Evidence of Safety and Effectiveness for a Drug-Eluting Stent

Abstract

Drug-eluting stents (DES) were introduced to the coronary artery disease treatment market in 2003 with much exuberance and fanfare. With >70% reduction in restenosis and no apparent safety concerns in 1-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 Article see p 1110 In the years since we have also learned that many patients with symptoms and angiographic evidence of coronary artery disease do as well on medical therapy alone as with stenting, or perhaps even worse with stenting if hemodynamic significance of a coronary lesion is not confirmed.9,10 Furthermore, among most patients with 3-vessel coronary artery disease, coronary artery bypass surgery has demonstrated clear benefit in comparison with the first-generation paclitaxel-eluting stent (PES).11 Within this context, the use of DES has equilibrated to ≈70% of stent procedures, appropriate-use criteria are widely discussed, and cardiac surgery and surgeons have survived. Meanwhile, new generations of DES have been developed and approved for use with modification of the design flaws that were implicated as factors in the delayed healing and ongoing risk of thrombosis with the first-generation devices. These improvements include polymers that are …