Daily Cardiology Research Analysis
Analyzed 254 papers and selected 3 impactful papers.
Summary
Analyzed 254 papers and selected 3 impactful articles.
Selected Articles
1. Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation.
In a 3000-patient international randomized trial of AF patients eligible for anticoagulation, device-based left atrial appendage closure was noninferior to NOACs for a 3-year composite of cardiovascular death, stroke, or systemic embolism and superior in reducing non–procedure-related bleeding.
Impact: This trial expands the potential indication for LAA closure beyond contraindication to anticoagulation, directly comparing it to NOAC therapy in eligible patients.
Clinical Implications: LAA closure can be considered a mainstream alternative to NOACs in AF patients suitable for anticoagulation, particularly for those at high bleeding risk, provided centers have procedural expertise and patients accept device-related procedural risk.
Key Findings
- LAA closure was noninferior to NOACs for the 3-year composite of cardiovascular death, stroke, or systemic embolism.
- Non–procedure-related bleeding was significantly lower with LAA closure than with NOAC therapy.
- Large, international randomized comparison in AF patients eligible for anticoagulation.
Methodological Strengths
- Large international randomized design with 3000 participants
- Prospectively defined noninferiority and superiority endpoints with blinded adjudication
Limitations
- Device-specific findings may not generalize to all LAAO systems
- Procedure-related risks and learning curve may affect real-world outcomes
Future Directions: Cost-effectiveness analyses, subgroup assessments (e.g., high bleeding risk, prior ICH), and long-term device safety including late leaks and thrombus will inform guideline updates and patient selection.
BACKGROUND: For patients with atrial fibrillation, the use of oral anticoagulant therapy to prevent stroke is limited by the risk of bleeding. Left atrial appendage closure is considered for patients who are unsuitable candidates for long-term anticoagulation, but its role in patients who are eligible for anticoagulants has not been established. METHODS: In this ongoing, prospective, international, randomized trial involving patients with atrial fibrillation who were suitable candidates for anticoagulation, we randomly assigned patients in a 1:1 ratio to receive either device-based left atrial appendage closure (device group) or non-vitamin K antagonist oral anticoagulant (NOAC) therapy (anticoagulation group). The primary efficacy end point - a composite of death from cardiovascular causes, stroke, or systemic embolism - was tested for noninferiority (noninferiority margin, 4.8 percentage points) after 3 years of follow-up. The primary safety end point, non-procedure-related bleeding, was tested for superiority. RESULTS: Of the 3000 patients who underwent randomization, 1499 were assigned to the device group and 1501 to the anticoagulation group. The mean (±SD) age of the patients was 71.7±7.5 years, 31.9% of the patients were women, and the mean CHA
2. Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for Acute Pulmonary Embolism.
Among 544 patients with intermediate-risk acute PE, ultrasound-facilitated catheter-directed fibrinolysis plus anticoagulation reduced 7-day PE-related clinical deterioration compared with anticoagulation alone, without an increase in intracranial hemorrhage; major bleeding rates were numerically higher but not statistically different.
Impact: Provides the first robust outcome data supporting catheter-directed therapy to prevent early decompensation in intermediate-risk PE, informing treatment pathways beyond anticoagulation alone.
Clinical Implications: In centers with expertise, ultrasound-assisted catheter-directed lysis may be considered for intermediate-risk PE patients with signs of cardiopulmonary compromise, balancing early benefit against bleeding risk and patient comorbidities.
Key Findings
- Primary 7-day composite outcome was reduced from 10.3% to 4.0% (RR 0.39) with catheter-directed lysis.
- Reduction driven by less cardiopulmonary decompensation/collapse; no intracranial hemorrhage observed.
- Major bleeding was numerically higher but not significantly different at 7 and 30 days.
Methodological Strengths
- Multinational randomized adaptive design with blinded outcome adjudication
- Clear physiologic enrichment (RV/LV ratio ≥1.0 and elevated troponin) and protocolized intervention
Limitations
- Primary endpoint focused on short-term (7-day) events; long-term mortality and functional outcomes not assessed
- Generalizability may depend on center experience and device availability
Future Directions: Evaluate long-term outcomes, quality of life, right ventricular recovery, and cost-effectiveness; identify subgroups with greatest net benefit and refine dosing/technique.
