Angioplasty's Golden Era May Be Fading

March 27, 2008— -- WASHINGTON -- One day last week, three doctors here reached inside a man's leaky heart and plugged a hole that threatened his life.

They did it without slicing open his chest or splitting his breastbone. They did it without touching him much at all.

The 87-year-old patient was too frail to risk open-heart surgery. Instead, they slipped a patch on the tip of a wire through a labyrinth of blood vessels into his heart.

"Very nice. Good job," exclaimed Zuyue Wang, an echocardiographer at Washington Hospital Center as a cardiologist maneuvered the device into place and it blossomed into view on the 3-D ultrasound monitor.

The approach the doctors used is derived from one of the most common procedures in medicine, coronary angioplasty, which is performed 650,000 to 1 million times a year in the USA alone.

But for the first time, independent analyses performed at the request of USA TODAY suggest the meteoric rise of angioplasty during the past three decades has ended.

"The rise of angioplasty procedures has leveled off and appears to be on the decline," says Duke University's Eric Peterson, who reviewed results of the analysis by the National Cardiovascular Data Registry.

Three major studies published in the past two years indicate that using the procedure to open blocked arteries to treat chest pain, or angina, may be riskier and no more beneficial than medication.

The research suggests angioplasty is used too often, and in many cases, the modest benefits don't justify the procedure's cost, which ranges from $10,000 to $12,000. The topic will be debated at the annual scientific session of the American College of Cardiology starting this weekend in Chicago.

The data registry analysis was one of two carried out at the request of USA TODAY. The second was performed by the Santa Fe-based market analysis firm Qforma, using data from the health care information company IMS Health.

The analyses found:

• The number of angioplasty procedures performed each year appears to have declined by 10 percent to 15 percent over the past two years, according to the data registry analysis that examined information from 337 hospitals.

• The use of angioplasty and stents -- mesh cylinders that prop open clogged arteries -- began dropping in June 2006, when results of two landmark studies that cast doubt on the procedure began filtering into the medical community before they were published, the Qforma analysis shows.

• Both analyses note a distinct shift in practice patterns. Doctors increasingly are choosing older, bare-metal stents rather than newer drug-coated versions that have been linked to lethal blood clots.

The USA TODAY analyses offer a first glimpse at the patterns emerging after these landmark studies. The decrease is not the final word, because doctors were unable to control other factors that might be involved, such as better heart-attack prevention or fewer repeat angioplasties because drug-coated stents effectively keep arteries from shutting again.

The Rise of Angioplasty

In its simplest form, angioplasty involves guiding a tiny balloon to a blocked artery supplying the heart. Inflating the balloon clears the blockage and restores blood flow. The tubes and wires used in angioplasty also allow doctors to turn arteries into so-called therapeutic highways to fix other defects, such as the hole in the man's heart.

Angioplasty is so effective for clearing blocked arteries during a heart attack that doctors have launched a nationwide campaign to make it available within 90 minutes after a patient reaches the emergency room.

Although angioplasty won't prevent a heart attack or prolong a person's life, it is widely used to treat the crushing, often debilitating chest pain that signals an oxygen-starved heart.

The procedure, introduced in 1977 by German radiologist Andreas Gruentzig, has grown into an $8-billion-a-year industry in the USA alone, says William Weintraub of Christiana Care Health System of Newark, Del. But the popular procedure has been battered by bad news over the past two years.

One study, called BASKET-LATE, released at an American College of Cardiology meeting in March 2006, found drug-coated stents can cause potentially lethal blood clots a year or more after the procedure.

When results from the same study were released that September at the European Society of Cardiology meeting, they made headlines around the world.

Doctors have since changed their guidelines for the procedure, recommending that patients who have drug-coated stents take the anti-clotting drug Plavix for a year or more.

Two other studies, called OAT and COURAGE, show that "optimal" therapy with cholesterol-lowering statins, blood pressure medication and other potent heart drugs is just as good at preventing heart attacks and death as angioplasty if patients follow what their doctors say.

OAT involved 2,166 patients who hadn't received angioplasty quickly enough to avert damage from a heart attack. Before the 2006 study, many doctors would have recommended angioplasty anyway on the theory that patients would benefit. In OAT, doctors tested that theory with stunning results.

