Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes

Completed

• Conditions: Coronary Artery Disease; Cancer

• Registration Number: NCT06357000
• Lead Sponsor: Samsung Medical Center

Brief Summary

To evaluate the association between time from PCI to cancer surgery and cardiovascular and oncologic outcomes in early-stage cancer patients, A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database.

Detailed Description

Early-stage-cancer patients with a history of PCI who underwent cancer surgery (N = 3621) were included. The patients were divided into two groups based on the time between the dates of PCI and cancer surgery (\<12 months and ≥12 months). Patients were stratified into early-surgery and late-surgery, defined as patients who underwent surgery ≥1 and \<1 month after cancer diagnosis. Outcomes included bleeding, spontaneous myocardial infarction (MI), repeat revascularization, cancer recurrence, and death.

Study Timeline

• Study Start: 2008-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2024-04
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3621

Inclusion Criteria

• men and women aged ≥18 years who were diagnosed with cancer and underwent cancer surgery within 1 year following diagnosis.
• patients who underwent PCI (procedure code: M6551-M6572, O1640-O1649, OA640-OA649) prior to the cancer surgery

Exclusion Criteria

• participants who received neoadjuvant or adjuvant treatment for cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurence of Bleeding	up to 5 years	Bleeding requiring transfusion was defined by the transfusion codes (X2021, X2022, X2031, X2032, X2091, X2092, X2111, X2112, X2131, X2132).

Secondary Outcome Measures

Name	Time	Method
Occurence of All cause death	up to 5 years	Vital status was obtained from death certification collected by Statistics Korea at the Ministry of Strategy and Finance of South Korea.
Occurence of Cancer recurrence	up to 5 years	Cancer recurrence was defined as the presence of chemotherapy and/or radiation therapy that began more than 6 months after surgery completion.
Occurence of Repeat revascularization	up to 5 years	Repeat revascularization was defined as the presence of a procedure code after cancer surgery.
Occurence of Spontaneous myocardial infarction	up to 5 years	Spontaneous myocardial infarction (MI) was defined as hospitalization for MI (ICD-10 codes I21 and I22)