Another Study Finds Medicated Stents Safer Than Older Ones

Drug-coated stent, which is facing questions from heart experts who are doubtful about the device’s long-term safety, has once again proved itself safer than the older, bare-metal stents, a new study by the University of Pittsburgh said, providing relief to millions of chest pain and heart attack sufferers around the world.

A drug-coated or medicated stent is a tiny, expandable mesh-like metal cylinder, coated with medicine that decreases scar formation on the stent, and fits over an uninflated angioplasty balloon. These stents are used to open up a coronary (heart) blood vessel that is narrowed or blocked by plaque build-up (atherosclerosis), and to maintain that opening by permanently placing a metal stent within the heart artery. These metal stents help restore normal blood flow to the heart muscle.

However, for the last few months, the drug-coated stent therapy is facing criticism globally. Some health experts think these wire-mesh tubes may raise the risk of life-threatening blood clots months and even years later unless people stay on Plavix, placing their long-term safety in doubts.

Now, the new study, published in today's New England Journal of Medicine, has found that compared to bare-metal stents, off-label use of medicated stents to open clogged arteries is not associated with increased risk of death or heart attack after one year in patients with complex heart problems.

Off-label use is the practice of prescribing drugs for a purpose not officially approved by the Food and Drug Administration. Nearly half of stents currently placed in heart patients in the United States are used outside the scope of the drug's approved label.

To reach their findings, Oscar C. Marroquin, the lead author of the new study who is also an assistant professor of medicine at the University of Pittsburgh School of Medicine, and colleagues looked at the experiences of 6,551 people who received bare-metal or drug-secreting stents at more than a dozen hospitals in the United States.

Researchers found that after one year, there were no significant differences in the adjusted risk of death or heart attack in patients treated off-label with drug-coated stents compared to those who received bare-metal stents. The researchers found that patients with drug-coated stents had a 94 percent to 96 percent chance of being alive a year after their procedure, which was nearly the same as patients with bare-metal stents.

The researchers also found that the patients who got the drug-coated stents were 37 percent less likely to require a repeat procedure a year later, and even slightly reduced their chances of suffering a heart attack compared with patients who received a bare-metal stent.

"In off-label use . . . there is no mortality increase, and they are more effective than bare-metal stents in sicker, higher-risk patients," Marroquin concluded.

Since they were introduced in 2003, drug-coated stents have grown to dominate the U.S. stent market, which is estimated at more than $5 billion a year. Nearly 6 million patients have received medicated stents since its launch. These newer types of stents with a drug lining already account for 90% of the cardiac stents used in the United States.

Of approximately sixty lakh patients worldwide, estimated 4 million Americans are walking around with the drug stents implanted inside their bodies, while about 1.5 lakh patients using them in India since June 2002. As per the estimates of the Interventional Council of India, 60% of the 65,000 stents implanted in the country last year were drug-coated.

These drug coated stents cost around three times as much as old, bare-metal devices.