Cardiology and Therapy最新文献

Introduction: The PRECISE-DAPT score is a useful tool for predicting the risk of bleeding after percutaneous coronary intervention (PCI) requiring dual antiplatelet therapy. We aimed to validate the PRECISE-DAPT score as a mid-term mortality predictor in acute coronary syndrome (ACS).

Methods: All patients with ACS hospitalized between October 2018 and October 2023 were analyzed. Mortality data were acquired in cooperation with the Institute of Health Information and Statistics of the Czech Republic. We used a standard PRECISE-DAPT threshold ≥ 25. A receiver operating characteristic (ROC) curve analysis was used to assess the predictive performance of the PRECISE-DAPT score for mortality with a mean follow-up of 1.9 years. Area under the curve (AUC) was calculated for each ACS subtype and different antithrombotic strategy regimes at discharge to quantify discrimination ability, with higher values indicating better prediction.

Results: We included 2953 patients with ACS. There were mostly men (69.1%, n = 2040), 37.1% ST-elevation myocardial infarction (STEMI, n = 1095), 45.2% non-ST-elevation myocardial infarction (NSTEMI, n = 1336) and 17.7% unstable angina pectoris (UAP, n = 522) patients. The mean age was 67.4 (SD 12.5) years. There were 78.4% patients treated by PCI (n = 2314). The PRECISE-DAPT score best predicts mortality in STEMI, AUC = 0.84 (95% confidence interval [CI] from 0.82 to 0.87), while its predictive ability is lower for NSTEMI, 0.78 (95% CI from 0.76 to 0.80) and UAP 0.75 (95% CI from 0.71 to 0.79). Antithrombotic treatment strategy at discharge does not influence the predictive ability of the PRECISE-DAPT score (AUC = 0.78, 071 and 0.72 for dual antiplatelet therapy, dual antithrombotic therapy, and triple therapy, respectively), p = 0.61.

Conclusions: The PRECISE-DAPT score may be used for predicting mid-term all-cause mortality in acute coronary syndrome, with the best predictive ability in STEMI. The standard threshold ≥ 25 maintain acceptable prognostic performance regardless of antithrombotic treatment strategy at discharge.

Introduction: Patients with heart failure with reduced ejection fraction (HFrEF) experience higher rates of in-hospital and all-cause mortality. On the basis of the VERINA trial, vericiguat is indicated for patients who have had a worsening heart failure (WHF) event despite optimal heart failure (HF) therapy, or for those with tolerability concerns.

Methods: This multicenter, prospective, single-arm, non-randomized, real-world, descriptive study assessed the efficacy and safety of vericiguat in Indian patients aged ≥18 years with chronic HFrEF who were vericiguat-naïve and started treatment as per the local label. This analysis is based on interim data and the final results may differ. The main endpoint was a composite of cardiovascular (CV) death or first HF hospitalization. Secondary endpoints included each component of the primary outcome, all-cause death, and safety. Dose-titration parameters, including time to reach and duration at various dose levels, were also assessed.

Results: A total of 205 patients were enrolled (58.0 ± 13.27 years; 73.7% male; 34.1% aged ≥ 65 years, baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP) 2490.1 pg/mL). Left ventricular ejection fraction (LVEF) < 30% was observed in 48.8% patients, 24.9% were in New York Heart Association (NYHA) class III. WHF events included recent HF hospitalization within < 7 days (10.7%) or 7 days-3 months (30.2%). Common background therapies included β-blockers (84.9%), mineralocorticoids receptor antagonist (MRAs) (80.5%), sodium-glucose cotransporter 2 (SGLT2) inhibitors (75.6%), and angiotensin receptor-neprilysin inhibitor (ARNI) (52.7%), with 66.3% receiving triple HF therapy. Vericiguat target dose (10 mg) was achieved by 91.1% of patients.

Conclusion: This study enrolled high-risk patients with recent decompensation event consistent with the VICTORIA trial. The usage of standard of care (SoC) was as per current clinical practice in HF; VERINA enrolled 52.7% on ARNI compared to 14.5% in VICTORIA and 75.6% on SGLT2i compared to 2% in VICTORIA. Safety data did not reveal any new safety signals or adverse trends in the interim analysis.

Trial registration: Clinical Trials Registry of India (CTRI/2022/11/047636).

