The greatest recent mechanical advance in percutaneous coronary revascularization (PCR) has been the development of bare-metal stents, which compared with traditional balloon angioplasty substantially reduce angiographic restenosis and the need for repeat target vessel revascularization (TVR). Stents provide a larger arterial lumen diameter immediately postprocedure (acute gain), although their drawback is an increased reparative response of neointimal formation (late loss). Fortunately, the net gain remains greatest with stents compared with other PCR devices. In less complex lesions, the rate of TVR with bare-metal stents is approximately 10% to 15%, although this rate has been reported to be 2- to 3-fold higher in more complex lesions and unique patient subsets.1,2 In 2003, at a time when the use of bare-metal stents peaked, approximately 1 million coronary stents were placed in patients hospitalized in the United States.3 Even with a conservative estimate, this means at least 100 000 in-stent restenotic lesions occurred, making this an important clinical problem.
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Graphical summary of data from 10 randomized clinical trials4- 7,17- 22 treating in-stent restenosis with balloon angioplasty and/or rotational atherectomy without brachytherapy, angioplasty and/or atherectomy with vascular brachytherapy, bare-metal stent placement, or drug-eluting stent placement. Data markers represent weighted averages from the trials. Tinted area indicates net gain in lumen diameter. Highest net gain is in the lower right corner of the plot. The approximated acute gain is notably greater among patients receiving a stent (bare-metal, 2.1 mm; and drug-eluting, 1.4 mm) rather than angioplasty/atherectomy (balloon angioplasty, 1.3 mm; and brachytherapy, 1.1 mm), although late loss is lower among patients receiving local antiproliferative therapy (concomitant brachytherapy [0.4 mm] or a drug-eluting stent [0.3 mm] vs angioplasty/atherectomy without radiation [0.7 mm] or bare-metal stent [1.1 mm]). As a result, net gain is greatest with drug-eluting stents (1.2 mm) compared with the other therapies (0.7 mm).
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