New data presented at EuroPCR from the much debated ORBITA trial may provide some modest temporary lessening of the pain felt by interventional cardiologists in response to the initial negative ORBITA findings. But the pain relief is likely to be only temporary, and might even be fairly compared to a placebo effect, since the major…
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New ORBITA Findings May Offer Modest Symptomatic Pain Relief To Interventional Cardiologists
May 22, 2018 by 5 Comments
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…
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…
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….
CABANA: No Outcomes Benefit In First Big Trial Of AF Ablation
May 10, 2018 by 5 Comments
(Updated) Catheter ablation for atrial fibrillation (AF) produced no significant improvement in clinical outcomes in a large and important new clinical trial. CABANA is the first and long anticipated randomized controlled trial of AF ablation in the more than two decade long history of the procedure. The results will likely spark an intense controversy in…
More Controversy Over Major Cardiology Clinical Trial
March 30, 2018 by 7 Comments
Think about this: A new article reports that a major NIH-funded trial runs into trouble. The article raises all sorts of fundamental questions about our ability to perform meaningful clinical research. But instead of expressing concern about these legitimate problems, medical leaders ignore these questions and instead focus their ire and criticism on the article authors,…
Cardiology World Erupts Into Controversy Over Change In Major Clinical Trial
March 18, 2018 by 4 Comments
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…
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…
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…
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….
What If PCI Is Just A Sham?
September 18, 2017 by 3 Comments
–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…
Labscam: Rogue Laboratory Testing At Center Of Addiction Treatment Scandal
July 3, 2017 by 1 Comment
–‘Sober homes’ in Florida are just the tip of the iceberg. A massive scandal involving fraudulent addiction treatment centers and rogue laboratories has recently surfaced. Several recent news reports have focused on the scandal’s epicenter in Florida, but industry observers say that the scandal is the tip of an iceberg of corruption, abuse, and fraud…
FDA Approves First New Atherectomy Device In 20 Years
October 22, 2013 by Leave a Comment
The FDA today granted PMA approval to the Diamondback 360 Coronary Orbital Atherectomy System (OAS) for the treatment of severely calcified coronary arteries. Cardiovascular Systems, the manufacturer of the device, said that the OAS was the first new coronary atherectomy system to receive FDA approval in 2 decades. The company said it would begin a controlled launch of the…
Twice a Stent Pioneer, J&J Abandons the Stent Market
June 15, 2011 by Leave a Comment
Johnson & Johnson, the company which pioneered the original stent market in the 1990s and the drug-eluting stent market in the 2000s, is abandoning the stent market. On both occasions the company completely revolutionized the field of interventional cardiology, and on both occasions the company spectacularly lost its leading position and failed to build a…
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