Paris, August 28 th 2011 Is TAVI the definitive treatment in high risk patients? Impact Of Coronary Artery Disease In Elderly Patients Undergoing TAVI: Insight The Italian CoreValve Registry Gian Paolo Ussia on behalf of the CoreValve Italian Registry Investigators Cardiovascular Department and Division of Cardiology Ferrarotto Hospital - University of Catania Catania, Italy
Disclosure Proctor physician for CoreValve Medtronic
Background Coronary artery disease in patients with degenerative aortic stenosis is a common condition The presence of CAD increases procedural risk with conventional aortic valve replacement When both conditions are present, a strategy of CABG and AVR in the same session is the current standard of care Impact of ischemic heart disease on outcomes of TAVI has not been well delineated yet
171 patients Coexisting coronary artery disease negatively impacts procedural outcomes and long-term survival in patients undergoing TAVI 136 patients Presence of CAD or nonrevascularized myocardium was not associated with an increased risk of adverse events
First patient June 2007 Methods The Italian CoreValve Registry Since June 2007 a web-based registry was started 14 participating sites Catania, University Pisa, University Brescia, H. Civile Padova, University Milano, S.Ambrogio 663 patients treated with TAVI 359 patients with CAD 54.5% Milano, Niguarda Firenze, Careggi Milano, S.Raffaele Bologna, University Roma, S. Camillo Legnano Firenze, Careggi Bari, University Mirano
Methods Endpoints & Definitions Prior Myocardial Infarction Prior PCI Angiographic finding of coronary stenosis >70% Prior CABG One of these Coronary Artery Disease
Results Baseline Clinical Characteristics I Overall population (n = 659) CAD group (n = 356) nocad group (n = 303) p value Age, years±sd 81.2±5.8 80.9±5.7 81.6 ±5.9 0.102 Female gender, n (%) 368 (55.8) 159 (44.3) 209 (68.9) <0.001* Diabetes mellitus, n (%) 173 (26.2) 106 (29.5) 67 (22.1) 0.026* Hypertension, n (%) 494 (74.9) 270 (75.2) 224 (73.9) 0.572 Prior acute pulmonary edema, n (%) 212 (32.2) 120 (33.4) 92 (30.4) 0.360 Prior balloon valvuloplasty, n (%) 112 (16.9) 62 (17.3) 50 (16.5) 0.756 Prior stroke, n (%) 48 (7.3) 28 (7.8) 20 (6.6) 0.534 Peripheral vascular disease, n (%) 126 (19.1) 96 (26.7) 30 (9.9) <0.001* COPD, n (%) 139 (21.1) 72 (20.0) 67 (22.1) 0.554 Cirrhosis Child class A or B, n (%) 13 (1.9) 5 (1.4) 8 (2.6) 0.256 Prior neoplasia, n (%) 86 (13.0) 52 (14.5) 34 (11.2) 0.198
Results Baseline Clinical Characteristics II Overall population (n = 659) CAD group (n = 356) nocad group (n = 303) p value Renal insufficiency, n (%) 154 (23.3) 102 (28.4) 42 (13.9) 0.001* Atrial fibrillation, n (%) 108 (16.4) 41 (11.4) 67 (22.1) 0.001* Prior pacemaker, n (%) 42 (6.4) 22 (6.1) 20 (6.6) 0.826 Porcelain aorta, n (%) 72 (10.9) 51 (14.2) 21 (6.9) 0.002* Unstable Angina, n (%) 31 (4.7) 24 (6.7) 7 (2.3) 0.001* Prior CABG, n (%) 104 (15.8) 104 (28.9) - - Prior PCI, n (%) 188 (28.5) 188 (52.4) - - Prior MI, n (%) 143 (21.7) 143 (39.8) - - NYHA class III and IV, n (%) 471 (71.5) 246 (68.5) 225 (74.2) 0.144 CCS class 2, 3 and 4 102 (15.5) 73 (20.3) 29 (9.6) <0.001* Logistic Euroscore, %±SD 23.1±13.7 25.5±14.4 20.0±12.1 <0.001*
Results Baseline Echo characteristics Overall population CAD group nocad group p value (n = 659) (n = 356) (n = 303) Left ventricular ejection fraction, %±SD 51.2±13.3 49.4±13.3 53.3±12.9 <0.001* Peak pressure gradient, mmhg±sd 83.4±24.7 79.1±23.8 87.2±25.0 <0.001* Mean pressure gradient, mmhg±sd 52.1±16.9 49.3±16.5 53.9±17.0 0.002* Mitral regurgitation 3+ or 4+, n (%) 41 (6.2) 23 (6.4) 18 (5.9) 0.783
Results Procedural variables Overall population CAD group nocad group p value (n = 659) (n = 356) (n = 303) Procedure time, minutes±sd 79.1±33.6 79.3±33.9 78.1±33.3 0.866 Approach 0.013* Trans-femoral, n (%) 595 (90.3) 312 (86.9) 283 (93.4) Trans-subclavian, n (%) 64 (9.7) 44 (13.1) 20 (6.6) Anesthesia 0.111 Local, n (%) 476 (72.2) 248 (69.9) 228 (75.2) General, n (%) 183 (27.8) 108 (30.1) 75 (24.8) Device 0.001* CRS 26-mm 403 (61.1) 188 (52.4) 215 (70.9) CRS 29-mm 256 (38.9) 155 (47.6) 101 (33.3)
