Heart Trouble

The tiny stent sparked a lucrative industry--and made Dr. Samin Sharma a star. Then questions arose about the device's safety and efficacy.

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On a sweltering summer morning, Dr. Samin K. Sharma marches into the cardiology wing of Mount Sinai Hospital in New York, prepared for a 16-hour day in which he will clear and repair the arteries of 18 patients. Sharma specializes in installing stents, tiny metal devices that hold open blocked blood vessels. As he'll be the first to note, he does more stent procedures than anyone else in doctor-rich New York and possibly in the entire country. An immigrant from India who had to plead for his first cardiology job here, he has played a critical role in popularizing the stent as an alternative to drugs. In the process, he has helped fuel a booming stent market and revive the fortunes of Mount Sinai, a prestigious old institution that just a few years ago was stumbling financially.

But this morning a slight shadow of doubt hangs over the court of the King of Stents. On the table, patient David Viggiano is asking questions. (Although sedated, stent patients remain awake.) Viggiano, a 42-year-old security guard with colorful tattoos on his arms, suffered a heart attack three years ago near his home in suburban New York. He was riding his bicycle through a cemetery, a setting that still haunts him. As he awaits his procedure, Viggiano is aware that qualms have arisen over certain kinds of stents. "I heard they had problems," he says, as an X-ray machine whirs back and forth over his chest.

Sharma considers the patient's hazy anxiety. Since Viggiano is relatively young, and potent drugs may interfere with his active lifestyle, the doctor sticks with his preferred treatment and installs a stent. "Everything looks good," Sharma tells Viggiano in a booming voice, as he implants the device. "In about five hours, you'll go home with an open artery."

NATIONWIDE DEBATE

Before the next patient is wheeled in, another signal of uncertainty arrives. A nurse calls out to Sharma about a cardiologist who's on the phone. The other doctor wonders whether a patient whom Sharma is scheduled to see needs to be treated with stents at all. Later, Sharma says that he now fields calls like this all the time. "Every day," he says, "every day."

Sharma, a spiritual man who fasts once a week in a Hindu purifying ritual, explains his devotion to stents in terms of relieving patient suffering. But recently the 50-year-old physician finds himself enmeshed in a nationwide debate over whether his specialty, interventional cardiology, has been driven by economic motives to overuse the device. Galvanizing the controversy is a series of scientific studies released since last year that raise a pair of vexing questions: Do stents coated with drugs intended to prevent arteries from closing up again sometimes cause potentially fatal blood clots? And apart from the question of dangerous side effects, are stents really more effective than medicine, improved diet, and exercise in treating coronary artery disease?

The stir over stents has jolted a whole industry that took shape in the 1990s to cash in on the device's popularity. Boston Scientific (BSX ) and Johnson & Johnson (JNJ ), both of which make drug-coated stents and for which Sharma has performed many clinical trials, have slipped badly. With stent procedures down 13% nationally this year, Boston Scientific's stock is off 17%, and the company is expected to announce layoffs; J&J has said it will lay off more than 3,400 people, including many in its stent business. JPMorgan Chase (JPM ) estimates that sales of drug-coated stents will drop 23% in 2007, to $4.1 billion.

At Mount Sinai, a highly regarded teaching hospital on Manhattan's Upper East Side, the spreading angst shows up in hallways and classrooms. Traditional cardiologists are openly challenging Sharma, sending him fewer referrals. "It's a lot easier for doctors in general to send someone to angioplasty"--during which stents are implanted--"than it is to take the time to explain to them why they don't need it," says Dr. Ira S. Nash, an associate professor of cardiology at Sinai who favors the use of drugs. "He is incredibly enthusiastic about angioplasty," says Nash, referring to Sharma, "but in my heart of hearts, I believe he's overselling it." After double-digit growth in angioplasties by Sharma's team since 2002, volume in his cath (short for catheterization) lab has fallen 3% this year.

If top management at the hospital is worried about these developments, there's little outward evidence of it. Sinai executives repeatedly have fended off rivals attempting to hire away Sharma and grab his lucrative practice. The star doctor's salary has risen steadily over the years and now stands at $3 million.

Sharma admits to passing moments of doubt, even at one point comparing stents to atomic energy. "From the genius of Einstein came Hiroshima," he muses. But in the cath lab, he exudes only confidence. From among the confusing welter of research, he cites studies showing that arteries propped open with drug-coated stents are less likely to clog up again than those repaired with an older bare-metal variety. "Do you have a choice of stent?" he asks one patient as she's wheeled in. "The one where I don't have to come back," she jokes. "Right answer," declares the doctor, who proceeds to insert a medicated stent.

He reassures patients that they can prevent clots by taking blood-thinning drugs for several years. And he insists that people with severe chest pain, fatigue, and other symptoms of angina feel better when they get stents than when they're treated with medicine alone. "In my opinion, we are doing the right thing for society and for the patients," Sharma says.

