Angiographic and Clinical Outcome after Cutting Balloon Angioplasty

To evaluate the safety and efficacy of cutting balloon angioplasty, we reviewed the early angiographic and clinical outcomes of 160 consecutive patients with 173 lesions undergoing this procedure. Angiographic core laboratory analysis was available in 150 of these lesions. Eccentricity was the most common (49%) unfavorable pre-procedural morphologic feature; other morphologic findings included length ³ 10 mm (28%), calcification (23%), angulation ³ 45 degrees (13%), irregularity (7%), ostial location (3%), and thrombus (1%). ÒStand-aloneÓ cutting balloon angioplasty was performed in 106 (71%) lesions and an adjunct balloon or new device was used in 44 (29%) lesions to treat a residual stenosis > 40% after cutting balloon angioplasty. The reference artery size was 2.80 +/- 0.42 mm. The 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 stenosis ) was obtained in 145 (97%) lesions. The residual stenosis was higher 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 ratios in those lesions with and without dissections after cutting balloon use (1.00 +/- 0.11 versus 0.97 +/- 0.13, respectively; p = 0.29). A significant inverse relationship between the cutting balloon:artery ratio and the final % diameter stenosis was noted (R = 0.33; p = 0.0003). There were no major in-hospital complications after cutting balloon use. This series demonstrates the safety and efficacy of cutting balloon angioplasty as an alternative to conventional balloon angioplasty in patients with non complex coronary artery disease. A multicenter, randomized comparison of cutting balloon angioplasty with conventional balloon angioplasty for prevention of restenosis is currently underway.