1. Procedural factors associated with PCI-related ischemic stroke
Rajiv Gulati MD PhD FACC
Associate Professor of Medicine
Division of Cardiovascular Diseases
Mayo Clinic
April 2012

2. Disclosures
No financial disclosures

3. Incidence of PCI-stroke 1994 – 2009 Mayo Clinic
Overall 0.36%
Stroke complications/1,000 PCIs
P=0.47
Year
Hoffman et al JACC Intv 2011

4. Stroke After PCI In-Hospital Outcomes
Controls Post-PCI stroke n=24,037 n=89
Variable No. % No. % P
Procedural success 19, <0.001
In-hospital death <0.001
In-hospital any MI 1, <0.001
In-hospital QMI
In-hospital CABG
In-hospital death/MI/CABG/TRedil 1, <0.001
Emergency use of IABP <0.001
Hypotension complication 1, <0.001
Bradycardia complication 1, <0.001
Arterial thrombosis complication
Femoral bleed complication
Hematoma complication
ST elevation complication
Cardiac arrest complication <0.001
Shock complication <0.001
Heart block complication <0.001
Renal failure complication <0.001

5. Long-term adjusted Survival
Controls
Survival (%)
Post-PCI stroke/TIA
P=0.046
Years after discharge
Hoffman et al JACC Intv 2011

6. Independent predictors of CVA Multivariate logistic regression analyses
Age
Female gender
MI within 7 days prior
Previous stroke
Intracoronary thrombus
Multivessel PCI
Hoffman et al JACC Intv 2011

7. Risk of CVA with Age and Past History of CVA Stroke complication (%)
No prior stroke; P<0.001
Prior stroke; P=0.001
Stroke complication (%)
Years

8. What causes ischemic strokes related to PCI?
Hypoperfusion
Air micro-emboli
Thrombus
Dissection
Aortic plaque displacement

9. Debris from 1000 guiding catheters
Keeley et al. JACC 1998

11. PCI related ischemic stroke
Demographic factors are not modifiable
Are procedural factors (which may be modifiable) associated with occurrence of PCI-related ischemic stroke?

12. Procedural factors and ischemic stroke
Retrospective single-center study
21,502 PCI hospitalizations
Ischemic stroke (n=79)
Stroke 60, TIA 19
Overall incidence 0.37%
Matching based on a predicted probability of stroke developed from a logistic regression model. age, gender, body mass index, unstable angina, pre-PCI MI, pre-PCI shock, CHF at presentation, hypertension, history of peripheral vascular disease, history of stroke or TIA, diabetes, chronic renal disease, ejection fraction < 40%, number of diseased vessels, presence of thrombus, multivessel intervention. Controls must have had their PCI within 2 years of their matched stroke patient and the propensity score had to be within one quarter of the sample standard deviation. Conditional logistic regression was used to compare clinical, angiographic and procedural variables between stroke patients and the matched controls.
Hoffman et al JACC Intv 2012

13. Ischemic Stroke vs Non-stroke Population
Controls PCI-stroke Variable n=21418 n=79 P
Age, yrs ± ± <0.001
Male gender (71%) (49%) <0.001
Body mass index, kg/m2 29.5± ±
Unstable angina (60%) 40 (51%) 0.089
MI within 7 days prior (32%) (59%) <0.001
History of MI (>7 days) (32%) 19 (24%) 0.14
Pre-procedural shock (4%) (11%) <0.001
CHF status
Never (85%) 55 (76%)
Previous (4%) 4 (6%)
Current (11%) 13 (18%)
History of cholesterol ≥ (75%) 56 (80%) 0.38
Peripheral vascular disease (11%) 15 (19%) 0.034
History of CVA or TIA (11%) (35%) <0.001
Diabetes (25%) 24 (31%) 0.25
Moderate-to-severe renal disease (4%) 6 (8%) 0.081
Tumor/lymphoma/leukemia (12%) 10 (13%) 0.82
Metastatic cancer (1%) 1 (1%) 0.72
EF ≤40% (10%) 13 (16%) 0.056

14. Procedural factors compared with matched control group
Ischemic stroke (n = 79) vs matched controls (n= 158)
Age, gender, BMI, unstable angina, pre-PCI MI,
pre-PCI shock, CHF, HTN, PAD, prior history
of stroke/TIA, DM, CRF, EF<40, no of diseased
vessels, presence of thrombus, multivessel intv
Procedure within 2 yrs, propensity score
within 1.4SD
Chart and procedural review
Matching based on a predicted probability of stroke developed from a logistic regression model. age, gender, body mass index, unstable angina, pre-PCI MI, pre-PCI shock, CHF at presentation, hypertension, history of peripheral vascular disease, history of stroke or TIA, diabetes, chronic renal disease, ejection fraction < 40%, number of diseased vessels, presence of thrombus, multivessel intervention. Controls must have had their PCI within 2 years of their matched stroke patient and the propensity score had to be within one quarter of the sample standard deviation. Conditional logistic regression was used to compare clinical, angiographic and procedural variables between stroke patients and the matched controls.

15. Matched controls PCI-stroke Variable n=158 n=79 P
Age, yrs ± ±
Male gender (54%) 39 (49%) 0.48
Body mass index, kg/m ± ±
Unstable angina (44%) 40 (51%) 0.36
MI within 7 days prior (59%) 46 (59%) 1.00
History of MI (>7 days) (21%) 19 (24%) 0.51
Pre-procedural shock 19 (12%) 9 (11%) 0.89
CHF status
Never 115 (78%) 55 (76%)
Previous 8 (5%) 4 (6%)
Current 25 (17%) 13 (18%)
History of cholesterol ≥ (68%) 56 (80%) 0.035
Peripheral vascular disease (24%) 15 (19%) 0.38
History of CVA or TIA (36%) 26 (35%) 0.95
Diabetes (36%) 24 (31%) 0.49
Hypertension 123 (81%) 65 (84%) 0.47
Moderate-to-severe renal disease (12%) 6 (8%) 0.28
Current/former smoker
Never (78%) (76%)
Former (5%) (6%)
Current (17%) (18%)
Prior PTCA (24%) 16 (20%) 0.51
Prior CABG (22%) 14 (18%) 0.63
Tumor/lymphoma/leukemia (12%) 10 (13%) 0.83
Metastatic cancer 3 (2%) 1 (1%) 0.72
EF ≤40% (16%) 13 (16%) 0.90
History of atrial fibrillation 14 (10%) 8 (10%) 0.82

16. Pre-PCI medications Controls PCI-stroke Variable n=158 n=79 P
Heparin (75%) (81%)
Thrombolytic (4%) (10%)
Anti-arrhythmic 19 (12%) 11 (14%) 0.69
ACE inhibitor 67 (42%) 24 (30%) 0.07
Aspirin 137 (87%) 71 (90%) 0.47
Thienopyridine 23 (15%) 16 (20%) 0.26
Beta blocker 107 (68%) 56 (73%) 0.50
Calcium channel blocker 36 (23%) 18 (23%) 1.00
Cardiac glycoside 15 (9%) 6 (8%) 0.64
Diuretic 58 (37%) 35 (45%) 0.26
Lipid-lowering 49 (31%) 21 (28%) 0.60

17. Angiographic Characteristics
Matched controls PCI-stroke Variable n=158 n=79 P
No. of Diseased vessels (70/50)
Single 35 (23%) 17 (21%)
Double (37%) 31 (37%)
Triple 58 (39%) 32 (40%)
Thrombus in any lesion 68 (47%) 38 (54%) 0.50
No. of Lesions
(62%) (53%)
(25%) (34%)
(10%) (10%)
(1%) (1%)
Urgency of PCI
Elective (26%) (24%)
Urgent (44%) (38%)
Emergency (30%) (38%)
Vein graft intervention (9%) (10%)
Procedural success (85%) (71%)

18. Procedural characteristics (1)
PCI-stroke Matched Controls P
Total No. stents placed ± ±
No. of Segments treated ± ±
Total no. vessels treated
(77%) 126 (80%)
(22%) (19%)
(1%) (1%)
Prophylactic IABP (5%) (5%)
Urgent IABP (11%) (3%)
Left ventricular assist device (1%) (1%)
GP IIb/IIIa inhibitor use (52%) (44%)
Peak ACT (sec), Median (Q1, Q3) (286, 341) (267, 349)
Hoffman et al JACC Intv 2012

19. Procedural characteristics (2)
PCI-stroke Matched Controls
Variable n= n= P
LV angio 16 (20%) (19%)
Aortic angio (1%) (2%)
Thrombectomy (8%) (4%)
Rotational atherectomy (10%) (3%)
Fluoro time (min), median (Q1, Q3) 23 (18, 39) (13, 30)
Contrast volume (cc), median (Q1, Q3) 250 (160, 350) 218 (150, 275)
Sheath size (Fr), Median (Q1, Q3) (6, 8) (6, 8) <0.001
No. of Catheters, Median (Q1, Q3) (3, 4) (2, 3) <0.001
Guide caliber <0.001
5 Fr (0%) (12%)
6 Fr (34%) (46%)
7 Fr (18%) (10%)
8+ Fr (48%) (31%)
No. of catheters <0.001
(5%) (13%)
(5%) (24%)
(59%) (40%)
(10%) (15%)
(20%) (8%)
Hoffman et al JACC Intv 2012

20. Caliber of guiding catheter PCI-stroke vs matched controls70 60 50 40
Percentage 30 20 10
5-6 Fr
7-8+ Fr
Caliber of Guiding Catheter

21. Procedural factors and ischemic PCI-stroke
Guide caliber
Number of catheter exchanges
Contrast volumes
Rotational atherectomy

22. Procedural factors and ischemic PCI-stroke
Whether relationship between procedural factors and stroke is causative remains uncertain
Plausible mechanisms (guide caliber, exchanges etc)
However may just be surrogate markers of disease complexity
Are these procedural factors truly modifiable?

23. Review of PCIs that caused stroke
18/30 8Fr procedures could have been done 6Fr
12/30 non-modifiable procedures requiring 8Fr
support (n=6), large burr atherectomy (n=4), planned or possible 2-stent strategy (n=7)
16/30 6Fr procedures could have been done 5Fr
14/30 non-modifiable
support (n=10), atherectomy (n=2), two-balloon approaches (n=9)
. Conservatively it was found that 18/30 (60%) of 8 Fr procedures could have been performed 6 Fr without impacting upstream stent strategy, procedural difficulty, or anticipated strategy in case of failure. Those procedures that were non-modifiable (n = 12) required 8 Fr guides for support due to aortic and coronary anatomy (n = 6), large burr rotational atherectomy (n = 4), simultaneous kissing stents or crush stenting approaches (n = 3) and because of an elevated risk of conversion to a two-stent strategy (n = 4). Of the 6 Fr procedures, 16/30 (53%) could be performed 5 Fr in the current era. The remaining, non-modifiable procedures required 6 Fr guides for support (n = 10), rotational atherectomy (n = 2), upfront simultaneous balloon approaches (n = 4), and anticipated risk of requiring a simultaneous balloon approach (n = 5).

24. PCI-stroke and procedural factors What can be done?
Recognize high-risk demographics eg elderly females with prior neurologic history
Meticulous procedural planning – starting with the correct guide upfront, minimizing exchange
Limit guide size
Simpler bifurcation techniques
Alternative support strategies eg guideliner
Cerebral protection in high-risk?
. Conservatively it was found that 18/30 (60%) of 8 Fr procedures could have been performed 6 Fr without impacting upstream stent strategy, procedural difficulty, or anticipated strategy in case of failure. Those procedures that were non-modifiable (n = 12) required 8 Fr guides for support due to aortic and coronary anatomy (n = 6), large burr rotational atherectomy (n = 4), simultaneous kissing stents or crush stenting approaches (n = 3) and because of an elevated risk of conversion to a two-stent strategy (n = 4). Of the 6 Fr procedures, 16/30 (53%) could be performed 5 Fr in the current era. The remaining, non-modifiable procedures required 6 Fr guides for support (n = 10), rotational atherectomy (n = 2), upfront simultaneous balloon approaches (n = 4), and anticipated risk of requiring a simultaneous balloon approach (n = 5).

25. Thank You For Your Time