With the introduction of the drug eluting stent (des), the criteria for coronary intervention has broadened. The standard of care for intervention and stent placement involves a clinically significant lesion (>70 percent occluded) with ischemic heart disease --, i.e., upon stress test, blood flow is limited. Please see the American College of Cardiology Guidelines:
However, physicians are closer to the medical device industry than ever, receiving grants, gifts, and are typically reimbursed per vessel; therefore, there is a strong financial incentive to intervene in multiple vessels and place an additional stent during the procedure, even though a lesion may not be symptomatic. This practice is concerning where lesions less than 70 percent occluded are being stented. While it is recognized as malpractice, many physicians argue that this is "clinical judgment".
This argument is not supported by the objective guidlines outlined in the literature or the FDA. The clinical data does not support that stent placements in non acute patients reduces the risk of myocardial infarction (MI) or Death. Therefore there is no clinical benefit to the patient. Nevertheless, the use of stents in "off label", i.e., in patients unapproved by the FDA, has reached 60% of all stent surgeries. This means that 60% of all patients undergoing des placement are undergoing surgery where the available data does not prove it is safe or effective for them. Indeed, the introduction of a stent for these patients may in fact increase the risk of MI and death. Furthermore, patients have to stay on Plavix (a very strong blood thinner) indefinitely, which adds risks of severe bleeding. Please see the FDA comments on "off label" uses:
For those patients who suffered side effects, adverse reaction, including MIs, strokes, or death, they may consider a medical malpractice claim to investigate whether a stent was appropriate in their loved one.
