Quality of life of patients with coronary heart disease treated with the bioresorbable vascular scaffold (ABSORB™): 2-year results from the GABI-R-registry

Kathrin Pahmeier, Silke Neusser, Christian Hamm, Johannes Kastner, Jochen Wöhrle, Ralf Zahn, Stephan Achenbach, Julinda Mehilli, Tommaso Gori, Christoph Naber, Holger Nef, Till Neumann, Gert Richardt, Axel Schmermund, Christoph Claas, Thomas Riemer, Janine Biermann-Stallwitz, GABI-R Study Group, Kathrin Pahmeier, Silke Neusser, Christian Hamm, Johannes Kastner, Jochen Wöhrle, Ralf Zahn, Stephan Achenbach, Julinda Mehilli, Tommaso Gori, Christoph Naber, Holger Nef, Till Neumann, Gert Richardt, Axel Schmermund, Christoph Claas, Thomas Riemer, Janine Biermann-Stallwitz, GABI-R Study Group

Abstract

Background: Numerous studies have reported clinical endpoints following coronary revascularization using bioresorbable vascular scaffolds (BVS), while information about the impact on health-related quality of life is sparse. In this analysis of the German-Austrian ABSORB RegIstRy, the 2 year results concerning quality of life development in a large cohort of patients treated with BVS were reported.

Methods: Data were collected at baseline as well as 30 days, 6 and 24 months after coronary revascularization using BVS. The EQ-5D score, EQ visual analogue scale (VAS) and Seattle Angina Questionnaire (SAQ) were determined for each time point. Patients were categorized according to the indication for coronary revascularization [acute coronary syndrome (ACS), stable angina pectoris (SAP), silent myocardial ischemia (SMI), or other]. Binary logistic regression analysis was performed to determine factors that predict above-average scores two years after implantation.

Results: Data from 1317 patients in 88 centres were included. Reasons for revascularization were: ACS (n = 643), SAP (n = 443), SMI (n = 52), and other (n = 179). Mean EQ-5D was significantly increased after six months, while a value comparable to baseline was found two years after implantation. EQ VAS and four of five dimensions of SAQ were significantly improved over baseline at all follow-up surveys. Particularly strong improvements were seen in SAQ scores angina frequency and quality of life. Binary regressions showed different statistically significant predictors in the respective models.

Conclusions: Following coronary revascularization with BVS strong decrease in self-reported angina frequency and increase of self-reported quality of life were observed with continuous improvements over two years of follow-up. Trial registration ClinicalTrials.gov Identifier: NCT02066623.

Keywords: Bioresorbable vascular scaffold; Coronary artery disease; Quality of life; Stents.

Conflict of interest statement

Mr. Gori received Speakers’ honoraria and research support from Abbott Vascular. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Quality of life values of the entire study population. To use a uniform labelling of the y-axis across all scales, the values of the EQ-5D score were multiplied by 100

