Terapia gênica com VEGF para angiogênese na angina refratária: Ensaio clínico fase I/II

Abstract

Objective: To evaluate the safety, feasibility and initial and clinical effects on myocardial perfusion, intramyocardial, transthoracic administration of plasmid VEGF 165 in patients with advanced coronary artery disease and refractory angina, which are not qualified for percutaneous revascularization and surgery. Methods: A cohort study phase I. Thirteen patients with ischemic heart disease refractory angina despite maximum medical treatment for at least six months, not qualifying for surgical or catheter underwent intramyocardial injection of VEGF 165 plasmid 2000ìg. Patients were evaluated by myocardial scintigraphy, exercise testing, quality of life questionnaire (Minnesota) and determining the classes of heart failure (NYHA) and angina (CCS). Results: There were no deaths or recurrences. During the period of maximum medical treatment, there was no difference in myocardial scintigraphy, exercise stress tests and questionnaires on quality of life also found a trend towards worsening of NYHA class (P = 0.05) and CCS (P = 0.05). Three months after intervention we observed improvements in scintigraphic SSS scores (18.38 ± 7.51 vs. 15.31 ± 7.29, P = 0.003) and SRS (11.92 ± 7.49 vs. 8.53 ± 6.68, P = 0.002) but not in proportion to the areal extent of ischemic myocardium (23.38 ± 13.12% vs. 20.08 ± 13.88%, P = 0.1). There was a trend towards improvement of the METs in ergometry (7.66 ± 4.47 vs. 10.29 ± 4.36, P = 0.08), improved quality of life score (48.23 ± 18.35 vs. 30.15 ± 20.13, P = 0.02) and NYHA class (3.15 ± 0.38 vs. 1.77 ± 0.83, P = 0.001) and CCS (3.08 ± 0.64 vs. 1.77 ± 0.83, P = 0.001) in the same period. Conclusions: The therapy has proved to be safe and feasible in this series of patients. Initial results tend to show improvement in the severity of angina and reduction in the intensity of myocardial ischemia.