scholarly journals Thromboprophylaxis for Patients with Newly Diagnosed Vs. Recurrent Cancers: A Post-Hoc Analysis of the Avert Trial

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3660-3660
Author(s):  
Marina Atalla ◽  
James Zhang ◽  
Ranjeeta Mallick ◽  
Philip S. Wells ◽  
Marc Carrier
Keyword(s):  
Major Bleeding ◽  
Research Funding ◽  
Bleeding Complications ◽  
Primary Efficacy ◽  
Newly Diagnosed ◽  
Recurrent Cancer ◽  
Post Hoc Analysis ◽  
Increased Risk ◽  
Bleeding Episodes ◽  
Post Hoc

Background: The risk of venous thromboembolism (VTE) is increased in cancer patients, which can result in significant increases in mortality, morbidity and healthcare expenditures. The recent AVERT trial (N Engl J Med 2019 Feb 21;380(8):711-719), showed that prophylactic apixaban lowered the rate of VTE when compared to placebo in cancer patients starting chemotherapy. However, the risk-benefit ratio of primary thromboprophylaxis in patients initiating chemotherapy for recurrent disease compared to those with newly diagnosed patients who are chemotherapy naïve is unknown. Methods: This is a post-hoc analysis of the AVERT trial. The AVERT trial assessed apixaban therapy vs. placebo for prophylaxis among patients with cancer who were intermediate-to-high risk for VTE (Khorana score ≥2; the Khorana score is ranged from 0 to 6 with higher scores reflecting an increased risk of VTE) and were initiating chemotherapy. It was a randomized, placebo-controlled, double-blind clinical trial. The primary efficacy outcome was VTE and the main safety outcomes were major bleeding episodes. Secondary outcome measures included clinically relevant non-major bleeding (CRNMB). The severity of major bleeding was stratified from category 1 to 4, with category 4 being the most severe type. We performed time-to-event analysis on the primary efficacy and main safety end-points in patients with recurrent and new diagnosed cancers. The hazard ratio (HR) for the outcomes were estimated using a Cox regression model controlling for age, gender, and center. Results: A total of 574 patients were randomized in the AVERT trial. 563 were included in the modified intention-to-treat analysis. 237 and 232 patients with newly diagnosed cancer were allocated to the apixaban and placebo groups, respectively. Similarly, 51 and 43 patients with recurrent cancer were allocated to the apixaban and placebo groups, respectively. Baseline demographics and clinical characteristics are depicted in Table 1A and Table 1B. In patients with newly diagnosed cancers, the use of apixaban was associated with a significantly lower risk of VTE (HR: 0.45; 95% CI: 0.27-0.76; p = 0.002) and a higher rate of major bleeding complications (HR: 2.10; 95% CI: 1.09-4.08; p = 0.028) but not of CRNMB (HR: 1.06; 95% CI: 0.61-1.82) (Table 2A). A majority of the major bleeding complications were of category 2. In patients with recurrent cancer, apixaban was associated with a significant lower rate of VTE (HR: 0.26; 95% CI: 0.13-0.53; p < 0.001) without an associated significant increased risk of major bleeding complication (HR: 1.82; 95% CI: 0.36-9.15; p = 0.466) but with a significant increase rate of CRNMB (HR: 2.78; 95% CI: 0.58-1.34; p = 0.006) (Table 2B). Major bleeding episodes were split evenly between severity category 1 and 2. Conclusion: The risk-benefit ratio of primary thromboprophylaxis with apixaban might differ between patients with recurrent or newly diagnosed cancers. Apixaban was associated with a lower rate of VTE compared to placebo in both groups. Patients with recurrent cancer initiating chemotherapy may potentially have a more favorable risk benefit profile, as shown through the HR and the prevalence of major bleeding episodes. However, more trials are required to confirm these findings to help tailor thromboprophylaxis in this patient population. (AVERT ClinicalTrials.gov number, NCT02048865.) Disclosures Wells: BMS/Pfizer: Honoraria, Research Funding; Bayer: Honoraria; Sanofi: Honoraria; Daiichi Sankyo: Honoraria. Carrier:Leo Pharma: Honoraria, Research Funding; BMS: Honoraria, Research Funding; Servier: Honoraria; Bayer: Honoraria; Pfizer: Honoraria, Research Funding. OffLabel Disclosure: Apixaban can be used as postoperative prophylaxis of DVT/PE and for treatment of DVT/PE. This study will show whether the prophylactic effects of apixaban will be more effective when used with patients with recurrent cancer or patients with newly diagnosed cancer.

