Radiation Oncology/Benign/Vascular Brachytherapy/Randomized

De novo lesions: Stent +/- VBT

• BetAce, 2007 PMID 17307419 -- "Intracoronary beta-irradiation for the treatment of de novo lesions: 5-year clinical follow-up of the BetAce randomized trial." (Ferrero V, Am Heart J. 2007 Mar;153(3):398-402.)
  • Randomized. 64 de novo coronary lesions. Treated with 1) bare metal stents (control) vs. 2) intracoronary beta RT. Median F/U 5 years
  • EFS: 6-month control 35% vs. RT 13% (SS), 5-years: control 43% vs. RT 45% (NS)
  • Conclusion: Significant benefit at 6 months, no difference at 5 years

In-stent restenosis: VBT vs. drug-eluting stents

• Vienna; 2007 PMID 16971011 -- "Randomized comparison between intracoronary beta-radiation brachytherapy and implantation of paclitaxel-eluting stents for the treatment of diffuse in-stent restenosis." (Schukro C, Radiother Oncol. 2007 Jan;82(1):18-23. Epub 2006 Sep 12.). F/U 6 months
  • Randomized. 37 patients with diffuse in-stent restenosis. Arm 1) Beta-Cath vs. Arm 2) Taxus-Express2
  • Outcome: restenosis >50% Beta-Cath 3 patients vs. Taxus-Express2 0 patients (SS). No difference in major adverse cardiac outcomes.
  • Procedure time: Beta-Cath 60 min vs. Taxus-Express2 31 min (SS)
  • Conclusion: Significanly better restenosis rate in Taxus arm, no clinical difference

• TAXUS V ISR; 2006 (2003-2004) PMID 16531618 -- "Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial." (Stone GW, JAMA. 2006 Mar 15;295(11):1253-63.)
  • Randomized. 396 patients, in-stent restenosis of previously implanted bare-metal coronary stent. Treated with angioplasty plus beta-source vascular brachy vs. paclitaxel-eluting stent. DM in 35% patients. Angiography at 9 months
  • 9-month outcome: need for ischemic revascularization: 17% vs. 10% (SS); major cardiac events: VBT 20% vs. TAXUS 11% (SS); similar rate of cardiac death and MI (4-5%)
  • Conclusion: Paclitaxel-eluting stents better than VBT for in-stent restenosis

• SISR; 2006 (2003-2004) PMID 16531619 -- "Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial." (Holmes DR Jr, JAMA. 2006 Mar 15;295(11):1264-73.)
  • Randomized. 384 patients, in-stent restenosis of previously implanted bare-metal stent. Treated with VBT or sirolimus-eluting stent. Angiography at 9 months
  • 9-month outcome: need for revascularization: VBT 19% vs. sirolimus stent 8% (SS)
  • Conclusion: Sirolimus-eluting stents superior than VBT for in-stent restenosis