P-022 Multicenter mid term safety and efficacy of the LVIS EVO stent

Vanadium compounds are able to reduce blood glucose in experimentally- induced diabetic rats and type 2 diabetic patients, but data about their long- term safety and efficacy in diabetic patients are scarce. Fourteen type 1 diabetic patients received oral vanadyl sulfate (50 - 100 mg TID) for a period of 30 months. Fasting blood sugar (FBS), lipid levels, hematologic, and biochemical parameters were measured before and periodically during the treatment. The daily doses of insulin decreased from 37.2 ± 5.5 to 25.8 ± 17.3 units/day and at the same time the mean FBS decreased from 238 ± 71 to 152 ± 42 mg/dL. Meanwhile, there was a decrease in plasma total cholesterol without any change in triglyceride level. No significant clinical or paraclinical side effects, with the exception for mild diarrhea at the beginning of treatment, were observed during 30 months therapy. Vanadium is effective and safe for long- term use in type 1 diabetic patients.

Magnetic sphincter augmentation (MSA) was introduced in 2007 as an alternative surgical procedure for patients with gastroesophageal reflux disease (GERD). The majority of data since MSA's introduction has focused on short and intermediate-term results, demonstrating safety and high efficacy in terms of reflux symptom control, freedom from proton pump inhibitor use and normalization of distal esophageal acid exposure. However, GERD is a chronic condition that demands a long-term solution. Limited available data from studies reporting outcomes at 5years or later following MSA demonstrate that the promising short- and mid-term efficacy and safety profile of MSA remains relatively constant in the long term. Compared with Nissen fundoplication, MSA has a much lower rate of gas-bloat and inability to belch at a short-term follow-up, a difference that persists in the long-term. The most common complaint after MSA at a short-term follow-up is dysphagia. However, limited data suggest dysphagia rates largely decrease by 5years. Dysphagia is the most common indication for dilation and device removal in both early- and long-term studies. However, the overall rates of dilation and removal are similar in short- and long-term reports, suggesting the majority of these procedures are performed in the short-term period after device implantation. The indications and standard practices of MSA have evolved over time. Long-term outcome data currently available are all from patient cohorts who were selected for MSA under early restricted indications and outdated regimens. Therefore, further long-term studies are needed to corroborate the preliminary, yet encouraging long-term results.

ABSTRACTIntroduction: New-generation drug-eluting stents (DES) represent the current standard of care in patients undergoing percutaneous coronary intervention (PCI). Biodegradable polymer DES (BP-DES) were recently developed to overcome current limitations of newer-generation durable polymer DES (DP-DES) attributed to sustained inflammatory responses induced by permanent polymers. The Orsiro DES (Biotronik AG, Bülach, Switzerland) is a novel thin-strut cobalt-chromium sirolimus-eluting stent with biodegradable polymer that features some of the latest developments in DES technology.Areas covered: This article aims to review the currently available evidence on the clinical performance of the Orsiro BP-DES and its future perspectives.Expert commentary: The Orsiro DES is a recent newer-generation BP-DES that combines a highly deliverable thin-strut cobalt-chromium stent platform and a unique hybrid concept with passive and active coatings designed to enhance tissue biocompatibility. In preclinical and intravascular imaging studies, the Orsiro BP-DES was shown to induce low inflammation and promote very early arterial healing. Recently, large randomized non-inferiority clinical trials have shown similar short- and mid-term efficacy and safety outcomes with Orsiro BP-DES compared with currently established newer-generation DES among all-comers and high-risk subgroups. The potential clinical superiority of Orsiro BP-DES over Xience DP-DES in patients with STEMI is currently investigated in the BIOSTEMI trial (NCT02579031).

The long term efficacy and safety of adjuvant opioids in older persons with rheumatoid arthritis

Background and importanceAlirocumab is a monoclonal antibody approved for the treatment of hypercholesterolaemia but long term clinical data are still limited.Aim and objectivesTo assess the long term efficacy, safety and...

