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Medientyp:
E-Artikel
Titel:
Intracoronary β-Irradiation With a Rhenium-188–Filled Balloon Catheter : A Randomized Trial in Patients With De Novo and Restenotic Lesions
:
A Randomized Trial in Patients With De Novo and Restenotic Lesions
Beschreibung:
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<jats:bold>
<jats:italic>Background—</jats:italic>
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Restenosis requiring reintervention is the main limitation of coronary angioplasty. Intracoronary irradiation reduces neointimal proliferation. We studied the efficacy of a self-centering liquid rhenium-188–filled balloon catheter for coronary β-brachytherapy.
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<jats:bold>
<jats:italic>Methods and Results—</jats:italic>
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After successful coronary angioplasty with or without stenting, 225 patients (71% de novo lesions) were randomly assigned to receive 22.5 Gy intravascular β-irradiation in 0.5-mm tissue depth (n=113) or to receive no additional intervention (n=112). Clinical and procedural data did not differ between the groups except a higher rate of stenting in the control group (63%) compared with the rhenium-188 group (45%,
<jats:italic>P</jats:italic>
<0.02). After 6 months of follow-up, late loss was significantly lower in the irradiated group compared with the control group, both of the target lesion (0.11±0.54 versus 0.69±0.81 mm,
<jats:italic>P</jats:italic>
<0.0001) and of the total segment (0.22±0.67 versus 0.70±0.82 mm,
<jats:italic>P</jats:italic>
<0.0001). This was also evident in the subgroup of patients with de novo lesions and independent from stenting. Binary restenosis rates were significantly lower at the target lesion (6.3% versus 27.5%,
<jats:italic>P</jats:italic>
<0.0001) and of the total segment (12.6% versus 28.6%,
<jats:italic>P</jats:italic>
<0.007) after rhenium-188 brachytherapy compared with the control group. Target vessel revascularization rate was significantly lower in the rhenium-188 (6.3%) compared with the control group (19.8%,
<jats:italic>P</jats:italic>
=0.006).
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<jats:p>
<jats:bold>
<jats:italic>Conclusions—</jats:italic>
</jats:bold>
Intracoronary β-brachytherapy with a rhenium-188 liquid-filled balloon is safe and efficiently reduces restenosis and revascularization rates after coronary angioplasty.
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