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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

NCT ID: NCT02941588

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1582 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-11-30

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.

Conditions

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Acute Coronary Syndrome Drug-eluting Stent Aspirin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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non-cardiac surgery after DES

The patients who underwent non-cardiac surgery after percutaneous coronary intervention with drug-eluting stent

Non-cardiac surgery

Intervention Type PROCEDURE

Any surgery with general anesthesia except cardiac surgery

Interventions

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Non-cardiac surgery

Any surgery with general anesthesia except cardiac surgery

Intervention Type PROCEDURE

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Won Ho Kim, MD

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1604-023-753

Identifier Type: -

Identifier Source: org_study_id