Abstract
The limitations of balloon angioplasty have led to the introduction of new devices designed to improve the short- and long-term efficacy of percutaneous revascularization techniques. Preliminary single-operator experience and registry data have suggested that these devices may be useful in particular anatomical situations. Last year saw the beginning of the next phase of device assessment, the randomized study, directly comparing the new devices with coronary angioplasty either in the total angioplasty patient population or in selected subgroups. Two major randomized studies, the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT) and the Canadian Coronary Atherectomy Trial (CCAT), directly compared directional coronary atherectomy with balloon angioplasty and suggested that coronary atherectomy offers no particular advantage over balloon angioplasty. This year will see the publication of the Belgium Netherlands Stent (BENESTENT) and Stent Restenosis Study (STRESS) randomized trials, which compared coronary stents with balloon angioplasty; further studies comparing balloon angioplasty with other devices are currently under way. We are now entering a new era where randomized studies will directly assess the safety and efficacy of the new devices compared with balloon angioplasty and demonstrate, in a scientific manner, the validity (or otherwise) of their superiority over balloon angioplasty.
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