scholarly journals North American lower-extremity revascularization and amputation during COVID-19: Observations from the Vascular Quality Initiative

2021 ◽  
pp. 1358863X2110219
Author(s):  
Jun-Yang Lou ◽  
Kevin F Kennedy ◽  
Matthew T Menard ◽  
J Dawn Abbott ◽  
Eric A Secemsky ◽  
...  
Keyword(s):  
Time Series ◽  
Lower Extremity ◽  
North American ◽  
Limb Ischemia ◽  
Outcome Data ◽  
Acute Limb Ischemia ◽  
Volume Changes ◽  
Time Series Regression ◽  
Lower Extremity Revascularization ◽  
Final Cohort

Introduction: The coronavirus disease 2019 (COVID-19) pandemic’s impact on vascular procedural volumes and outcomes has not been fully characterized. Methods: Volume and outcome data before (1/2019 – 2/2020), during (3/2020 – 4/2020), and following (5/2020 – 6/2020) the initial pandemic surge were obtained from the Vascular Quality Initiative®. Volume changes were determined using interrupted Poisson time series regression. Adjusted mortality was estimated using multivariable logistic regression. Results: The final cohort comprised 57,181 patients from 147 US and Canadian sites. Overall procedure volumes fell 35.2% (95% CI 31.9%, 38.4%, p < 0.001) during and 19.8% (95% CI 16.8%, 22.9%, p < 0.001) following the surge, compared with presurge months. Procedure volumes fell 71.1% for claudication (95% CI 55.6%, 86.4%, p < 0.001) and 15.9% for chronic limb-threatening ischemia (CLTI) (95% CI 11.9%, 19.8%, p < 0.001) but remained unchanged for acute limb ischemia (ALI) when comparing surge to presurge months. Adjusted mortality was significantly higher among those with claudication (0.5% vs 0.1%; OR 4.38 [95% CI 1.42, 13.5], p = 0.01) and ALI (6.4% vs 4.4%; OR 2.63 [95% CI 1.39, 4.98], p = 0.003) when comparing postsurge with presurge periods. Conclusion: The first North American COVID-19 pandemic surge was associated with a significant and sustained decline in both elective and nonelective lower-extremity vascular procedural volumes. When compared with presurge patients, in-hospital mortality increased for those with claudication and ALI following the surge.

Abstract 13474: Rivaroxaban Reduces Major Cardiovascular and Limb Events in Patients With the High-risk Triad of Chronic Kidney Disease, Peripheral Artery Disease and Recent Lower Extremity Revascularization: Insights From VOYAGER PAD

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Judith A Hsia ◽  
Sonia Anand ◽  
Mark R Nehler ◽  
Rupert Bauersachs ◽  
Manesh R Patel ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
High Risk ◽  
Kidney Disease ◽  
Lower Extremity ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Acute Limb Ischemia ◽  
Peripheral Artery ◽  
Artery Disease ◽  
Lower Extremity Revascularization

Introduction: Chronic kidney disease (CKD) is common among patients undergoing lower extremity revascularization (LER) for peripheral artery disease (PAD) and identifies a population at high risk for adverse outcomes. The VOYAGER PAD trial demonstrated the efficacy of rivaroxaban in PAD patients after LER on a composite of cardiovascular (CV) and limb ischemic events (HR 0.85 vs placebo, 95% CI 0.76-0.96; p=0.009); this analysis examines the prespecified subgroup of patients with CKD. Methods: VOYAGER PAD (NCT02504216) was a double-blind, placebo-controlled trial which randomized PAD patients with recent LER to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily. The primary endpoint was a composite of acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke or CV death. The primary safety endpoint was TIMI major bleeding. Analysis of the intention-to-treat population utilized Kaplan Meier estimates and Cox proportional-hazards models. Results: Among 6319 VOYAGER patients with baseline estimated glomerular filtration rate (eGFR), 21% were <60 (mostly CKD stage 3) and 79% were ≥60 ml/min/1.73m 2 . During 28-month (median) follow up, patients with CKD had a higher rate of major CV and limb events: placebo group 10.0 events/100 patient-years (95% CI 8.5, 11.8) for eGFR <60 vs 7.4 (95% CI 6.7, 8.2) for eGFR ≥60. Rivaroxaban reduced primary outcome events with no heterogeneity by eGFR category (Figure, p for interaction 0.62). Acute limb ischemia and major amputation were significantly reduced among patients with eGFR<60 (HR 0.55, 95% CI 0.36, 0.86) as well as ≥60 (HR 0.77, 95% CI 0.63, 0.94). TIMI major bleeding was numerically more frequent among patients with CKD with no heterogeneity by treatment group (Figure, p for interaction 0.37). Conclusions: Rivaroxaban reduced major CV and limb events in patients with PAD undergoing LER, including those with CKD, a particularly high-risk population.

