Interventional Cardiology Unit, Cardiovascular Department, Ospedale della Misericordia, Grosseto, Italy.
Heart. 2010 Aug;96(16):1291-6. doi: 10.1136/hrt.2010.195057.
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.
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.
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).
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.
即使使用药物洗脱支架（DES），小血管经皮冠状动脉介入治疗（PCI）的再狭窄和不良预后风险仍然增加。近年来，紫杉醇涂层球囊（PCB）已被证明可减少支架内再狭窄患者的新生内膜增殖和靶病变血运重建（TLR）的需要。本研究评估了 PCB 在小冠状动脉 PCI 中的作用，并与最广泛使用的 DES 之一进行了比较。
在 PICCOLETO 随机临床试验中，接受小冠状动脉（<或=2.75mm）PCI 的稳定性或不稳定性心绞痛患者被随机分为 Dior PCB 组（28 例）或 Taxus DES 组（29 例）。主要研究终点为 6 个月血管造影随访时的百分比直径狭窄（非劣效性），次要终点为血管造影二元再狭窄和 9 个月随访时的主要不良心脏事件（MACE：死亡、Q 波心肌梗死、TLR）的发生。
两组患者的临床和血管造影特征无明显差异。由于一个研究组的明显优势，在入组三分之二的患者后研究被中断。主要终点未达到，因为 PCB 组的百分比直径狭窄更高（43.6%比 24.3%，p=0.029）；血管造影再狭窄也更高（32.1%比 10.3%，p=0.043），而 PCB 组的 MACE 发生率为 35.7%，DES 组为 13.8%（p=0.054）。
在小冠状动脉 PCI 中，Dior PCB 未能在血管造影终点方面显示与 Taxus DES 等效。临床试验注册号（EUDRACT 代码）：2009-012268-15。