scholarly journals Peak Thrombin and D-Dimer Levels in Subjects with Severe Hemophilia Receiving Acute Treatment for Bleeding Episodes Experienced during Prophylactic Marstacimab Treatment

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 33-34
Author(s):  
Satyaprakash Nayak ◽  
Sangeeta Raje ◽  
John Teeter ◽  
Lutz Harnisch ◽  
Steven Arkin
Keyword(s):  
Bleeding Episode ◽  
Phase 2 ◽  
Bleeding Events ◽  
Post Hoc Analysis ◽  
On Demand ◽  
Increased Risk ◽  
Phase 2 Study ◽  
Bleeding Episodes ◽  
Post Hoc ◽  
D Dimer

Introduction: Marstacimab is a fully humanized monoclonal immunoglobulin G1 that targets the shared K2 domains of tissue factor pathway inhibitor (TFPI)α and (TFPI)β and is currently in phase 3 development. The intended indication is routine prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B (with or without inhibitors). Factor replacement or bypass treatment for bleeding events may lead to increased levels of peak thrombin and D-dimer associated with an increased risk of thrombosis . In this post hoc analysis of data from a phase 2 study in patients with hemophilia with and without bleeding episodes, receiving prophylactic marstacimab treatment, peak thrombin and D-dimer levels were investigated to assess the changes in these biomarker levels observed after bleeding episodes. Methods: Individual subject data from the phase 2 study (clinicaltrials.gov identifier: NCT02974855)were used for this analysis. Biomarker data for healthy volunteers who received single doses of marstacimab in a phase 1 dose escalation study (clinicaltrials.gov identifier: NCT02531815) were used as control data, as these subjects represent an intact and uncompromised coagulation system. Study subjects in the phase 2 study received subcutaneous (SC) marstacimab at doses of (1) 150 mg once weekly (QW), with a loading dose of 300 mg, (2) 300 mg QW, and (3) 450 mg QW. All subjects with bleeding episodes were identified, along with on-demand treatment administered for each bleeding episode. Treatments permitted for bleeding episodes included activated coagulation factor VIIa, factor VIII, or factor IX; use of activated prothrombin complex concentrate was prohibited. D-dimer and peak thrombin data collected within 3 days after each bleeding episode were used for this analysis. Time profiles of peak thrombin and D-dimer levels were analyzed to assess the effect of bleed treatment. Biomarker profiles were compared between subjects with and without bleeding episodes, as well as with the data from healthy volunteers (n=41). Results: A total of 15 bleeding episodes were reported in 8 of 26 subjects during the study (excluding screening and follow-up). No subject participating in the study showed any relevant increases in D-dimer levels after receiving on-demand treatment for a bleeding episode while receiving regular prophylaxis with marstacimab, compared with levels seen in subjects who did not experience a bleeding episode. Based on the peak thrombin data (see Figure), 150 nM was observed as the upper limit for 18 of 26 subjects who did not experience any bleeding episodes, which was approximately 50% of the 300 nM observed in healthy volunteer controls treated with 450 mg intravenous marstacimab. Transient increases in peak thrombin of >150 nM were observed at several time points in 3 of 8 subjects who experienced bleeding episodes. The highest peak thrombin level reported was approximately 211 nM in one subject receiving marstacimab 300 mg SC QW and factor VIII concentrate on demand during the study. Conclusions: No transient increases in D-dimer could be attributed to the administration of bleeding episode treatment. The transient increases in peak thrombin levels following on-demand treatment for bleeding episodes did not exceed peak thrombin levels seen in subjects without bleeding events or the levels seen in healthy volunteer controls receiving single doses of marstacimab. Based on peak thrombin and D-dimer levels observed in this post hoc analysis, there does not appear to be any indication of an increased risk of thrombosis post administration of acute on-demand bleeding episode treatment while on prophylactic marstacimab therapy at the doses studied. Disclosures Nayak: Pfizer Inc.: Current Employment, Other. Raje:Pfizer Inc.: Current Employment, Other. Teeter:Pfizer Inc.: Current Employment. Harnisch:Pfizer Inc.: Current Employment, Other. Arkin:Pfizer: Current Employment, Current equity holder in publicly-traded company, Other: own stock/options in the company.

