TY - JOUR

T1 - Aspirin in Patients With Previous Percutaneous Coronary Intervention Undergoing Noncardiac Surgery

AU - Graham, Michelle M

AU - Sessler, Daniel I

AU - Parlow, Joel L

AU - Biccard, Bruce M

AU - Guyatt, Gordon

AU - Leslie, Kate

AU - Chan, Matthew T V

AU - Meyhoff, Christian S.

AU - Xavier, Denis

AU - Sigamani, Alben

AU - Kumar, Priya A

AU - Mrkobrada, Marko

AU - Cook, Deborah J

AU - Tandon, Vikas

AU - Alvarez-Garcia, Jesus

AU - Villar, Juan Carlos

AU - Painter, Thomas W

AU - Landoni, Giovanni

AU - Fleischmann, Edith

AU - Lamy, Andre

AU - Whitlock, Richard

AU - Le Manach, Yannick

AU - Aphang-Lam, Meylin

AU - Cata, Juan P

AU - Gao, Peggy

AU - Terblanche, Nicolaas C S

AU - Ramana, Pamidimukkala V

AU - Jamieson, Kim A

AU - Bessissow, Amal

AU - Mendoza, Gabriela R

AU - Ramirez, Silvia

AU - Diemunsch, Pierre A

AU - Yusuf, Salim

AU - Devereaux, P J

PY - 2018

Y1 - 2018

N2 - Background: Uncertainty remains about the effects of aspirin in patients with prior percutaneous coronary intervention (PCI) having noncardiac surgery.Objective: To evaluate benefits and harms of perioperative aspirin in patients with prior PCI.Design: Nonprespecified subgroup analysis of a multicenter factorial trial. Computerized Internet randomization was done between 2010 and 2013. Patients, clinicians, data collectors, and outcome adjudicators were blinded to treatment assignment. (ClinicalTrials.gov: NCT01082874).Setting: 135 centers in 23 countries.Patients: Adults aged 45 years or older who had or were at risk for atherosclerotic disease and were having noncardiac surgery. Exclusions were placement of a bare-metal stent within 6 weeks, placement of a drug-eluting stent within 1 year, or receipt of nonstudy aspirin within 72 hours before surgery.Intervention: Aspirin therapy (overall trial, n = 4998; subgroup, n = 234) or placebo (overall trial, n = 5012; subgroup, n = 236) initiated within 4 hours before surgery and continued throughout the perioperative period. Of the 470 subgroup patients, 99.9% completed follow-up.Measurements: The 30-day primary outcome was death or nonfatal myocardial infarction; bleeding was a secondary outcome.Results: In patients with prior PCI, aspirin reduced the risk for the primary outcome (absolute risk reduction, 5.5% [95% CI, 0.4% to 10.5%]; hazard ratio [HR], 0.50 [CI, 0.26 to 0.95]; P for interaction = 0.036) and for myocardial infarction (absolute risk reduction, 5.9% [CI, 1.0% to 10.8%]; HR, 0.44 [CI, 0.22 to 0.87]; P for interaction = 0.021). The effect on the composite of major and life-threatening bleeding in patients with prior PCI was uncertain (absolute risk increase, 1.3% [CI, -2.6% to 5.2%]). In the overall population, aspirin increased the risk for major bleeding (absolute risk increase, 0.8% [CI, 0.1% to 1.6%]; HR, 1.22 [CI, 1.01 to 1.48]; P for interaction = 0.50).Limitation: Nonprespecified subgroup analysis with small sample.Conclusion: Perioperative aspirin may be more likely to benefit rather than harm patients with prior PCI.Primary Funding Source: Canadian Institutes of Health Research.

AB - Background: Uncertainty remains about the effects of aspirin in patients with prior percutaneous coronary intervention (PCI) having noncardiac surgery.Objective: To evaluate benefits and harms of perioperative aspirin in patients with prior PCI.Design: Nonprespecified subgroup analysis of a multicenter factorial trial. Computerized Internet randomization was done between 2010 and 2013. Patients, clinicians, data collectors, and outcome adjudicators were blinded to treatment assignment. (ClinicalTrials.gov: NCT01082874).Setting: 135 centers in 23 countries.Patients: Adults aged 45 years or older who had or were at risk for atherosclerotic disease and were having noncardiac surgery. Exclusions were placement of a bare-metal stent within 6 weeks, placement of a drug-eluting stent within 1 year, or receipt of nonstudy aspirin within 72 hours before surgery.Intervention: Aspirin therapy (overall trial, n = 4998; subgroup, n = 234) or placebo (overall trial, n = 5012; subgroup, n = 236) initiated within 4 hours before surgery and continued throughout the perioperative period. Of the 470 subgroup patients, 99.9% completed follow-up.Measurements: The 30-day primary outcome was death or nonfatal myocardial infarction; bleeding was a secondary outcome.Results: In patients with prior PCI, aspirin reduced the risk for the primary outcome (absolute risk reduction, 5.5% [95% CI, 0.4% to 10.5%]; hazard ratio [HR], 0.50 [CI, 0.26 to 0.95]; P for interaction = 0.036) and for myocardial infarction (absolute risk reduction, 5.9% [CI, 1.0% to 10.8%]; HR, 0.44 [CI, 0.22 to 0.87]; P for interaction = 0.021). The effect on the composite of major and life-threatening bleeding in patients with prior PCI was uncertain (absolute risk increase, 1.3% [CI, -2.6% to 5.2%]). In the overall population, aspirin increased the risk for major bleeding (absolute risk increase, 0.8% [CI, 0.1% to 1.6%]; HR, 1.22 [CI, 1.01 to 1.48]; P for interaction = 0.50).Limitation: Nonprespecified subgroup analysis with small sample.Conclusion: Perioperative aspirin may be more likely to benefit rather than harm patients with prior PCI.Primary Funding Source: Canadian Institutes of Health Research.

KW - Aged

KW - Antihypertensive Agents/therapeutic use

KW - Aspirin/adverse effects

KW - Biomarkers/blood

KW - Clonidine/therapeutic use

KW - Drug Administration Schedule

KW - Drug Therapy, Combination

KW - Female

KW - Hemorrhage/chemically induced

KW - Humans

KW - Male

KW - Middle Aged

KW - Myocardial Infarction/prevention & control

KW - Percutaneous Coronary Intervention

KW - Platelet Aggregation Inhibitors/adverse effects

KW - Postoperative Complications/chemically induced

KW - Surgical Procedures, Operative

KW - Treatment Outcome

U2 - 10.7326/M17-2341

DO - 10.7326/M17-2341

M3 - Journal article

C2 - 29132159

VL - 168

SP - 237

EP - 244

JO - Annals of Internal Medicine

JF - Annals of Internal Medicine

SN - 0003-4819

IS - 4

ER -