Clinical trial NCT05846893: Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
Official title: Randomised Trial of Drug-Coated Balloon Versus Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Ischemia
Acute Coronary Syndrome
Coronary Stenosis
De Novo Stenosis
Keywords: de novo
large vessel
coronary artery disease
cardiovascular disease
coronary occlusion
heart disease
acute coronary syndrome
angina
ischemia
stenosis
percutaneous coronary intervention
angioplasty
drug-coated balloon
drug-eluting stent
SeQuent Please
randomised trial
Lead sponsor: B. Braun Medical Industries Sdn. Bhd.
Sponsor class: INDUSTRY
Collaborators: name: B. Braun Melsungen AG
name: Ulsan University Hospital
name: European Cardiovascular Research Center
name: Seoul National University Hospital
name: Universität des Saarlandes
First posted: 2023-05-06
Enrollment: 1436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease.

Detailed description: Although several reports suggested that DCB application was safe for larger coronary artery lesions and showed good long-term outcomes, there is limited randomised controlled trial (RCT) data on the safety and efficacy of DCB in large coronary artery disease.

Therefore, the study aims to demonstrate the non-inferiority of the drug-coated balloon (DCB) treatment against current-generation drug-eluting stenting (DES) in patients with de novo lesions in large coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation).

The hypothesis of the study is the clinical outcomes of patients treated with DCB are non-inferior to those treated with current-generation DES.

Eligibility criteria: Inclusion Criteria:

* Patient-related:

  1. Patient must be ≥ 18 years of age
  2. Patient is able to verbally confirm understanding of the study aim, risks, benefits, and treatment alternatives of receiving DCB or DES and he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure
  3. (i) Clinical evidence of angina, and/or (ii) an abnormal functional study demonstrating myocardial ischemia due to the target lesion(s), or (iii) acute coronary syndrome \[unstable angina or non-ST-elevation myocardial infarction (NSTEMI) or uneventful STEMI (≥ 48 hours after primary PCI and no sign of thrombus in lesion(s) to treat)\]
  4. Patient with lesions suitable for PCI with a DCB (and/or DES) according to the Instructions for Use
  5. Patient is able to comply with the study protocol and agrees to undergo the clinical follow-up of 30 days, 6 months, 12 months, 24 months, and 36 months
* Lesion-related:

  1. Presence of significant de novo large vessel coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation) with either ≥ 70% diameter stenosis or intermediate ≥ 50% to \<70% diameter stenosis with abnormal functional test or symptom of ischemia
  2. Successful lesion preparation. For randomisation, the lesion must satisfy the following criteria after optimal balloon angioplasty: no flow-limiting dissection (TIMI=3), and residual stenosis is ≤ 30%
* Multivessel disease with two or more vessels showing diameter stenosis of 50% or more is not an exclusion as long as it fulfills all study's eligibility criteria.
* In diffuse lesion, inclusion is possible if the proximal reference vessel diameter is 3.0 mm or more.

Exclusion Criteria:

* Patient-related:

  1. Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: Iopromide)
  2. Severe allergy to contrast media
  3. Recent STEMI (ongoing or \< 48 hours after primary PCI and/or has sign of thrombus in lesion(s) to treat)
  4. NSTEMI hemodynamically unstable
  5. Known left ventricular ejection fraction of \<30%
  6. Inability to take dual antiplatelet therapy or anticoagulation, or single antiplatelet therapy for at least six months
  7. Non-cardiac co-morbid conditions that may result in protocol non-compliance and inability of patient to complete the study (per the site investigator's medical judgment)
  8. Patient with concomitant medical illnesses that require cytostatic, radiation therapy or renal replacement therapy
  9. Patient who is currently/ planning to participate in another clinical trial when such participation could confound the treatment or outcomes of this study, except for observational registry
  10. Pregnancy or lactation
  11. Patient under administrative or judicial custody
* Lesion-related:

  1. Small vessel disease, defined as \<3.0 mm of reference vessel diameter by visual estimation
  2. In-stent restenosis lesions for study lesions
  3. Patient will be excluded if meet any of the following angiographic exclusion criteria after lesion preparation:

     (i) Flow limiting dissection with TIMI flow \< III (ii) Residual diameter stenosis \>30%

     \* The case of persistent ischemic symptoms/signs is up to the operator's decision
  4. Lesions which are untreatable with PCI or other interventional techniques and coronary artery spasm in the absence of a significant stenosis
  5. Left main disease or aorta-ostial lesion requiring revascularization
  6. Severely calcified or tortuous vessels precluding DCB or DES application
  7. Prior Coronary Artery Bypass Graft (CABG)

Primary outcomes:
measure: Net Adverse Clinical Event (NACE)
timeFrame: At 1 year
Secondary outcomes:
measure: All-cause death
timeFrame: At 12, 24, and 36 months
measure: Non-fatal myocardial infarction
timeFrame: At 12, 24, and 36 months
measure: Clinically driven target vessel revascularization
timeFrame: At 12, 24, and 36 months
measure: Major bleeding (BARC type 3 to 5)
timeFrame: At 12, 24, and 36 months
measure: Cardiac death
timeFrame: At 12, 24, and 36 months
measure: Target vessel myocardial infarction
timeFrame: At 12, 24, and 36 months
measure: Periprocedural myocardial infarction
timeFrame: At 12, 24, and 36 months
measure: Target lesion revascularization
timeFrame: At 12, 24, and 36 months
measure: Stent/lesion thrombosis in treated lesion defined according to the Academic Research Consortium-2 (ARC-2) criteria
timeFrame: At 12, 24, and 36 months
measure: Rehospitalization related to study endpoints
timeFrame: At 30 days, 12 months, 24 months, and 36 months
measure: Stroke (ischemic and hemorrhagic)
timeFrame: At 12, 24, and 36 months
measure: Total angioplasty procedure time
timeFrame: During the index procedure
measure: Fluoroscopy time of the angioplasty procedure
timeFrame: During the index procedure
measure: Contrast volume of the angioplasty procedure
timeFrame: During the index procedure
measure: Number of devices (DCB/ DES) used for PCI treatment
timeFrame: During the index procedure
Other outcomes:
measure: Late lumen loss (LLL)
timeFrame: At 9-12 months post-procedure
measure: Percentage of diameter stenosis
timeFrame: At 9-12 months post-procedure
measure: Minimal lumen diameter
timeFrame: At 9-12 months post-procedure
measure: Binary restenosis
timeFrame: At 9-12 months post-procedure
measure: Quality of life analysis
timeFrame: After 12, 24, and 36 months
measure: Incidence of angina
timeFrame: At baseline and 12 months
measure: Dual Antiplatelet Therapy (DAPT) duration
timeFrame: At 30 days, 6 months, and 12 months
measure: Comparison of NACE between DCB vs. DES in sex difference, diabetes mellitus, and multivessel disease patients
timeFrame: At 1 year
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
state: Gangwon-do
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
state: Gyeongsangnam-do
city: Donggu
country: Korea, Republic of
facility: Ulsan University Hospital
state: Ulsan
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Kota Kinabalu
country: Malaysia
facility: Queen Elizabeth II Hospital
state: Sabah
city: Kuching
country: Malaysia
facility: Sarawak Heart Center
state: Sarawak
city: Kajang
country: Malaysia
facility: Sultan Idris Shah Serdang Hospital
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: National Heart Institute Malaysia
city: Kuala Lumpur
country: Malaysia
facility: Cardiac Vascular Sentral Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Novena
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Eun-Seok Shin, MD, Ph.D
role: STUDY_CHAIR
References: