1. POISE-2
PeriOperative ISchemic Evaluation-2 Trial
Aspirin in patients with previous percutaneous coronary intervention (PCI) undergoing noncardiac surgery: The POISE-2 PCI Substudy
Dr. Michelle M. Graham
University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Canada
on behalf of POISE-2 Investigators

2. Background Globally >200 million noncardiac surgeries annually
10 million suffer major vascular complication
increased mortality, hospitalization, costs
Providers commonly encounter patients with previous PCI undergoing surgery
increased risk of major perioperative complications
Uncertainty remains regarding effects of aspirin in patients with prior PCI who are undergoing noncardiac surgery

3. POISE-2
POISE-2 randomized 10,010 patients having noncardiac surgery to aspirin versus placebo
aspirin did not prevent primary outcome of death/MI but increased risk of major bleeding
Steering Committee did not expect randomization of patients with prior PCI and did not pre-specify PCI subgroup analysis
however, 470 prior PCI patients were randomized
We therefore undertook analyses to determine whether subgroup effect was present among patients with prior PCI

4. Methods Design – blinded 2 X 2 factorial RCT
Aspirin versus placebo and clonidine versus placebo
Eligibility criteria – undergoing noncardiac surgery, ≥45 yrs, at risk of vascular complication
Excluded patients
BMS <6 weeks before surgery
DES <1 year before surgery
took aspirin within 72 hrs before surgery

5. Methods 2 aspirin strata Intervention Primary outcome
initiation stratum
continuation stratum
Intervention
aspirin/placebo (200 mg) just before surgery
continued daily (100 mg) 30 days in initiation stratum and 7 days in continuation stratum
Primary outcome
death or nonfatal MI at 30 days

6. Outcome definitions MI – universal definition of MI
Major bleed – bleeding event
Hb ≤70 g/L and ≥2 units RBCs;
Hb drop ≥50 g/L and ≥2 units of RBCs;
≥4 units of RBCs within 24 hr period;
intervention (e.g., embolization); or
retroperitoneal, intraspinal, or intraocular bleed

7. Prior PCI subgroup 470 patients with prior PCI
randomized at 82 centres in 21 countries
234 randomized to aspirin
236 randomized to placebo
30-day follow-up 99.9% complete

8. Preoperative characteristics
Aspirin
(N=234)
Placebo
(N=236)
age – (mean yrs)
67.3
68.0
female (%)
22.6
22.0
major surgery (%)
59.4
59.3
diabetes (%)
29.5
30.5
CHF (%)
6.0
3.0
hypertension (%)
76.9
82.2
chronic kidney disease (%)
3.8
1.7
continuation stratum (%)
85.9
85.6

9. PCI characteristics PCI characteristics N (%) Bare-metal stent
255 (54.3)
drug-eluting stent
119 (25.3)
unknown type of stent
55 (11.7)
no stent
41 (8.7)
PCI with uncertainty regarding whether stent was used
2 (0.4%)
median duration from PCI to noncardiac surgery
64 months
(IQR )

10. Outcomes Outcome Aspirin n/N (%) Placebo HR (95% CI) Interaction
P Value
Death/MI
overall trial
No Prior PCI
Prior PCI
351/4998 (7.0)
337/4764 (7.1)
14/234 (6.0)
355/5012 (7.1)
328/4776 (6.9)
27/236 (11.4)
0.99 ( )
1.03 ( )
0.50 ( )
0.036

11. Outcomes Outcome Aspirin n/N (%) Placebo HR (95% CI) Interaction
P Value
Death/MI
overall trial
No Prior PCI
Prior PCI
351/4998 (7.0)
337/4764 (7.1)
14/234 (6.0)
355/5012 (7.1)
328/4776 (6.9)
27/236 (11.4)
0.99 ( )
1.03 ( )
0.50 ( )
0.036 MI
309/4998 (6.2)
297/4764 (6.2)
12/234 (5.1)
315/5012 (6.3)
289/4776 (6.1)
26/236 (11.0)
0.98 ( )
1.03 ( )
0.44 ( )
0.021

12. Outcomes Outcome Aspirin n/N (%) Placebo HR (95% CI) Interaction
P Value
Death/MI
overall trial
No Prior PCI
Prior PCI
351/4998 (7.0)
337/4764 (7.1)
14/234 (6.0)
355/5012 (7.1)
328/4776 (6.9)
27/236 (11.4)
0.99 ( )
1.03 ( )
0.50 ( )
0.036 MI
309/4998 (6.2)
297/4764 (6.2)
12/234 (5.1)
315/5012 (6.3)
289/4776 (6.1)
26/236 (11.0)
0.98 ( )
1.03 ( )
0.44 ( )
0.021
Death
65/4998 (1.3)
63/4764 (1.3)
2/234 (0.9)
62/5012 (1.2)
59/4776 (1.2)
3/236 (1.3)
1.05 ( )
1.07 ( )
0.65 ( )
0.61

13. Death/MI in prior PCI patients

14. Outcomes Outcome Aspirin n/N (%) Placebo HR (95% CI) Interaction
P Value
Major bleeding
overall trial
No Prior PCI
Prior PCI
230/4998 (4.6)
222/4764 (4.7)
8/234 (3.4)
189/5012 (3.8)
180/4776 (3.8)
9/236 (3.8)
1.22 ( )
1.24 ( )
0.85 ( )
0.50

15. Primary outcome

16. Post-hoc analysis of overall POISE-2 population
Subgroup analysis based upon history of coronary artery disease (CAD) (n=2268)
to assess if PCI subgroup effect was simply reflective of CAD
In contrast to PCI subgroup analyses
CAD subgroup analysis for primary outcome and MI demonstrated no support for subgroup effect
interaction p values >0.45

17. Conclusions
For every 1000 patients with prior PCI, perioperative aspirin will prevent 59 MIs but cause 8 major bleeds
Among those with prior PCI undergoing noncardiac surgery, preoperative aspirin may be more likely to benefit than harm patients