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In-hospital and readmission outcomes of patients with cancer admitted for pulmonary embolism treated with or without catheter-based therapy

Leiva, Orly; Yang, Eric H; Rosovsky, Rachel P; Alviar, Carlos; Bangalore, Sripal
BACKGROUND:Cancer patients are at risk of pulmonary embolism (PE). Catheter-based therapies (CBT) are novel reperfusion options for PE though data in patients with cancer is lacking. STUDY DESIGN AND METHODS/METHODS:Patients with intermediate- or high-risk PE were identified using the National Readmission Database (NRD) from 2017 to 2020. Primary outcome were in-hospital death and 90-day readmission. Secondary outcomes were in-hospital bleeding, 90-day readmission for venous thromboembolism (VTE)-related or right heart failure-related reasons and bleeding. Propensity scores were estimated using logistic regression and inverse-probability treatment weighting (IPTW) was utilized to compare outcomes between CBT and no CBT as well as CBT versus systemic thrombolysis. RESULTS:A total of 7785 patients were included (2511 with high-risk PE) of whom 1045 (13.4%) were managed with CBT. After IPTW, CBT was associated with lower rates of index hospitalization death (OR 0.89, 95% CI 0.83-0.96) and 90-day readmission (HR 0.75, 95% CI 0.69-0.81) but higher rates of in-hospital bleeding (OR 1.11, 95% CI 1.03-1.20) which was predominantly post-procedural bleeding. CBT was associated with lower risk of major bleeding (20.8% vs 24.8%; OR 0.80, 95% CI 0.68-0.94) compared with systemic thrombolysis. INTERPRETATION/CONCLUSIONS:Among patients with cancer with intermediate or high-risk PE, CBT was associated with lower in-hospital death and 90-day readmission. CBT was also associated with decreased risk of index hospitalization major bleeding compared with systemic thrombolysis. Prospective, randomized trials with inclusion of patients with cancer are needed to confirm these findings.
PMID: 38750964
ISSN: 1874-1754
CID: 5658722

McConnell's sign predicts normotensive shock in patients with acute pulmonary embolism [Letter]

Zhang, Robert S; Rhee, Aaron J; Yuriditsky, Eugene; Nayar, Ambika C; Elbaum, Lindsay S; Horowitz, James M; Greco, Allison A; Postelnicu, Radu; Alviar, Carlos L; Bangalore, Sripal
BACKGROUND:Patients with intermediate-risk pulmonary embolism (PE) and normotensive shock may have worse outcomes. However, diagnosis of normotensive shock requires invasive hemodynamics. Our objective was to assess the predictive value of McConnell's sign in identifying normotensive shock in patients with intermediate-risk PE. METHODS:and clinical evidence of hypoperfusion (i.e. elevated lactate, oliguria). The primary outcome was the association between McConnell's sign and normotensive shock. RESULTS:, p = 0.003), and higher rates of normotensive shock (76 % vs 27 %, p = 0.005). McConnell's sign had a sensitivity of 88 % and specificity of 53 % for identifying intermediate-risk PE patients with normotensive shock. Patients with McConnell's sign had an increased odds (odds ratio 8.38, confidence interval: 1.73-40.53, p = 0.008; area under the curve 0.70, 95 % confidence interval: 0.56-0.85) of normotensive shock. CONCLUSION/CONCLUSIONS:This is the first study to suggest that McConnell's sign may identify those in the intermediate-risk group who are at risk for normotensive shock. Larger cohorts are needed to validate our findings.
PMID: 38906415
ISSN: 1876-4738
CID: 5672452

Catheter-based therapy for high-risk or intermediate-risk pulmonary embolism: death and re-hospitalization

