Do Patients Participating in Multi-Center Cardiovascular Randomized Controlled Trials Gain Additional Clinical Benefit Independent of Study Result or Trial Arm Allocation?

Background: It is unclear whether there is any additional benefit to patients who are recruited to multi-center randomized clinical trials (RCT), regardless of their allocation to the active or placebo arm.

Methods: We retrospectively studied all patients who participated in a "negative" multi-center international RCT (the `study group`), and an age and gender matched control group of patients who were hospitalized due to ACS during the same time period (control group). We examined the incidence of major adverse coronary events (MACE) and of metabolic parameters, i.e. levels of low-density lipoprotein (LDL) and high-density lipoprotein (HDL) levels during the study period – 28 months – as indicators of additional clinical benefit.

Results: A total of 174 patients were included in the analysis; 87 in each group. The MACE rate over 28 months of follow-up was similar in both groups (p=0.532). Comparing the mean change of LDL and HDL between baseline and the last test result, no significant difference was found between the study group and the control group (ΔLDL = -20.8 vs. -28.45, respectively, p=0.135). None of the groups reached the recommended average target LDL of ≤70 mg% (90.8 and 82.3 mg%, respectively).

Conclusions: We could not find any additional clinical benefit to patients recruited to multi-center international RCT. Our study indicates that these patients deserve an improved holistic preventive measures and clinical follow-up.