Comparison of angiographic and clinical outcomes between rotational atherectomy and cutting balloon angioplasty followed by radiation therapy with a rhenium 188-mercaptoacetyltriglycine-filled balloon in the treatment of diffuse in-stent restenosis

Am Heart J. 2005 Sep;150(3):577-82. doi: 10.1016/j.ahj.2004.10.011.

Abstract

Background: Rotational atherectomy (RA) and cutting balloon angioplasty (CBA) have been shown to effectively dilate in-stent restenosis (ISR). It is not known, however, which of these technique, when followed by beta-radiation, is more effective. Therefore, we performed a prospective randomized study comparing RA and CBA before beta-radiation therapy for diffuse ISR.

Methods: Patients with diffuse ISR were randomly assigned to receive RA (group 1, n = 58) or CBA (group 2, n = 55) before beta-radiation therapy with a rhenium 188-mercaptoacetyltriglycine-filled balloon, with the radiation dose being 18 Gy at a depth of 1.0 mm into the vessel wall. The primary end point was angiographic restenosis at 6 months, and the secondary end point was major adverse cardiac events (myocardial infarction, death, target lesion revascularization) at 9 months.

Results: The 2 groups were similar in baseline characteristics. Mean lesion length was 21.0 +/- 11.2 mm in group 1 and 20.8 +/- 10.2 mm in group 2 (P = .77). Radiation was delivered successfully to all patients. We obtained 6-month angiographic follow-up in 90 patients (80%). The rates of angiographic restenosis were 14.9% (7 of 47) in group 1 and 14.0% (6 of 43) in group 2 (P = .89). No patient experienced myocardial infarction or death during the 9-month follow-up period. Rates of target lesion revascularization or major adverse cardiac events were 3.4% in group 1 and 3.6% in group 2 (P = .94) during the 9-month follow-up.

Conclusions: Either RA or CBA, followed by beta-radiation using a rhenium 188-mercaptoacetyltriglycine-filled balloon, is equally safe and effective for diffuse ISR in 6-month angiographic and 9-month clinical outcomes.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angioplasty, Balloon / methods*
  • Atherectomy, Coronary / methods*
  • Brachytherapy*
  • Combined Modality Therapy
  • Coronary Angiography*
  • Coronary Restenosis / therapy*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Oligopeptides / therapeutic use*
  • Organometallic Compounds / therapeutic use*
  • Prospective Studies

Substances

  • Oligopeptides
  • Organometallic Compounds
  • rhenium-mercaptoacetyltriglycine