A Prospective, Randomized Multicenter Trial of Cutting Balloon Before Stenting in Patients Undergoing PCI - REDUCE III

Description:

The goal of the trial was to compare the effect of cutting balloon vs plain balloon angioplasty (POBA) as a predilation strategy prior to stenting.

Study Design

Study Design:

Patients Enrolled: 520

Drug/Procedures Used:

This is a Japanese prospective multicenter randomized study involving 520 patients in 38 centers. Angiographic follow-up was obtained in 87% of the patients.

Principal Findings:

There is no difference in complication or in-hospital MACE.

Cutting balloon vs POBA
TLR: 10.4% vs 14.9%
TVR 10.8% vs 15.3%
Restenosis 11.8% vs 19.1%, p=0.032

Interpretation:

The strategy of predilation with cutting balloon appeared to reduce restenosis clinically as well as angiographically compared with plain balloon angioplasty. Prior studies have shown that cutting balloons redistribute plaque more than expanding the vessels, thus potentially inducing less injury to the vessel.

References:

Presented at Late-breaking Clinical Trials session at TCT 2003 Conference, Washington, DC.

Keywords: Follow-Up Studies, Coronary Restenosis, Angioplasty, Balloon, Coronary


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