New stents promising, but not everyone will get them

At Good Samaritan Hospital, where 90% of patients have health insurance, nearly every angioplasty patient will get drug-coated stents to prop open newly unclogged arteries.

But down the road at Harbor-UCLA Medical Center, which principally treats poor, minority patients with little or no insurance, only a few will have the benefit of the newly approved metallic devices.

At $3,195, triple the cost of current bare metal versions, the new stents are expected to make angioplasties more effective, reducing invasive cardiac bypass surgery and repeat procedures -- but only for those fortunate enough to get them.

“For the first time ever, we would not be providing the poorer patients, which includes many elderly patients, appropriate care,” says Dr. William J. French, who runs the Harbor-UCLA unit that performs artery-clearing procedures.

Stents are expandable mesh tubes, one-quarter-inch to 1 1/4 inches long, that cardiologists place inside a diseased artery after inflating a tiny balloon to flatten plaque buildup and restore blood flow.

But balloon angioplasty also injures the artery. The body responds by forming scar tissue inside the stent within about a month in 15% to 30% of patients.

On April 24, the Food and Drug Administration approved the first drug-coated stent, which for four to six weeks continuously releases medication that interferes with scar tissue formation.

The Cypher stent, made by Johnson & Johnson’s Cordis Corp., is coated with a polymer that contains sirolimus, a naturally occurring antibiotic also used to prevent rejection of transplanted kidneys. Boston Scientific hopes by year’s end to win FDA approval of its Taxus stent, which works similarly.

In well-designed scientific studies, coated stents more than halved the rate of artery reclogging, called restenosis, and dramatically reduced repeat angioplasties. More than 800,000 Americans undergo angioplasty annually.

But significant obstacles stand in the way of providing them to all who might benefit. It’s not just a matter of whether heath plans will cover drug-coated stents: Medicare agreed to pay extra for procedures using the Cypher six months before FDA approval.

The extra reimbursement still falls below full costs, especially when multiple stents are used, leaving hospitals to absorb the difference. Because it’s important that drug-coated stents deliver medication to entire diseased stretches of arteries, cardiologists likely would need to use more of them than of bare metal stents placed only in the most severely affected areas.

Also, by decreasing patients’ need for open-heart surgeries and repeat angioplasties, coated stents will cut into a major source of hospital revenue that could be funneled into paying for more stents.

Cash-strapped hospitals may reserve the more expensive stents for patients at high risk of reclogging: diabetics, those with blockages in small vessels and those with diffuse plaque.

The day after the FDA decision, Dr. Ray V. Matthews, director of interventional cardiology at Good Samaritan, was placing them in patients. By early this past week, so was Dr. Vicken Aharonian, director of the regional cardiac catheterization lab at Kaiser Permanente Los Angeles Medical Center.

Despite wide speculation that HMOs, with a fixed amount of money to treat each patient, might limit access to coated stents, Aharonian said Kaiser Permanente considered the issue in advance and began offering them without restriction, although the state’s largest HMO will probably review its stance in a couple of months.

Leading cardiology organizations, including the American Heart Assn., haven’t yet issued guidelines for the new stents. In March, the Society for Cardiac Angiography and Interventions published a position statement acknowledging “significant” clinical, economic, legal and policy issues associated with their use. In a member survey that included 252 U.S. cardiologists, 73% were concerned about the legal implications of not using coated stents.

It’s probably too soon for litigation. “But given that so many health plans and hospitals are doing so many this quickly, certainly those who don’t are going to be opening themselves up to claims by patients that they don’t provide them,” said Carol Jimenez, a Los Angeles attorney who advises patient advocacy groups.