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Serial volumetric intravascular ultrasound analysis of the efficacy of beta irradiation in preventing recurrent in-stent restenosis

      Stents have been shown to reduce restenosis; however, in-stent restenosis has become a major clinical problem.
      • Mintz G.S
      • Mehran R
      • Waksman R
      • Pichard A.D
      • Kent K.M
      • Satler L.F
      • Leon M.B
      Treatment of in-stent restenosis.
      ,
      • Mehran R
      • Mintz G.S
      • Satler L.F
      • Pichard A.D
      • Kent K.M
      • Bucher T.A
      • Popma J.J
      • Leon M.B
      Treatment of in-stent restenosis with excimer laser coronary angioplasty. Mechanisms and results compared to PTCA alone.
      Intracoronary irradiation (brachytherapy) is a promising approach to prevent or treat restenosis.
      • Liermann D.D
      • Boettcher H.D
      • Kollatch J
      • Schopol B
      • Strassman G
      • Strecker E.P
      • Breddin K.H
      Prophylactic endovascular radiotherapy to prevent intimal hyperplasia after stent implantation in femoro-popliteal arteries.
      ,
      • Condado J.A
      • Waksman R
      • Gurdiel O
      • Espinosa R
      • Gonzalez J
      • Burger B
      • Villoria G
      • Acquatella H
      • Crocker I.R
      • Seung K.B
      • Liprie S.F
      Long-term angiographic and clinical outcome after percutaneous transluminal coronary angioplasty and intracoronary radiation therapy in humans.
      ,
      • Teirstein P.S
      • Massullo V
      • Jani S
      • Popma J.J
      • Mintz G.S
      • Russo R.J
      • Schatz R.A
      • Guarneri E.M
      • Steuterman S
      • Morris N.B
      • Leon M.B
      • Tripuraneni P
      Catheter-based radiotherapy to inhibit restenosis after coronary stenting.
      Animal studies have shown reduction in neointima formation both with γ and β radiation.
      • Wiedermann J.G
      • Marboe C
      • Amols H
      • Schwartz A
      • Weinberger J
      Intracoronary irradiation markedly reduces restenosis after balloon angioplasty in a porcine model.
      ,
      • Waksman R
      • Robinson K.A
      • Crocker I.R
      • Gravanis M.B
      • Cipolla G.D
      • King III, S.B
      Endovascular low-dose irradiation inhibits neointima formation after coronary artery balloon injury in swine. A possible role for radiation therapy in restenosis prevention.
      ,
      • Waksman R
      • Robinson K.A
      • Crocker I.R
      • Gravanis M.B
      • Palmer S.J
      • Wang C
      • Cipolla G.D
      • King III, S.B
      Intracoronary radiation before stent implantation inhibits neointima formation in stented porcine coronary arteries.
      ,
      • Waksman R
      • Robinson K.A
      • Crocker I.R
      • Wang C
      • Gravanis M.B
      • Cipolla G.D
      • Hillstead R.A
      • King III, S.B
      Intracoronary low-dose beta-irradiation inhibits neointima formation after coronary artery balloon injury in the swine restenosis model.
      ,
      • Verin V
      • Popowski Y
      • Urban P
      • Belenger J
      • Redard M
      • Costa M
      • Widmer M.C
      • Rouzaud M
      • Nouet P
      • Grob E
      • et al.
      Intra-arterial beta irradiation prevents neointimal hyperplasia in a hypercholesterolemic rabbit restenosis model.
      In randomized clinical trials, γ radiation has been shown to reduce recurrent in-stent restenosis,
      • Condado J.A
      • Waksman R
      • Gurdiel O
      • Espinosa R
      • Gonzalez J
      • Burger B
      • Villoria G
      • Acquatella H
      • Crocker I.R
      • Seung K.B
      • Liprie S.F
      Long-term angiographic and clinical outcome after percutaneous transluminal coronary angioplasty and intracoronary radiation therapy in humans.
      ,
      • Waksman R
      • White L
      • Chan R
      • Porrazo M.S
      • Bass B.G
      • Satler L.F
      • Kent K.M
      • Geirlach L.M
      • Mehran R
      • Murphy M
      • Mintz G.S
      • Leon M.B
      Intracoronary radiation therapy for patients with in-stent restenosis 6 month follow-up of a randomized clinical study.
      ,
      • Leon M.B
      • Teirstein P.S
      • Lansky A.J
      • Moses J.W
      • Wong S.C
      • Willerson J.T
      • Ellis S.G
      • Nawaz D.M
      • Kereikas D.J
      • Hermiller J.B
      • Holmes D.R
      • George B.S
      • Kluck B.W
      • Kuntz R.E
      Intracoronary gamma radiation to reduce instent restenosis the multicenter Gamma-I randomized clinical trial (abstr).
      but the safety, handling, and prolonged dwell times with γ sources are considered practical limitations. On the other hand, β emitters are less penetrating, have shorter dwell times, cause less exposure to patients and personnel, and require less shielding. Although limited preclinical studies found β emitters to be efficacious,
      • Waksman R
      • Robinson K.A
      • Crocker I.R
      • Wang C
      • Gravanis M.B
      • Cipolla G.D
      • Hillstead R.A
      • King III, S.B
      Intracoronary low-dose beta-irradiation inhibits neointima formation after coronary artery balloon injury in the swine restenosis model.
      ,
      • Verin V
      • Popowski Y
      • Urban P
      • Belenger J
      • Redard M
      • Costa M
      • Widmer M.C
      • Rouzaud M
      • Nouet P
      • Grob E
      • et al.
      Intra-arterial beta irradiation prevents neointimal hyperplasia in a hypercholesterolemic rabbit restenosis model.
      the preliminary clinical results were not conclusive.
      • Verin V
      • Urban P
      • Popowski Y
      • Schwager M
      • Nouet P
      • Dorsaz P.A
      • Chatelain P
      • Kurtz J.M
      • Rutishauser W
      Feasibility of intracoronary beta-irradiation to reduce restenosis after balloon angioplasty. A clinical pilot study.
      ,
      • King S.B
      • Williams D.O
      • Chougule P
      • Klein J.L
      • Waksman R
      • Hilstead R
      • MacDonald J
      • Andergerg K
      • Crocker I.R
      Endovascular beta-radiation to reduce restenosis after coronary balloon angioplasty. results of the beta energy restenosis trial (BERT).
      The rapid falloff of the radial dose, low penetration, and potential problem of shielding of β radiation by stents are concerns, especially for the treatment for in-stent restenosis.
      • Amols H.I
      • Trichter F
      • Weinberger J
      Intracoronary radiation for prevention of restenosis dose perturbations caused by stents.
      The present study uses serial (postintervention and follow-up) volumetric intravascular ultrasound (IVUS) analysis to assess the efficacy of β irradiation in preventing recurrent in-stent restenosis.
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