Clin Res Cardiol (2021) DOI DOI https://doi.org/10.1007/s00392-021-01843-w

Visualization of successful revascularization has no additional short-term effect on symptoms or quality of life in chronic coronary syndrome: 1-month outcome of the PLA-pCi-EBO-pilot-trial

M. Wester1, F. Koll1, M. Lüdde2, C. Langer3, M. Resch4, A. Luchner5, N. Frey6, K. Müller7, M. Koller7, L. S. Maier1, S. T. Sossalla1

1Klinik und Poliklinik für Innere Med. II, Kardiologie, Universitätsklinikum Regensburg, Regensburg; 2Kardiologische Gemeinschaftspraxis, Bremerhaven; 3am Klinikum Links der Weser, Kardiologisch-Angiologische Praxis, Bremen; 4Klinik für Innere Medizin, Caritas Krankenhaus St. Josef, Regensburg; 5Klinik für Kardiologie, Krankenhaus Barmherzige Brüder Regensburg, Regensburg; 6Klinik für Innere Med. III, Kardiologie, Angiologie u. Pneumologie, Universitätsklinikum Heidelberg, Heidelberg; 7Zentrum für klinische Studien, Universitäsklinikum Regensburg, Regensburg;

Background: Chronic coronary syndrome (CCS) is a highly prevalent disease with often disabling symptoms such as angina pectoris (AP) and dyspnea. It is well known that antianginal treatment strategies also consist of a relevant placebo effect in addition to their specific efficacy. We examined the effect of visual angiographic demonstration of the coronary arteries before and after successful percutaneous coronary intervention (PCI) on the symptom burden of CCS. Methods: The PLA-pCi-EBO-pilot-trial is a prospective, multi-centre, randomized, controlled investigator-initiated pilot trial to study the effects of visual demonstration of successful PCI on quality of life (QoL) and angina pectoris (AP) in patients with symptomatic stable CCS. All patients with stable CCS and successful PCI were screened at five centres in Germany. Inclusion criteria were age>18 years, symptomatic CCS, AP frequency > 2/week, implantation of ≥ 1 coronary artery stent. Exclusion criteria were among others cardiac ejection fraction ≤ 35%, severe pulmonary disease, significant valvular disease, and anaemia. 145 eligible patients with a frequency of AP ≥ 2/week were randomized 1:1 and stratified either to daily or non-daily AP. The control group received the common written procedural report on the procedure. Patients in the “picture group” (intervention group) were additionally given a print-out picture of their coronary angiogram both before and after PCI with a brief explanation of the printouts. Primary endpoints were change in the Seattle angina questionnaire (SAQ)-derived disease perception score 1 months after PCI (a SAQ score of 100 equals symptom-free)  . Secondary endpoints are changes in other SAQ-derived scores and dyspnea (NYHA score) 1 month after PCI. Results: 138 patients completed the 1-month follow-up (control group n=64, picture group n=74). Mean age was 70 years and 68% were male. At baseline, the mean time since onset of AP was 6 months and 97% presented with a CCS score of II or III (43% and 54% respectively). Half of the patients had three-vessel disease and a quarter each one- or two-vessel disease. Patients received a mean of 2 stents, the most frequently treated vessel was the left anterior descending artery (56%). After PCI, all SAQ scores (except for treatment satisfaction) and the NYHA scale significantly and strongly improved for the 1-month follow-up. There was no significant difference between the control and picture group for the SAQ subscales (see figure) which were the primary endpoint of this study. Interestingly, there was a non-significant trend (p=0.26) for improvement of disease perception in the picture group after 1 month (SAQ DP 76.0 pts. vs 71.4 pts.). Also, there was no difference for changes in NYHA score from baseline to the 1-month follow-up between the control and the picture group (improvement 45% vs 49%, no change 44% vs 42%, worsening 11% vs 10%) which was the secondary endpoint of this study. Discussion: The one-time visual demonstration of successful PCI provides no additional short-term positive effect on AP or dyspnoea. Whether this intervention may be a valuable tool to positively influence disease perception has to be investigated in larger clinical trials. Trial registration: German Clinical Trials Register DRKS00017524 (5th, July 2019).

https://dgk.org/kongress_programme/jt2021/aP358.html