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N-acetylcysteine (NAC) and sodium bicarbonate (SOB) therapies may prevent contrast-induced nephropathy (CIN). However, the efficacy of using combination over individual therapies was not established, and there was no large randomised study comparing abbreviated SOB therapy with conventional sustained saline pre-hydration with oral NAC.In a multi-centre, open-label, randomised, controlled trial (NCT00497328), we prospectively enrolled 548 patients with at least moderate renal impairment undergoing cardiac catheterisation with or without percutaneous coronary intervention. Patients were randomly assigned to 3 groups: 1) NAC: 154 mEq/L sustained sodium chloride regime (1 mL/kg/h 12 h before, during and 6h after the procedure) with oral NAC at 1.2g bid for 3 days (n=185); 2) SOB: 154 mEq/L abbreviated SOB regime at 3 mL/kg/h 1h before the procedure, and 1 mL/kg/h during and 6h after the procedure (n=182); and 3) COM: combination of abbreviated SOB regime and oral NAC (n=181). The primary end point was incidence of CIN. The secondary end points were rise in serum creatinine, hospitalisation duration, haemodialysis, morbidity and mortality within 30 days.The 3 groups had similar baseline characteristics: age 68 ± 10 years, 76% male, 48% diabetic and baseline glomerular filtration rate (GFR) 47.7 ± 13.0 mL/min. There were 41 (8.8%) patients with GFR30. The CIN incidences were NAC 6.5%, SOB 12.8% and COM 10.6%. The COM regimen was not superior to either the NAC (relative risk (RR)=1.61, 95% confidence interval (CI): 0.76 to 3.45, p=0.225) or SOB (RR=0.83, 95% CI: 0.44 to 1.56, p=0.593) regimens. The CIN incidence was lower in the NAC group than the SOB group (adjusted odds ratio (OR)=0.40, 95% CI: 0.17 to 0.92; p=0.032). Multivariate analysis showed contrast volume (OR=1.99, 95% CI: 1.33 to 2.96, p0.001 per 100mL), female (OR=2.47, 95% CI: 1.22 to 5.00, p=0.012) and diabetes (OR=2.03, 95% CI: 1.03 to 3.99, p=0.041) were independent risk predictors. There were no differences in the secondary outcomes among the 3 groups.The combination regimen was not superior to individual regimens in preventing CIN in patients with baseline renal impairment. There was a trend suggesting that the 12-hour sustained sodium chloride pre-hydration regimen was more protective than the 1-hour abbreviated SOB regimen.

Background There are safety concerns on drug-eluting stents (DESs) using durable polymer. The long-term outcome of next generation DESs using bioabsorbable polymer technology remains unknown. Methods From March to June, 2005, a novel sirolimus-eluting (170 μg/cm2), bioabsorbable polymer (PLA and PLGA, eroded over 45 days) coated stent was implanted for treatment of acute myocardial infarction (AMI) in 49 patients (male 86%, age 55+10 years, diabetes 31%). All culprits were de novo lesions in the native coronary artery. On discharge, aspirin and clopidogrel for 3 months followed by life-long aspirin were prescribed. Angiographic follow-up was performed at 8 months. Clinical follow-up was performed at 4, 9 and 24 months. Results Angiographic success rate was 100%. In-hospital adverse events consisted of 1 death (2%). All except one patient (due to aspirin allergy) were compliant to the 3 months dual antiplatelet therapy, and there was no adverse event during this period. One patient developed re-infarction in another coronary territory at 6 months. Twenty-seven patients (56%) underwent 8-month angiographic follow-up (Table 3). At 24 months, 6 patients had 7 major adverse cardiac events (12.2%, 1 death, 2 re-infarctions and 4 target lesion revascularizations). There were no incidences of subacute or late stent thrombosis. Conclusions The Cura stent, using bioabsorbable polymer technology, appears to be safe at 2 years follow-up. Although the angiographic follow-up parameters were unfavorable, this report paves the way for further studies on DES using bioabsorbable polymer technology.