The Impact of Early Surgery and Maintenance of Antiplatelet Therapy on Intraoperative Bleeding and Major Adverse Cardiovascular Event After Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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Recent guidelines of the ACC/AHA suggest that elective non-cardiac surgery (NCS) should optimally be delayed one year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Regarding the antiplatelet agents, dual antiplatelet therapy, or at least aspirin is recommended to be continued considering the relative risk of bleeding and stent thrombosis especially during the first 4 to 6 weeks after DES implantation. However, these recommendations are based upon insufficient and conflicting evidences.

Detailed Description
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Recent guidelines of the ACC/AHA suggest that elective non-cardiac surgery (NCS) should optimally be delayed one year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Regarding the antiplatelet agents, dual antiplatelet therapy, or at least aspirin is recommended to be continued considering the relative risk of bleeding and stent thrombosis especially during the first 4 to 6 weeks after DES implantation. However, these recommendations are based upon insufficient and conflicting evidences. The aim of our study was (1) to determine independent risk factors for postoperative adverse events and the strength of their association, (2) to assess the incidences of postoperative morbidities including major adverse cardiovascular and cerebral event as a function of time between PCI and surgery and (3) to compare bleeding amount and transfusion requirements between different intervals from PCI to surgery and durations of antiplatelet agent administration prior to surgery. To achieve this aim, we undertook a retrospective cohort study of the patients who underwent noncardiac surgery after PCI with DES.

Official Title
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The Impact of Early Surgery and Maintenance of Antiplatelet Therapy on Intraoperative Bleeding and Major Adverse Cardiovascular Event After Percutaneous Coronary Intervention

Conditions
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Acute Coronary Syndrome, Drug-eluting Stent, Aspirin

Intervention / Treatment
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* Procedure: Non-cardiac surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients who underwent non-cardiac surgery within 5 years after percutaneous coronary intervention with drug-eluting stent at Seoul National University Hospital between April 2004 and August 2017 Exclusion Criteria: Patients who underwent percutaneous coronary intervention with balloon angioplasty or bare metal stent

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-cardiac surgery after DES<br>The patients who underwent non-cardiac surgery after percutaneous coronary intervention with drug-eluting stent | Procedure: Non-cardiac surgery<br>* Any surgery with general anesthesia except cardiac surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular and cerebral event | a composite of non-fatal myocardial infarction, coronary revascularization, pulmonary embolism and stroke | during postoperative 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite morbidity | composite of overall postoperative morbidity, including Major adverse cardiovascular and cerebral event and all respiratory, cardiac, renal and other complications during postoperative 30 days. | during postoperative 30 days | 
| Major bleeding event | a bleeding event with any one of the following (1) A preoperative hematocrit ≤ 30% or a drop of hematocrit ≥10% as well as transfusion of ≥2 units of RBC during the surgery, or (2) the patient received a transfusion of ≥4 units of red blood cells within a 24 hour period, or (3) any one of the following interventions (i.e., embolization, superficial vascular repair, nasal packing); or retroperitoneal, intraspinal or intraocular bleeding (confirmed clinically or on imaging). | during the 24 hours from the surgery |