Diagnostic, Technical and Medical

Transcription

1 Diagnostic, Technical and Medical Approaches to Reduce CABG Related Stroke Pieter Kappetein, Michael Mack, M.D. Dept Thoracic Surgery, Rotterdam, The Netherlands Baylor Healthcare System Dallas, TX

2 Background Risk of Stroke Neurological deficit > 72 hours In hospital/ 30 days CABG STS Database , n= 774,881 Stroke =1.4% PCI NCDR Database, , n=706,782 Stroke = 0.22 % SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 2

3 CVA (Stroke) to 12 Months CABG (N=897) TAXUS (N=903) (%) 20 P=0.003 * Cumu ulative Ev vent Rate Months Since Allocation Event rate ± 1.5 SE. * Fisher exact test 2.2% 0.6% ITT population SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 3

4 In SYNTAX, with CABG one is trading a stroke for repeat revascularization. Who wouldn t want to risk repeat revascularization with PCI rather than a stroke with CABG Common interventional cardiologist s interpretation of Syntax results

5 CVA to 3 Years CABG (N=897) TAXUS (N=903) P=0.07 Cumula ative Even nt Rate (% %) Before 1 year * 1-2 years * 2-3 years * 2.2% vs 0.6% 0.6% vs 0.7% 0.5% vs 0.6% P=0.003 P=0.82 P= % 2.0% Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*binary rates EACTS 2010 Three-year Outcomes of the SYNTAX Trial Kappetein Slide 5 ITT population

6 Patients with Stroke in SYNTAX Randomized Cohort, Intent-to-Treat Enrolled N=1800 CABG TAXUS * n=897 n=903 1 Year Follow-up N=1740 (96.7%) CABG TAXUS * n=849 n=891 Stroke n=19 Stroke n=5 * TAXUS Express SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 6

7 Outcomes Following Stroke (Per Patient) CABG (n=19) PCI (n=5) Death 10.5% (n=2) Non-fatal stroke 89.5% (n=17) Non-fatal stroke 100% (n=5) SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 7

8 Stroke With CABG Causes Preoperative Intraoperative Postoperative SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 8

9 Timing of Stroke CABG PCI Total 30 (2.8%) 18 (1.4%) Pre-procedure 3(03%) (0.3%) 0 Procedural- 30 days 9 (1%) 2 (0.2%) 30 days- 1Y Year 7(08%) (0.8%) 3(03%) (0.3%) 1-2 Years 6 (0.6%) 7 (0.7%) 2-3 Years 5 (0.5%) 6 (0.6%) SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 9 Syntax September 3, 9

10 Timing of Stroke CABG PCI Total 30 (2.8%) 18 (1.4%) Pre-procedure 3(03%) (0.3%) 0 Procedural- 30 days 9 (1%) 2 (0.2%) 30 days- 1Y Year 7(08%) (0.8%) 3(03%) (0.3%) 1-2 Years 6 (0.6%) 7 (0.7%) 2-3 Years 5 (0.5%) 6 (0.6%) SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 10 10

11 Stroke With CABG Risk Factors Preoperative Intraoperative Postoperative SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 11

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13 Early -35% Delayed- 65% Female Prior Stroke Female Prior Stroke Aortic Aortic Atherosclerosis Atherosclerosis Duration of CPB Diabetes Atrial Fibrillation SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 13

14 EACTS 2010 Three-year Outcomes of the SYNTAX Trial Kappetein Slide 14

15 Metabolic Syndrome Stroke Rate 4.7% vs 2.1% EACTS 2010 Three-year Outcomes of the SYNTAX Trial Kappetein Slide 15

16 EACTS 2010 Three-year Outcomes of the SYNTAX Trial Kappetein Slide 16

17 EACTS 2010 Three-year Outcomes of the SYNTAX Trial Kappetein Slide 17

18 Periprocedural Multivariate Predictors of Stroke at 12 Months Predictors by Treatment tarm 12 P CABG (n=897) Odds Ratio ± 95% CI OR 95% CI value Poor or moderate LVEF , 18.4 <0.001 Prior MI 0.1 0, Age , TAXUS (n=903) Hyperlipidemia Female , , Time to treatment , Reduced Increased 0 *TAXUS Express SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 18

19 Stroke With CABG Risk Factors Preoperative Intraoperative Postoperative SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 19

20 Timing of Stroke CABG PCI Total 25 (2.8%) 12 (1.4%) Pre-procedure 3(03%) (0.3%) 0 Procedural- 30 days 9 (1%) 2 (0.2%) 30 days- 1Y Year 7(08%) (0.8%) 3(03%) (0.3%) 1-2 years 6 (0.6%) 7 (0.7%) SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 20 Syntax September 3, 20

21 CVA to 12 Months by SYNTAX Score Tercile CABG TAXUS 12 Mon nth Event Rate, % P=0.10 P=0.21 P= Scores 0-22 Scores Scores 33 KM Event Rate; chi-square test RCT ITT pts; site-reported data SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 21

