High-dose plasmid-mediated VEGF gene transfer is safe in patients with severe ischemic heart disease (GENESIS-I). A phase I, open-label, two years follow-up trial
Catheterization and Cardiovascular Interventions, 07/11/2012
Favaloro L et al. – High–dose intramyocardial pVEGF165 is safe at 2 years follow–up in patients with severe coronary artery disease (CAD). The efficacy results observed must be taken cautiously given the uncontrolled, open–label study design.Methods
- Using an injection catheter, 10 patients with severe CAD not amenable for revascularization received 10 intramyocardial injections of 0.38 mg (total dose 3.8 mg) pVEGF165 in zones exhibiting myocardial ischemia, as assessed by combined stress 99mTc–sestamibi single photon emission computed tomography and stress echocardiography
- No serious adverse events related to either VEGF or the injection procedure occurred over 2 years follow–up.
- One patient suffered femoral artery thrombosis after a follow–up coronary angiography, successfully resolved with medical treatment.
- Six patients suffered uncomplicated coronary ischemic events during the second year follow–up.
- Angina functional class decreased from 2.6±0.2 to 1.2±0.3 (mean±SEM, P<0.05), quality of life increased from 56.9±3.2 to 82.6±2.4 (P<0.05), the summed difference score of myocardial perfusion decreased from 13.4±2 to 7.7±1.8 (P<0.04) and stress ejection fraction did not change (44.2±3.6 to 47.8±3.1%, P=NS).