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Enrico Romagnoli

Comparison of Coronary Artery Bypass Surgery versus Percutaneous Coronary Intervention With Drug-Eluting Stents in Patients with Chronic Kidney Disease. Enrico Romagnoli. Interventional Cardiology Unit Policlinico Casilino , Rome, Italy enromagnoli@gmail.com. Background I.

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Enrico Romagnoli

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  1. Comparison of Coronary Artery Bypass Surgery versus Percutaneous Coronary Intervention With Drug-Eluting Stents in Patients with Chronic Kidney Disease Enrico Romagnoli Interventional Cardiology Unit PoliclinicoCasilino, Rome, Italy enromagnoli@gmail.com

  2. Background I • The patient with Chronic Kidney Disease (CKD) and Coronary Artery Disease (CAD) represents special challenge for interventionalists and cardiologists in general. • Indeed, CKD is associated to worse outcomes both with percutaneous and surgical coronary revascularization with an increased incidence of both in-hospital and long-term clinical events.

  3. Background II • A post-hoc analysis of patients with CKD enrolled in the Arterial Revascularization Therapies Study (ARTS) trial comparing CABG versus PCI showed equivalent mortality and morbidity at 5 year, but the requirement for repeat procedures remained significantly higher after PCI treatment. • More recently, the non-randomized ARTS II study demonstrated a comparable need for repeat revascularization both with PCI and CABG in general population.

  4. Rationaleof the study • At present, available data on DES safety and efficacy in patients with CKD are limited to small single-center registries, therefore it is not known whether the improved outcomes in PCI with DES will be extended to patients with CKD disease. • With this study we sought to compare the impact of DES introduction on clinical outcome of patients with CKD, when compared to CABG.

  5. Methods I: end-points • We retrospectively identified all patients with Chronic kidney disease who underwent coronary revascularization at San Raffaele Hospital between 2002 and 2006. • Primary end-point of the study was freedom from cerebrovascular accident, non fatal MI, or death. The Secondary end-point was the need for repeat revascularization by percutaneous or surgery. • Additional clinical end-points were post-operative acute renal failure or contrast induced nephropathy, sepsis and bleeding complication rates.

  6. Methods II: patientsselection • For the purposes of this study, only patients who received DES stents were included in the percutaneous revascularization group. • Patients who had a prior PCI or CABG, with valvular heart disease, congenital heart disease, obstructive or restrictive cardiomyopathy, and candidate for cardiac or renal transplantation were excluded. • In general, patients who were thought not to be equal candidates for either CABG or PCI with DES (e.g. limited life expectancy, intolerance to aspirine or ticlopidine) were not included in the final analysis.

  7. Methods III: CKD definition • Creatinine levels were measured the day before the time of the procedure, and renal function was assessed based on the CrCl using the Cockcroft-Gault formula*: (140-age) x weight (Kg) CrCl (ml/min) = (x 0.85 for females) 72 x serum creatinine (mg/dl) • Renal impairment was defined as a calculated creatinine clearance <60 ml/min, the cut-off value proposed by the National Kidney Foundation’s Kidney Disease Outcome Quality Initiative Advisory Board to identify patients who have moderate renal impairment. *Cockroft DW, Gault MH. Nephron. 1976;16:31– 41.

  8. Study period 2002-2006 724 patients with CKD (<60 CrCl mil/min) PCI group CABG group 407 317 26 10 36 patients with ESRD or dialysis 12 137 149 patients with valvulopathy 51 5 56 patients without LAD disease 180 28 208 patients with previous PCI or CABG 138 137 275 patients included in the final analysis

  9. Studypopulationcharacteristics

  10. Study procedural characteristics

  11. PCI CABG Results: in-hospital outcome primary end-points P=0.02 P=0.44 P=0.33 P=0.03 P= n.s. 16.1% 9.5% 6.5% 5.8% 4.4% 3.6% 1.4% 0% 0% 0% TIA/Stroke TVR/TLR Death MI TIA/Stroke Death MI