Half of the patients in the study were given angioplasty and medical therapy; half were given drugs alone. Over the next four years, more than 17 percent of angioplasty patients died, had another heart attack or developed heart failure, compared with 15 percent of patients on the best available medicines.

Many doctors were so convinced of the benefits of angioplasty for blocked coronary arteries, OAT researchers encountered resistance from major medical centers that declined to take part in the trial because their cardiologists routinely perform angioplasty, says Judith Hochman, chief of clinical cardiology at New York University, the study's lead investigator.

COURAGE involved 2,287 patients from a much bigger group -- thousands of people with chronic, stable chest pain, or angina. The study found that over five years, the rates of heart attacks and deaths were 19 percent in the angioplasty group; 18.5 percent in the drug group.

The death rate was about 8 percent in both groups. Although angioplasty relieved angina symptoms more quickly, that advantage vanished within three years, researchers say.

The study's release provoked a backlash among cardiologists who perform angioplasty, many of whom challenge the results.

Hearts suffer from an inadequate supply of blood, says Bonnie Weiner, president of the Society for Coronary Angiography and Interventions. "(Angioplasty) is very effective at achieving more blood flow to the heart."

Weiner says some advocates of medical therapy are deliberately trying to tip the scales against angioplasty.

"It was clear to us that there was spin going on even before the COURAGE results were released last year. We're trying to get a balanced interpretation of the data out," she says.

George Diamond, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, defends the trial. It demonstrated that angioplasty improved the quality of life and symptoms, he says, but the benefit didn't last more than three years.

In the first year, he says, 58 percent of angioplasty patients reported that clearing their arteries relieved their chest pain, compared with 50 percent who took only drugs, a difference of 8 percentage points. "And yet an entire medical industry is based on those small, rather marginal differences," he says.

The furor prompted the ACC, the angioplasty group and the Society of Thoracic Surgeons to draft criteria to be released this summer to help doctors decide when angioplasty is appropriate, says Ralph Brindis, a scientific adviser for Northern California Kaiser Permanente, who helped lead the effort.

Studies Put the Word Out

"I personally wasn't surprised by the results," says Michael Rich, a cardiologist at Washington University School of Medicine in St. Louis who will debate the study at the heart meeting.

"Angioplasty isn't going to make you live any longer. It won't decrease the risk of a heart attack. But it will decrease the likelihood of your having symptoms," Rich says.

The analyses conducted for the newspaper also reflect what may be the beginning of a broader change in medicine: a move toward "evidence-based" care drawing on reams of data from medical research and patient treatment.

The time it once took for the findings of medical studies to reach a patient's bedside also has shrunk, Qforma CEO Kelly Myers says.

That shift is evident not only in angioplasty procedures but also in other measures of how doctors practice medicine, such as which type of stent they chose.

QForma's analysis, Myers says, shows that sales of drug-coated stents, which conquered the market after they were introduced in 2003, dropped quickly in the fall of 2006, when news broke that they can promote clots. Bare-metal stent sales, which had been stagnant, began to rise.

Peterson says the analysis agrees with data to be presented at the heart meeting showing that in the past year alone, the use of drug-coated stents fell from a high of 90 percent of those used in angioplasty procedures to about half. Roughly a third of the stents now in use are bare metal, up from 10 percent in early 2006.

Effectiveness of Drugs Alone

Two other major studies released in 2004 had an effect on angioplasty's fortunes, though the link wasn't obvious at the time.

The studies, called REVERSAL and PROVE-IT, pitted a more aggressive cholesterol-lowering regimen against a weaker one. Both made worldwide headlines by showing that pushing bad cholesterol to below recommended levels could put heart disease on hold.

The success of aggressive treatment with statins meant doctors could treat cholesterol buildup throughout the network of arteries that supply the heart, while angioplasty can treat only two or three blockages. They may not be the type of plaques that are likely to burst and cause a heart attack.

But many studies have shown that patients are notoriously lax about following doctors' orders.

"COURAGE proved that optimal medical therapy is not an academic vision," says Diamond, of Cedars-Sinai. "It is a reality. It can be delivered to patients in the real world."