The incidence and relevance of site-reported vs. patient-reported angina: insights from the ABSORB II randomized trial comparing Absorb everolimus-eluting bioresorbable scaffold with XIENCE everolimus-eluting metallic stent
| Autor: | Peter Staehr, Pannipa Suwannasom, Roseann White, Bernard Chevalier, John B. Hernandez, Angel Cequier, Dariusz Dudek, Robbert J. de Winter, Manel Sabaté, Maik J. Grundeken, Yuki Ishibashi, Susan Veldhof, Adrianus J. van Boven, Yoshinobu Onuma, Patrick W. Serruys, Hector M. Garcia-Garcia, Jan J. Piek, Wai-Fung Cheong, Michael Haude, Andreas Baumbach, Steffen Helqvist, Joanna J. Wykrzykowska |
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| Přispěvatelé: | Graduate School, Amsterdam Cardiovascular Sciences, Cardiology, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, ACS - Heart failure & arrhythmias |
| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment 030204 cardiovascular system & hematology law.invention Coronary artery disease Angina 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Interquartile range law Internal medicine medicine 030212 general & internal medicine Adverse effect Everolimus business.industry Health Policy Percutaneous coronary intervention Stent medicine.disease Surgery Cardiology Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | European Heart Journal-Quality of Care and Clinical Outcomes, 2(2), 108-116. Oxford University Press |
| ISSN: | 2058-1742 2058-5225 |
| DOI: | 10.1093/ehjqcco/qcv022 |
| Popis: | In the ABSORB II trial, comparing Absorb™ bioresorbable vascular scaffold with metallic XIENCE™ everolimus-eluting stent (EES), a difference was found in site-reported new or worsening angina using adverse event (AE) reporting. However, the clinical relevance of this site-reported angina is unclear. The aim of the present study was therefore to investigate the clinical relevance of site-reported angina by evaluating its relation with cardiac endpoints, cardiovascular resource utilization (including diagnostics and treatment), positive exercise stress tolerance tests (ETTs), and Seattle Angina Questionnaire (SAQ).Site-reported new or worsening angina was captured on cardiac AE forms. There was a wide variation in the total number of days with site-reported angina (overall interquartile range 35-279 days). Patients with site-reported angina showed higher rates of cardiovascular events [including the patient-oriented composite endpoint of all deaths, all myocardial infarctions (MI), or all revascularizations (21.1 vs. 4.2%, P0.0001), all MIs (2.3 vs. 0%, P = 0.03), and all revascularizations (21.1 vs. 0.7%, P0.0001)], cardiovascular resource utilization (including stress tests, anti-anginal medication, diagnostic angiographies, and hospitalization), and positive ETTs (51.9 vs. 14.9%, P0.001), compared with those without site-reported angina. Furthermore, an event-based analysis of the SAQ showed that patients with ongoing angina within the recall period of 4 weeks prior to the SAQ assessment have clinically and statistically significant decrements of14 points in SAQ scores compared with those with no reported angina.We showed that the site-reported angina through AE reporting may be clinically relevant because of their relation with cardiovascular events (mostly repeat revascularizations), cardiovascular resource utilization, ETT, and SAQ.https://clinicaltrials.gov/ct2/show/NCT01425281; Unique identifier: NCT01425281. |
| Databáze: | OpenAIRE |
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