Stenting of infrainguinal lesions can be rather challenging due to the mechanical stress applied on the arteries during motion. We assessed the short-term and mid-term safety and efficacy of Supera interwoven nitinol stent for the treatment of infrainguinal arterial disease. We conducted a systematic review for articles published from December 2011 up to May 2021 regarding studies assessing the safety and efficacy of Supera interwoven nitinol stents for the treatment of infra-inguinal peripheral arterial disease. Studies that involved synchronous application of the Supera stent and drug delivering devices, or any alternative endoprosthesis were excluded. Pooled Kaplan-Meier survival curves and smoothed hazard estimates were generated. Data were meta-analyzed using a random effects model. Primary endpoints included primary patency and freedom from clinically driven target lesion revascularization (TRL). Secondary endpoints included technical success and major amputation at 1 year post intervention. Seventeen studies with 2015 patients (65.3% males) and a mean lesion length of 137.2 mm were included. Of the total treated lesions, 44.9% involved femoropopliteal artery and 37.4% the popliteal artery. Chronic total occlusions made up 49% of the treated lesions. There were no stent fractures reported. The pooled technical success rate is 99.84% (95% CI: 99.26-100). Pooled major amputation rate at 1 year is 1.48% (95% CI: 0.47-2.87). Pooled primary patency and freedom from TLR rates at 1 year are 83.5% (95% CI: 80.24-86.54) and 90.32% (95% CI: 88.75-91.79), respectively. Pooling of individual patient data produced primary patency and freedom from TLR rates of 84.48% (95% CI: 82.66-86.11) and 90.81% (95% CI: 88.64-92.58) respectively. According to the smoothed hazard ratio estimate the risk for losing primary patency peaked between 4 and 5 months while the risk for TLR peaked between 7 and 8 months after the intervention. This review and meta-analysis indicated the safety and efficacy of Supera stents for the treatment of challenging infrainguinal lesions in the short-term and mid-term periods, with acceptable primary patency and freedom from TLR rates. Clinicians should be aware that between 4 and 5 months patients face a higher risk for event occurrence.

Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies. To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial. In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded. The primary endpoint of complete aneurysm occlusion at 180 d (73.6%) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8% (79/91), 93.4% (71/76), and 95.2% (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7%) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1% (1/96), 3.5% (3/85), and 0% (0/81) of subjects. There were 4 (3.7%) reported deaths in our trial. Seventy-eight (96.3%) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. No recanalization of a previously occluded aneurysm was observed. Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.

A novel 3D-printed biodegradable cage composed of polycaprolactone (PCL) and beta-tricalcium phosphate (β-TCP) in a mass ratio of 50:50, with stable resorption patterns and mechanical strength has been developed for lumbar interbody fusion. This is a prospective cohort study to evaluate the short- and mid-term safety and efficacy of this biodegradable cage in posterior lumbar interbody fusion (PLIF) surgery. This was a prospective single-arm pilot clinical trial in 22 patients with a follow-up time of 1, 3, 6, and 12 months, postoperatively. Clinical outcomes were assessed using the Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and Visual analogue scale (VAS) for leg pain and low back pain. Radiological examination included X-ray, CT scan, and three-dimensional reconstruction to evaluate surgical indications, intervertebral space height (ISH), intervertebral bone fusion and cage degradation. A total of 22 patients was included, with an average age of 53.5 years. Among 22 patients, one patient lost to follow-up and one patient withdrew from the clinical trial because of cage retropulsion. The remaining 20 patients showed significant improvement in clinical and imaging outcomes compared to the preoperative period. The overall mean VAS for back decreased from 5.85 ± 0.99 preoperatively to 1.15 ± 0.86 at the 12-month follow-up (p < .001); the VAS for leg decreased from 5.75 ± 1.11 to 1.05 ± 0.76 (p < .001); the JOA score improved from 13.8 ± 2.64 to 26.45 ± 2.46 (p < .001). The mean intervertebral space height (ISH) increased from 11.01 ± 1.75 mm preoperatively to 12.67 ± 1.89 mm at the 12-month follow-up and the bone fusion reached 95.2% (20/21 disc segments). Partial resorption (inferior to 50% compared with the initial cage size) were found in all cages (21/21). The clinical and radiological assessments showed that the application of 3D-printed biodegradable PCL/β-TCP cages in PLIF yielded satisfactory results at the 12-month follow-up. In the future, long-term clinical observations and controlled clinical trials are required to further validate the safety and efficacy of this novel cage.

