---
title: "Registry vs Adjudicated Cardiovascular Events in BETAMI‑DANBLOCK: Validation of National Registry"
id: "pubmed-41934630"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-41934630"
content_type: "clinical_feed_article"
specialty: "Cardiology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/41934630/"
doi: "10.1093/ehjqcco/qcag055"
published_at: "2026-09-16T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Registry vs Adjudicated Cardiovascular Events in BETAMI‑DANBLOCK: Validation of National Registry
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-41934630
- **Specialty:** [Cardiology](https://medichelpline.com/clinical-feed/cardiology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/41934630/)
- **DOI:** [10.1093/ehjqcco/qcag055](https://doi.org/10.1093%2Fehjqcco%2Fqcag055)
- **Published At:** 2026-09-16T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- Registry-based randomized trials can improve feasibility and data capture but risk bias from misclassification or missing information. The BETAMI‑DANBLOCK trial evaluated this issue in patients post‑myocardial infarction without heart failure. - In BETAMI‑DANBLOCK, 5,574 patients were randomized to **beta-blocker** therapy or no beta-blocker. Primary endpoints included all‑cause mortality, recurrent **myocardial infarction**, ischemic stroke, heart failure, unplanned coronary revascularization, and malignant ventricular arrhythmias. - Primary endpoint events were identified through Danish and Norwegian national **registries**, self‑reported questionnaires, and medical records. All registry-identified events except all‑cause mortality underwent blinded **adjudication**. - National registries captured 99.7% of primary endpoint events that were recorded by self‑report and medical records, indicating very high registry completeness for event capture. - Of registry-identified primary endpoint events, 75% were confirmed after adjudication, corresponding to a change from an incidence rate of 6.23 to 4.43 per 100 person‑years after adjudication. - Confirmation rates varied by time and event type: confirmation was lower during the first 6 months and ranged from 92% for ischemic stroke down to 45% for unplanned coronary revascularizations and heart failure, indicating event‑specific misclassification. - Treatment effect estimates for the composite primary endpoint were consistent whether derived from non‑adjudicated registry data (HR 0.88, 95% CI 0.78–0.98) or adjudicated events (HR 0.85, 95% CI 0.75–0.98), although differences existed for heart failure and revascularization outcomes. - The study concludes that registry data yielded comparable effect estimates to adjudicated data for the primary endpoint, but adjudication substantially reduced event counts and revealed misclassification, particularly early after the index MI. - Trial registration numbers reported were NCT03646357 and NCT03778554. The authors note registry benefits and the remaining role for adjudication to address event misclassification.
## Clinical Analysis & Structured Key Points
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more resources ](https://pubmed.ncbi.nlm.nih.gov/41934630/#linkout) Title & authors Abstract Conflict of interest statement Similar articles Publication types MeSH terms Substances Associated data Related information Grants and funding LinkOut - more resources Randomized Controlled Trial Eur Heart J Qual Care Clin Outcomes Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Eur+Heart+J+Qual+Care+Clin+Outcomes%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Eur+Heart+J+Qual+Care+Clin+Outcomes%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/41934630/) . 2026 Sep 16;12(6):903-911. doi: 10.1093/ehjqcco/qcag055. # Validating national registry data for randomized trials: comparison of registry-derived cardiovascular events with and without adjudication in the BETAMI-DANBLOCK trial [Therese Lucia Friis Holmager](https://pubmed.ncbi.nlm.nih.gov/?term=Holmager+TLF&cauthor_id=41934630)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#full-view-affiliation-1 "Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Nordre Fasanvej 57, Copenhagen 2000 Frederiksberg, Denmark."), [Anna Meta Dyrvig Kristensen](https://pubmed.ncbi.nlm.nih.gov/?term=Kristensen+AMD&cauthor_id=41934630)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#full-view-affiliation-1 "Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Nordre Fasanvej 57, Copenhagen 2000 Frederiksberg, Denmark."), [Morten Wang Fagerland](https://pubmed.ncbi.nlm.nih.gov/?term=Fagerland+MW&cauthor_id=41934630)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#full-view-affiliation-2 "Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, 0372 Oslo, Norway."), [Dan Atar](https://pubmed.ncbi.nlm.nih.gov/?term=Atar+D&cauthor_id=41934630)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#full-view-affiliation-3 "Department of Cardiology, Oslo University Hospital Ullevaal, 0450 Oslo, Norway.")