Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment

This prospective, single-center, randomized, controlled trial aims to evaluate and compare the differential effects of sirolimus-coated versus paclitaxel-coated drug-coated balloons (DCBs) on local inflammatory responses and plaque healing characteristics in patients with acute coronary syndrome (ACS) with optical coherence tomography (OCT).

• Sirolimus-coated DCB (Device): Treatment of sirolimus-coated DCB
• Paclitaxel-coated DCB (Device): Treatment of paclitaxel-coated DCB

Primary outcomes

• Optical coherence tomography assessment of target lesion healing and repair at 3-month follow-up after the procedure [3 months]: OCT assessment of target lesion healing based on three morphological criteria: fibrous cap thickness (FCT), maximum lipid arc, and macrophage infiltration. Target lesion is defined as unhealed if any of the following criteria are met: (1) FCT <75μm, (2) maximum lipid arc >180°, or (3) presence of macrophage infiltration. Target lesion is defined as healed only if all three criteria are met: (1) FCT ≥75μm; (2) maximum lipid arc ≤180°; (3) absence of macrophage infiltration. The primary outcome is reported as the proportion of patients with healed target lesions.

Secondary outcomes

• OCT-measured minimum lumen area change at 3 months post-procedure [3 months]: Change in minimum lumen area (MLA) measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: mm².
• OCT-measured fibrous cap thickness change at 3 months post-procedure [3 months]: Change in fibrous cap thickness (FCT) measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: μm.
• OCT-measured maximum lipid arc change at 3 months post-procedure [3 months]: Change in maximum lipid arc measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: degrees.
• OCT assessment of macrophage infiltration change at 3 months post-procedure [3 months]: Change in macrophage infiltration presence and characteristics assessed by optical coherence tomography from baseline to 3 months post-procedure.
• OCT-measured thin-cap fibroatheroma count change at 3 months post-procedure [3 months]: Change in number of thin-cap fibroatheroma (TCFA) lesions measured by optical coherence tomography from baseline to 3 months post-procedure. TCFA defined as lipid-rich plaque with fibrous cap thickness <65μm. Unit: count.
• OCT-measured lipid pool length change at 3 months post-procedure [3 months]: Change in lipid pool length measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: mm.
• OCT assessment of microchannel change at 3 months post-procedure [3 months]: Change in microchannel presence and characteristics assessed by optical coherence tomography from baseline to 3 months post-procedure.
• OCT-measured minimum lumen diameter change at 3 months post-procedure [3 months]: Change in minimum lumen diameter measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: mm.
• CCTA-measured perivascular fat attenuation index change at 6 months [6 months]: Change in perivascular fat attenuation index (FAI) measured by coronary computed tomography angiography from baseline to 6 months post-procedure. FAI is defined as the mean CT attenuation value of perivascular adipose tissue surrounding the coronary artery. Unit: Hounsfield Units (HU).
• CCTA-measured low-attenuation plaque volume change at 6 months post-procedure [6 months]: Change in low-attenuation plaque volume measured by coronary computed tomography angiography from baseline to 6 months post-procedure. Low-attenuation plaque is defined as plaque with CT value <30 HU. Unit: mm³.
• CCTA-measured plaque burden change at 6 months post-procedure [6 months]: Change in plaque burden measured by coronary computed tomography angiography from baseline to 6 months post-procedure. Plaque burden is calculated as plaque volume divided by total vessel volume multiplied by 100%. Unit: percentage (%).
• Incidence of target lesion failure (TLF) at 6 months post-procedure [6 months]: Target lesion failure (TLF) was defined as a composite endpoint consisting of cardiovascular death, target vessel-related myocardial infarction, and clinically-driven target lesion revascularization.
• Incidence of patient-oriented composite endpoint (PoCE) at 6 months post-procedure [6 months]: Patient-oriented composite endpoint (PoCE) was defined as a composite of all-cause death, any stroke, any myocardial infarction, and any revascularization.

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

Subjects must meet all of the following criteria to be enrolled:

1. Age between 18 and 80 years old, both genders eligible;
2. Coronary angiography showing non-complex lesions with acute coronary syndrome (non-ST-elevation myocardial infarction and unstable angina) deemed suitable for drug-coated balloon treatment by the investigator;
3. Visually estimated lesion length ≤28mm, visually estimated vessel diameter ≥2.5mm and ≤3.0mm;
4. Successful lesion pre-dilation (must simultaneously meet all 3 criteria: no Type C or greater dissection; TIMI flow grade 3; visually estimated residual stenosis ≤30%);
5. Able to understand the study purpose, willing to complete follow-up visits, and voluntarily provide informed consent.

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

1. Total occlusion (TIMI 0 flow) lesion;
2. In-stent restenosis lesion;
3. Concurrent left main disease or severe three-vessel disease requiring coronary artery bypass grafting;
4. Target lesion with severe calcification or tortuosity that cannot be crossed by guidewire;
5. Coronary artery bypass graft stenosis;
6. Confirmed ST-elevation myocardial infarction;
7. Cardiogenic shock or requiring mechanical respiratory and circulatory support;
8. Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
9. Severe renal insufficiency or undergoing hemodialysis;
10. Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media, paclitaxel, sirolimus and/or other analogues;
11. Systemic lupus erythematosus or other systemic autoimmune diseases;
12. History of stroke within 6 months prior to enrollment;
13. Scheduled elective surgery within 6 months after enrollment requiring discontinuation of anticoagulant or antiplatelet medications;
14. Currently participating in other drug or interventional medical device clinical studies;
15. Other conditions deemed unsuitable for enrollment by the investigator.

• Jie Zhao, MD, PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital