A Propensity-Adjusted Large-Scale Claims Dataset Analysis

[Posted 28/Dec/2022]

AUDIENCE: Cardiology, Emergency Medicine

KEY FINDINGS:

BACKGROUND: Impella was approved by the Food and Drug Administration in 2015 for use during high-risk percutaneous coronary interventions (PCIs); however, its safety and efficacy compared with intra-aortic balloon pump (IABP) has not been evaluated in contemporary practice and remains debated. Study was aimed to compare postapproval outcomes and costs of Impella versus IABP support for high-risk PCI in real-world practice across hospitals in the United States.

DETAILS: Patients were identified from the Premier Healthcare Database undergoing nonemergent Impella- or IABP-supported high-risk PCI. Used propensity adjustment to control baseline, procedure, and post-PCI medical treatment differences between treatment groups. Patients undergoing nonemergent single-PCI procedures with either Impella or IABP support were included and excluded patients presenting with acute ST-elevation myocardial infarction or cardiogenic shock or requiring >1 mechanical support devices during index hospitalization. Outcomes included in-hospital survival, myocardial infarction (MI), cardiogenic shock, stroke, bleeding requiring transfusion, acute kidney injury, index hospitalization length of stay, and costs. From April 2016 to June 2019, a total of 48,179 patients were treated with Impella or IABP mechanical circulatory support at 304 hospitals in the United States. Among these, we identified 2,156 patients undergoing nonemergent high-risk PCI treated with Impella (n = 1,447) or IABP (n = 709). After propensity adjustment, Impella use was associated with improved survival (odds ratio [OR] 1.55, 95% confidence interval [CI] 1.02 to 2.36) and less MI (OR 0.29, 95% CI 0.18 to 0.46) and cardiogenic shock (OR 0.54, 95% CI 0.39 to 0.74). Stroke, bleeding requiring transfusion, and acute kidney injury were similar between groups. In conclusion, this Premier Healthcare Database propensity-adjusted analysis, Impella use during nonemergent high-risk PCI was associated with improved survival and reduced in-hospital MI and cardiogenic shock compared with IABP.

Copyright © Elsevier Inc. All rights reserved.

Source: Lansky, A. J., Tirziu, D., Moses, J. W., et al. (2022). Impella Versus Intra-Aortic Balloon Pump for High-Risk PCI: A Propensity-Adjusted Large-Scale Claims Dataset Analysis. Am J Cardiol.. 2022; 145: 29-36. Published: December 15, 2022. DOI: 10.1016/j.amjcard.2022.08.032.

Rationale and Design of the OPTIMA-6 Trial.

[Posted 20/Nov/2023]

AUDIENCE: Cardiology, Emergency Medicine

KEY FINDINGS: OPTIMA-6 will reveal the efficacy and safety of a contemporary facilitated PCI with a bolus of half-dose r-SAK in combination with ticagrelor in patients with STEMI.

BACKGROUND: Time to reperfusion is the key to the treatment of patients with ST-elevation myocardial infarction (STEMI). It is uncertain whether adjunctive thrombolytic therapy combined with contemporary antiplatelet agent ticagrelor improves outcomes as administered prior to primary percutaneous coronary intervention (PCI) expected to be performed within 120 minutes.

DETAILS: OPTIMA-6 is a multicenter, randomized, double-blind, placebo-controlled, and superiority trial to evaluate the efficacy of a bolus of half-dose recombinant staphylokinase (r-SAK) vs placebo prior to timely primary PCI in patients with STEMI. Enrollment began in April 2023 and is expected to enroll 2,260 patients at approximately 50 centers. Patients with acute STEMI presenting <=12 hours of symptom onset and expected to undergo primary PCI within 120 minutes but more than 30 minutes are to be randomized to a bolus of half-dose r-SAK or placebo. All recruited patients will be mandatory to take aspirin and ticagrelor and receive a bolus of loading dose heparin before the thrombolytic therapy. The primary efficacy endpoint is major adverse cardiovascular events (MACE) within 90 days, and the MACE is defined as a composite of all-cause death, reinfarction, unplanned target vessel revascularization, heart failure or cardiogenic shock, and major ventricular arrhythmia. The primary safety endpoints are major bleeding events (BARC 3, 5) within 90 days.

Copyright © Elsevier Inc. All rights reserved.

Source: Li, C., Eikelboom, J. W., Zhong, Z., et al. (2023). Efficacy And Safety Of A Bolus Of Half-Dose r-SAK Prior To Primary PCI In ST-Elevation Myocardial Infarction: Rationale and Design of the OPTIMA-6 Trial. Am Heart J. 2023; 265: 31-39. Published: November, 2023. DOI: 10.1016/j.ahj.2023.06.012.