scholarly journals Rituximab Yielded a Significantly Longer Response Compared to Placebo in Steroid Free Population - a Post Hoc Analysis of the Ritp Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2358-2358
Author(s):  
Waleed Ghanima ◽  
Marc Michel ◽  
Abderrahim Khelif ◽  
Bernadette Darne ◽  
Pal André Holme
Keyword(s):  
Platelet Count ◽  
Treatment Failure ◽  
Research Funding ◽  
Post Hoc Analysis ◽  
Risk Of Bleeding ◽  
Adequate Response ◽  
Duration Of Response ◽  
Bleeding Episodes ◽  
Time To Relapse ◽  
Post Hoc

Immune thrombocytopenia (ITP) is an autoimmune disease characterized by immune mediated platelet destruction causing thrombocytopenia and increase risk of bleeding. Treatment is indicated in patients who present with bleeding or are at risk of bleeding. Corticosteroids (CS) are the main first-line treatment in adult patients, but since not all patients achieve adequate response to CS, most patients require a second line therapy. Rituximab is one of the most widely used second line therapies; its advantages include the ability to induce relatively long lasting remissions after 2-4 infusions and its favorable safety profile. The RITP study was a randomized placebo-controlled trial in which ITP patients who failed to achieve adequate response to CS were randomized to receive rituximab or placebo. The study outcomes were treatment failure (splenectomy or meeting criteria for splenectomy), response rates and duration of response during an 18-month follow-up period. Apart from a longer duration of response in the rituximab arm, the study showed no significant differences in the other outcomes (Ghanima et al. Lancet 2015; 385: 1653-61). The use of stable dose of CS was allowed during the study. This report represents a post-hoc analysis of the RITP trail, restricting the population to those who did not receive any CS during the study, until relapse or treatment failure in the two arms. By this we aimed to eliminate the possible interference resulting from concomitant use of CS on the effect and safety of rituximab and placebo. For effect, we estimated the duration of response, splenectomy rates, platelet counts, and time to bleeding and for safety we estimated time to infection episodes in both arms. We included patients who did not receive CS before treatment failure or relapse or until the end the of the study, if none of the endpoints was achieved. The duration of response was estimated from time of achieving response to relapse (platelet count <30x109/L). Kaplan Meier plots were constructed to depict time to relapse, bleeding and infections using log-rank test to determine statistical significance between the two study groups. Of the 109 included patients, 45 (41%) patients did not receive CS in the two arms. Of these 45 patients, 27 achieved a response during the study; 14 in the rituximab arm and 13 in the placebo arm. Median duration of response was significantly longer in the rituximab arm (median 308 days; IQR: 168- not reached) vs placebo (41 days; IQR: 36-42) arm (p=0.0019), figure 1. Splenectomy rates did not differ between the two arms; 4 in the rituximab arm vs 3 in the placebo. A trend towards lower bleeding episodes was observed in the rituximab arm (p=0.12), figure 2. Mean platelet count was higher during the study in the rituximab arm compared to placebo as shown in figure 3. There was no difference in time to infection in both arms. One of the limitations of the RITP study was that CSs (prednisolone) were allowed in an unstandardized fashion. Thus, use of corticosteroids could have reduced the difference in effect between the two treatment arms masking some of the benefit of rituximab. Interestingly, no difference was found in the rate of response in the 2 arms; however, almost all those who were classified as responders in the placebo arm, relapsed within the first few weeks, whereas a much longer time to relapse was observed after rituximab. The unexpectedly high response rates in the placebo arm may be explained by the use of pre-medications, with CS received prior to infusion. Although the duration of response was also significantly longer in the original study, a greater difference was observed when restricting the population to those who did not use CS. Nevertheless, splenectomy rates were similar. In conclusion, rituximab yielded significantly longer duration of response and although response to rituximab was transient, half of the patients, displayed a treatment free response of more than 10 months, as well as it resulted in higher platelet count and less bleeding episodes without causing more infections. Disclosures Ghanima: Amgen: Consultancy, Honoraria; Pfizer/BMS: Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Bayer: Honoraria, Research Funding. Michel:Novartis: Consultancy; Amgen: Consultancy; Rigel: Consultancy. OffLabel Disclosure: Rituximab for ITP

Bleeding complications and antithrombotic treatment in 264 pregnancies in antiphospholipid syndrome