Introduction: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive, often fatal disease. Tafamidis demonstrated efficacy in ATTR-CM clinical trials; however, real-world disease outcomes are not thoroughly characterized. We examined real-world outcomes among patients with wild-type (ATTRwt-CM) and variant (ATTRv-CM) ATTR-CM treated with tafamidis, the only approved treatment at the time of the study.

Methods: This retrospective observational study analyzed Komodo Healthcare Map® data (1/1/2016‒6/30/2024) for tafamidis-treated patients with ATTR-CM. Outcomes included all-cause hospitalization, cardiovascular-related hospitalization (CVH), heart failure (HF)-related hospitalization, outpatient worsening HF (OWHF) with oral diuretic intensification, and mortality. Subgroup analyses examined outcomes by ATTR-CM type and N-terminal pro-B-type natriuretic peptide (NT-proBNP)/B-type natriuretic peptide (BNP) baseline levels.

Results: Among 3239 tafamidis-treated patients (mean age 77.2 years; 75.9% male; 83.0% ATTRwt-CM; 11.7% ATTRv-CM), the cumulative incidence of first all-cause hospitalization was 22% at 6 months and 36% at 12 months, and that of first CVH was 22% and 35%, respectively. Median time to first CVH was 699 days. The cumulative incidence of OWHF with oral diuretic intensification was 22% at 6 months and 33% at 12 months. Mortality was 12.0% over the 5-year follow-up, and 6.2% at 12 months. The cumulative incidence of the composite endpoint (CVH, OWHF, or death) was 37% within 6 months and 53% within 12 months. In the subgroup with NT-proBNP/BNP baseline measurements (n = 412), patients with high NT-proBNP (> 3000 pg/mL, or BNP > 600 pg/mL) had worse outcomes, including a higher cumulative incidence of first CVH (51% vs. 27%) and higher mortality (9.7% vs. 4.1%) at 12 months.

Conclusions: In this large real-world cohort of tafamidis-treated patients, the cumulative incidences of hospitalization and worsening HF were substantial regardless of ATTR-CM subtype. Elevated NT-proBNP/BNP at baseline was associated with worse outcomes. These findings characterize the burden of disease outcomes in tafamidis-treated patients and underscore ongoing unmet needs in ATTR-CM management.

Introduction: The Burden of Disease survey characterized the humanistic burden of transthyretin amyloid cardiomyopathy (ATTR-CM) in 208 international patients not receiving disease-modifying therapy and their primary caregivers.

Methods: Post hoc univariate analyses evaluated the relationships between patients' current symptoms and ability to complete activities of daily living (ADLs) with their caregivers' Zarit Burden Interview (ZBI), Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue, and Hospital Anxiety and Depression Survey Anxiety (HADS-A) and Depression (HADS-D) subscale scores.

Results: Most patients had wild-type ATTR-CM (91%; n = 141/155) and a New York Heart Association functional classification of I/II (78%; n = 156/199). Caregivers (n = 208) were a median age of 68 years, 85% were female, and 66% lived with the patient. Current patient symptoms of paralysis, heart failure, weakness (especially in the legs), leg pain, leg and ankle swelling, loss of sensation in the legs/arms, fatigue, insomnia, and weight loss were associated with a significantly (P < 0.05) higher caregiver ZBI score. Many of these symptoms were also associated with significantly (P < 0.05) higher PROMIS Fatigue and HADS-A scores; heart failure and weakness (especially in the legs) were associated with a significantly (P < 0.05) higher HADS-D score. Inability of patients to independently clean, bathe, cook, get in/out of bed, or walk were associated with significantly (P < 0.05) higher caregiver ZBI and HADS-D scores. Inability to independently clean and walk were associated with significantly (P < 0.05) higher PROMIS Fatigue and HADS-A scores.

Conclusions: Burden is higher in caregivers of patients with ATTR-CM who have specific symptoms (including those causing disability) or an inability to independently complete ADLs. Graphical Abstract available for this article.

Introduction: Prior trials evaluating the benefit of colchicine in patients with acute coronary syndrome (ACS) have yielded mixed results. Hence, we conducted a meta-analysis of randomized controlled trials (RCTs) to evaluate the role of colchicine after ACS.

Methods: We performed an electronic search of MEDLINE, Embase, and Cochrane databases through November 2024 for studies comparing colchicine with placebo after ACS. Our study's primary outcome was major adverse cardiac events (MACE).

