PeriOperative Aspirin in Noncardiac Surgery After PCI: POISE-2 PCI Substudy

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 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

9. PCI characteristics

10. Outcomes

11. Outcomes

12. Outcomes

13. Death/MI in prior PCI patients

14. Outcomes

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