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Long-Term Outcomes Following Catheter-Based Therapies in Older Adults With Acute Pulmonary Embolism

Watanabe, Atsuyuki; Kuno, Toshiki; Miyamoto, Yoshihisa; Ueyama, Hiroki A; Gotanda, Hiroshi; Bangalore, Sripal; Tsugawa, Yusuke
BACKGROUND:Despite the increasing use of catheter-based therapies (CBTs) for acute pulmonary embolism (PE), evidence is limited regarding the long-term outcome. OBJECTIVES/OBJECTIVE:We aimed to investigate the efficacy of CBT for high- and intermediate-risk PE in older adults. METHODS:We included Medicare fee-for-service beneficiaries aged 65 to 99 years admitted for PE from 2017 to 2020 and compared in-hospital and long-term outcomes between patients treated with and without CBT. Propensity score matching weight and instrumental variable analyses were implemented. RESULTS:We included 6,742 and 23,750 patients with high-risk and intermediate-risk PE, of which 11.4% and 15.1% patients were treated with CBT. In high-risk PE, patients treated with CBT, compared with those without, experienced lower in-hospital death (29.0% vs 43.9%; adjusted OR [aOR]: 0.73; 95% CI: 0.61-0.87) and 3-year mortality (45.7% vs 65.5%; adjusted HR: 0.76; 95% CI: 0.67-0.85) but higher intracranial hemorrhage (2.1% vs 1.0%; aOR: 2.29; 95% CI: 1.18-4.44). In intermediate-risk PE, we found no evidence that the incidence of in-hospital death differed between the 2 groups (3.1% vs 4.1%; aOR: 0.93; 95% CI: 0.75-1.16), but patients treated with CBT experienced lower 3-year mortality (14.9% vs 30.3%; adjusted HR: 0.69; 95% CI: 0.63-0.75) and higher incidence of intracranial hemorrhage (0.5% vs 0.3%; aOR: 2.04; 95% CI: 1.17-3.55). The association between the use of CBT and lower 3-year mortality was consistent in the instrumental variable analysis. CONCLUSIONS:Among older adults with high-risk or intermediate-risk PE, patients treated with CBT experienced lower mortality over the follow-up of up to 3 years, but higher risk of in-hospital bleeding complications.
PMID: 40439656
ISSN: 2772-963x
CID: 5854752

Use of Coronary Artery Bypass Graft Surgery and Percutaneous Coronary Intervention and Associated Outcomes in the ISCHEMIA Trial

White, Harvey D; O'Brien, Sean M; Boden, William E; Fremes, Stephen E; Bangalore, Sripal; Reynolds, Harmony R; Stone, Gregg W; Ali, Ziad A; Parakh, Neeraj; Lopez-Sendon, Jose Luis; Wang, Yixin; Chen, Ying Qing; Mark, Daniel B; Chaitman, Bernard R; Spertus, John A; Maron, David J; Hochman, Judith S; ,
BACKGROUND:In the ISCHEMIA Trial, 5179 patients with stable coronary disease were randomized to initial invasive or conservative management. METHODS:PCI was recommended with a SYNTAX score 0-22 (low) and CABG with a SYNTAX score ≥33 (high). Either could be recommended for intermediate scores. The composite primary outcome was cardiovascular death, MI, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. There were two cohorts in this analysis. The descriptive cohort included patients who underwent CABG or PCI within 180 days of randomization and had no primary outcome before revascularization. The comparative cohort excluded participants with prior CABG, single vessel disease, SYNTAX score ≥ 45, and without core laboratory assessment. We focused on the intermediate (23-32) SYNTAX comparative group for which either CABG or PCI could be recommended. RESULTS:For 1935 patients in the descriptive cohort (485 CABG, 1450 PCI), the SYNTAX score was 27.3 ± 11.0 in the CABG group and 15.3 ± 8.6 in the PCI group, p<0.0001. Most patients with low SYNTAX scores underwent PCI (87.1%), while most with high SYNTAX scores underwent CABG (72.6%). For the 1203 patients (385 CABG, 818 PCI) in the entire comparative cohort, the adjusted 4-year primary event rate was 14.5% for CABG and 13.2% for PCI (difference 1.3%, 95% CI, -4.9% to 7.7%). For the 346 patients (163 CABG, 183 PCI) in the intermediate SYNTAX group, the adjusted 4-year primary event rate was 10.6% for CABG and 18.3% for PCI (difference -7.6%, 95% CI, -16.1% to 0.9%). CONCLUSIONS:Selection of revascularization method resulted in more PCI in the low SYNTAX group and more CABG in the high SYNTAX group. There was no statistical evidence of a difference between PCI and CABG in the intermediate SYNTAX group but the CIs are broad, reflecting uncertainty. GOV IDENTIFIER/UNASSIGNED:NCT01471522; https://clinicaltrials.gov/ct2/show/NCT01471522.
PMID: 40404111
ISSN: 1097-6744
CID: 5853492

