A study published in last week’s New England Journal of Medicine is shining a favorable light on the often-controversial off-label use of drug-eluting stents (DES) in certain cardiovascular procedures.

The study, which analyzed 6,500 patients over a one-year period, provides evidence that doctors can safely use DES to open up complicated blockages in coronary arteries, for which the devices weren’t originally designed – and can do a much better job of it than bare-metal stents. It was conducted by the National Heart, Lung and Blood Institute Dynamic Registry.

“It’s the largest analysis to date relating to drug-eluting stents versus bare-metal stents,” Oscar Marroquin, MD, director of the Center for Interventional Cardiology Research at the University of Pittsburgh, who headed the study, told Medical Device Daily.

Marroquin’s study follows hot on the heels of several studies released within the last few months that show support for DES. Boston Scientific (Natick, Massachusetts) and Johnson & Johnson (J&J; New Brunswick, New Jersey) released favorable findings at the 19th annual Transcatheter Cardiovascular Therapeutics (TCT) meeting last fall that supported the safety of DES (Medical Device Daily Oct. 25, 2007).

And the Society for Cardiovascular Angiography and Interventions (SCAI; Washington) even issued an updated report on the Swedish Coronary Angiography and Angiolasty Registry (SCAAR), which now says that longer-term data indicates that the use of DES is safe (MDD Sept. 21, 2007). This contradicts an initial report from SCAAR in late 2006.

According to Marroquin’s study, re-narrowing occurred more often in off-label uses than in approved ones (13% vs. 8%), the drug-secreting stents reducing the rate by about one-third, compared with bare-metal stents, in the year after the device was inserted. It also says that patients who have received a drug-coated stent in an off-label area had about the same chance of dying or having a heart attack as patients who received a bare-metal stent in the same place.

There is a small chance — about 1 in 250 — of a clot forming in a stent and blocking the artery, a complication that can cause a heart attack and even death.

“When we say DES is safe — we mean that we didn’t see an increase in heart attacks or deaths following up to one year of placement,” he said. “We just received funding from the National Institute of Health to observe the patients over a longer time period than a year.”

It’s no secret that the safety of using DES has come into question lately. After a string of reports that linked DES to late stent thrombosis, the reputation of what was once called a novel approach was significantly tarnished. With nearly six million of the devices implanted, the use of DES fell from 80% to 60%.

Even med-tech giant J&J felt the financial impact of the negative DES reports — and ended up cutting 4,820 from its pharma unit and Cordis (Miami Lakes, Florida)subsidiary to salvage its earnings results (MDD, Aug. 1, 2007). Cordis is the maker of the Cypher drug-eluting stent, which was the first such product approved for commercialization in the U.S.

Marroquin doesn’t deny that DES have come under a lot of fire lately. In fact, he said the controversy was the driving force between the research for this study.

Boston Scientific has gotten behind the study in hopes of easing patient and physician concern over the drug-eluting devices. The company’s lead DES is the Taxus.

In a press release, Donald Baim, MD, chief medical and scientific officer of Boston Scientific, said these data are consistent with a series of other large registry analyses comparing drug-eluting and bare-metal stents that have emerged over the last year, and which have reasserted the underlying safety and efficacy of drug-eluting stents. “This series includes the most recent data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), which reversed the findings from the SCAAR group’s earlier analysis suggesting higher mortality with drug-eluting stents,” he said.

Baim added that “The most recent SCAAR data showed no difference in mortality for drug-eluting stents compared to bare-metal stents. In addition, a number of other studies — including the Western Denmark, New York State, Ontario and Massachusetts registries, as well as our own meta-analysis of all published mortality data containing nearly 150,000 patients — have found that drug-eluting stents may actually reduce mortality by more than 20% compared to bare-metal stents, while also significantly reducing the need for repeat procedures to treat restenosis.”