No Mortality Signal With Stellarex Low-Dose Paclitaxel DCB: ILLUMENATE Pivotal 4-Year Outcomes

2022 ◽  
pp. 152660282110687
Author(s):  
Sean P. Lyden ◽  
Peter L. Faries ◽  
Khusrow A. K. Niazi ◽  
Ravish Sachar ◽  
Ash Jain ◽  
...  
Keyword(s):  
Low Dose ◽  
Controlled Trial ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Safety And Efficacy ◽  
Kaplan Meier ◽  
Safety Endpoint ◽  
Mortality Difference

Background: Paclitaxel-coated balloons have shown safety and efficacy in the short- to intermediate-term; however, long-term data remain limited. Objectives: To report late safety and efficacy outcomes for a low-dose paclitaxel drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions from a large randomized controlled trial (RCT). Methods: ILLUMENATE Pivotal is a multicenter, single-blind RCT conducted across 43 US and EU centers to examine the safety and efficacy of the Stellarex DCB for the treatment of femoropopliteal disease. Assessments were recorded for all active patients at 36 and 48 months. Vital status of patients formally exited from the study was also collected. Results: Primary patency through 36 months for patients treated with DCB was significantly higher compared with PTA (p=0.016). The primary safety endpoint through 36 months was 77.4% and 72.4%, respectively (p=0.377). Kaplan-Meier analysis indicated that a higher proportion of DCB subjects were event-free compared with PTA at all study visits. The rate of major adverse event (MAE) through 48 months was 32.9% in the DCB group and 37.9% in the PTA group (p=0.428). No differences in the rate of mortality were evident through 48 months of follow-up with 15.6% in the DCB group and 15.2% in the PTA group (p=0.929). Conclusions: Stellarex DCB was associated with significantly higher patency compared with PTA through 3 years with no mortality difference detected through 4 years. The data from the ILLUMENATE Pivotal RCT support the long-term safety and efficacy of the low-dose Stellarex DCB.

Long Term Safety and Efficacy Of Low Fixed Dose Hydroxyurea In Pediatric Patients With Sickle Cell Anemia: A Single Center Study From Central India

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1000-1000 ◽  
Author(s):  
Dipty L. Jain ◽  
Lakshmanan Krishnamurti ◽  
Vijaya Sarathi ◽  
Saumil Desai ◽  
Amruta Gokhale
Keyword(s):  
Sickle Cell Anemia ◽  
Low Dose ◽  
Pediatric Patients ◽  
Central India ◽  
Fixed Dose ◽  
Acute Chest Syndrome ◽  
Severe Anemia ◽  
Safety And Efficacy

Abstract Introduction Hydroxyurea (HU) therapy ameliorates the morbidity associated with Sickle cell anemia (SCA). HU is typically escalated to maximum tolerated doses (MTD) for treatment of SCA patients. Monitoring HU for toxicity poses potential challenges in low resource settings. We have previously reported the safety and efficacy of fixed low dose HU at 10mg/kg body weight ( Jain et al 2013). We studied the long term safety and efficacy of low dose HU in pediatric patients with SCA. Methods Long term observational follow up of 40 young Indian SCA patients was carried out for a period of 10 years in a single tertiary care center in central India. The number of clinical events including vasocclusive crises, acute chest syndrome, stroke, sequestration crises, avascular bone necrosis in the entire cohort was assessed prior to starting HU and subsequently every 3 months. Laboratory parameters including hemoglobin levels, Hb F levels, mean corpuscular volume, mean corpuscular hemoglobin concentration were also followed up over the same time period. Results The total number of patients in this study was 40 (17 females & 23 males). Mean age was 12.95 years ± 9.62. All patients had HbSS. There was an increase in mean hemoglobin, HbF, MCV and MCH over time in the patient population ( Table 1). There was a decrease in the mean number of hospitalizations, vasocclusive crises, acute chest syndromes, stroke and severe anemia ( Table 2). HU was well tolerated with minimal hematological or other toxicity (Table3). Patients who experienced transient hematological, liver or renal toxicity were able to resume HU at the same dose. HU was permanently discontinued in 2 patients who had manifestations of HIV/AIDS. HU was temporarily interrupted in one patient who was receiving treatment for tuberculosis and in one patient for the duration of a normal pregnancy. There was one death attributable to severe septicemia without evidence of neutropenia after 2 years follow up. There were 3 subjects who were lost to follow up, one after 2 years follow up and remaining 2 after 5 years of follow up. Of note, patients had a high HbF level at baseline. High HbF levels at baseline, the variable relationship of HbF to disease severity and amelioration of disease in Indian patients with high HbF has been previously reported ( Jain et al 2012, Patel et al 2012, Italia et al 2009). Conclusions Low fixed dose HU is well tolerated and is efficacious in reducing incidence of VOC, hospitalizations, severe anemia, stroke and acute chest syndrome. Low fixed dose HU may be advantageous in low resource settings because of lower toxicity and consequently less need for monitoring. There is a need for multi-center randomized comparisons of low fixed dose HU with conventional escalation of HU dose to MTD. Disclosures: Krishnamurti: GlycoMimetics, Inc.: Research Funding.

