BACKGROUND: Contrast-induced nephropathy (CIN) is an adverse consequence of contrast media use that results in significant morbidity and mortality and adds significant costs to diagnostic and interventional cardiology procedures. Various pathophysiological mechanisms have been proposed for CIN and various agents have been tested for its prevention. There is currently a general agreement that adequate pre-procedure hydration constitutes the cornerstone of prevention, yet there are reports of the use of some other agents with various efficacies. We prospectively tested pentoxifylline (PTX), an antioxidant, anti-inflammatory drug, for CIN prevention in patients undergoing coronary angioplasty. MATERIALS AND METHODS: In this prospective, randomized, single-blind, single-center clinical trial, 286 consecutive patients were randomly assigned to the control group (n = 146), with routine treatment and no PTX, or the study group (n = 140), with routine treatment and PTX, 400 mg/tid from 24 h before to 24 h after coronary angioplasty. Serum creatinine was measured before and 2 days after the procedure. The primary end point was the occurrence of CIN within 48 h. RESULTS: The control and PTX groups were comparable in the overall predicted risk of CIN. Also, the type and volume of the contrast agent were not significantly different between the two groups. Following angioplasty, CIN occurred in 20 (13.69%) patients in the control group and in 12 (8.5%) patients in the study group; the difference was not statistically significant (P = 0.17). Additionally, there was no mortality and need for hemodialysis in either group. CONCLUSION: In angioplasty patients, the prophylactic oral use of PTX could be recommended for CIN prevention, although no statistically significant protective effect was documented.
RCT Entities:
BACKGROUND: Contrast-induced nephropathy (CIN) is an adverse consequence of contrast media use that results in significant morbidity and mortality and adds significant costs to diagnostic and interventional cardiology procedures. Various pathophysiological mechanisms have been proposed for CIN and various agents have been tested for its prevention. There is currently a general agreement that adequate pre-procedure hydration constitutes the cornerstone of prevention, yet there are reports of the use of some other agents with various efficacies. We prospectively tested pentoxifylline (PTX), an antioxidant, anti-inflammatory drug, for CIN prevention in patients undergoing coronary angioplasty. MATERIALS AND METHODS: In this prospective, randomized, single-blind, single-center clinical trial, 286 consecutive patients were randomly assigned to the control group (n = 146), with routine treatment and no PTX, or the study group (n = 140), with routine treatment and PTX, 400 mg/tid from 24 h before to 24 h after coronary angioplasty. Serum creatinine was measured before and 2 days after the procedure. The primary end point was the occurrence of CIN within 48 h. RESULTS: The control and PTX groups were comparable in the overall predicted risk of CIN. Also, the type and volume of the contrast agent were not significantly different between the two groups. Following angioplasty, CIN occurred in 20 (13.69%) patients in the control group and in 12 (8.5%) patients in the study group; the difference was not statistically significant (P = 0.17). Additionally, there was no mortality and need for hemodialysis in either group. CONCLUSION: In angioplasty patients, the prophylactic oral use of PTX could be recommended for CIN prevention, although no statistically significant protective effect was documented.
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