Results Procedural Outcomes Overall population (n = 659) CAD group (n = 356) nocad group (n = 303) p value Procedural success, n (%) 648 (98.3) 351 (97.8) 297 (98.0) 0.565 Valve-in-Valve, n (%) 24 (3.6) 14 (3.9) 10 (3.3) 0.666 Post dilatation, n (%) 67 (10.2) 41 (11.4) 26 (8.6) 0.214 Death, n (%) 6 (0.9) 3 (0.8) 3 (0.9) 0.579 Myocardial infarction, n (%) 0 (0) 0 (0) 0 (0.0) 1.000 Stroke, n (%) 8 (1.2) 3 (0.8) 5 (1.6) 0.278 Conversion to open heart surgery, n (%) 5 (0.8) 3 (0.8) 2 (0.7) 0.470 MACCE, n (%) 14 (2.1) 6 (1.7) 8 (2.6) 0.397 Major access site complications, n (%) 13 (1.9) 6 (1.7) 7 (2.3) 0.565 Cardiac tamponade, n (%) 8 (1.2) 5 (1.4) 3 (0.9) 0.454
Survival, probability (%) Results 1-year survival 1.0 0.8 86.1% 84.0% 0.6 0.4 nocad group CAD group N=659 pts 0.2 0.0 Adjusted HR 1.01 (95% CI 0.55 to 1.88) Log Rank: p=0.967 0 60 120 180 240 300 360 Days (time)
Freedom from MI, probability (%) Results 1-year freedom from spontaneous MI 1.0 0.8 100% 98.0% 0.6 0.4 nocad group CAD group N=659 pts 0.2 Log Rank: p=0.014 0.0 0 60 120 180 240 300 360 Days (time)
Freedom from MACCE, probability (%) Results 1-year freedom from MACCE 1.0 84.5% 0.8 82.3% 0.6 0.4 nocad group CAD group N=659 pts 0.2 0.0 Adjusted HR 0.84 (95% CI 0.46 to 1.53) Log Rank: p=0.579 0 60 120 180 240 300 360 Days (time)
Results Subgroups Analysis 1 year MACCE 1 year All-cause death HR 95% LCL 95% UCL P value P interaction HR 95% LCL 95% UCL P value P interaction Angina + 0.87 0.12 6.16 0.891 0.94 0.07 11.55 0.906 0.872 Angina - 0.81 0.51 1.32 0.414 0.80 0.49 1.30 0.373 Age>75 0.77 0.46 1.29 0.322 0.83 0.48 1.41 0.485 0.491 Age 75 0.86 0.27 2.72 0.793 0.71 0.20 2.58 0.604 LV-EF>40 0.63 0.37 1.07 0.088 0.67 0.39 1.18 0.166 0.346 LV-EF 40 1.33 0.51 3.51 0.559 1.32 0.46 3.79 0.608 Diabetes mellitus + 0.76 0.37 1.54 0.446 0.70 0.33 1.74 0.344 0.629 Diabetes mellitus - 0.86 0.48 1.56 0.620 0.94 0.50 1.77 0.853 Logistic EuroSCORE>20 0.76 0.41 1.41 0.382 0.79 0.41 1.48 0.446 0.805 Logistic EuroSCORE 20 0.94 0.47 1.85 0.850 0.96 0.46 2.00 0.918 0.461 0.722 0.424 0.353 0.591
Results Type of revascularization pre TAVI 100% 80% N=275 pts* 83% 60% 40% 51% 49% 41% 33% 26% 20% 0% 5% 0% 1-vessel 2-vessels 3-vessels 12% Complete revascularization Incomplete revascularization No-revascularization *patents with significant coronary stenosis (not protected by bypass grafting), found at the time of the angiographic screening for TAVI
Survival, probability (%) Results Type of revascularization - Mortality 1.0 84.2% 0.8 82.3% 0.6 0.4 Complete revascularization Incomplete revascularization No revascularization 81.9% 0.2 N=275 pts 0.0 Log Rank: p=0.911 0 60 120 180 240 300 360 Days (time)
Freedom from MACCE, probability (%) Results Type of revascularization - MACCE 1.0 82.5% 0.8 81.4% 0.6 0.4 Complete revascularization Incomplete revascularization No revascularization 79.0% 0.2 N=275 pts 0.0 Log Rank: p=0.823 0 60 120 180 240 300 360 Days (time)
86 yo Angina CCs3/Pulmonary Edema Aortic Stenosis LM, LAD, Cx disease BAV PCI LM & LAD Study Limitations
PCI LAD Endeavor 2.5/18, 2.5/18, 2.75/241 LM Endeavor 3.5/9 NYHA 2 Successful TAVI with CRS 26 1 month later 3 years follow up NYHA class 2
Study Limitations Potential differences in TAVI experience among the participating centers Short Follow-up (The presence and extent of CAD is likely to impact long-term survival in patients treated with TAVI, but the length of follow-up reported in this analysis was not adequate to demonstrate this difference) The lack of specific tools such as fractional flow reserve, intravascular ultrasound, quantitative coronary analysis to assess significance of coronary stenosis
Conclusions The association of aortic stenosis and CAD is frequent Acute and mid-term outcomes of patients who underwent TAVI with CRS device were not affected by the presence of concomitant CAD In a TAVI setting for elderly, complete revascularization might not be always necessary Heart Team involvement is mandatory in the decision making
Conclusions Heart Team Mission Indications for PCI? Timing of PCI? PCI with or without Balloon Valvuloplasty? Complete or incomplete revascularization? Which stent? Reconsider SAVR + CABG? Optimal Medical Therapy?
Thank you on behalf of the CoreValve Italian Registry investigators