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Enrico Romagnoli Comparison of Coronary Artery Bypass Surgery versus Percutaneous Coronary Intervention With Drug-Eluting Stents in Patients with Chronic.

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Presentation on theme: "Enrico Romagnoli Comparison of Coronary Artery Bypass Surgery versus Percutaneous Coronary Intervention With Drug-Eluting Stents in Patients with Chronic."— Presentation transcript:

1 Enrico Romagnoli Comparison of Coronary Artery Bypass Surgery versus Percutaneous Coronary Intervention With Drug-Eluting Stents in Patients with Chronic Kidney Disease Interventional Cardiology Unit Policlinico Casilino, Rome, Italy Interventional Cardiology Unit Policlinico Casilino, Rome, Italy

2 Background I The patient with Chronic Kidney Disease (CKD) and Coronary Artery Disease (CAD) represents special challenge for interventionalists and cardiologists in general. 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. 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. 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. More recently, the non-randomized ARTS II study demonstrated a comparable need for repeat revascularization both with PCI and CABG in general population.

4 Rationale of 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 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 We retrospectively identified all patients with Chronic kidney disease who underwent coronary revascularization at San Raffaele Hospital between 2002 and Primary end-point of the study was freedom from cerebrovascular accident, non fatal MI, or death. 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. Additional clinical end-points were post-operative acute renal failure or contrast induced nephropathy, sepsis and bleeding complication rates.

6 Methods II: patients selection For the purposes of this study, only patients who received DES stents were included in the percutaneous revascularization group. 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. 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. 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. * Cockroft DW, Gault MH. Nephron. 1976;16:31– 41.

8 CABG group PCI group patients included in the final analysis 275 patients included in the final analysis patients with CKD (<60 CrCl mil/min) 724 patients with CKD (<60 CrCl mil/min) Study period patients with ESRD or dialysis patients with valvulopathy patients without LAD disease patients with previous PCI or CABG

9 Overall PCI group CABG group p Male gender (%) Age (year) 75±873±877±7<0.01 Creatinine (mg/dl) 1.4±0.51.5±0.51.3±0.5<0.01 Creatinine Clearance (ml/min) 45.3± ± ± Previous MI (%) CAD family history (%) Hypertension (%) Hypercholesterolemia (%) Current smoker (%) Diabetes (%) Insulin treatment (%) Left ventricle ejection fraction (%) 49.2± ± ± Peripheral vascular disease (%) Chronic lung disease (%) Neurological dysfunction (%) Additive EuroSCORE 7±37±37±30.56 Logistic EuroSCORE 12±1411±1212± EuroSCORE > Study population characteristics

10 Overall PCI group CABG group pDiagnosis Acute Myocardial infarction (%) Unstable angina (%) Stable angina (%) Number of vessel disease (%) < <0.01 Left Main disease <0.01 Number of stents implanted- 3.0± Stented segment length (mm)- 74.0± Number of conduits grafted-- 2.7±1.1 - OPCAB (%) IABP use (%) Incomplete revascularization (%) Intended (%) Unwilling (%) Study procedural characteristics

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

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

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

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

15 1-year outcome comparison

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17 Correlation between renal failure and outcomes

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19 In hospital major adverse avent predictors Diabetes OR=2.4; 95%CI, , p=0.024 Unstable angina OR=1.96; 95%CI, , p=0.009 OR=5.4; 95%CI, , p=<0.01 eGFR decrease >25% CABG OR=2.4; 95%CI, , p=0.033 Hypertension OR=2.8; 95%CI, , p=0.101 OR=2.4; 95%CI, , p=0.047 Left Main disease Univariate analysis

20 In hospital major adverse avent predictors Diabetes OR=2.2; 95%CI, , p=0.056 OR=4.9; 95%CI, , p=<0.01 eGFR decrease >25% OR=2.7; 95%CI, , p=0.032 Left Main disease Multivariate analysis

21 One-year major adverse avent predictors Diabetes OR=2.0; 95%CI, , p=0.035 Unstable angina OR=2.2; 95%CI, , p=0.015 Left main disease OR=1.5; 95%CI, , p=0.275 Hypertension OR=1.9; 95%CI, , p=0.136 OR=3.3; 95%CI, , p=0.070 Emergency procedure Univariate analysis Male gender OR=2.1; 95%CI, , p=0.074 Smoking history OR=1.8; 95%CI, , p=0.071 OR=3.4; 95%CI, , p=<0.01 eGFR decrease >25%

22 One-year major adverse avent predictors Unstable angina OR=1.9; 95%CI, , p=0.052 Multivariate analysis Male gender OR=2.0; 95%CI, , p=0.093 OR=2.9; 95%CI, , p=<0.01 eGFR decrease >25%

23 This study confirms patients with CKD having a worse outcome with high rate of major adverse events, regardless of the revascularization strategy. 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. 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. 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. Discussion: DES impact on CKD

24 CABG treatment is associated with an increased risk of peri-procedural major adverse events, when compared to PCI. 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. 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. Discussion: CABG impact on CKD

25 At multivariate analysis the occurrence of post-procedural renal insufficiency is the strongest predictor of major adverse event (death, MI, or cerebrovascular events) 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. 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. Discussion: CKD impact on CKD

26 Study limitations Retrospective design and limited sample size constitute the main limitations of this study. 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. 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. 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 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. 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 Coll Cardiol Intv. 2008;1:22–31. Romagnoli E, Sangiorgi GM, Cosgrave J, et al. Drug eluting stenting the case for post- dilation. J Am Coll Cardiol Intv. 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, 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) 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 Coll Cardiol Intv. 2008;1:56–61. 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 Coll Cardiol Intv. 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). 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) 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 Pz.CauseAgeLVEF%Vessel diseaseEuroSCOREtreatment 1Pulmonary embolism (27.5%)PCI 2Tumore osseo (6.7%)PCI 3Myocardial infarction (30.4%)PCI 4Myocardial infarction (71.8%)PCI 5Infarto renale (7.3%)PCI 6Heart failure LM11 (22.9%)PCI 7Acute renal failure (11.6%)PCI 8Death during new PCI (9.6%)PCI 9Heart failure LM12 (27.4%)PCI 10Sudden death (4.7%)PCI 11Sudden death (10.2%)PCI 12Acute coronary syndrome (3.5%)CABG 13Sepsi (5.9%)CABG 14Acute renal failure LM11 (23.7%)CABG 15Heart failure (18.6%)CABG 16Infarto intestinale LM8 (9.1%)CABG 17Stroke LM4 (2.8%)CABG 18Sudden death (6.0%)CABG 19Tumore polmonare LM10 (17.3%)CABG

30 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) 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) Euroscore risk model evidences 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) Predictor of in-hospital mortality after percutaneous coronary intervention (Romagnoli et al, Heart 2008)Predictor of in-hospital mortality after percutaneous coronary intervention (Romagnoli et al, Heart 2008) 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) Predictor of in-hospital mortality after percutaneous coronary intervention (Romagnoli et al, Heart 2008)Predictor of in-hospital mortality after percutaneous coronary intervention (Romagnoli et al, Heart 2008)

31 Euroscore risk model The European System for Cardiac Operative Risk Evaluation is a method of calculating predicted operative mortality for patients undergoing cardiac surgery. 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) ; 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); Operation related factors Emergency (score 2) ; Surgery on thoracic aorta (score 3) ; Post-infarct septal rupture (score 4);

32 For these and further slides on these topics please feel free to visit the metcardio.org website:


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