Promising efficacy of primary gradual and prolonged balloon angioplasty in small coronary arteries: a randomized comparison with cutting balloon angioplasty and conventional balloon angioplasty.
BACKGROUND
Small vessel size represents a critical risk factor for an adverse outcome after both conventional balloon angioplasty (POBA) and stenting. Gradual and prolonged balloon angioplasty (GPBA) has been shown to cause less arterial trauma, which results in higher procedural success rates and fewer in-hospital complications than POBA. The aim of this study was to assess the clinical and angiographic benefits of primary GPBA with a perfusion balloon in small coronary arteries, as compared with cutting balloon angioplasty (CBA) and POBA.


METHODS
A total of 263 patients with symptoms and reference diameters <3.0 mm were randomly assigned to undergo GPBA (n = 85), CBA (n = 88), or POBA (n = 90). The cumulative inflation time must be >10 minutes in GPBA. Crossover to stent was allowed for inadequate results. Follow-up angiography was performed after 6 months. The primary end point was angiographic restenosis at follow-up.


RESULTS
Compared with POBA, GPBA resulted in a lower final residual diameter stenosis (27.3% vs 34.2%, P =.01) and decreased the need for stent placement (8.0% vs 22.2%, P =.031). At follow-up, the restenosis rates were lower with GPBA (31.3%, P =.034) and CBA (32.9%, P =.059) than POBA (50.6%). Target lesion revascularization was less frequently needed with GPBA (20.5%, P =.043) and CBA (20.0%, P =.033) than POBA (37.6%). Additionally, the event-free survival rate was higher with GPBA (77.1%, P =.033) and CBA (76.4%, P =.047) than POBA (58.8%).


CONCLUSIONS
In small coronary arteries, both GPBA and CBA resulted in favorable angiographic and clinical outcomes. With a lower restenosis rate and target lesion revascularization rate, GPBA may be a superior strategy for small vessels compared with POBA.
Umeda
Hisashi
H
Division of Cardiology, Aichi Prefuctural Owari Hospital, Ichinomiya, Japan.
Iwase
Mitsunori
M
Kanda
Hirohumi
H
Izawa
Hideo
H
Nagata
Kohzo
K
Ishiki
Ryoji
R
Sawada
Ken
K
Murohara
Toyoaki
T
Yokota
Mitsuhiro
M
D000368:Aged; D000704:Analysis of Variance; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D017225:Atherectomy, Coronary / Q000379:methods; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000517:prevention & control; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D003331:Coronary Vessels / Q000473:pathology*; D018592:Cross-Over Studies; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018709:Statistics, Nonparametric; D015607:Stents; D016896:Treatment Outcome