Treatment of diffuse in-stent restenosis with drug-eluting stents vs. intracoronary beta-radiation therapy: INDEED Study.

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 > or = 10 mm) were randomly assigned to either SES implantation (n=65, group I) or beta-radiation with 188Re-MAG(3)-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.

• Authors: Seong-Wook Park, Seung-Whan Lee, Bon Kwon Koo, Duk-Woo Park, Se-Whan Lee, Young-Hak Kim, Cheol Whan Lee, Myeong-Ki Hong, Jae-Joong Kim, Ken Mori, Alexandra J Lansky, Gary S Mintz, Myoung-Mook Lee, Seung-Jung Park
• Journal: International journal of cardiology (Int J Cardiol) Vol. 131 Issue 1 Pg. 70-7 (Dec 17 2008) ISSN: 1874-1754 [Electronic] Netherlands
• PMID: 18190986 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Sirolimus

Topics

• Aged
• Brachytherapy (adverse effects, trends)
• Coronary Restenosis (etiology, radiotherapy, surgery)
• Drug-Eluting Stents (adverse effects, trends)
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Sirolimus (administration & dosage)