I’m looking at this morning’s news and I’m seeing headlines like these: “Stents Overused in Stable Heart Patients” (WebMD), “Pills as good as stents for stable heart patients” (Reuters), “No Extra Benefits Are Seen in Stents for Coronary Artery Disease” (New York Times), and “Stents no better than pills for some heart patients” (MassDevice) — and I think I have time-traveled half a decade back to March 2007 when the results of the COURAGE study were presented at the American College of Cardiology Annual Meeting. Continue reading
Stents vs. Pills — Summer Re-run in February
Filed under Clinical Trials / Studies, COURAGE, Media Coverage, Stent
Transradial Stent in New Jersey
This is a picture of a patient, Nancy Vitale, who just had a blockage in her very complex, calcified and tortuous right coronary artery opened up with angioplasty and a stent. She is getting up off the cath lab table and walking to recovery, where she’ll be sitting up in a chair. For those readers familiar with angioplasty, you may be wondering why she is not lying flat on her back for four hours or more. The answer is “it’s all in the wrist”. Continue reading
Filed under Patient Experience, Transradial Approach
Stent Pioneer Gary Roubin Leaving Lenox Hill
Gary S. Roubin, MD,
PhD, FSCAI
Interventional cardiology pioneer, Dr. Gary Roubin, is leaving Lenox Hill Heart & Vascular Institute in New York, where he has served as chair of Interventional Cardiac & Vascular Services for almost a decade.
Dr. Roubin confirmed his departure to Angioplasty.Org and stated that he is “moving on to bigger and more challenging projects.” Dr. Roubin’s departure was first reported yesterday by Shelley Wood of theheart.org.
Roubin told me that he feels he has “much more to contribute to the field of cardiovascular medicine”, although looking through his list of accomplishments, one might think that difficult to top because so many of those accomplishments start with the word “First“, as in: First abstract on balloon angioplasty in multivessel disease (with Andreas Gruentzig, inventor of the procedure); First balloon expandable coronary stent; First carotid bifurcation stent; First intracranial stent. Continue reading
Filed under History, Innovators, Video
FAME II is Not the “Anti-COURAGE”: Stents and Angioplasty in the Spotlight
There’s been much talk this week in the interventional cardiology community (and among stock market analysts) about stents and angioplasty, given the news that the FAME II clinical trial ended enrollment early, due to ethical concerns that were generated by the fact that patients randomized to Optimal Medical Therapy (OMT) alone were returning to the hospital in significant numbers for “urgent revascularization”, i.e. stenting!
So is this, as several analysts have suggested, a reversal of the COURAGE trial results? Not according to the principal investigators of both the FAME II trial AND the COURAGE trial, whom I have spoken with in the past 48 hours. Continue reading
Filed under Clinical Trials / Studies, COURAGE, FAME I / FAME II, FFR
Does FAME II Trump COURAGE? FFR: Key to Stents and Angioplasty
Positive news today from St. Jude Medical (NYSE:STJ) about FFR as a clinical decision-making tool. The company announced that it is stopping enrollment in its FAME II trial after only 2/3 of the planned patients were included. Why? Because the interim data so clearly favor the use of Fractional Flow Reserve (FFR) to guide stenting (PCI) in stable angina patients that the independent Data Safety Monitoring Board (DSMB) for the trial has concluded that it would be unethical to continue to randomize patients to optimal medical therapy (OMT) alone. Turns out that patients receiving OMT only experienced a highly statistically significant increased risk of hospital readmission and urgent revascularization.
Wait a minute! Did they say that using optimal medical therapy alone was unethical for the treatment of stable angina patients? That’s pretty big news! Continue reading
Filed under COURAGE, FAME I / FAME II, FFR, Stent
AAA Stent Graft Revisited
Last year at this time, I wrote about a patient who had been posting in our Patient Forum. He had received a stent graft to treat an abdominal aortic aneurysm (AAA) and wanted to share his story, and also wanted to find other AAA patients. This type of aneurysm was previously only treatable via open surgery. But with advances in device technology, patients were able to receive a AAA stent graft percutaneously, through a catheter in the femoral artery (groin/leg) much like standard angioplasty. Continue reading
Boston Scientific’s New Drug-Eluting Stent in the News Again
Which stent platform do you think compresses more easily: Boston Scientific’s Element (top) or Medtronic’s Integrity (bottom)?
I first heard concerns about stent deformation, primarily seen in the PROMUS Element stent made by Boston Scientific (NYSE: BSX), during a presentation at a small interventional meeting last summer. The issue was then reported in two journal articles, just prior to the TCT meeting in November, where it became a topic of much attention — although most interventional cardiologists felt that it was nothing like the problem of late stent thrombosis, first seen as a “rare” event in the first generation of drug-eluting stents five years ago. Continue reading
RSS Feed
