Publications

IMPORTANCE: Paclitaxel-coated peripheral devices have been associated with increased mortality, yet this harm signal has not been replicated outside of meta-analyses of small trials.

OBJECTIVE: To provide a longitudinal assessment of the safety of femoropopliteal endovascular treatment with peripheral drug-coated devices (DCDs) among Medicare beneficiaries.

DESIGN, SETTING, AND PARTICIPANTS: SAFE-PAD (Safety Assessment of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices) was a retrospective cohort study designed with the US Food and Drug Administration to evaluate the noninferiority of mortality between DCDs and non-drug-coated devices (NDCDs) for femoropopliteal revascularization performed in 2978 inpatient and outpatient facilities in the US from April 1, 2015, through December 31, 2018. Evaluation of the primary outcome was assessed through May 31, 2020. Participants were Medicare fee-for-service beneficiaries 66 years and older with 1 or more years of enrollment prior to femoropopliteal revascularization. Prespecified subgroups included low-risk cohorts, procedure location, disease severity, and device type. Inverse probability weighting was used to account for imbalances of observed characteristics. Sensitivity analyses were used to evaluate the potential influence of unmeasured confounding.

EXPOSURES: Treatment with DCDs vs NDCDs as determined by claims codes during the index procedure.

MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause mortality. Secondary outcomes included repeated hospitalization, repeated lower extremity revascularization, and lower extremity amputation. Falsification end points were acute myocardial infarction, congestive heart failure, and pneumonia.

RESULTS: Of 168 553 patients, 70 584 (41.9%) were treated with a DCD. The mean (SD) age was 77.0 (7.6) years, 75 744 (44.9%) were female, 136 916 of 167 197 (81.9%) were White individuals, 85 880 of 168 553 (51.0%) had diabetes, 82 554 of 168 553 (49.0%) used tobacco, 78 665 of 168 553 (45.7%) had critical limb ischemia (CLI), and 13 296 of 168 553 (7.9%) had a prior amputation. Median follow-up was 2.72 years (interquartile range, 0.87-3.77; longest, 5.16 years). After weighting, the cumulative incidence of all-cause mortality was 53.8% with DCDs and 55.1% with NDCDs (hazard ratio [HR], 0.95; 95% CI, 0.94-0.97; noninferiority P < .001). Cox regression and instrumental variable analyses were consistent with the primary findings. No harm associated with DCDs was observed among subgroups, including those treated with stents (HR, 0.97; 95% CI, 0.95-1.00) or balloons (HR, 0.94; 95% CI, 0.92-0.96), with or without CLI (CLI: HR, 0.95; 95% CI, 0.93-0.97; non-CLI: HR, 0.97; 95% CI, 0.95-0.99), and those within the lowest quartile of total comorbidities (HR, 0.95; 95% CI, 0.92-0.99).

CONCLUSIONS AND RELEVANCE: In this initial report from the SAFE-PAD cohort study, DCDs were found to be noninferior to NCDCs in respect to mortality through a median follow-up of 2.72 years. This finding remained robust in sensitivity analyses and was consistent across prespecified subgroups.

OBJECTIVE: To investigate the trend and outcomes of acute pulmonary embolism (PE) during pregnancy and puerperium using a large national database.

PATIENTS AND METHODS: The National Inpatient Sample was queried to identify pregnancy-related hospitalizations in the United States from January 1, 2007, through September 30, 2015. Temporal trends in the rates of acute PE and in-hospital mortality rates were extracted.

RESULTS: Among 37,524,314 hospitalizations, 6,333 patients (0.02%) had acute PE. The prevalence of comorbidities and risk factors such as hypertension, obesity, and smoking increased, but rates of acute PE did not change significantly (18.01 in 2007 vs 19.36 in 2015, per 100,000 hospitalizations, Ptrends=.21). Advanced therapies were used in a small number of women (systemic thrombolysis: 2.4%, surgical pulmonary embolectomy: 0.5%, and inferior vena cava filter in 8.3%). Rates of in-hospital mortality were almost 200-fold higher among those who had acute PE (29.3 vs 0.13, per 1000 pregnancy-related, P<.001). The rate of in-hospital mortality did not change among women with acute PE (2.6% in 2007 vs 2.5% in 2015, Ptrends=.74).