References

    1. Berg SK, Thorup CB, Borregaard B, Christensen AV, Thrysoee L, Rasmussen TB, Ekholm O, Juel K, Vamosi M. Patient-reported outcomes are independent predictors of one-year mortality and cardiac events across cardiac diagnoses: findings from the national DenHeart survey. Eur J Prev Cardiol. 2019;26(6):624–637. doi: 10.1177/2047487318769766.
    1. De Smedt D, Clays E, Hofer S, Oldridge N, Kotseva K, Maggioni AP, Pogosova N, Dolzhenko M, De Bacquer D. The use of HeartQoL in patients with coronary heart disease: association with risk factors and European reference values. The EUROASPIRE IV study of the European Society of cardiology. Eur J Prev Cardiol. 2016;23(11):1174–1186. doi: 10.1177/2047487316631400.
    1. Li J, Loerbroks A, Bosma H, Angerer P. Work stress and cardiovascular disease: a life course perspective. J Occup Health. 2016;58(2):216–219. doi: 10.1539/joh.15-0326-OP.
    1. Frank A. Vocational rehabilitation: supporting Ill or disabled individuals in (to) work: a UK perspective. Healthcare. 2016;4(3):46. doi: 10.3390/healthcare4030046.
    1. Cauter JV, Bacquer D, Clays E, Smedt D, Kotseva K, Braeckman L. Return to work and associations with psychosocial well-being and health-related quality of life in coronary heart disease patients: Results from EUROASPIRE IV. Eur J Prev Cardiol. 2019;26(13):1386–1395. doi: 10.1177/2047487319843079.
    1. Wu Y, Zhu B, Chen Z, Duan J, Luo A, Yang L, Yang C. New insights into the comorbidity of coronary heart disease and depression. Curr Probl Cardiol. 2019;46(3):100413. doi: 10.1016/j.cpcardiol.2019.03.002.
    1. Brophy J, Belisle P, Joseph L. Evidence for use of coronary stents. A hierarchical bayesian meta-analysis. Ann Intern Med. 2003;138(10):777–786. doi: 10.7326/0003-4819-138-10-200305200-00005.
    1. Bangalore S, Bezerra HG, Rizik DG, Armstrong EJ, Samuels B, Naidu SS, Grines CL, Foster MT, Choi JW, Bertolet BD, et al. The state of the absorb bioresorbable scaffold: consensus from an expert panel. JACC Cardiovasc Interv. 2017;10(23):2349–2359. doi: 10.1016/j.jcin.2017.09.041.
    1. Serruys PW, Chevalier B, Sotomi Y, Cequier A, Carrie D, Piek JJ, Van Boven AJ, Dominici M, Dudek D, McClean D, et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016;388(10059):2479–2491. doi: 10.1016/S0140-6736(16)32050-5.
    1. Kereiakes DJ, Ellis SG, Metzger C, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, et al. 3-year clinical outcomes with everolimus-eluting bioresorbable coronary scaffolds: the ABSORB III trial. J Am Coll Cardiol. 2017;70(23):2852–2862. doi: 10.1016/j.jacc.2017.10.010.
    1. Serruys PW, Chevalier B, Dudek D, Cequier A, Carrie D, Iniguez A, Dominici M, van der Schaaf RJ, Haude M, Wasungu L, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015;385(9962):43–54. doi: 10.1016/S0140-6736(14)61455-0.
    1. de la Torre Hernandez JM, Rumoroso JR, Ojeda S, Brugaletta S, Cascon JD, Ruisanchez C, Sanchez Gila J, Roa J, Tizon H, Gutierrez H, et al. Angina and ischemia at 2 years with bioresorbable vascular scaffolds and metallic drug-eluting stents. ESTROFA ischemia BVS-mDES Study. Rev Esp Cardiol (Engl Ed) 2018;71(5):327–334. doi: 10.1016/j.recesp.2017.03.021.
    1. Nef H, Wiebe J, Achenbach S, Munzel T, Naber C, Richardt G, Mehilli J, Wohrle J, Neumann T, Biermann J, et al. Evaluation of the short- and long-term safety and therapy outcomes of the everolimus-eluting bioresorbable vascular scaffold system in patients with coronary artery stenosis: Rationale and design of the German-Austrian ABSORB RegIstRy (GABI-R) Cardiovasc Revasc Med. 2016;17(1):34–37. doi: 10.1016/j.carrev.2015.09.002.
    1. Ludwig K, Graf von der Schulenburg JM, Greiner W. German value set for the EQ-5D-5L. Pharmacoeconomics. 2018;36(6):663–674. doi: 10.1007/s40273-018-0615-8.
    1. Manolis AJ, Ambrosio G, Collins P, Dechend R, Lopez-Sendon J, Pegoraro V, Camm AJ. Impact of stable angina on health status and quality of life perception of currently treated patients. The BRIDGE 2 survey. Eur J Intern Med. 2019;70:60–67. doi: 10.1016/j.ejim.2019.09.013.
    1. Baron SJ, Chinnakondepalli K, Magnuson EA, Kandzari DE, Puskas JD, Ben-Yehuda O, van Es GA, Taggart DP, Morice MC, Lembo NJ, et al. Quality-of-life after everolimus-eluting stents or bypass surgery for left-main disease: results from the EXCEL trial. J Am Coll Cardiol. 2017;70(25):3113–3122. doi: 10.1016/j.jacc.2017.10.036.
    1. Cohen DJ, Van Hout B, Serruys PW, Mohr FW, Macaya C, den Heijer P, Vrakking MM, Wang K, Mahoney EM, Audi S, et al. Quality of life after PCI with drug-eluting stents or coronary-artery bypass surgery. N Engl J Med. 2011;364(11):1016–1026. doi: 10.1056/NEJMoa1001508.
    1. Hajek A, Bock JO, Saum KU, Schottker B, Brenner H, Heider D, Konig HH. Morbidity differences by health insurance status in old age. Gesundheitswesen. 2018;80(6):551–556.

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