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. 2016 Apr 1;2(2):108-116.
doi: 10.1093/ehjqcco/qcv022.

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

Maik J Grundeken  1 , Roseann M White  2 , John B Hernandez  2 , Dariusz Dudek  3 , Angel Cequier  4 , Michael Haude  5 , Adrianus J van Boven  6 , Jan J Piek  1 , Steffen Helqvist  7 , Manel Sabate  8 , Andreas Baumbach  9 , Pannipa Suwannasom  10 , Yuki Ishibashi  10 , Peter Staehr  2 , Susan Veldhof  2 , Wai-Fung Cheong  2 , Robbert J de Winter  1 , Hector M Garcia-Garcia  10 , Joanna J Wykrzykowska  1 , Yoshinobu Onuma  10 , Patrick W Serruys  11 , Bernard Chevalier  12
Affiliations

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

Maik J Grundeken et al. Eur Heart J Qual Care Clin Outcomes. .

Abstract

Aims: 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).

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 = 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.

Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT01425281; Unique identifier: NCT01425281.

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