Balloon Angioplasty Versus Optimal Atherectomy Trial - BOAT

Description:

Optimal directional atherectomy vs. PTCA for angiographic restenosis in CAD.

Hypothesis:

Optimal DCA can provide an outcome comparable to PTCA.

Study Design

Study Design:

Patients Screened: 1,000
Patients Enrolled: 989
Mean Follow Up: 1 year

Patient Populations:

De-novo lesions <15mm in length, amenable to DCA approach with a 7F device
Vessels > 3mm, < 4.5mm

Primary Endpoints:

Angiographic binary restenosis rate after the intervention

Secondary Endpoints:

Acute outcome
6-month clinical outcome
Long-term outcome

Drug/Procedures Used:

DCA of EX or greater-torque-output (GTO) type, 7F size
PTCA

Principal Findings:

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).

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).

Interpretation:

Previous trials of DCA failed to demonstrate a significant reduction in restenosis, complications, or mortality compared to conventional balloon angioplasty. BOAT selected skilled DCA operators and second- or third-generation DCA devices to optimize the probability of successful DCA outcome. Optimal DCA had favorable short-term angiographic outcomes compared to conventional PTCA, but failed to reach statistical significance for reducing late clinical events compared with PTCA with stent backup.

References:

1. Coronary Artery Disease 1996; 7: 282-289.
2. Circulation 97:322-31, 1998

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: Myocardial Infarction, Follow-Up Studies, Creatine Kinase, Atherectomy, Coronary, Constriction, Pathologic, Probability, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Stents


< Back to Listings