Leiva, Orly; Alviar, Carlos; Khandhar, Sameer; Parikh, Sahil A; Toma, Catalin; Postelnicu, Radu; Horowitz, James; Mukherjee, Vikramjit; Greco, Allison; Bangalore, Sripal
BACKGROUND AND AIMS/OBJECTIVE:Catheter-based therapies (CBTs) have been developed as a treatment option in patients with pulmonary embolism (PE). There remains a paucity of data to inform decision-making in patients with intermediate-risk or high-risk PE. The aim of this study was to characterize in-hospital and readmission outcomes in patients with intermediate-risk or high-risk PE treated with vs. without CBT in a large retrospective registry. METHODS:Patients hospitalized with intermediate-risk or high-risk PE were identified using the 2017-20 National Readmission Database. In-hospital outcomes included death and bleeding and 30- and 90-day readmission outcomes including all-cause, venous thromboembolism (VTE)-related and bleeding-related readmissions. Inverse probability of treatment weighting (IPTW) was utilized to compare outcomes between CBT and no CBT. RESULTS:A total of 14 903 [2076 (13.9%) with CBT] and 42 829 [8824 (20.6%) with CBT] patients with high-risk and intermediate-risk PE were included, respectively. Prior to IPTW, patients with CBT were younger and less likely to have cancer and cardiac arrest, receive systemic thrombolysis, or be on mechanical ventilation. In the IPTW logistic regression model, CBT was associated with lower odds of in-hospital death in high-risk [odds ratio (OR) 0.83, 95% confidence interval (CI) 0.80-0.87] and intermediate-risk PE (OR 0.76, 95% CI 0.70-0.83). Patients with high-risk PE treated with CBT were associated with lower risk of 90-day all-cause [hazard ratio (HR) 0.77, 95% CI 0.71-0.83] and VTE (HR 0.46, 95% CI 0.34-0.63) readmission. Patients with intermediate-risk PE treated with CBT were associated with lower risk of 90-day all-cause (HR 0.75, 95% CI 0.72-0.79) and VTE (HR 0.66, 95% CI 0.57-0.76) readmission. CONCLUSIONS:Among patients with high-risk or intermediate-risk PE, CBT was associated with lower in-hospital death and 90-day readmission. Prospective, randomized trials are needed to confirm these findings.
PMID: 38573048
ISSN: 1522-9645
CID: 5664662

Comparing Management Strategies in Patients With Clot-in-Transit

Zhang, Robert S; Yuriditsky, Eugene; Zhang, Peter; Elbaum, Lindsay; Bailey, Eric; Maqsood, Muhammad H; Postelnicu, Radu; Amoroso, Nancy E; Maldonado, Thomas S; Saric, Muhamed; Alviar, Carlos L; Horowitz, James M; Bangalore, Sripal
BACKGROUND/UNASSIGNED:Clot-in-transit is associated with high mortality, but optimal management strategies remain uncertain. The aim of this study was to compare the outcomes of different treatment strategies in patients with clot-in-transit. METHODS/UNASSIGNED:This is a retrospective study of patients with documented clot-in-transit in the right heart on echocardiography across 2 institutions between January 2020 and October 2023. The primary outcome was a composite of in-hospital mortality, resuscitated cardiac arrest, or hemodynamic decompensation. RESULTS/UNASSIGNED:=0.067). CONCLUSIONS/UNASSIGNED:In this study of CBT in patients with clot-in-transit, CBT or systemic thrombolysis was associated with a significantly lower rate of adverse clinical outcomes, including a lower rate of death compared with anticoagulation alone driven by the CBT group. CBT has the potential to improve outcomes. Further large-scale studies are needed to test these associations.
PMID: 38841833
ISSN: 1941-7632
CID: 5665552

Cardiometabolic Comorbidity Burden and Circulating Biomarkers in Patients with Chronic Coronary Disease in the ISCHEMIA Trials

