Heart surgery’s benefits questioned
$100M study: Stents, bypass are no more effective than drugs for clogged arteries
A major federally funded study shows stents, bypass surgeries are no more effective than drugs for clogged arteries.
Some of the most common invasive heart procedures in America are no better at preventing heart attacks and death in patients with stable heart disease than pills and lifestyle improvements alone, according to a massive federally funded study designed to resolve a long-standing controversy in cardiology.
Researchers found that invasive procedures to unclog blocked arteries — in most cases, the insertion of a stent, a tiny mesh tube that props open a blood vessel after artery-clearing angioplasty — were measurably better than pills at reducing patients’ chest pain during exercise. But the study, called ISCHEMIA, found no difference in a constellation of major heart-disease outcomes, including cardiac death, heart attacks, heartrelated hospitalizations and resuscitation after cardiac arrest.
Overall, the keenly anticipated ISCHEMIA study results suggest that invasive procedures, stents and bypass surgery, should be used more sparingly in patients with stable heart disease and the decision to use them should be less rushed, experts said.
The $100 million trial, presented Saturday at the annual meeting of the American Heart Association ahead of publication in a peer-reviewed journal, is the latest entry into a long and contentious argument over how to treat artery blockages, one that has pitted powerful factions of American heart specialists against each other. It echoes a similar study 12 years ago that was heavily disputed by interventional cardiologists, the doctors performing the invasive procedures.
“This is a milestone study that people will talk about and write about for years to come,” said Elliott Antman, a cardiologist at Brigham and Women’s Hospital who was not involved in the study and praised it for the wealth of information gathered and the rigor and sophistication of the analyses.
The ability to implant stents using a catheter inserted through blood vessels in the arm or groin has transformed cardiology over the past three decades. Stents have been clearly demonstrated to save lives in people who are suffering from a heart attack.
But as heart medicines such as statins have improved, there has been active debate about whether stents and other invasive procedures are more effective for people who aren’t in the throes of a heart attack, but have stable heart disease — generally defined as having clogged arteries, sometimes accompanied by chest pain, or angina, when they exert themselves.
A major study more than a decade ago found stents didn’t work better than drugs, but it triggered criticism, and proper use of stents has become one of the most heated debates in medicine — in part because so much is at stake. Coronary heart disease affects 17.6 million Americans; companies that make stents are multibillion-dollar enterprises; the procedures are a major income stream to interventional cardiologists and hospitals; and many people who have stents credit their good health to the procedure.
The new study was designed to finally settle the question of whether stents are better for patients with stable heart disease — and it could change how tens of thousands of people are treated in hospitals, transform how cardiologists talk with patients about their options, and save hundreds of millions of dollars in health-care spending each year.
But the debate over the trial’s results began before it even finished. Critics compared a change to the trial’s design to moving the goal posts midway through and worried that it would make the results of the trial hard to interpret.
The leaders of the trial fired back that the change was part of the original trial design.
Now, the debate can begin about the evidence. More than 5,000 patients with moderate to severe stable heart disease from 320 sites in 37 countries were randomly assigned after a stress test indicated heart disease. Half received medical therapy and lifestyle counseling alone, and the other half received stents or bypass surgery plus medicine. Patients were followed, on average, for four years. There was no difference in the two groups’ experience of a composite of five disease-related events, including cardiac death, heart attack, hospitalizations for heart failure and unstable angina, and resuscitation after a cardiac event.
The new study, Antman said, will give patients and doctors a solid framework to discuss the benefits and risks. For example, an elderly patient with stable heart disease who isn’t very active but suffers some chest pain may decide on drug therapy. A younger patient who has more frequent chest pain that impedes active daily life could try medical therapy, and opt for a more invasive strategy if their lifestyle is still limited.
“We want patients to understand that it’s OK to pause and it’s not urgent that they have a procedure,” said David Maron, director of preventive cardiology at Stanford University, one of the study’s leaders. “It’s important for physicians to understand how symptomatic a patient is — and what is it worth to the patient to go ahead and have a procedure.”
The study presented Saturday suggests that invasive procedures should be used more sparingly in those with heart disease.