Faculty Bibliography

BACKGROUND:Catheter-directed therapies are increasingly used to treat acute pulmonary embolism (PE). However, randomized data on reperfusion treatments, including large-bore mechanical thrombectomy (LBMT), for patients with High-Risk PE are lacking. METHODS:PERSEVERE (NCT06588634) is a multinational randomized controlled trial comparing the FlowTriever LBMT system vs. standard of care (SoC) in patients with High-Risk PE, with the modified intention-to-treat population planned for 200 patients from 40 sites in Europe and the US. Patients are randomized 1:1 to LBMT or SoC (systemic thrombolysis [ST], surgical embolectomy, extracorporeal membrane oxygenation [ECMO], or anticoagulation alone). Key inclusion criteria are the presence of proximal pulmonary thrombus on computed tomography plus ≥1 of the following: (1) systolic hypotension or need for vasopressors, (2) venous lactate ≥4 mmol/L with clinical signs suggesting obstructive shock, (3) need for mechanical circulatory support, (4) resuscitated cardiac arrest. Exclusion criteria include known chronic thromboembolic pulmonary hypertension and key absolute contraindications to ST. Patients are followed for 3 months. The primary endpoint is a composite of events through hospital discharge or 7 days post randomization, whichever occurs first: (1) all-cause death, (2) cardiac arrest requiring cardiopulmonary resuscitation, (3) bailout to rescue treatment, (4) major bleeding, and (5) ECMO in place on day 7. Secondary endpoints include a broad spectrum of functional and patient-reported outcomes (quality of life, functional status and healthcare resource utilization) at 3 months. The trial is funded by Inari. CONCLUSION/CONCLUSIONS:The PERSEVERE study will assess the potential superiority of LBMT over SoC for the treatment of High-Risk PE. CLINICALTRIALS/RESULTS:gov Identifier: NCT06588634.

IMPORTANCE/UNASSIGNED:The optimal dual antiplatelet therapy after percutaneous coronary intervention (PCI) in patients with diabetes is not clearly defined. Although both ticagrelor and prasugrel are potent inhibitors of P2Y purinergic receptor 12 (P2Y12), evidence directly comparing their efficacy and safety in this high-risk group remains limited. OBJECTIVE/UNASSIGNED:To compare the clinical outcomes of ticagrelor vs prasugrel, each in combination with aspirin, in patients with diabetes and multivessel coronary artery disease who underwent percutaneous coronary intervention. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:The Ultrathin Strut vs Xience in a Diabetic Population With Multivessel Disease 2-India Study (TUXEDO-2) is an investigator-initiated, prospective, open-label, multicenter, 2 × 2 factorial design, 1:1 randomized clinical trial. Participants with diabetes and multivessel disease undergoing percutaneous coronary intervention were enrolled at 66 clinical sites from February 2020 to August 2024. INTERVENTIONS/UNASSIGNED:Patients undergoing percutaneous coronary intervention were randomized to receive either ticagrelor or prasugrel, each in combination with low-dose aspirin. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcome was a composite of death, nonfatal myocardial infarction, stroke, or major bleeding as defined by the Bleeding Academic Research Consortium at 1 year. The trial was designed to test the noninferiority of ticagrelor compared with prasugrel with a noninferiority margin of 5%. RESULTS/UNASSIGNED:Among the 1800 participants randomized, mean (SD) age was 60 (10) years with 1296 (72.0%) male participants, 436 (24.2%) receiving insulin therapy, and 1530 (85.0%) with triple-vessel disease. At 1 year, the primary end point occurred in 129 participants (16.6%) taking ticagrelor and 107 participants (14.2%) taking prasugrel (P = .12). The risk difference of 2.33 percentage points (95% CI, -2.07 to 6.74 percentage points) failed to meet the prespecified threshold for noninferiority (P = .84). There was numerically higher (but not statistically significant) composite of death, myocardial infarction, stroke (10.43% vs 8.63%; P = .30), and major bleeding (8.41% vs 7.14%; P = .19) with ticagrelor when compared with prasugrel. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In patients with diabetes and multivessel disease undergoing PCI, ticagrelor was not noninferior to prasugrel for the reduction of primary outcome at 1 year of follow-up. TRIAL REGISTRATION/UNASSIGNED:CTRI/2019/11/022088.

