Beneficial effects of 1-year optimal medical treatment with and without additional PTA on inflammatory markers of atherosclerosis in patients with PAD. Results from the Oslo Balloon Angioplasty versus Conservative Treatment (OBACT) study

Abstract

Abstract:The influence of optimal medical treatment (OMT) with or without additional percutaneous transluminal angioplasty (PTA) on vascular inflammation in peripheral arterial occlusive disease (PAD) patients was investigated. Patients with intermittent claudication (IC) and angiographically verified PAD were randomized to OMT (n ϭ 28) or OMT ϩ PTA (n ϭ 28) and followed for 12 months. Ankle-brachial index (ABI), treadmill walking distances (WD), visual analogue scale (VAS), and blood sampling for the determination of selected soluble biomarkers were undertaken at baseline and after 3 and 12 months. After both 3 and 12 months, ABI, WD and VAS were highly significantly improved in favour of OMT ϩ PTA (p Ͻ 0.05 for all). Significant improvements were recorded in both groups in serum lipids (p Ͻ 0.01 for all), except for triglycerides, and in the inflammatory markers P-selectin, interleukin-6, interleukin-10, monocyte chemoattractant protein-1 and fibrinogen (p Ͻ 0.05 for all). There were, however, no differences in the changes from baseline between the groups in any variable. Intervention with OMT alone or in combination with PTA did not differ with regard to the effects on serum lipids and markers of inflammation in our population of PAD patients. The combined treatment was, however, better for the treadmill walking distance.

Systematic review of exercise training or percutaneous transluminal angioplasty for intermittent claudication

“…One trial reported 'few' complications 19,20 and the other four trials three, four, six and seven complications respectively 13,21 -23,25 . These complications consisted primarily of haematomas, but bleeding, artery dissections and artery rupture also occurred.…”

“…Two trials compared PTA plus ET advice with ET advice alone 15,16,19,20 , four compared PTA with SET 13,18,22 -24 , two compared PTA plus SET with SET 21,24 and two compared PTA plus SET with PTA 24,25 ( Table 4). Table 5 summarizes the diverse exercise programmes varying from home-based exercise without supervision 15,16,19,20 to SET programmes 13,18,21 -25 .…”

“…Table 5 summarizes the diverse exercise programmes varying from home-based exercise without supervision 15,16,19,20 to SET programmes 13,18,21 -25 . The exercise programme included dynamic leg exercises 13 , exercise advice 15,16,19,20 , a walking circuit 21 , an exercise circuit 18,24 and treadmill training 22,23,25 . In four trials, the intervention covered both PTA with, or without selective stent placement 19 -23,25 ; the other trials referred to PTA alone.…”

“…Two RCTs prescribed an antiplatelet drug alone 15,16,21 , and one trial acted in accordance with the management of PAD in primary care, which was not specified 18 . One RCT advised an antiplatelet drug and a statin 24 , one recommended an antiplatelet drug, a statin and treatment of hypertension on indication 19,20 , and another advised an antiplatelet drug, a statin and regular check-up by an internist of risk profile, diabetes, lipids and hypertension 22,23 . The same holds for the remaining RCT, which also included lifestyle advice given according to the Dutch guidelines for cardiovascular risk management, and advice on smoking cessation 25 .…”

“…Table 6 also shows the various instruments used EuroQol Group, Rotterdam, The Netherlands) 22,11,25 . Three RCTs used the disease-specific Vascular Quality of life questionnaire (VascuQol) 22 -24 and the Claudication Scale (CLAU-S) 19,20 . Other applied questionnaires were the Walking Impairment Questionnaire (WIQ) 25 and a visual analogue scale score for pain 19,20 .…”