What will it take to make open-heart bypass surgery obsolete? Since the late seventies, balloon angioplasty and new drugs have been chipping away at the number of cardiac patients who require the chest-splitting intervention. In the past decade, stents represented another quantum leap. Inserted via catheter through a small incision in the leg, the tubular metallic devices work like miniature scaffolding to keep blocked arteries open. But close to a fifth of the devices fail because of restenosis, or arterial scarring, brought on by the body’s tendency to reject foreign objects.
Then came Jeffrey Moses and the drug-coated stent. Approved by the FDA last year, the novel stent, sprayed with an immunosuppressant called sirolimus, blunts the body’s rejection response and prevents scar tissue from forming. As a result, the stent failure rate has plummeted, and patients require fewer follow-up procedures and live healthier, more active lives.
“The remarkable thing has been that the outcomes are even better in the real world than in the clinical trials,” says Moses, Lenox Hill Hospital’s chief of interventional cardiology. Moses was a lead investigator on a large 2002 clinical trial, the first in the U.S., which demonstrated the enormous potential of the new stents. (He tested Johnson & Johnson’s Cypher stents; new brands are also coming to market.) Restenosis was reduced by 75 percent, and only 4 percent of patients required follow-up procedures to reopen their vessels, compared with 17 percent of the controls. Since FDA approval, Cypher stents have found their way into more than half a million patients. They now go into 95 percent of Lenox Hill’s stent patients and close to 70 percent nationwide. Edward Dobrovolski, a 56-year-old lawyer from Fair Haven, New Jersey, has received four drug-coated stents. Before Moses inserted the devices, Dobrovolski had trouble even getting out of bed and often had to lie down in the middle of the workday. Now, he says, “I feel like I’m 900 percent better. I still have to lose some weight, but other than that, I’m great.”
Nationally, the failure rate for drug-coated stents is approaching 5 percent—the rate for repeat bypass procedures is 3 percent.
“We’re finally zeroing in on making this technology as durable as bypass,” says Moses. “We have faith that after a quarter of a century of frustration, this looks like the solution.”