Did you really need that coronary stent?

by Carolyn Thomas  ♥ @HeartSisters

A New York study has revisited the issue of stent-happy cardiologists implanting the tiny metal devices that help prop open – or revascularize – blocked coronary arteries. Essentially, this study(1) suggests that two-thirds of the justifications for this procedure in non-emergency patients were either “uncertain” or “inappropriate“. For any heart patient who has ever been told by those with the letters M.D. after their names that this type of cardiac intervention was recommended, it’s yet more troubling news. And the fact that this issue simply will not go away makes me wonder why cardiologists themselves are keeping suspiciously mum about the controversy.

When cardiologists do speak up, not surprisingly, many hasten to pre-emptively defend their interventional colleagues. An editorial that accompanied this study’s publication in the Journal of the American College of Cardiology, for example, explained:

“There are certain to be patients rated as ‘inappropriate’ for which almost all competent cardiologists would recommend intervention.”

In other words, pay no attention to the man behind the curtain. 

Granted, I’m merely a dull-witted heart attack survivor, but to me this confusing explanation seems to suggest that being able to tell whether a blockage in a coronary artery is worrisome or not isn’t dependent on evidence-based treatment guidelines.

In fact, only 36.1% of the balloon angioplasty procedures in this study were identified by investigators as “appropriate” (according to the appropriate use criteria developed by the American College of Cardiology and six other cardiac societies).

In the study, Dr. Edward Hannan and his team analyzed data from 33,970 patients who had undergone balloon angioplasty with a stent implanted (PCI) and 8,168 other patients who had undergone open heart bypass surgery (CABG).

The important difference between this New York study and previous controversial papers is that these patients all had one thing in common: none of them had been diagnosed with Acute Coronary Syndrome, a known precursor to heart attack, defined by Mayo Clinic cardiologists as “a condition brought on by sudden reduced blood flow to the heart”.

In other words, the health conditions of these 42,000+ people were not considered to be urgent emergencies, as they would be in those patients at high risk for having a heart attack.

This may be a critically important distinction.

Researchers are not talking about patients like me who have suffered a heart attack because of a fully occluded coronary artery. The stents we have had implanted are (according to interventional cardiologists who make a living implanting stents) are “necessary” stents, followed by a protocol of prescribed cardiac medications. But as another study published in The Lancet (2)  – among other corroborating studies – have concluded that stents do NOT relieve stable angina symptoms when compared to placebo procedures.

Rather, the patients involved in this New York study are those who may have had a partial blockage in a coronary artery resulting in some type of symptom that brought the patient to a doctor in the first place.

McMaster University’s Dr. Salim Yusuf is one outspoken Canadian cardiologist who has frequently argued that coronary stents are being overused, yet has openly questioned whether interventional cardiologists will actually change  – despite a growing body of compelling research evidence. He told The New York Times:

“We’re going to have a hell of a time putting the genie back in the bottle. It’s a $15-$20 billion industry. You have huge vested interests that are going to push you back.”

The rate of those cardiac procedures has increased 300% over the last decade. About 65% of balloon angioplasties are currently performed as elective procedures on non-emergency patients who have only partial coronary artery lesions.  Some hospitals have in fact become angioplasty factories, as described by Consumer Reports Health in an article called Too Much Angioplasty.

And both patients and their doctors overestimate the benefits of angioplasty procedures, suggests a September 2010 survey of patients and their doctors in Massachusetts. Just 63% of physicians knew that except in urgent emergencies, angioplasties can only address symptoms. And even those who were up-to-date apparently did not necessarily inform their patients: 88% of patients who consented to the procedure mistakenly believed it would reduce their risk of having a heart attack. 

In cardiovascular disease, the care model is arguably built entirely around opening blockages in patients with late disease, which may relieve symptoms but does not prevent heart attack.

Research called the COURAGE study was released in March 2007; it investigated over 2,200 patients who were treated for chronic, stable chest pain, and it revealed that taking anti-clotting blood-thinning medications alone reduced chest pain just about as well as when these drugs were combined with stenting.

Some experts deduce that this surprising outcome is probably due to the fact that stenting fixes only one coronary artery blockage at a time, while drug therapy affects all arteries.

And the landmark research of Germany’s Dr. Rainer Hambrecht found that patients with significant coronary artery blockages actually do better in longterm follow-up studies when they participate in regular exercise programs compared to those having invasive cardiac procedures done  to help revascularize those blocked arteries.(3)

Other research has suggested that the over-stenting problem is not isolated to a few overzealous cardiologists, like the industry poster boy Mark Midei, now relieved of his license to practice medicine in Maryland. He was once famously celebrated with an expensive roast whole pig feast by his stent manufacturing pals at Abbott Labs for implanting a record 31 of their stents in one single day at St. Joseph’s Hospital in Towson.

