Clinical trial NCT06742931: Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2
Official title: Discontinuation of Antiplatelet Agent After Drug-Coated Balloon Angioplasty in Stabilized Patients With High Bleeding Risk and Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Coronary Syndrome
Keywords: Coronary artery stenosis
Antiplatelet agent
Drug-coated balloon
Chronic coronary syndrome
Prognosis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Chonnam National University Hospital
First posted: 2024-12-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, multi-center, open-label, randomized controlled, and superiority trial.
Primary purpose: TREATMENT

Brief summary: A prospective, multi-center, open-label, randomized controlled, and superiority trial. The trial will compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure.

Detailed description: In patients with chronic coronary syndrome, the benefit of percutaneous coronary intervention (PCI) has been controversial for a survival benefit while reducing the risk of spontaneous myocardial infarction (MI) or anginal symptoms. Therefore, unlike patients with acute coronary syndrome, routine PCI with drug-eluting stents (DES) for patients with chronic coronary syndrome should be individualized, considering the risk of long term possibility of stent failure and the need for maintaining dual antiplatelet therapy (DAPT) for certain period due to permanent vascular implant and increased risk of bleeding, especially in patients with high bleeding risk (HBR). Drug-coated balloon (DCB), a novel treatment strategy, which has benefit of having shorter antiplatelet therapy duration due to the absence of metallic scaffolds and polymers, could be an alternative treatment for patients with chronic coronary syndrome, especially in patients with HBR. Given the expanding indications for DCB including de novo coronary artery lesions, shorter duration of DAPT, and potentially reduced risk of bleeding might be a reasonable treatment strategy in patients with HBR.

In current guidelines, standard duration of DAPT after PCI is recommended for 1 to 3 months in patients with HBR. Then, it is recommended as Class IA recommendation for maintaining single antiplatelet agent for lifelong as a secondary prevention, regardless of the devices used during PCI and the risk of patients' bleeding risk. However, it should be noted that the supporting evidence for lifelong maintenance of single antiplatelet agent were derived from previous randomized controlled trials conducted in patients with acute myocardial infarction or stroke. In addition, the supporting evidence for lifelong maintenance of single antiplatelet agent after PCI was derived from the recent randomized controlled trials using metallic stents including bare metal stent, 1st generation DES, or 2nd generation DES. The gap in the evidence is that no previous trial evaluated the need of lifelong maintenance of single antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty after standard duration of DAPT. Furthermore, although recent trial have shown that long-term antiplatelet monotherapy with clopidogrel demonstrated better clinical outcomes than antiplatelet monotherapy with aspirin in patients with chronic coronary syndrome undergoing PCI with DES, there has been scarce data regarding long-term antiplatelet therapy for HBR patients with chronic coronary syndrome treated by DCB angioplasty after standard duration of DAPT.

On this background, the current trial aims to compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure. Having this evidence will be able to more establish the evidence for the post-adjunctive medical treatment in patients with HBR after DCB angioplasty.

Eligibility criteria: Inclusion Criteria:

1. Subject must be at least 19 years of age
2. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
3. Patients with chronic coronary syndrome and at least one de novo lesion of reference vessel size ≥2.25 mm, treated with DCB angioplasty
4. Patients with high bleeding risk: one or more of the criteria listed A. Age ≥ 75 years old B. Baseline Hemoglobin \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) C. Any prior intra-cerebral bleed D. Hospital admission for bleeding during the prior 12 months E. Non skin cancer diagnosed or treated \< 3 years F. Planned daily NSAID (other than aspirin) or steroids for \>30 days after PCI G. Planned surgery that would require interruption of DAPT (within next 12 months) H. Renal failure defined as calculated creatinine clearance \<40 ml/min or on dialysis I. Hematological disorders (platelet count \<100,000/mm3 or any coagulation disorder) J. Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice K. Expected non-compliance to secondary prevention medications after PCI for other medical reasons
5. Patients who completed standard duration of DAPT (1-3months) and followed by maintenance of single antiplatelet agent (aspirin or P2Y12 inhibitor) for at least 1 year from index procedure.
6. No bleeding (BARC 2, 3, or 5 bleeding) or ischemic events (cardiovascular death, non-fatal MI, or clinically-indicated repeat revascularization) for at least 1 year from index procedure.

Exclusion Criteria:

1. Patients unable to provide consent
2. Patients with acute myocardial infarction or unstable angina
3. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of DCB
4. Patients with indication of oral anticoagulant
5. Patients with concomitant drug-eluting stent implantation during index PCI
6. Patients with history of ischemic stroke or previous myocardial infarction
7. Patients with peripheral arterial occlusive disease
8. Patients with angiographic findings of A. Left main coronary artery disease B. In-stent restenosis is the cause of target lesion C. Target lesion in bypass graft D. True bifurcation lesion that requires upfront 2-stenting E. Patients with residual stenosis on non-target vessels after PCI (\>70% diameter stenosis or FFR≤0.80)
9. Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year
10. Patients who may result in protocol non-compliance (site investigator's medical judgment)
11. Patients with cardiogenic shock or cardiac arrest
12. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
13. Patients with severe valvular heart disease requiring open heart surgery
14. Pregnant or lactating women

Primary outcomes:
measure: Major bleeding (BARC 2, 3, or 5 bleeding)
timeFrame: 1 year after last patient enrollment
Secondary outcomes:
measure: Patient-oriented composite outcome
timeFrame: 1 year after last patient enrollment
measure: Cardiovascular death
timeFrame: 1 year after last patient enrollment
measure: All-cause death
timeFrame: 1 year after last patient enrollment
measure: Target-vessel myocardial infarction
timeFrame: 1 year after last patient enrollment
measure: Non-fatal MI
timeFrame: 1 year after last patient enrollment
measure: Clinically indicated target-lesion revascularization (TLR)
timeFrame: 1 year after last patient enrollment
measure: Clinically indicated target-vessel revascularization (TVR)
timeFrame: 1 year after last patient enrollment
measure: Any revascularization
timeFrame: 1 year after last patient enrollment
measure: Cardiovascular death or target-vessel MI
timeFrame: 1 year after last patient enrollment
measure: All-cause death or non-fatal MI
timeFrame: 1 year after last patient enrollment
measure: Target vessel failure
timeFrame: 1 year after last patient enrollment
measure: Severe major bleeding (BARC 3 or 5 bleeding)
timeFrame: 1 year after last patient enrollment
measure: Major bleeding (TIMI major bleeding)
timeFrame: 1 year after last patient enrollment
measure: Cerebrovascular accident (CVA)
timeFrame: 1 year after last patient enrollment
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital, University of Ulsan College of Medicine
city: Goyang
country: Korea, Republic of
facility: Ilsan Paik hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital, Chonnam National University Medical School
city: Gwangmyeong
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital
city: Incheon
country: Korea, Republic of
facility: Catholic Kwandong University International St. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon Cardiovascular Research Institute, Gachon University
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital and Chonbuk National University Medical School
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary Hospital
Study officials:
affiliation: Samsung Medical Center
name: Joo-Yong Hahn, MD, PhD
role: STUDY_CHAIR
affiliation: Samsung Medical Center
name: Young Bin Song, MD, PhD
role: STUDY_CHAIR
affiliation: Samsung Medical Center
name: Joo Myung Lee, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: