Intramyocardial plasmid-encoding human vascular endothelial growth factor A165/basic fibroblast growth factor therapy using percutaneous transcatheter approach in patients with refractory coronary artery disease (VIF-CAD) - 06/08/11
, Lidia Chojnowska, MD, PhD a, Maciej Dąbrowski, MD a, Adam Witkowski, MD, PhD a, Zbigniew Chmielak, MD, PhD a, Mirosław Skwarek, MD, PhD a, Jacek Kądziela, MD, PhD a, Anna Teresińska, PhD a, Maciej Małecki, MD, PhD b, Przemysław Janik, MD, PhD b, Zbigniew Lewandowski, PhD c, Mariusz Kłopotowski, MD a, Jacek Wnuk, MD, PhD a, Witold Rużyłło, MD, PhD aRésumé |
Background |
VIF-CAD randomized, placebo-controlled, double-blind trial was an attempt to induce therapeutic angiogenesis by percutaneous intramyocardial transfer of bicistronic (vascular endothelial growth factor/fibroblast growth factor [VEGF/FGF]) plasmid (pVIF) in patients with refractory heart ischemia. Myocardial perfusion, clinical symptoms, exercise tolerance, left ventricular function, and safety were assessed.
Methods |
Fifty-two patients with refractory coronary artery disease were randomized to receive VEGF/FGF plasmid (n = 33) or placebo plasmid (n = 19) into myocardial region showing stress-induced perfusion defects. Repeat stress and rest technetium Tc 99m sestamibi single-photon emission computed tomography at 5 months was the primary efficacy measure. Secondary assessment included Canadian Cardiovascular Society class and exercise tolerance at 5 and 12 months.
Results |
Rest- and stress-induced perfusion defects did not differ between groups. Canadian Cardiovascular Society functional class improved after 5 (P = .0210) and 12 months (P = .0607) in the treatment group. The exercise tolerance of treated patients improved: total exercise time increased marginally (P = .0541); maximum workload (P = .0419) and total test distance (P = .0473) increased significantly, compared to placebo.
Conclusion |
Bicistronic VEGF/FGF plasmid therapy did not improve myocardial perfusion measured by single-photon emission computed tomography. However, treated patients experienced improvement with respect to exercise tolerance and clinical symptoms. Intramyocardial VEGF/FGF bicistronic plasmid transfer seemed safe throughout the follow-up period of 1 year.
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| RCT registration no. NCT00620217. |
Vol 161 - N° 3
P. 581-589 - mars 2011 Retour au numéro
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