[ 4 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#full-view-affiliation-4 "Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0372 Oslo, Norway."), [Michael Hecht Olsen](https://pubmed.ncbi.nlm.nih.gov/?term=Hecht+Olsen+M&cauthor_id=41934630)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#full-view-affiliation-5 "Department of Clinical Medicine, University of Copenhagen, 2200 Copenhagen, Denmark.")[ 6 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#full-view-affiliation-6 "Department of Internal Medicine 1, Holbæk Hospital, 4300 Holbæk, Denmark."), [Arnhild Bakken](https://pubmed.ncbi.nlm.nih.gov/?term=Bakken+A&cauthor_id=41934630)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#full-view-affiliation-3 "Department of Cardiology, Oslo University Hospital Ullevaal, 0450 Oslo, Norway."), [John Munkhaugen](https://pubmed.ncbi.nlm.nih.gov/?term=Munkhaugen+J&cauthor_id=41934630)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#full-view-affiliation-7 "Department of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, 3004 Drammen, Norway.")[ 8 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#full-view-affiliation-8 "Department of Behavioural Medicine, Faculty of Medicine, University of Oslo, 0372 Oslo, Norway."), [Eva Prescott](https://pubmed.ncbi.nlm.nih.gov/?term=Prescott+E&cauthor_id=41934630)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#full-view-affiliation-1 "Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Nordre Fasanvej 57, Copenhagen 2000 Frederiksberg, Denmark.") Affiliations Expand ### Affiliations * 1 Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Nordre Fasanvej 57, Copenhagen 2000 Frederiksberg, Denmark. * 2 Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, 0372 Oslo, Norway. * 3 Department of Cardiology, Oslo University Hospital Ullevaal, 0450 Oslo, Norway. * 4 Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0372 Oslo, Norway. * 5 Department of Clinical Medicine, University of Copenhagen, 2200 Copenhagen, Denmark. * 6 Department of Internal Medicine 1, Holbæk Hospital, 4300 Holbæk, Denmark. * 7 Department of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, 3004 Drammen, Norway. * 8 Department of Behavioural Medicine, Faculty of Medicine, University of Oslo, 0372 Oslo, Norway. * PMID: **41934630** * DOI: [ 10.1093/ehjqcco/qcag055 ](https://doi.org/10.1093/ehjqcco/qcag055) Item in Clipboard Randomized Controlled Trial # Validating national registry data for randomized trials: comparison of registry-derived cardiovascular events with and without adjudication in the BETAMI-DANBLOCK trial Therese Lucia Friis Holmager et al. Eur Heart J Qual Care Clin Outcomes. 2026. Show details Display options Display options Format Abstract PubMed PMID Eur Heart J Qual Care Clin Outcomes Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Eur+Heart+J+Qual+Care+Clin+Outcomes%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Eur+Heart+J+Qual+Care+Clin+Outcomes%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/41934630/) . 2026 Sep 16;12(6):903-911. doi: 10.1093/ehjqcco/qcag055. ### Authors [Therese Lucia Friis Holmager](https://pubmed.ncbi.nlm.nih.gov/?term=Holmager+TLF&cauthor_id=41934630)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#short-view-affiliation-1 "Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Nordre Fasanvej 57, Copenhagen 2000 Frederiksberg, Denmark."), [Anna Meta Dyrvig Kristensen](https://pubmed.ncbi.nlm.nih.gov/?term=Kristensen+AMD&cauthor_id=41934630)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#short-view-affiliation-1 "Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Nordre Fasanvej 57, Copenhagen 2000 Frederiksberg, Denmark."), [Morten Wang Fagerland](https://pubmed.ncbi.nlm.nih.gov/?term=Fagerland+MW&cauthor_id=41934630)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#short-view-affiliation-2 "Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, 0372 Oslo, Norway."), [Dan Atar](https://pubmed.ncbi.nlm.nih.gov/?term=Atar+D&cauthor_id=41934630)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#short-view-affiliation-3 "Department of Cardiology, Oslo University Hospital Ullevaal, 0450 Oslo, Norway.")[ 4 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#short-view-affiliation-4 "Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0372 Oslo, Norway."), [Michael Hecht Olsen](https://pubmed.ncbi.nlm.nih.gov/?term=Hecht+Olsen+M&cauthor_id=41934630)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#short-view-affiliation-5 "Department of Clinical Medicine, University of Copenhagen, 2200 Copenhagen, Denmark.")[ 6 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#short-view-affiliation-6 "Department of Internal Medicine 1, Holbæk Hospital, 4300 Holbæk, Denmark."), [Arnhild Bakken](https://pubmed.ncbi.nlm.nih.gov/?term=Bakken+A&cauthor_id=41934630)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#short-view-affiliation-3 "Department of Cardiology, Oslo University Hospital Ullevaal, 0450 Oslo, Norway."), [John Munkhaugen](https://pubmed.ncbi.nlm.nih.gov/?term=Munkhaugen+J&cauthor_id=41934630)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#short-view-affiliation-7 "Department of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, 3004 Drammen, Norway.")