CONCLUSION: In this contemporary analysis of pregnancy-related hospitalizations, acute PE was uncommon, but rates have not decreased over the past decade. Acute PE during pregnancy and puerperium was associated with high maternal mortality, and the rates of in-hospital mortality have not improved. Future studies to improve prevention and management of acute PE during pregnancy and puerperium are warranted.

BACKGROUND: In-stent restenosis (ISR) is highly prevalent and leads to repeat revascularisation. Long-term implications of ISR are poorly understood.

AIMS: This study aimed to evaluate the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) for ISR.

METHODS: National Cardiovascular Data Registry CathPCI records for individuals aged ≥65 years undergoing PCI from July 2009 to December 2014 were linked to Medicare claims. Baseline characteristics and long-term rates of death, myocardial infarction (MI), repeat revascularisation including target vessel revascularisation (TVR), and major adverse cardiovascular and cerebrovascular events (MACCE) were compared between ISR PCI versus de novo lesion PCI.

RESULTS: Of 653,304 individuals, 10.2% underwent ISR PCI and 89.8% underwent de novo lesion PCI. The median duration of follow-up was 825 days (quartile 1: 352 days-quartile 3: 1,379 days). The frequency of MACCE (55.6% vs 45.0%; p<0.001), all-cause mortality (27.8% vs 25.5%; p<0.001), MI (19.0% vs 12.3%; p<0.001), repeat revascularisation (31.9% vs 18.6%; p<0.001), TVR (22.4% vs 8.0%; p<0.001), and stroke (8.8% vs 8.3%; p=0.005) was higher after ISR PCI. After multivariable adjustment, ISR PCI remained associated with worse long-term outcomes than after de novo lesion PCI (hazard ratio [HR] for MACCE 1.24 [95% CI: 1.22, 1.26], mortality 1.07 [95% CI: 1.05, 1.09], MI 1.44 [95% CI: 1.40, 1.48], repeat revascularisation 1.55 [95% CI: 1.51, 1.59], and TVR 2.50 [95% CI: 2.42, 2.58]).

CONCLUSIONS: ISR PCI was common and was associated with a significantly higher risk of recurrent long-term major ischaemic events compared to patients undergoing de novo lesion PCI. There remains a need for new strategies to minimise ISR.

[Figure: see text].

BACKGROUND: Meta-analyses of randomised trials of paclitaxel-coated peripheral devices found an association with worse long-term survival.

AIMS: We aimed to assess long-term mortality in patients treated with drug-coated versus non-drug-coated devices who are insured by Medicare Advantage (MA), an alternative to traditional Medicare that represents >30% of the Medicare eligible population. We analysed data from an MA administrative claims data source that includes both inpatient and outpatient femoropopliteal artery revascularisation procedures.

METHODS: Patients treated with or without drug-coated devices for femoropopliteal artery revascularisation from 4/2015-12/2017 were studied using Optum's De-identified Clinformatics Datamart Database. Mortality was assessed up to December 2019 using Kaplan-Meier cumulative mortality curves and Cox proportional hazard models. Inverse probability of treatment weighting was used to adjust for differences between groups.

RESULTS: Of 16,796 patients revascularised, 4,427 (26.4%) were treated with drug-coated devices: 3,600 (81.3%) balloons and 827 (18.7%) stents. The median follow-up was 2.66 years (IQR 2.02-3.52). Treatment with drug-coated devices was associated with similar long-term mortality to non-drug-coated devices (adjusted HR 1.03, 95% CI: 0.96-1.10; p=0.39). Results were comparable for patients treated with balloons alone (adjusted HR 1.00, 95% CI: 0.92-1.08; p=0.96) or stents (adjusted HR 1.02, 95% CI: 0.88-1.18; p=0.78). These findings did not differ based on treatment setting, disease severity, age, sex or comorbidity burden (interaction p>0.05 for all).

CONCLUSIONS: In this large cohort, there was no evidence of increased long-term mortality following treatment with drug-coated devices.

Stroke is the fifth leading cause of death in the United States and is a leading cause of disability. Extracranial internal carotid artery stenosis is a major cause of ischemic stroke, as it is estimated to cause 8% to 15% of ischemic strokes. It is critical to improve our strategies for stroke prevention and treatment in order to reduce the burden of this disease. Herein, we review approaches for the diagnosis and risk stratification of carotid artery disease as well as interventional strategies for the prevention and treatment of strokes caused by carotid artery disease.

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward.

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 (VQI). 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.