Results: Our final analysis included five RCTs with 12,979 patients with a mean follow-up of 26.6 months. The weighted mean age was 59.8 years. Colchicine was associated with a modest reduction of MACE with marginal significance and high heterogeneity (7.3% vs. 8.3%; relative risk [RR] 0.73; 95% confidence interval [CI] 0.54-0.99; I² = 68%) compared with placebo. This benefit was inconsistent after excluding the study with higher heterogeneity. There was no significant difference between colchicine and placebo in all-cause mortality (3.4% vs. 3.5%; RR 1.04; 95% CI 0.71-1.53; I² = 43%), cardiac mortality (2.2% vs. 2.2%; RR 1.02; 95% CI 0.81-1.29; I² = 0), myocardial infarction (MI) (3.1% vs. 3.6%; RR 0.82; 95% CI 0.61-1.11; I² = 35%), ischemia-driven repeat revascularization (4.3% vs. 4.6%; RR 0.75; 95% CI 0.37-1.50; I² = 54%), and stroke (0.9% vs. 1.1%; RR 0.51; 95% CI 0.18-1.44; I² = 68%). Colchicine had a higher risk of gastrointestinal (GI) side effects (11.7% vs. 8.6%; RR 1.36; 95% CI 1.07-1.71; I² = 67%) compared with placebo.

Conclusions: Among patients with ACS, colchicine may modestly reduce the incidence of MACE compared with placebo, but this effect is not robust after excluding the study with a higher risk of bias. In addition, no significant benefits were observed for the main individual outcomes of MACE, including all-cause mortality, cardiac mortality, MI, ischemia-driven repeat revascularization and stroke. Yet, colchicine was associated with a higher risk of GI side effects.

Introduction: High-risk percutaneous coronary intervention (HR-PCI) involves patients with complex coronary disease, adverse hemodynamics, and/or severe comorbidities who are often ineligible for surgery. Mechanical circulatory support (MCS) may reduce procedural risk and facilitate complete revascularization. However, comparative data on outcomes and left ventricular ejection fraction (LVEF) recovery are limited. We hypothesized that the benefits of MCS-supported PCI observed in prior studies would extend to contemporary, real-world, non-protocolized all-comer datasets, where outcomes and LVEF recovery in patients undergoing non-emergent Impella- or intra-aortic balloon counterpulsation (IABP)-supported HR-PCI can be evaluated.

Methods: We synthesized an MCS-specific cohort using de-identified electronic health record data (2017-2025). Adults undergoing non-emergent HR-PCI supported with cardiac unloading via a continuous, forward high-flow pump (Impella) or IABP were included. Admissions with emergent status, right heart failure, cardiogenic shock, or ST-elevation myocardial infarction, or those undergoing coronary artery bypass grafting, were excluded. Propensity score matching (1:1) adjusting for baseline differences was performed. Outcomes included all-cause mortality (7, 30, and 90 days) and 30-day, medical code-derived (cd) adverse events (acute kidney injury [cd-AKI] and cd-bleeding requiring transfusion). LVEF change within 1 year was assessed in a predefined subgroup.

Results: Before matching, patients supported with Impella had more comorbidities, lower baseline LVEF, and more complex procedural characteristics than IABP-supported patients. After matching, baseline characteristics were balanced. Impella was associated with lower all-cause mortality at 30 days (12.7% vs. 16.6%) and 90 days (15.2% vs. 19.6%), and reduced cd-AKI (15.7% vs. 20.3%). In patients matched for baseline LVEF values and collection timing, both groups demonstrated LVEF improvement (+ 7% for Impella; + 3% for IABP).

Conclusion: In contemporary, non-protocolized, non-emergent HR-PCI, the use of Impella was associated with improved outcomes and greater LVEF recovery compared to IABP.

Introduction: There is a well-known correlation between lower socioeconomic status and health outcomes. Patient zip codes and the Centers for Disease Control and Prevention's (CDC) Social Vulnerability Index (SVI) can be surrogates for income and socioeconomic status to compare outcomes following transcatheter aortic valve replacement (TAVR).

Methods: We performed a retrospective study among patients who underwent TAVR at the University of Illinois at Chicago (UIC) in Chicago, Illinois, between March 2018 and June 2023. Using income data from the Census Bureau and the SVI, we assigned patients to two income groups: lower (LIG) or higher (HIG). Primary outcomes were composite major adverse cardiac events (MACE) (consisting of cardiovascular death, myocardial infarction, or cerebrovascular accident) and all-cause death. Secondary outcomes included congestive heart failure exacerbations and major bleeding events. Outcomes were analyzed at 30 days, 6 months, and 12 months.

