Clinical characteristics and outcomes of percutaneous coronary intervention in octogenarians: real-world data from nationwide Thai PCI registry

Objective
Due to the growing ageing population worldwide, more percutaneous coronary interventions (PCI) are being performed on elderly patients; however, current national data in Southeast Asian developing countries regarding patient characteristics, procedural details and PCI outcomes in elderly patients are insufficient.

Design
Observational study.

Setting
Nationwide registry from 39 primary PCI facilities across Thailand.

Participants
Between May 2018 and August 2019, the Thai PCI registry enrolled a total of 22 741 patients who underwent PCI. We examined patient characteristics, PCI technique and in-hospital outcomes in octogenarians (≥80 years) and non-octogenarians (18–79 years).

Results
There were 2099 patients (9.2%) over the age of 80. Octogenarians were at greater risk for atherosclerosis and calcified coronary lesions that required plaque modification and a higher risk of cardiogenic shock during presentation than non-octogenarians. The success rate of PCI in octogenarians was high (95.5%) and comparable to non-octogenarians (96%). The respective PCI failure rate in non-octogenarians and octogenarians was 4% and 4.5% (p=0.251). Octogenarians had a substantially greater incidence of periprocedural problems (5.6% vs 4.5%, p=0.011). PCI was linked with more than threefold increase in in-hospital mortality in octogenarians compared with non-octogenarians (7.67% vs 2.3%, p 0.001). Nonetheless, revascularisation with PCI in octogenarians increased the EQ-5D (European Quality of Life 5 Dimensions) score by 15.7 after PCI and before hospital discharge.

Conclusions
According to the Thai PCI registry, octogenarians had more complicated coronary anatomy, as well as higher procedural complications and mortality than non-octogenarians. Nonetheless, PCI in the octogenarian had a high success rate and potentially improved the patient’s quality of life.

Leggi
Aprile 2025

Association Between Real-World Actigraphy and Poststroke Motor Recovery

Stroke, Ahead of Print. BACKGROUND:Stroke is a leading cause of long-term disability, but advances for rehabilitation have lagged those for acute treatment. Large biological studies (eg, omics) may offer mechanistic insights for recovery but require collecting detailed recovery phenotypes at scale, for example, in thousands of people with minimal burden for participants and researchers. This study investigates the concurrent validity between remotely collected wearable sensor data and in-clinic assessments of motor recovery poststroke.METHODS:Utilizing a large, harmonized multisite dataset of adults at various stages of recovery poststroke, we analyzed cross-sectional (N=198; from 0 to >52 weeks) and longitudinal (N=98; from 0 to 26 weeks) changes in the use ratio, the Action Research Arm Test, and the Fugl-Meyer Assessment upper extremity subscale. The use ratio is the ratio of the time the paretic arm is active divided by the time the nonparetic arm is active.RESULTS:Our findings indicate strong concurrent validity of the use ratio, the Action Research Arm Test, and the Fugl-Meyer Assessment upper extremity subscale both cross-sectionally (differences between people) and longitudinally (changes within a person), for example,r=0.87 (95% CI, 0.80–0.91) at 0 to 6 weeks, declining tor=0.58 (95% CI, 0.39–0.72) at ≥52 weeks for correlations between use ratio and Action Research Arm Test.CONCLUSIONS:Although the use ratio strongly correlated with the Fugl-Meyer Assessment upper extremity subscale and Action Research Arm Test early after stroke, these correlations reduced with longer elapsed time poststroke. This decreasing correlation might be explained by the increasing influence that personal and environmental factors play as recovery progresses.

Leggi
Aprile 2025

Safety surveillance of respiratory syncytial virus (RSV) vaccine among pregnant individuals: a real-world pharmacovigilance study using the Vaccine Adverse Event Reporting System

Objectives
To describe the post-marketing safety profile of respiratory syncytial virus prefusion F (RSVpreF) vaccine among pregnant individuals.

Design
This study analysed adverse event (AE) reports submitted to the U.S. Food and Drug Administration’s Vaccine Adverse Event Reporting System (VAERS) database following RSVpreF immunisation from 1 September 2023 to 23 February 2024.