Hamo, Carine E; Liu, Richard; Wu, Wenbo; Anthopolos, Rebecca; Bangalore, Sripal; Held, Claes; Kullo, Ifitkhar; Mavromatis, Kreton; McManus, Bruce; Newby, L Kristin; Reynolds, Harmony R; Ruggles, Kelly V; Wallentin, Lars; Maron, David J; Hochman, Judith S; Newman, Jonathan D; Berger, Jeffrey S; ,
Cardiometabolic comorbidities, diabetes (DM), hypertension (HTN), and obesity, contribute to cardiovascular disease (CVD). Circulating biomarkers facilitate prognostication for patients with CVD. We explored the relationship between cardiometabolic comorbidity burden in patients with chronic coronary disease (CCD) and biomarkers of myocardial stretch, injury, inflammation, and platelet activity. We analyzed participants from the ISCHEMIA Trials biorepository with plasma biomarkers (NT-proBNP, hs-cTnT, hs-CRP, IL-6, sCD40L, and GDF-15) and clinical risk factors [hemoglobin A1c (HbA1c), systolic blood pressure (SBP), and body mass index (BMI)] at baseline. We defined cardiometabolic comorbidities as DM, HTN, and obesity at baseline. Comorbidity burden characterized by number and severity of comorbidities. Controlled comorbidities were defined as HbA1c <7% for those with DM, SBP <130 mmHg for those with HTN and BMI <30 kg/m2. Severely uncontrolled was defined as HbA1c ≥8%, SBP ≥160 mmHg, and BMI ≥35 kg/m2. We performed linear regression analyses to examine the association between comorbidity burden and log-transformed biomarker levels adjusting for age, sex, eGFR controlled for hemodialysis, and left ventricular ejection fraction. A total of 752 individuals (mean age 66, 19% female, 84% white) were included in this analysis. Self-reported Black race, current smokers, history of MI and HF had greater cardiometabolic comorbidity burden. The presence of ≥ 1 severely uncontrolled comorbidity was associated with significantly higher baseline levels of hs-cTnT, hs-CRP, IL-6, and GDF-15 compared to participants with no comorbidities. In conclusion, increasing cardiometabolic comorbidity burden in patients with CCD is associated with higher levels of circulating biomarkers of myocardial injury and inflammation.
PMID: 38844195
ISSN: 1879-1913
CID: 5665722

Factors Associated With Coronary Angiography Performed Within 6 Months of Randomization to the Conservative Strategy in the ISCHEMIA Trial

Pracoń, Radosław; Spertus, John A; Broderick, Samuel; Bangalore, Sripal; Rockhold, Frank W; Ruzyllo, Witold; Demchenko, Elena; Nageh, Thuraia; Grossman, Gabriel Blacher; Mavromatis, Kreton; Manjunath, Cholenahally N; Smanio, Paola E P; Stone, Gregg W; Mancini, G B John; Boden, William E; Newman, Jonathan D; Reynolds, Harmony R; Hochman, Judith S; Maron, David J; ,
BACKGROUND/UNASSIGNED:ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) did not find an overall reduction in cardiovascular events with an initial invasive versus conservative management strategy in chronic coronary disease; however, there were conservative strategy participants who underwent invasive coronary angiography early postrandomization (within 6 months). Identifying factors associated with angiography in conservative strategy participants will inform clinical decision-making in patients with chronic coronary disease. METHODS/UNASSIGNED:Factors independently associated with angiography performed within 6 months of randomization were identified using Fine and Gray proportional subdistribution hazard models, including demographics, region of randomization, medical history, risk factor control, symptoms, ischemia severity, coronary anatomy based on protocol-mandated coronary computed tomography angiography, and medication use. RESULTS/UNASSIGNED:Among 2591 conservative strategy participants, angiography within 6 months of randomization occurred in 8.7% (4.7% for a suspected primary end point event, 1.6% for persistent symptoms, and 2.6% due to protocol nonadherence) and was associated with the following baseline characteristics: enrollment in Europe versus Asia (hazard ratio [HR], 1.81 [95% CI, 1.14-2.86]), daily and weekly versus no angina (HR, 5.97 [95% CI, 2.78-12.86] and 2.63 [95% CI, 1.51-4.58], respectively), poor to fair versus good to excellent health status (HR, 2.02 [95% CI, 1.23-3.32]) assessed with Seattle Angina Questionnaire, and new/more frequent angina prerandomization (HR, 1.80 [95% CI, 1.34-2.40]). Baseline low-density lipoprotein cholesterol <70 mg/dL was associated with a lower risk of angiography (HR, 0.65 [95% CI, 0.46-0.91) but not baseline ischemia severity nor the presence of multivessel or proximal left anterior descending artery stenosis >70% on coronary computed tomography angiography. CONCLUSIONS/UNASSIGNED:Among ISCHEMIA participants randomized to the conservative strategy, angiography within 6 months of randomization was performed in <10% of patients. It was associated with frequent or increasing baseline angina and poor quality of life but not with objective markers of disease severity. Well-controlled baseline low-density lipoprotein cholesterol was associated with a reduced likelihood of angiography. These findings point to the importance of a comprehensive assessment of symptoms and a review of guideline-directed medical therapy goals when deciding the initial treatment strategy for chronic coronary disease. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.
PMCID:11187765
PMID: 38629312
ISSN: 1941-7632
CID: 5671492