Results: We analyzed 276 patients; the LIG comprised 222 (80%) of these patients. No significant differences between groups were found in the primary or secondary outcomes post-TAVR at the 6- or 12-month interval. There were significant differences in SVI between those experiencing bleeding events at 12 months. There were no differences in primary outcomes between racial groups in a subanalysis.

Conclusion: Following TAVR, patients in the LIG and HIG had no differences in adverse events at 6 and 12 months post-TAVR. Patients in regions with higher SVI (more vulnerable regions) had higher periprocedural bleeding events.

Introduction: Anticoagulation is a well-established treatment for patients with atrial fibrillation (AF) for the prevention of stroke/systemic embolism (SE). However, although nearly all elderly patients with AF are at risk for thrombotic events, they also have a heightened risk of bleeding, and evidence regarding the optimal anticoagulation regimen in very elderly patients remains limited. This study aimed to evaluate the safety and effectiveness of apixaban versus warfarin in a cohort of very elderly patients with AF in Japan.

Methods: This was a retrospective analysis of administrative claims for patients with AF newly initiated on apixaban or warfarin from acute care hospitals. Clinical and demographic characteristics were balanced between cohorts using an inverse probability of treatment weighting with stabilized weights (s-IPTW) method. Prespecified subgroup analyses were also conducted to assess treatment interaction with some baseline/demographic factors.

Results: A total of 77,814 eligible patients with AF were balanced between the apixaban group (N = 33,834) and warfarin group (N = 43,671) using s-IPTW. The incidence of stroke/SE-primary effectiveness outcome-was 55.8 and 75.2 per 1000 person-years and that of major bleeding-primary safety outcome-was 17.3 and 25.3 per 1000 person-years in the apixaban and warfarin groups, respectively. Apixaban was associated with a significantly lower risk of stroke/SE (hazard ratio [HR], 0.75; 95% confidence interval [CI] [0.71-0.80], P < 0.001) and major bleeding (HR, 0.69; 95% CI [0.62-0.76], P < 0.001). Consistent trends were observed across all prespecified secondary outcomes. Additionally, there was no evidence of interaction between treatment and the variables examined, such as age, number of medications, Charlson Comorbidity Index, and activities of daily living.

Conclusions: In very elderly patients with AF, apixaban was associated with a significantly lower risk of stroke/SE and bleeding compared with warfarin.

Trial registration: ClinicalTrials.gov identifier NCT05438888.

Introduction: Cardiovascular trials often underrepresent non-White participants, women, and older individuals.

Methods: We evaluated the impact of digital recruitment on improving diversity in two large prospective cardiovascular studies: the Apple Heart Study (AHS) and the Project Baseline Health Study (PBHS). While both leveraged digital tools, their strategies differed-AHS used a passive, app-based approach followed by a direct-to-participant outreach effort, while PBHS implemented an enrollment model to reach a prespecified diversity goal.

Results: While both methods led to a cohort of participants who were comparably aligned with the US Census, we found that intentional, goal-driven digital outreach, and participant selection targeting demographic representation improved inclusion of historically underrepresented groups.

Conclusions: These findings suggest that digital tools, when paired with intentional strategy, may help support more inclusive, representative cardiovascular research.

Hypertension remains a leading global health challenge, affecting over 1.3 billion individuals worldwide and contributing significantly to cardiovascular morbidity and mortality. In recent years, interventional device-based therapies have emerged as promising adjuncts by targeting sympathetic overactivity and autonomic dysregulation, key mechanisms in the pathogenesis of hypertension. Currently, the use of these interventional therapies is primarily reserved for patients with resistant hypertension (RH) who remain uncontrolled despite optimal medical therapy. This review provides an overview of the evolving landscape of interventional approaches, including renal denervation (RDN), baroreceptor activation therapy (BAT), carotid body modulation, hepatic denervation, and cardiac neuromodulation. Among these, RDN has the most robust clinical trial evidence, while other neuromodulatory strategies are being evaluated in early-phase studies. Additionally, this review underscores the importance of systematically identifying and managing secondary causes of hypertension, such as primary aldosteronism, renovascular disease, and obstructive sleep apnea, before considering procedural interventions. As the field advances, these therapies may assume a more prominent role in precision-based hypertension management.