22 Stroke With CABG Risk Factors Intraoperative Aortic Atherosclerosis Aortic Manipulation Cardiopulmonary Bypass Cerebral Perfusion On pump vs. Off pump SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 22

23 Procedural Characteristics Notable Differences CABG RCT + Registry Procedure-related CABG RCT * (n=897) CABG Reg (n=644) Off-pump surgery, % Graft revascularization, % At least one arterial graft Arterial graft to LAD LIMA + venous Double LIMA/RIMA Complete arterial revascularization Venous graft only Grafts per patient, mean ±SD 2.8 ± ± 0.9 Distal anastomoses, mean ±SD 3.2 ± ± 1.0 * SYNTAX: Stroke TCT 2009 M.J. Mack For descriptive purposes only; no statistical comparisons done San Francisco, CA 22sep2009 Slide 23

24 Procedural Characteristics Potential Risk Factors for Stroke CABG N=897 TAXUS N=903 P value Urgent Procedure, % Emergent Procedure, % Time to procedure, d, mean ± SD 17.4 ± ± 13.0 <0.001 Off-pump surgery % Off Pump On Pump P value Stroke 1/134 (0.7%) 18/763 (2.3%) ns Site-reported data Allocation to procedure For PCI patients, includes time for staged procedure

25 EACTS 2010 Three-year Outcomes of the SYNTAX Trial Kappetein Slide 25

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27 Risk Factors, and Outcomes Associated With Stroke After Coronary Artery Bypass Grafting.more than half of strokes occurred postoperatively rather than intraoperatively JAMA. 2011;305(4): SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 27

28 EACTS 2010 Three-year Outcomes of the SYNTAX Trial Kappetein Slide 28

29 SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 29

30 Ascending Aortic Atherosclerosis SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 30

31 Ascending Aortic Atherosclerosis SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 31

32 Stroke With CABG Risk Factors Preoperative Intraoperative Postoperative SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 32

33 Timing of Stroke CABG PCI Total 25 (2.8%) 12 (1.4%) Pre-procedure 3(03%) (0.3%) 0 Procedural- 30 days 9 (1%) 2 (0.2%) 30 days- 1Y Year 7(08%) (0.8%) 3(03%) (0.3%) 1-2 years 6 (0.6%) 7 (0.7%) Syntax September 3, 33

34 Medications Potential Risk Factors for Stroke Pre/periprocedural p Medication CABG N=897 TAXUS N=903 P value Aspirin, % <0.001 Heparin (unfractionated), % <0.001 Heparin (low molecular weight), % Bivalirudin, % <0.001 Thienopyridine, % < Aprotinin, % Medication at Discharge Aspirin, % <0.001 Thienopyridine, % <0.001 Coumadin, % < Statin, % Site-reported data

35 Medications at 12 Months Potential Risk Factors for Stroke CABG N=897 TAXUS N=903 P value Aspirin, % <0.001 Statin, % Beta blockers, % ACE inhibitors, % Thienopyridines, % <0.001 Diuretics, % Calcium channel blockers, % Angiotensin II receptor antagonists, % Nitrates <0.001 Oral antidiabetic, non insulinsensitizer, % H2-receptor blockers, % Medications taken by 10% of patients in either group. Site-reported data

36 Adverse Cardiac Events to 12 Months CABG (n=19) 6 patients experienced atrial fibrillation (1 patient had an additional ST elevation MI); in 2 of these patients, the arrhythmia possibly led to the stroke 13 -no adverse cardiac events PCI (n=5) 3 patients had cardiac events (cardiac failure, angina, ST+MI) 2 -no adverse cardiac events SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 36

37 30 day Mortality and stroke higher in the 24% of patients with AF (2.4 % vs 19%) 1.9%) SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 37

38 Antiplatelet Therapy Status at Time of Stroke (Per Patient) Neither 26.3% (n=5) Unknown 10.5% (n=2) CABG (n=19) Aspirin i 52.6% (n=10) PCI (n=5) Dual Antiplatelet Therapy 80.0% (n=4) Clopidogrel Dual Antiplatelet only Therapy 53%(n=1) 5.3% 53%( 5.3% (n=1) Unknown 20.0% (n=1) SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 38

39 SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 39

40 Statins Reduce: Stroke Atrial Fibrillationill Inflammatory Response from CPB SVG Disease Native CAD SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 40

41 EACTS 2010 Three-year Outcomes of the SYNTAX Trial Kappetein Slide 41

42 Conclusions How to Reduce Stroke With CABG Preoperative Screening Recognition of High Risk Patients Epiaortic Scanning on ALL Patients At Least Selective Use of Off Pump CABG No Touch Aortic Technique as Much As Possible Aggressive Treatment of AF Anticoagulation of Postoperative AF??? Aggressive Use of Statins Consider dual anti-platelet therapy (DAPT) especially with Off Pump SYNTAX: Stroke TCT 2009 M.J. Mack San Francisco, CA 22sep2009 Slide 42 42