Abstract
The use of drug-coated devices in intravascular therapy is aimed at preventing neointimal hyperplasia caused by excessive proliferation of vascular smooth muscle and thereby restenosis. Although its use seemed initially promising, a recent publication has shown an increased risk of mortality with paclitaxel-coated devices, and there is an urgent need to reaffirm assessments of drug-eluting stents (DES). Objective: The aim of the study was to compare mortality and effectiveness of paclitaxel-coated stents and bare-metal stents (BMS) in the treatment of peripheral arterial disease (PAD) with long-term follow-up. Materials and methods: In a single center randomized study, 256 patients with PAD were treated intravascularly with stent implantation. Patients were randomized into two groups: the first (n = 126) were treated with DES, and the second (n = 130) were treated with BMS. The study included evaluation after the procedure, after about 6 months and 36 months. Co-morbidities, with risks for atherosclerosis, were analyzed in all patients. Patients were evaluated for clinical outcome, restenosis frequency, and safety (complications and total mortality). Results: Clinical benefit at the end of the investigation was statistically significantly better in the DES group compared with the BMS group: 85.7% versus 66.2% (p = 0.0003), respectively. Restenosis occurred significantly less frequently in patients with DES: 16.0% versus BMS: 35.0%, p = 0.012. There was no significant effect of comorbidities on the frequency of restenoses. There were no differences in all-cause mortality over the three years with paclitaxel and no-paclitaxel stents cohorts (8.7% versus 7.1%; long-rank p = 0.575). No association was found with mortality and treatment with DES or BMS. Conclusions: The use of paclitaxel-coated stents gave good clinical benefit and caused a significantly lower frequency of restenosis compared to bare-metal stents. The use of paclitaxel-coated stents did not increase mortality.
Highlights
Peripheral arterial disease (PAD) is a global health problem associated with a 3 to 5-fold increase in mortality relative to the general population [1]
Antimitotic drugs have been used with drug-coated balloons (DCB) and drug-eluting stents (DES), which reduce the frequency of restenosis caused by neointimal hyperplasia after surgery
Clinical benefit at the end of observation in both groups occurred in 195 patients (76.2%) and was statistically significantly more frequent in the DES group with 108 patients (85.7%) versus in the bare-metal stents (BMS) group with 85 patients (66.2%); X2 p = 0.0003
Summary
Peripheral arterial disease (PAD) is a global health problem associated with a 3 to 5-fold increase in mortality relative to the general population [1]. Neointimal hyperplasia in a vessel that has been subjected to intravascular surgery is much faster than in cases of de novo lesions. For this reason, antimitotic drugs have been used with drug-coated balloons (DCB) and drug-eluting stents (DES), which reduce the frequency of restenosis caused by neointimal hyperplasia after surgery. The concept of preventing vascular endothelial hyperplasia (and restenosis) by delivering an antimitotic drug directly to the site of stenosis seemed to be a promising method, but recently, a sensational publication has been presented in which Prof. Katsanos showed increased mortality after treatment with drug-eluting devices [4]. The aim of the present study was to compare the safety and effectiveness of paclitaxel-coated and bare-metal stents in the treatment of PAD with long-term follow-up
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