He first arrived at Mount Sinai unannounced and unwelcome in 1988, after completing his U.S. training at another New York hospital. He showed up in the office of Valentin Fuster, Sinai's chief of cardiology, and begged for an angioplasty fellowship. When Fuster politely informed him that all fellowships were taken by Sinai graduates, Sharma offered to work for free. "We just don't do that," Fuster recalls saying. "But I saw passion and depth. I thought he might be an exception." Sharma refused to go away. He volunteered for scut work and toiled in the emergency room to earn cash. A year later, Fuster hired him.

Sharma, by all accounts, developed a virtuoso touch for threading catheters into blood vessels and clearing arteries others wouldn't touch. Back then, angioplasty was performed with a small balloon inflated inside the artery. Sharma relishes memories of patients half-asleep on the table, thanking him for letting them breathe freely without the stunning chest pain caused by angina. "Instant gratification," he calls it. "You open the artery, put in the balloon, and the pain goes away."

The advent of the bare-metal stent in 1994, and the drug-coated variety nine years later, greatly lessened the risk that newly opened arteries would close up. The drug-eluting stent is a $2,000 woven stainless-steel tube no more than an inch long. Each incremental stent improvement has intensified Sharma's enthusiasm for angioplasty as a primary weapon against heart disease. He's not alone: As angioplasty rose over the past decade, it partly displaced bypass surgery, which fell by 25%. By last year, more than 80% of patients getting stents received the drug-coated variety.

A diminutive figure who wears dapper business suits when not in his blue operating scrubs, Sharma recites his stats like a baseball player boasting about home runs. "In 1999, I did 1,000 cases," he says. "Last year I did about 1,400. I'm the only one in New York State who has been doing more than 1,000 since 1999." (No one keeps national figures.) Counting procedures by the 11 other members of his staff, the Sharma cath lab did 5,174 angioplasties in 2006, nearly double the number performed three years earlier. The lab also boasts one of the best safety records in the state. Every other month, Sharma travels to India for the weekend to perform angioplasties, free of charge, at a heart hospital he built in his hometown of Jaipur. In September he made an extra trip home to install two stents in his 72-year-old mother after she complained of shortness of breath during her daily two-mile walk. She is recovering well, he says.

HIGH-MARGIN SPECIALTY

Sharma played a central role in another sort of recovery at Mount Sinai. The 2,000-doctor hospital was struggling in March, 2003, when Dr. Kenneth L. Davis took over as chief executive. During the previous six months, Sinai had lost $50 million, partly as the result of tougher caps on Medicare reimbursement rates. A merger with neighboring New York University Medical School turned out to be such an administrative disaster that Davis dissolved the union. While trimming costs, Davis also decided to build up practices in high-margin specialties. "Interventional cardiology was one of myriad areas where we were eager to facilitate growth," he says. Sharma's cath lab was central to this campaign, performing procedures that typically brought in as much as $20,000 apiece for the hospital.

Sharma convinced his bosses that to capitalize fully on the stent boom, Mount Sinai should turn his cath lab into a 24/7 operation. At a cost of $400,000 a year, he figured, the hospital could put enough doctors and nurses on call to do emergency angioplasties late at night and on weekends. Soon the lab was averaging 15 off-hours patients a month. Interventional cardiology became a key revenue source for Sinai. By the end of 2006 the hospital's total patient revenues had grown 41%, to $1.2 billion. Cardiology services, excluding surgeries such as heart bypass, contribute 15% of that, most of which comes from Sharma's cath lab.

After years of giddy growth, the stent business hit its first bump in March, 2006. A Swiss study concluded that a potentially deadly clot called late stent thrombosis is twice as likely to occur in patients who receive drug-coated stents as in those who get bare-metal stents. Several studies presented at a conference in Barcelona six months later reiterated the risk. Although late stent thrombosis is rare, occurring in fewer than 1% of patients by some estimates, it happens without warning a year or more after the device is implanted, and "most cases are catastrophic," Sharma says. He has seen patients die of late stent thrombosis. "They felt so good for one year, and then they disappeared."

In March of this year, a trial conducted by scientists with the Veterans Affairs Dept. delivered a bigger blow. The VA study, known by its acronym, Courage, found that using stents to treat patients with minor blockages and mild symptoms was no more effective in preventing heart attacks or death than a cocktail of medicines, including cholesterol-fighting statins and blood pressure drugs. Sharma and other critics have complained that Courage didn't give stents due credit for relieving pain. They blasted the trial investigators for using bare-metal stents instead of drug-coated ones. Nevertheless, Sharma concedes the research has prompted introspection unlike any in his 20-year career. "What Courage really told us," he says, "is that maybe we were doing more angioplasties than we needed to be doing."

