A novel endovascular method of atherectomy for calcified common femoral and popliteal disease using the crosser system: Crossbow and Rambow techniques

Vascular ◽  
2022 ◽  
pp. 170853812110673
Author(s):  
Yusuke Sato ◽  
Kazushi Urasawa ◽  
Michinao Tan ◽  
Taichi Hayashi ◽  
Takashi Miwa
Keyword(s):  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Retrograde Approach ◽  
Technical Success ◽  
Peripheral Artery ◽  
Safety Outcome ◽  
Efficacy Outcome ◽  
Protection Devices ◽  
The Common ◽  
Artery Disease

Objectives This study aims to report the efficacy and safety of new atherectomy methods using the Crosser system for calcified lesions in the common femoral and popliteal artery: the Crosser system supported by bended 0.014 wire (Crossbow) technique and retrograde approach of sheathless Crosser system supported by bended 0.014 wire (Rambow) technique. Materials and Methods This report describes a single-center, retrospective study. A total of 23 patients (mean ± SD age, 73 ± 10 years; 19 men) with symptomatic peripheral artery disease received the Crossbow technique and Rambow technique for treatment of calcified common femoral and popliteal disease; these patients were enrolled between October 2013 and October 2015. The primary efficacy outcome was acute technical success, defined as achievement of residual stenosis < 30% for stenting and < 50% for angioplasty or atherectomy. The primary safety outcome was assessed on the basis of angiographic complications. Results The Crossbow and Rambow techniques were undertaken in 100% and 17% of the patients, respectively. Acute technical success was achieved in 96% of the patients. There were two embolic events. Conclusion Crossbow and Rambow techniques could be effective atherectomy methods of calcified common femoral and popliteal disease. Regarding safety, embolic protection devices may be needed for our atherectomy methods.

Effect of Rivaroxaban and Aspirin in Patients with Peripheral Artery Disease Undergoing Surgical Revascularization: Insights from the VOYAGER PAD Trial

Circulation ◽  
2021 ◽  
Author(s):  
E. Sebastian Debus ◽  
Mark R. Nehler ◽  
Nicholas Govsyeyev ◽  
Rupert M. Bauersachs ◽  
Sonia S. Anand ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Placebo Group ◽  
Peripheral Artery Disease ◽  
Major Bleeding ◽  
Cumulative Incidence ◽  
Efficacy And Safety ◽  
Peripheral Artery ◽  
Safety Outcome ◽  
Fatal Bleeding ◽  
Artery Disease

Background: Patients with peripheral artery disease (PAD) requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. VOYAGER PAD demonstrated that rivaroxaban significantly reduced this risk. The efficacy and safety of rivaroxaban has not been described in patients who underwent surgical LER. Methods: The VOYAGER PAD trial randomized patients with PAD after surgical and endovascular LER to rivaroxaban 2.5mg twice daily plus aspirin or matching placebo plus aspirin and followed for a median of 28 months. The primary endpoint was a composite of acute limb ischemia, major vascular amputation, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. International Society on Thrombosis and Haemostasis (ISTH) bleeding was a secondary safety outcome. All efficacy and safety outcomes were adjudicated by a blinded independent committee. Results: Of the 6564 randomized, 2185 (33%) underwent surgical LER and 4379 (67%) endovascular. Compared to placebo, rivaroxaban reduced the primary endpoint consistently regardless of LER method (p-interaction 0.43). Following surgical LER, the primary efficacy outcome occurred in 199 (18.4%) patients in the rivaroxaban group and 242 (22.0%) patients in the placebo group with a cumulative incidence at 3 years of 19.7% and 23.9%, respectively (HR 0.81, 95% CI 0.67 - 0.98; p=0.026). In the overall trial, TIMI major bleeding and ISTH major bleeding were increased with rivaroxaban. There was no heterogeneity for TIMI major bleeding (p-interaction 0.17) or ISTH major bleeding (p-interaction 0.73) based on LER approach. Following surgical LER, the principal safety outcome occurred in 11 (1.0%) patients in the rivaroxaban group and 13 (1.2%) patients in the placebo group; 3-year cumulative incidence 1.3% and 1.4% respectively (HR 0.88, 95% CI 0.39-1.95; p=0.75) Among surgical patients, the composite of fatal bleeding or intracranial hemorrhage (p=0.95) and postprocedural bleeding requiring intervention (p=0.93) were not significantly increased. Conclusions: The efficacy of rivaroxaban is associated with a benefit in surgical LER patients. While bleeding was increased with rivaroxaban plus aspirin, the incidence was low, with no significant increase in fatal bleeding, intracranial hemorrhage or postprocedural bleeds requiring intervention. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT02504216

