Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study.
BACKGROUND
Percutaneous coronary intervention (PCI) of small vessels is limited by an increased risk of restenosis and adverse outcome, even when drug-eluting stents (DES) are employed. In recent years, the paclitaxel-coated balloon (PCB) has been shown to reduce neointimal proliferation and the need for target lesion revascularization (TLR) in an in-stent restenosis setting. The impact of a PCB during PCI of small coronary vessels was evaluated and compared to one of the most widely used DES.


METHODS
In the PICCOLETO randomised clinical trial, patients with stable or unstable angina undergoing PCI of small coronary vessels (< or = 2.75 mm) were randomised to Dior PCB (28 patients) or Taxus DES (29 patients). The primary study end point was per cent diameter stenosis at 6-month angiographic follow-up (non-inferiority), secondary end points were angiographic binary restenosis and occurrence of major adverse cardiac events (MACE: death, Q-wave myocardial infarction, TLR) at 9 month follow-up.


RESULTS
The two groups were not dissimilar regarding clinical and angiographic characteristics. Study was interrupted after enrolment of two-thirds of patients due to a clear superiority of one study group. The primary end point was not met, because the PCB group showed higher per cent diameter stenosis (43.6% vs 24.3%, p=0.029); angiographic restenosis was higher as well (32.1 vs 10.3%, p=0.043), whereas MACE were 35.7% in the PCB group and 13.8% in the DES group (p=0.054).


CONCLUSIONS
Dior PCB failed to show equivalence to Taxus DES regarding angiographic end points during PCI of small coronary arteries. CLINICAL TRIAL REGISTRATION NUMBER (EUDRACT CODE): 2009-012268-15.
Cortese
Bernardo
B
Interventional Cardiology Unit, Cardiovascular Department, Ospedale della Misericordia, Grosseto, Italy. bcortese@gmail.com
Micheli
Andrea
A
Picchi
Andrea
A
Coppolaro
Amelia
A
Bandinelli
Loria
L
Severi
Silva
S
Limbruno
Ugo
U
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control; D023921:Coronary Stenosis / Q000188:drug therapy / Q000628:therapy*; D016503:Drug Delivery Systems / Q000295:instrumentation*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011859:Radiography; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D017239:Paclitaxel