Clinical trials have shown the benefits of coronary stenting with BMS over other methods of angioplasty, including balloon angioplasty and atherectomy. Drug-eluting stents (DES) have also been extensively studied, and are generally superior to bare-metal stents as regards Major Adverse Cardiac Events (MACE, generally defined as death, myocardial infarction, or the need for a repeat revascularization procedure.) Stents are indicated to improve the diameter of the coronary artery lumen, when narrowing (generally because of atherosclerosis) causes ischemia (reduced oxygen delivery to the muscle supplied by that artery.)
Drug-eluting stents also have been shown to be superior to bare-metal stents in reducing short-term complications of stenting in saphenous vein grafts ; however, use in these bypass grafts is an example of an "off-label" use of drug-eluting stents. That is, this application has not been sufficiently examined by the Food and Drug Administration for that agency to recommend the use. For "on-label" applications, the FDA "believes that coronary drug-eluting stents remain safe and effective when used for the FDA-approved indications. These devices have significantly reduced the need for a second surgery to treat restenosis for thousands of patients each year.".
As enthusiasm for the new devices abates, there is some concern about overzealous use of stents in general. Two studies found that about half of patients received stents for unapproved reasons, with worse outcomes for the patients in both studies. More recent data suggests that off label use of both bare metal stents as well as drug eluting stents have increased risks. However, DES seemed to have similar or improved rates of death or MI compared with BMS, and consistently reduced need for TVR. Overall, the data supports the use of DES for off-label indications.
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