Lupus ◽  
2018 ◽  
Vol 27 (10) ◽  
pp. 1679-1686 ◽  
Author(s):  
C M Yelnik ◽  
M Lambert ◽  
E Drumez ◽  
V Le Guern ◽  
J-L Bacri ◽  
...  
Keyword(s):  
Antiphospholipid Syndrome ◽  
Major Bleeding ◽  
Pregnancy Outcomes ◽  
Prospective Cohort ◽  
Retrospective Cohort ◽  
Post Partum ◽  
Bleeding Complications ◽  
Minor Bleeding ◽  
Increased Risk ◽  
History Of

Purpose The purpose of this study was to evaluate the safety of antithrombotic treatments prescribed during pregnancy in patients with antiphospholipid syndrome (APS). Methods This international, multicenter study included two cohorts of patients: a retrospective French cohort and a prospective US cohort (PROMISSE study). Inclusion criteria were (1) APS (Sydney criteria), (2) live pregnancy at 12 weeks of gestation (WG) with (3) follow-up data until six weeks post-partum. According to APS standard of care, patients were treated with aspirin and/or low-molecular weight heparin (LMWH) at prophylactic (pure obstetric APS) or therapeutic doses (history of thrombosis). Major bleeding was defined as abnormal blood loss during the pregnancy and/or post-partum period requiring intervention for hemostasis or transfusion, or during the peripartum period greater than 500 mL and/or requiring surgery or transfusion. Other bleeding events were classified as minor. Results Two hundred and sixty-four pregnancies (87 prospectively collected) in 204 patients were included (46% with history of thrombosis, 23% with associated systemic lupus). During pregnancy, treatment included LMWH ( n = 253; 96%) or low-dose aspirin ( n = 223; 84%), and 215 (81%) patients received both therapies. The live birth rate was 89% and 82% in the retrospective and prospective cohorts, respectively. Adverse pregnancy outcomes occurred in 28% of the retrospective cohort and in 40% of the prospective cohort. No maternal death was observed in either cohort. A combined total of 45 hemorrhagic events (25%) occurred in the retrospective cohort, but major bleeding was reported in only six pregnancies (3%). Neither heparin nor aspirin alone nor combined therapy increased the risk of hemorrhage. We also did not observe an increased rate of bleeding in the case of a short interval between last LMWH (less than 24 hours) or aspirin (less than five days) doses and delivery. Only emergency Caesarean section was significantly associated with an increased risk of bleeding (odds ratio (OR) 5.03 (1.41–17.96); p=.016). In the prospective cohort, only one minor bleeding event was reported (vaginal bleeding). Conclusion Our findings support the safety of antithrombotic therapy with aspirin and/or LMWH during pregnancy in high-risk women with APS, and highlight the need for better treatments to improve pregnancy outcomes in APS. PROMISSE Study ClinicalTrials.gov identifier: NCT00198068.

scholarly journals The “Gender Factor” in Wearing-Off among Patients with Parkinson’s Disease: A Post Hoc Analysis of DEEP Study

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Delia Colombo ◽  
Giovanni Abbruzzese ◽  
Angelo Antonini ◽  
Paolo Barone ◽  
Gilberto Bellia ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Cross Sectional Study ◽  
Motor Symptom ◽  
Cross Sectional ◽  
Post Hoc Analysis ◽  
Increased Risk ◽  
Wearing Off ◽  
Gender Factor ◽  
Post Hoc

Background. The early detection of wearing-off in Parkinson disease (DEEP) observational study demonstrated that women with Parkinson’s disease (PD) carry an increased risk (80.1%) for wearing-off (WO). This post hoc analysis of DEEP study evaluates gender differences on WO and associated phenomena.Methods. Patients on dopaminergic treatment for ≥1 year were included in this multicenter observational cross-sectional study. In a single visit, WO was diagnosed based on neurologist assessment as well as the use of the 19-item wearing-off questionnaire (WOQ-19); WO was defined for scores ≥2. Post hoc analyses were conducted to investigate gender difference for demographic and clinical features with respect to WO.Results. Of 617 patients enrolled, 236 were women and 381 were men. Prevalence of WO was higher among women, according to both neurologists’ judgment (61.9% versus 53.8%,P=0.045) and the WOQ-19 analysis (72.5% versus 64.0%,P=0.034). In patients with WO (WOQ-19), women experienced ≥1 motor symptom in 72.5% versus 64.0% in men and ≥1 nonmotor symptom in 44.5% versus 36.7%, in men.Conclusions. Our results suggest WO as more common among women, for both motor and nonmotor symptoms. Prospective studies are warranted to investigate this potential gender-effect.

