Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry.

BACKGROUND: The aim of this study was to evaluate 12-month effectiveness of the endovascular treatment of femoropopliteal (FP) atherosclerotic lesions with the Ranger drug-coated balloon (DCB) in a real-world setting. METHODS: In this prospective, observational, multicenter trial (ClinicalTrials.gov Identifier: NCT02462005) 172 consecutive patients with 226 de novo, restenosed, or reoccluded native superficial femoral and/or popliteal artery lesions were treated with the Ranger paclitaxel-coated balloon angioplasty. Mean lesion length was 129 mm (5-400 mm). Fifty-nine (26%) of 226 lesions were moderately or heavily calcified. Provisional stenting was conducted in 55 (22%) of 226 lesions. Main effectiveness outcomes were procedural success, 6- and 12-month hemodynamic or clinical improvement, and primary patency based and clinically driven target lesion revascularization (TLR) at 6 and 12 months. RESULTS: Procedural success (<30% residual stenosis and no major adverse event within 30 days) was achieved in 126 (73%) of 172 patients with DCB alone and in all patients if bailout procedures were included. Primary patency was 91.0% at 6 months and 84.1% at 12 months. Freedom TLR was 92.4% at 6 months and 89.2% at 12 months. ABI, pain-free walking distance and Rutherford category improved significantly (P<0.001) after 6 and 12 months. CONCLUSIONS: Results suggest that angioplasty with the Ranger paclitaxel-coated balloon with provisional stenting is efficacious for the treatment of a broad range of femoropopliteal atherosclerotic lesions. No safety concerns arose.

Long-term outcomes after medical and interventional therapy of critical limb ischemia.

BACKGROUND: Recommendations of clinical guidelines for the treatment of critical limb ischemia (CLI) are based on randomized controlled trials. Recent data from clinical practice are however lacking. Therefore a prospective observational study in patients with critical limb ischemia (CLI) in 3 hospitals with a specialized vascular medicine department was conducted to document the clinical course and outcome of patients with critical limb ischemia (CLI) in clinical practice. METHODS: 155 patients were stratified: 56 received endovascular intervention, 82 prostanoids and 17 antibiotic treatment. Patients with surgical revascularisation and primary amputation were excluded. All patients received structured wound treatment, analgesia and vascular risk factor treatment during hospital stay. RESULTS: Age 72.0+/-12.7 years, hospitalisation 23.2+/-20.3 days. 56.1% had Diabetes, 9.7% multiresistant staphylococcus aureus infection. 40% patients had rest pain, 60% ischemic tissue loss. At discharge 40.0% had no ulcers, 48.4% ongoing trophic alterations, 10.3% received major amputation and 4.5% had stable necrosis. After 18 month rate of major amputation was 6.3% (prostanoids), 14.5% (endovascular treatment; p=n.s. vs. prostanoids) and 26.7% (antibiotics; p=0.0323 vs. prostanoids). Major amputations were not different in logistic regression analyses adjusting for baseline characteristics. Wound healing and mortality rate was not different between groups (26.8, 25.0 and 23.5%). CONCLUSION: Structured therapy at specialized vascular centres in combination with interventional or conservative treatment is beneficial in patients with critical limb ischemia. Survival without amputation is higher than expected over 18 months.

Mobilization versus immobilization in the treatment of acute proximal deep venous thrombosis: a prospective, randomized, open, multicentre trial.

OBJECTIVE: The aim of prescribing strict bed rest for acute deep venous thrombosis is to reduce the risk of pulmonary embolism and pain in the legs, as well as swelling. This study was performed in order to compare outcome of mobilization against 5 days of strict bed rest in patients with acute proximal deep venous thrombosis (DVT). METHODS: 103 in-patients with proximal DVT or patients admitted to the hospital because of proximal DVT were recruited to a randomized study. All patients were treated in hospital and given a lower leg and thigh compression bandage as well as therapeutic doses of the low molecular weight heparin, dalteparin-sodium (Fragmin). RESULTS: Seven of 52 patients (13.5%) in the mobile group versus 14 of 50 patients (28.0%) in the immobile group suffered at least one of the outcomes defined under the combined primary endpoint (clinically relevant pulmonary embolisms, pulmonary embolisms detectable by scintigraphy or computer tomography, progression of thrombosis or new thrombosis, nosocomial infections and/or serious adverse events) (p = 0.088), whereby serious adverse events occurred once in the mobile group and three times in the immobile group. New pulmonary embolisms over the course were seen in 10 of 50 patients (20%) with a perfusion disorder at baseline scintigraphy, while such was ascertained only in one of 52 patients (1.9%) without a perfusion disorder at baseline scintigraphy. Leg pain was reduced from 54.1 (+/-30.4) to 20.7 (+/-19.2) in the mobilized group and from 41.0 (+/-26.8) to 14.0 (+/-11.1) in the immobilized patients. Leg pain was assessed using the visual analogue scale (0 = no pain, 100 = maximum pain). More immobilized patients complained of increasing back pain (23% versus 6%) and disturbed micturition (10% versus 2%) as well as defecation (13% versus 6%) on day 5. More patients in the mobile group reported increased stress from the thrombosis and its treatment (15% versus 6%). CONCLUSIONS: No benefit of prescribing bed rest in patients with deep venous thrombosis could be detected in this study. Based on data available, strict bed rest for at least 5 days is not justified if adequate therapy with low molecular weight heparin and adequate compression is assured. It remains open whether patients with initial signs of pulmonary embolism might profit from a brief immobilization.