Early versus delayed catheter-based therapies in patients hospitalised with acute pulmonary embolism

Leiva, Orly; Rosovsky, Rachel P; Alviar, Carlos; Bangalore, Sripal
BACKGROUND:Acute pulmonary embolism (PE) is a common cause of cardiovascular morbidity and mortality. Catheter-based therapies (CBT) are emerging technologies that provide reperfusion for patients with PE. However, the optimal timing of these interventions from initial presentation is unknown. AIMS/OBJECTIVE:This study aimed to determine whether the timing of CBT affects outcomes among patients with acute PE managed with CBT. METHODS:This was a retrospective cohort study of patients with PE who underwent CBT and were included in the Nationwide Readmissions Database between January 2017 and December 2020. Patients who underwent early CBT (≤1 day from admission) were compared with those who underwent delayed CBT (>1 day). The primary outcome was death at 90 days, and secondary outcomes included 90-day readmissions. Propensity scores were estimated using logistic regression, and propensity score weighting (PSW) was utilised to compare outcomes between early and delayed CBT. Cox proportional hazards modelling was used to estimate the risk of primary and readmission outcomes. RESULTS:A total of 12,137 patients were included: 1,992 (16.4%) had high-risk PE, and 1,856 (15.3%) were treated with delayed CBT. After PSW, early CBT was associated with a lower risk of 90-day death in both intermediate-risk (hazard ratio [HR] 0.55, 95% confidence interval [CI]: 0.46-0.66) and high-risk (HR 0.89, 95% CI: 0.80-0.99) PE. Early CBT was associated with lower rates of all-cause readmission in patients with intermediate-risk PE (HR 0.86, 95% CI: 0.78-0.95) and in those with high-risk PE (HR 0.84, 95% CI: 0.69-1.05). CONCLUSIONS:Among patients with intermediate- or high-risk PE, early CBT was associated with a lower risk of 90-day death and readmission. A further prospective study on the optimal timing for reperfusion using CBT is needed.
PMID: 40325984
ISSN: 1969-6213
CID: 5839022

Mechanical Thrombectomy vs Catheter-Directed Thrombolysis for High-Risk Pulmonary Embolism: A Target Trial Emulation

Watanabe, Atsuyuki; Kuno, Toshiki; Miyamoto, Yoshihisa; Ueyama, Hiroki A; Gotanda, Hiroshi; Bangalore, Sripal; Tsugawa, Yusuke
BACKGROUND:Evidence is limited regarding the comparative effectiveness and safety of mechanical thrombectomy (MT) vs catheter-directed thrombolysis (CDT) for high-risk pulmonary embolism (PE). OBJECTIVES/OBJECTIVE:This observational study aimed to compare the outcomes of older adults with high-risk PE treated with MT vs CDT using a target trial emulation framework. METHODS:We included Medicare fee-for-service beneficiaries aged 65 to 99 years admitted with high-risk PE (defined by cardiac arrest, shock, and vasopressor use) who underwent MT/CDT from 2017 to 2020. We evaluated 1-year mortality using an inverse probability of treatment weighting approach, controlling for 62 baseline covariates. We also evaluated readmissions and in-hospital outcomes, including intracranial hemorrhage. Patients were followed from the date of the index procedure to the outcomes of interest, 1 year, or December 2020. RESULTS:We included 235 and 484 patients in the MT and CDT groups, respectively. The absolute risk of 1-year mortality was 48.4% (95% CI: 34.1%-63.3%) in the MT group and 45.4% (95% CI: 37.8%-55.8%) in the CDT group, with an adjusted HR of 1.16 (95% CI: 0.84-1.59). We found no evidence that all-cause readmission (MT vs CDT; subdistribution HR: 0.89; 95% CI: 0.56-1.40), intracranial hemorrhage (adjusted OR: 0.36; 95% CI: 0.07-1.77), or transfusions (adjusted OR: 0.96; 95% CI: 0.52-1.76) differed significantly between the 2 groups. CONCLUSIONS:Among older adults with high-risk PE treated with catheter-based therapies, the clinical outcomes were similar between the patients treated with MT vs CDT. Randomized trials are needed to confirm our findings.
PMCID:12018976
PMID: 40286366
ISSN: 2772-963x
CID: 5830912