scholarly journals Therapeutic versus Prophylactic Anticoagulation for Patients Admitted to Hospital with COVID-19 and Elevated D-dimer Concentration (ACTION): An Open-Label, Multicentre, Randomised, Controlled Trial

2021 ◽  
Vol 5 (2) ◽  
pp. 103-108
Author(s):  
Gilson Soares Feitosa-Filho ◽  
Gabriella S. Sodré ◽  
Juliane Penalva C. Serra ◽  
Rhanniel Theodorus-Villar ◽  
Tatiana Otero Mendelez ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Primary Efficacy ◽  
Therapeutic Group ◽  
Open Label ◽  
Safety Outcome ◽  
Therapeutic Anticoagulation ◽  
Efficacy Outcome ◽  
Randomised Controlled ◽  
Prophylactic Anticoagulation ◽  
D Dimer

Background. COVID-19 is associated with a prothrombotic state leading to adverse clinical outcomes. Whether therapeutic anticoagulation improves outcomes in patients hospitalised with COVID-19 is unknown. We aimed to compare the efficacy and safety of therapeutic versus prophylactic anticoagulation in this population. Methods. We did a pragmatic, open-label (with blinded adjudication), multicentre, randomised, controlled trial, at 31 sites in Brazil. Patients (aged ≥18 years) hospitalised with COVID-19 and elevated D-dimer concentration, and who had COVID-19 symptoms for up to 14 days before randomisation, were randomly assigned (1:1) to receive either therapeutic or prophylactic anticoagulation. Therapeutic anticoagulation was in-hospital oral rivaroxaban (20 mg or 15 mg daily) for stable patients, or initial subcutaneous enoxaparin (1 mg/kg twice per day) or intravenous unfractionated heparin (to achieve a 0·3–0·7 IU/mL anti-Xa concentration) for clinically unstable patients, followed by rivaroxaban to day 30. Prophylactic anticoagulation was standard in-hospital enoxaparin or unfractionated heparin. The primary efficacy outcome was a hierarchical analysis of time to death, duration of hospitalisation, or duration of supplemental oxygen to day 30, analysed with the win ratio method (a ratio >1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding through 30 days. This study is registered with ClinicalTrials.gov (NCT04394377) and is completed. Findings. From June 24, 2020, to Feb 26, 2021, 3331 patients were screened and 615 were randomly allocated (311 [50%] to the therapeutic anticoagulation group and 304 [50%] to the prophylactic anticoagulation group). 576 (94%) were clinically stable and 39 (6%) clinically unstable. One patient, in the therapeutic group, was lost to follow-up because of withdrawal of consent and was not included in the primary analysis. The primary efficacy outcome was not different between patients assigned therapeutic or prophylactic anticoagulation, with 28.899 (34.8%) wins in the therapeutic group and 34.288 (41.3%) in the prophylactic group (win ratio 0.86 [95% CI 0.59–1.22], p=0·40). Consistent results were seen in clinically stable and clinically unstable patients. The primary safety outcome of major or clinically relevant non-major bleeding occurred in 26 (8%) patients assigned therapeutic anticoagulation and seven (2%) assigned prophylactic anticoagulation (relative risk 3.64 [95% CI 1.61–8.27], p=0.0010). Allergic reaction to the study medication occurred in two (1%) patients in the therapeutic anticoagulation group and three (1%) in the prophylactic anticoagulation group. Interpretation. In patients hospitalised with COVID-19 and elevated D-dimer concentration, in-hospital therapeutic anticoagulation with rivaroxaban or enoxaparin followed by rivaroxaban to day 30 did not improve clinical outcomes and increased bleeding compared with prophylactic anticoagulation. Therefore, use of therapeutic-dose rivaroxaban, and other direct oral anticoagulants, should be avoided in these patients in the absence of an evidence-based indication for oral anticoagulation.

