), which is basically the equivalent of the Vatican for interventional cardiologists. The subject line of the email was nothing out of the ordinary:

Sponsored Message from Volcano: ADAPT-DES Webcast and Investigator Interview

I get lots of these sort of messages from different medical organizations. I’m not crazy about them but I understand that these groups have to pay their bills. But it’s vitally important that these groups maintain a clear separation between commercial messages like these and genuine educational content.

The text of the email makes some astonishing claims. It makes the case– not surprising in a promotional message– that interventional cardiologists should use IVUS more often during their procedures. But the text fails to mention that the numbers mentioned in the text come not from a randomized controlled trial but from an observational study. The findings thus should be considered hypothesis generating. In addition, as is so often the case when medical results are being hyped, the relative differences sound quite impressive– 50% reduction in stent thrombosis and 33% reduction in MI– but the absolute differences are much less impressive: at one year stent thrombosis was reduced from 1.04% to  0.52% and MI was reduced from 3.7% to 2.5%. And remember, since these differences are not the result of a randomized comparison they may be completely illusory.

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Early Results: Antiplatelet Drug Cangrelor Appears Effective For PCI Reply

The experimental antiplatelet drug cangrelor was superior to traditional clopidogrel in reducing ischemic events at 48 hours in PCI patients, according to the Medicines Company, which is developing the drug. The company today announced positive results from the phase 3 CHAMPION PHOENIX trial, a randomized, double-blind study comparing intravenous cangrelor to oral clopidogrel in PCI patients. The primary endpoint was the composite of death, MI, revascularization and stent thrombosis at 48 hours.

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Ohio Hospital And Cardiology Group Pay $4.4 Million To Settle Charges Over Unnecessary PCIs 2

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 but whose blood vessels were not sufficiently occluded to require the particular procedures at issue.”

The leader of the cardiology group defends its quality of care and says it “settled this matter so we can put it behind us and move forward.”

Read my complete story about this on Forbes.