Low left ventricular outflow tract velocity time integral predicts normotensive shock in patients with acute pulmonary embolism [Letter]

Zhang, Robert S; Yuriditsky, Eugene; Nayar, Ambika C; Elbaum, Lindsay; Greco, Allison A; Rhee, Aaron J; Mukherjee, Vikramjit; Keller, Norma; Alviar, Carlos L; Horowitz, James M; Bangalore, Sripal
In this study, we found that a low LVOT VTI (<15 cm), a simple bedside point-of-care measurement, predicts normotensive shock in patients with acute intermediate-risk PE.
PMID: 38670834
ISSN: 1097-6744
CID: 5657872

Outcomes with treatment interventions for clot-in-transit in patients with pulmonary embolism: a meta-analysis

Maqsood, Muhammad Haisum; Zhang, Robert S; Zlotnick, David M; Parikh, Sahil A; Bangalore, Sripal
OBJECTIVES:Clot-in-transit (CIT) in patients with pulmonary embolism (PE) has been associated with a high mortality rate and poor prognosis. The aim of this study was to evaluate the pooled efficacy of each of the 4 interventions (anticoagulation [AC] alone, systemic thrombolytic [ST] therapy, surgical thrombectomy, and catheter-based thrombectomy [CBT]) using mortality as the primary outcome. METHODS:A time limited search until March 28, 2024 was conducted using PubMed (National Institutes of Health) and EMBASE (Elsevier) databases. RESULTS:Thirteen studies (6 retrospective, 4 non-randomized prospective, and 3 pooled studies of case-reports) were included in the calculation of weighted proportion of mortality, including a total of 492 patients with CIT and PE with a mean age of 60.6 years; 50.1% were males. ST was the most frequently used treatment intervention (38.2%), followed by surgical thrombectomy (33.8%), AC alone (22.6%), and CBT (5.9%). The unweighted mortality was highest with AC alone 32.4% (36/111), followed by surgical thrombectomy 23.2% (38/164), CBT 20.7% (6/29), and ST 13.8% (26/188). The weighted mortality for AC alone was 35% (95% CI, 21% to 49%; 12 studies), surgical thrombectomy was 31% (95% CI, 16% to 47%; 12 studies), CBT was 20% (95% CI, 6% to 34%; 3 studies), and ST was 12% (95% CI, 5% to 19%; 12 studies). CONCLUSIONS:In this meta-analysis of patients with CIT and PE, the highest mortality was observed with AC alone, followed by surgical thrombectomy, CBT, and ST therapy. However, there remains a need for randomized clinical trial data to determine the best treatment.
PMID: 38776476
ISSN: 1557-2501
CID: 5654692

One- versus three-month dual antiplatelet therapy in high bleeding risk patients undergoing percutaneous coronary intervention for non-ST-segment elevation acute coronary syndromes

