COVID-19 Antibody Testing in Healthcare Workers in Arkansas.

Introduction Seroprevalence surveys can estimate the cumulative incidence of SARS-CoV-2 infection in a symptom-independent manner, offering valuable data, including herd immunity, that can inform national and local public health policies. To our knowledge, there have been no large studies reporting seroprevalence in healthcare workers (HCWs) in the state of Arkansas. The objective of this study is to measure SARS-CoV-2 seroprevalence in HCWs in a large tertiary-care healthcare system prior to vaccine availability. Methods The Central Arkansas Veterans Healthcare System offered SARS-CoV-2 antibody testing prior to the widespread availability of vaccines. After Central Arkansas Veterans Healthcare System institutional review board (IRB) approval had been obtained, a retrospective chart review was used to identify all Central Arkansas Veterans Healthcare System HCWs who had undergone SARS-CoV-2 antibody testing from July 1, 2020, to September 30, 2020. Descriptive analysis was performed using Microsoft Excel (Microsoft Corporation, Redmond, Washington, United States). Correlation and regression tests were performed using SAS 9.4 software (SAS Institute Inc., Cary, NC). Results Over the study interval, 170 healthcare personnel had undergone SARS-CoV-2 anti-spike IgG antibody testing. Thirty-seven (21.8%) had positive antibody results. The 37 individuals were mostly women (94.5%), and the average age of the group was 47 years (range 29-69 years). The median antibody titers for those testing positive for antibodies were 10.8 units (range 1.1-58.5). Of the 37 people, 32 had a history of COVID-19 infection proven by reverse transcriptase polymerase chain reaction (RT-PCR). Conclusion Serologic testing is feasible for healthcare workers to document an immune response to a prior infection. In this study of HCWs, the rate of positivity among those tested was 21.8%. Data that do not incorporate the cohort of patients with prior infections will underestimate the impact of prior infections on herd immunity statistics and may misinform public policy.

Tuberculosis and Risk of Emphysema among US Adults in the NHANES I Epidemiologic Follow-Up Study Cohort, 1971-1992.

(1) Background: History of TB is a known risk factor for long-term respiratory impairment affecting lung functions in both restrictive and obstructive lung disease. (2) Methods: We analyzed data from the NHANES I Epidemiologic Follow-up Study (NHEFS), a longitudinal study conducted on a noninstitutionalized adult US population aged 25-74 years. Approximately 93 percent of the original NHANES I cohort was successfully traced by the end of the survey period and was available for analysis. The final adjusted model included age groups, gender, family income, lifetime smoking, body mass index (BMI), and frequency of alcohol consumption as potential confounders. (3) Results: The estimated hazards ratio of developing emphysema during follow-up for individuals with a past diagnosis of TB was 54% lower (95% CI = 0.35, 0.61) that that in individuals with no past TB, after controlling for potential confounders and using proportional hazards regression appropriate to the complex sample design. The association, however, was not statistically significant (HR = 0.86, p-value = 0.38) when only a self-reported history of TB was considered as the exposure in an unadjusted model. (4) Conclusions: Tuberculosis (self-reported or LTBI) was strongly (but inversely) associated with emphysema incidence. The association was not statistically significant with only a self-reported history of TB as exposure.

Marijuana and the Lung: Evolving Understandings.

Human beings have used marijuana products for centuries. Relatively recent data showing extensive cannabinoid receptors, particularly in the brain, help to explain the impacts of cannabinoids on symptoms/diseases, such as pain and seizures, with major nervous system components. Marijuana can cause bronchitis, but a moderate body of literature suggests that distal airway/parenchymal lung disease does not occur; marijuana does not cause chronic obstructive pulmonary disease and probably does not cause lung cancer, distinctly different from tobacco. Potentials for cognitive impairment and for damage to the developing brain are contextually important as its beneficial uses are explored.

A 2:1 randomized, open-label, phase II study of selinexor vs. physician's choice in older patients with relapsed or refractory acute myeloid leukemia.

