As a major clinical trial in cardiology nears completion it has provoked a storm of criticism and controversy. The brouhaha erupted in response to a late change to one of the most important— and already controversial— trials in cardiovascular medicine. The NIH-funded ISCHEMIA trial was designed back in 2011 to provide a definitive answer to…
Cardiology World Erupts Into Controversy Over Change In Major Clinical Trial
March 18, 2018 by 4 Comments
The ODYSSEY Trial Ends Well— But Will It Be Enough?
March 10, 2018 by 8 Comments
Sanofi and Regeneron achieved a modest victory with the much anticipated ODYSSEY Outcomes trial of its cholesterol lowering drug Praluent (alirocumab). The trial met its primary endpoint and even reported a significant improvement in all-cause mortality. But the mortality finding has an asterisk attached to it and it is far from clear whether the overall…
Esperion Releases Top Line Results For First Pivotal Phase 3 Study
March 7, 2018 by 4 Comments
Esperion announced positive results today for the first in a series of pivotal phase 3 studies of its cholesterol lowering drug. The trial (Study 4, or 1002-048) compared bempedoic acid to placebo in 269 patients with atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD who have high LDL cholesterol levels (100 mg/dl or greater)…
Device Companies Fund Courses For Doctors In Training
February 27, 2018 by 1 Comment
At a crucial early stage of their careers young interventional cardiologists attend brief training courses that are considered essential for their careers. It is not generally appreciated that large device and drug companies provide the money that enable these young doctors to attend these meetings. The money from industry covers the cost of travel, hotel, meals,…
Low-Carb And Low-Fat Diets Battle To A Draw
February 20, 2018 by 7 Comments
A new study comparing a low-carbohydrate diet with a low-fat diet found no important differences in weight loss or other important outcomes between the two diets. Some experts believe the result shows that the debate over the relative worth of these different diets has been overblown and confirms the view that calories count. Others say…
Moment Of Truth For Struggling And Expensive Cholesterol Drugs
February 15, 2018 by 7 Comments
It will be the moment of truth for the expensive new cholesterol drugs known as PCSK9 inhibitors. Next month we will learn much more about the PCSK9 inhibitor class of cholesterol drugs. A lot of the remaining uncertainty about the efficacy— or lack of efficacy— of these drugs will be resolved when a large cardiovascular…
The Hypertension Guideline War Is Not A Fake War
February 11, 2018 by 14 Comments
The war over the new blood pressure guideline is not a fake war or a childish dispute. It is a real war over genuine differences in how we should think about health and disease and prevention. The publication last November of the new US blood pressure guideline sparked a vigorous and important debate. A central part…
Statin Critic Accused Of Image Manipulation In Earlier Research
February 8, 2018 by 7 Comments
A journalist who has been a frequent critic of statins has been publicly accused of scientific misconduct involving image manipulation in an earlier research paper. Maryanne Demasi is an Australian journalist who has a PhD in Rheumatology from the Royal Adelaide Hospital in South Australia. She has been a frequent critic of statins, a proponent of…
More Mini-Trials And Fewer Mega-Trials?
January 2, 2018 by 5 Comments
Just as dinosaurs ruled the earth for millions of years, for more than 30 years now cardiology has been ruled by mega-trials. Over the years the cardiology landscape would shake and tremble as ever more gigantic mega-trials emerged to dominate the field. Just as the giant dinosaurs paid no attention to the seemingly inconsequential little…
Nuance And The Healthcare Apocalypse
December 21, 2017 by 5 Comments
(Updated) If you actually have a life you may not be aware that there’s been a fierce debate on Twitter and the blogosphere over Lisa Rosenbaum’s NEJM article decrying the oversimplification and self-righteousness of the “less is more crusade.” In response to fierce criticism, from myself, the Lown Institute, and others, Saurabh Jha praised and defended Rosenbaum for embracing nuance…
Ms. Inappropriate Defends The Status Quo
December 18, 2017 by 11 Comments
I think I would have liked the younger Lisa Rosenbaum, the cardiologist who last week in the New England Journal of Medicine launched a missile at the “less is more” movement. Here’s how her piece begins: They called me Ms. Appropriate. When I was a cardiology fellow, health care costs were skyrocketing, and I considered devoting…
Will ORBITA Change Clinical Practice? The Role of Perverse Economic Incentives
December 11, 2017 by 2 Comments
Editor’s note: In this guest post Sanjay Kaul (Cedars-Sinai) explains why it is unlikely that the ORBITA trial will have a big impact on clinical practice. Guest Post: Will ORBITA Change Clinical Practice? The Role of Perverse Economic Incentives. by Sanjay Kaul, MD (Cedars-Sinai Medical Center) Shortly after celebrating the 40th anniversary of PCI, first…
In Defense Of ORBITA
December 10, 2017 by 4 Comments
–The trial investigators respond to their numerous critics. If you’ve been reading about ORBITA then you probably know that the first ever placebo-controlled trial of PCI was interesting and provocative. But you’ve also probably heard that the trial was too small, too short and performed in patients who should not have been studied. Simultaneously, you…
After Slow Start Entresto Is Poised For Takeoff
December 5, 2017 by 1 Comment
–Novartis sees open road to blockbuster status for heart failure drug After a slow start, the novel heart failure drug Entresto (valsartan/sacubitril) is now poised to become a blockbuster, if drugmaker Novartis’s projections are on target. The combination pill will record sales of about $500 million in 2017 and may eventually achieve $5 billion in…
Why was ORBITA MIA at the AHA?
November 22, 2017 by 1 Comment
By offering a last minute 2-for-1 deal shortly before its annual meeting in Anaheim the American Heart Association signalled its desperation. During the meeting, as the tumbleweed rolled down the lonely halls of the Anaheim Convention Center, the reason for the deal was apparent to everyone. The lack of crowds, the low energy, the paucity…
The Survey Says: BP Measurement In SPRINT Was All Over The Place
November 14, 2017 by 1 Comment
–BP measurement question limits the trial’s ability to inform clinical practice. A long-promised report from the SPRINT investigators offers important new information about how blood pressure was monitored in the trial. The report is unlikely to satisfy critics or resolve the larger controversy of how the trial should be interpreted. At the American Heart Association…
AHA President Suffers A Heart Attack Monday Morning
November 13, 2017 by 18 Comments
–The AHA reports that he received a stent and is doing well. The president of the American Heart Association, John Warner, had a “mild heart attack” on Monday morning, according to the AHA. Warner received a stent at an undisclosed hospital. The AHA said he is “doing well.” Warner is 52. The attack occurred while…
New Blood Pressure Guideline Sets Lower 130/80 Threshold
November 13, 2017 by 11 Comments
Expanded guideline means more than 100 million people have high blood pressure. The new US blood pressure guideline lowers the definition of high blood pressure to 130/80 mm Hg. This means that more than 100 million adults will now have high blood pressure, though many will be unaware of the diagnosis. The 192 page guideline…
CANTOS Substudy Shows Major Role For Inflammation
November 13, 2017 by 1 Comment
–Large reductions in hsCRP appeared to foretell improved outcomes. ANAHEIM — An important CANTOS trial substudy bolsters evidence that inflammation plays an independent role in cardiovascular disease (CVD) and may point toward a new targeted approach to treatment of CVD and perhaps even more profoundly impact cancer treatment. The report, presented by Paul Ridker (Brigham…
ORBITA Trial Puts Interventional Cardiologists On The Defensive
November 8, 2017 by 6 Comments
(Updated) Since it’s debut a week ago the ORBITA trial has provoked the most furious debate in cardiology since the COURAGE trial a decade earlier. But the ORBITA debate has proceeded far faster, fuelled by Twitter and its ability to instantaneously deliver point and counterpoint. Although ORBITA has been showered with praise for its innovative…
The Story Behind The NY Times ORBITA Anecdote
November 3, 2017 by 7 Comments
–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…
Diving Deep Into The ORBITA Trial
November 2, 2017 by 3 Comments
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….
Small Trial Raises Big Concerns That PCI In Stable Angina Is Just A Placebo
November 2, 2017 by 5 Comments
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….
Guest Post: Future Cardiologists Lack Vision
October 24, 2017 by 2 Comments
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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