Why the study?
Does rotational atherectomy with or without adjunctive balloon angioplasty improve initial success and one-year clinical outcomes compared to balloon angioplasty alone in patients with in-stent restenosis?
Does rotational atherectomy with or without adjunctive balloon angioplasty improve initial success and one-year clinical outcomes compared to balloon angioplasty alone in patients with in-stent restenosis?
Debulking with rotational atherectomy followed by adjunctive balloon angioplasty provides clinical benefit over balloon angioplasty alone in the management of in-stent restenosis.
May support rotational atherectomy plus balloon angioplasty in in-stent restenosis; hypothesis-generating, needs randomized confirmation.
The BARASTER registry was formed to evaluate the initial success and long-term results of rotational atherectomy in the management of in-stent restenosis. Rotational atherectomy was used in 197 cases of in-stent restenosis: 46 with stand-alone rotational atherectomy or at most 1 atmosphere of balloon inflation (Rota strategy), and 151 with rotational atherectomy and adjunctive balloon angioplasty <1 atmosphere (Combination strategy). These were compared with 107 episodes of in-stent restenosis treated with balloon angioplasty alone. In this observational study, the use of Combination therapy was associated with a slightly higher initial success rate (95% vs. 87% with the Rota strategy and 89% with Balloons, P = 0.08). There was a reduction in one year clinical outcomes (death, myocardial infarction or target lesion revascularization) in the combination group (38% vs. 60% with Rota and 52% with balloons, P = 0.02). These data support a benefit of the strategy of debulking with rotational atherectomy followed by adjunctive balloon angioplasty, in the management of in-stent restenosis.
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Goldberg et al. (2000) studied this question.
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