Susanne Hadorn

External validity of a contemporaneous primary percutaneous coronary intervention trial in patients with acute ST-elevation myocardial infarction: insights from a single-centre investigation

AIMS Randomised controlled trials (RCTs) represent the most robust source of evidence-based medicine. However, the generalisability of RCTs is limited by the inclusion of selected populations. We sought to assess the external validity of a contemporary trial including patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). METHODS AND RESULTS Patients presenting to Bern University Hospital during the inclusion period of the COMFORTABLE AMI trial were divided into three groups: RCT participants (41%), eligible not included (17.5%), and excluded patients (41.5%). Major adverse cardiac events (MACE) were defined as one-year death and myocardial infarction. RCT participants compared with RCT-eligible patients had comparable baseline characteristics and outcomes; however, excluded patients differed in risk and had higher rates of MACE (HR 3.63, 95% CI: 2.03-6.48, p<0.001), death (HR 6.23, 95% CI: 2.93-13.24, p<0,001) and definite/probable stent thrombosis (HR 3.63, 95% CI: 1.79-7.36, p<0.001). Inability to provide consent was the most frequent exclusion criterion and was independently associated with an increased risk for MACE (HR 6.85, 95% CI: 3.97-11.81, p<0.001). CONCLUSIONS In this single-centre investigation, results from the COMFORTABLE AMI trial appeared applicable to a broad representation of RCT-eligible patients. However, patients excluded from the trial represented a higher-risk population with impaired clinical outcomes and a lower adherence to cardiovascular medication.

Rehospitalizations Following Primary Percutaneous Coronary Intervention in Patients With ST-Elevation Myocardial Infarction: Results From a Multi-Center Randomized Trial.

Background Rehospitalizations (RHs) after ST‐elevation myocardial infarction carry a high economic burden and may deteriorate quality of life. Characterizing patients at higher risk may allow the design of preventive measures. We studied the frequency, reasons, and predictors for unplanned cardiac and noncardiac RHs in ST‐elevation myocardial infarction patients undergoing primary percutaneous coronary intervention. Methods and Results In this post‐hoc analysis of the COMFORTABLE AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST‐Elevation Myocardial Infarction; NCT00962416) trial including 1137 patients, unplanned cardiac and noncardiac RHs occurred in 133 (11.7%) and in 79 patients (6.9%), respectively, at 1 year. The most frequent reasons for unplanned cardiac RHs were recurrent chest pain without evidence of ischemia (20.4%), recurrent chest pain with ischemia and coronary intervention (16.9%), and ischemic events (16.9%). Unplanned noncardiac RHs occurred most frequently attributed to bleeding (24.5%), infections (14.3%), and cancer (9.1%). On multivariate analysis, left ventricular ejection fraction (22% increase in the rate of RHs per 10% decrease; P=0.03) and angiographic myocardial infarction Syntax score (34% increase per 10‐point increase; P=0.01) were independent predictors of unplanned cardiac RHs. Age emerged as the only independent predictor of unplanned noncardiac RHs. Regional differences for unplanned cardiac RHs were observed. Conclusions Among ST‐elevation myocardial infarction patients undergoing primary percutaneous coronary intervention in the setting of a randomized, clinical trial, unplanned cardiac RHs occurred in 12% with recurrent chest pain being the foremost reason. Unplanned noncardiac RHs occurred in 7% with bleeding as the leading cause. Left ventricular ejection fraction and Syntax score were independent predictors of unplanned cardiac RHs and identified patient subgroups in need for improved secondary prevention. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00962416.

The big bad wolf’s view: The evaluation clients’ perspectives on independence of evaluations

The independence of evaluations has gained increasing attention in research. So far, research has mainly focused on evaluators’ experiences when confronted with pressure, leading to a restricted view of the complex context in which evaluations take place. Therefore, this article broadens the debate and follows the call by previous studies to pay attention to evaluation clients, which have been identified as the main influencing stakeholders within evaluation processes. The findings of an online survey among Swiss evaluation clients show that most clients have never been told by evaluators that they put the latter under pressure, even though previous studies found that half of the evaluators feel pressured. Nonetheless, clients frequently experience conflicts during evaluations that are often caused by a lack of a common understanding between evaluators and clients. Thus, we conclude that preventive measures are needed to increase the parties’ mutual comprehension, and ultimately, the quality of evaluation results.