scholarly journals VTE Rates and Safety Analysis of Newly Diagnosed Multiple Myeloma Patients Receiving Carfilzomib-Lenalidomide-Dexamethasone (KRD) with or without Rivaroxaban Prophylaxis

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1835-1835 ◽  
Author(s):  
Katrina M Piedra ◽  
Hani Hassoun ◽  
Larry W. Buie ◽  
Sean M. Devlin ◽  
Jessica Flynn ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Venous Thromboembolism ◽  
Board Of Directors ◽  
Research Funding ◽  
High Dose ◽  
Newly Diagnosed ◽  
Advisory Committees ◽  
Cancer Trial ◽  
Oncology Research ◽  
Increased Risk

Introduction Immunomodulatory agents (IMiD's) are associated with an increased risk of venous thromboembolism (VTE), particularly when combined with high dose steroids. Studies evaluating the use of lenalidomide-bortezomib-dexamethasone (RVD) and carfilzomib-lenalidomide-dexamethasone (KRD) in the frontline setting for multiple myeloma (MM) have reported a 6% and 24% incidence of thrombosis, respectively, despite primary thrombotic prophylaxis with aspirin (ASA) (Richardson, et al. Blood. 2010; Korde, et al. JAMA Oncol 2015). Recent data, including the Hokusai VTE Cancer Trial, have suggested that safety and efficacy of direct oral anticoagulants (DOACs) are preserved in the setting of treatment of solid malignancy-associated thrombosis (Raskob, et al. N Engl J Med. 2018; Mantha, et al. J Thromb Thrombolysis. 2017). Despite this data, there is limited experience and use of DOACs in prevention of thromboses in the setting of hematologic malignancies, specifically MM. After careful review of literature, since early 2018, we changed our clinical practice and routinely placed newly diagnosed MM (NDMM) patients receiving KRD at Memorial Sloan Kettering Cancer Center (MSKCC) on concomitant rivaroxaban 10 mg once daily, regardless of VTE risk stratification. In the following abstract, we present VTE rates and safety data for newly diagnosed MM patients receiving RVD with ASA vs. KRD with ASA vs. KRD with rivaroxaban prophylaxis. Methods This was an IRB-approved, single-center, retrospective chart review study. All untreated patients with newly diagnosed MM, receiving at least one cycle of RVD or KRD between January 2015 and October 2018 were included. The period of observation included the time between the first day of therapy until 90 days after completion of induction therapy. Patients were identified by querying the pharmacy database for carfilzomib or bortezomib administration and outpatient medication review of thromboprophylaxis with rivaroxaban or ASA. VTE diagnoses were confirmed by ICD-10 codes and appropriate imaging studies (computed tomography and ultrasound). Descriptive statistics were performed. Results During the observation period, 241 patients were identified to have received RVD or KRD in the frontline (99 RVD with ASA; 97 KRD with ASA; 45 KRD with rivaroxaban). Baseline characteristics were well distributed among the three arms, with a median age of 60 (30-94) in the RVD ASA arm, 62 (33-77) in the KRD ASA arm, and 60 (24-79) in the KRD rivaroxaban arm. Patients had International Staging System (ISS) stage 3 disease in 13% (N=13), 9.3% (N=9), and 11% (N=5) of the RVD ASA, KRD ASA, and KRD rivaroxaban arms, respectively. Median weekly doses of dexamethasone were higher in both KRD arms, 40 mg (20-40) vs. 20 mg (10-40) in the RVD ASA arm. The average initial doses of lenalidomide were 22 mg in the RVD ASA arm compared to 25 mg in both the KRD ASA and KRD rivaroxaban arms. After querying the pharmacy database, no patients were identified to have a history or concomitant use of erythropoietin stimulating agent (ESA) use. Treatment-related VTE's occurred in 4 patients (4.0%) in the RVD ASA arm, 16 patients (16.5%) in the KRD ASA arm, and in 1 patient (2.2%) in the KRD rivaroxaban arm. Average time to VTE was 6.15 months (Range 5.42, 9.73) after treatment initiation in the RVD ASA group, while it was 2.61 months (Range 0.43, 5.06) in the KRD ASA group and 1.35 months in the KRD rivaroxaban group. Minor, grade 1 bleeding events per the Common Terminology Criteria for Adverse Events (CTCAE) were identified in 1 (1.1%) patient in the RVD ASA arm, 5 (5.2%) patients in the KRD ASA arm, and 1 (2.2%) patient in the KRD rivaroxaban arm. Conclusion More efficacious MM combination therapies have been found to increase the risk of VTE when using ASA prophylaxis, indicating better thromboprophylaxis is needed. We found patients receiving ASA prophylaxis with KRD were more likely to experience a VTE and these events occurred earlier compared to patients receiving ASA prophylaxis with RVD. Importantly, the rate of VTE was reduced to the same level as ASA prophylaxis with RVD when low-dose rivaroxaban 10 mg daily was used with KRD, and without necessarily increasing bleeding risk. Our retrospective data support the development of prospective clinical trials further investigating DOAC use in thromboprophylaxis for NDMM patients receiving carfilzomib-based treatments. Figure Disclosures Hassoun: Novartis: Consultancy; Janssen: Research Funding; Celgene: Research Funding. Lesokhin:BMS: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria; Janssen: Research Funding; GenMab: Consultancy, Honoraria; Serametrix Inc.: Patents & Royalties; Genentech: Research Funding; Juno: Consultancy, Honoraria. Mailankody:Juno: Research Funding; Celgene: Research Funding; Janssen: Research Funding; Takeda Oncology: Research Funding; CME activity by Physician Education Resource: Honoraria. Smith:Celgene: Consultancy, Patents & Royalties, Research Funding; Fate Therapeutics and Precision Biosciences: Consultancy. Landgren:Theradex: Other: IDMC; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Abbvie: Membership on an entity's Board of Directors or advisory committees; Karyopharm: Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck: Other: IDMC; Sanofi: Membership on an entity's Board of Directors or advisory committees; Adaptive: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. OffLabel Disclosure: Off-label use of rivaroxaban for outpatient prophylaxis of venous thromboembolism (VTE) will be explicitly disclosed to the audience.

