Everyone knows that cannibalism was practiced widely in pre-Colombian Mexico. Go online and you will quickly learn that 15,000 to 20,000 Aztecs were sacrificed each year. This “fact” colors our view of that civilization, and makes it a bit easier to give a pass to the conquistadors who, for all their own rapacity, brought “civilization”…
New ORBITA Findings May Offer Modest Symptomatic Pain Relief To Interventional Cardiologists
May 22, 2018 by 5 Comments
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…
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…
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…
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….
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…
Julio Palmaz Really Doesn’t Want You To Read This Story
September 11, 2017 by 8 Comments
—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…
Abbott Pulls Troubled Absorb Stent From European Market
April 6, 2017 by Leave a Comment
(Updated) Abbott Laboratories has sent a letter to European physicians informing them that the Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS “will only be available for use in clinical registry setting at select sites/institutions.” The company’s action comes in response to an avalanche of bad news for the controversial device. Last fall 3-year results from…
The Impact Of ABSORB II: Down The Slippery Slope
November 2, 2016 by 2 Comments
When it was approved earlier this year in July the Absorb (Abbott) bioresorbable stent provoked a fair amount of discussion about the “slippery slope of noninferiority.” Although the stent met the FDA criteria for approval, the available trial results went in the wrong direction and there was a particularly concerning warning sign of a higher…
Interventional Cardiology And The Rejection Of Science
July 22, 2016 by 6 Comments
–Prominent interventional cardiologist says clinical trials are slowing progress In their eagerness to embrace a glorious future of ever more spectacular technology-based advances, interventional cardiology— a subspecialty never exactly known for caution, patience, or self reflection— is poised to reject science, evidence-based medicine, and randomized controlled trials. “Generating and publishing evidence is a tedious job,”…
Reality Check On The ‘Noninferior’ Abbott Bioresorbable Stent
July 12, 2016 by Leave a Comment
–The slippery slope of noninferiority. Last week the big news in interventional cardiology was the approval of Abbott’s bioresorbable stent, Absorb. There’s no doubt that this represents a remarkable technical achievement, propping open a clogged artery and then gradually disappearing. There are all sorts of theoretical reasons why this might represent an important advance over traditional stents that…
Stent Pioneer’s Company In Bankruptcy And Under Investigation
April 25, 2016 by Leave a Comment
–Julio Palmaz hasn’t been able to recreate his earlier success A company founded by stent pioneer Julio Palmaz has declared bankruptcy and is being investigated for misconduct, according to the San Antonio Express-News. Palmaz, along with Richard Schatz, was the inventor of the enormously successful Palmaz-Schatz stent marketed by Johnson & Johnson. In March Palmaz…
Vulnerable Plaque: The Paradigm That Failed
February 24, 2016 by 4 Comments
Is it a hallowed paradigm or a hype-othesis? The “holy grail” of cardiology is to stop heart attacks before they happen by identifying– quickly, noninvasively, and specifically– those coronary artery lesions that result in heart attacks. The key theoretical underpinning driving this goal has been the vulnerable plaque hypothesis, which holds that the vast majority…
FDA Approves New Noninvasive FFR Technology
November 26, 2014 by Leave a Comment
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. …
Big Study Looks At Length of Drug Treatment After Stent Implantation
November 16, 2014 by Leave a Comment
The advent of drug-eluting stents dramatically reduced the restenosis (reclogging) rate associated with bare-metal stents but prompted new concerns about the rare but potentially lethal complication of stent thrombosis (ST). Cardiologists have relied upon dual antiplatelet therapy to prevent ST but there has been considerable uncertainty and controversy about the ideal duration of therapy. The…
Cardiology Group Withdraws ‘Choosing Wisely’ Recommendation
September 22, 2014 by Leave a Comment
In the end it wasn’t wisdom for the ages. The American College of Cardiology said today that it was withdrawing one of its five recommendations in the “Choosing Wisely” campaign. In 2012 the ACC recommended that heart attack patients should have only their culprit artery unblocked. It said that patients and caregivers should question whether complete revascularization of all…
Fractional Flow Reserve Gains Support in Stable CAD and NSTEMI
September 2, 2014 by Leave a Comment
In recent years interventional cardiologists have started to use a new catheter technique, called fractional flow reserve (FFR), in an attempt to assess which blocked vessels might benefit from a stent. Two studies presented at the European Society of Cardiology meeting in Barcelona offered new support for FFR, which has been slowly but surely gaining traction in the…
Study Offers Reassurance About Newer Drug-Eluting Stents
July 1, 2014 by Leave a Comment
Drug-eluting stents (DES) have been viewed as a great advance over earlier stents and balloon angioplasty because they result in many fewer cases of restenosis. But enthusiasm for the first generation of DES was somewhat curbed due to reports of late stent thrombosis (ST), a rare but very dangerous complication. Now findings from a large ongoing…
Prescription Delay Following Stent Implantation Is a Common and Deadly Problem
May 28, 2014 by Leave a Comment
After receiving a stent, many patients delay or fail to fill their prescription for clopidogrel or another antiplatelet agent. Now, a study published in the Journal of the American Heart Association offers evidence that this problem is widespread and often leads to serious consequences. Researchers analyzed data from all stent implantations performed in British Columbia from 2004 through…
New Study Lends Support For Alternative Heart Attack Treatment Strategy
April 22, 2014 by 2 Comments
It is generally agreed that the best treatment for heart attack patients is to immediately reperfuse the blocked artery with a stent. But many people live in areas where this strategy, known as primary PCI, is not available within the time frame when it produces the greatest benefit. Previous studies have found good short term…
Stents Lose In Comparisons With Surgery And Medical Therapy
December 3, 2013 by Leave a Comment
Despite the enormous increase in the use of stents in recent decades, there is little or no good evidence comparing their use to the alternatives of CABG surgery or optimal medical therapy in patients also eligible for these strategies. Now two new meta-analyses published in JAMA Internal Medicine provide new evidence that the alternatives to PCI remain attractive…
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