Do Pulmonary Embolism Response Teams in Acute Pulmonary Embolism Improve Outcomes? Insights from a Meta-analysis

Maqsood, M Haisum; Zhang, Robert S; Rosenfeld, Kenneth; Moriarty, John M; Rosovsky, Rachel P; Horowitz, James M; Alviar, Carlos L; Bangalore, Sripal
Pulmonary embolism response teams (PERTs) are being increasingly used for the management of patients admitted with acute pulmonary embolism (PE) and are endorsed by societal guidelines. Whether PERT improves outcomes remains unknown. The objective of this meta-analysis was to compare the outcomes of patients with acute PE treated by a PERT versus no PERT.A systematic review and study level meta-analysis was conducted by searching PubMed and EMBASE databases from inception until November 10, 2024 and included studies evaluating efficacy of PERT vs no PERT in patients admitted for acute PE. Outcomes included all-cause mortality (in-hospital and 30-day mortality), major and clinically relevant bleeding, advanced therapies utilization, length of stay (LOS), and 30-day readmission. Twenty-four retrospective observational studies met the inclusion criteria, comprising 15,809 patients (mean age 61.6 years with 49% male) with acute PE of which 6228 were treated with a PERT and 9,581 without a PERT. Lower all-cause mortality (in-hospital or 30-day mortality) [odds ratio (OR)= 0.72; 95% CI: 0.56 to 0.93; 24 studies], major or clinically relevant bleeding (OR= 0.60; 95% CI: 0.42 to 0.86; 15 studies), higher utilization of advanced therapies (OR= 3.16; 95% CI: 1.81 to 5.49; 19 studies), and lower hospital LOS (MD= -1.49; 95% CI: -2.59 to -0.39; 14 studies) were seen in the patients treated by a PERT compared to those not treated by a PERT. In this large meta-analysis of observational studies comparing outcomes in patients treated by PERT versus not treated by PERT, there were significantly lower short-term mortality, lower major or clinically relevant bleeding, higher utilization of advanced therapies and lower hospital length of stay with the existence of PERT. PERT should be the standard of care for the management of patients with acute PE.
PMID: 40258457
ISSN: 1879-1913
CID: 5830012

Anticoagulation alone versus large-bore mechanical thrombectomy in acute intermediate-risk pulmonary embolism

