Coronary Angioplasty Versus Excisional Atherectomy Trial I - CAVEAT I

Description:

Directional atherectomy vs. PTCA for adverse event in CAD.

Hypothesis:

To compare directional atherectomy with coronary angioplasty.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 1,012
Mean Follow Up: 1 year
Mean Patient Age: 59
Female: 27

Patient Populations:

Angiographically proven native coronary lesions
Lesion length < 12mm
Stenosis ≥ 60%

Exclusions:

Acute MI within 5 days

Primary Endpoints:

Death, MI, target vessel revascularization, hospitalization, and stroke

Secondary Endpoints:

Angiographic measures

Drug/Procedures Used:

Directional atherectomy (DCA), balloon angioplasty (PTCA)

Concomitant Medications:

Aspirin, calcium channel blockade, heparin

Principal Findings:

A total of 512 patients were assigned to DCA, and 500 patients were assigned to PTCA.

DCA produced less residual stenosis initially (89% vs 80%), with favorable early angiographic outcomes. Early complications were significantly more frequent in DCA patients (11% vs 5%, p < 0.001.).

At six months, restenosis was not significantly different between groups (p=0.06), although the trend indicated less frequent restenosis for DCA (50%) compared to PTCA (57%).

At one year, myocardial infarction had occurred in 8.9% of the DCA patients compared to 4.4% of the PTCA patients (p=0.005). The association between DCA and increased rates of death or myocardial infarction persisted after controlling for covariates.

Interpretation:

Directional atherectomy was associated with a trend toward lower rates of restenosis at 6 months, and increased mortality and ischemic events at one year. DCA resulted in higher rates of early complications at a higher cost and with no clinical benefit. Paradoxically, initial dissemination of these study results produced a transient increase in use of directional atherectomy at CAVEAT-I sites. Among investigators in the trial, there may have been a lack of influence of trial data on clinical practice patterns 1 year after publication of the results.

References:

1. N Engl J Med 1993;329:221-7. Final results
2. Circulation 1995;91:2158-66. One-year follow-up
3. J Am Coll Cardiol 1998;31:265-72. Influence on practice

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Aortic Surgery, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Myocardial Infarction, Coronary Angiography, Atherectomy, Constriction, Pathologic, Angioplasty, Balloon, Coronary


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