AMMUNITION FOR CRITICS

At Sinai, the double impact of safety and efficacy worries is apparent every day. Sharma and his colleagues have adopted the term "Courage type" to describe patients who come in with minor blockages and few symptoms. More often than before, those people are being sent home with prescriptions, not stents. For those who do get drug-coated stents, Sharma now recommends they stay on the blood-thinning medications Plavix and aspirin for three years, which is triple the recommendation of the Food & Drug Administration and the American College of Cardiology. The risk of late stent thrombosis, he says, increases after patients stop taking blood thinners.

The recent research has provided ammunition to stent critics. During a "grand rounds," or teaching session for medical residents and fellows, Sharma invites one advocate of drug therapy, the cardiologist Nash, to discuss the latest studies and treatment options. First, Sharma whips through PowerPoint displays on patients who in years past, he says, would have been treated with stents but no longer will be because of the Courage trial. "What have we learned from this much-hyped trial?" he asks the young doctors filling a large conference room, a tinge of annoyance in his voice. He describes one patient with a minor blockage, who was sent home with drugs. "I'm confident we didn't do a disservice to him," Sharma says, "but chances are this patient will come back to the cath lab within a year" to receive a stent.

Nash counters with a slide listing all the drawbacks of stents: They're pricey, they have to be given in the hospital, they don't decrease the mortality risk, and they can cause heart attacks. If angioplasty were a drug, he suggests, doctors would hesitate to prescribe it. Boisterous debate erupts about the design and real-world value of the Courage trial. "[It] was not helpful for the physician," shouts a doctor. Fuster, the head of cardiology, shouts back: "I think this trial has made us think twice."

From angioplasty's earliest days, Sharma has pushed the boundaries of what more conservative physicians believe is the proper use of the procedure. "He was anxious to take every case he could," says Dr. Jonathan D. Marmur, who worked with Sharma at Mount Sinai from 1988 to 2003. Marmur recalls one night when Sharma learned of a patient who had arrived in the emergency room suffering from a heart attack. Even then, before the advent of the stent, cardiologists debated whether balloon angioplasty was as safe and effective as clot-busting drugs--the standard treatment at the time. "It was close to midnight; we had done a lot of angioplasties that day," says Marmur, now a professor of medicine and director of the cath lab at the State University of New York Health Science Center in Brooklyn. "But he got wind of that patient, called the ER, and said: 'Get that patient up here.'" The ER complied. Sharma confirms the account. "Push the envelope," he says. "'Be a leader' is my motto."

'A GOOD DOCTOR IN THE FAMILY'

Proud of the institution he has built, Sharma displays medical association awards in a giant case in his office. Articles about him from the Indian press are taped to the walls of the cath lab, along with graphs showing how many procedures each doctor in his group has performed annually and their safety records. Married, with two children, he notes that his college-age son has decided to be a doctor. Sharma wouldn't be mistaken for a modest man, but by the standards of high-end medicine, "he's not an egomaniac," says his boss, Fuster. "An egomaniac criticizes everyone around him. Never have I heard him say a bad word about a colleague. He's just thankful for what he's achieved."

Sharma grew up in a middle-class family, one of four children. His father, Anandi Lal Sharma, who worked in the forestry department, woke his son every day at 5 to study. The elder Sharma's brother and grandfather had died of heart failure, losses that gave him "a thought of having a good doctor in the family," he says in an e-mail. After Samin earned his medical degree at Sawai Man Singh Medical College in Jaipur in 1982, his father encouraged him to move to the U.S., where he would have more opportunity to advance quickly.

Sharma has many friends in New York's community of Indian immigrants, one of whom inadvertently gave him a preview of the stent controversy. In 2004, Sharma treated Santosh Dugar, a diamond dealer who is a longtime neighbor in tony Scarsdale, N.Y., with four drug-coated stents. He kept him on blood thinners for a year, then took him off medications. But one Sunday, the merchant suddenly broke out in a cold sweat while gardening. "I was so tired," he recalls. "I was scared." Dugar paged Sharma, who rushed to his house. The next day, at Mount Sinai, Sharma discovered late stent thrombosis, the dangerous clot. He cleared it and placed a new stent to prop open the damaged artery. Only strong bloodflow on the other side of Dugar's heart had kept him alive.

Now, with the fall cardiology conference season in full swing, the latest research is adding to the confusion over stents. In September one study suggested that the blood clot risk might be lower than originally reported. Other studies conclude that the specific brand of stent dictates the risk. Yet another reported that patients given drug-coated stents to treat heart attacks--a popular use, but one for which the stents were never approved--faced four times greater odds of dying within two years, compared with patients treated with nonmedicated stents. There may never be a definitive resolution of these concerns. Large, long-term trials comparing drug-coated stents with other treatments are difficult to design and even harder to finance.

Sharma has no intention of slowing down. On a Friday in mid-September, he rushes to catch a plane to India. A friend's 87-year-old father requires an angioplasty, so Sharma flies in for the weekend to lend a hand. After two 15-hour flights sandwiching one quick stent installation, he lands back in New York at 4 a.m. on Monday. He heads straight to Mount Sinai.

By Arlene Weintraub

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