The Story Behind The NY Times ORBITA Anecdote

–Brahmajee Nallamothu fills in the details about the patient who didn’t get a stent because of ORBITA. Editor’s note: The New York Times story by Gina Kolata on the ORBITA trial focused on one patient who decided not to have a stent implanted when he heard about the ORBITA trial. Here is a more complete…

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Diving Deep Into The ORBITA Trial

William Boden, Ajay Kirtane, and Dan Mark analyze the ORBITA trial. Editor’s note: I asked a wide variety of cardiologists for their thoughts about ORBITA, presented at the TCT meeting in Denver and published simultaneously in the Lancet. Three of them, William Boden, Ajay Kirtane, and Dan Mark, sent highly detailed comments about the trial….

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Small Trial Raises Big Concerns That PCI In Stable Angina Is Just A Placebo

ORBITA trial may spark a heated debate in the cardiology community. It is only a small trial but it may have an enormous impact as it raises major questions about one of the core beliefs of clinical cardiology as it suggests that PCI for stable coronary disease has no more effect than a sham procedure….

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New And Improved LDL Lab Numbers

–Lab companies start reporting more accurate LDL cholesterol measurements. The LDL cholesterol number, which has been the obsessive focus of physicians and patients for several decades now, is getting a major upgrade. A new and improved method to calculate the LDL cholesterol number is starting to filter into standard laboratory reports. Until now LDL cholesterol,…

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Guest Post: Future Cardiologists Lack Vision

Editor’s note: Ethan Weiss, MD, is a cardiologist at the University of California at San Francisco. He recently tweeted his thoughts after interviewing applicants for his hospital’s cardiology fellowship. Here is a lightly edited version of his thread. Just finished cardiology fellowship interviews for the season – a few thoughts: Career path: Still fewer applicants…

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Blacks Face Higher Mortality from Heart Disease, Stroke

–CV disease accounts for large portion of health disparities. Cardiovascular disease led to the loss of more than 2 millions years of life in the African-American population between 1999 and 2010. A new scientific statement from the American Heart Association, Cardiovascular Health in African Americans, makes clear that, compared to whites, African Americans suffer disproportionately…

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Imaging Studies Offer New Insights Into Inflammation In CV Disease

–Preliminary evidence that colchicine may reduce coronary plaque. Interest in inflammation has risen considerably in the cardiology community as a result of the recent CANTOS trial. The large 10,000 patient trial validated the role of inflammation by demonstrating the efficacy of canakinumab— a monoclonal antibody that targets interleukin-1β— in reducing cardiovascular events in people with…

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New Anticoagulants Not Linked To Excess Bleeding Rates

–Observational study compares new anticoagulants to warfarin in VTE population. In clinical trials the new oral anticoagulants (NOACs) have been shown to have similar efficacy and safety compared to warfarin, but questions have been raised about whether the results are similar in real world settings. Now a new observational study lends some measure of reassurance…

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Why Do Doctors Still Rely On LDL Instead Of Non-HDL Cholesterol?

–There’s broad agreement that non-HDL is a better measure than LDL. For decades lipid experts have been saying that non-HDL is preferable to LDL cholesterol in the assessment of cardiovascular risk. The subject is not controversial. Although they may disagree about its precise significance, every expert I contacted agreed that non-HDL is superior to LDL….

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Merck Drops Development Of Once Promising CETP Inhibitor

–Despite positive results in the REVEAL trial anacetrapib is dead. Merck announced on Wednesday that it would not seek regulatory approval for its cholesterol drug anacetrapib. The decision did not surprise most observers, despite the fact that investigators recently reported positive results for the drug in the enormous 30,000+ patient REVEAL trial. The trial was…

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Side Effects In Drug Ads Don’t Add Up

–The long recitation of all possible side effects dilutes the perception of risk. One of the most perplexing aspects of the ubiquitous direct to consumer (DTC) prescription drug advertisements is the seemingly endless recitation of side effects in drug ads. The list is, alternatively, horrifying, boring, concerning, and silly. It is reasonable to wonder how these…

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Upcoming US Guideline Will Likely Set 130/80 As New Blood Pressure Target

–The highly anticipated AHA/ACC BP guideline will be published in November. The new magic number will be 130 over 80 mm Hg. That’s the new blood pressure goal that many hypertension experts say will be the centerpiece of the new US blood pressure guidelines. The new guideline will be introduced next month in Anaheim during the…

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Some Doctors Reluctant To Deactivate LVADs