scholarly journals Prospective long-term study of outcomes of 100 arteriovenous fistulas in patient with chronic renal failure

2018 ◽  
Vol 5 (4) ◽  
pp. 1475
Author(s):  
Mithun Panchal
Keyword(s):  
Primary Patency ◽  
Diabetic Patients ◽  
Basilic Vein ◽  
Flow Rates ◽  
Arteriovenous Fistulas ◽  
Long Term Study ◽  
Kaplan Meier ◽  
Vein Diameter

Background: This study describes the experience of arteriovenous fistula (AVF) creation as vascular access for haemodialysis.Methods: This study has been carried out in our hospital from January 2004 to December 2016. A total of 154 AVFs were created in 100 patients. Maximum follow-up was 2 years, and minimum was 6 months.Results: In this study of 100 cases of AVFs, primary patency rates by Kaplan Meier analysis showed 78.81% patency of fistulas at the end of 1 year and patency dropped to 14.81% at the end of 5 years. The primary failure rate was 21.2%. Basilic vein was used in 26.35% cases, cephalic vein in 63.5%, and antecubital vein in 9.75% cases. On table, bruit was present in 134 (90.9%) and thrill in 126 (89.3%) cases. During dialysis, flow rate >250ml/min was obtained in 40(29.9%) cases. In complications, 2 (0.4%) patients developed distal oedema.Conclusions: Presence of on table thrill and bruit are indicators of successful AVF. If vein diameter is <2mm, chances of AVF failure are high. Flow rates in patients with vein diam. More than 2mm was significantly higher as compared with patients with vein diam. Less than 2mm (P< 0.001). Flow rates are higher in non-diabetic patients as compared to diabetic patients (P <0.001). Average blood urea and serum creatinine values are significantly lesser in patients undergoing dialysis through successful fistulas as compared to patients with failed fistulas. Correspondingly, incidence of deaths is significantly lesser in patients with successful fistulas. During proximal side-to-side fistula between antecubital/basilic vein and brachial artery, dilating of the first valve toward wrist helps to develop distal veins in the forearm by retrograde flow. This technique avoids requirement of superficialization of basilic vein in the arm.

Can the fistula arm be used to lift heavy items? Six-pound dumbbells versus handgrip exercise in a 6-month follow-up secondary analysis of a randomized controlled trial

2019 ◽  
Vol 21 (5) ◽  
pp. 602-608
Author(s):  
Ya-wen Mo ◽  
Li Song ◽  
Jing-ya Huang ◽  
Chun-yan Sun ◽  
Li-fang Zhou ◽  
...  
Keyword(s):  
Adverse Events ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Primary Patency ◽  
Arteriovenous Fistulas ◽  
Significant Difference ◽  
Long Term Follow Up

Introduction: Patients with arteriovenous fistulas are advised to avoid carrying heavy objects draped over the fistula arm. Awareness gradually leads to overprotection and a reduction in the use of the fistula arm. However, restricting motion in the fistula arm leads to decreased quality of life and diminished muscle strength. The current safety recommendations regarding lifting heavy items with the fistula arm are primarily based on experience. Few studies have provided evidence clarifying the scope of safe activity and the influence of load bearing on the continued patency of arteriovenous fistulas. Methods: This prospective observation was based on a long-term follow-up study in which 86 hemodialysis recipients with arteriovenous fistulas were randomized into either a dumbbell group or a handgrip group. The dumbbell group exercised with 6-lb dumbbells, while the handgrip group squeezed rubber balls. Postintervention primary patency and adverse events at the 6-month follow-up were analyzed. Results: No significant difference in postintervention primary patency was observed between the dumbbell group and the handgrip group at 6 months (97.4% vs 95.0%). There were two participants with high-flow fistulas in the dumbbell group and three in the handgrip group, with no significant difference between the two groups (5.3% vs 7.5%). In both groups, there were no other adverse events reported regarding cardiac failure, aneurysm, puncture site hematoma, or hemorrhage. Conclusion: Hemodialysis patients can safely use their fistula arm to lift objects weighing less than 6 lb, which encourages increased motion and helps preserve the functionality of the fistula arm.

