Baim D S, Cutlip D E, Sharma S K, Ho K K, Fortuna R, Schreiber T L, Feldman R L, Shani J, Senerchia C, Zhang Y, Lansky A J, Popma J J, Kuntz R E
Beth Israel Deaconess Medical Center, Boston, Mass 02215, USA.
Circulation. 1998 Feb 3;97(4):322-31. doi: 10.1161/01.cir.97.4.322.
Previous directional coronary atherectomy (DCA) trials have shown no significant reduction in angiographic restenosis, more in-hospital complications, and higher 1-year mortality than conventional balloon angioplasty (percutaneous transluminal coronary angioplasty [PTCA]). DCA, however, has subsequently evolved toward a more "optimal" technique (larger devices, more extensive tissue removal, and routine postdilation to obtain diameter stenosis <20%).
The Balloon vs Optimal Atherectomy Trial (BOAT) was conducted to evaluate whether optimal DCA provides short- and long-term benefits compared with balloon angioplasty. One thousand patients with single de novo, native vessel lesions were randomized to either DCA or PTCA at 37 participating centers. Lesion success was obtained in 99% versus 97% (P=.02) of patients to a final residual diameter stenosis of 15% versus 28% (P<.0001) for DCA and PTCA, respectively, the latter including stents in 9.3% of the patients. There was no increase in major complications (death, Q-wave myocardial infarction, or emergent coronary artery bypass 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% of eligible patients at 7.2+/-2.6 [median, 6.9] months) showed a significant reduction in the prespecified primary end point of angiographic restenosis by DCA (31.4% versus 39.8%; P=.016). Clinical 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), target-site revascularization (15.3% versus 18.3%; P=.23), and target-vessel failure (death, Q-wave myocardial infarction, or target-vessel revascularization, 21.1% versus 24.8%; P=.17).
Optimal DCA provides significantly higher short-term success, lower residual stenosis, and lower angiographic restenosis than conventional PTCA, despite failing to reach statistical significance for reducing late clinical events compared with PTCA with stent backup.
既往冠状动脉定向旋切术（DCA）试验显示，与传统球囊血管成形术（经皮腔内冠状动脉血管成形术[PTCA]）相比，其血管造影显示的再狭窄率无显著降低，院内并发症更多，1年死亡率更高。然而，DCA随后已发展为一种更“优化”的技术（更大的器械、更广泛的组织切除以及常规的后扩张以获得直径狭窄<20%）。
进行了球囊血管成形术与优化旋切术试验（BOAT），以评估优化的DCA与球囊血管成形术相比是否能带来短期和长期益处。1000例新发单支天然血管病变患者在37个参与中心被随机分为DCA组或PTCA组。DCA组和PTCA组分别有99%和97%的患者获得病变成功，最终残余直径狭窄分别为15%和28%（P<0.0001），PTCA组9.3%的患者置入了支架。主要并发症（死亡、Q波心肌梗死或急诊冠状动脉搭桥手术）无增加（2.8%对3.3%），尽管DCA组肌酸激酶-MB>正常上限3倍更为常见（16%对6%；P<0.0001）。血管造影复查（79.6%符合条件的患者在7.2±2.6[中位数，6.9]个月时进行）显示，DCA组血管造影再狭窄这一预设主要终点显著降低（31.4%对39.8%；P=0.016）。至1年的临床随访显示，研究的DCA组死亡率（0.6%对1.6%；P=0.14）、靶血管血运重建率（17.1%对19.7%；P=0.33）、靶部位血运重建率（15.3%对18.3%；P=0.23）以及靶血管失败率（死亡、Q波心肌梗死或靶血管血运重建，21.1%对24.8%；P=0.17）虽有降低但无统计学意义。
优化的DCA与传统PTCA相比，短期成功率显著更高，残余狭窄更低，血管造影再狭窄更低，尽管与有支架辅助的PTCA相比，在降低晚期临床事件方面未达到统计学意义。
