A patient sat across from me last Friday with concern written across his face and asked one of the smartest questions a patient can ask: "What would you do if you were sitting on the exam table in my situation?" His circumstances are similar to those of many other patients. Gerald Jones (not his real name) had a small heart attack 10 weeks ago and was treated with a drug-eluting stent, or DES, in the blocked artery that caused his heart attack. He's done quite well with his exercise, diet, and lifestyle changes. In fact he feels better now than before his heart attack.
Jones' internist diagnosed him with an elevated prostate-specific antigen level, which suggests that he has prostate cancer. But to definitively determine whether or not Jones has prostate cancer, he must undergo a biopsy of his prostate, and his having a TAXUS drug-eluting stent from Boston Scientific (NYSE:BSX) placed recently complicates his care. He is supposed to be on Plavix, the blood thinner sold by Bristol-Myers Squibb (NYSE:BMY) and Sanofi-Aventis (NYSE:SNY), for six months to keep the artery from clotting. But he cannot undergo a biopsy, not to mention potential surgery on his prostate, unless he stops the drug for about a week to reduce bleeding problems associated with the biopsy or surgery. By the look on his face, I wondered if Jones had read the recent front-page article about problems with drug-eluting stents in The New York Times.
Coronary angioplasty had an inauspicious beginning. In September 1977, a young doctor, Andreas Gruentzig, asked a patient with a severe blockage if he wanted to be the first person to undergo a procedure to correct the blockage, called coronary angioplasty. During this procedure, a doctor using a catheter inserts a balloon into a heart artery that has a blockage. The balloon is inflated and the plaque is squished against the inside of the arterial wall. As fate would have it that fall day in Zurich, Switzerland, the patient was a professional gambler, and the first angioplasty went splendidly. Shortly afterward, Gruentzig stopped having to make his own catheters because the procedure was widely adopted, with many manufacturers making angioplasty catheters and balloons during the 1980s.
A major problem with plain balloon angioplasty is that occasionally the artery tears and closes, causing a heart attack. With bad tears, patients had to be sent for bypass surgery immediately. In 1993, bare metal stents (BMS) -- wire meshes that abut the artery being treated -- became the next major breakthrough. By using stents, severe tears requiring emergency surgery became uncommon. Moreover, BMS also reduced, but did not eliminate, angioplasty's other problem child. Restenosis is when the stretched artery -- having been injured by the balloon -- develops a new blockage filled with cells sent to repair the artery. Some patients who underwent angioplasty of a 70% to 80% blocked artery found themselves with a new 90% blockage after restenosis struck.
In 2003, Cordis, owned by Johnson & Johnson (NYSE:JNJ), received approval for the first DES, the CYPHER stent. The CYPHER stents slowly release a chemical that keeps the artery from reacting to injury, greatly decreasing the risk of restenosis. In 2004, Boston Scientific released the TAXUS stent, which is the other DES available. Sales of drug-eluting stents are about $6 billion annually, with 6 million patients having received a DES.
In September, bad news about those stents was presented at the European Society of Cardiology meeting. That data suggested that the drug-eluting stents were more likely than the bare metal stents to clot months after being inserted. At the Transcatheter Cardiovascular Therapeutics meeting last week, much of the discussion focused on the safety of drug-eluting stents. Some said that drug-eluting stents are overused, while others touted their safety.
No patient wants to read that a product permanently inserted into his or her heart arteries may not be safe, so I suspect that sales of drug-eluting stents will decline. The stent story will be a dynamic one as more research is published and additional guidelines incorporating new information are developed. Last week, Abbott Laboratories (NYSE:ABT) presented early data about a bioabsorbable DES that may turn out to be the next big thing in stent design if it prevents restenosis without causing clots later.
But for now, the biggest winners will be Bristol-Myers Squibb and Sanofi-Aventis, whose Plavix is an expensive thinner given to patients with stents. A major disadvantage of drug-eluting stents compared with BMS is that Plavix needs to be taken for at least three to six months with a DES rather than one month with a bare metal stent. Safety concerns about drug-eluting stents will likely motivate doctors to keep their patients on Plavix for a year or indefinitely.
Given the new data, Jones, the patient, will wait another two weeks to complete three months of Plavix. His urologist will gauge if he can wait an additional three months for a biopsy so that he will complete the standard six-month course of Plavix before stopping it to have a biopsy. If the urologist believes that the biopsy and subsequent treatment needs to be soon, then the patient will stop the Plavix for five days, undergo his biopsy, then restart Plavix with a loading dose. Fortunately, the artery that caused his heart attack was not his most important one, so that places him at a little less risk, as does the brief time he will stop the drug. Given the recent news about drug-eluting stents, Jones will be taking Plavix for a longer time than we had anticipated.
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Fool contributor Michael Cecil is a cardiologist and the author of Drugs for Less. To discuss the article, feel free to email him.Dr. Cecil does not own any of the stocks mentioned in the article. The Fool has adisclosure policy.
