Clinical trial NCT06742125: Drug-Coated Balloon Versus Drug-Eluting Stent in Patient With Premature ST-Segment Elevation Myocardial Infarction
Official title: Drug-Coated Balloon Versus Drug-Eluting Stent in Patient With Premature ST-Segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ST-elevation Myocardial Infarction (STEMI)
Keywords: Drug-coated balloon
Drug-eluting stent
premature ST-segment elevation myocardial infarction
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: Peking University First Hospital
name: Suzhou Municipal Hospital
name: First Affiliated Hospital of Ningbo University
First posted: 2024-12-19
Enrollment: 1244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The incidence of premature coronary artery disease (PCAD) is on the rise, and there is a critical need to improve long-term outcomes. Drug-coated balloon (DCB) represent a promising treatment option for patients with PCAD. However, high-quality clinical data on the impact of DCB on the long-term prognosis of myocardial infarction patients are lacking. This study aims to compare the 12-month clinical outcomes, including all-cause mortality, non-fatal myocardial infarction, and any revascularization, of DCB versus drug-eluting stent (DES) in patients with premature ST-segment elevation myocardial infarction (STEMI). The objective is to verify the efficacy and safety of the DCB implant-free regimen in these patients.

Detailed description: Objectives of Study:

Compare the clinical outcomes of drug-coated balloon (DCB) and drug-eluting stent (DES) treatment in patients with premature ST-segment elevation myocardial infarction (STEMI).

Design of Study:

Investigator-Initiated，Open Label，Prospective，Multicenter，Randomized Clinical Trial.

Patients Selected： This study aims to premature STEMI patients who have successfully completed lesion pretreatment in multiple medical centers in China. Patients who meet the inclusion criteria and have no exclusion criteria will be randomly assigned 1:1 to the drug coated balloon group and drug eluting stent group, totaling 1244 cases (622 cases per group).

Primary Endpoints:

Patient-oriented composite endpoints (POCE) within 12 months, including all-cause mortality, non-fatal myocardial infarction, and any revascularization.

Hypothesis:

The 12-month POCE rate in the DCB group of premature STEMI patients is not inferior to that of the DES group.

Sample's Size:

Sample size calculation based on the event rates of previous trials. DES group had a predetermined events' rate of 8.0%, the DCB group had a predetermined events' rate of 6.3%.

* Design: Non-inferiority, delta=2.5%
* Ratio of Specimen: DCB : DES= 1:1
* Type I Error (α): Single side 2.5%
* Duration of Participation: 2 years
* Setting: The 12-month clinical events' rates for the DCB group and DES group were 6.3% and 8.0%, respectively.
* Statistical Testing Efficiency (1- β): 80%
* Main Statistical Methods: Kaplan-meier survival analysis using log rank testing
* Dropout Rate: 5% of all the patients Based on the above assumptions and dropout rate, we need to include a total of 1244 cases (622 cases per group).

Eligibility criteria: Inclusion Criteria:

1. . Age of Patients ≥18 years old; Male ≤ 55 years old/female ≤ 65 years old were diagnosed as coronary atherosclerotic heart disease;
2. Acute myocardial infarction patients with onset symptoms\<48 hours require emergency PCI;
3. . Diagnosis: Chest pain and other ischemic symptoms accompanied by ST segment elevation in at least two adjacent leads on electrocardiogram (① V2 or V3 lead: male\<40 years ≥ 0.25mV, ≥ 40 years ≥ 0.2mV; Female ≥1.5mV；② Other leads ≥ 1mV), or new left bundle branch block occurs;
4. Criminal blood vessels with clear requirements for emergency PCI;
5. Coronary artery in situ lesions, with a visual reference lumen diameter of ≥ 2mm and ≤ 4mm; Lesion's length\<40mm；
6. After thrombus aspiration and pre dilation, the lesion stenosis is ≤ 50% and there is no C-type or above dissection.
7. He/she or his/her legal representative voluntarily participates in this study and signs an informed consent form.

Exclusion Criteria:

1. The patient has allergies or contraindications to the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Cilostazol, Indobufen, Contrast Medias (Patients with clear contrast agent allergies such as rash but can be controlled with effective drugs such as glucocorticoids and diphenhydramine in advance can be selected);
2. The patient has active pathological bleeding;
3. History of significant gastrointestinal or urogenital bleeding or bleeding tendency within 3 months prior to surgery, known coagulation disorders (including heparin induced thrombocytopenia);
4. Patients who are pregnant or have the intention to become pregnant during the period of research;
5. Non cardiogenic combined lesions show an expected life expectancy of less than one year;
6. Left main trunk's stenosis ≥ 50%
7. History of coronary artery bypass grafting in the past;
8. Intubation or mechanical ventilation status;
9. . Cardiogenic Shock
10. . Without signature on informed consent

Primary outcomes:
measure: Incidence of patient-oriented composite endpoints (POCE) (Direct measurement and coronary angiography)
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of patient-oriented composite endpoints (POCE) (Direct measurement and coronary angiography)
timeFrame: 36 months, 60 months
measure: Incidence of target vessel failure (Direct measurement and coronary angiography)
timeFrame: 12 months
measure: Incidence of all-cause mortality (Direct measurement)
timeFrame: 36 months, 60 months
measure: Incidence of non-fatal MI (Direct measurement)
timeFrame: 36 months, 60 months
measure: Incidence of any revascularization (coronary angiography)
timeFrame: 36 months, 60 months
measure: Incidence of all-cause and cardiac death (Direct measurement)
timeFrame: 12 months, 36 months, 60 months
measure: Incidence of any non-fatal MI without peri-procedural MI (Direct measurement)
timeFrame: 12 months, 36 months, 60 months
measure: Incidence of any non-fatal MI with peri-procedural MI (Direct measurement)
timeFrame: 12 months, 36 months, 60 months
measure: Incidence of any target vessel/lesion revascularization (Coronary angiography)
timeFrame: 12 months, 36 months, 60 months
measure: Incidence of any non-target vessel/lesion revascularization (Coronary angiography)
timeFrame: 12 months, 36 months, 60 months
measure: Incidence of any revascularization (ischemia-driven or all) (Coronary angiography)
timeFrame: 12 months, 36 months, 60 months
measure: Incidence of non-fatal stroke (ischemic and hemorrhagic) (Direct measurement)
timeFrame: 12 months, 36 months, 60 months
measure: Cost-effectiveness analysis
timeFrame: 12 months, 36 months, 60 months
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jun Jiang
role: STUDY_DIRECTOR
References: