Abstract
Background
The main potential benefits of participating in a clinical trial is to have access to a treatment that is not available yet and to have a regular and careful attention from physicians. Several data have suggested that inclusion in a research study was associated with better clinical outcome.
Aims
The aim of this study is to describe the prevalence of inclusions in a research study (i.e., device or medication), clinical characteristics, management and clinical outcome in patients admitted for acute myocardial infarction (AMI) according to participation in a research study (versus not) using data from the French registries of Acute ST-or non-ST-elevation Myocardial infarction (FAST-MI) 2010 and 2015.
Methods
We used data from 2 one-month French registries, conducted 5 years apart, including 9,414 AMI admitted to coronary or intensive care units. We analyzed baseline characteristics, management and one-year survival according to participation in a research study.
Results
From 2010 to 2015, the prevalence of patients included in a research study decreased from 6.8% to 3.6% (P<0.001). Inclusions were performed mainly in university hospitals (8%). Clinical characteristics according to participation in a research study were strongly different. Overall, patients included in a research study were younger (61.2±12.7 vs 65.7±14.1; P<0.001) with less previous medical history and co-morbidities. Clinical presentation was preferentially a ST-elevation myocardial infarction (STEMI: 70% vs 52%; P<0.001) in these patients who had a lower GRACE score (133±32 vs. 141±35; P<0.001). The use of invasive strategies was more used in patients included in a research study (coronary angiogram: 99% vs 95%, P<0.001) as prescriptions of recommended medications (i.e., antiplatelet agents, beta-blockers, angiotensin-converting-enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB) and statins) at discharge (72% vs 63%; P<0.001).
In a cox multivariate analysis, participation in a research study was not associated with lower mortality at one-year (HR= 0.68, 95% CI, 0.39–1.18, P=0.17). Similar results were observed in patients discharge alive (HR= 0.81, 95% CI, 0.44–1.48, P=0.49). Recommended medications were however more used in patients included in a clinical trial (OR=1.34; 95% CI, 1.09–1.65; P=0.007).
Conclusions
The number of inclusions in a research study related to AMI in France is low. Our data suggest that patients included in a research study are selected and received more recommended medications and invasive strategies. However, this management is not associated with a lower mortality at one-year.
Funding Acknowledgement
Type of funding source: None
Discussion of a well-designed clinical trial which did not demonstrate effectiveness: UIC center for botanical dietary supplements research study of black cohosh and red clover
