RESUMEN
Ischemia reperfusion injury can lead to further myocardiocyte damage in patients with ST-elevation myocardial infarction (STEMI). Pentoxifylline is a methylxanthine derivative with known anti-inflammatory, antioxidant, vasodilator, and rheological properties which can be a promising agent in preventing reperfusion injury. PENTOS-PCI is a single-center, randomized, double-blind, placebo-controlled trial which evaluated the efficacy and safety of preprocedural administration of intravenous pentoxifylline in patients undergoing primary percutaneous coronary intervention (PCI). Patients with acute STEMI who were eligible for PCI were randomized to receive either 100-mg intravenous infusion of pentoxifylline or placebo, prior to transferring to catheterization laboratory. Overall, 161 patients were included in our study of whom 80 patients were assigned to pentoxifylline and 81 to the control groups. Per-protocol analysis of primary endpoint indexing PCI's success rate as measured by thrombolysis in myocardial infarction (TIMI) flow grade 3 was not significantly different between pentoxifylline and placebo (71.3% and 66.3% respectively, P = 0.40). In addition, pentoxifylline could not improve secondary angiographic endpoints including myocardial blush grade 3 (87.5% and 85.2%, P = 0.79) and corrected TIMI frame count (22.8 [± 9.0] and 24.0 [± 5.1], P = 0.33) in the intervention and placebo groups respectively. The rates of major adverse cardiac and treatment emergent adverse effects were not significantly different between the two groups. Administration of intravenous pentoxifylline before primary PCI did not improve the success rate of the procedure in patients with STEMI. Intravenous administration of pentoxifylline was well tolerated, and there were no significant differences regarding adverse drug reactions in the two groups. Panel A, background: pentoxifylline is a methylxanthine derivative with known anti-inflammatory, antioxidant, vasodilator, and rheological properties which can be a promising agent in preventing reperfusion injury. Panel B: study design and main results of the PENTOS-PCI trial. cTFC corrected TIMI frame count, ED emergency department, IRI ischemia reperfusion injury, MBG myocardial blush grade, PCI percutaneous coronary intervention, PPCI primary PCI, PTX pentoxifylline, ROS reactive oxygen species, SD standard deviation, STEMI ST-elevation myocardial infarction, TIMI thrombolysis in myocardial infarction.
Asunto(s)
Infarto del Miocardio , Pentoxifilina , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Humanos , Infusiones Intravenosas , Antioxidantes , Administración Intravenosa , VasodilatadoresRESUMEN
OBJECTIVE: The aim of the present study was to determine the effects of intravenous (IV) and intracoronary administration of Vitamin C on the incidence of periprocedural myocardial injury in patients undergoing primary percutaneous coronary intervention (PCI). METHODS: In this prospective, double-blind, randomized clinical trial, that was conducted in Tehran Heart Center, Iran, between October 2016 and March 2017, 252 patients undergoing primary PCI were enrolled to receive either 3 g of IV Vitamin C before PCI and 100 mg of intracoronary Vitamin C during PCI in addition to the routine treatment (n = 126) or just the routine treatment (n = 126). Cardiac biomarkers were measured before and then 6 and 12 h postprocedurally. We determined the occurrence of contrast-induced acute kidney injury (CI-AKI), according to the levels of serum creatinine, neutrophil gelatinase-associated lipocalin, and platelet activation biomarker (P-selectin) in a subset of 119 patients before and 6 h after PCI. FINDINGS: In the patients who received Vitamin C, the serum levels of troponin T after 12 h and creatine kinase-MB after 6 h were significantly lower than those in the placebo group (P = 0.003 andP = 0.00, respectively). CI-AKI occurred in 6 (4.7%) patients in the study group and 8 (6.3%) patients in the control group; there was no significant reduction in CI-AKI in the study group. In addition, the two groups were statically similar as regards the changes in the level of P-selectin. CONCLUSION: In primary PCI patients, the prophylactic use of IV and intracoronary Vitamin C can confer additional clinical benefits such as cardioprotection.