Setting
VAERS, as a national spontaneous vaccine safety surveillance system, provides insights into the safety profile of the RSVpreF vaccine in a real-world setting.

Participants
Surveillance data included all AE reports submitted to VAERS in pregnant individuals following vaccination.

Exposure
Receipt of RSVpreF vaccine among pregnant individuals in the USA.

Primary and secondary outcome measures
Descriptive statistics were used to assess all AE reports with RSVpreF, including frequency, gestational age at vaccination, time to AE onset, reported outcomes and proportion of serious reports. Data mining techniques were employed to identify disproportionate reporting of RSVpreF-event pairs. Reports of preterm births were clinically reviewed.

Results
VAERS received 77 reports pertaining to RSVpreF vaccination in pregnant individuals, with 42 (54.55%) classified as serious. The most frequently reported non-pregnancy-specific AEs were headache, injection site erythema and injection site pain. For pregnancy-specific AEs, preterm birth was the most frequently reported (12.8%), followed by AE terms such as preterm premature rupture of membranes and caesarean section (each at 3.3%), and cervical dilatation, haemorrhage during pregnancy and uterine contractions during pregnancy (each at 1.4%). Our disproportionality analysis indicated signals for various AEs, particularly preterm birth, indicating that reports of preterm birth in conjunction with RSVpreF vaccination were observed more frequently than statistically expected. Most of the reported preterm births were moderate to late, occurring between 32 and less than 37 weeks of gestation. The median time from immunisation to the onset of preterm birth was 3 days, with two-thirds of cases reported within a week of vaccination.

Conclusions
The AEs reported to VAERS among pregnant individuals vaccinated with RSVpreF largely aligned with the safety profile observed in prelicensure studies; however, this analysis also highlights the previously observed safety signal for preterm birth. Active surveillance studies focusing on maternal and perinatal outcomes are needed to further evaluate this signal and guide future clinical recommendations.

Leggi
Aprile 2025

Outcomes of Transcatheter Aortic Valve Replacement in Low-Risk Patients in the United States: A Report From the STS/ACC TVT Registry

Circulation, Ahead of Print. BACKGROUND:Real-world low-risk transcatheter aortic valve replacement (TAVR) outcomes in the United States have not been assessed comprehensively versus pivotal trials, which is a key component of measuring the quality of clinical technology adoption.METHODS:We identified heart team–designated low-risk patients undergoing TAVR for trileaflet severe, symptomatic aortic stenosis in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Registry, as well as a subset of patients who met low-risk trial inclusion and exclusion criteria, from January 2020 to March 2024. Outcomes (mortality, stroke, new pacemaker, and “alive and well,” defined as alive at 1 year with Kansas City Cardiomyopathy Questionnaire score ≥60 and ≤10-point decrease from baseline) at 30 days and 1 year were assessed. Multivariable models were developed to assess predictors of death within 1 year after TAVR.RESULTS:Among 383 030 patients who underwent TAVR during the study period, 108 407 (28%) were designated low risk by the heart team, and 68 194 (18%) met other study inclusion and exclusion criteria. Of these, 62% (n=42 093) would have been eligible for the low-risk trials. In the overall heart team–designated low-risk population, 30-day outcomes included 0.8% mortality, 1.5% stroke, and 8.4% new permanent pacemaker requirement; 1-year outcomes included 4.6% mortality, 2.6% stroke, and 90% alive and well. In the trial-eligible population, 0.6% mortality, 1.4% stroke, and 8.0% new permanent pacemaker requirement had occurred by 30 days; values at 1 year included 3.1% mortality, 2.4% stroke, and 92% alive and well. Notable multivariable predictors of 1-year mortality were atrial fibrillation, nontransfemoral access, and lower baseline Kansas City Cardiomyopathy Questionnaire score.CONCLUSIONS:One-year outcomes among real-world trial-eligible patients are excellent, but adverse events are higher compared with published clinical trial data, likely because of greater comorbidity burden and lower baseline Kansas City Cardiomyopathy Questionnaire score. These data can help inform expected outcomes and health status after low-risk TAVR.

Leggi
Aprile 2025