Intramyocardial Adenovirus-Mediated VEGF-DΔNΔC Gene Transfer in Patients with No-Option Coronary Artery Disease: Interim Safety Analysis of the Kuopio Angiogenesis Trial 301

Vascular endothelial growth factor gene transfer therapy for coronary artery disease: A systematic review and meta‐analysis

“…The outcome measures were not reported in all of the trials. In this meta‐analysis, seven studies assessed mortality . There was no statistically significant difference in mortality between the VEGF gene therapy group and the control group (RR: 0.79; 95%CI: 0.29, 2.13; P = 0.64), although the subgroup analysis was performed on different VEGF gene types and vectors.…”

“…By browsing full‐text articles, we excluded 11 records for not being RCTs, not involving VEGF gene therapy, or having no outcome information. Finally, a total of 14 RCTs were included . Only one trial reported outcomes at 8 years (Hedman et al), and this publication reported the same patients as Hedman et al.…”

“…All the included studies were RCTs. Six trials reported the method of double‐blinding, 8 studies reported allocation concealment, 7 trials reported complete outcome data, and three trials may have had selective reporting . There was an unclear risk of bias in allocation concealment, blinding of outcome assessment, incomplete outcome data, and selective reporting.…”

“…In this meta‐analysis, 10 studies assessed serious cardiac events . Pooling data from these studies showed that VEGF gene therapy led to a significantly decreased risk of serious cardiac events (11.7% vs 21.2%, RR: 0.56; 95%CI: 0.37, 0.84; P = 0.005).…”

“…Five trials described the adverse effects in detail, and the remaining trials reported no adverse effects. The main adverse effects were peripheral vascular disorder, peripheral edema, retinal disease, musculoskeletal pain, inflammation, and pericardial effusion.…”