By Alex Ginsberg
Long Island Jewish Medical Center in New Hyde Park and New York Hospital Queens in Flushing are the only two hospitals in the borough to offer a newly approved device that doctors say can significantly reduce the likelihood that a patient will have to return for a second angioplasty.
“In realistic terms, it represents a 50 percent reduction in the number of patients who will need another procedure within three to six months,” Dr. Barry Kaplan, LIJ’s director of interventional cardiology, said in an interview.
Kaplan was among the first doctors in New York City to use the new drug-coated stents outside of clinical trials, having inserted one into a patient’s coronary artery at 9:20 a.m. Friday, one day after the Food and Drug Administration approved the devices.
Metal stents are inserted during angioplasty procedures to keep blocked arteries open so blood can flow through them freely. But for patients who receive standard uncoated stents — still the state of the art until Friday — there is a 15 to 20 percent chance of restenosis, a subsequent clogging of the artery due to growth of scar tissue.
According to Kaplan, the new Cypher stents, which are manufactured by Johnson & Johnson, reduce that risk to between 5 and 10 percent.
Angioplasty is a procedure used to clear blocked arteries. The patient is conscious but sedated while a doctor inserts a thin tube into an artery and snakes it through the blood vessels to the point of the blockage. The doctor then inflates a small balloon inside the artery to crush any obstruction and stretch the vessel and may also insert a stent, a metal tube about the size of a large magic marker. Both measures create small tears that can lead to the growth of scar tissue.
But Dr. Gregory Gustafson, Kaplan’s counterpart at NYHQ, was not as enthusiastic about the stents.
“It’s a step forward but not what I would consider a revolutionary step,” he said. “It’s an evolutionary step. There is the promise of reducing the reoccurrence rate that we experience … but you need to get your hands on it, get a feel for it in the real world as opposed to studies.”
Nevertheless, the approval of the devices was awaited so eagerly by doctors at both hospitals that some patients were told to delay their angioplasties. Patients with acute blockages, however, had little choice but to go ahead with the uncoated stents.
“That’s been a very difficult thing about the last nine months,” said Gustafson, who used the new stents for the first time Monday. “There are clearly people for whom this will be a godsend. But are you hurting the patient by making them wait?”
The devices work by releasing a drug called Sirolimus into the surrounding tissue. Sirolimus, originally developed to prevent the body’s immune system from rejecting transplanted kidneys, prevents the buildup of cellular materials that results in scar tissue.
Restenosis alone is not life-threatening, because additional angioplasties can easily correct the problem. So while the prevention of restenosis may not save lives, it should make life easier for those who undergo the procedure.
“The study data clearly shows — and that will be confirmed — that we’ll see a reduction in recurrence,” Gustafson agreed. “The issue becomes extending that to procedures we would have avoided in the past.”
He cited treatment of post-bypass restenosis as one situation in which it was not clear what, if anything, the new stents could offer.
Kaplan agreed, but added that the new stents could change the overall approach of many doctors for the better.
“It will make interventional cardiologists more daring and more comfortable stenting lesions that are borderline and might have gotten left alone, meaning a 50 to 60 percent blockage,” he said.
A 70 percent blockage, he said, was the generally accepted level at which a procedure is warranted.
“Under ideal circumstances if all sizes and shapes and lengths were available, you could make the argument that these stents … should be used in all cases that you can,” he added. “The only dilemma … is the cost of the device.”
Johnson & Johnson charges about $3,000 for each stent — roughly three times the price of the older, uncoated devices.
The high cost of the device is one of the factors that made Gustafson cautious in his outlook.
“Everybody is pushing these things very, very hard,” he said, “and Johnson & Johnson could see a huge windfall.”
“I’ve been in this field 25 years, and I’ve seen a lot of things go up and down. I’m a bit cautious about saying ‘hosanna’ until we see what these things can do for us.”
Reach reporter Alex Ginsberg by e-mail at Timesledger@aol.com or call 718-229-0300, Ext. 157.
