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Final results of the Balloon vs Optimal Atherectomy Trial (BOAT)
D S Baim1, D E Cutlip, S K Sharma
1Beth Israel Deaconess Medical Center, Boston, Mass 02215, USA.
Insights
Optimal directional coronary atherectomy (DCA) significantly improves procedural success and reduces restenosis compared to conventional percutaneous transluminal coronary angioplasty (PTCA). While not statistically significant, long-term clinical event rates showed a trend toward improvement with optimal DCA.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Technology Evaluation
Background:
- Previous directional coronary atherectomy (DCA) trials reported no significant reduction in restenosis and higher mortality versus percutaneous transluminal coronary angioplasty (PTCA).
- Evolution of DCA to an "optimal" technique involved larger devices, more extensive tissue removal, and routine postdilation to achieve <20% diameter stenosis.
Purpose of the Study:
- To evaluate if "optimal" DCA offers short- and long-term benefits compared to conventional PTCA.
- To assess the efficacy and safety of optimal DCA in patients with single de novo native vessel lesions.
Main Methods:
- The Balloon vs Optimal Atherectomy Trial (BOAT) randomized 1000 patients to optimal DCA or PTCA.
- Lesion success, final residual stenosis, major complications, and angiographic restenosis were assessed.
- Clinical follow-up to 1 year evaluated mortality, target-vessel revascularization, and target-vessel failure.
Main Results:
- Optimal DCA achieved higher lesion success (99% vs 97%) and lower residual stenosis (15% vs 28%) than PTCA (P<.02).
- Angiographic restenosis was significantly reduced with optimal DCA (31.4% vs 39.8%; P=.016).
- Major complications were similar, but creatine kinase-MB elevation was more frequent with DCA (16% vs 6%; P<.0001).
Conclusions:
- Optimal DCA demonstrates superior short-term success and lower angiographic restenosis compared to conventional PTCA.
- The study did not achieve statistical significance in reducing late clinical events versus PTCA with stent backup.
- Optimal DCA represents an advancement over previous DCA techniques for coronary interventions.
Background:
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%).
Methods And Results:
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).
Conclusions:
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.