1. POISE-2 PeriOperative ISchemic Evaluation-2 Trial
Aspirin in pa)ents with previous percutaneous coronary interven)on (PCI) undergoing noncardiac surgery: The POISE-2 PCI Substudy
Dr. Michelle M. Graham
University of Alberta and Mazankowski Alberta Heart Ins>tute,
Edmonton, Canada
on behalf of POISE-2 Inves>gators

2. Background Globally >200 million noncardiac surgeries annually
10 million suffer major vascular complica>on
increased mortality, hospitaliza>on, costs
Providers commonly encounter pa>ents with previous PCI undergoing surgery
increased risk of major periopera>ve complica>ons
Uncertainty remains regarding effects of aspirin in pa>ents with prior PCI who are undergoing noncardiac surgery

3. POISE-2
POISE-2 randomized 10,010 pa>ents having noncardiac surgery to aspirin versus placebo
aspirin did not prevent primary outcome of death/MI but increased risk of major bleeding
Steering CommiQee did not expect randomiza>on of pa>ents with prior PCI and did not pre-specify PCI subgroup analysis
however, 470 prior PCI pa>ents were randomized
We therefore undertook analyses to determine
whether subgroup effect was present among pa>ents 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 complica>on
Excluded pa>ents
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 defini)ons MI – universal defini>on 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;
interven>on (e.g., emboliza>on); 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. Preopera)ve characteris)cs
Aspirin
Placebo
(N=234)
(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
con>nua>on stratum (%)
85.9
85.6

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

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

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

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

13. Death/MI in prior PCI pa)ents

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

15. Primary outcome

16. Post-hoc analysis of overall POISE-2 popula)on
Subgroup analysis based upon history of coronary artery disease (CAD) (n=2268)
to assess if PCI subgroup effect was simply reflec>ve of CAD
In contrast to PCI subgroup analyses
CAD subgroup analysis for primary outcome and MI demonstrated no support for subgroup effect
interac>on 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