FINAL RESULTS OF THE BALLOON VS OPTIMAL ATHERECTOMY TRIAL (BOAT)

Background-Previous directional coronary atherectomy (DCA) trials have shown no significant reduction in angiographic restenosis, more in-ho spital complications, and higher 1-year mortality than conventional ba lloon angioplasty (percutaneous transluminal coronary angioplasty [PTC A]). DCA, however, has subsequently evolved toward a more ''optimal'' technique (larger devices, more extensive tissue removal, and routine postdilation to obtain diameter stenosis <20%). Methods and Results-Th e Balloon vs Optimal Atherectomy Trial (BOAT)) was conducted to evalua te whether optimal DCA provides short-and long-term benefits compared with balloon angioplasty. One thousand patients with single de novo, n ative vessel lesions were randomized to either DCA or PTCA at 37 parti cipating centers. Lesion success was obtained in 99% versus 97% (P=.02 ) of patients to a final residual diameter stenosis oi 15% versus 28% (P<.0001) for DCA and PTCA, respectively, the latter including stents in 9.3% oi the patients. There was no increase in major complications (death, Q-wave myocardial infarction, or emergent coronary artery bypa ss graft surgery [2.8% versus 3.3%]), although creatine kinase-MB >3X normal was more common with DCA (16% versus 6%; P<.0001). Angiographic restudy (in 79.6% oi eligible patients at 7.2+/-2.6 [median, 6.9] mon ths) showed a significant reduction in the prespecified primary end po int of angiographic restenosis by DCA (31.4% versus 39.8%; P=.016). Cl inical follow-up to 1 year showed nonsignificant 13% to 17% reductions in the DCA arm of the study for mortality rate (0.6% versus 1.6%; P=. 14), target-vessel revascularization (17.1% versus 19.7%; P=.33), targ et-site revascularization (15.3% versus 18.3%; P=.23), and target vess el failure (death, Q-wave myocardial infarction, or target-vessel reva scularization, 21.1% versus 24.8%; P=.17). Conclusions-Optimal DCA pro vides significantly higher short-term success, lower residual stenosis , and lower angiographic restenosis than conventional PTCA, despite fa iling to reach statistical significance for reducing late clinical eve nts compared with PTCA with stent backup.