Endoluminal Beta-Radiation Therapy for the Prevention of Coronary Restenosis after Balloon Angioplasty
Vitali Verin, M.D., Youri Popowski, M.D., Bernard de Bruyne, M.D., Dietrich Baumgart, M.D., Wolfgang Sauerwein, M.D., Markus Lins, M.D., Gyorgy Kovacs, M.D., Martyn Thomas, M.D., Francis Calman, M.D., Clemens Disco, M.Sc., Patrick W. Serruys, M.D., William Wijns, M.D., Marleen Piessens, Ph.D., John Kurtz, M.D., Ruediger Simon, M.D., Patrice Delafontaine, M.D., Raimund Erbel, M.D., for The Dose-Finding Study Group
Background Beta radiation is effective in reducing vascularneointimal proliferation in animals after injury caused by balloonangioplasty. However, the lowest dose that can prevent restenosisafter coronary angioplasty has yet to be determined.
Methods After successful balloon angioplasty of a previouslyuntreated coronary stenosis, 181 patients were randomly assignedto receive 9, 12, 15, or 18 Gy of radiation delivered by a centeredyttrium-90 source. Adjunctive stenting was required in 28 percentof the patients. The primary end point was the minimal luminaldiameter six months after treatment, as a function of the delivereddose of radiation.
Results At the time of follow-up coronary angiography, the meanminimal luminal diameter was 1.67 mm in the 9-Gy group, 1.76mm in the 12-Gy group, 1.83 mm in the 15-Gy group, and 1.97mm in the 18-Gy group (P=0.06 for the comparison of 9 Gy with18 Gy), resulting in restenosis rates of 29 percent, 21 percent,16 percent, and 15 percent, respectively (P=0.14 for the comparisonof 9 Gy with 18 Gy). At that time, 86 percent of the patientshad had no serious cardiac events. In 130 patients treated withballoon angioplasty without a stent, restenosis rates were 28percent, 17 percent, 16 percent, and 4 percent, respectively(P= 0.02 for the comparison of 9 Gy with 18 Gy). Among thesepatients, there was a dose-dependent enlargement of the lumenin 28 percent, 50 percent, 45 percent, and 74 percent of patients,respectively (P<0.001 for the comparison of 9 Gy with 18Gy). The rate of repeated revascularization was 18 percent with9 Gy and 6 percent with 18 Gy (P=0.26).
Conclusions Intracoronary beta-radiation therapy produces asignificant dose-dependent decrease in the rate of restenosisafter angioplasty. An 18-Gy dose not only prevents the renarrowingof the lumen typically observed after successful balloon angioplasty,but actually induces luminal enlargement.
Source Information
From the University Hospital, Geneva (V.V., Y.P.); the Cardiovascular Center, Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium (B.B., W.W.); the University Hospital, Essen, Germany (D.B., W.S.); the University Hospital, Kiel, Germany (M.L., G.K.); King's College Hospital, London (M.T., F.C.); and Cardialysis and Erasmus University, Rotterdam, the Netherlands (C.D., P.W.S.). Other authors were Marleen Piessens, Ph.D., Cardiovascular Center, Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium; John Kurtz, M.D., University Hospital, Geneva; Ruediger Simon, M.D., University Hospital, Kiel, Germany; Patrice Delafontaine, M.D., University Hospital, Geneva; and Raimund Erbel, M.D., University Hospital, Essen, Germany.
Address reprint requests to Dr. Wijns at the Cardiovascular Center, OLV Hospital, B 9300 Aalst, Belgium, or at william.wijns{at}olvz-aalst.be.
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