No significant differences in outcomes were observed over time between patients in observational studies and those in landmark trials despite varying characteristics.
Do the baseline characteristics and outcomes of real-world patients undergoing transcatheter edge-to-edge repair for secondary MR differ from those enrolled in landmark trials?
Real-world patients undergoing transcatheter edge-to-edge repair for secondary MR have varying baseline characteristics compared to landmark trial populations, but achieve similar procedural success and 12-month mortality outcomes.
Absolute Event Rate: 0% vs 0%
BACKGROUND Observational studies reported characteristics and outcomes of patients with secondary mitral valve regurgitation (MR) who underwent transcatheter edge-to-edge repair of the mitral valve. No study investigated the temporal trend of patient characteristics and outcomes in comparison with the published randomized trials. AIM To investigate the temporal trend in baseline characteristics and outcomes of patients with secondary MR who underwent transcatheter edge-to-edge repair of the mitral valve in the real world compared with those from the published landmark trials. METHODS A comprehensive systematic literature search was conducted using MEDLINE, EMBASE, and CENTRAL databases, and the identified observational studies were divided into two five-year recruitment periods. The first period included 36 studies that enrolled patients between 2008 and 2012, and the second period included 25 studies that recruited patients between 2013 and 2017-2018. Pooled variables of each five-year recruitment period were compared with those of the landmark trials. A random-effects model was used for statistical comparisons. RStudio and RevMan software were used for the analysis. RESULTS Overall, there were no major variations in the findings between the first and the second five-year recruitment periods. EVEREST program vs observational studies: Patients in the EVEREST program were more likely to have non-ischemic MR etiology odds ratio (OR) = 3.59, 95% confidence interval (CI): 2.92-4.42 and atrial fibrillation (OR = 1.71, 95%CI: 1.42-2.06). They were less likely to receive angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (OR = 0.72, 95%CI: 0.58-0.90) and implantable cardiac device (OR = 0.41, 95%CI: 0.33-0.49) as well as less likely to be symptomatic at hospital presentation without a difference in MR grade ≤ 2+ or mortality at 12-month follow-up. COAPT trial vs observational studies: COAPT patients were more likely to have prior myocardial infarction (OR = 1.62, 95%CI: 1.27-2.06) and renal insufficiency (OR = 2.66, 95%CI: 2.05-3.45). They were more likely to receive beta-blockers (OR = 2.54, 95%CI: 1.68-3.85) and an implanted cardiac device (OR = 2.20, 95%CI: 1.71-2.84). There was no difference in procedure success or mortality. MITRA-FR trial vs observational studies: MITRA-FR patients were less likely to have atrial fibrillation (OR = 0.49, 95%CI: 0.34-0.69) and renal insufficiency (OR = 0.18, 95%CI: 0.11-0.28) but more likely to have a history of myocardial infarction (OR = 1.48, 95%CI: 1.06-2.05) and to receive diuretics (OR = 19.81, 95%CI: 2.75-142.48) and implantable cardiac devices (OR = 1.69, 95%CI: 1.21-2.37). At hospital presentation, they were less likely to be symptomatic (OR = 0.25, 95%CI: 0.18-0.35) without a difference in MR grades 3+ and 4+. There was no difference in terms of MR grade or mortality at 12-month follow-up. CONCLUSION Patients in the landmark studies may have favourable or unfavourable characteristics when compared to those in the observational studies, but this did not translate into different outcomes over time.
Kaddoura et al. (Wed,) reported a other. No significant differences in outcomes were observed over time between patients in observational studies and those in landmark trials despite varying characteristics.