The PICCOLETO study and beyond.
OBJECTIVE
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.


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 We hypothesise that it concerned the lack of efficacy of the device used (which has since been replaced by its second generation) rather than a class-effect in native coronary vessels.
Interventional Cardiology, Cliniche Humanitas Gavazzeni, Bergamo, Italy. bcortese@gmail.com
Bernardo
B
Cortese
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D016503:Drug Delivery Systems / Q000295:instrumentation*; D054855:Drug-Eluting Stents; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel