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Completed

NCT Number: NCT02941588

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

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.

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Key information

Conditions

Acute Coronary Syndrome Aspirin Cardiovascular Diseases Drug-Eluting Stent Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-cardiac surgery

Procedure

Any surgery with general anesthesia except cardiac surgery

Primary outcomes

  1. Major adverse cardiovascular and cerebral event

    Time frame: during postoperative 30 days

    a composite of non-fatal myocardial infarction, coronary revascularization, pulmonary embolism and stroke

Secondary outcomes

  1. Composite morbidity

    Time frame: during postoperative 30 days

    composite of overall postoperative morbidity, including Major adverse cardiovascular and cerebral event and all respiratory, cardiac, renal and other complications during postoperative 30 days.

  2. Major bleeding event

    Time frame: during the 24 hours from the surgery

    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).

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2016
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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