Selinexor, a selective inhibitor of nuclear export, has demonstrated promising activity in patients with acute myeloid leukemia (AML). This randomized, phase II study evaluated selinexor 60 mg twice weekly (n = 118) vs. physician's choice (PC) treatment (n = 57) in patients aged ≥60 years with relapsed/refractory (R/R) AML. The primary outcome was overall survival (OS). Median OS did not differ significantly for selinexor vs. PC (3.2 vs. 5.6 months; HR = 1.18 [95% CI: 0.79-1.75]; p = 0.422). Complete remission (CR) plus CR with incomplete hematologic recovery trending in favor of selinexor occurred in a minority of patients. Selinexor treated patients had an increased incidence of adverse events. The most common grade ≥3 adverse events were thrombocytopenia, febrile neutropenia, anemia, hyponatremia. Despite well-balanced baseline characteristics, there were numerically higher rates of TP53 mutations, prior myelodysplastic syndrome, and lower absolute neutrophil counts in the selinexor group; warranting further investigation of selinexor in more carefully stratified R/R AML patients.Registered trial: NCT02088541.

Overall survival with oral selinexor plus low-dose dexamethasone versus real-world therapy in triple-class-refractory multiple myeloma.

Triple-class-refractory multiple myeloma (MM) describes MM refractory to proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies. In the Phase IIb STORM study (NCT02336815), oral selinexor plus low-dose dexamethasone (Sel-dex) demonstrated a 26.2% overall response rate in triple-class-refractory MM. Here, we compare overall survival (OS) of 122 patients with triple-class-refractory MM who received Sel-dex in STORM Part 2 with that of 64 similar patients treated with other available therapies in a Flatiron Health Analytic Database (FHAD) cohort. OS from the date that the patients' MM became triple-class-refractory was longer in STORM versus FHAD, with an unadjusted hazard ratio (HR) of 0.43 (P =  .0002; adjusted HR 0.35 [P  =  .011]). In a subset analysis of highly resistant patients receiving further therapies after their MM first became at least triple-class-refractory (i.e., who received Sel-dex in STORM, n = 64, and non-Sel-dex in FHAD, n = 36), the OS was significantly longer in STORM with an unadjusted HR of 0.52 (P = .0331; adjusted HR 0.33 [P = .041]). Within the limits of this analysis, the OS of patients with at least triple-class-refractory MM was significantly better with Sel-dex versus available therapies, suggesting that Sel-dex may be associated with a meaningful OS benefit in these patients.

Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial.

BACKGROUND: Selinexor combined with dexamethasone has shown activity in patients with heavily pre-treated multiple myeloma. In a phase 1b/2 study, the combination of oral selinexor with bortezomib (a proteasome inhibitor) and dexamethasone induced high response rates with low rates of peripheral neuropathy, the main dose-limiting toxicity of bortezomib. We aimed to evaluate the clinical benefit of weekly selinexor, bortezomib, and dexamethasone versus standard bortezomib and dexamethasone in patients with previously treated multiple myeloma. METHODS: This phase 3, randomised, open-label trial was done at 123 sites in 21 countries. Patients aged 18 years or older, who had multiple myeloma, and who had previously been treated with one to three lines of therapy, including proteasome inhibitors, were randomly allocated (1:1) to receive selinexor (100 mg once per week), bortezomib (1·3 mg/m2 once per week), and dexamethasone (20 mg twice per week), or bortezomib (1·3 mg/m2 twice per week for the first 24 weeks and once per week thereafter) and dexamethasone (20 mg four times per week for the first 24 weeks and twice per week thereafter). Randomisation was done using interactive response technology and stratified by previous proteasome inhibitor therapy, lines of treatment, and multiple myeloma stage. The primary endpoint was progression-free survival in the intention-to-treat population. Patients who received at least one dose of study treatment were included in the safety population. This trial is registered at ClinicalTrials.gov, NCT03110562. The trial is ongoing, with 55 patients remaining on randomised therapy as of Feb 20, 2020. FINDINGS: Of 457 patients screened for eligibility, 402 were randomly allocated-195 (49%) to the selinexor, bortezomib, and dexamethasone group and 207 (51%) to the bortezomib and dexamethasone group-and the first dose of study medication was given between June 6, 2017, and Feb 5, 2019. Median follow-up durations were 13·2 months [IQR 6·2-19·8] for the selinexor, bortezomib, and dexamethasone group and 16·5 months [9·4-19·8] for the bortezomib and dexamethasone group. Median progression-free survival was 13·93 months (95% CI 11·73-not evaluable) with selinexor, bortezomib, and dexamethasone and 9·46 months (8·11-10·78) with bortezomib and dexamethasone (hazard ratio 0·70 [95% CI 0·53-0·93], p=0·0075). The most frequent grade 3-4 adverse events were thrombocytopenia (77 [39%] of 195 patients in the selinexor, bortezomib, and dexamethasone group vs 35 [17%] of 204 in the bortezomib and dexamethasone group), fatigue (26 [13%] vs two [1%]), anaemia (31 [16%] vs 20 [10%]), and pneumonia (22 [11%] vs 22 [11%]). Peripheral neuropathy of grade 2 or above was less frequent with selinexor, bortezomib, and dexamethasone (41 [21%] patients) than with bortezomib and dexamethasone (70 [34%] patients; odds ratio 0·50 [95% CI 0·32-0·79], p=0·0013). 47 (24%) patients in the selinexor, bortezomib, and dexamethasone group and 62 (30%) in the bortezomib and dexamethasone group died. INTERPRETATION: A once-per-week regimen of selinexor, bortezomib, and dexamethasone is a novel, effective, and convenient treatment option for patients with multiple myeloma who have received one to three previous lines of therapy. FUNDING: Karyopharm Therapeutics.

Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial.

BACKGROUND: Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) is an aggressive cancer with a median overall survival of less than 6 months. We aimed to assess the response to single-agent selinexor, an oral selective inhibitor of nuclear export, in patients with relapsed or refractory DLBCL who had no therapeutic options of potential clinical benefit. METHODS: SADAL was a multicentre, multinational, open-label, phase 2b study done in 59 sites in 19 countries. Patients aged 18 years or older with pathologically confirmed diffuse large B-cell lymphoma, an Eastern Cooperative Oncology Group performance status of 2 or less, who had received two to five lines of previous therapies, and progressed after or were not candidates for autologous stem-cell transplantation were enrolled. Germinal centre B-cell or non-germinal centre B-cell tumour subtype and double or triple expressor status were determined by immunohistochemistry and double or triple hit status was determined by cytogenetics. Patients received 60 mg selinexor orally on days 1 and 3 weekly until disease progression or unacceptable toxicity. The study was initially designed to evaluate both 60 mg and 100 mg twice-weekly doses of selinexor; however, the 100 mg dose was discontinued in the protocol (version 7.0) on March 29, 2017, when an improved therapeutic window was observed at 60 mg. Primary outcome was overall response rate. The primary outcome and safety were assessed in all patients who received 60 mg selinexor under protocol version 6.0, or enrolled under protocol versions 7.0 or higher and received at least one dose of selinexor. This trial is registered at ClinicalTrials.gov, NCT02227251 (active but not enrolling). FINDINGS: Between Oct 21, 2015, and Nov 2, 2019, 267 patients were randomly assigned, with 175 allocated to the 60 mg group and 92 to the discontinued 100 mg group. 48 patients assigned to the 60 mg group were excluded due to enrolment before version 6.0 of the protocol; the remaining 127 patients received selinexor 60 mg and were included in analyses of primary outcome and safety. The overall response rate was 28% (36/127; 95% CI 20·7-37·0); 15 (12%) achieved a complete response and 21 (17%) a partial response. The most common grade 3-4 adverse events were thrombocytopenia (n=58), neutropenia (n=31), anaemia (n=28), fatigue (n=14), hyponatraemia (n=10), and nausea (n=8). The most common serious adverse events were pyrexia (n=9), pneumonia (n=6), and sepsis (n=6). There were no deaths judged as related to treatment with selinexor. INTERPRETATION: Single-drug oral selinexor induced durable responses and had a manageable adverse events profile in patients with relapsed or refractory DLBCL who received at least two lines of previous chemoimmunotherapy. Selinexor could be considered a new oral, non-cytotoxic treatment option in this setting. FUNDING: Karyopharm Therapeutics Inc.

Climate change and respiratory diseases: a 2020 perspective.

PURPOSE OF REVIEW: To present an overview of the impact of climate change upon human respiratory health. RECENT FINDINGS: Climate change involves two major types of change. First, there is overall progressive warming. Second, there is increased variability/unpredictability in weather patterns. Both types of change impact negatively upon human respiratory health. Worsening air quality and increased allergens can worsen existing disease. Climate-related changes in allergens and in vectors for infection can cause new disease. Redundant sophisticated studies have projected marked increases in respiratory morbidity and mortality throughout the world as a direct result of climate change. This article summarizes some of those studies. SUMMARY: The clarity of our vision with respect to the dramatic impact of climate change upon human respiratory health approaches 20/20. The data represent a mandate for change. Change needs to include international, national, and individual efforts.

