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SWEDEPAD Interim Analysis Shows No Mortality Difference Found for Paclitaxel-Coated Devices.
On December 9, 2020, the New England Journal of Medicine published an article based on the findings from the Swedish Drug Elution Trial in Peripheral Arterial Disease (SWEDEPAD). The SWEDEPAD trial is a multicenter, randomized, open-label, registry-based trial that aims to evaluate the effect of drug-elution technology on the incidence of amputation among patients with chronic limb-threatening ischemia and health-related quality of life among patients with intermittent claudication1. An unplanned interim analysis of the trial shows no difference between Paclitaxel-coated or uncoated endovascular device groups in all-cause mortality.
The SWEDEPAD trial had enrolled 2289 patients randomly assigned to treatment with Paclitaxel-coated devices (the drug-coated–device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). The authors reported in NEJM that during a mean follow-up of 2.49 years, 574 patients died, including 293 (25.5%) patients in the Paclitaxel-coated–device group and 281 (24.6%) patients in the uncoated-device group (hazard ratio, 1.06; 95% CI, 0.92-1.22). The 1-year all-cause mortality was 10.2% (117 patients) in the drug-coated–device group and 9.9% (113 patients) in the uncoated-device group. There was no significant difference in the incidence of death between the groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated–device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively), during the entire follow-up period.
The concerns regarding the safety of paclitaxel-coated devices have been raised by Konstantinos Katsanos, MD, et al. in a study published in Journal of the American Heart Association since Dec, 2018. The Katsanos et al. meta-analysis of randomized trials concluded an increased risk of all-cause mortality after application of the paclitaxel-coated devices in the femoral and/or popliteal arteries2. The SWEDEPAD trial was paused later in the same month for mortality data review in order to reduce the concerns regarding the safety of paclitaxel-coated devices and to support the completion of ongoing trials investigating the efficacy of such devices in peripheral artery disease, mentioned the authors1.
The findings of the unplanned interim analysis have reassured physicians and patients that the application of Paclitaxel-coated devices unlikely increases patient mortality, and the devices can be safely used for PAD patients in everyday practice.
1.Nordanstig, J., James, S., Andersson, M., Andersson, M., Danielsson, P., & Gillgren, P. et al. (2020). Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease. New England Journal Of Medicine, 383(26), 2538-2546. doi: 10.1056/nejmoa2005206
2.Katsanos, K., Spiliopoulos, S., Kitrou, P., Krokidis, M., & Karnabatidis, D. (2018). Risk of Death Following Application of Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials. Journal Of The American Heart Association, 7(24). doi: 10.1161/jaha.118.011245