Propensity Score-Matched Analysis of Patients Treated With Paclitaxel-Coated Versus Uncoated Balloons

Abstract

Paclitaxel (PTX)-coated balloons have been shown to decrease restenosis rates, but their use has been linked to a potential increase in late mortality. The purpose of this study was to examine 4-year outcomes after angioplasty with PTX compared with a matched control group treated without PTX. We retrospectively reviewed 1424 consecutive patients who underwent femoropopliteal artery intervention by angioplasty, atherectomy, stent placement, or combination between 2011 and 2019. Primary outcome measures were survival, amputation-free survival, freedom from major amputation, and freedom from target vessel revascularization (FF-TVR). Groups were divided into patients who received PTX and those who did not. Patients were propensity score matched 1:1 with respect to comorbidities and Rutherford class using a caliper width of 0.001 without replacement. Data were analyzed using Kaplan-Meier survival analysis, with log-rank P < .05 considered significant. Multivariable analyses used Cox proportional hazards. There were 1424 patients (PTX, n = 830; non-PTX, n = 594) who were propensity score matched, yielding 529 PTX and 529 non-PTX patients. After matching, all comorbidities were similar (P > .20), including presence of chronic limb-threatening ischemia (CLTI; 70.3% vs 67.1%; P = .29), diabetes (59.2% vs 58.2%; P = .80), chronic kidney disease (CKD; 36.3% vs 34.6%; P = .61), and smoking (72.4% vs 72.0%; P = .95). Through 4-year follow-up, patients in the PTX group demonstrated superior survival (Fig 1; 62.1% vs 51.8%; P = .04), amputation-free survival (Fig 2; 59.3% vs 46.4%; P = .0003), and freedom from major amputation (Fig 2; 91.3% vs 85.5%; P = .001). FF-TVR showed a benefit for PTX out to 3 years (year 1, 87.0% vs 80.2% [P = .003]; year 2, 81.4% vs 76.4% [P = .01]; year 3, 76.5% vs 74.8% [P = .047]). FF-TVR rates were similar at 4 years (73.6% vs 71.0%; P = .052). Multivariable Cox regression found that age, CLTI, CKD, diabetes, and hyperlipidemia were associated with mortality and that age, CLTI, CKD, and smoking history were associated with amputation. In a propensity score-matched analysis, patients treated with PTX achieved greater survival, amputation-free survival, and freedom from major amputation through 4-year follow-up than matched non-PTX patients. In addition, FF-TVR was higher in PTX patients until year 3 and became similar to that of non-PTX patients at year 4.Fig 2Kaplan-Meier survival analysis of freedom from major amputation (FF-Amp, gray lines) and amputation-free survival (AFS, black lines) based on the use of paclitaxel (PTX). SE, Standard error.View Large Image Figure ViewerDownload Hi-res image Download (PPT)