Efficacy and Safety of Edoxaban Versus Enoxaparin for the Prevention of Venous Thromboembolism Following Total Hip Arthroplasty: STARS J-V trial

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3320-3320 ◽  
Author(s):  
Takeshi Fuji ◽  
Satoru Fujita ◽  
Shintaro Tachibana ◽  
Yohko Kawai ◽  
Yukihiro Koretsune ◽  
...  
Keyword(s):  
Total Hip Arthroplasty ◽  
Major Bleeding ◽  
Thromboembolic Events ◽  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Primary Efficacy Outcome ◽  
Treatment Groups ◽  
Efficacy Outcome ◽  
Lead Investigator

Abstract Abstract 3320 Introduction: Edoxaban is an oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic events. The aim of this non-inferiority trial was to determine the efficacy and safety of edoxaban compared with enoxaparin sodium (enoxaparin) after total hip arthroplasty (THA) in Japan. Methods: This was a randomized, double-blind, double-dummy, enoxaparin-controlled, multicenter trial. Patients were randomized to oral edoxaban 30 mg once daily (QD) or subcutaneous enoxaparin 2,000 IU, equivalent to 20 mg, twice daily (BID) for 11 to 14 days. Edoxaban was initiated 6–24 hours after surgery and enoxaparin was initiated 24–36 hours after surgery which is the Japanese standard of care. The primary efficacy outcome was the composite of symptomatic and asymptomatic deep vein thrombosis (DVT), and pulmonary embolism (PE). The primary safety outcome was the incidence of major and clinically relevant non-major bleeding. Results: A total of 610 patients were randomized. There were no clinically relevant differences in baseline characteristics between the treatment groups. The mean age was 62.8 years and mean body weight was 57.4 kg (Efficacy analysis set). The primary efficacy outcome occurred in 6 of 255 (2.4%) patients receiving edoxaban and 17 of 248 (6.9%) patients receiving enoxaparin (relative risk reduction=65.7%; absolute risk difference -4.5%, 95% CI, -8.6% to -0.9%; P<0.001 for non-inferiority; P=0.0157 for superiority). The thromboembolic events were all asymptomatic DVT (Table). No symptomatic DVT or PE was observed in both treatment groups. The incidence of major and clinically relevant non-major bleeding events was 2.6% (8/303) vs 3.7% (11/301) in the edoxaban and enoxaparin groups, respectively (P=0.475). Major bleeding occurred in 0.7% of the edoxaban group and 2.0% of the enoxaparin group. The rates of elevated serum aminotransferase levels of more than 3 times the upper limit of normal was 2.6% with edoxaban versus 10% with enoxaparin. Conclusions: The STARS J-V trial demonstrated that oral edoxaban 30 mg QD has efficacy superior to enoxaparin 2,000 IU BID in the prevention of thromboembolic events following THA and is associated with a similar incidence of major and clinically relevant non-major bleeding events. Disclosures: Fuji: Astellas: Consultancy; Showa Ikakogyo: Consultancy; Daiichi Sankyo: Consultancy; Bayer: Consultancy. Fujita:Daiichi Sankyo: Consultancy; Astellas: Consultancy; GlaxoSmithkline: Consultancy. Tachibana:Daiichi Sankyo: Consultancy. Kawai:Daiichi Sankyo: Consultancy; Toyama Chemical: Consultancy. Koretsune:Daiichi Sankyo: Consultancy, National Lead Investigator. Yamashita:Daiichi Sankyo: Consultancy, National Lead Investigator; Otsuka Pharmaceutical: Paid instructor; Sanofi-aventis: Paid instructor; Teijin Pharma: Paid instructor. Nakamura:Daiichi Sankyo: Consultancy; GlaxoSmithkline: Consultancy; Astellas: Consultancy.

scholarly journals Hemodynamic effects of balloon pulmonary angioplasty for the treatment of total and subtotal pulmonary artery occlusions in inoperable chronic thromboembolic pulmonary hypertension

