Does participation in a long-term clinical trial lead to survival gain for patients with coronary artery disease?
OBJECTIVE
Little is known about the advantages and disadvantages of participation in a clinical trial for patients with coronary heart disease. We hypothesized that participation itself in a long-term clinical trial with regular clinical evaluation and adjustment of treatments might lead to survival gain among patients with coronary artery disease who agreed or refused to participate in the Bezafibrate Infarction Prevention study.


METHODS
The study was performed in 18 university hospitals. There were 3502 patients who fulfilled the inclusion criteria. Among them, 3122 patients signed informed consent and were included in the study ("participants"), whereas 380 declined to participate ("nonparticipants"). For all participants, routine visits to the clinics were scheduled bimonthly for study medication distribution and compliance assessment, and every 4 months for clinical evaluation and management. Nonparticipants continued with community-based treatment and were followed only for mortality.


RESULTS
The two groups were similar with regard to age, sex, and the prevalence of most cardiovascular diseases, risk factors, and medications, except that participants were more likely to have presented with an anginal syndrome (1788 [57%] vs. 190 [50%]) and to have symptomatic heart failure (754 [25%] vs. 66 [18%]). During follow-up (mean [+/- SD], 7.7 +/- 0.8 years), 475 patients died. All-cause mortality was similar in participants (n = 423 [13.6%]) and nonparticipants (n = 52 [13.7%]). In a multivariate analysis, participation in the clinical trial was not associated with all-cause mortality (hazard ratio [HR] = 0.96; 95% confidence interval [CI]: 0.70 to 1.30) or cardiac mortality (HR = 1.12; 95% CI: 0.72 to 1.74).


CONCLUSIONS
Participation in a long-term clinical trial in a country with readily accessible community-based medicine may not lead to survival gain in patients with coronary artery disease.
Tenenbaum
Alexander
A
Cardiac Rehabilitation Institute, Neufeld Cardiac Research Institute, Chaim Sheba Medical Center, Tel-Hashomer, Israel.
Motro
Michael
M
Fisman
Enrique Z
EZ
Boyko
Valentina
V
Mandelzweig
Lori
L
Shotan
Avraham
A
Behar
Solomon
S
D000368:Aged; D000787:Angina Pectoris / Q000188:drug therapy / Q000401:mortality*; D006805:Human Experimentation; D006801:Humans; D007557:Israel / Q000453:epidemiology; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000188:drug therapy / Q000401:mortality*; D016032:Randomized Controlled Trials as Topic; D016019:Survival Analysis