scholarly journals Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization

Circulation ◽  
2020 ◽  
Vol 142 (23) ◽  
pp. 2219-2230
Author(s):  
William R. Hiatt ◽  
Marc P. Bonaca ◽  
Manesh R. Patel ◽  
Mark R. Nehler ◽  
Eike Sebastian Debus ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Lower Extremity ◽  
International Society ◽  
Major Bleeding ◽  
Limb Ischemia ◽  
Hazard Ratio ◽  
Acute Limb Ischemia ◽  
Peripheral Artery ◽  
Artery Disease ◽  
Lower Extremity Revascularization

Background: The VOYAGER PAD trial (Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) demonstrated superiority of rivaroxaban plus aspirin versus aspirin to reduce major cardiac and ischemic limb events after lower extremity revascularization. Clopidogrel is commonly used as a short-term adjunct to aspirin after endovascular revascularization. Whether clopidogrel modifies the efficacy and safety of rivaroxaban has not been described. Methods: VOYAGER PAD was a phase 3, international, double-blind, placebo-controlled trial in patients with symptomatic PAD undergoing lower extremity revascularization randomized to rivaroxaban 2.5 mg twice daily plus 100 mg aspirin daily or rivaroxaban placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety end point was TIMI (Thrombolysis in Myocardial Infarction) major bleeding, with International Society on Thrombosis and Haemostasis major bleeding a secondary safety outcome. Clopidogrel use was allowed at the discretion of the investigator for up to 6 months after the qualifying revascularization. Results: Of the randomized patients, 3313 (50.6%) received clopidogrel for a median duration of 29.0 days. Over 3 years, the hazard ratio for the primary outcome of rivaroxaban versus placebo was 0.85 (95% CI, 0.71–1.01) with clopidogrel and 0.86 (95% CI, 0.73–1.01) without clopidogrel without statistical heterogeneity ( P for interaction=0.92). Rivaroxaban resulted in an early apparent reduction in acute limb ischemia within 30 days (hazard ratio, 0.45 [95% CI, 0.14–1.46] with clopidogrel; hazard ratio, 0.48 [95% CI, 0.22–1.01] without clopidogrel; P for interaction=0.93). Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use ( P for interaction=0.71). With clopidogrel use >30 days, rivaroxaban was associated with more International Society on Thrombosis and Haemostasis major bleeding within 365 days (hazard ratio, 3.20 [95% CI, 1.44–7.13]) compared with shorter durations of clopidogrel ( P for trend=0.06). Conclusions: In the VOYAGER PAD trial, rivaroxaban plus aspirin reduced the risk of adverse cardiovascular and limb events with an early benefit for acute limb ischemia regardless of clopidogrel use. The safety of rivaroxaban was consistent regardless of clopidogrel use but with a trend for more International Society on Thrombosis and Haemostasis major bleeding with clopidogrel use >30 days than with a shorter duration. These data support the addition of rivaroxaban to aspirin after lower extremity revascularization regardless of concomitant clopidogrel, with a short course (≤30 days) associated with less bleeding. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02504216.

