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Revisiting the Efficacy and Safety of Bivalirudin in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention: Insights From a Mixed Treatment Comparison Meta-Analysis of Randomized Trials
Maqsood, M Haisum; Tamis-Holland, Jacqueline E; Feit, Frederick; Bangalore, Sripal
BACKGROUND:Randomized trials of bivalirudin in patients with ST elevation myocardial infarction (STEMI) have yielded heterogeneous results. AIMS/OBJECTIVE:Our aim was to evaluate the efficacy and safety of four antithrombin regimens-unfractionated heparin (UFH), bivalirudin (stopped soon after percutaneous coronary intervention [PCI]), extended bivalirudin (continued for a few hours after PCI), and combined UFH and a Gp2b3a inhibitors (GPI) in patients who present with STEMI. METHODS:A PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized clinical trials (RCTs) of the above antithrombin in patients with STEMI. The primary outcome was net adverse cardiovascular events (NACE). The primary ischemic endpoint was major adverse cardiovascular events (MACE), and the primary safety endpoint was major bleeding, and other endpoints included all-cause mortality and stent thrombosis. The primary analysis compared the effect of these antithrombin regimens in reference to UFH using a mixed treatment comparison meta-analysis. RESULTS:In the 14 RCTs evaluating 25,415 patients with STEMI, when compared to UFH monotherapy, extended bivalirudin lowered NACE (OR = 0.71 with 95% CI: 0.53-0.96; moderate level of confidence) driven by a significant decrease in major bleeding (OR = 0.42 with 95% CI: 0.26-0.68; high level of confidence) without any significant difference in MACE or all-cause mortality. When compared with UFH monotherapy, UFH+GPI reduced risk of MACE (OR = 0.76 with 95% CI: 0.60-0.97; high level of confidence) but at the expense of an increase in major bleeding (OR = 1.48 with 95% CI: 1.11-1.98; high level of confidence) with no difference in NACE or all-cause mortality. For major bleeding, extended bivalirudin infusion ranked #1, bivalirudin ranked #2, UFH monotherapy ranked #3, and combined UFH and GPI ranked #4. For NACE, extended bivalirudin infusion ranked #1, bivalirudin ranked #2, combined UFH and GPI ranked #3, and UFH monotherapy ranked #4. Cluster plots for MACE and major bleeding demonstrated that extended bivalirudin had the best balance for efficacy and safety. CONCLUSIONS:In patients undergoing PCI for STEMI, extended bivalirudin offers the best balance for primary ischemic (MACE) and safety (major bleeding) outcomes.
PMID: 39506500
ISSN: 1522-726x
CID: 5779532
Comparing Real-World Outcomes of Catheter-Directed Thrombolysis and Catheter-Based Thrombectomy in Acute Pulmonary Embolism: A Post PEERLESS Analysis
Zhang, Robert S; Zhang, Peter; Yuriditsky, Eugene; Taslakian, Bedros; Rhee, Aaron J; Greco, Allison A; Elbaum, Lindsay; Mukherjee, Vikramjit; Postelnicu, Radu; Amoroso, Nancy E; Maldonado, Thomas S; Alviar, Carlos L; Horowitz, James M; Bangalore, Sripal
BACKGROUND:The recently published PEERLESS trial compared catheter-directed thrombolysis (CDT) and catheter-based thrombectomy (CBT) in acute pulmonary embolism (PE). However, it included a low proportion of patients with contraindications to thrombolytic therapy (4.4%), leaving uncertainty about how CDT would perform relative to CBT in a real-world cohort with higher bleeding risk. AIMS/OBJECTIVE:This study aims to address this gap by comparing real-world outcomes of CDT and CBT in patients with acute PE. METHODS:This retrospective analysis included patients who underwent CDT and CBT at two tertiary care centers from January 2020 to January 2024. The primary outcome was a composite of 30-day mortality, resuscitated cardiac arrest, or hemodynamic decompensation. Secondary outcomes included major bleeding and intracranial hemorrhage (ICH). Inverse probability treatment weighting (IPTW) was used to adjust for baseline variables. RESULTS:A total of 162 (mean age 58 years, 45.7% women, 17.3% high-risk, 28% contraindication to lytics, 28% CDT, 72% CBT) patients were included, with 12.4% patients experiencing the primary outcome. There was no difference in the rates of the primary outcome between CBT versus CDT (11.2% vs. 15.2%, IPTW HR: 0.80; 95% CI: 0.27-2.38, p = 0.69). CBT was associated with a lower risk of hemodynamic decompensation (5% vs. 21.7%, p = 0.036), major bleeding (7.8% vs. 17.4%, IPTW HR 0.26; 95% CI: 0.07-0.95, p = 0.042) and ICH (0 vs. 4.3%, p = 0.024) compared to CDT. CONCLUSION/CONCLUSIONS:Among a real-world cohort of patients with acute PE with higher bleeding risk than PEERLESS undergoing catheter-based therapies, CBT was associated with a lower rate of hemodynamic deterioration, major bleeding, and ICH with similar rate of primary composite outcome when compared with CDT. Additional randomized controlled trials are needed to validate these findings.