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
J Stepniewski ◽  
W Magon ◽  
R Przybylski ◽  
G Kopec
Keyword(s):  
Pulmonary Hypertension ◽  
Pulmonary Artery ◽  
Therapeutic Option ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Funding Sources ◽  
Efficacy Outcome ◽  
Balloon Pulmonary Angioplasty ◽  
Thromboembolic Pulmonary Hypertension

Abstract Background Balloon pulmonary angioplasty (BPA) has become a therapeutic option for inoperable chronic thromboembolic pulmonary hypertension (CTEH). Despite significant improvement in the technique, treatment of subtotal (STO) and total (TO) pulmonary artery occlusions with BPA may pose risk, but the efficacy is unknown. Aim We aimed to study to assess safety and efficacy of BPA in STO/TO. Methods We included consecutive patients with inoperable CTEPH, who underwent BPA treatment. To evaluate the efficacy and safety we grouped all BPA sessions into those in which recanalization of at least one STO or TO was performed and into those without. The primary efficacy outcome was improvement in pulmonary vascular resistance (PVR) in BPA sessions with STO/TO recanalization as compared to those without. Results We analyzed 169 BPA sessions in 50 CTEPH patients. Out of a total number of 832 lesions subjected for BPA, 168 were classified as STOs or TOs [129 (15,5%) and 39 (4,7%) respectively]. Three (2,3%) STOs and 8 (20,5%) TOs were not recanalized despite repeated attempts. There were 90 BPA sessions with at least one STO/TO recanalization. Racanalization of at least one STO/TO was associated with a trend towards PVR improvement as compared to non-STO/TO BPAs (−69±162 vs −38±135 dyn s cm–5, p=0,19). Recanalization of STO/TO at the level of segmental pulmonary artery as compared to subsegmental-only STO/TO recanalizations or no-STO/TO recanalization was associated with significant PVR improvement (−126±192 vs −38±135 dyn s cm–5, p=0.007). The rate of complications was similar in STO/TO and non-STO/TO BPA sessions (14.4% vs 12.6%, p=0.56). Conclusions The use of BPA for the recanalization of subtotal and total PA occlusions is safe and effective. Recanalization of segmental STO/TOs leads to significant improvement in PVR. FUNDunding Acknowledgement Type of funding sources: None.

Abstract 13760: Intensive versus Standard Blood Pressure Control in Patients With Peripheral Artery Disease: The Systolic Blood Pressure Intervention Trial (SPRINT)

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Johanna Frary ◽  
Christina Byrne ◽  
Muthiah Vaduganathan ◽  
Tor Biering-srensen ◽  
Michael H Olsen ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Adverse Events ◽  
Peripheral Artery Disease ◽  
Primary Outcome ◽  
Standard Group ◽  
Efficacy And Safety ◽  
Peripheral Artery ◽  
Serious Adverse Events ◽  
Risk Of Death ◽  
Artery Disease

Background: High blood pressure (BP) is the strongest modifiable risk factor for cardiovascular (CV) disease and is highly prevalent among individuals with peripheral artery disease (PAD). Purpose: To assess the efficacy and safety of intensive versus standard BP control in patients with PAD, and to assess if the presence of PAD modified treatment effect. Methods: SPRINT was a randomized, controlled, open-label trial in which individuals aged ≥50 years, at high CV risk, and with a systolic BP 130-180 mmHg were randomized to intensive (systolic BP target <120mmHg) or standard BP control (systolic BP target 135-139 mmHg). The primary outcome was the composite of acute coronary syndromes, stroke, heart failure, or CV death. Safety outcomes included serious adverse events, such as hypotension, syncope, electrolyte abnormalities, acute kidney injury or failure, or injurious falls. We assessed the risk of events in patients with PAD versus those without and assessed the efficacy and safety of intensive BP in patients with PAD. Subgroup heterogeneity was evaluated using interaction analyses. Results: Of 9361 participants, 503 (5.3%) had baseline PAD (intensive group 250 (5.3%) versus standard group 253 (5.4%); P=0.90). Median follow-up duration was 3.2 years (range 0-4.6 years). PAD was independently associated with a higher risk of both the primary outcome (hazard ratio (HR) 1.61, 95% confidence interval (CI): 1.23-2.12; P<0.001) and composite serious adverse events (HR 1.49, 95% CI: 1.32-1.69; P<0.001). The presence of PAD did not modify the efficacy and safety of intensive versus standard BP control (P≥0.05). However, due to the higher baseline risk in PAD patients, the absolute risk reduction of the primary outcome with intensive treatment was larger compared with patients without PAD (1.8% versus 1.6%), as was the risk of death from any cause (2.3% versus 1.1%) (Figure) . Conclusion: Intensive BP control reduced CV events and death in patients with hypertension and PAD.

