Excimer laser, Rotational atherectomy, Balloon Angioplasty Complications Study - ERBAC

Description:

Excimer laser, rotational atherectomy, and balloon angioplasty for CAD.

Hypothesis:

To compare procedural success of excimer laser, rotational atherectomy, and balloon angioplasty.

Study Design

Study Design:

Patients Screened: 700
Patients Enrolled: 620
Mean Patient Age: 62
Female: 20

Patient Populations:

native de novo ACC/AHA Type B2 or C lesions suitable to all three techniques

Exclusions:

Evolving myocardial infarction
Recent (<4 months) percutaneous intervention
Lesions that were chronic total occlusions, involving a bifurcation, heavily calcified, contained thrombus, or were angulated >60 degrees

Primary Endpoints:

Cost analyses and long-term clinical and angiographic outcomes (no restenosis >50%)

Secondary Endpoints:

Excimer laser, rotational atherectomy, balloon angioplasty

Drug/Procedures Used:

Composite endpoint of emergency coronary artery bypass graft (CABG), death or Q-wave MI; rates of procedural success (defined as <50% residual restenosis) and in-hospital complications.

Principal Findings:

Rotational atherectomy and excimer laser are virtually never stand-alone procedures, particularly if there is a conservative approach to device sizing relative to the arterial reference diameter.

Adjunctive balloon angioplasty is often required to obtain an acceptable residual stenosis and smooth lumen in the target segment.

In a head-to-head comparison, excimer laser catheters more frequently failed to cross the stenosed arterial segment and resulted in more frequent clinical complications than rotational atherectomy devices.

Acceptable angiographic results were obtained with adjunct balloon inflations at relatively low pressures after the use of either atherectomy device. This suggests that these devices may affect plaque compliance in addition to debulking, thereby facilitating balloon angioplasty. Theoretically, low-pressure balloon inflations are less likely to cause excessive procedural dissections; the lower acute complication rates after rotational atherectomy may be evidence of that.

Use of rotational and laser atherectomy provided no benefit on clinical or angiographic outcome, implying that chronic recoil and neointimal proliferation were not prevented by these new device catheters.

Interpretation:

Restenosis remains the major limitation for all percutaneous approaches to myocardial revascularization.

References:

1. Curr Probl Cardiol 1995;20:122-190. Review
2. Eur Heart J 1994;15(Abstr Suppl):130. Final results

Keywords: Coronary Artery Disease, Atherectomy, Coronary, Constriction, Pathologic, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Lasers, Excimer


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