PMID: 39726241
ISSN: 1522-726x
CID: 5767842
Fasting prior to percutaneous cardiovascular procedures: is it time to abandon this time-honoured practice?
Bangalore, Sripal; Maqsood, Muhammad H
PMID: 39545812
ISSN: 1522-9645
CID: 5753762
Venoarterial extracorporeal membrane oxygenation in high-risk pulmonary embolism: A narrative review
Yuriditsky, Eugene; Bakker, Jan; Alviar, Carlos L; Bangalore, Sripal; Horowitz, James M
Emergent reperfusion, most commonly with the administration of thrombolytic agents, is the recommended management approach for patients presenting with high-risk, or hemodynamically unstable pulmonary embolism. However, a subset of patients with a more catastrophic presentation, including refractory shock and impending or active cardiopulmonary arrest, may require immediate circulatory support. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) can be deployed rapidly by the well-trained team and provide systemic perfusion allowing for hemodynamic stabilization. Subsequent embolectomy or a standalone strategy allowing for thrombus autolysis may be followed with decannulation after several days. Retrospective studies and registry data suggest favorable clinical outcomes with the use of VA-ECMO as an upfront stabilization strategy even among patients presenting with cardiopulmonary arrest. In this review, we discuss the physiologic rationale, evidence base, and an approach to ECMO deployment and subsequent management strategies among select patients with high-risk pulmonary embolism.
PMID: 39079203
ISSN: 1557-8615
CID: 5689722
Evaluating the hemodynamic impact of saddle versus non-saddle pulmonary embolism: insights from a thrombectomy cohort
Zhang, Robert S; Yuriditsky, Eugene; Bailey, Eric; Elbaum, Lindsay; Greco, Allison A; Postelnicu, Radu; Mukherjee, Vikramjit; Keller, Norma; Alviar, Carlos L; Horowitz, James M; Bangalore, Sripal
OBJECTIVES:The aim of this study was to compare the hemodynamic impact and clinical outcomes of saddle vs non-saddle pulmonary embolism (PE). METHODS:This was a retrospective analysis of clinical characteristics and outcomes among patients with saddle and non-saddle PE within a cohort referred for catheter-based thrombectomy (CBT) with invasive hemodynamic assessments. Patients who underwent CBT between August 2020 and January 2024 were included. The primary outcome was the proportion of patients with a low cardiac index (CI < 2.2 L/min/m²). Secondary outcomes included 30-day mortality, intensive care unit (ICU) length of stay (LOS), and hospital LOS. RESULTS:A total of 107 patients (84 intermediate risk, 23 high-risk; mean age 58 years, 47.6% female) were included in the study, with 44 patients having saddle PE and 63 having non-saddle PE. There were no significant differences in baseline demographics and clinical characteristics between saddle and non-saddle PE, including rates of high-risk PE (25% vs 16%, P = .24), rates of RV dysfunction, pulmonary artery systolic pressure (55 vs 53 mm Hg, P = .74), mean pulmonary artery pressure (34 mm Hg vs 33 mm Hg), low cardiac index (56% vs 51%, P = .64), rates of normotensive shock (27% vs 20%, P = .44), or Composite Pulmonary Embolism Shock scores (4.5 vs 4.7, P = .25). Additionally, 30-day mortality (6% vs 5%, P = .69), ICU LOS, and hospital LOS were similar between the groups. CONCLUSIONS:Among patients undergoing CBT, there were no significant differences in invasive hemodynamic parameters or clinical outcomes between those with saddle and non-saddle PE.