An Inverse Marker of Morbidity and Mortality in Patients With Myocardial Infarction

[Posted 27/Oct/2023]

AUDIENCE: Internal Medicine, Cardiology

KEY FINDINGS: Patients with the highest LDL-C levels at MI had the lowest incidence of mortality and morbidity. This seems to reflect lower age at MI, less underlying morbidities, paired with the modifiability of LDL-C. However, supporting the causal association between LDL-C and ischemic heart disease, elevated LDL-C was simultaneously associated with an increased risk of nonfatal MI.

BACKGROUND: The incidence of atherosclerotic cardiovascular disease increases with levels of low-density lipoprotein cholesterol (LDL-C). Yet, a paradox may exist where lower LDL-C levels at myocardial infarction (MI) are associated with poorer prognoses. Aim of this study is to assess the association between LDL-C levels at MI with risk factor burden and cause-specific outcomes.

DETAILS: Statin-naive patients hospitalized for a first MI and registered in SWEDEHEART were included. Data were linked to Swedish registers. Primary outcomes were all-cause mortality and nonfatal MI. Associations between LDL-C and outcomes were assessed using adjusted proportional hazards models. Among 63,168 patients (median age, 66 years), the median LDL-C level was 3.0 mmol/L (interquartile range 2.4-3.6). Patient age and comorbidities increased as LDL-C decreased. During a median follow-up of 4.5 years, 10,236 patients died, and 4973 had nonfatal MI. Patients with the highest LDL-C had a lower risk of mortality (hazard ratio [HR] 0.75; 95% confidence interval [CI] 0.71-0.80). The risk of hospitalization for pneumonia, hip fracture, chronic obstructive pulmonary disease, and new cancer diagnosis was lower with higher LDL-C (HR range, 0.40-0.81). Patients with the highest LDL-C had a greater risk of recurrent MI (HR 1.16; 95% CI 1.07-1.26).

Copyright © John Wiley & Sons, Inc. All rights reserved

Source: Schubert, J., Lindahl, B., Melhus, H., et al. (2023). Elevated Low-Density Lipoprotein Cholesterol: An Inverse Marker of Morbidity and Mortality in Patients With Myocardial Infarction. JIM. 2023; 294(5): 616-627. Published: November, 2023. DOI: 10.1111/joim.13656.

A Systematic Review and Meta-Analysis of Randomised Controlled Trials

[Posted 24/Oct/2023]

AUDIENCE: Nursing

KEY FINDINGS: Patients with heart failure benefit from home-based cardiac telerehabilitation intervention. With the rapid development of information and communication technology, home-based cardiac telerehabilitation has great potential and may be used as an adjunct or substitute for centre-based cardiac rehabilitation.

BACKGROUND: Purpose of this study is to evaluate the effectiveness of home-based cardiac telerehabilitation in patients with heart failure.

DETAILS: This systematic review and meta-analysis of randomised controlled trials were designed and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Two researchers independently screened eligible studies. The Cochrane Handbook for Systematic Reviews of Interventions was used to assess the risk of bias within the included studies. A fixed- or random-effects meta-analysis model was used to determine the mean difference, based on the results of the heterogeneity test. A total of 2291 studies were screened. The meta-analysis included data from 16 studies representing 4557 participants. The results indicated that home-based cardiac telerehabilitation could improve heart rate, VO2 peak, 6-minute walk distance, quality of life and reduce readmission rates. No significant differences were observed in the left ventricular ejection fraction percentages between the home-based cardiac telerehabilitation and usual care groups. Compared with centre-based cardiac rehabilitation, home-based cardiac telerehabilitation showed no significant improvement in outcome indicators.

Copyright © John Wiley & Sons Ltd. All rights reserved.

Source: Gao, Y., Wang, N., Zhang, L., et al. (2023). Effectiveness of Home-Based Cardiac Telerehabilitation in Patients With Heart Failure: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. J Clin Nurs. 2023; 32(21-22): 7661-7676. Published: October, 2023. DOI: 10.1111/jocn.16726.

[Posted 16/Oct/2023]

AUDIENCE: Cardiology, Emergency Medicine

KEY FINDINGS: CH is associated with worse heart function and prognosis in patients with HFpEF, and a murine experimental model of Tet2-mediated CH displays greater features of HFpEF.

BACKGROUND: Clonal hematopoiesis (CH), which results from an array of nonmalignant driver gene mutations, can lead to altered immune cell function and chronic disease, and has been associated with worse outcomes in patients with heart failure (HF) with reduced ejection fraction. However, the role of CH in the prognosis of HF with preserved ejection fraction (HFpEF) has been understudied. This study aimed to characterize CH in patients with HFpEF and elucidate its causal role in a murine model.

DETAILS: Using a panel of 20 candidate CH driver genes and a variant allele fraction cutoff of 0.5%, ultradeep error-corrected sequencing identified CH in a cohort of 81 patients with HFpEF (mean age, 71±6 years; ejection fraction, 63±5%) and 36 controls without a diagnosis of HFpEF (mean age, 74±7 years; ejection fraction, 61.5±8%). CH was also evaluated in a replication cohort of 59 individuals with HFpEF. Compared with controls, there was an enrichment of Tet2-mediated CH in the HFpEF patient cohort (12% versus 0%, respectively; P=0.02). In the HFpEF cohort, patients with CH exhibited exacerbated diastolic dysfunction in terms of E/e' (14.9 versus 11.7, respectively; P=0.0096) and E/A (1.69 versus 0.89, respectively; P=0.0206) compared with those without CH. The association of CH with exacerbated diastolic dysfunction was corroborated in a validation cohort of individuals with HFpEF. In accordance, patients with HFpEF, an age >=70 years, and CH exhibited worse prognosis in terms of 5-year cardiovascular-related hospitalization rate (hazard ratio, 5.06; P=0.042) compared with patients with HFpEF and an age >=70 years without CH. To investigate the causal role of CH in HFpEF, nonconditioned mice underwent adoptive transfer with Tet2-wild-type or Tet2-deficient bone marrow and were subsequently subjected to a high-fat diet/L-NAME (Nω-nitro-l-arginine methyl ester) combination treatment to induce features of HFpEF. This model of Tet2-CH exacerbated cardiac hypertrophy by heart weight/tibia length and cardiomyocyte size, diastolic dysfunction by E/e' and left ventricular end-diastolic pressure, and cardiac fibrosis compared with the Tet2-wild-type condition.

Copyright © American Heart Association, Inc. All rights reserved.

Source: Cochran, J. D., Yura, Y., Thel, M. C., et al. (2023). Clonal Hematopoiesis in Clinical and Experimental Heart Failure With Preserved Ejection Fraction. Circulation. Published: October, 2023. DOI: 10.1161/CIRCULATIONAHA.123.064170Circulation. 2023;148:1165-1178.

3-Year Follow-Up of the FAME 3 Trial

[Posted 20/Sep/2023]

AUDIENCE: Cardiology, Emergency Medicine

KEY FINDINGS: At 3-year follow-up, there was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI with current-generation drug-eluting stents compared with CABG. There was a higher incidence of MI after PCI compared with CABG, with no difference in death or stroke. These results provide contemporary data to allow improved shared decision-making between physicians and patients with 3-vessel coronary artery disease.

BACKGROUND: Previous studies comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel coronary disease not involving the left main have shown significantly lower rates of death, myocardial infarction (MI), or stroke after CABG. These studies did not routinely use current-generation drug-eluting stents or fractional flow reserve (FFR) to guide PCI.

DETAILS: FAME 3 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) is an investigator-initiated, multicenter, international, randomized trial involving patients with 3-vessel coronary artery disease (not involving the left main coronary artery) in 48 centers worldwide. Patients were randomly assigned to receive FFR-guided PCI using zotarolimus drug-eluting stents or CABG. The prespecified key secondary end point of the trial reported here is the 3-year incidence of the composite of death, MI, or stroke. A total of 1500 patients were randomized to FFR-guided PCI or CABG. Follow-up was achieved in >96% of patients in both groups. There was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI compared with CABG (12.0% versus 9.2%; hazard ratio [HR], 1.3 [95% CI, 0.98-1.83]; P=0.07). The rates of death (4.1% versus 3.9%; HR, 1.0 [95% CI, 0.6-1.7]; P=0.88) and stroke (1.6% versus 2.0%; HR, 0.8 [95% CI, 0.4-1.7]; P=0.56) were not different. MI occurred more frequently after PCI (7.0% versus 4.2%; HR, 1.7 [95% CI, 1.1-2.7]; P=0.02).

Copyright © American Heart Association, Inc. All rights reserved.

Source: Zimmermann, F. M., Ding, V., Pijls, N. H. J., et al. (2023). Fractional Flow Reserve-Guided PCI or Coronary Bypass Surgery for 3-Vessel Coronary Artery Disease: 3-Year Follow-Up of the FAME 3 Trial. Circulation. 2023; 148(12): 950-958. Published: September, 2023. DOI: 10.1161/CIRCULATIONAHA.123.065770.