Treatment of diffuse IN-stent restenosis with Drug-Eluting stents vs. intracoronary bEta-raDiation therapy: INDEED Study

Seong Wook Park, Seung Whan Lee, Bon Kwon Koo, Duk Woo Park, Se Whan Lee, Young Hak Kim, Cheol Whan Lee, Myeongki Hong, Jae Joong Kim, Ken Mori, Alexandra J. Lansky, Gary S. Mintz, Myoung Mook Lee, Seung Jung Park

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Abstract

Background: We compared sirolimus-eluting stent (SES) implantation and intracoronary brachytherapy (ICBT) for diffuse bare metal in-stent restenosis (ISR) to identify more effective treatment modality. Methods: Patients (n = 129) with diffuse ISR (lesion length ≥ 10 mm) were randomly assigned to either SES implantation (n = 65, group I) or beta-radiation with 188Re-MAG3-filled balloon (n = 64, group II). The radiation dose was 20 Gy at a depth of 1.0 mm into the vessel wall. The primary end point was late loss in analysis segment at 6 months. The secondary end points were 6-month angiographic restenosis and 1-year major adverse cardiac events (MACE) including myocardial infarction (MI), cardiac death, and target lesion revascularization (TLR). Results: Baseline characteristics were similar between two groups. The lesion length was 27.52 ± 13.98 mm in group I and 27.75 ± 14.25 mm in group II (p = 0.927). Late loss in analysis segment at 6 months was smaller in group I than in group II (0.15 ± 0.62 vs. 0.55 ± 0.69 mm, p = 0.003). Angiographic restenosis for analysis segment at 6 months was 8.0% (4/50) in group I and 30.2% (16/53) in group II (p = 0.006). One MI and two deaths (all from group I) occurred during follow-up. TLR (4.6% vs. 18.8%, p = 0.014) and MACEs (7.7% vs. 18.8%, p = 0.073) were lower in group I than group II at 1 year. Conclusion: Compared to ICBT, SES implantation for diffuse bare metal ISR showed less late loss, lower restenosis, and a trend toward lower 1-year MACEs. SES implantation appears to be superior to ICBT for treating diffuse ISR.

Original languageEnglish
Pages (from-to)70-77
Number of pages8
JournalInternational Journal of Cardiology
Volume131
Issue number1
DOIs
Publication statusPublished - 2008 Dec 17

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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    Park, S. W., Lee, S. W., Koo, B. K., Park, D. W., Lee, S. W., Kim, Y. H., Lee, C. W., Hong, M., Kim, J. J., Mori, K., Lansky, A. J., Mintz, G. S., Lee, M. M., & Park, S. J. (2008). Treatment of diffuse IN-stent restenosis with Drug-Eluting stents vs. intracoronary bEta-raDiation therapy: INDEED Study. International Journal of Cardiology, 131(1), 70-77. https://doi.org/10.1016/j.ijcard.2007.09.003