Cao, Davide; Vranckx, Pascal; Valgimigli, Marco; Sartori, Samantha; Angiolillo, Dominick J; Bangalore, Sripal; Bhatt, Deepak L; Feng, Yihan; Ge, Junbo; Hermiller, James; Makkar, Raj R; Neumann, Franz-Josef; Saito, Shigeru; Picon, Hector; Toelg, Ralph; Maksoud, Aziz; Chehab, Bassem M; Choi, James W; Campo, Gianluca; De la Torre Hernandez, José M; Krucoff, Mitchell W; Kunadian, Vijay; Sardella, Gennaro; Spirito, Alessandro; Thiele, Holger; Varenne, Olivier; Vogel, Birgit; Zhou, Yujie; Windecker, Stephan; Mehran, Roxana
BACKGROUND:A short dual antiplatelet therapy (DAPT) duration has been proposed for patients at high bleeding risk (HBR) undergoing drug-eluting coronary stent (DES) implantation. Whether this strategy is safe and effective after a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) remains uncertain. AIMS/OBJECTIVE:We aimed to compare the impact of 1-month versus 3-month DAPT on clinical outcomes after DES implantation among HBR patients with or without NSTE-ACS. METHODS:This is a prespecified analysis from the XIENCE Short DAPT programme involving three prospective, international, single-arm studies evaluating the safety and efficacy of 1-month (XIENCE 28 USA and Global) or 3-month (XIENCE 90) DAPT among HBR patients after implantation of a cobalt-chromium everolimus-eluting stent. Ischaemic and bleeding outcomes associated with 1- versus 3-month DAPT were assessed according to clinical presentation using propensity score stratification. RESULTS:Of 3,364 HBR patients (1,392 on 1-month DAPT and 1,972 on 3-month DAPT), 1,164 (34.6%) underwent DES implantation for NSTE-ACS. At 12 months, the risk of the primary endpoint of death or myocardial infarction was similar between 1- and 3-month DAPT in patients with (hazard ratio [HR] 1.09, 95% confidence interval [CI]: 0.71-1.65) and without NSTE-ACS (HR 0.88, 95% CI: 0.63-1.23; p-interaction=0.34). The key secondary endpoint of Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding was consistently reduced in both NSTE-ACS (HR 0.57, 95% CI: 0.37-0.88) and stable patients (HR 0.84, 95% CI: 0.61-1.15; p-interaction=0.15) with 1-month DAPT. CONCLUSIONS:Among HBR patients undergoing implantation of an everolimus-eluting stent, 1-month, compared to 3-month DAPT, was associated with similar ischaemic risk and reduced bleeding at 1 year, irrespective of clinical presentation.
PMCID:11100501
PMID: 38776146
ISSN: 1969-6213
CID: 5654662

Sex Differences in Revascularization, Treatment Goals, and Outcomes of Patients With Chronic Coronary Disease: Insights From the ISCHEMIA Trial

Reynolds, Harmony R; Cyr, Derek D; Merz, C Noel Bairey; Shaw, Leslee J; Chaitman, Bernard R; Boden, William E; Alexander, Karen P; Rosenberg, Yves D; Bangalore, Sripal; Stone, Gregg W; Held, Claes; Spertus, John; Goetschalckx, Kaatje; Bockeria, Olga; Newman, Jonathan D; Berger, Jeffrey S; Elghamaz, Ahmed; Lopes, Renato D; Min, James K; Berman, Daniel S; Picard, Michael H; Kwong, Raymond Y; Harrington, Robert A; Thomas, Boban; O'Brien, Sean M; Maron, David J; Hochman, Judith S; ,
BACKGROUND:Women with chronic coronary disease are generally older than men and have more comorbidities but less atherosclerosis. We explored sex differences in revascularization, guideline-directed medical therapy, and outcomes among patients with chronic coronary disease with ischemia on stress testing, with and without invasive management. METHODS AND RESULTS/RESULTS:=0.49), with no significant sex-by-treatment-group interactions. CONCLUSIONS:Women had less extensive coronary artery disease and, therefore, lower revascularization rates in the invasive group. Despite lower risk factor goal attainment, women with chronic coronary disease experienced similar risk-adjusted outcomes to men in the ISCHEMIA trial. REGISTRATION/BACKGROUND:URL: http://wwwclinicaltrials.gov. Unique identifier: NCT01471522.
PMCID:10944079
PMID: 38410945
ISSN: 2047-9980
CID: 5645612