Feasibility and safety of only DCB approach in consecutive patients undergoing contemporary CTO PCI; the all-comers
Sevket Gorgulu1, Sefa Sural2, Mahmut Uluganyan3
1Cardiology Department, Biruni University Medical School, Istanbul, Türkiye.
Insights
The "only drug-coated balloon" strategy is feasible in over half of chronic total occlusion percutaneous coronary intervention patients, showing acceptable mid-term outcomes for this complex group.
Area of Science:
- Cardiovascular Interventions
- Interventional Cardiology
- Medical Devices
Background:
- Limited evidence exists for an
Purpose of the Study:
- Evaluate the feasibility, safety, and mid-term outcomes of an
Main Methods:
- Multicenter observational study of 457 chronic total occlusion percutaneous coronary intervention procedures.
- Intention-to-treat "only drug-coated balloon" strategy.
- Primary endpoint: major adverse cardiac and cerebrovascular events (MACCE).
Main Results:
- Feasibility of the "only drug-coated balloon" strategy was 58.62% in 423 lesions.
- Mid-term MACCE rate was 13.9% (28 patients), with 13.4% target vessel failure.
- Angiographic follow-up showed positive vessel remodeling and late lumen gain in over 45% of lesions.
Conclusions:
- The "only drug-coated balloon" strategy is feasible in complex, all-comer chronic total occlusion percutaneous coronary intervention populations.
- Acceptable mid-term clinical and angiographic outcomes were observed.
- Further research may support this strategy in selected CTO PCI cases.
Background:
Evidence regarding an "only drug-coated balloon (DCB)" strategy in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) remains limited, particularly in complex all-comer populations. We aimed to evaluate the feasibility, safety, and mid-term outcomes of an only DCB strategy in consecutive patients undergoing contemporary CTO PCI.
Methods:
This multicenter observational study included consecutive CTO PCI procedures performed between January 2024 and April 2026 at three high-volume CTO centers. All procedures were initially attempted using an intention-to-treat "only DCB" strategy. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), defined as cardiac death, target lesion revascularization (TLR), target vessel myocardial infarction, or stroke.
Results:
A total of 457 CTO PCI procedures were evaluated. After excluding unsuccessful guidewire crossing procedures, 423 lesions underwent lesion preparation using the only DCB protocol. Final treatment with an "only DCB" strategy was achieved in 248 lesions, corresponding to a feasibility rate of 58.62%. Mean J-CTO score was 1.97 ± 1.04. Antegrade wiring was used in 95.2% of procedures, whereas retrograde wiring was used in 16.9%. Mean follow-up duration was 231.1 ± 130.3 days. MACCE occurred in 28 patients (13.9%), and target vessel failure in 27 (13.4%). Follow-up mortality occurred in one patient (0.5%), and no patient had a stroke. Patients with angiographic restenosis ≥70% had smaller final minimum lumen diameter (1.69 ± 0.64 mm vs. 2.23 ± 0.80 mm; p = 0.001). Among patients with angiographic follow-up, late lumen gain was observed in 55.5% of lesions, whereas lumen gain>0.2 mm was observed in 45.4%, supporting positive vessel remodeling after DCB treatment.
Conclusions:
In an all-comer CTO PCI population, an only DCB strategy appears feasible in more than half of patients, with acceptable mid-term clinical and angiographic outcomes.