scholarly journals Reduction in Acute Limb Ischemia with Rivaroxaban versus Placebo in Peripheral Artery Disease after Lower Extremity Revascularization: Insights from VOYAGER PAD

Circulation ◽  
2021 ◽  
Author(s):  
Connie N. Hess ◽  
E. Sebastian Debus ◽  
Mark R. Nehler ◽  
Sonia S. Anand ◽  
Manesh R. Patel ◽  
...  
Keyword(s):  
Lower Extremity ◽  
Peripheral Artery Disease ◽  
Cumulative Incidence ◽  
Low Dose ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Acute Limb Ischemia ◽  
Peripheral Artery ◽  
Artery Disease ◽  
Lower Extremity Revascularization

Background: Patients with peripheral artery disease (PAD) are at heightened risk of acute limb ischemia (ALI), a thrombotic event associated with amputation, disability, and mortality. Prior lower extremity revascularization (LER) is associated with increased ALI risk in chronic PAD. However, the pattern of risk, clinical correlates, and outcomes after ALI early after LER are not well-studied, and effective therapies to reduce ALI post-LER are lacking. Methods: VOYAGER PAD (NCT02504216) randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily or placebo on a background of low-dose aspirin. The primary outcome was a composite of ALI, major amputation of vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. ALI was prospectively ascertained and adjudicated by a blinded committee. The cumulative incidence of ALI was calculated using Kaplan Meier estimates, and Cox proportional-hazards models were used to generate hazard ratios and associated confidence intervals. Analyses were performed as intention-to-treat. Results: Among 6,564 patients followed for a median of 2.3 years, 382 (5.8%) had a total of 508 ALI events. In placebo patients, the 3-year cumulative incidence of ALI was 7.8%. After multivariable modeling, prior LER, baseline ABI <0.50, surgical LER, and longer target lesion length were associated with increased risk of ALI. Incident ALI was associated with subsequent all-cause mortality (HR 2.59, 95% CI 1.98-3.39) and major amputation (HR 24.87, 95% CI 18.68-33.12). Rivaroxaban reduced ALI relative to placebo by 33% (absolute risk reduction 2.6% at 3 years, HR 0.67, 95% CI 0.55-0.82, P=0.0001), with benefit starting early (HR 0.45, 95% CI 0.24-0.85, P=0.0068 at 30 days). Benefit was present for severe ALI (associated with death, amputation, or prolonged hospitalization and ICU stay, HR 0.58, 95% CI 0.40-0.83, P=0.003) and regardless of LER type (surgical vs endovascular revascularization, p-interaction=0.42) or clopidogrel use (p-interaction=0.59). Conclusions: After LER for symptomatic PAD, ALI is frequent, particularly early after LER, and is associated with poor prognosis. Low-dose rivaroxaban plus aspirin reduces ALI after LER, including ALI events associated with the most severe outcomes. The benefit of rivaroxaban for ALI appears early, continues over time, and is consistent regardless of revascularization approach or clopidogrel use.

Abstract 18615: Impact of Peripheral Atherectomy Utilization on the Outcomes of Lower Extremity Arterial Intervention - A Cross-sectional US Experience

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Shilpkumar Arora ◽  
Sopan Lahewala ◽  
Nilay Patel ◽  
Kanishk Agnihotri ◽  
Sidakpal Panaich ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Lower Extremity ◽  
Arterial Intervention ◽  
Limb Ischemia ◽  
Outcome Data ◽  
Drug Eluting Stent ◽  
P Value ◽  
Diagnostic Code ◽  
Cross Sectional ◽  
Arterial Revascularization

