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.
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.
Lee
Seung-Whan
SW
Department of Medicine, Soonchunhyang University, Bucheon Hospital, Bucheon, Korea.
Park
Seong-Wook
SW
Hong
Myeong-Ki
MK
Kim
Young-Hak
YH
Han
Ki Hoon
KH
Moon
Dae Hyuk
DH
Oh
Seung Jun
SJ
Lee
Cheol Whan
CW
Kim
Jae-Joong
JJ
Park
Seung-Jung
SJ
D000800:Angioplasty, Balloon / Q000379:methods*; D017225:Atherectomy, Coronary / Q000379:methods*; D001918:Brachytherapy; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use*; D009942:Organometallic Compounds / Q000627:therapeutic use*; D011446:Prospective Studies
D009842:Oligopeptides; D009942:Organometallic Compounds; C114893:rhenium-mercaptoacetyltriglycine