Kidney Dysfunction and Long-Term Outcome in Post-PCI Acute Coronary Syndrome Patients Treated by High-Dose Tirofiban: The Role of Creatinine Clearance
Paolo Emilio Puddu *
Department of Cardiovascular Sciences, Laboratory of Biotechnologies Applied to Cardiovascular Medicine, Sapienza, University of Rome, Italy.
Michele Schiariti
Department of Cardiovascular Sciences, Laboratory of Biotechnologies Applied to Cardiovascular Medicine, Sapienza, University of Rome, Italy and Sant’Anna Hospital, Catanzaro, Italy.
Domenico Cuturello
Department of Cardiovascular Sciences, Laboratory of Biotechnologies Applied to Cardiovascular Medicine, Sapienza, University of Rome, Italy.
Loredana Iannetta
Department of Cardiovascular Sciences, Laboratory of Biotechnologies Applied to Cardiovascular Medicine, Sapienza, University of Rome, Italy.
Angela Saladini
Sant’Anna Hospital, Catanzaro, Italy.
Raffaele Bugiardini
Department of Internal Medicine, Section of Cardiology, University of Bologna, Bologna, Italy.
*Author to whom correspondence should be addressed.
Abstract
Aims: Few data exist on kidney dysfunction (KD) and glycoprotein IIb/IIIa inhibitors (GPI) in acute coronary syndrome (ACS) patients treated by percutaneous coronary intervention (PCI) and whether they impact on long-term outcome since most frequently patients with various degrees of KD are excluded.
Study Design: Comparison of independent but concomitant arms of a randomized investigation on GPI.
Place and Duration of Study: The Sant’ANna TIrofiban Safety study (SANTISS www.clinicaltrials.gov Identifier: NCT00566891) was an open-label investigator-initiated single centre registry at Sant’Anna Hospital, Catanzaro, during a 5-year enrollment period.
Methodology: We considered 726 ACS patients with PCI under either triple (aspirin, clopidogrel including high-dose tirofiban) or double (aspirin and clopidogrel) anti-aggregating drugs (AAD). Serum creatinine levels, creatinine clearance (CrCl, using the Cockcroft-Gault formula) and estimated glomerular filtration rate (eGFR, using both MDRD and CKD_EPI formulas) were used as continuous co-variables. Cox’s proportional hazards model tested the multivariable contribution of covariates all fitted simultaneously (forced method) in order to predict the incidence of 1-year cumulative ischemic events (CIE).
Results: There were 69 (9.5%) 1-year CIE. Incidences were 5.4, 9.8 and 13.4% (P=0.012) in CrCl tertiles 1 (96-216 ml/min), 2 (73-95 ml/min) and 3 (15-72 ml/min), respectively. Compared to CrCl, the percentile distributions of eGFR, by MDRD or CKD_EPI formulas were similar: all were comparable and significant predictors multivariately (p<0.001) of long-term CIE. The presence of diabetes (hazard ratios, HRs 1.84-1.91), intra aortic balloon pump (HRs 3.59-4.03), and thrombolysis (a protective factor) by tenecteplase (HRs 0.30-0.30) were further significant risk factors. With high-dose tirofiban there was a 20% lower but not statistically different incidence of 1-year CIE.
Conclusion: KD assessed by CrCl or eGFR in ACS patients treated by PCI equally predicted and similarly impacted on 1-year CIE, independent of the formula adopted for eGFR calculation and the presence of GPI with high-dose tirofiban
Keywords: Kidney dysfunction, creatinine clearance, estimated glomerular filtration rate, acute coronary syndrome, percutaneous coronary intervention, tirofiban.