BACKGROUND:In patients with intermediate-risk pulmonary embolism (PE), there are limited tools to assess therapeutic response following catheter-based intervention. This study evaluates pulmonary vascular resistance (PVR), an invasive marker of right ventricular (RV) afterload, and its prognostic significance in acute PE. METHODS:This single-center retrospective study included patients from October 2020-May 2025 with intermediate-high risk PE undergoing large bore mechanical thrombectomy (LBMT) with pulmonary artery catheter-derived hemodynamic indices obtained pre- and post-procedure. The primary objective was to evaluate the effect of LBMT on PVR. Secondary objective was to evaluate the predictors of post procedure elevated PVR (defined as PVR >2 Wood units, WU) and its effect on clinical composite outcome (PE mortality, resuscitated cardiac arrest, hemodynamic instability and 90-day hospital readmission) and hospital length of stay (LOS). RESULTS:A total of 131 patients were included. Following LBMT, median PVR decreased significantly from 2.9 to 1.8 WU (p < 0.001), with greater reduction in patients with higher baseline PVR (baseline PVR tertile 3 to 1: 50% vs. 40% vs. 20%; p < 0.001). Persistently elevated post procedure PVR (>2 WU) was seen in 43.6% of patients. However, the incidence of post-procedure severe PVR >5 WU was extremely low (11.5% pre-procedure, 0.8% post-procedure). Multivariable predictors of elevated post-procedural PVR were pre-procedural mean pulmonary artery pressure (OR: 1.07, 95% CI 1.01-1.14, p = 0.026) and pre-procedural PVR (OR 2.20, 95% CI: 1.20-4.04, p = 0.011). In an age and sex adjusted model, elevated post-procedure PVR was associated with a longer in-hospital LOS of 4.2 days (95% CI: 0.60-7.88; p = 0.023) and a 4-fold higher risk of the composite outcome (20.7% vs 5.3%, adjusted hazard ratio: 4.02, 95% CI: 1.28-12.61, p = 0.017). CONCLUSIONS:In patients with intermediate-high risk PE, LBMT significantly reduced PVR and may be a valuable hemodynamic marker of disease severity and treatment response. Elevated post-procedural PVR identified patients at increased risk of adverse outcomes.

BACKGROUND:Research comparing the prognostic value of stress cardiac magnetic resonance (CMR) to other stress modalities in patients with coronary disease is limited. OBJECTIVES/OBJECTIVE:The authors compared the prognostic value of stress CMR vs alternative testing by either single-photon emission computed tomography or stress echocardiography (SPECT/echo) in the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial. METHODS:CMR vs SPECT/echo was compared in 3,909 patients randomized in ISCHEMIA after sites' interpretation of moderate to severe ischemia. Ischemia and infarct extent, measured by either CMR or SPECT/echo, were each associated with the trial's primary outcome of cardiovascular death, nonfatal myocardial infarction (MI), or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, at a median follow-up of 3.37 years (Q1-Q3: 2.20-4.56 years). RESULTS:Compared with SPECT/echo (n = 5,627), CMR participants (n = 313) were not different in key demographic factors but were more likely to have severe ischemia (57% vs 38%; P < 0.001) and to be randomized (n = 257, 82%, vs n = 3,652, 65%; P < 0.001). Ischemia severity (no/mild, moderate, severe) by CMR core laboratory was associated with cumulative 4-year event rates of all trial-specific endpoints, including the primary outcome (P = 0.042), cardiovascular death/MI (P = 0.041), and nonfatal MI (P = 0.03), but SPECT/echo ischemia severity was not. No/mild, moderate, and severe ischemia by CMR were associated with 0%, 14%, and 23% 4-year primary outcome rates, respectively, compared with 18%, 15%, and 16%, by SPECT/echo. After adjustment for age, estimated glomerular filtration rate, and diabetes, the association between ischemia extent and the primary endpoint differed by imaging modality, with each additional ischemic segment on CMR associated with a 13% increase in hazard (interaction P = 0.02). In participants assigned to initial conservative management who had no/mild ischemia on imaging, 4-year rates of invasive referral and coronary revascularization were lower in the CMR than SPECT/echo group (16.7% and 0%, respectively, for CMR; and 31% and 13.3%, respectively, for SPECT/echo). CONCLUSIONS:Ischemia severity by CMR had a stronger association with all ISCHEMIA trial endpoints compared with SPECT/echo.

