POISE-2 PeriOperative ISchemic Evaluation-2 Trial

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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

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

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

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

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

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

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

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

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 34-113)

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 (0.86-1.15) No Prior PCI 337/4764 (7.1) 328/4776 (6.9) 1.03 (0.89-1.20) 0.036 Prior PCI 14/234 (6.0) 27/236 (11.4) 0.50 (0.26-0.95)

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 (0.86-1.15) No Prior PCI 337/4764 (7.1) 328/4776 (6.9) 1.03 (0.89-1.20) 0.036 Prior PCI 14/234 (6.0) 27/236 (11.4) 0.50 (0.26-0.95) MI 0.98 (0.84-1.15) 1.03 (0.88-1.21) 0.44 (0.22-0.87) 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

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 (0.86-1.15) No Prior PCI 337/4764 (7.1) 328/4776 (6.9) 1.03 (0.89-1.20) 0.036 Prior PCI 14/234 (6.0) 27/236 (11.4) 0.50 (0.26-0.95) MI overall trial 309/4998 (6.2) 315/5012 (6.3) 0.98 (0.84-1.15) No Prior PCI 297/4764 (6.2) 289/4776 (6.1) 1.03 (0.88-1.21) 0.021 Prior PCI 12/234 (5.1) 26/236 (11.0) 0.44 (0.22-0.87) Death overall trial 65/4998 (1.3) 62/5012 (1.2) 1.05 (0.74-1.49) No Prior PCI 63/4764 (1.3) 59/4776 (1.2) 1.07 (0.75-1.53) 0.61 Prior PCI 2/234 (0.9) 3/236 (1.3) 0.65 (0.11-3.91)

Death/MI in prior PCI pa)ents

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 (1.01-1.48) 222/4764 (4.7) 180/4776 (3.8) 1.24 (1.02-1.51) 0.50 8/234 (3.4) 9/236 (3.8) 0.85 (0.33-2.20)

Primary outcome

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

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