Objective Pulmonary embolism is a common cardiovascular emergency with the characteristics of high incidence, high mortality. This study compared pulmonary artery catheter thrombolysis with peripheral intravenous thrombolysis for acute pulmonary embolism in the mid-term clinical efficacy. Methods From June 2011 to September 2015, 68 patients were given pulmonary artery interventional therapy, 54 cases received peripheral intravenous thrombolysis; discharged patients were followed up for 3-12 months to evaluate the curative rate, effective rate, recurrence rate and the incidence of complications. Results Follow up rate was 79.5%. The cure rate of the treatment group was higher than that of the control group (47.3% vs 23.8%, P<0.05); The significant effective rate of the treatment group was higher than that of the control group(81.8% vs 52.4%, P<0.05); The incidence of Chronic pulmonary hypertension (1.8%) was lower than that of the control group (16.7%); There was no significant difference in improvement rate, recurrence rate and mortality. Conclusion The medium-term efficacy of pulmonary artery catheter directed thrombolysis is superior to that of peripheral intravenous thrombolysis; it can effectively reduce the incidence of chronic thromboembolic pulmonary hypertension. Key words: Pulmonary embolism; Mechanical thrombolysis; Interventional therapy

Long term efficacy and compliance of sildenafil citrate following radical prostatectomy: SHIM (IIEF-5) analysis

A prospective comparative observational study was performed to assess the short--term efficacy and safety of the peri-saphenous infiltration of tumescence solution (PST) in great saphenous vein (GSV) long catheter foam sclerotherapy (LCFS) combined with phlebectomy of the varicose tributaries. Since November 2006 through November 2010 fifty-one consecutive patients (16 males and 35 females, mean age 51.5 years) who underwent LCFS of GSV + multiple phlebectomies were prospectively enrolled, without any pre-selection criteria, in three different groups (17 patients per group) and reviewed as to their outcomes: i) patients without additional PST; ii) with PST under visual control; iii) with ultrasound-guided PST. All procedures were performed in local anesthesia and an average of 7 mL [interquartile range (IQR) 6.5-7.5] of 3% sodiumtetradecylsulfate CO2+O2-based sclerosant foam was injected in the diseased segment of GSV (median caliber 7) (IQR 6-8) by means of a 4F long catheter. Clinical and color-duplex ultrasound (CDU) follow-up was performed at regular intervals, the last of which 14 months after the treatment. At 14 months follow-up no varicose veins were visible in 94%, 94% and 100% of the cases in group I, II and III respectively. The CDUbased outcomes were the following: 71%, 71% and 84% GSV occlusion rate in group I, II and III respectively; reflux was found in 5, 4 and 1 cases in group I, II and III respectively. Clinical and CDU morphologic and hemodynamic results were assembled and scored through an arbitrary system. The relative statistical analysis showed a significant (P&amp;lt;0.0001) improvement of the results for patients who received ultrasound guided PST over the other two groups. No relevant complications were recorded in all 51 cases. GSV treatment by means of LCFS + phlebectomy of varicose tributaries proved to be effective and safe in this prospective observational study. The addition of ultrasound guided PST resulted in a significant improvement of GSV occlusion rate and of varicose vein clinical resolution.

Objective To compare the long term efficacy and adverse events of dual blockade of the renin-angiotensin system with monotherapy.Design Systematic review and meta-analysis.Data sources PubMed, Embase, and the Cochrane central...

FRI0496 Long Term Safety and Efficacy of Anakinra in Adult Patients with Refractory Recurrent Idiopathic Pericarditis

Background Denosumab and zoledronate are increasingly prescribed for primary and secondary osteoporosis long-term management. Methods A retrospective audit was conducted at Basildon Hospital during 2012-2019 using the NICE guidelines standards to evaluate the long term safety and efficacy of denosumab and zoledronate. Number of patients was 84, diagnosed with osteoporosis or osteopenia, 34 of them received 10 or more denosumab injections and 50 patients planned to receive 5 zoledronate infusions (9 patients received 5 and 38 patients received 4). Results Forty percent of the patients were at their 8th decade followed by 28.57% and 21.42 % at their 9th and 7th decades respectively. More than 90% were Caucasian females. Primary prevention was in 39.28% and secondary prevention in 60.71%. The commonest sites of fracture were the wrist and vertebrae at 34.37% for each; followed by the neck of femur and humerous at 12.5% for each. Denosumab was the 1st, 2nd, 3rd or 4th line of treatment in 9.52%, 13.09%, 16.66% and 1.19% respectively; whereas zoledronate was the 1st, 2nd or 3rd line of treatment in 13.09%, 40.47% and 5.95% respectively. The commonest reason for choosing denosumab as the first line was chronic kidney disease, whereas the reason for choosing it as the 2nd or 3rd line was inefficacy of bisphosphonate in 69% or gastrointestinal side effects in 14%. Zoledronate was chosen in all cases because of intolerability to oral bisphosphonate or gastrointestinal side effects. Repeat DXA scan was performed after the 5th, 10th denosumab injections and the 3rd zoledronate infusions. After the 5th Denosumab, DXA scan showed improvement or stability in 100% and 85.29% at the spine and hip respectively whilst deterioration was seen in 14.7% at the hip. After the 10th denosumab, the rate of improvement or stability at the spine was reduced to 88.23% and decline was seen in 2.94%. At the hip area, 73.52% continued to show improvement or stability, whilst 17.66 % showed deterioration. After the 3rd zoledronate, 98% and 88% showed improvement or stability at the spine and hip respectively whilst deterioration seen in 2% and 12% at the spine and hip respectively. One patient on zoledronate experienced dental issues after the 4th injection and stopped treatment. There were no jaw osteonecrosis, no new fractures and no significant side effects with either denosumab or zoledronate. Ninety percent of patients who completed 10 denosumab injections were planned to continue for another 5 injections. Conclusion After the period of 3-5 years, denosumab and zoledronate were well tolerated and BMD was either stable or improved at both spinal and hip sites. There were few cases of deterioration mainly at the hip area with both zoledronate and denosumab. Future researches are needed to stratify guidelines on discontinuation of denosumab. Disclosures Z. Alkutobi None. D. Laila None. M. Tariq None. A. Nandagudi None.

