Evidence of Safety and Effectiveness for a Drug-Eluting Stent: How Should We Respond this Time?
Drug-eluting stents (DES) were introduced to the coronary artery disease treatment market in 2003 with much exuberance and fanfare. With over 70% reduction in restenosis and no apparent safety concerns in one year reports from large randomized clinical trials,1,2 the opportunity for expansion of the technology seemed limitless. Interventional cardiologists responded with confidence and quickly expanded use to a wide array of "off-label" indications, limited only by initial inventory constraints.3,4 Some even considered DES as a potential therapy for vulnerable lesions or regions that were not yet hemodynamically significant, and there were concerns by hospitals and others that widespread use of these devices for treatment of traditional surgical disease would place cardiac surgery programs in jeopardy.5,6 The realization of an increased risk of late and very late stent thrombosis with the first generation DES, especially in patients with increased lesion complexity, dampened this enthusiasm.7,8 (SELECT FULL TEXT TO CONTINUE)
- Received January 24, 2012.
- Accepted January 27, 2012.
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