Cutting balloon versus conventional balloon angioplasty for the treatment of in-stent restenosis
Key result
Cutting balloon angioplasty fails to reduce seven-month binary restenosis compared with conventional PTCA.
- P=0.82
- n=428
Why the study?
Does cutting balloon angioplasty reduce recurrent restenosis compared to conventional balloon angioplasty in patients with coronary in-stent restenosis?
Population
428 patients with all types of coronary in-stent restenosis
Comparison
Cutting balloon angioplasty (CBA) vs Conventional balloon angioplasty
Design
RCT, randomized
Follow-up
seven months
Authors
Discussion
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Implication
Cutting balloon angioplasty does not reduce recurrent in-stent restenosis compared to conventional angioplasty, though it offers some procedural advantages like less balloon slippage.
Key Points
- This trial aims to compare the effectiveness of cutting balloon angioplasty with conventional balloon angioplasty in treating coronary in-stent restenosis.
- Multicenter, randomized, prospective trial involving 428 patients with all types of in-stent restenosis.
- Patients received either cutting balloon angioplasty or conventional balloon angioplasty.
- Outcomes were assessed based on procedural metrics and binary restenosis rates at seven-month follow-up.
- In the CBA group, only one balloon was used in 82.3% of cases compared to 75% in the PTCA group (p=0.03).
- Balloon slippage occurred in 6.5% of the CBA group versus 25% in the PTCA group (p<0.01).
- The binary restenosis rate was similar between groups: CBA 29.8% vs PTCA 31.4% (p=0.82) at seven months.
Study Design
Type
RCT (n=428)
Randomization
randomized
Multicenter
Yes
Structured PICO
Does cutting balloon angioplasty reduce recurrent restenosis compared to conventional balloon angioplasty in patients with coronary in-stent restenosis?
P
Population
428 patients with all types of coronary in-stent restenosis, followed for 7 months.
I
Intervention
Cutting balloon angioplasty (CBA)
C
Comparator
Conventional balloon angioplasty (percutaneous transluminal coronary angioplasty [PTCA])
O
Outcome
Binary restenosis rate at seven-month angiographic follow-upsurrogate
Main Result
Absolute Event Rate: 29.8% vs 31.4%
p-value: p=0.82
Cutting balloon angioplasty does not reduce recurrent in-stent restenosis compared to conventional angioplasty, though it offers some procedural advantages like less balloon slippage.
Cite This Study
Albiero et al. (2004) conducted an RCT in coronary in-stent restenosis (ISR) (n=428). Cutting balloon angioplasty (CBA) vs. Conventional balloon angioplasty (PTCA) was evaluated on binary restenosis rate at seven-month angiographic follow-up (p=0.82). Cutting balloon angioplasty did not reduce the seven-month binary restenosis rate compared with conventional PTCA (29.8% vs 31.4%; p=0.82), despite some procedural advantages.