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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02941588
Enrollment
1582
Registered
2016-10-21
Start date
2016-04-30
Completion date
2017-11-30
Last updated
2017-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Aspirin, Drug-eluting Stent

Brief summary

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

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.

Interventions

PROCEDURENon-cardiac surgery

Any surgery with general anesthesia except cardiac surgery

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiovascular and cerebral eventduring postoperative 30 daysa composite of non-fatal myocardial infarction, coronary revascularization, pulmonary embolism and stroke

Secondary

MeasureTime frameDescription
Composite morbidityduring postoperative 30 dayscomposite of overall postoperative morbidity, including Major adverse cardiovascular and cerebral event and all respiratory, cardiac, renal and other complications during postoperative 30 days.
Major bleeding eventduring the 24 hours from the surgerya 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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026