Zhang, Robert S; Yuriditsky, Eugene; Zhang, Peter; Truong, Hannah P; Xia, Yuhe; Maqsood, Muhammad H; Greco, Allison A; Mukherjee, Vikramjit; Postelnicu, Radu; Amoroso, Nancy E; Maldonado, Thomas S; Alviar, Carlos L; Horowitz, James M; Bangalore, Sripal
BACKGROUND:Patients with intermediate-risk pulmonary embolism (PE) have outcomes worse than uncomplicated ST elevation myocardial infarction. Yet, no large-scale study has compared the outcomes of large-bore mechanical thrombectomy (LBMT) with anticoagulation alone (AC). The aim of this study was to compare the clinical outcomes among patients receiving LBMT vs AC alone. METHODS:This was a two-center retrospective study that included patients with intermediate-risk PE from October 2016 - October 2023 from the institution's Pulmonary Embolism Response Team (PERT) database. The primary outcome was a composite of 30-day mortality, resuscitated cardiac arrest or hemodynamic decompensation. Inverse probability of treatment weighting (IPTW) was used to balance covariates; Kaplan Meir curves and IPTW multivariable Cox regression were used to assess the relationship between treatment groups and outcomes. RESULTS:Of the 273 patients included in the analysis, 192 (70 %) patients received AC alone and 81 (30 %) patients received LBMT and AC. A total of 30 (10.9 %) patients experienced the primary composite outcome over a median follow-up of 30 days. The primary composite outcome was significantly lower in the group that received LBMT compared to those on AC alone (1.2 % vs 15.1 %, log-rank p < 0.001; adjusted HR: 0.02; 95 % CI: 0.002-0.17, p < 0.001) driven by a lower rate of 30-day all-cause mortality (0 % vs 7.3 %, log-rank p = 0.01), resuscitated cardiac arrest (0 % vs 6.8 %, log-rank p = 0.016) and new or worsening hemodynamic instability (4 % vs 11.1 %, log-rank p = 0.007). CONCLUSION/CONCLUSIONS:In this largest cohort to date comparing LBMT versus AC alone in acute intermediate-risk PE, LBMT had a significantly lower rate of the primary composite outcome including a lower rate of all-cause mortality when compared to AC alone. Ongoing randomized trials will test these associations.
PMID: 40234154
ISSN: 1878-0938
CID: 5827832

Clonal Hematopoiesis of Indeterminate Potential in Chronic Coronary Disease: A Report From the ISCHEMIA Trials Biorepository [Letter]

Muller, Matthew; Liu, Richard; Shah, Farheen; Hu, Jiyuan; Held, Claes; Kullo, Iftikhar J; McManus, Bruce; Wallentin, Lars; Newby, L Kristin; Sidhu, Mandeep S; Bangalore, Sripal; Reynolds, Harmony R; Hochman, Judith S; Maron, David J; Ruggles, Kelly V; Berger, Jeffrey S; Newman, Jonathan D
PMID: 40207358
ISSN: 2574-8300
CID: 5824082

Optical Coherence Tomography vs. Angiography Alone to Guide PCI for Complex Lesions: A Meta-Analysis of Randomized Controlled Trials

Ezenna, Chidubem; Krishna, Mrinal Murali; Joseph, Meghna; Ibrahim, Sammudeen; Pereira, Vinicius; Jenil-Franco, Ancy; Nanna, Michael G; Bangalore, Sripal; Goldsweig, Andrew M
PMID: 40159113
ISSN: 1941-7632
CID: 5818612

Invasive vs Conservative Management of Patients With Chronic Total Occlusion: Results From the ISCHEMIA Trial

Bangalore, Sripal; Mancini, G B John; Leipsic, Jonathan; Budoff, Mathew J; Xu, Yifan; Anthopolos, Rebecca; Brilakis, Emmanouil S; Dwivedi, Aeshita; Spertus, John A; Jones, Phil G; Cho, Yoon Joo; Mark, Daniel B; Hague, Cameron J; Min, James K; Reynolds, Harmony R; Elghamaz, Ahmed; Nair, Rajesh Goplan; Mavromatis, Kreton; Gosselin, Gilbert; Banerjee, Subhash; Pejkov, Hristo; Lindsay, Steven; Grantham, J Aaron; Williams, David O; Stone, Gregg W; O'Brien, Sean M; Hochman, Judith S; Maron, David J; ,
BACKGROUND:Randomized trials of chronic total occlusion (CTO) revascularization vs medical therapy have yielded inconsistent results. OBJECTIVES/OBJECTIVE:The aim of this study was to evaluate outcomes with an initial invasive strategy (INV) vs an initial conservative strategy (CON) in patients with coronary computed tomographic angiography (CCTA)-determined CTO in the ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) trial. METHODS:Participants in ISCHEMIA who underwent CCTA evaluated for CTO by the core laboratory (3,113 of 5,179 randomized patients [60%]) were categorized into subgroups with (100% stenosis) and without (<100% stenosis) CTO. Primary analysis compared outcomes in those randomized to INV vs CON using an intention-to-treat approach. Secondary analyses compared outcomes using inverse probability weighting to model successful CTO revascularization (REV) in all INV participants vs CON participants. RESULTS:Of the 3,113 CCTA-evaluable participants, 1,470 had at least 1 CTO (752 INV and 718 CON). INV did not reduce cardiovascular (CV) death or myocardial infarction (MI) (5-year difference -3.5%; 95% CI: -7.8% to 0.8%) and resulted in more procedural MIs (2.5%; 95% CI: 1.0%-4.0%) but fewer spontaneous MIs (-6.3%; 95% CI: -9.7% to -3.2%) than CON. CTO REV modeled across INV had a high probability (>90%) of any lower CV death or MI, MI, spontaneous MI, unstable angina, and heart failure counterbalanced by a higher rate of procedural MI. CTO REV significantly improved angina-related quality of life (mean difference 4.6 points), Rose Dyspnea Scale score (rescaled) (mean difference 5.3 points), and EQ-5D visual analog scale score (4.6 points). CONCLUSIONS:In the ISCHEMIA trial, the risks and benefits of INV compared with CON were similar among patients with and without CCTA-determined CTO (more frequent procedural MI, less frequent spontaneous MI, and significantly improved angina and dyspnea-related quality of life). In an observational comparison, successful CTO REV was associated with a high probability of lower CV death or MI (driven by lower MI) compared with CON. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522).
PMID: 40139890
ISSN: 1558-3597
CID: 5816262