  12. PCI CABG Results: in-hospital outcome secondary end-points P=<0.01 P=<0.01 P=0.027 P=0.99 P=0.02 P=0.01 47.5% 35.7% 16.0% 9.5% 10.2% 8.0% 7.2% 2.9% 1.4% 2.9% 2.2% 0.7% Sepsis Major bleeding MAE GFR >25% GFR>75% (dialysis) GFR >50%

  13. PCI CABG Results: 1-year follow up primary end-points P=0.73 P=0.99 P=0.98 P=0.07 P=<0.01 23.2% 19.7% 17.4% 10.9% 10.2% 8.0% 7.3% 5.1% 2.2% 0.7% TIA/Stroke repeat revascularization Death MI TIA/Stroke Death Cum MI

  14. PCI CABG Results: long term follow up primary end-points (median 38 months) P=0.86 P=0.98 P=0.97 P=0.21 P=<0.01 29.0% 27.0% 25.4% 15.2% 14.6% 11.6% 10.9% 5.8% 4.4% 2.2% TIA/Stroke repeat revascularization Death MI TIA/Stroke Death Cum MI

  15. 1-year outcomecomparison

  16. 1-year outcomecomparison

  17. Correlation between renal failure and outcomes

  18. Correlation between renal failure and outcomes

  19. In hospital major adverseaventpredictors 0.01 0.1 1 5 10 15 Univariate analysis CABG OR=2.4; 95%CI, 1.1-5.6, p=0.033 Hypertension OR=2.8; 95%CI, 0.8-9.6, p=0.101 Left Main disease OR=2.4; 95%CI, 1.0-5.6, p=0.047 Diabetes OR=2.4; 95%CI, 1.1-5.3, p=0.024 Unstable angina OR=1.96; 95%CI, 0.9-4.3, p=0.009 eGFR decrease >25% OR=5.4; 95%CI, 2.4-11.9, p=<0.01 0.01 0.1 1 5 10 15

  20. In hospital major adverseaventpredictors 0.01 0.1 1 5 10 15 Multivariate analysis Diabetes OR=2.2; 95%CI, 1.0-5.1, p=0.056 Left Main disease OR=2.7; 95%CI, 1.1-6.8, p=0.032 eGFR decrease >25% OR=4.9; 95%CI, 2.2-11.2, p=<0.01 0.01 0.1 1 5 10 15

  21. One-year major adverseaventpredictors 0.01 0.1 1 5 10 15 Univariate analysis Left main disease OR=1.5; 95%CI, 0.7-3.3, p=0.275 Smoking history Male gender Hypertension OR=1.8; 95%CI, 0.9-3.4, p=0.071 OR=2.1; 95%CI, 0.9-4.7, p=0.074 OR=1.9; 95%CI, 0.8-4.5, p=0.136 Emergency procedure OR=3.3; 95%CI, 0.9-12.4, p=0.070 Diabetes OR=2.0; 95%CI, 1.1-3.7, p=0.035 Unstable angina OR=2.2; 95%CI, 1.2-4.2, p=0.015 eGFR decrease >25% OR=3.4; 95%CI, 1.7-6.6, p=<0.01 0.01 0.1 1 5 10 15

  22. One-year major adverseaventpredictors 0.01 0.1 1 5 10 15 Multivariate analysis Male gender OR=2.0; 95%CI, 0.9-4.7, p=0.093 Unstable angina OR=1.9; 95%CI, 1.0-3.8, p=0.052 eGFR decrease >25% OR=2.9; 95%CI, 1.4-5.8, p=<0.01 0.01 0.1 1 5 10 15

  23. Discussion: DES impact on CKD • This study confirms patients with CKD having a worse outcome with high rate of major adverse events, regardless of the revascularization strategy. • At 1-year follow up, multivessel stenting with DES showed similar outcomes of death, MI or cerebrovascular events when compared to surgical revascularization. • The higher rate of TVR at 1-year follow up in the PCI group suggests that use of DES does not prevent repeat revascularization when compared to CABG.

  24. Discussion: CABG impact on CKD • CABG treatment is associated with an increased risk of peri-procedural major adverse events, when compared to PCI. • In particular, renal impairment and cerebrovascular event was 5 folds higher in the CABG group. At 1-year follow up the difference is still significant for cerebrovascular events.

