BACKGROUND:Coronary artery disease is common in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to assess whether deferral of percutaneous coronary intervention (PCI) is non-inferior to routine PCI before TAVI in patients with coronary artery disease. METHODS:In this investigator-initiated, open-label, randomised controlled trial, done at 12 hospitals in the Netherlands, TAVI patients with coronary artery disease were randomly assigned in a 1:1 ratio to deferral of PCI or PCI before TAVI. Randomisation was done by use of a web-based system with random block sizes of 2 and 4, and stratification by presence of coronary artery disease involving proximal left anterior descending artery. The primary endpoint was a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding at 1 year. Non-inferiority testing was done in the intention-to-treat population against the prespecified margin of 11 percentage points. The study is registered with ClinicalTrials.gov (NCT05078619) and long-term follow-up is ongoing. FINDINGS:Between Oct 7, 2021, and Nov 19, 2024, 466 patients were enrolled: 233 were assigned to deferral of PCI and 233 to PCI before TAVI. Median age was 81 years (IQR 78-84), and 166 (36%) of 466 patients were female. The primary endpoint occurred in 56 (24%) of 233 patients in the deferral group as compared with 60 (26%) of 233 patients in the PCI group (rate difference -1·7% [95% CI -9·5 to 6·2]; hazard ratio 0·89 [95% CI 0·62-1·28]; p=0·0008 for non-inferiority; p=0·68 for superiority). INTERPRETATION:In patients with coronary artery disease undergoing TAVI, deferral of PCI was non-inferior to PCI before TAVI for the 1-year composite of all-cause mortality, myocardial infarction, stroke, and major bleeding. These findings suggest that an initial conservative strategy can be appropriate in selected patients, although patient-tailored treatment decisions remain essential. FUNDING:ZonMw.
BACKGROUND:Hodgkin lymphoma (HL) survivors are at increased risk of late adverse events, eg, cardiovascular diseases (CVD), breast cancer (BC), hypothyroidism and severe infections. At Dutch BETER clinics, HL survivors are regularly screened for (risk factors for) these adverse events. The impact of survivorship care on the burden of disease from adverse outcomes has rarely been evaluated. METHODS:In a nationwide retrospective cohort study, we compared HL survivors invited for BETER care in 2013-2016 (intervention group) with matched survivors who were eligible for such care but were not invited until 2019-2024 (comparison group). Incidence and mortality rates for CVD, BC, hypothyroidism, and severe infections were collected from general practitioners and nationwide registries. Disability-adjusted life years (DALYs) attributable to late adverse events were compared using multivariable regression models. RESULTS:At study start, survivors in the intervention group (n = 491) and comparison group (n = 373) had a median age of 46 years; median time since HL diagnosis was 15-18 years. After 8.5 years (median), there were no significant differences in DALYs attributable to CVD, BC, hypothyroidism, and severe infections between the groups. In both groups, approximately one third of survivors acquired DALYs attributable to adverse events. Adherence to recommended screening diagnostics was high, but cardiovascular risk management and vaccination rates were suboptimal. CONCLUSION:After 8.5 years of follow-up, survivorship care for HL survivors was not associated with lower disease burden. Better care coordination, amendment of the cardiovascular risk management guidelines, and greater survivor involvement may improve long-term effectiveness of measures to prevent late adverse events.
BACKGROUND:Patients with incurable gastroesophageal adenocarcinoma have an impaired health-related quality of life (HRQOL). Exercise combined with nutritional support may improve this outcome. Careful evaluation of this supportive care strategy is needed to avoid burdening patients at this vulnerable stage with interventions that may offer no (meaningful) benefit. Therefore, this study aims to investigate the effects of a combined exercise and nutritional intervention on HRQOL in patients with incurable gastroesophageal adenocarcinoma. METHODS:RADICES (the effect of exeRcise And Diet on quality of life in patients with Incurable Cancer of Esophagus and Stomach) is a multicenter randomized controlled trial aiming to include 196 patients with incurable gastroesophageal adenocarcinoma. Participants are randomly assigned (1:1) to a patient-tailored intervention or a control group. The intervention group is provided with 2 training sessions per week and biweekly nutritional consultations, delivered by trained physiotherapists and dietitians, during 12 weeks. The control group receives usual care supplemented with general physical activity advice. The primary outcome is the difference in HRQOL between the intervention group and the control group at 12 weeks, accounting for baseline HRQOL, measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 summary score. HRQOL is assessed at baseline, 6 weeks, 12 weeks, and every 3 months thereafter up to 1 year. Key secondary outcomes include patient-reported outcomes, cardiorespiratory fitness, dietary intake, disease progression, overall survival, and cost-effectiveness. Adherence and safety are monitored throughout the intervention period. CONCLUSION:This study will generate evidence on the effectiveness of a patient-tailored combined exercise and nutritional intervention in patients with incurable gastroesophageal adenocarcinoma. If effective for HRQOL, this intervention could be integrated into standard care for patients with incurable gastroesophageal adenocarcinoma. TRIAL REGISTRATION:clinicaltrials.gov NCT06138223. Date of trial registration: November 18, 2023 Date and version study protocol: 28-04-2025 version 3.1 Date start recruitment: 19-01-2024.
