In patients with symptomatic femoropopliteal peripheral artery disease (PAD), there is an absolute 4.6% increased morality risk associated with the use of paclitaxel-containing device (PTXD) use compared with balloon angioplasty at a median four-year follow-up, according to a study published in Circulation.

Krishna J. Rocha-Singh, MD, et al., performed an individual patient data (IPD) meta-analysis to evaluate mortality in PAD patients treated with PTXD. The authors sought to conduct an IPD meta-analysis after a recent aggregate-data meta-analysis reported increased late mortality in patients treated with PTXD. The study used de-identified IPD from manufacturers of U.S. Food and Drug Administration-approved and commercially available devices in the U.S.

The authors of the study identified 2,185 patients of whom 1,382 were assigned to PTXD and 803 to control. There were 386 deaths from eight PTXD trials with a four-year median follow-up. The primary analysis showed a 38% relative increase in mortality for PTXD relative to control, corresponding to a 4.6% absolute increase at five years associated with PTXD. With inclusion of recovered vital status data, the excess relative mortality risk was 27%. Exploratory analyses identified no paclitaxel drug dose-mortality relationship. The analysis did not identify a specific cause of death as being particularly responsible for the overall increase in mortality.

"Despite [the] contrary data from large population studies, safety in coronary trials, and established drug safety for systemic use [of PTXD], the issue of risk versus benefit must be considered given the increased mortality we are reporting," write the authors. "Nevertheless, some patients may prefer gains in quality of life and reduced revascularization procedures even at the expense of potentially increased mortality risk."

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Interventions and Vascular Medicine

Keywords: Paclitaxel, Quality of Life, Peripheral Arterial Disease, Cause of Death, Follow-Up Studies, United States Food and Drug Administration, Angioplasty, Balloon, Angioplasty, Balloon, Coronary, Risk

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