To evaluate the safety and efficacy of cutting balloon angioplasty, we
reviewed the early angiographic and clinical outcomes of 160 consecut
ive patients with 173 lesions undergoing this procedure. Angiographic
core laboratory analysis was available in 150 of these lesions. Eccent
ricity was the most common (49%) unfavorable pre-procedural morphologi
c feature; other morphologic findings included length greater than or
equal to 10 mm (28%), calcification (23%), angulation greater than or
equal to 45 degrees (13%), irregularity (7%), ostial location (3%), an
d thrombus (1%). ''Stand-alone'' cutting balloon angioplasty was perfo
rmed in 106 (71%) lesions and an adjunct balloon or new device was use
d in 44 (29%) lesions to treat a residual stenosis >40% after cutting
balloon angioplasty. The reference artery size was 2.80 +/- 0.42 mm. T
he minimal lumen diameter increased from 1.02 +/- 0.30 mm to 2.01 +/-
0.42 mm (p<0.001) and the % diameter stenosis was reduced from 64 +/-
9% to 29 +/- 12% (p<0.001). Angiographic success (<50% diameter stenos
is) was obtained in 145 (97%) lesions. The residual stenosis was highe
r in lesions treated with stand-alone cutting balloon angioplasty than
in those undergoing adjunct balloon or new device angioplasty (31 +/-
10 versus 24 +/- 14; p=0.0006). The average cutting balloon:artery ra
tio was 0.98 +/- 0.12 (range 0.64-1.34). There were no differences in
the cutting balloon:artery ratios in those lesions with and without di
ssections after cutting balloon use (1.00+/-0.11 versus 0.97+/-0.13, r
espectively; p=0.29). A significant inverse relationship between the c
utting balloon:artery ratio and the final % diameter stenosis was note
d (R=0.33; p=0.0003). There were no major in-hospital complications af
ter cutting balloon use. This series demonstrates the safety and effic
acy of cutting balloon angioplasty as an alternative to conventional b
alloon angioplasty in patients with non complex coronary artery diseas
e. A multicenter, randomized comparison of cutting balloon angioplasty
with conventional balloon angioplasty for prevention of restenosis is
currently underway.