Sedoanalgesia with intravenous midazolam and fentanyl for angioplasty of dysfunctional arteriovenous access: A retrospective single-center analysis

2021 ◽  
pp. 112972982110501
Author(s):  
Shih-Ming Huang ◽  
Honda Hsu ◽  
Ing-Heng Hii ◽  
Chien-Hwa Chang
Keyword(s):  
Patency Rate ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Dialysis Access ◽  
Average Pain ◽  
Average Pain Score ◽  
Arteriovenous Access ◽  
One Year

Background: Endovascular therapy, such as percutaneous transluminal angioplasty (PTA), stenting, or embolization, is a well-established form of treatment to prolong the lifespan of arteriovenous access. These procedures, especially PTA, can be accompanied with severe pain. We reviewed and analyzed the efficacy, safety, and outcome of sedoanalgesia using intravenous midazolam and fentanyl, for pain relief during these procedures. Methods: Two hundred and two consecutive patients with dysfunctional dialysis access that had undergone endovascular procedure in our institute between July and November 2017 were included in this study. The dialysis access profile, procedure complication, and 10-point Visual Analog Scale (VAS) were collected. One-year clinical follow-up record was also collected to evaluate arteriovenous access patency and long-term complications. Results: Among the 202 patients, the mean age was (mean ± SD) 67.0 ± 12.08 years. Dialysis access profile of these patients were 119 (58.9%) native arteriovenous fistula and 162 (74.2%) forearm access. The number of lesions treated were 1.63 ± 0.802. Immediate complications included 11 (5.44%) nausea/vomiting, 24 (11.88%) desaturation (SpO2 < 90%, resolved after pillow removal or jaw trust), 16 (7.9%) hypotension (SBP < 90 mmHg, resolved without inotropic agents). There was a low average pain score (1.16 ± 1.594) during the procedure with 136 (67.3%) no pain (VAS 0–1) and 56 (27.7%) mild pain (VAS 2–4). Higher VAS score correlated with overweight patients, longer PTA time and pain after procedure. Six-month primary patency rate was 49.17% and primary assisted patency rate was 93.04%. Conclusions: Sedoanalgesia with intravenous midazolam and fentanyl is an easy, safe, and effective method for surgeons.

scholarly journals Prospective long-term study of patency and outcomes of 505 arteriovenous fistulas in patients with chronic renal failure: Authors experience and review of literature

2014 ◽  
Vol 47 (03) ◽  
pp. 362-369 ◽  
Author(s):  
Parag Sahasrabudhe ◽  
Tushar Dighe ◽  
Nikhil Panse ◽  
Shraddha Deshpande ◽  
Amit jadhav ◽  
...  
Keyword(s):  
Primary Patency ◽  
Diabetic Patients ◽  
Basilic Vein ◽  
Flow Rates ◽  
Arteriovenous Fistulas ◽  
Long Term Study ◽  
Kaplan Meier ◽  
Vein Diameter

ABSTRACT Background: This study describes our experience of arteriovenous fistula (AVF) creation as vascular access for haemodialysis. Materials and Methods: This study has been carried out in our hospital from January 2004 to December 2012. A total of 505 AVFs were created in 443 patients. Maximum follow-up was 8 years, and minimum was 6 months. Observations and Results: In this study of 505 cases of AVFs, primary patency rates by Kaplan — Meier analysis showed 78.81% patency of fistulas at the end of 1 year and patency dropped to 14.81% at the end of 5 years. Our primary failure rate was 21.2%. Basilic vein was used in 26.35% cases, cephalic vein in 63.5%, and antecubital vein in 9.75% cases. On table, bruit was present in 459 (90.9%) and thrill in 451 (89.3%) cases. During dialysis, flow rate >250 ml/min was obtained in 150 (29.9%) cases. In complications, 2 (0.4%) patients developed distal oedema, 33 (6.5%) developed steal phenomenon. Conclusions: Presence of on table thrill and bruit are indicators of successful AVF. If vein diameter is <2 mm, chances of AVF failure are high. Flow rates in patients with vein diam. >2 mm were significantly higher as compared with patients with vein diam. <2 mm (P < 0.001). Flow rates are higher in non-diabetic patients as compared to diabetic patients (P < 0.001). Average blood urea and serum creatinine values are significantly lesser in patients undergoing dialysis through successful fistulas as compared to patients with failed fistulas. Correspondingly, incidence of deaths is significantly lesser in patients with successful fistulas. During proximal side-to-side fistula between antecubital/basilic vein and brachial artery, dilating of the first valve toward wrist helps to develop distal veins in the forearm by retrograde flow. This technique avoids requirement of superficialization of basilic vein in the arm.