Marijuana and lung diseases.

PURPOSE OF REVIEW: Cannabis sativa (marijuana) is used throughout the world, and its use is increasing. In much of the world, marijuana is illicit. While inhalation of smoke generated by igniting dried components of the plant is the most common way marijuana is used, there is concern over potential adverse lung effects. The purpose of this review is to highlight recent studies that explore the impact upon the respiratory system of inhaling marijuana smoke. RECENT FINDINGS: Smoking marijuana is associated with chronic bronchitis symptoms and large airway inflammation. Occasional use of marijuana with low cumulative use is not a risk factor for the development of chronic obstructive pulmonary disease. The heavy use of marijuana alone may lead to airflow obstruction. The immuno-histopathologic and epidemiologic evidence in marijuana users suggests biological plausibility of marijuana smoking as a risk for the development of lung cancer; at present, it has been difficult to conclusively link marijuana smoking and cancer development. SUMMARY: There is unequivocal evidence that habitual or regular marijuana smoking is not harmless. A caution against regular heavy marijuana usage is prudent. The medicinal use of marijuana is likely not harmful to lungs in low cumulative doses, but the dose limit needs to be defined. Recreational use is not the same as medicinal use and should be discouraged.

IFN-γ release assay conversions and reversions. Challenges with serial testing in U.S. health care workers.

RATIONALE: IFN-γ release assays (IGRAs) including the QuantiFERON-TB gold in-tube test (QFT-GIT) are increasingly used in place of the tuberculin skin test (TST) in surveillance programs for Mycobacterium tuberculosis infection in the United States. However, data on conversions, reversions, and predictive value of QFT in such programs for health care workers (HCWs) are limited. OBJECTIVES: The purpose of this study is to assess long-term reproducibility and conversion and reversion rates of QFT-GIT among HCWs who underwent serial testing at a tertiary care center in the United States. METHODS: Retrospective chart review of HCWs at the Central Arkansas Veterans Healthcare System (CAVHS) who underwent serial testing with QFT-GIT as a part of their employee screening between November 1, 2008 and January 31, 2011. MEASUREMENTS AND MAIN RESULTS: A total of 2,303 HCWs had at least 2 QFT-GITs 1 year apart. The initial QFT-GIT was positive for 69 and 2 were indeterminate. Of these 69 HCWs, 31 (45%) reverted on repeat testing, and 25 of 31 (80.6%) HCWs who reverted had a negative look-back TST. Of the 2,232 HCWs with an initial negative QFT-GIT, 71 (3.2%) converted on repeat testing. A third QFT-GIT assay was performed in 41 of the 71 converters and 90% (37 of 41) reverted back to negative. Only two HCWs had TST and QFT-GIT conversion. CONCLUSIONS: Poor IGRA reproducibility and a low predictive value of QFT-GIT conversions indicate that QFT-GIT with current interpretation criteria should not be used for serial screening of U.S. HCWs. Negative TSTs have higher reproducibility than QFT-GIT for serial testing of HCWs in low tuberculosis incidence settings.

Racial differences in long-term outcomes after percutaneous coronary intervention with paclitaxel-eluting coronary stents.

OBJECTIVES: To assess the influence of race on long-term outcomes following percutaneous coronary intervention (PCI) with paclitaxel-eluting stents (PES). BACKGROUND: Data on the influence of race on long-term outcomes following PCI with drug-eluting stents are limited because of severe underrepresentation of minority populations in randomized trials. METHODS: We compared 5-year outcomes of 2,301 whites, 127 blacks, and 169 Asians treated with PES in the TAXUS IV, V, and ATLAS trials. Outcomes were adjusted using a propensity score logistic regression model with 1:4 matching. RESULTS: Blacks were more likely than whites to be female, have a history of hypertension, diabetes mellitus, congestive heart failure, and stroke, but were less likely to have prior coronary artery disease. Compared with whites, Asians were younger, more likely to be male, have stable angina, and left anterior descending disease, and less likely to have silent ischemia, previous coronary artery bypass surgery, prior coronary artery disease, diabetes mellitus, peripheral vascular disease, and to receive glycoprotein IIb/IIIa inhibitors. Despite higher antiplatelet compliance, the adjusted 5-year rates of myocardial infarction (15.4% vs. 5.4%, P < 0.001) and stent thrombosis (5.6% vs. 1.1%, P = 0.002) were higher in blacks than whites. Despite lower antiplatelet compliance, Asians had no differences in myocardial infarction and stent thrombosis compared with whites. Mortality and revascularization rates were similar between the three groups. CONCLUSIONS: The long-term risk of major thrombotic events after PCI with PES was higher in blacks, but not Asians, compared with whites. The mechanisms underlying these racial differences warrant further investigation.

Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent.

OBJECTIVES: This study sought to compare the safety and efficacy of 2 dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) (Boston Scientific Corp., Natick, Massachusetts) compared with the durable polymer PROMUS Element EES (Boston Scientific Corp.). BACKGROUND: Durable polymer coatings on drug-eluting stents have been associated with chronic inflammation and impaired healing. Bioabsorbable polymer-coated drug-delivery systems may reduce the risk of late adverse events, including stent thrombosis, and thus the need for prolonged dual-antiplatelet therapy. METHODS: A total of 291 patients with a de novo lesion ≤28 mm in length, in a coronary artery of ≥2.25 to ≤3.5 mm diameter, were enrolled in the EVOLVE study, a prospective, randomized, single-blind, noninferiority trial. Patients were randomly assigned in a 1:1:1 ratio to PROMUS Element, SYNERGY, or SYNERGY half dose. The primary clinical endpoint was the 30-day rate of target lesion failure, defined as cardiac death or myocardial infarction related to the target vessel, or target lesion revascularization. The primary angiographic endpoint was 6-month in-stent late loss measured by quantitative coronary angiography. RESULTS: The 30-day primary clinical endpoint of target lesion failure occurred in 0%, 1.1%, and 3.1% of patients in the PROMUS Element, SYNERGY, and SYNERGY half dose groups, respectively. The 6-month in-stent late loss was 0.15 ± 0.34 mm for PROMUS Element, 0.10 ± 0.25 mm for SYNERGY, and 0.13 ± 0.26 mm for SYNERGY half dose (SYNERGY, difference -0.06, upper 95.2% confidence limit: 0.02, p for noninferiority <0.001; SYNERGY half dose, difference -0.03, upper 95.2% confidence limit: 0.05, p for noninferiority <0.001). Clinical event rates remained low and comparable between groups, with no stent thromboses in any group at 6 months. CONCLUSIONS: The EVOLVE trial confirms the effective delivery of everolimus by a unique directional bioabsorbable polymer system utilizing the SYNERGY stent. (A Prospective Randomized Multicenter Single-Blind Noninferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System [Evolution Stent System] for the Treatment of a De Novo Atherosclerotic Lesion [EVOLVE]; NCT01135225).

Symptom burden in chronic obstructive pulmonary disease and cancer.

PURPOSE OF REVIEW: Chronic obstructive pulmonary disease (COPD) is a crippling disease with a high worldwide prevalence. The purpose of this review is to highlight recent studies which define the global impact of COPD on quality of life. There are direct implications for care. RECENT FINDINGS: Dyspnea is a dominant and defining symptom for patients with COPD, but the overall degree of impairment suffered by patients with COPD extends far beyond shortness of breath. A series of recent studies gives us insight into both the physical and the psychosocial burdens of the disease and their negative net effects upon quality of life. The suffering of patients with COPD is similar to that of patients with cancer, and palliative measures have been shown to be an important component of comprehensive care. SUMMARY: The symptom burden in patients with severe COPD is high and is comparable to that of patients with cancer. Ironically, patients with COPD could be said to suffer more than those with cancer; the symptom burden is similar, but patients with COPD tend to live longer. The literature is replete with evidence that a palliative care approach to patients with cancer increases the quality of life (and perhaps even the quality of death). The same palliative care approach can and should be used for patients with COPD. There are now objective data to support the benefits of such an approach.

Hydrochemical profile for assessing the groundwater quality of Sambhar lake city and its adjoining area.

