The aim of this study is to evaluate the long-term efficacy and safety of drug-coated balloon (DCB) strategies, including DCB alone or hybrid strategies of DCB and drug-eluting stent (DES), compared to DES-only in patients with chronic total occlusion (CTO) after successful recanalization. Through a prospective, multicenter randomized controlled trial, we will directly compare the long-term outcomes of these two treatment strategies in CTO patients to fill the gap in existing research regarding direct comparative data between DCB and DES in CTO treatment. This study expects to provide high-quality evidence for optimizing CTO treatment, potentially improving treatment strategies in complex cases, reducing stent usage, lowering the risk of complications, and ultimately enhancing patient prognosis.
Patient voluntarily participates in the study and has provided written informed consent.
Presence of clinical indication for Percutaneous Coronary Intervention (PCI) of the Chronic Total Occlusion (CTO) (e.g., symptoms of angina pectoris or evidence of myocardial ischemia).
Target lesion is located in a de novo coronary artery.
Angiographically confirmed CTO (TIMI grade 0 flow), with evidence supporting an occlusion duration of ≥ 3 months.
Target CTO lesion is the culprit vessel responsible for the presenting Acute Myocardial Infarction (AMI).
Patient is in cardiogenic shock.
Presence of severe heart failure (New York Heart Association [NYHA] Class IV) or Left Ventricular Ejection Fraction (LVEF) < 30%.
History of stroke or Transient Ischemic Attack (TIA) within the previous 3 months.
Parallel
DES Implantation
Procedure/SurgeryDrug-eluting stents meeting study criteria (e.g., sirolimus-, paclitaxel-, or everolimus-eluting stents; specific models selected by operators according to clinical practice) were chosen. Stent diameter was determined by the target vessel reference diameter (2.25-4.0 mm), with length covering the occluded segment plus 5 mm of healthy vessel proximal and distal to the lesion. Stents were deployed at 8-16 atm to ensure optimal apposition. Intraoperative angiography confirmed no residual stenosis (\<10%) and TIMI grade 3 flow. When multiple stents were required, an overlapping technique was utilized to ensure complete lesion coverage.
DCB Angioplasty
Procedure/SurgeryDrug-coated balloons meeting study criteria (e.g., paclitaxel- or sirolimus-coated DCB; specific models selected by operators according to clinical practice) were chosen. DCB diameter was determined by the target vessel reference diameter (2.25-4.0 mm), with length covering the occluded segment plus 5 mm proximal and distal to the lesion. DCB inflation was maintained for ≥60 seconds at 8-12 atm to ensure adequate drug delivery to the vessel wall. Intraoperative angiography confirmed \<50% residual stenosis, TIMI grade 3 flow, and absence of serious complications. DES implantation was permitted (recorded as hybrid strategy) if any of the following conditions occurred after DCB application: Residual stenosis ≥50% with hemodynamic significance; Non-flow-limiting dissection requiring stent support based on operator judgment; Other technical difficulties resulting in DCB-alone treatment failure. DES selection was consistent with the DES-only group.
In-segment Late Lumen Loss, LLL
Measured via planned, mandatory follow-up coronary angiography. Standardized, blinded analysis performed by an independent core laboratory using Quantitative Coronary Angiography (QCA). The "segment" is defined as the target lesion plus 5 mm proximal and distal margins. LLL = Post-procedure Minimum Lumen Diameter (MLD\_post-procedure) - Follow-up Minimum Lumen Diameter (MLD\_follow-up).
In-segment Binary Restenosis / Re-occlusion Rate
Determined by core laboratory QCA analysis. Defined as diameter stenosis ≥50% or TIMI 0 flow in the target lesion segment (consistent with LLL segment definition) on follow-up angiography.
Target Lesion Failure, TLF
Assessed through clinical follow-up, adjudicated by an independent Clinical Events Committee (CEC). Composite endpoint includes the first occurrence of cardiac death, target vessel myocardial infarction (TV-MI, per SCAI definition), or clinically driven target lesion revascularization (CD-TLR).
Cardiac Death
Determined through clinical follow-up, adjudicated by CEC. Defined as any death due to a confirmed cardiovascular cause or sudden death where a cardiovascular cause cannot be excluded.
Clinically Driven Target Lesion Revascularization (CD-TLR)
Evaluated via clinical follow-up and angiography, adjudicated by CEC. Defined as revascularization driven by symptoms (e.g., angina) or ischemic evidence, with angiographic confirmation of target lesion diameter stenosis ≥50% or occlusion requiring intervention.
Intravascular Ultrasound (IVUS) Metrics
Performed in a designated subgroup immediately post-procedure and at 9-month follow-up. IVUS measures Minimum Lumen Area (MLA), etc. Blinded analysis conducted by the core laboratory.
Quality of Life (QoL)
Assessed using the EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version) questionnaire to evaluate health-related quality of life. It assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with levels ranging from "no problems" to "extreme problems," plus a 0-100 visual analogue scale (VAS) for self-rated health. Patient-reported data collected by study coordinators, with utility scores calculated.
Health Economics
Assessed through Cost-Effectiveness Analysis (CEA) and Cost-Utility Analysis (CUA). Direct medical costs and indirect costs are collected. Utility is measured in Quality-Adjusted Life Years (QALYs) derived from EQ-5D scores. Data are aggregated by the study coordinating center, calculating the Incremental Cost-Effectiveness Ratio (ICER).
Click on the lead sponsor to view all of their trials.