Background: Contemporary outcome data regarding effects of atherectomy in lower extremity arterial revascularization is lacking. Methods: We queried HCUP’s Nationwide Inpatient Sample (NIS) for 2012 using the appropriate primary ICD 9-CM diagnostic code for peripheral vascular disease and procedural codes 39.90 (bare metal stent - BMS), 00.55 (drug eluting stent - DES), 17.56 (peripheral artherectomy) and 39.50 for angioplasty. Only procedures performed in patients >= 18 years were included. Hierarchical mixed effects logistic regression models were generated to evaluate multivariate predictors of outcomes. Results: In total 13,206 (weighted: 66,030) lower extremity arterial revascularization were analyzed (65.5% white, 56.2% Male & 97.4% angioplasty). Atherectomy utilization (23.2%) was associated with significant reduction in amputation (11.5% vs 13.4%), any complications (13.2% vs 16.3%) and in hospital morality (0.8% vs 1.4%) compared to no atherectomy group (p < 0.001). Multivariate analysis showed similar results with decrease amputation (OR, 95% CI; p - value) (0.83, 0.71 - 0.97, p = 0.02) and in hospital mortality/any complication (0.79, 0.69 - 0.90, p = 0.001) with atherectomy (similar results were observed with propensity score matching). “Atherectomy only” was utilized only in 2.3%. post-hoc analysis also shows better outcomes when atherectomy was used with either angioplasty or stenting (figure a & b). subgroup multivariate analysis shows significant reduction in amputation when atherectomy was utilized in chronic limb ischemia (0.74, 0.59 - 0.93, p = 0.01) and with angioplasty (0.72, 0.60 - 0.87, p = 0.001) and trend towards advantage while used along with stents but not reaching statistical significant. Conclusion: Lower extremity atherectomy utilization was associated with significant reduction in amputation and overall complication. We observed better outcomes when atherectomy was used in conjunction with angioplasty.

Association between Preoperative Indications and Outcomes after Major Lower Extremity Amputation

2019 ◽  
Vol 85 (10) ◽  
pp. 1083-1088
Author(s):  
◽  
James Andersen ◽  
Joshua Gabel ◽  
Kristyn Mannoia ◽  
Sharon Kiang ◽  
...  
Keyword(s):  
Lower Extremity ◽  
Limb Ischemia ◽  
Lower Extremity Amputation ◽  
Myocardial Infarctions ◽  
Tissue Loss ◽  
Acute Limb Ischemia ◽  
Indications For Surgery ◽  
Rest Pain ◽  
Ischemic Tissue ◽  
Extremity Amputation

Despite aggressive limb salvage techniques, lower extremity amputation (LEA) is frequently performed. Major indications for LEA include ischemia and uncontrolled infection (UI). A review of the national Vascular Quality Initiative amputation registry was performed to analyze the influence of indication on outcomes after LEA. Retrospective review of the Vascular Quality Initiative LEA registry (2012–2017) identified all above- and below-knee amputations. Outcome measures included 30-day mortality, return to operating room (OR), postoperative myocardial infarctions, and postoperative SSI. Indications for surgery included ischemic rest pain, ischemic tissue loss (TL), acute limb ischemia (ALI), UI, and neuropathic TL. A total of 6701 patients met the inclusion criteria. The indications for surgery included TL (49.0%), UI (31.7%), ALI (8.0%), rest pain (6.6%), and neuropathic TL (2.3%). Patients with ALI had the highest 30-day mortality (12.0%) compared with TL (6.6%) and UI (6.4%) [ P < 0.001]. The highest rate of return to OR occurred in the UI group (12.6%) [ P < 0.001]. Multivariate analysis demonstrated that patients with UI have significantly higher rates of return to OR, whereas those with ALI have a 30-day mortality twice as high as other indications (both P < 0.001). These data can inform expectations after LEA based on the indications for surgery.

scholarly journals Acute limb ischemia of the lower extremity associated with left upper lobe surgery for primary lung cancer

2018 ◽  
Vol 4 (2) ◽  
pp. 83-86 ◽  
Author(s):  
Shigesato Inoue ◽  
Sosei Kuma ◽  
Takefumi Ohga ◽  
Keita Tokuishi ◽  
Kan Okabayashi
Keyword(s):  
Lung Cancer ◽  
Lower Extremity ◽  
Primary Lung Cancer ◽  
Limb Ischemia ◽  
Acute Limb Ischemia
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