Objective: To compare the long term safety and efficacy of the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent(Firehawk stent) and permanent polymer coating everolimus eluting stent(Xience V stent) for the treatment of coronary de novo lesions. Methods: This prospective, multi-center, non-inferiority, randomized control trial(TARGETⅠ trial) was performed between August 2010 and April 2011, a total of 460 patients with primary, de novo, single vessel and single coronary lesion from 16 medical centers were enrolled. The diameter stenosis of target lesion was ≥70%, and lesion length was≤24 mm. The patients were randomly assigned to treatment with Firehawk stent (Firehawk stent group) or Xience V stent (Xience V stent group) groups by a web-based allocation system and was stratified by center. The late lumen loss after 9 months, target lesion failure (TLF) which was a composite of cardiac death, target vessel myocardial infarction, or ischemia driven target lesion revascularization, patient-oriented composite endpoint (PoCE) which was a composite of all cause death, all cause myocardial infarction, or any revascularization, and stent thrombosis after 5 years were compared between the two groups. Results: (1) There were 2 patients without stent implantation dropped out of this trial. There were 227 patients in Firehawk stent group, and 231 patients in Xience V stent group. The baseline characteristics were similar between the two groups(all P>0.05). (2) The 9 months late lumen loss in Firehawk stent group was non-inferior to that in Xience V stent group ((0.13±0.24)mm vs. (0.13±0.18)mm, P=0.94). (3) A total of 442 (96.5%) patients completed 5 years clinical follow-up. There were no significant differences on 5-year TLF rate (6.0%(13/217) vs. 6.7% (15/225), P=0.77) and PoCE rate (12.0%(26/217) vs. 17.8% (40/225), P=0.09) between the Firehawk stent group and Xience V stent group. (4) Kaplan-Meier analysis showed that TLF rates between 1-5 years were similar in Firehawk stent group and Xience V stent group (5.7% and 6.6% respectively, HR=0.88, 95%CI 0.42-1.84, P=0.72). Land-Mark analysis showed that TLF rates bewteen 1-5 years were similar in Firehawk stent group and Xience V stent group (3.6% and 4.4% respectively, HR=0.83, 95%CI 0.34-2.00, P=0.67). Kaplan-Meier analysis showed that PoCE rates between 1-5 years were also similar in Firehawk stent group and Xience V stent group (11.4% and 17.3% respectively, HR=0.64, 95%CI 0.39-1.04, P=0.07). Land-Mark analysis showed that PoCE rates after 5 years were similar in Firehawk stent group and Xience V stent group (8.4% and 10.0% respectively, HR=0.66, 95%CI 0.40-1.10, P=0.11). (5) No stent thrombosis was documented in Firehawk stent group during the 5 years follow-up period, and there was 1 case of stent thrombosis in Xience V stent group after 3 years of stent implantation. Conclusion: TARGETⅠ trial results of 5 years follow up indicate the novel Firehawk stent have a durable safety and efficacy profile which is comparable to the Xience V stent in treating patients with single de novo coronary lesion. Clinical Trial Registration North American Clinical Trial Registration Center, NCT01196819.