Aspirin in Patients With Previous Percutaneous Coronary Intervention Undergoing Noncardiac Surgery

Michelle M Graham; Daniel I Sessler; Joel L Parlow; Bruce M Biccard; Gordon Guyatt; Kate Leslie; Matthew T V Chan; Christian S. Meyhoff; Denis Xavier; Alben Sigamani; Priya A Kumar; Marko Mrkobrada; Deborah J Cook; Vikas Tandon; Jesus Alvarez-Garcia; Juan Carlos Villar; Thomas W Painter; Giovanni Landoni; Edith Fleischmann; Andre Lamy; Richard Whitlock; Yannick Le Manach; Meylin Aphang-Lam; Juan P Cata; Peggy Gao; Nicolaas C S Terblanche; Pamidimukkala V Ramana; Kim A Jamieson; Amal Bessissow; Gabriela R Mendoza; Silvia Ramirez; Pierre A Diemunsch; Salim Yusuf; P J Devereaux

doi:10.7326/M17-2341

Aspirin in Patients With Previous Percutaneous Coronary Intervention Undergoing Noncardiac Surgery

Michelle M Graham, Daniel I Sessler, Joel L Parlow, Bruce M Biccard, Gordon Guyatt, Kate Leslie, Matthew T V Chan, Christian S. Meyhoff, Denis Xavier, Alben Sigamani, Priya A Kumar, Marko Mrkobrada, Deborah J Cook, Vikas Tandon, Jesus Alvarez-Garcia, Juan Carlos Villar, Thomas W Painter, Giovanni Landoni, Edith Fleischmann, Andre LamyRichard Whitlock, Yannick Le Manach, Meylin Aphang-Lam, Juan P Cata, Peggy Gao, Nicolaas C S Terblanche, Pamidimukkala V Ramana, Kim A Jamieson, Amal Bessissow, Gabriela R Mendoza, Silvia Ramirez, Pierre A Diemunsch, Salim Yusuf, P J Devereaux

Department of Clinical Medicine

32 Citations (Scopus)

Abstract

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.

Original language	English
Journal	Annals of Internal Medicine
Volume	168
Issue number	4
Pages (from-to)	237-244
Number of pages	8
ISSN	0003-4819
DOIs	https://doi.org/10.7326/M17-2341
Publication status	Published - 20 Feb 2018

Keywords

Aged
Antihypertensive Agents/therapeutic use
Aspirin/adverse effects
Biomarkers/blood
Clonidine/therapeutic use
Drug Administration Schedule
Drug Therapy, Combination
Female
Hemorrhage/chemically induced
Humans
Male
Middle Aged
Myocardial Infarction/prevention & control
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors/adverse effects
Postoperative Complications/chemically induced
Surgical Procedures, Operative
Treatment Outcome

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10.7326/M17-2341

Cite this

Graham, M. M., Sessler, D. I., Parlow, J. L., Biccard, B. M., Guyatt, G., Leslie, K., Chan, M. T. V., Meyhoff, C. S., Xavier, D., Sigamani, A., Kumar, P. A., Mrkobrada, M., Cook, D. J., Tandon, V., Alvarez-Garcia, J., Villar, J. C., Painter, T. W., Landoni, G., Fleischmann, E., ... Devereaux, P. J. (2018). Aspirin in Patients With Previous Percutaneous Coronary Intervention Undergoing Noncardiac Surgery. Annals of Internal Medicine, 168(4), 237-244. https://doi.org/10.7326/M17-2341

Graham, MM, Sessler, DI, Parlow, JL, Biccard, BM, Guyatt, G, Leslie, K, Chan, MTV, Meyhoff, CS, Xavier, D, Sigamani, A, Kumar, PA, Mrkobrada, M, Cook, DJ, Tandon, V, Alvarez-Garcia, J, Villar, JC, Painter, TW, Landoni, G, Fleischmann, E, Lamy, A, Whitlock, R, Le Manach, Y, Aphang-Lam, M, Cata, JP, Gao, P, Terblanche, NCS, Ramana, PV, Jamieson, KA, Bessissow, A, Mendoza, GR, Ramirez, S, Diemunsch, PA, Yusuf, S & Devereaux, PJ 2018, 'Aspirin in Patients With Previous Percutaneous Coronary Intervention Undergoing Noncardiac Surgery', Annals of Internal Medicine, vol. 168, no. 4, pp. 237-244. https://doi.org/10.7326/M17-2341

@article{2ce542268ee2460d8b0868a477c04159,

title = "Aspirin in Patients With Previous Percutaneous Coronary Intervention Undergoing Noncardiac Surgery",

abstract = "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.",

keywords = "Aged, Antihypertensive Agents/therapeutic use, Aspirin/adverse effects, Biomarkers/blood, Clonidine/therapeutic use, Drug Administration Schedule, Drug Therapy, Combination, Female, Hemorrhage/chemically induced, Humans, Male, Middle Aged, Myocardial Infarction/prevention & control, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors/adverse effects, Postoperative Complications/chemically induced, Surgical Procedures, Operative, Treatment Outcome",

author = "Graham, {Michelle M} and Sessler, {Daniel I} and Parlow, {Joel L} and Biccard, {Bruce M} and Gordon Guyatt and Kate Leslie and Chan, {Matthew T V} and Meyhoff, {Christian S.} and Denis Xavier and Alben Sigamani and Kumar, {Priya A} and Marko Mrkobrada and Cook, {Deborah J} and Vikas Tandon and Jesus Alvarez-Garcia and Villar, {Juan Carlos} and Painter, {Thomas W} and Giovanni Landoni and Edith Fleischmann and Andre Lamy and Richard Whitlock and {Le Manach}, Yannick and Meylin Aphang-Lam and Cata, {Juan P} and Peggy Gao and Terblanche, {Nicolaas C S} and Ramana, {Pamidimukkala V} and Jamieson, {Kim A} and Amal Bessissow and Mendoza, {Gabriela R} and Silvia Ramirez and Diemunsch, {Pierre A} and Salim Yusuf and Devereaux, {P J}",

year = "2018",

month = feb,

day = "20",

doi = "10.7326/M17-2341",

language = "English",

volume = "168",

pages = "237--244",

journal = "Annals of Internal Medicine",

issn = "0003-4819",

publisher = "American College of Physicians",

number = "4",

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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 - 2018/2/20

Y1 - 2018/2/20

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

SN - 0003-4819

VL - 168

SP - 237

EP - 244

JO - Annals of Internal Medicine

JF - Annals of Internal Medicine

IS - 4

ER -

Aspirin in Patients With Previous Percutaneous Coronary Intervention Undergoing Noncardiac Surgery

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Keywords

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