Percutaneous lower extremity arterial interventions using plain balloon angioplasty vs. cryoplasty with the PolarCath®: a randomized trial




Background


Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) vs. cryoplasty (CRYO) in the treatment of de novo infrainguinal disease has not been well defined in randomized trials.




Methods


In this prospective, two-center randomized trial of PTA vs. CRYO of infrainguinal vessels, the primary endpoint of TLR was evaluated at 6 months. Secondary endpoints included the rate of bailout stenting because of suboptimal acute angiographic results (defined as a residual narrowing of ≥30% or type C or higher dissection) and target vessel revascularization (TVR). Major Adverse events including death and amputations were recorded. A two-sample t test was used to compare the two groups on the continuous variables. For categorical variables, cross-tabular analysis was conducted with nonparametric tests ( χ 2 and Fisher’s Exact Test) used to test for significant differences.

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Nov 16, 2017 | Posted by in CARDIOLOGY | Comments Off on Percutaneous lower extremity arterial interventions using plain balloon angioplasty vs. cryoplasty with the PolarCath®: a randomized trial

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