Cutting Balloon versus Conventional Angioplasty Study - CUBA

Description:

Safety and efficacy of cutting balloon vs. conventional balloon PTCA.

Hypothesis:

To determine the effectiveness, safety, and feasibility of using a cutting balloon instead of a conventional balloon for balloon angioplasty.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 306
Mean Follow Up: 7 months
Female: 0

Patient Populations:

De novo lesion in native vessels
Lesion length less than 15mm
Lesion reference diameter of 2.5 - 4mm

Exclusions:

Bifurcated lesions
Calcification
Thrombus
Severe tortuosity or angulation

Primary Endpoints:

MLD, restenosis rate (> 50%), and % diameter stenosis at 6 months

Secondary Endpoints:

MI
Target lesion revascularization
Combination of death, MI, or target lesion revascularization.

Drug/Procedures Used:

Cutting balloon vs. conventional PTCA

Principal Findings:

The cutting balloon is a device that focuses the force exerted by the balloon inflation through several (3 or 4) microblades attached to the balloon. As a consequence, dilation may be obtained with lower inflation pressure and, hypothetically, less vessel stretching and trauma. Since restenosis has been linked to vessel wall trauma, the CUBA investigators undertook the study to determine whether the particular mode of action of the cutting balloon could result in a lower restenosis rate.

After randomization, there was a 1-month follow-up and a 6-month angiographic follow-up for all patients whose treatment was successful under the protocol. There was a 7-month clinical follow-up for those patients and for all other patients initially enrolled in the study. The total number of patients randomized was 153 in the conventional balloon group and 153 in the cutting balloon group.

Initial treatment was successful for 136 patients (88%) in the conventional balloon group and 138 patients (91%) in the cutting balloon group. Stent implantation was required in 18 patients in the conventional balloon group (12%) compared to 12 patients (8%) in the cutting balloon group. An additional 2 patients in the cutting balloon group crossed over to conventional angioplasty because of inability to reach the lesion with the cutting balloon device.

Angiographic follow-up was conducted on 131 patients in the conventional balloon group and 134 patients in the cutting balloon group. Post-procedure MLD was 2 ± 0.4 mm for both groups; MLD at 6 months was 1.7 ± 0.8 mm for the cutting balloon group and 1.5 ± 0.7 mm for the balloon group. The risk ratio for restenosis (balloon/cutting balloon) was 1.37, with 95% CI (1.0 to 1.9).

At 7 months, the incidence of death, MI, or any TLR was 20% for the cutting balloon group and 26% for the conventional balloon group.

Interpretation:

The CUBA study investigators concluded that cutting balloon PTCA provides similar acute angiographic results when compared with conventional balloon angioplasty. The in-hospital results and need for stenting were also similar. The cutting balloon showed a moderate decrease in restenosis, mainly due to smaller late loss and loss index. Despite these differences, however, there were no significant differences in 7-month clinical outcomes between the two groups.

References:

1. Eur Heart J 1998;19(Abstr Suppl):48.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease

Keywords: Odds Ratio, Coronary Artery Disease, Follow-Up Studies, Research Personnel, Angioplasty, Balloon, Coronary, Stents


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