The Randomized Freeway Stent Study: Drug-Eluting Balloons Outperform Standard Balloon Angioplasty for Postdilatation of Nitinol Stents in the SFA and PI Segment.

PURPOSE: The prospective randomized multicenter Freeway study evaluated the possible hemodynamic and clinical benefits of primary stent insertion followed by percutaneous transluminal angioplasty (PTA) with drug-eluting balloons (DEB) over post-stent insertion PTA with standard balloons in the treatment of symptomatic femoropopliteal arteriosclerotic lesions. METHODS: In total, 204 patients in 13 centers in Germany and Austria were enrolled and randomized to primary stenting followed by either FREEWAY™ drug-eluting balloon or standard PTA balloon angioplasty. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 6 months; the secondary endpoints include TLR rate at 12 months and primary patency, shift in Rutherford classification, ankle-brachial index (ABI) and major adverse events (MAE) at 6 and 12 months. Lesion characteristics and vessel patency were analyzed by an independent and blinded corelab. RESULTS: At 6-month and 12-month follow-up, TLR rate was lower in the DEB arm compared to standard PTA but did not reach statistical significance (4.1% vs. 9.0% p = 0.234 and 7.9% vs. 17.7% p = 0.064, respectively). Primary patency was significantly better for patients treated with the DEB at 6 months (90.3% vs. 69.8% p = 0.001) and 12 months (77.4% vs. 61.0% p = 0.027). Improvement in Rutherford classifications was likewise significantly better for patients in the DEB group at 6 (94.9% vs. 84.3% p = 0.027) and 12 months (95.5% vs. 79.9% p = 0.003). The percentage of patients with an improved ABI of 1.0-1.2 was significantly higher in the DEB group compared to the PTA group at 6 months (55.3% vs. 35.3%; p = 0.015) but without significant difference at 12 months (48.2% vs. 32.9%; p = 0.055). At 6 months, rate of major adverse events (MAE) was 1% in both arms, and at 12 months 2.2% for the DEB and 3.8% for the PTA group. CONCLUSION: The Freeway Stent Study shows that the usage of DEB as a restenosis prophylaxis seems to be safe and feasible. The 12-month follow-up results give a clear sign in favor of the DEB group.

Large left innominate vein aneurysm presenting as an anterior mediastinal tumour in a young female.

We report a rare case of large innominate vein aneurysm in a young women clinically presenting with persistent dry cough and retrosternal pressure. Chest X-ray showed a mediastinal widening leading to thoracic computed tomography, MRI, and phlebography. Initial conservative treatment with regular follow-up was performed. Upon aneurysm growth and recurrent pulmonary infection we decided to surgically resect the aneurysm via a minimally invasive approach.

Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial.

The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividual, randomized study design, both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy, sensitivity, and specificity to correctly classify focal lesions of the kidney. To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading. The average diagnostic accuracy across the three blinded readers ('average reader') was 83.7% for gadobutrol and 87.3% for gadopentate dimeglumine. The increase in accuracy from precontrast to combined precontrast and postcontrast MRI was 8.0% for gadobutrol and 6.9% for gadopentate dimeglumine. Sensitivity of the average reader was 85.2% for gadobutrol and 88.7% for gadopentate dimeglumine. Specificity of the average reader was 82.1% for gadobutrol and 86.1% for gadopentate dimeglumine. In conclusion, this study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentate dimeglumine in the diagnostic assessment of renal lesions with CE-MRI.

Mycotic aneurysms affecting both lower legs of a patient with Candida endocarditis--endovascular therapy and open vascular surgery.

The purpose of this study was to report the endovascular and open surgery treatment of Candida-associated mycotic aneurysms in both lower limbs. A 53-year-old patient suffering from Candida endocarditis following aortic valve replacement developed mycotic aneurysms in both lower limbs. The angiography revealed a large aneurysm of the tibioperoneal trunk affecting the right leg. In the left leg, sacculation had developed in section III of the popliteal artery. The right aneurysm was obliterated by embolization with coils. On the left side, the large aneurysm of the popliteal artery was resected; vascular continuity was re-established by interposing a segment of the patient's greater saphenous vein. The postoperative course was uneventful. Mycotic aneurysm is a rare disease. A site in the crural vessels is regarded as exceptionally seldom. To our knowledge, no Candida-associated mycotic aneurysm has been described in this region before. Both endovascular treatment and open surgery proved to be successful.