Key result
Balloon angioplasty plus cilostazol resulted in a 6-month angiographic restenosis rate of 13.2% compared to 24.5% with primary stenting in small coronary artery disease (P=0.11).
Why the study?
Does balloon angioplasty plus cilostazol reduce 6-month angiographic restenosis compared to primary stenting in small coronary artery disease?
RCT (n=106)
Does balloon angioplasty plus cilostazol reduce 6-month angiographic restenosis compared to primary stenting in small coronary artery disease?
Absolute Event Rate: 13.2% vs 24.5%
p-value: p=0.11
Balloon angioplasty plus cilostazol showed a non-significant trend toward lower angiographic restenosis compared to primary stenting in small coronary arteries.
Does not support changing practice; leaves open a possible benefit of angioplasty plus cilostazol in small vessels.
Efficacy of primary stenting in small coronary artery disease is still controversial. Cilostazol has been reported to control restenosis after balloon angioplasty (BA). The aim was to compare primary stenting with BA plus cilostazol administration in small coronary artery disease. Of 106 lesions located in small coronary artery (reference < 3.0 mm), 50 lesions were randomly assigned to the stenting and 56 lesions to the BA-cilostazol group. Multilink stent was implanted in the stenting group. In the BA-cilostazol group, cilostazol (200 mg/day) without aspirin was administered for 6 months after BA. Ticlopidine was given for 1 month when bailout stent was implanted. Serial quantitative angiography was performed at the procedure and 6 months. The primary endpoint was 6-month angiographic restenosis. Clinical event rates at 1 year were also assessed. Baseline characteristics were similar. All procedures were successful. Bailout stenting was performed in three lesions in the BA-cilostazol group. No side effects of cilostazol were observed. Postprocedural lumen diameter was significantly larger (2.69 vs. 2.03 mm; P < 0.0001) in the stenting group. However, the follow-up lumen diameter was not different (1.76 vs. 1.85 mm, stenting vs. BA-cilostazol). Although the difference was not statistically significant, restenosis rate was lower in the BA-cilostazol group (13.2% vs. 24.5%; P = 0.11). Subacute thrombosis occurred in one patient and target revascularization rate was higher in the stenting group (22.0% vs. 10.7%; P = 0.10). BA plus cilostazol administration seems to be a favorable strategy for small coronary artery disease.
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Tsuchikane et al. (2004) conducted an RCT in Small coronary artery disease (n=106). Balloon angioplasty plus cilostazol vs. Primary stenting was evaluated on 6-month angiographic restenosis (p=0.11). Balloon angioplasty plus cilostazol resulted in a 6-month angiographic restenosis rate of 13.2% compared to 24.5% with primary stenting in small coronary artery disease (P=0.11).
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