BACKGROUND/UNASSIGNED:Stenting of bifurcation and non-aorto-ostial coronary lesions presents significant challenges due to geographic miss and restenosis. Drug-coated balloons (DCBs) offer an attractive alternative to drug-eluting stents in the treatment of these lesions. METHODS/UNASSIGNED:We conducted a systematic review of studies published from 2001 to 2024 comparing DCBs with plain old balloon angioplasty and/or drug-eluting stents (DES) in de novo coronary bifurcation lesions and non-aorto-ostial (NAO) lesions. A meta-analysis was performed with target lesion failure (TLF) as the selected outcome, defined as a composite of target lesion revascularization, target vessel myocardial infarction, or cardiovascular death. RESULTS/UNASSIGNED:= .0015), respectively. CONCLUSIONS/UNASSIGNED:In our meta-analysis, DCBs were associated with a lower rate of TLF compared with plain old balloon angioplasty and DES. These findings suggest that DCBs could be preferred for the treatment of bifurcation and NAO lesions.

Coronary artery disease is one of the leading causes of morbidity and mortality worldwide. Although it can present with an acute coronary syndrome, it is often characterised by long periods of stability, known as chronic coronary artery disease. This Review presents a comprehensive overview of the diagnosis of the disease, with a focus on cardiac imaging. We discuss various cardiac imaging modalities, including CT coronary angiography, stress echocardiogram, stress single-photon emission CT, PET, and stress cardiac magnetic resonance. We also compare the roles of anatomical (eg, CT coronary angiography) versus functional (eg, stress echocardiogram) tests and examine the potential utility of artificial intelligence in more detail.

BACKGROUND/UNASSIGNED:Drug-coated balloons (DCBs) are now a Food and Drug Administration--approved treatment option for the management of in-stent restenosis (ISR) based on superior outcomes compared with plain old balloon angioplasty (POBA) alone. However, the efficacy of DCB compared with drug-eluting stent (DES; repeat stenting) for ISR is uncertain, with prior studies showing inferiority of DCB. We aimed to compare the outcomes of DES, DCB, or POBA in patients with coronary ISR. METHODS/UNASSIGNED:We searched PubMed, EMBASE, and clinicaltrials.gov databases (until August 1, 2025) for randomized clinical trials that compared DCB, DES, or POBA alone for ISR. Outcomes included major adverse cardiovascular events, target lesion revascularization, all-cause mortality, cardiovascular mortality, stent thrombosis, late lumen loss, and postprocedure minimum lumen diameter. RESULTS/UNASSIGNED:From 18 randomized clinical trials that randomized 3820 patients with ISR, at mean follow-up of 18 months, compared with POBA, both DCB and DES were associated with reduction in major adverse cardiovascular events (odds ratio, 0.34 [95% CI, 0.24-0.50]; odds ratio, 0.37 [95% CI, 0.25-0.54]) driven by reduction in target lesion revascularization (odds ratio, 0.28 [95% CI, 0.15-0.50]; odds ratio, 0.21 [95% CI, 0.10-0.42]). DCB had a lower postprocedure minimum lumen diameter but lower late lumen loss (mean difference, -0.16 [95% CI, -0.29 to -0.04] mm) compared with DES with no difference in other clinical outcomes. CONCLUSIONS/UNASSIGNED:In patients with ISR, DCB reduced major adverse cardiovascular events/target lesion revascularization compared with POBA. There was no significant difference in clinical outcomes between DCB and DES. REGISTRATION/UNASSIGNED:URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42024598433.

