Aims: In the ABSORB II trial, comparing AbsorbTM bioresorbable vascular scaffold with metallic XIENCETM 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).
Methods and results: 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%, P, 0.0001), all MIs (2.3 vs. 0%, P ¼ 0.03), and all revascularizations (21.1 vs. 0.7%, P, 0.0001)], cardiovascular resource utilization (including stress tests, anti-anginal medication, diagnostic angiographies, and hospitalization), and positive ETTs (51.9 vs. 14.9%, P, 0.001), 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 of .14 points in SAQ scores compared with those with no reported angina.
Conclusions: 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.

Additional Metadata
Keywords Angina, Coronary artery disease, Metallic drug-eluting stent, Percutaneous coronary intervention, Polymeric bioresorbable vascular scaffold, Seattle Angina Questionnaire
Persistent URL dx.doi.org/10.1093/ehjqcco/qcv022, hdl.handle.net/1765/106211
Journal European Heart Journal - Quality of Care and Clinical Outcomes
Citation
Grundeken, M.J, White, R, Hernandez, J.B. (John B.), Dudek, D, Cequier, A, Haude, M, … Chevalier, B. (2015). The incidence and relevance of site-reported vs. patient-reported angina. European Heart Journal - Quality of Care and Clinical Outcomes, 2(2), 108–116. doi:10.1093/ehjqcco/qcv022