Abstract 299: Association of Chronic Lung Disease with Treatments and Outcomes of Acute Coronary Syndromes: Results from the NCDR®

2012 ◽  
Vol 5 (suppl_1) ◽  
Author(s):  
Jonathan R Enriquez ◽  
James A de Lemos ◽  
Ramin Farzaneh-Far ◽  
Anand Rohatgi ◽  
S. A Peng ◽  
...  
Keyword(s):  
Hospital Mortality ◽  
Lung Disease ◽  
Major Bleeding ◽  
Chronic Lung Disease ◽  
Beta Blockers ◽  
Bleeding Risk ◽  
Bleeding Complications ◽  
Processes Of Care ◽  
Increased Risk ◽  
The Impact

Background: Previous reports are conflicting regarding outcomes, treatments, and processes of care after acute myocardial infarction (MI) for patients with chronic lung disease (CLD). Methods: Using the NCDR ACTION Registry ® -GWTG ™ (AR-G), demographics, clinical characteristics, treatments, processes of care, and in-hospital adverse events after NSTEMI and STEMI were compared between patients with (n= 22,624; 14.2%) and without (n= 136,266; 85.8%) CLD. CLD was defined by a history of COPD, chronic bronchitis, or emphysema. Multivariable adjustment using published AR-G in-hospital mortality and major bleeding risk adjustment models was performed to quantify the impact of CLD on treatments and outcomes. Results: CLD was present in 10.1% of STEMI patients and 17.0% of NSTEMI patients. In both STEMI and NSTEMI, CLD patients were older, more likely to be female, and had more comorbidities including diabetes, renal disease, prior MI and heart failure, compared to those without CLD. Although on admission CLD patients were more likely to be on cardiovascular medications, by discharge slightly fewer CLD patients received composite core measures (aspirin, beta-blockers, ACE-inhibitors, and statins) (table). In NSTEMI, CLD was also associated with less use of invasive procedures and with increased risk of both death and major bleeding. In STEMI, major bleeding but not mortality was increased. Conclusions: CLD is a common comorbidity and is independently associated with an increased risk for major bleeding after MI. In NSTEMI, CLD is also associated with receiving fewer evidence-based medications, less timely angiography and revascularization, and increased in-hospital mortality. Close attention should be given to this high-risk subgroup for the prevention and management of bleeding complications after MI, and further investigation is needed to determine the reasons for treatment and outcome disparities in NSTEMI.

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