BACKGROUND/UNASSIGNED:Obesity increases the risk of pulmonary embolism (PE) through multiple mechanisms. OBJECTIVES/UNASSIGNED:This study examined mortality trends in patients with coexisting PE and obesity. METHODS/UNASSIGNED:< .05. RESULTS/UNASSIGNED:< .001). CONCLUSIONS/UNASSIGNED:The analysis reveals a significant rise in mortality from concurrent PE and obesity, with higher rates observed in women, middle-aged adults, non-Hispanic Black individuals, and residents of nonmetropolitan areas. These findings highlight the need for targeted interventions in these high-risk groups.

BACKGROUND/UNASSIGNED:Among patients with intermediate-risk pulmonary embolism undergoing mechanical thrombectomy, the mean change in cardiac index (CI) is modest. We sought to identify variables associated with a hemodynamic super-response or a CI increase of ≥25% postthrombectomy. METHODS/UNASSIGNED:This was a single-center retrospective study including patients with intermediate-risk pulmonary embolism undergoing mechanical thrombectomy with pulmonary artery catheter-derived hemodynamic indices obtained preprocedure and postprocedure. RESULTS/UNASSIGNED:was associated with a hemodynamic super-response (odds ratio, 3.76 [95% CI, 1.09-13.0]). CONCLUSIONS/UNASSIGNED:Patients with intermediate-risk pulmonary embolism with the more severe hemodynamic derangements had the greatest improvement in CI post thrombectomy. This group can be identified with commonly available noninvasive indices of right ventricular dysfunction.

BACKGROUND:Catheter-based percutaneous mechanical aspiration (PMA) is an emerging acute intervention for debulking infective vegetations in right-sided infective endocarditis (RSIE); however, its outcomes and safety remain undefined. OBJECTIVES/OBJECTIVE:The authors sought to assess early clinical outcomes and safety of PMA in patients with RSIE. METHODS:The CLEAR-IE (Cardiac Lesion Extraction and Aspiration Registry for Infective Endocarditis) is a large multicenter retrospective registry of consecutive patients with RSIE who have undergone PMA. Procedural success was defined as a ≥70% reduction in site-reported vegetation size or a residual size ≤1 cm on intraprocedural echocardiography, which included transesophageal echocardiography (TEE), intracardiac echocardiography (ICE), and transthoracic echocardiography (TTE), selected at the operator's discretion to guide the intervention. The primary endpoint was a composite of in-hospital mortality, new pulmonary embolism (PE), or emergency surgery. Secondary endpoints included each component of the primary endpoint and in-hospital worsening tricuspid regurgitation (TR). RESULTS:Between January 2014 and January 2024, 256 patients from 19 institutions were included. Median age was 43 years; 43% were women, and 51% had history of injection drug use. Acute PE (50.8%) and shock (27%) were frequent at presentation. Tricuspid valve involvement was present in 70%, with a median site-reported vegetation size of 2.4 cm (Q1-Q3: 0.6-9 cm). Severe TR was noted in 31.3% at baseline. Staphylococcus aureus was the predominant pathogen (73.8%). Procedural success was achieved in 89.4%, with a median residual vegetation size of 0.7 cm (Q1-Q3: 0.2-1.1 cm). Overall, 86.9% completed the procedure free from procedure-related complications. The primary endpoint occurred in 18% (mortality: 9.8%; new PE: 8.3%; emergency surgery: 3.1%). Among those without baseline severe TR, worsening TR occurred in 16.9%. On univariate analysis, shock (OR: 2.27; 95% CI: 1.15-4.43; P = 0.03) and hypoxia (OR: 3.62; 95% CI: 1.83-7.17; P < 0.001) were significantly associated with the primary endpoint, whereas worsening TR was not. On multivariate analysis, hypoxia (OR: 2.76; 95% CI: 1.34-5.73; P = 0.006) remained significantly associated with the primary outcome. CONCLUSIONS:PMA of RSIE is feasible with high procedural success. Adverse events were acceptable and largely driven by underlying RSIE. Randomized trials are warranted to confirm the clinical impact and safety of PMA in RSIE.