Intimal Hyperplasia Inhibition with Beta In-stent Trial - INHIBIT

Mar 09, 2002
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Date Presented:
01/01/2000
Date Published:
01/01/2000
Date Updated:
03/09/2002
Original Posted Date:
03/09/2002
References

Description:

Use of beta-radiation brachytherapy with a P-32 source (Nucleon afterloader) for treatment of diffuse in-stent restenosis

Hypothesis:

Beta-radiation brachytherapy with a P-32 source can reduce MACE and restenosis after treatment of in-stent restenosis

Study Design

Study Design:

Patients Enrolled: 332
Mean Follow Up: 9 months

Patient Populations:

Single native vessel in-stent restenosis Reference vessel diameter 2.4-3.7 mm Lesion length <45 mm

Primary Endpoints:

Composite safety endpoint of death, Q wave MI and TLR Angiographic binary restenosis

Drug/Procedures Used:

P-32 beta emitter versus placebo delivered through a centering catheter via an automatic afterloader after PTCA for in-stent restenosis

Principal Findings:

There was a 56% reduction (14% irradiated versus 31% control) in composite endpoint of death, Q wave myocardial infarction, and target lesion resvascularization(p=0.0002) among patients treated with P-32 beta irradiation. There was a 50% reduction (26% irradiated versus 52% control) in the angiographic binary restenosis rate (p=0.0003)among patients treated with P-32 beta irradiation.

Interpretation:

Beta-radiation with the P-32 source is associated with a reduction in restenosis and MACE after treatment of in-stent restenosis.

References:

Circulation 2000;102:e9046. Lancet 2002 Feb 16;359(9306):551-7

Keywords: Myocardial Infarction, Beta Particles, Coronary Restenosis, Brachytherapy, Stents


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