scholarly journals Efficacy and Safety of TurboHawk Plaque Rotation Combined With Drug-coated Balloon in Treating Diabetic Patients With Lower Extremity Arterial Disease

2020 ◽  
Vol 26 ◽  
pp. 107602962091597
Author(s):  
Kehua Wang ◽  
Ying Li ◽  
Fengli Gao ◽  
Haiwen Gong ◽  
Xueru Li ◽  
...  

To evaluate the efficacy and safety of TurboHawk plaque rotation system combined with drug-coated balloon in treating lower extremity arterial disease (LEAD) of diabetes patients, a total of 145 diabetic patients with LEAD from March 2015 to September 2016 were recruited in our study. Lower extremity arterial disease was diagnosed by ultrasound and CT angiography (CTA). According to the surgical method, 65 cases underwent TurboHawk plaque rotation combined with drug-coated balloon (group A), 80 cases underwent simple drug-coated balloon expansion (group B). The characteristics of lesion, function test, ankle-brachial index (ABI), and postoperative complications were analyzed. All the patients were followed up at 1, 3, 6, 12, and 24 months after operation. At baseline, there was no difference in all the characteristics between the 2 groups. The early postoperation minimum lumen diameter (MLD), lumen stenosis rate, and ABI in 2 groups both improved. As the follow-up time increased, patients in group A had significantly higher MLD and ABL value, as well as lower level of lumen stenosis rate, restenosis rate, late lumen loss, and target lesion revascularization (all P < .05). Accordingly, functional testing revealed the 6-minute walk distance, 6-minute claudication distance, resting ABI, and post-exercise ABI in group A were significantly higher than those in group B (all P < .05). Besides, major graft reintervention (4.62% vs 11.25%) and major adverse limb events (6.15% vs 12.5%) in group A occurred less frequently than group B (all P < .05). In conclusion, the long-term effect of the combined approach was better than only drug-coated balloon in LEAD in Chinese diabetes patients.

2020 ◽  
pp. 66-72
Author(s):  
S. Yu. Gorokhovsky ◽  
A. A. Lyzikov ◽  
M. L. Kaplan ◽  
V. E. Tihmanovich

Objective: to evaluate the results of correction of lower extremity arterial disease using invasive intraoperative hemodynamic monitoring of peripheral circulation and to assess the influence of this method on selection of surgical tactics.Material and methods. The outcomes of revascularization were compared in patients of two comparable groups: the patients of the first group had undergone interventions under intraoperative hemodynamic monitoring of peripheral circulation in addition to angiography, and for the patients of the second group a decision about the extent of correction had been made on the basis of angiography without intrapeorational functional evaluation.Results. The application of the above method made it possible to decrease the length of the performed reconstructions: 90 mm (80; 125) in the first group vs. 70 mm (112.5; 247.5) (p = 0.018) in the second group with a comparable satisfactory outcome. The postoperative ABI values after the interventions in the first and second groups amounted to 0.86 (0.78; 1) and 0.8 (0.7; 0.86), respectively, which was associated with a favorable clinical prognosis in these patients.Conclusion. The use of invasive intraoperative hemodynamic monitoring makes it possible to decrease the extent of reconstructions in multisegment lesions with the achievement of a satisfactory clinical outcome.


ESC CardioMed ◽  
2018 ◽  
pp. 944-946
Author(s):  
Lucia Mazzolai ◽  
Victor Aboyans ◽  
Marianne Brodmann

The risk of lower extremity arterial disease (LEAD) is markedly increased among patients with diabetes and ischaemic event rates are more frequent in LEAD populations with than among those without diabetes. A multidisciplinary approach to LEAD diabetic patients is essential. Proper diagnosis and management is crucial in this selected group of patients to reduce cardiovascular burden and decrease limb adverse events. This chapter reviews the clinical implications of LEAD in diabetic patients, diagnostic strategies, and management.


2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Kallirroi Kalantzi ◽  
Nikolaos Tentolouris ◽  
Andreas J. Melidonis ◽  
Styliani Papadaki ◽  
Michail Peroulis ◽  
...  

Background Type 2 diabetes mellitus is a risk factor for lower extremity arterial disease. Cilostazol expresses antiplatelet, anti‐inflammatory, and vasodilator actions and improves the claudication intermittent symptoms. We investigated the efficacy and safety of adjunctive cilostazol to clopidogrel‐treated patients with type 2 diabetes mellitus exhibiting symptomatic lower extremity arterial disease, in the prevention of ischemic vascular events and improvement of the claudication intermittent symptoms. Methods and Results In a prospective 2‐arm, multicenter, open‐label, phase 4 trial, patients with type 2 diabetes mellitus with intermittent claudication receiving clopidogrel (75 mg/d) for at least 6 months, were randomly assigned in a 1:1 ratio, either to continue to clopidogrel monotherapy, without receiving placebo cilostazol (391 patients), or to additionally receive cilostazol, 100 mg twice/day (403 patients). The median duration of follow‐up was 27 months. The primary efficacy end point, the composite of acute ischemic stroke/transient ischemic attack, acute myocardial infarction, and death from vascular causes, was significantly reduced in patients receiving adjunctive cilostazol compared with the clopidogrel monotherapy group (sex‐adjusted hazard ratio [HR], 0.468; 95% CI, 0.252–0.870; P =0.016). Adjunctive cilostazol also significantly reduced the stroke/transient ischemic attack events (sex‐adjusted HR, 0.38; 95% CI, 0.15–0.98; P =0.046) and improved the ankle‐brachial index and pain‐free walking distance values ( P =0.001 for both comparisons). No significant difference in the bleeding events, as defined by Bleeding Academic Research Consortium criteria, was found between the 2 groups (sex‐adjusted HR, 1.080; 95% CI, 0.579–2.015; P =0.809). Conclusions Adjunctive cilostazol to clopidogrel‐treated patients with type 2 diabetes mellitus with symptomatic lower extremity arterial disease may lower the risk of ischemic events and improve intermittent claudication symptoms, without increasing the bleeding risk, compared with clopidogrel monotherapy. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02983214.


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