Oral Rivaroxaban for the Treatment of Symptomatic Venous Thromboembolism: A Pooled Analysis of the EINSTEIN DVT and EINSTEIN PE Studies

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 20-20 ◽  
Author(s):  
Harry Roger Buller
Keyword(s):  
Body Weight ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Standard Therapy ◽  
Pooled Analysis ◽  
Fixed Dose ◽  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Efficacy Outcome ◽  
Subgroup Analyses

Abstract Abstract 20 Harry R. Büller, MD, PhD on behalf of the EINSTEIN Investigators. Background The EINSTEIN DVT and EINSTEIN PE studies showed that a fixed-dose regimen of rivaroxaban was non-inferior to standard therapy of subcutaneous enoxaparin followed by vitamin K antagonist (VKA) for the treatment of symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), with similar occurrence of clinically relevant bleeding (The EINSTEIN Investigators. N Engl J Med 2010;363:2499–510; The EINSTEIN–PE Investigators. N Engl J Med 2012;366:1287–97). This prespecified pooled analysis compared rivaroxaban with the standard therapy for the primary efficacy and safety outcomes, including subgroup analyses for body weight, age, and renal function. Methods This data pool included all patients and events from EINSTEIN DVT (patients with acute symptomatic DVT without PE) and EINSTEIN PE (patients with acute symptomatic PE with or without DVT). Both studies shared an open-label, randomized, non-inferiority design and compared oral, fixed-dose rivaroxaban alone (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with subcutaneous body weight-adjusted enoxaparin followed by warfarin or acenocoumarol (international normalized ratio 2–3) for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism (the composite of recurrent DVT or nonfatal or fatal PE); safety outcomes included the composite of major and clinically relevant non-major bleeding, and major bleeding alone. Adjudication was done by a single committee. Subgroup analyses for efficacy and safety were performed. Results The intention-to-treat population included 4150 rivaroxaban patients and 4131 enoxaparin/VKA patients. Rivaroxaban demonstrated non-inferior efficacy to enoxaparin/VKA for the primary efficacy outcome (rivaroxaban: 86 events [2.1%], enoxaparin/VKA: 95 events [2.3%]; hazard ratio [HR] 0.89; 95% confidence interval [CI] 0.66–1.19; p<0.0001 for non-inferiority). Major and clinically relevant non-major bleeding occurred in 388 patients (9.4%) in the rivaroxaban group and 412 patients (10.0%) in the enoxaparin/VKA group (HR=0.93; 95% CI 0.81–1.06; p=0.272), and major bleeding occurred in 40 (1.0%, 3 fatal) and 72 (1.7%, 8 fatal) of the rivaroxaban and enoxaparin/VKA recipients, respectively (HR=0.54; 95% CI 0.37–0.79; p=0.002). Efficacy was consistent for rivaroxaban compared with enoxaparin/VKA among the various subgroups, whereas increasing age and declining renal function were associated with a strong reduction in major bleeding in favor of rivaroxaban (Table). Major bleeding was consistently lower in the rivaroxaban recipients for all body weight categories. Conclusion This analysis demonstrates that the simple, single-drug approach with oral rivaroxaban has an improved benefit–risk profile compared with standard therapy for the treatment of symptomatic venous thromboembolism. The reduction in major bleeding in favor of rivaroxaban was most pronounced in elderly patients and those with moderate renal impairment (creatinine clearance <50 mL/min), and was consistent among various body weight categories, thereby obviating the need for a rivaroxaban dose adjustment in these subgroups. Disclosures: No relevant conflicts of interest to declare.

Sign in / Sign up

Export Citation Format

Share Document