Comparison of Cardiovascular Risks Between Hip Fracture Surgery With Continued DAPT（Dual Antiplatelet Therapy ） Within 6 Weeks vs After 6 Weeks Post-PCI（Percutaneous Coronary Intervention）: A Prospective Observational Cohort Study

NCT07024446 | Not Yet Recruiting

• 1 other identifier: Continued DAPT after PCI
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Percutaneous coronary intervention (PCI) is commonly used to treat stable ischemic heart disease. Among patients, 7.5% require surgical treatment, and up to 20% may need noncardiac surgery (NCS) within two years. Compared to patients without coronary stents, those requiring NCS shortly after PCI face an increased risk of perioperative major adverse cardiac and cerebrovascular events (MACCE), primarily manifested as thrombotic and bleeding events. Guidelines recommend 6-12 months of dual antiplatelet therapy (DAPT) post-PCI to prevent stent thrombosis, which is associated with an elevated risk of perioperative bleeding during NCS. Multiple retrospective studies suggest that the incidence of MACCE decreases as the interval between PCI and NCS lengthens, reaching a risk level similar to non-PCI patients after 12 months. However, other studies indicate that the risk in patients with similar PCI-NCS intervals correlates more with surgical complexity and urgency. Guidelines advise adequate antiplatelet therapy post-PCI to prevent stent thrombosis and recommend avoiding elective surgery within 4-6 weeks after PCI, contingent on bleeding and thrombotic risk assessments. Many post-PCI patients facing NCS option to delay surgery after weighing the risks of discontinuing antiplatelet therapy versus postponement, which not only reduces quality of life but also increases the risks associated with delayed surgery. Additionally, retrospective studies have found that in unavoidable emergency or time-sensitive surgeries, the heightened perioperative cardiovascular risk is primarily due to the underlying surgical condition affecting organ function, rather than the PCI-NCS interval or antiplatelet therapy discontinuation. Recent advancements in minimally invasive surgical techniques have reduced trauma and bleeding, leading to broader indications for surgery in patients on anticoagulant or antiplatelet therapy. The widespread use of newer-generation drug-eluting stents (DES) with advanced antiproliferative drugs has further lowered stent thrombosis rates. Moreover, refined PCI techniques minimize vascular injury during stent placement, reducing the likelihood of extra-stent restenosis. From an anesthesiology perspective, concerns for post-PCI surgical patients extend beyond bleeding risks to whether cardiac function can withstand perioperative hemodynamic changes. As surgical and anesthetic techniques evolve, traditional single-method anesthesia is increasingly replaced by combined techniques that ensure adequate analgesia while minimizing hemodynamic disturbances, maintaining oxygen supply-demand balance, and reducing ischemic and bleeding events. Hip fractures in elderly patients, often termed the "last fracture in life," carry high surgical and anesthetic risks for those with coronary artery disease. While PCI addresses coronary stenosis, the use or discontinuation of antiplatelet therapy exposes patients to bleeding and ischemic risks. The optimal timing for hip fracture surgery is within 48 hours; delays may lead to malunion, prolonged bedrest complications (e.g., pressure sores, pneumonia), and increased deep vein thrombosis risk. Modern hip fracture surgeries (e.g., internal fixation, hip replacement, Proximal femoral nail antirotation internal fixation) are well-established, with reduced bleeding and faster recovery, making it feasible to perform surgery without interrupting antiplatelet therapy. Existing research primarily consists of retrospective analyses of cardiovascular risk prediction in post-PCI patients undergoing NCS, with no recent prospective studies. Guideline recommendations on PCI-NCS intervals remain unchanged since 2016. Consequently, many PCI patients must delay surgery, enduring unpredictable risks and diminished quality of life. This study aims to prospectively observe the incidence of MACCE in hip fracture surgery performed within six weeks post-PCI without discontinuing DAPT. The findings may provide evidence for the feasibility of early post-PCI surgery, offer clinicians and patients safer antithrombotic strategies, and present a new option to improve patient quality of life.

Conditions

PCI Patients; DAPT(Dual Antiplatelet Therapy); Hip Fracture Surgeries

Outcome Measures

Primary Outcomes (4)

• Perioperative changes in blood High-sensitivity cardiac troponin I （hs-cTnI） levels

  Detection using chemiluminescence immunoassay (CLIA)

  From admission to discharge

• Electrocardiogram ST-T changes

  From admission to discharge

• Perioperative surgical site blood loss

  Including intraoperative blood drainage volume, gauze usage, and postoperative wound bleeding drainage volume

  Perioperative period

• Occurrence of Perioperative Adverse Events and Patient Self-Reported Symptoms

  From admission to discharge

Secondary Outcomes (3)

• Changes in blood hs-cTnI levels

  Once a month within six months after discharge.

• Electrocardiogram ST-T changes

  Once a month within six months after discharge

• Occurrence of Perioperative Adverse Events and Patient Self-Reported Symptoms

  Half a year after discharge

Other Outcomes (9)

• Gender

  Preoperative

• Duration of surgery

  postoperative

• PCI Stent Types

  Preoperative

Study Arms (2)

Observation group

Within 6 weeks after PCI

Other: The time interval between PCI and NCS

Control group

beyond 6 weeks after PCI

Other: The time interval between PCI and NCS

Interventions

The time interval between PCI and NCS OTHER

Using 6 weeks post-PCI as the demarcation point, patients within 6 weeks were assigned to the observation group, while those beyond 6 weeks formed the control group.

Control group; Observation group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stable coronary artery disease undergoing hip fracture surgery after PCI were divided into two groups: 25 cases in the surgery group within 6 weeks after PCI (observation group) and 25 cases in the surgery group after 6 weeks post-PCI (control group).

You may qualify if:

• Normal hs-cTnI levels prior to NCS BMI 20-28 kg/m² Post-PCI procedure, currently on regular DAPT therapy Complete PCI procedural documentation (date, quantity, stent type) Mentally sound, capable of normal communication

You may not qualify if:

• Abnormal hs-cTnI before NCS; Accompanied by dysfunction of other organs History of other major surgeries Risk factors for stent thrombosis (age \>79 years, impaired left ventricular function, stent implantation due to acute coronary syndrome, multiple stents, diabetes, renal insufficiency with creatinine \>1.5 mg/dl) Abnormal coagulation function Local anesthesia surgery Inability to cooperate

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

MeSH Terms

Interventions

Zinostatin

Intervention Hierarchy (Ancestors)

Enediynes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Diynes; Polyynes; Alkynes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-05