POLESTAR Trial
Research type
Research Study
Full title
Project to look for early discharge in patients undergoing TAVI with ACURATE An International multi-center early discharge TAVI program
IRAS ID
301582
Contact name
David John Ryvet Hildick-Smith
Contact email
Sponsor organisation
Erasmus University Medical Center
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
This study is designed by the Erasmus University Medical Center in Rotterdam, the Netherlands and will include 250 participants from different countries around the world. The study is an international multi-center prospective observational study.
Patients with severe aortic stenosis and selected for transfemoral TAVI with the ACURATE valve and eligible for early discharge within 48 hours post TAVI can participate. This valve is produced by the company: Boston Scientific. The objective is to address safety and feasibility of an early discharge protocol in these patients and to investigate the experiences of patients after placement of this valve combined with a short hospital stay. Physical complaints and quality of life will be recorded.
Patients will receive the usual treatment for valvular disease and visit the hospital per standard of care.Summary of results
Early discharge (ED) within 48 hours after transcatheter aortic valve implantation (TAVI) seems feasible and safe. The POLESTAR study demonstrated good 30-day outcomes of ED after TAVI using the ACURATE valve, but also identified patients requiring prolonged hospitalization. Long-term outcomes of ED remain unknown.
Objectives: To determine the long-term impact of successful ED and prolonged hospitalization.
Methods: POLESTAR was a prospective, multicenter, observational trial enrolling patients deemed eligible for ED prior to transfemoral TAVI with ACURATE Neo/Neo2. One-year outcomes were determined and compared between those who achieved ED and those who did not. The primary endpoint was a landmark analysis of major adverse cardiovascular events (MACE), including all-cause mortality, stroke, myocardial infarction, and cardiac rehospitalization, occurring between 30 days and 1 year post-procedure.
Results: Among 252 patients from 15 sites in four countries, ED was achieved in 173 (69%) patients, while 78 (31%) required prolonged hospital stay (non-ED). One year survival was 97%. Landmark 30 day analysis showed MACE occurring in 4.7% of ED patients vs. 11.7% of non-ED patients at 1 year (HR 0.38[0.15–0.98] p=0.045). Rehospitalization was numerically lower in ED group (HR 0.56[0.27-1.19]; p=0.12). Kansas City Cardiomyopathy Questionnaire (KCCQ) scores improved significantly in the full cohort (18.5 improvement; 95%CI: 15.9-21.0, p<0.01), with no statistically significant difference between ED and non-ED cohorts (p for interaction=0.30).
Conclusions: An ED strategy after TAVI with ACURATE Neo can be safely adopted in selected patients without compromising longer-term outcomes or health-related quality of life. Patients not achieving ED experienced significantly more MACE after 30 days.REC name
London - Riverside Research Ethics Committee
REC reference
21/PR/1219
Date of REC Opinion
11 Oct 2021
REC opinion
Further Information Favourable Opinion