Management and outcomes of patients with ST-elevation myocardial infarction and liver disease-Insights from the Nationwide Readmissions Database

Kumar, Manoj; Nso, Nso; Khlidj, Yehya; Ali, Shafaqat; Kumar, Nomesh; Ponna, Pramod Kumar; Attanasio, Steve; Aronow, Wilbert S; Butler, Javed; Valencia, Javier Gomez; Alaxendar, Kevin M; Zelniker, Thomas A; Pursnani, Amit; Erwin, John Preston; Ricciardi, Mark J; Pareek, Manan; Bangalore, Sripal; Qamar, Arman
BACKGROUND/UNASSIGNED:The association between cardiovascular disease and advanced liver disease is incompletely understood. To explore this interaction, we compared management, clinical outcomes, readmission rates, and resource utilization in ST-elevation myocardial infarction (STEMI) patients with and without liver disease. METHODS/UNASSIGNED:The Nationwide Readmissions Database (2016-2020) was queried to identify hospitalizations for STEMI. Cohorts were stratified by presence of liver disease. Liver disease was defined as documented diagnosis of liver cirrhosis or liver failure. Multivariable regression model and propensity score matching was used to compare the risk of outcomes. RESULTS/UNASSIGNED:Among 1,029,608 hospitalizations for STEMI; 45,478 (4.4 %) patients had a history of significant liver disease. Patient with liver disease had higher baseline prevalence of diabetes, chronic kidney disease, anemia, and heart failure. After propensity matching (N = 24,067 in each group), patients with liver disease had higher in-hospital mortality (48.8 % vs 17.3 %, aOR: 6.80 [CI: 6.55-7.06], p < 0.001) and adverse events, including cerebrovascular accidents (6.8 % vs 4.4 %, aOR:1.74 [CI: 1.62-1.86], p < 0.001), cardiac arrest (24.4 % vs 10.3 %, aOR:3.34 [CI: 3.21-3.48], p < 0.001), cardiogenic shock (55.9 % vs 21.1 %, aOR: 6.4 [CI: 6.18-6.64], p < 0.001), mechanical circulatory support requirement (36.2 % vs 14.4 %, aOR: 4.2 [CI: 4.01-4.34], p < 0.001), and major adverse cardiovascular and cerebrovascular events (61.1 % vs 25.3 %, aOR:6.5 [CI: 6.28-6.75], p < 0.001). From 2016 to 2020, in-hospital mortality for STEMI did not change significantly for patients with liver disease (47.4 % to 48.6 % p-trend: 0.826), however percutaneous coronary intervention (PCI) use increased from 43.6 % to 52.2 % (p-trend <0.001). CONCLUSION/UNASSIGNED:In STEMI hospitalizations, patients with liver disease have significantly higher mortality, and adverse events as compared with those without liver disease. Despite the increasing use of primary PCI, mortality remains high in STEMI patients with liver disease.
PMCID:11930748
PMID: 40129618
ISSN: 2666-6022
CID: 5814982