–LVAD deactivation is not euthanasia or physician-assisted suicide. Left ventricular assist devices (LVADs) are used increasingly as destination therapy instead of as a temporary bridge until a donor heart becomes available for transplantation. Now patients, their families, and their caregivers are forced to confront the extremely difficult question of when and how to turn off…

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FDA’s Gottlieb Preparing To Lower The Bar To Approval

–Shifting the burden of proof from preapproval to postapproval. The new FDA commissioner Scott Gottlieb is quietly and persistently revamping the FDA to make it easier for drug and device companies to get their products on the market. The news, which is being welcomed by industry, also almost certainly means that more people will be…

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Genotyping Reduces Adverse Events with Warfarin

–But still unclear whether benefit justifies the cost. Because its effects can be highly variable, warfarin is a notoriously difficult drug to administer. In recent years warfarin has resulted in more medication-related visits to emergency departments among older patients than any other drug. Researchers have long hoped that genotype-guided dosing of warfarin might reduce the…

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Stopping Aspirin Hikes CV risk

–37% increase in events seen after discontinuation in Sweden People who quit taking aspirin have an increased risk for a cardiovascular event, a large national registry has shown. The use of aspirin for primary prevention against cardiovascular disease has fallen from favor in recent years but aspirin for secondary prevention is still broadly popular and…

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Benefits Of Physical Activity Seen Worldwide

–Latest findings from the influential PURE study Observational studies have consistently established a link connecting physical activity and cardiovascular health, but the vast majority of this research has occurred in high-income countries, where physical activity is often recreational. Now the latest report from an enormous worldwide observational study offers powerful evidence that the connection exists…

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Barely Half of Postmarket Studies Completed After 5 Years

–FDA fails to enforce requirements. Pharmaceutical and device companies are often taking advantage of a lenient (or, some would say, negligent) FDA to shirk their obligation to perform timely post-approval studies, a new Perspective published in the New England Journal of Medicine shows. The topic has gained increasing visibility and importance as the FDA has…

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What If PCI Is Just A Sham?

–A small study might upset assumptions about the benefits of stent. What if PCI for stable ischemic heart disease (SIHD) is just a big lie? That is, what if it’s no better than a sham procedure? This may seem like a crazy proposition, but there’s at least an outside chance that a small trial coming…

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Cardiac Stem Cell Therapies May Get Boost From New FDA

–The FDA may not require companies to prove that stem cell therapies are safe and effective prior to approval. Cardiac stem cell therapy could gain FDA approval far earlier than most people expect, despite the fact that these therapies have consistently failed to produce any convincing evidence of safety and efficacy. Under the old FDA…

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Julio Palmaz Really Doesn’t Want You To Read This Story

—Raising questions about a trial provokes a ‘cease-and-desist’ letter. The world  stent pioneer Julio Palmaz really doesn’t want you to read this post. After I raised questions about a recent paper involving Palmaz I received a “cease-and-desist” letter from his lawyer. Here is the background to this story: Last year I wrote a brief post…

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Cardiology Is Dead. Long Live Public Health.

Cardiology is dead. Here’s two new important pieces of evidence: The FDA’s Cardiovascular and Renal Drugs Advisory Committee hasn’t met since April 2015, and even then it was for the decidedly uninspiring drug cangrelor. And the committee has no meetings scheduled for the rest of this year. Take a look at the list of late-breaking…

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SPRINT Substudy Detects Mortality Signal

–Aggressive blood pressure lowering may sometimes be deadly. BARCELONA — A new examination of data from the SPRINT trial raises the fear that adopting the aggressive blood pressure target of 120 mm Hg in some hypertensive patients with baseline BP of 160 mm Hg or more may increase the risk of death. Tzung-Dau Wang, MD,…

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Huge Diet Study Questions Conventional Wisdom About Carbs And Fats

–But PURE also challenges belief that more is better for fruits and vegetables. BARCELONA — An enormous prospective study of food intake in adults, reported here, challenges several staunchly held beliefs about dietary components and their association with health risks: finding, for example that diets rich in fats, including saturated fats, don’t increase mortality risk,…

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REVEAL Revealed: A Slightly Positive CETP Inhibitor Trial

—After 3 strikes a CETP inhibitor finally scores. BARCELONA — Finally there is a CETP inhibitor that actually confers more benefit than risk: anacetrapib. The benefit emerged from the Randomized EValuation of the Effects of Anacetrapib through Lipid-modification (HPS3/TIMI55-REVEAL) trial which was presented here at the European Society of Cardiology meeting and published simultaneously in…

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