  25. Discussion: CKD impact on CKD • At multivariate analysis the occurrence of post-procedural renal insufficiency is the strongest predictor of major adverse event (death, MI, or cerebrovascular events) • There is a correlation between the grade of post-procedural renal impairment and the rate of adverse events, with the worst outcome in patients requiring dialysis treatment.

  26. Studylimitations • Retrospective design and limited sample size constitute the main limitations of this study. • Only minority of patients were jointly evaluated by cardiac surgery and interventional cardiology consultants, then the choice of the revascularization strategy has been left to the patient-referring physician.

  27. Conclusions • This is the first study to compare clinical outcomes of DES versus CABG in patients with CKD. • The use of DES does not seem to confer incremental benefits in death, MI or cerebrovascular events when compared to CABG, and does not offer comparable results in term of need for repeat revascularization. • The lower rate of in hospital adverse events suggests that PCI with DES could be an acceptable and less invasive alternative to CABG in patients at high surgical risk.

  28. Main goals during the Master As first author: • Romagnoli E, Sangiorgi GM, Cosgrave J, et al. Drug eluting stenting the case for post-dilation. J Am CollCardiolIntv. 2008;1:22–31. • Romagnoli E, Chieffo A,Ferrari A, et al. Randomized Comparison between Sirolimus (Cypher)/Sirolimus-analogous (Xience, Promus) vs. Paclitaxel (Taxus vs. Costar) Eluting Stents in Coronary Lesions: a Single Centre Experience. The ABSOLUTE Trial (submitted) • Romagnoli E, Carminati M, Chessa M. Detachable coil use to treat residual shunt after PFO percutaneous closure (submitted) As co-author: • Rogacka R, Chieffo A, Michev I, et al. Dual antiplatelet therapy after percutaneous coronary intervention with stent implantation in patients taking chronic oral anticoagulation. J Am CollCardiolIntv. 2008;1:56–61. • Sangiorgi G, Romagnoli E, Biondi-Zoccai GGL, et al. Percutaneous coronary implantation of sirolimus-eluting stents in unselected patients and lesions: clinical results and multiple outcome predictors (submitted). • Butera G, Romagnoli E, Sangiorgi G, et al. Patent Foramen ovale percutaneous closure: the no-implannt approach. Expert Rev. Med Devices 2008;5 (in press)

  29. Euroscore risk model evidences • Predictor of late outcome after CABG • (Toumpouls IK et al Eur J Cardiothorac Surg. 2004; • Biancari F et al, Ann Thorac Surg. 2006) • Predictor of prolonged lenght stay and specific postoperative complications such as renal failure and sepsis and/or endocarditis after CABG • (Toumpoulis IK et al. Int J Cardiol 2005) • Independent predictor of myocardial damage • (Onorati F, Ann Thorac Surg. 2005) • Selection criterium of off-pump CABG in high risk patients (Euroscore≥10 and EF <30%) • (Kunt AS et al, Curr Control Trials Cardiovasc Med. 2005) • Predictorofin-hospitalmortalityafter percutaneous coronaryintervention(Romagnoli et al, Heart 2008)

  30. Euroscore risk model The European System for Cardiac Operative Risk Evaluation is a method of calculating predicted operative mortality for patients undergoing cardiac surgery. • Cardiac-related factors • Unstable angina (score 2); • LV dysfunction • LVEF 30-50% (score 1); • LVEF ≤29% (score 3); • Recent myocardial infarction (score 2); • PAPS >60 mmHg (score 2); • Patient-related factors • Age (score 1, per 5 years over 60 years); • Sex (score 1, per female); • Chronic pulmonary disease (score 1); • Peripheral vascular disease (score 2); • Neurological dysfunction (score 2); • Previous cardiac surgery (score 3); • Serum creatinine >200 mol/l (score 2); • Active endocarditis (score 3); • Critical pre-operative state (score 3); • Operation related factors • Emergency (score 2); • Surgery on thoracic aorta (score 3); • Post-infarct septal rupture (score 4);

  31. For these and further slides on these topics please feel free to visit the metcardio.org website:http://www.metcardio.org/slides.html

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