BACKGROUND: Whether anticoagulation alone is an adequate treatment for acute, intermediate-risk pulmonary embolism is uncertain. METHODS: We conducted a multinational, adaptive-design trial with blinded outcome adjudication. Patients with intermediate-risk pulmonary embolism (with a ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter of ≥1.0 and an elevated troponin level) were eligible if they had at least two indicators of cardiorespiratory distress (systolic blood pressure of ≤110 mm Hg, a heart rate of ≥100 beats per minute, or a respiratory rate of >20 breaths per minute). Patients were randomly assigned to undergo ultrasound-facilitated, catheter-directed fibrinolysis with alteplase plus anticoagulation (the intervention group) or anticoagulation alone (the control group) according to prespecified treatment protocols. The primary outcome was a composite of pulmonary embolism-related death, cardiorespiratory decompensation or collapse, or symptomatic recurrence of pulmonary embolism within 7 days. RESULTS: The intention-to-treat population comprised 544 patients: 273 in the intervention group and 271 in the control group. The mean (±SD) age was 58.2±13.5 years, and 42.6% of the patients were women. A primary-outcome event occurred in 11 patients (4.0%; 95% confidence interval [CI], 2.3 to 7.1) in the intervention group and 28 (10.3%; 95% CI, 7.2 to 14.5) in the control group (relative risk, 0.39; 95% CI, 0.20 to 0.77; P = 0.005). The effect was driven primarily by a lower risk of cardiorespiratory decompensation or collapse in the intervention group. Major bleeding occurred within 7 days after randomization in 11 patients (4.1%) in the intervention group and 6 (2.2%) in the control group (P = 0.32); major bleeding occurred within 30 days in 11 patients (4.1%) and 8 patients (3.0%), respectively (P = 0.64). No substantial between-group differences in the incidence of other serious adverse events were observed up to 30 days after randomization; no intracranial hemorrhage occurred. CONCLUSIONS: In patients with acute, intermediate-risk pulmonary embolism, ultrasound-facilitated, catheter-directed fibrinolysis plus anticoagulation led to a lower risk of the composite of pulmonary embolism-related death, cardiopulmonary decompensation or collapse, or symptomatic recurrence of pulmonary embolism within 7 days than anticoagulation alone. (Funded by Boston Scientific; HI-PEITHO ClinicalTrials.gov number, NCT04790370.).
3. Angiography-Derived Fractional Flow Reserve to Guide PCI.
In 1930 patients with intermediate coronary stenoses, angiography-derived FFR (FFRangio) was noninferior to pressure-wire–based FFR at 1 year for death, MI, or unplanned revascularization, with similar safety. This supports wire-free physiology to guide PCI without compromising outcomes.
Impact: Demonstrates that image-derived physiology can replace wire-based FFR for guiding PCI decisions, potentially increasing adoption of physiology-guided revascularization.
Clinical Implications: Catheterization laboratories can streamline procedures and avoid hyperemia/pressure wires by adopting validated angiography-derived FFR, provided image quality and workflow are optimized and teams are trained.
Key Findings
- FFRangio was noninferior to pressure-wire FFR for 1-year composite of death, MI, or unplanned revascularization.
- No differences in bleeding, acute kidney injury, or procedural adverse events between strategies.
- Randomized, international noninferiority design with 1930 patients supports wire-free physiology.
Methodological Strengths
- Large, international randomized noninferiority trial with hard clinical endpoints
- Balanced arms and rigorous statistical margins for noninferiority
Limitations
- Open-label design; performance may depend on angiographic image quality and operator workflow
- Follow-up limited to 1 year; longer-term outcomes and cost-effectiveness pending
Future Directions: Implementation studies on workflow integration, site training, cost-effectiveness, and head-to-head comparisons among different angiography-derived physiology algorithms.
BACKGROUND: Assessing intermediate coronary lesions with an intracoronary pressure wire improves clinical outcomes in patients undergoing cardiac catheterization and percutaneous coronary intervention (PCI). However, clinical use of pressure-wire-based physiological assessment remains low. Measurement of fractional flow reserve (FFR) derived from coronary angiographic images alone correlates well with pressure-wire-based FFR measurements and may simplify procedures, but its effect on clinical outcomes is unknown. METHODS: In this international noninferiority trial, we randomly assigned patients undergoing coronary angiography who were found to have at least one intermediate coronary stenosis to physiological assessment with measurements derived from angiographic images (FFRangio) or with pressure-wire-based measurements. The primary end point was a composite of death, myocardial infarction, or unplanned, clinically indicated coronary revascularization at 1 year. The noninferiority margin was 3.5 percentage points. RESULTS: A total of 1930 patients were randomly assigned to physiological assessment with FFRangio (FFRangio group; 965 patients) or a pressure-wire-based approach (pressure-wire group; 965 patients). The mean age of the patients was 68.4 years, and 25.0% of the patients were women. At 1 year, a primary end-point event had occurred in 64 patients (Kaplan-Meier estimate, 6.9%) in the FFRangio group and 65 patients (Kaplan-Meier estimate, 7.1%) in the pressure-wire group (hazard ratio, 0.98; 95% confidence interval, 0.70 to 1.39; difference, -0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval, 2.1 percentage points; P<0.001 for noninferiority). There were no apparent differences between the groups with respect to the incidence of bleeding, acute kidney injury, or procedure-related adverse events. CONCLUSIONS: Among patients with intermediate coronary-artery lesions undergoing physiological assessment in the cardiac catheterization laboratory, an angiography-guided strategy involving FFRangio was noninferior to a pressure-wire-guided strategy with respect to a composite end point of death, myocardial infarction, or unplanned clinically indicated coronary revascularization at 1 year. (Funded by CathWorks; ALL-RISE ClinicalTrials.gov number, NCT05893498.).