Επαλήθευση βαθμονομημένου μοντέλου κινδύνου για την εμφάνιση νεφροπάθειας από σκιαγραφικές ουσίες μετά τη διαδερμική στεφανιαία επαναιμάτωση

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Επαλήθευση βαθμονομημένου μοντέλου κινδύνου για την εμφάνιση νεφροπάθειας από σκιαγραφικές ουσίες μετά τη διαδερμική στεφανιαία επαναιμάτωση Δ. Τζιακάς 1, Γ. Χαλικιάς 1, Δ. Στάκος 1, Α. Altun 2, Ν.

Κωνσταντινίδης 1 1 Πανεπιστημιακή Καρδιολογική Κλινική, και 7 Πανεπιστημιακή Νεφρολογική Κλινική, Ιατρική Σχολή, Δημοκρίτειο Πανεπιστήμιο Θράκης, Αλεξανδρούπολη, Ελλάδα 2 Cardiology Department,

1 Επαλήθευση βαθμονομημένου μοντέλου κινδύνου για την εμφάνιση νεφροπάθειας από σκιαγραφικές ουσίες μετά τη διαδερμική στεφανιαία επαναιμάτωση Δ. Τζιακάς 1, Γ. Χαλικιάς 1, Δ. Στάκος 1, Α. Altun 2, Ν. Sivri 2, Ε. Yetkin 3, Μ. Gur 3, G. Stankovic 4, Z. Mehmedbegovic 4, B. Βούδρης 5, Σ. Χατζηκυριάκου 5, Χ. Garcia-Moll 6, Α. Serra 6, Π. Πασσαδάκης 7, Η. Θώδης 7, Β. Βαργεμέζης 7, JC. Kaski 8, Σ. Κωνσταντινίδης 1 1 Πανεπιστημιακή Καρδιολογική Κλινική, και 7 Πανεπιστημιακή Νεφρολογική Κλινική, Ιατρική Σχολή, Δημοκρίτειο Πανεπιστήμιο Θράκης, Αλεξανδρούπολη, Ελλάδα 2 Cardiology Department, Medical School, Trakya University, Edirne, Turkey 3 Middle East Hospital Cardiology Department & International Medical Center Cardiology Department, Mersin, Turkey 4 Department of Cardiology, Clinical Center of Serbia and Medical Faculty, University of Belgrade, Belgrade, Serbia 5 Β Αιμοδυναμικό Εργαστήριο, Ωνάσσειο Καρδιοχειρουργι- κό Κέντρο, Αθήνα, Ελλάδα 6 Servicio de Cardiologia, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain 8 Cardiovascular Sciences Research Centre, University of London, London, UK

2 CIN VALIDATION STUDY Single Centre Study 488 pts study cohort Validation by bootstrapping method

3 Aim of the Study In the present study, we prospectively validated the diagnostic performance of our CIN risk score model in a large multicenter international cohort of patients who underwent PCI Methods Consecutive patients admitted for elective or urgent PCI were eligible for inclusion in the study. CIN was defined as an increase (compared with the baseline values) of serum creatinine levels by at least 25% or at least 0.5 mg/dl 48 hours after PCI.

4 Methods 4 countries ; 6 centres Greece (2) Serbia (1) Spain (1) Turkey (2)

5 Methods 2,882 patients (PCI)

6 Results Contrast-induced nephropathy occurred within 48 hours postprocedure in 15.7% of the study population (423 of 2,689 patients).

7 Results

Results The predictive accuracy of the CIN risk score was good (c-statistic, 0.741; 95% CI, 0.713-0.769). ROC analysis identified a score of 3 as having the best diagnostic accuracy.

8 Results The predictive accuracy of the CIN risk score was good (c-statistic, 0.741; 95% CI, ). ROC analysis identified a score of 3 as having the best diagnostic accuracy. Blue line: Bartholomew s risk score model (0.589; 95% CI, ) Green line: Mehran s risk score model (0.594; 95% CI, ) Red line: Proposed risk score model (0.741; 95%CI, )

9 Results Using a predefined cut-off value of 3, our model exhibited an overall sensitivity of 67% and a specificity of 76%, corresponding to a negative predictive value of 93% and a positive predictive value of 34%. Moreover, our model yielded a positive likelihood ratio of 2.8 (95% CI 2.5 to 3.1) and a negative ratio of 0.4 (95% CI 0.4 to 0.5). Applying Bayes' theorem, if we consider 16% as the pretest probability for developing CIN, the post-test probability for developing CIN, when the risk score is 3, is 34% (95% CI 31 to 37). Similarly, the post-test probability for not developing CIN, when the risk score <3, is 7.5% (95% CI 6 to 8).

10 Results vs Mehran s Risk score vs Bartholomew s Risk score Patients who developed CIN Patients who did not developed CIN Reclassified to higher category Reclassified to lower category Reclassified to higher category Reclassified to lower category 220 / 423 (52%) 265 /423 (63%) 11 / 423 (3%) 1 / 423 (<1%) 460 /2266 (20%) 454 / 2266 (20%) 117 / 2266 (5%) 15 /2266 (<1%) Reclassification analysis P -value P-value NRI * (%) 34.3 < <0.001 IDI (%) 11.9 < <0.001

11 Results Criteria for CIN definition CIN incidence (%) AUC (95%CI) OR * (95% CI) Sn % Sp % +PV % -PV % Increase in serum creatinine levels at 48 hours after PCI compared to pre-pci levels 0.3 mg/dl ( ) 1.8 ( ) mg/dl ( ) 1.84 (1.67-2) mg/dl 3, ( ) 1.81 (1.61-2) % 2, ( ) 1.74 ( ) % ( ) 1.69 ( ) % or mg/dl ( ) 1.74 ( ) % or mg/dl ( ) 1.8 ( )

12 Results AUC (95%CI) CIN incidence (%) P value * Subgroup Age > 70 years ( ) 20.8 Age 70 years ( ) 13.7 Ejection fraction <35% ( ) 19.8 Ejection fraction 35% ( ) 15.3 Male ( ) 12.9 Female ( ) 22.4 Elective procedure ( ) 15.2 Urgent / emergency procedure ( ) 16.2 Hydration treatment ( ) 15.8 No hydration ( ) 15.6 Other prophylactic measures ( ) 12.6 Not other prophylactic measures ( ) 16.4 Low-osmolar or non-ionic contrast agent ( ) 14.5 Iso-osmolar or ionic contrast agent ( )

13 Discussion : Advantages Examined the development of a CIN risk model in all- comers, that is both elective and emergency PCI. Special care was taken during model construction to take into account pre existing co-morbidities and pre-pci medication. Simply requires the addition of the weighted scores of 5 readily available variables, instead of a more elaborate combination of 8 or more factors. Outperformed 2 established risk score models and re-classified more accurately PCI patients compared to established risk scores

14 Discussion : Limitations Head-to-head comparisons should be interpreted with caution due to different CIN definitions Most of the procedures included intervention in 1 vessel (92%) Patients with risk scores of up to 7 were included in the validation cohort The incidence of CIN patients requiring dialysis was relatively low (n = 11, 0.4%) to allow any statistical analysis A novel risk prediction algorithm for renal complications in PCI setting has recently been published (Blue Cross Blue Shield of Michigan) which was not used as a means of comparison

15 Discussion : Conclusions In conclusion, the new risk score can easily be applied in the setting of urgent or elective PCI, allows for robust risk assessment and offers the potential to improve the periinterventional management of patients at risk for CIN However, it must be underscored that, as previous prognostic strategies, the present risk score appears more clinically useful in the identification of patients unlikely to develop CIN.

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