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Paclitaxel-coated Versus Uncoated Balloon Angioplasty Reduces Target Lesion Revascularization in Patients With Femoropopliteal Arterial Disease: A Meta-Analysis of Randomized Trials

Paclitaxel-coated Versus Uncoated Balloon Angioplasty Reduces Target Lesion Revascularization in Patients With Femoropopliteal Arterial Disease: A Meta-Analysis of Randomized Trials

Salvatore Cassese, Robert A Byrne, Ilka Ott, Gjin Ndrepepa, Mateja Nerad, Adnan Kastrati, Massimiliano Fusaro

Circ Cardiovasc Interv. 2012 Aug 1;5(4):582-9.

PMID: 22851526

Abstract:

Background:
In disease of the femoropopliteal artery, paclitaxel-coated balloon (PCB) therapy improved angiographic outcomes as compared with uncoated balloon (UCB) angioplasty. Nevertheless, it remains uncertain whether PCB may reduce the need for reintervention.
Methods and results:
We searched Medline, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), scientific session abstracts, and relevant web sites for trials of PCB versus UCB angioplasty. Key words were: "superficial femoral artery," "popliteal artery," "angioplasty," "drug-eluting balloon," "paclitaxel-eluting balloon," and "randomized trial." Inclusion criteria were: (1) randomized design; (2) intention-to-treat analysis; and (3) ≥6-month follow-up. Exclusion criteria were: (1) vessel treated other than femoropopliteal artery; (2) device used other than PCB/UCB; and (3) irretrievable or duplicated data. No restrictions (language, publication date, or status) were applied. The primary end point was target lesion revascularization. Secondary end points were: angiographic binary restenosis and late lumen loss and all-cause mortality. A total of 381 patients enrolled in 4 randomized trials were included (PCB, n=186 versus UCB, n=195). Median follow-up was 10.3 months. Angioplasty with PCB versus UCB reduces target lesion revascularization (12.2% versus 27.7%; OR, 0.22; 95% CI, 0.13-0.38; P<0.00001), angiographic restenosis (18.7% versus 45.5%; OR, 0.26; 95% CI, 0.14-0.48; P<0.0001), and late lumen loss (range, -0.05 to 0.50 mm versus 0.61-1.7 mm; weighted mean difference, -0.75 mm; 95% CI, -1.06 to -0.45; P<0.00001). No mortality difference was observed for PCB versus UCB (2.1% versus 3.2%; OR, 0.99; 95% CI, 0.39-2.49; P=0.98).
Conclusions:
In femoropopliteal arterial disease, PCB therapy is associated with superior antirestenotic efficacy as compared with UCB angioplasty with no evidence of a differential safety profile.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP37680652	PCB No 18		37680-65-2	Price

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