PMID: 38935443
ISSN: 1557-2501
CID: 5733332
Relationship Between Severity of Ischemia and Coronary Artery Disease for Different Stress Test Modalities in the ISCHEMIA Trial
Reynolds, Harmony R; Page, Courtney B; Shaw, Leslee J; Berman, Daniel S; Chaitman, Bernard R; Picard, Michael H; Kwong, Raymond Y; Min, James K; Leipsic, Jonathon; Mancini, G B John; Budoff, Matthew J; Hague, Cameron J; Senior, Roxy; Szwed, Hanna; Bhargava, Balram; Celutkiene, Jelena; Gadkari, Milind; Bainey, Kevin R; Doerr, Rolf; Ramos, Ruben B; Ong, Peter; Naik, Sudhir R; Steg, Philippe Gabriel; Goetschalckx, Kaatje; Chow, Benjamin J W; Scherrer-Crosbie, Marielle; Phillips, Lawrence; Mark, Daniel B; Spertus, John A; Alexander, Karen P; O'Brien, Sean M; Boden, William E; Bangalore, Sripal; Stone, Gregg W; Maron, David J; Hochman, Judith S; ,
BACKGROUND/UNASSIGNED:The relationship between the extent and severity of stress-induced ischemia and the extent and severity of anatomic coronary artery disease (CAD) in patients with obstructive CAD is multifactorial and includes the intensity of stress achieved, type of testing used, presence and extent of prior infarction, collateral blood flow, plaque characteristics, microvascular disease, coronary vasomotor tone, and genetic factors. Among chronic coronary disease participants with site-determined moderate or severe ischemia, we investigated associations between ischemia severity on stress testing and the extent of CAD on coronary computed tomography angiography. METHODS/UNASSIGNED:Clinically indicated stress testing included nuclear imaging, echocardiography, cardiac magnetic resonance imaging, or nonimaging exercise tolerance test. Among those with preserved renal function who underwent coronary computed tomography angiography, we examined relationships between ischemia and CAD by coronary computed tomography angiography, overall, and by stress test modality, regardless of subsequent randomization. Core laboratories categorized ischemia as severe, moderate, mild, or none, while the extent and severity of anatomic CAD were categorized based on the modified Duke prognostic index. RESULTS/UNASSIGNED:Among 3601 participants with interpretable stress tests and coronary computed tomography angiography, ischemia severity was weakly associated with CAD extent/severity (r=0.27), with modest variability in strength of association by modality: nuclear (n=1532; r=0.40), echocardiography (n=827; r=0.15), cardiac magnetic resonance imaging (n=108; r=0.31), and exercise tolerance test (n=1134; r=0.18). The extent of infarction on nuclear imaging and echocardiography was weakly associated with CAD extent/severity. CONCLUSIONS/UNASSIGNED:Overall, ischemia severity on stress testing showed weak to moderate associations with the anatomic extent of CAD in this cohort with moderate or severe ischemia on local interpretation and controlled symptoms. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.
PMCID:11658795
PMID: 39689188
ISSN: 1941-7632
CID: 5764392
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
Short Versus One-Year Dual Antiplatelet Therapy After Percutaneous Coronary Intervention: an Updated Systematic Review and Meta-Analysis
Joseph, Meghna; Krishna, Mrinal Murali; Ezenna, Chidubem; Pereira, Vinicius; Ismayl, Mahmoud; Nanna, Michael G; Bangalore, Sripal; Goldsweig, Andrew M
The present guidelines recommend dual antiplatelet therapy (DAPT) for 6 to 12 months after percutaneous coronary intervention (PCI), with recent trials assessing the safety and efficacy of shortening DAPT duration to ≤3 months. A systematic search of PubMed, Scopus, and Cochrane Central databases identified studies comparing short DAPT, followed by P2Y12i monotherapy (78% ticagrelor) versus standard 12-month DAPT in patients who underwent PCI with a drug-eluting stent. A total of 9 randomized controlled trials, including 42,770 patients (short DAPT n = 21,370, 49.96%), of whom 28,307 (66.18%) presented with acute coronary syndrome (ACS). Short DAPT significantly reduced net adverse clinical events (NACEs) (risk ratio [RR] 0.78, 95% confidence interval [CI] 0.67 to 0.91, p = 0.001, I2 = 62%), major