It is often said that medicine is both an art and a science. In an imperfect world this is both inevitable and desirable. But it is extremely important that the two should not be confused with each other. In particular, because the “science” side of the equation has achieved overwhelming prestige and authority, it is…
Don’t Confuse the Art and Science of Medicine: PCI vs CABG for Left Main Disease
August 20, 2020 by 1 Comment
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,…
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….
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…
Waiting For ISCHEMIA: Why Won’t Cardiologists Enroll Patients?
November 8, 2015 by Leave a Comment
One of the most important unanswered questions in medicine today– the best treatment for stable ischemic heart disease– may never get a satisfactory answer because cardiologists are unwilling to enter their patients in a clinical trial. One major reason why the question is urgent: about a third of the 1 million PCI procedures performed each year in the…
FDA Grants Premarket Approval To AbioMed Heart Pump
March 24, 2015 by Leave a Comment
The FDA said today that it had approved Abiomed’s Impella 2.5 System. According to the company it is is the first hemodynamic support device to gain FDA premarket approval for use during high risk PCI procedures. The miniature blood pump is designed for temporary use in patients with severe symptomatic coronary artery disease and diminished (but stable) heart…
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. …
Study Raises Questions About Transfusions In PCI Patients
February 25, 2014 by Leave a Comment
A very large observational study raises important questions about the role of transfusions in PCI patients in the US. In a study published in JAMA, researchers from Duke and Yale analyzed data from more than 2.25 million percutaneous coronary intervention (PCI) procedures at more than 1,400 hospitals. The data came from the CathPCI Registry, a large ongoing study…
FDA Advisory Panel Recommends Against Approval Of Cangrelor
February 12, 2014 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee today recommended against the approval of cangrelor, the investigational new antiplatelet drug from the Medicines Company. In a 7-2 vote the panel first rejected an indication for the reduction of thrombotic cardiovascular events including stent thrombosis in patients undergoing PCI. The panel also voted unanimously to reject a second indication… … Click…
FDA Reviewers Deliver Split Opinion On The Medicines Company’s Cangrelor
February 10, 2014 by Leave a Comment
FDA reviewers presented two dramatically different views of The Medicines Company’s investigational new drug cangrelor. One reviewer says the drug should not be approved without a new trial and even states that the CHAMPION trials “were conducted unethically” and should not be approved “on that fact alone.” But two other reviewers recommend approval. … Click here to read…
Both Overuse And Underuse Explain Disparities In Heart Procedures
September 18, 2013 by 1 Comment
A new study finds that groups who have often been found to receive less medical care– non-whites, women, and people without private insurance or who are from urban and rural areas– are less likely to undergo coronary revascularization. But the same study finds that this disparity may be in no small part due to the fact…
Fibrinolysis May Benefit Late-Arriving STEMI Patients
March 10, 2013 by Leave a Comment
Although primary PCI has emerged as the best treatment for STEMI, most patients don’t receive this treatment within the early time frame when it is known to be most beneficial. Delay in presentation is one important factor. Another is that most patients don’t arrive at a PCI-capable hospital and cannot be transferred fast enough to a…
Cangrelor During PCI May Reduce Ischemic Events
March 10, 2013 by Leave a Comment
In the Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) trial, the intravenous platelet inhibitor cangrelor was tested for its effect on ischemic events associated with PCI. Cangrelor is a potent, fast-acting and reversible agent. Results of the trial were presented at the ACC in San Francisco and published simultaneously in…
Are Most People With Complex Coronary Disease Getting The Best Treatment?
February 22, 2013 by 1 Comment
The relative value of PCI (stents) and bypass surgery for the treatment of people with blocked coronary arteries has been a topic of intense interest and debate for more than a generation now. Over time, the less invasive and more patient-friendly (and less scary) PCI has become the more popular procedure, but the surgeons (who…
Are Cardiologists Worried About Being Accused Of Unnecessary PCI?
January 8, 2013 by 3 Comments
In the last week two cases highlighted, yet again, the continuing shift in standards regarding PCI. In his interventional cardiology blog on CardioExchange, Rick Lange asks cardiologists: Could You Be Accused of Doing Unnecessary PCI? “Public confidence is eroding as the number of reports of physician suspensions and monetary penalties for unnecessary PCIs grow. Accordingly, patients…
Ohio Hospital And Cardiology Group Pay $4.4 Million To Settle Charges Over Unnecessary PCIs
January 4, 2013 by 2 Comments
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…
CABG Highly Cost Effective In Diabetics With Multivessel Disease
January 2, 2013 by Leave a Comment
In November the main results of the FREEDOM trial showed that diabetics with multivessel disease do better with CABG than PCI. Now the findings of the trial’s cost-effectiveness study, published online in Circulation, demonstrate that CABG is also highly cost-effective when compared with PCI. Elizabeth Magnuson and colleagues found that although CABG initially cost nearly $9,000 more…
Missouri Board Issues Emergency Suspension Of Cardiologist Accused Of Implanting Unnecessary Stents
January 2, 2013 by Leave a Comment
A Missouri cardiologist who has been accused of unnecessarily implanting stents in six patients has been temporarily barred from seeing patients. The Missouri State Board of Registration for the Healing Arts, which licenses physicians and investigates and disciplines physicians in cases of accused misconduct, issued an emergency suspension of the cardiologist’s license to practice, according to…
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