Long-term hearing outcomes following stereotactic radiosurgery for vestibular schwannoma: patterns of hearing loss and variables influencing audiometric decline

2013 ◽  
Vol 118 (3) ◽  
pp. 579-587 ◽  
Author(s):  
Matthew L. Carlson ◽  
Jeffrey T. Jacob ◽  
Bruce E. Pollock ◽  
Brian A. Neff ◽  
Nicole M. Tombers ◽  
...  
Keyword(s):  
Stereotactic Radiosurgery ◽  
Vestibular Schwannoma ◽  
Tumor Size ◽  
Pure Tone ◽  
Low Dose ◽  
Pure Tone Average ◽  
Kaplan Meier ◽  
Hearing Outcomes

Object The goals of this retrospective cohort study were as follows: 1) to describe the long-term prevalence and timing of hearing deterioration following low-dose (12- to 13-Gy marginal dose) stereotactic radiosurgery (SRS) for vestibular schwannoma (VS); and 2) to identify clinical variables associated with long-term preservation of useful hearing following treatment. Methods Patients with serviceable hearing who underwent SRS for VS between 1997 and 2002 were studied. Data including radiosurgery treatment plans, tumor characteristics, pre- and posttreatment pure tone average, speech discrimination scores, and American Academy of Otolaryngology–Head and Neck Surgery hearing class were collected. Time to nonserviceable hearing was estimated using the Kaplan-Meier method. Univariate and multivariate associations with time to nonserviceable hearing were evaluated using Cox proportional hazards regression models. Results Forty-four patients met the study criteria and were included. The median duration of audiometric follow-up was 9.3 years. Thirty-six patients developed nonserviceable hearing at a mean of 4.2 years following SRS. The Kaplan-Meier estimated rates of serviceable hearing at 1, 3, 5, 7, and 10 years following SRS were 80%, 55%, 48%, 38%, and 23%, respectively. Multivariate analysis revealed that pretreatment ipsilateral pure tone average (p < 0.001) and tumor size (p = 0.009) were statistically significantly associated with time to nonserviceable hearing. Conclusions Durable hearing preservation a decade after low-dose SRS for VS occurs in less than one-fourth of patients. Variables including preoperative hearing capacity and tumor size may be used to predict hearing outcomes following treatment. These findings may assist in pretreatment risk disclosure. Furthermore, these data demonstrate the importance of long-term follow-up when reporting audiometric outcomes following SRS for VS.

Klinische Langzeitergebnisse der perkutanen transluminalen Angioplastie bei Patienten mit peripherer arterieller Verschlusskrankheit

VASA ◽  
2002 ◽  
Vol 31 (1) ◽  
pp. 36-42 ◽  
Author(s):  
. Bucek ◽  
Hudak ◽  
Schnürer ◽  
Ahmadi ◽  
Wolfram ◽  
...  
Keyword(s):  
Success Rate ◽  
Clinical Stage ◽  
Ankle Brachial Index ◽  
Clinical Situation ◽  
Clinical Results ◽  
Transluminal Angioplasty ◽  
Term Outcome ◽  
Long Term Outcome

Background: We investigated the long-term clinical results of percutaneous transluminal angioplasty (PTA) in patients with peripheral arterial occlusive disease (PAOD) and the influence of different parameters on the primary success rate, the rate of complications and the long-term outcome. Patients and methods: We reviewed clinical and hemodynamic follow-up data of 166 consecutive patients treated with PTA in 1987 in our department. Results: PTA improved the clinical situation in 79.4% of patients with iliac lesions and in 88.3% of patients with femoro-popliteal lesions. The clinical stage and ankle brachial index (ABI) post-interventional could be improved significantly (each P < 0,001), the same results were observed at the end of follow-up (each P < 0,001). Major complications occurred in 11 patients (6.6%). The rate of primary clinical long-term success for suprainguinal lesions was 55% and 38% after 5 and 10 years (femoro-popliteal 44% and 33%), respectively, the corresponding data for secondary clinical long-term success were 63% and 56% (60% and 55%). Older age (P = 0,017) and lower ABI pre-interventional (P = 0,019) significantly deteriorated primary clinical long-term success for suprainguinal lesions, while no factor could be identified influencing the outcome of femoro-popliteal lesions significantly. Conclusion: Besides an acceptable success rate with a low rate of severe complications, our results demonstrate favourable long-term clinical results of PTA in patients with PAOD.

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