By Laurence M. Deutsch and Steven E. North
A recent study reported in the British Medical Journal Lancet, casts serious doubt on the usefulness of heart stents for single vessel disease.
Stents, small tubes placed in the heart to unblock vessels, have been the mainstay of cardiology for many decades. Many cardiologists and many hospitals earn a large part of their revenue from placing these stents.
While once used fairly exclusively for life-threatening conditions, cardiology societies have in recent decades advocated expanded use for stents. They recommend them for patients with significant disease in only one heart vessel (single-vessel disease) on the theory that even if such patients are not at risk for a major heart attack, using a stent to open a vessel will likely reduce a patient’s chest pain and improve his or her quality of life. According to the Lancet, a large study conducted in the United Kingdom disproves that assumption.
Two groups were studied. One received stenting for single-vessel disease in the currently accepted manner. Another group underwent the same surgery for placement of a stent, although the stent was physically withdrawn from the body at the end of the procedure. This was a true, double-blind study as even the surgeon doing the procedure did not know which patients received the real stent and which patients had the stent withdrawn by others at the end of the procedure.
American cardiologists were so convinced of the need to stent single-vessel disease that many openly questioned the ethics of the British study, saying that patients should not be deprived of the benefits of stenting long established by the cardiology community.
Nonetheless, the results show the opposite. Both groups of patients, i.e., patients receiving the stent and those undergoing placebo surgery (no stent), showed the same level of observable improvement. Both groups of patients were put on aspirin and other clot blockers, and vessel-dilating medications after the surgery. Both sets of patients received the same post-op follow-up advice after their surgery.
These results cast real doubt on the effectiveness and necessity of subjecting patients to heart surgery for single-vessel disease. The results have been explained in various ways including the fact that patients with one blocked artery usually have more widespread disease, so even if other vessels are not fully blocked, they are experiencing lessened flow in multiple vessels not addressed by the stent.
In addition, the well-known “placebo effect” comes into play. Many patients undergoing surgery will report improvement regardless of whether the surgery does anything to actually improve their symptoms. In addition, we would suggest that many patients experience a "wake-up call" if they have to undergo something as serious as surgery for a life-threatening condition. Such patients will often take on lifestyle modifications such as improved diet, better exercise, etc., and may therefore achieve improvement after surgery, but not because of it.
Whether stents are necessary matters greatly because any surgery, particularly on the heart, carries significant risks, including death. Therefore, if studies do not demonstrate a proven benefit for stenting single-vessel disease, it no longer appears acceptable for a physician to simply tell a patient they “need a stent” because of one blocked vessel. At a minimum, any patient undergoing stenting deserves a serious and objective discussion, with the cardiologist giving current information on the expected benefits, risks, and alternatives to surgery.
Patients themselves have to be vigilant for unnecessary procedures. However, these recent studies also put the burden on the medical profession: those who know the most have a duty to offer pros and cons of surgery and not overstate the expected benefits of procedures that expose their patients to risk.
Source: New York Times, Health, 11/2/17
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1988, New York and U.S. District Court, Northern, Southern, Eastern and Western Districts of New York. Union College, Schenectady, B.A., magna cum laude, 1984 Phi Beta Kappa; University of Chicago Law School, J.D., 1987
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