A Randomized, Multicenter, Single-Blinded Trial Comparing Paclitaxel-Coated Balloon Angioplasty With Plain Balloon Angioplasty in Drug-Eluting Stent Restenosis
Key result
Paclitaxel-coated balloons reduce late lumen loss ~58% vs uncoated balloons for DES restenosis.
- P<0.001
- n=110
Why the study?
The impact of paclitaxel-coated balloon angioplasty compared with uncoated balloon angioplasty for treatment of drug-eluting stent restenosis was not well defined.
Does paclitaxel-coated balloon angioplasty reduce late lumen loss compared to uncoated balloon angioplasty in patients with drug-eluting stent restenosis?
Population
110 patients with drug-eluting stent restenoses in native coronary arteries
Comparison
Paclitaxel-coated balloon angioplasty vs uncoated balloon angioplasty
Design
Prospective, single-blind, multicenter, randomized trial
Follow-up
6 months
Authors
Discussion
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Implication
Paclitaxel-coated balloon angioplasty significantly reduces late lumen loss and composite clinical endpoints compared to plain balloon angioplasty for the treatment of drug-eluting stent restenosis.
Key Points
- To evaluate the efficacy and clinical safety of paclitaxel-coated balloon angioplasty compared to uncoated plain balloon angioplasty for treating coronary drug-eluting stent restenosis.
- Conducted a prospective, single-blind, multicenter randomized trial enrolling 110 patients with drug-eluting stent restenosis in a native coronary artery (NCT00998439).
- Assigned patients to paclitaxel-coated balloon angioplasty or uncoated plain balloon angioplasty, accompanied by 6 months of dual antiplatelet therapy.
- Evaluated late lumen loss as the primary endpoint and a composite of cardiac death, target-vessel myocardial infarction, or target lesion revascularization as the secondary clinical endpoint at 6-month angiographic follow-up.
- Paclitaxel-coated balloon angioplasty was superior to plain balloon angioplasty for late lumen loss, achieving 0.43 ± 0.61 mm versus 1.03 ± 0.77 mm (p < 0.001).
- Angiographic restenosis was significantly lower in the paclitaxel-coated balloon group compared with the plain balloon group (17.2% vs. 58.1%, p < 0.001).
- The secondary composite clinical endpoint occurred in 16.7% of patients receiving paclitaxel-coated balloons compared to 50.0% receiving plain balloons (p < 0.001).
Study Design
Type
RCT (n=110)
Blinding
Single-blind
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does paclitaxel-coated balloon angioplasty reduce late lumen loss compared to uncoated balloon angioplasty in patients with drug-eluting stent restenosis?
P
Population
110 patients with drug-eluting stent restenoses located in a native coronary artery, with angiographic follow-up at 6 months.
I
Intervention
Paclitaxel-coated balloon angioplasty, with dual antiplatelet therapy prescribed for 6 months
C
Comparator
Uncoated balloon angioplasty alone, with dual antiplatelet therapy prescribed for 6 months
O
Outcome
Late lumen loss at 6 months angiographic follow-upsurrogate
Main Result
Absolute Event Rate: 0.43% vs 1.03%
p-value: p=<0.001
Paclitaxel-coated balloon angioplasty significantly reduces late lumen loss and composite clinical endpoints compared to plain balloon angioplasty for the treatment of drug-eluting stent restenosis.
Cite This Study
Rittger et al. (2012) conducted an RCT in Drug-eluting stent restenosis (n=110). Paclitaxel-coated balloon angioplasty vs. Uncoated balloon angioplasty was evaluated on Late lumen loss (p=<0.001). Paclitaxel-coated balloon angioplasty was superior to uncoated balloon angioplasty for drug-eluting stent restenosis, significantly reducing late lumen loss (0.43 vs 1.03 mm; P<0.001).