Clinical guidelines require that a coronary artery must be at least 70% blocked before a stent is appropriate to help open it up (and most cardiologists consider anything less than 50%  blockage to be “insignificant”).

But Midei’s court documents, for example, alleged that some of his patients were told they had coronary blockages in the 90% range, while a subsequent review of their records shows actual blockages closer to 10% or less.

One factor leading to this overuse of angioplasty is that the same doctors who perform the procedure often also act as gatekeepers for a patient’s cardiac care.

For example, patients sign a consent form for balloon angioplasty even before going in for angiography – the initial diagnostic catheterization procedure.  Then, if the angiogram reveals blockages, the interventional cardiologist can recommend immediately clearing them with balloon angioplasty and (usually) implanting a stent while the patient is still on the cath lab table.

Even more troubling, the New York study authors found significant differences in unnecessary angioplasty rates depending on where the hospitals were located geographically throughout the state. Their oh-so-tactful observation about this wide variation among hospitals in the proportion of inappropriate cases:

“There is room for improvement in clinical decision-making for coronary revascularization.”

Yes, I’d say so, too. Meanwhile, here are the main findings of the New York study on the appropriate usage of these cardiac interventions:

PCI (Percutaneous Coronary Intervention = balloon angioplasty + stent)

• Appropriate: 36.1%
• Inappropriate: 14.3% (91% of these had 1- or 2-vessel disease without proximal left anterior descending coronary artery lesions, and little or no medication therapy)
• Uncertain: 49.6%

CABG (Coronary Artery Bypass Graft – open heart surgery)

• Appropriate: 90.0%
• Inappropriate: 1.1%
• Uncertain: 8.6%

But these study results were then muddled by a further final observation that this research was “unable to assess the amount of underuse of revascularization in New York State.”

UNDERuse? Aren’t we talking about OVERuse here?

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Definition of angioplasty =  the technique of mechanically widening a narrowed or obstructed blood vessel.  An empty and collapsed balloon on a guide wire, known as a balloon catheter, is passed into the narrowed location and then inflated to a fixed size, crushing the plaque deposits that caused the blockage, and opening up the blood vessel for improved flow. The balloon is then deflated and withdrawn.  Usually, a stainless steel mesh coronary stent is implanted at the same time to help keep the newly-opened blood vessel stable before the catheter is removed.

See also:

ISCHEMIA study: that blockage isn’t a time bomb in your chest

Physical Exercise vs. the ‘Plumber’s Pipe’ Theory of Heart Disease Treatment

Stent-happy docs on notice in Maryland health care fraud debate

What Prevents Heart Disease “Better Than Any Drug”?

Squishing, Burning and Implanting your Heart Troubles Away

Why Feel Helpless About Your Coronary Artery Disease?

“You Can Lead a Cardiologist to Water, But Apparently You Cannot Make Him Drink” 

Stent-happy Docs on Notice in Maryland Health Care Fraud Debate

Cardiologists Accused of Implanting Cardiac Stents That Weren’t Needed

10 things I didn’t know about angioplasty until I read this book

Cardiologists accused of implanting unnecessary stents

Cardiac society gets half of its funding from stent industry

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Q: Why do you think this overuse of coronary stents has happened?

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1. Edward Hannan. “Appropriateness of Coronary Revascularization for Patients Without Acute Coronary Syndromes.” Journal of the American College of Cardiology, 2012; 59:1870-1876.

2. Slomski A. Stenting Does Not Relieve Stable Angina Symptoms. JAMA. 2017;318(24):2419. doi:10.1001/jama.2017.19023

3.   Hambrecht R, Walther C, Möbius-Winkler S, et al. “Percutaneous coronary angioplasty compared with exercise training in patients with stable coronary artery disease: a randomized trial” – Circulation 2004; 109:1371-1378.

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NEWS UPDATE

On December 17, 2012, cardiologist Dr. Mehmood Patel began a 10-year prison sentence after the U.S. Court of Appeals, 5th Circuit upheld his 2009 conviction and rejected his request to appeal.

As reported by HeartWire, Patel, formerly of Our Lady of Lourdes Hospital and Lafayette General Hospital in Louisiana, was convicted on 51 counts of billing private and government health insurers for unnecessary coronary interventions and tests. During the criminal trial in 2008, the prosecution presented evidence that Patel falsified patient symptoms in medical records and billed more than $3 million over four years, resulting in his net profit of $500,000. His lawyers tried to argue that criminal laws ought not to be applied to a doctor’s judgment.

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