The PICCOLETO study and beyond.

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 We hypothesise that it concerned the lack of efficacy of the device used (which has since been replaced by its second generation) rather than a class-effect in native coronary vessels.