Dior paclitaxel-coated balloon failed to show non-inferiority to Taxus DES for percent diameter stenosis in small coronary vessels (43.6% vs. 24.3%, p=0.029).
RCT (n=57)
Does a paclitaxel-coated balloon improve percent diameter stenosis compared to a paclitaxel-eluting stent in patients with stable or unstable angina undergoing PCI of small coronary vessels?
The first-generation Dior paclitaxel-coated balloon failed to show non-inferiority to the Taxus drug-eluting stent in small coronary arteries, resulting in early trial termination due to worse angiographic and clinical outcomes.
Absolute Event Rate: 43.6% vs 24.3%
p-value: p=0.029
AIMS: After the excellent results of the PACCOCATH ISR and PEPCAD II trials in in-stent restenosis, paclitaxel-coated balloon (PCB) still has to prove its efficacy in native coronary disease. METHODS AND RESULTS: In the PICCOLETO randomised trial, patients with stable or unstable angina undergoing PCI of small coronary vessels (≤ 2.75 mm) were randomised to the Dior PCB (28 patients) or the Taxus DES (29 patients). The primary study endpoint was percent diameter stenosis at 6-month angiographic follow-up (non-inferiority); secondary endpoints were angiographic binary restenosis and major adverse cardiac events (MACE: death, Q-wave myocardial infarction, TLR) at 9-month follow-up (non-inferiority). The two groups were not dissimilar for clinical and angiographic data. The study was interrupted after enrolment of two-thirds of the patients due to a clear superiority of one study group. The primary endpoint was not met: the PCB group had higher percent diameter stenosis (43.6% vs. 24.3%, p=0.029), angiographic restenosis (32.1 vs. 10.3%, p=0.043), and higher occurrence of MACE (35.7% vs. 13.8%, p=0.054). CONCLUSIONS: Dior PCB failed to show equivalence to Taxus DES regarding angiographic endpoints during PCI of small coronary arteries. We hypothesise that it concerned the lack of efficacy of the device used (which has since been replaced by its second generation) rather than a class-effect in native coronary vessels.
Bernardo Cortese (Sun,) conducted a rct in stable or unstable angina undergoing PCI of small coronary vessels (n=57). Dior paclitaxel-coated balloon (PCB) vs. Taxus DES was evaluated on percent diameter stenosis at 6-month angiographic follow-up (p=0.029). Dior paclitaxel-coated balloon failed to show non-inferiority to Taxus DES for percent diameter stenosis in small coronary vessels (43.6% vs. 24.3%, p=0.029).
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