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

Spitzer, Ernest; Hadorn, Susanne; Zanchin, Thomas; Yamaji, Kyohei; Moschovitis, Aris; Pilgrim, Thomas; Stortecky, Stefan; Jüni, Peter; Heg, Dik; Windecker, Stephan; Räber, Lorenz (2016). External validity of a contemporaneous primary percutaneous coronary intervention trial in patients with acute ST-elevation myocardial infarction: insights from a single-centre investigation. EuroIntervention, 12(9), pp. 1135-1143. Europa Digital & Publishing 10.4244/EIJV12I9A185

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Yamaji, Kyohei; Moschovitis, Aris; Pilgrim, Thomas; Stortecky, Stefan; Heg, Dierik Hans; Windecker, Stephan and Räber, Lorenz

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

1774-024X

Publisher:

Europa Digital & Publishing

Language:

English

Submitter:

Judith Liniger

Date Deposited:

28 Nov 2016 15:41

Last Modified:

13 Jan 2017 11:47

Publisher DOI:

10.4244/EIJV12I9A185

PubMed ID:

27753599

BORIS DOI:

10.7892/boris.89640

URI:

https://boris.unibe.ch/id/eprint/89640

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