[ 8 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#short-view-affiliation-8 "Department of Behavioural Medicine, Faculty of Medicine, University of Oslo, 0372 Oslo, Norway."), [Eva Prescott](https://pubmed.ncbi.nlm.nih.gov/?term=Prescott+E&cauthor_id=41934630)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/41934630/#short-view-affiliation-1 "Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Nordre Fasanvej 57, Copenhagen 2000 Frederiksberg, Denmark.") ### Affiliations * 1 Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Nordre Fasanvej 57, Copenhagen 2000 Frederiksberg, Denmark. * 2 Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, 0372 Oslo, Norway. * 3 Department of Cardiology, Oslo University Hospital Ullevaal, 0450 Oslo, Norway. * 4 Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0372 Oslo, Norway. * 5 Department of Clinical Medicine, University of Copenhagen, 2200 Copenhagen, Denmark. * 6 Department of Internal Medicine 1, Holbæk Hospital, 4300 Holbæk, Denmark. * 7 Department of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, 3004 Drammen, Norway. * 8 Department of Behavioural Medicine, Faculty of Medicine, University of Oslo, 0372 Oslo, Norway. * PMID: **41934630** * DOI: [ 10.1093/ehjqcco/qcag055 ](https://doi.org/10.1093/ehjqcco/qcag055) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Aims:** Registry-based randomized clinical trials are increasingly applied in clinical research, providing advantages in feasibility and data capture. However, registry-based data may introduce bias through misclassification or missing information. **Methods and results:** In the BETAMI-DANBLOCK trial, 5574 patients with myocardial infarction (MI) and no heart failure were randomized to beta-blocker or no beta-blocker therapy. The primary endpoint events (all-cause mortality, MI, ischemic stroke, heart failure, unplanned coronary revascularization, and malignant ventricular arrhythmias) were identified from the Danish/Norwegian national patient registries, self-reported questionnaires, and medical records. All registry-identified events, except all-cause mortality, underwent blinded adjudication. We compared non-adjudicated and adjudicated events by calculating incidence rates and hazard ratios (HRs) for beta-blocker therapy vs. controls. National registries captured 99.7% of primary endpoint events registered by self-report and medical records. Of the primary endpoint events identified through the registries, 75% were confirmed by adjudication (incidence rate 6.23 vs. 4.43/100 person-years). The confirmation rate was lower during the first 6 months and varied by event type (from 92% for ischaemic stroke to 45% for unplanned coronary revascularizations and heart failure). Estimated treatment effects were consistent for the primary endpoint with non-adjudicated and adjudicated events (HR 0.88, 95% confidence interval (CI): 0.78-0.98 and HR 0.85, 95% CI: 0.75-0.98, respectively), with no apparent differences across event types except for heart failure and revascularization. **Conclusion:** Registry data provided effect estimates of beta-blockers comparable to adjudicated data. However, adjudication substantially reduced the number of cardiovascular endpoint events and event-specific misclassification appeared, particularly during the first months after the index event. **Trial registration number:** BETAMI-DANBLOCK ClinicalTrials.gov numbers, [NCT03646357](http://clinicaltrials.gov/show/NCT03646357 "See in ClinicalTrials.gov") and [NCT03778554](http://clinicaltrials.gov/show/NCT03778554 "See in ClinicalTrials.gov"). **Keywords:** Beta-blocker; Myocardial infarction; Randomized controlled trial; Registries; Validation. © The Author(s) 2026. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Conflict of interest: M.H.O. has received honoraria for lectures from Astra Zeneca A/S, Boehringer and Ingelheim, Novo Nordisk A/S, TEVA A/S, and Johnson & Johnson. He is also president of the Danish Hypertension Society and received travel grants from Astra Zeneca A/S. A.B. has received consulting fees from Idorsia Ltd. The other authors declare no conflict of interest. ## Similar articles * [ Design and rationale of the Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction: study protocol for a randomized controlled trial. ](https://pubmed.ncbi.nlm.nih.gov/32446298/) Kristensen AMD, Bovin A, Zwisler AD, Cerquira C, Torp-Pedersen C, Bøtker HE, Gustafsson I, Veien KT, Thomsen KK, Olsen MH, Larsen ML, Nielsen OW, Hildebrandt P, Foghmar S, Jensen SE, Lange T, Sehested T, Jernberg T, Atar D, Ibanez B, Prescott E.Kristensen AMD, et al.Trials. 2020 May 23;21(1):415. doi: 10.1186/s13063-020-4214-6.Trials. 2020.PMID: 32446298Free PMC article. * [ Beta-Blockers after Myocardial Infarction in Patients without Heart Failure. ](https://pubmed.ncbi.nlm.nih.gov/40888716/) Munkhaugen J, Kristensen AMD, Halvorsen S, Holmager T, Olsen MH, Bakken A, Sehested TSG, Ruddox V, Mæng M, Vikenes K, Jensen SE, Steigen T, Lambrechtsen J, Jortveit J, Bovin A, Schirmer H, Christiansen MK, Wiseth R, Mikkelsen D, Larsen AI, Lyngby Kjærgaard C, Andresen K, Gustafsson I, Tuseth V, Larsen ML, Deeg PS, Veien K, Bøhmer E, Bøtker HE, Brattrud AO, Brønnum-Schou J, Pettersen AR, Bang LE, Øie E, Engstrøm T, Borg EB, Kristens
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