Percutaneous vertebroplasty is not a risk factor for new osteoporotic compression fractures: results from VERTOS II

Background and purpose: Pv is increasingly used as treatment for osteoporotic vcfs. However, controversy exists as to whether pv increases the risk for new vcfs during follow-up. The purpose of our research was to assess the incidence of new vcfs in patients with acute vcfs randomized to pv and conservative therapy. Materials and methods: Vertos ii is a prospective multicenter randomized controlled trial comparing pv with conservative therapy in 202 patients. Incidence, distribution, and timing of new vcfs during follow-up were assessed from spine radiographs. In addition, further height loss during follow-up of treated vcfs was measured. Results: After a mean follow-up of 11.4 Months (Median, 12.0; Range, 1-24 months), 18 New vcfs occurred in 15 of 91 patients after pv and 30 new vcfs in 21 of 85 patients after conservative therapy. This difference was not significant (P = .44). There was no higher fracture risk for adjacent-versus-distant vertebrae. Mean time to new vcf was 16.2 Months after pv and 17.8 Months after conservative treatment (Logrank, p = .45). The baseline number of vcfs was the only risk factor for occurrence (Or, 1.43; 95% Ci, 1.05-1.95) And number (P = .01) Of new vcfs. After conservative therapy, further height loss of treated vertebrae occurred more frequently (35 Of 85 versus 11 of 91 patients, p < .001) And was more severe (P < .001) Than after pv. Conclusions: Incidence of new vcfs was not different after pv compared with conservative therapy after a mean of 11.4 Months' follow-up. The only risk factor for new vcfs was the number of vcfs at baseline. Pv contributed to preservation of stature by decreasing both the incidence and severity of further height loss in treated vertebrae

Randomized trial of Legflow® paclitaxel eluting balloon and stenting versus standard percutaneous transluminal angioplasty and stenting for the treatment of intermediate and long lesions of the superficial femoral artery (RAPID trial): Study protocol for a randomized controlled trial

Background: Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow® paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm.Methods/Design: A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera® stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention.Discussion: The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.Trial registration: ISRCTN47846578