Quality assessment of water is essential to ensure sustainable safe use of it for drinking, agricultural, and industrial purposes. For the same purpose the study was conducted for the samples of water of Sambhar lake city and its adjoining areas. The standard methods of APHA were used to analysis 15 samples collected from hand pumps and tube wells of the specified area. The analytical results show higher concentration of total dissolved solids, electrical conductivity sodium, nitrate, sulfate, and fluoride, which indicate signs of deterioration but values of pH, calcium, magnesium, total hardness, and carbonate are within permissible limits as per WHO standards. From the Hill-piper trilinear diagram, it is observed that the majority of groundwater from sampling stations are sodium-potassium-chloride-sulfate type water. The values of sodium absorption ratio and electrical conductivity of the groundwater were plotted in the US salinity laboratory diagram for irrigation water. Only the one sample fall in C(3)S(1) quality with high salinity hazard and low sodium hazard. Other samples fall in high salinity hazard and high sodium hazard. Chemical analysis of groundwater shows that mean concentration of cation is in order sodium > magnesium > calcium > potassium while for the anion it is chloride > bicarbonate > nitrate > sulfate.

Hydrochemical investigations and correlation analysis of groundwater quality.

A study was conducted to evaluate the water quality of Sambhar lake city (India) and its adjoining areas. Groundwater samples from hand pumps and tube wells of fifteen sampling stations were analyzed during post-monsoon session with the help of standard methods of APHA. The analytical results showed higher concentrations of TDS, EC, Sodium, Nitrate, Sulphate and Fluoride, which indicate signs of deterioration but values of pH, Calcium, Magnesium, TH and Carbonate were found within permissible limits as per the WHO standards. From correlation analysis it was observed that very strong correlations exist between Na+ and Cl- (0.99) as well as EC and Cl-. From Hill-piper trilinear diagram it is observed that the majority of groundwater from sampling stations was sodium-potassium-chloride-sulphate type water. The values of sodium absorption ratio and EC of groundwater were plotted in the US salinity laboratory diagram of irrigation water. Only one sample was found to fall in C3S1 quality with high salinity hazard and low sodium hazard. Another samples were found to fall in high salinity hazard and high sodium hazard. Chemical analysis of groundwater showed that mean concentration of cation is in order sodium > magnesium > calcium > potassium while for the anion it is chloride > bicarbonate > nitrate > sulphate.

Everolimus-eluting stents: update on current clinical studies.

Everolimus-eluting stents (EES) have become the most commonly implanted coronary stents worldwide. This review describes and analyzes the clinical data supporting the use of EES, focusing primarily on published, randomized, controlled trials. Everolimus-eluting stents have been shown to have less restenosis, stent thrombosis, and periprocedural myocardial infarction compared with earlier generation paclitaxel-eluting stents (PES). Lower rates of adverse events for EES compared with PES were generally seen in all subgroups, with the notable exception of patients with diabetes mellitus. There have been fewer, randomized, clinical trials comparing EES with either sirolimus-eluting stents or zotarolimus-eluting stents, although very good results with EES have been observed in the trials that have been performed. Recent clinical trial data suggest that this excellent safety and efficacy profile is maintained in a next-generation EES designed to have improved mechanical properties and radiopacity.

Influence of sex on long-term outcomes after percutaneous coronary intervention with the paclitaxel-eluting coronary stent: results of the "TAXUS Woman" analysis.

OBJECTIVES: We conducted the "TAXUS Woman" analysis to assess the influence of sex on long-term outcomes after percutaneous coronary intervention using paclitaxel-eluting stents (PES) in a broad spectrum of patients. BACKGROUND: Previous studies indicate that the sex gap suggesting worse outcomes in women has narrowed. However, limited data are available on long-term sex-based outcomes with drug-eluting stents despite their extensive use in current practice. METHODS: We analyzed 2,271 PES-treated patients (women = 665), from 5 randomized trials and 7,492 PES-treated patients (women = 2,449) from 2 "real-world" registries. The trial and registry datasets were stratified by sex to compare long-term outcomes. Additionally, the outcomes in PES-treated women were compared with bare-metal stent-treated women (n = 395) in the randomized trials. RESULTS: In the randomized trials, PES-treated women had a lower target lesion revascularization (TLR) rate (11.5% vs. 22.6%, p < 0.001) than bare-metal stent-treated women, with no significant sex-based differences in death, myocardial infarction, stent thrombosis, or TLR through 5 years. In both the trials and the registries, although women had more adverse baseline characteristics including advanced age, hypertension, and diabetes, they had similar outcomes to men. In expanded-use patients, however, women showed significantly higher rates of death and TLR, although only the higher TLR rate was confirmed by multivariate analysis. CONCLUSIONS: This study of nearly 10,000 patients including more than 3,000 women demonstrates that despite their higher-risk profile, women have comparable benefits to men from percutaneous coronary intervention with PES except for a slightly higher revascularization rate in the high-risk cohort.