10.3205/HTA000098
Gorenoi, Vitali
Vitali
Gorenoi
Schönermark, Matthias P.
Matthias P.
Schönermark
Hagen, Anja
Anja
Hagen
Percutaneous coronary intervention with optimal medical therapy vs. optimal medical therapy alone for patients with stable angina pectoris
German Medical Science GMS Publishing House
2011
JournalArticle
acute coronary syndrom/therapy
angina pectoris/*
angioplasty
balloon-dilation/therapy
blood flow
blood supply
CAD
cardiac muscle
circulatory disorder
coronary heart disease
cost-benefit analysis
drug therapy/*
drug therapy/*economics
drug-eluting stents
drug-eluting stents/adverse effects
drug-eluting stents/economics
drug-eluting stents/utilization
Germany
health economic analysis
heart diseases/*
humans
ischemia
medicamental therapy
meta analysis
meta analysis as topic
myocardial insufficiency
myocardial ischemia
myocardium
PCI
percutaneous coronary intervention
perfusion
prevention
primary prevention
prophylaxis
randomized controlled trial
randomized controlled trial as topic
RCT
review literature
stable angina pectoris
stenting
systematic review
therapeutics
treatment
610 Medical sciences; Medicine
2011-11-10
2011
en
urn:nbn:de:0183-hta0000980
hta000098
text/html
GMS Health Technology Assessment; 7:Doc07; ISSN 1861-8863
Scientific background
Stable Angina Pectoris (AP) is a main syndrome of chronic coronary artery disease (CAD), a disease with enormous epidemiological and health economic relevance. Medical therapy and percutaneous coronary interventions (PCI) are the most important methods used in the treatment of chronic CAD.
Research questions
The evaluation addresses questions on medical efficacy, incremental cost-effectiveness as well as ethic, social and legal aspects in the use of PCI in CAD patients in comparison to optimal medical therapy alone.
Methods
A systematic literature search was conducted in June 2010 in the electronic databases (MEDLINE, EMBASE etc.) and was completed by a hand search.
The medical analysis was initially based on systematic reviews of randomized controlled trials (RCT) and was followed by the evaluation of RCT with use of current optimal medical therapy. The results of the RCT were combined using meta-analysis. The strength and the applicability of the determined evidence were appraised.
The health economic analysis was initially focused on the published studies. Additionally, a health economic modelling was performed with clinical assumptions derived from the conducted meta-analysis and economic assumptions derived from the German Diagnosis Related Groups 2011.
Results
Seven systematic reviews (applicability of the evidence low) and three RCT with use of optimal medical therapy (applicability of the evidence for the endpoints AP and revascularisations moderate, for further endpoints high) were included in the medical analysis. The results from RCT are used as a base of the evaluation. The routine use of the PCI reduces the proportion of patients with AP attacks in the follow-up after one and after three years in comparison with optimal medical therapy alone (evidence strength moderate); however, this effect was not demonstrated in the follow-up after five years (evidence strength low). The difference in effect in the follow-up after four to five years was not found for the further investigated clinical endpoints: death, cardiac death, myocardial infarction and stroke (evidence strength high) as well as for severe heart failure (evidence strength moderate).
Two studies were included in the health economic analysis. The costs estimations from these studies are not directly transferable to the corresponding costs in Germany. The average difference in the total costs for PCI in comparison with optimal medical therapy alone, which was calculated in the modelling, was found to be 4,217 Euro per patient. The incremental cost-effectiveness ratio per life-year of a patient with avoided AP attacks was estimated to be 24,805 Euro (evidence strength moderate).
No publication was identified concerning ethical, social or legal aspects.
Discussion
Important methodical problems of the studies are a lack of blinding of the patients and incomplete data for several endpoints in the follow-up. The determined incremental cost-effectiveness ratio per life-year of a patient with avoided AP attacks was appraised not to be cost-effective.
Conclusions
From a medical point of view the routine use of PCI in addition to the optimal medicinal therapy in patients with stable AP can be recommended for the reduction of the proportion of patients with AP attacks after one year and after three years (recommendation degree weak). Otherwise, PCI is to be performed in patients with refractory or progressing AP despite of optimal medical therapy use; in this case PCI is expected to be applied in 27% to 30% of patients in five years.
From the health economic view the routine use of PCI in addition to an optimal medical therapy in patients with stable AP cannot be recommended.
No special considerations can be made concerning special ethical, social or legal aspects in the routine use of PCI in addition to optimal medical therapy in patients with stable AP.
GMS Health Technology Assessment; 7:Doc07; ISSN 1861-8863