Results Of Largest Cardiology Study Reflects That In Many Cases, Invasive Procedures Such as Angioplasty, Bypass and Stenting Is Not Really Needed
Findings from a new international study involving 5179 patients at over 320 hospital locations worldwide and involving more than 20 prestigious medical universities are creating a huge buzz in the medical industry especially in the field of cardiology
and the placement of artery-opening stents
: for decades, millions of Americans and millions worldwide have undergone these expensive, invasive procedures to help treat clogged vessels. Its almost a trillion dollar industry by itself with many hospitals racking in huge profits, device suppliers also getting huge cuts, doctors, cardiologists
and heart surgeons becoming filthy rich.
However, the results of a large and long-awaited clinical trial suggest that, in most cases, these procedures may not have provided any benefit over medications and lifestyle changes.
In reality, people treated with meds and healthy changes in lifestyle wound up about as healthy as those who underwent an invasive procedure to open their hardened arteries, researchers reported last week at the American Heart Association (AHA) annual meeting in Philadelphia.
The study showed that only a small subgroup of patients who suffered from frequent angina
appeared to receive any benefit from an invasive procedure, and that benefit was in their quality of life, not in lowering their odds of death or future heart problems.
Dr. Alice Jacobs, director of the Cardiac Catheterization Laboratory and Interventional Cardiology at Boston Medical Center told Thailand Medical
News. "Based on the trial results to date, I as a clinician would feel comfortable advising my patient not to undergo the invasive strategy if their angina
was absent or controlled or it was tolerated." She wasn't involved in the new research.
The study new findings are expected to give physicians more confidence in saying no to invasive treatments, the experts said.
The research did not focus on people who are admitted to a hospital with a heart attack these patients often receive bypass, angioplasty
to quickly open a blocked artery. Instead, the trial focused on patients with stable but severe heart disease.
An example of a typical patient in this group might be a 71-year-old grandmother who has noticed during the past two months some chest heaviness walking from the parking lot to her grandkids' soccer game, the AHA presenters said. Stress testing and imaging scans could reveal some moderately clogged arteries leading to her heart.
The research study was very comprehensive, involving nearly 5,200 patients across 37 countries. Half were randomly assigned to undergo an invasive procedure: About three-quarters underwent angioplasty
(most receiving a stent
as well), while the others had a bypass operation. The other half of patients were treated with medications and lifestyle changes alone.
The medical researchers mainly focused on whether the invasive procedure would reduce a patient's risk of heart-related death,heart attack
, hospitalization with unstable angina, heart failure
or cardiac arrest
On the whole, an invasive strategy "did not demonstrate a reduced risk over a median 3.3 years" compared with the more conservative, drugs/lifestyle therapy, said trial co-chair Dr. Judith Hochman, a cardiologist and senior associate dean of clinical sciences at NYU Langone Health, in New York City.
Invasive procedures did have a positive impact on one small patient subgroup: People who regularly suffer the chest pain and shortness of breath associated with angina
, said co-researcher Dr. John Spertus. He directs health outcomes research at Saint Luke's Mid-America Heart Institute in Kansas City.
Dr. John Spertus told Thailand Medical
News, "For a patient who has weekly angina
, there would be 15% of them who would be expected to be angina
-free with the conservative approach, while 45% would be expected to be angina
-free with the invasive approach. This is such a large difference that you would only have to treat about three patients with weekly angina
for one to be angina
-free at three months."
But, patients who did not
regularly have angina
received only minimal quality-of-life or symptom benefits after undergoing an invasive procedure, Dr Spertus added.
Even more so, a smaller set of trials this time focused on patients with chronic kidney disease revealed even less promising results, researchers said. Patients didn't gain any health benefits and didn't have any improvement in their quality of life after getting an invasive treatment. Angioplasty
might even help put them on dialysis earlier or increase their risk of stroke
, the study found.
Professor Dr. Glenn Levine, from Baylor College of Medicine in Houston, said that when it comes to kidney patients with clogged arteries, he "will treat them with medical drug therapy alone" unless they have marked or uncontrolled angina
Medical experts said the main message from these studies is that doctors shouldn't feel pressured to immediately send patients with clogged arteries into a catheterization lab, especially if they aren't suffering any symptoms. That could free up physicians to focus on getting patients to take their medications, Jacobs said. If drug therapy helps relieve their occasional angina or other symptoms, then angioplasty
might be avoided in two out of every three patients, she estimated.
The research trials were funded by the U.S. National Heart, Lung, and Blood Institute.