bleeding (RR 0.54, 95% CI 0.39 to 0.73, p <0.001, I2 = 63%), and any bleeding (RR 0.55, 95% CI 0.43 to 0.72, p <0.001, I2 = 77%) at 12 months compared with 1-year DAPT. No significant differences were observed in major adverse cardiovascular/cerebrovascular events, myocardial infarction, stroke, stent thrombosis, mortality, or revascularization. Ticagrelor monotherapy after short DAPT further reduced major adverse cardiovascular/cerebrovascular events (RR 0.85, 95% CI 0.73 to 0.99, p = 0.040, I² = 22%), NACE (RR 0.74, 95% CI 0.61 to 0.89, p = 0.001, I² = 68%), and major bleeding (RR 0.56, 95% CI 0.40 to 0.78, p <0.001, I² = 71%) compared with 1-year DAPT; however, the test for subgroup interaction (Pinteraction >0.05) for clopidogrel subgroup was not significant. P2Y12i monotherapy reduced the risk of NACEs (RR 0.77, 95%CI 0.66 to 0.90, p = 0.001, I2 = 52%, Pinteraction = 0.58) and major bleeding (RR 0.44, 95%CI 0.35 to 0.55, p <0.001, I2 = 0%, Pinteraction <0.01) in the ACS cohort but not in the chronic coronary syndrome cohort. In conclusion, short DAPT for ≤3 months followed by P2Y12i monotherapy (particularly, ticagrelor) was associated with decreased NACEs and bleeding without differences in other outcomes and should be considered a favorable option in patients with either ACS or chronic coronary syndrome after PCI with a drug-eluting stent.
PMID: 39577682
ISSN: 1879-1913
CID: 5758962
Use of Multimodal Imaging for Diagnosis and Management of Pulmonary Artery Sarcoma Mimicking as Acute Pulmonary Embolism [Case Report]
Cerezo, Juan; Cohen, Rachel; Banco, Darcy; Yongue, Camille; Hena, Kerry; Bangalore, Sripal; Chan, Justin C Y
Pulmonary artery sarcoma is a rare intravascular tumor that mimics pulmonary embolus. Early recognition and referral to surgery is important because nonsurgically treated tumors have a poor prognosis. Here, we describe a case of pulmonary artery sarcoma diagnosed with multimodal imaging, which also aided in surgical planning.
PMCID:11602593
PMID: 39619039
ISSN: 2666-0849
CID: 5804262
Right Ventricular-Pulmonary Arterial Uncoupling as a Predictor of Invasive Hemodynamics and Normotensive Shock in Acute Pulmonary Embolism
Yuriditsky, Eugene; Zhang, Robert S; Zhang, Peter; Postelnicu, Radu; Greco, Allison A; Horowitz, James M; Bernard, Samuel; Leiva, Orly; Mukherjee, Vikramjit; Hena, Kerry; Elbaum, Lindsay; Alviar, Carlos L; Keller, Norma M; Bangalore, Sripal
Right ventricular-pulmonary arterial coupling describes the relation between right ventricular contractility and its afterload and is estimated as the ratio of the tricuspid annular plane systolic excursion (TAPSE) to pulmonary arterial systolic pressure (PASP) by way of echocardiography. Whether TAPSE/PASP is reflective of invasive hemodynamics or occult shock in acute pulmonary embolism (PE) is unknown. This was a single-center retrospective study over a 3-year period of consecutive patients with PE who underwent mechanical thrombectomy and simultaneous pulmonary artery catheterization with echocardiograms performed within 24 hours before the procedure. A total of 70 patients (81% intermediate risk) had complete invasive hemodynamic profiles and echocardiograms, with TAPSE/PASP calculated. The optimal cutoff for TAPSE/PASP as a predictor of a reduced cardiac index (CI) (CI ≤2.2 L/min/m2) was 0.34 mm/mm Hg, with an area under the curve of 0.97 and sensitivity, specificity, positive predictive value, and negative predictive value of 97.3%, 90.9%, 92.3%, and 96.8%, respectively. Every 0.1 mm/mm Hg decrease in TAPSE/PASP was associated with a 0.24-L/min/m2 decrease in the CI. This relation was similar when restricted to intermediate-risk PE. The TAPSE/PASP ratio was predictive of normotensive shock with an odds ratio of 2.63 (95% confidence interval 1.42 to 4.76, p = 0.002) per unit decrease in the ratio. In conclusion, in patients with acute PE who underwent mechanical thrombectomy, TAPSE/PASP was a strong predictor of a reduced CI and normotensive shock. This means that noninvasive point-of-care assessment of hemodynamics may have added value in PE risk stratification.
PMID: 39505227
ISSN: 1879-1913
CID: 5766852