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Published on: March 12, 2018
Validation of complex PCI criteria in drug-coated balloon angioplasty
Francesco Tartaglia1,2, Mauro Gitto1,2, Pier Pasquale Leone3
1Department of Biomedical Sciences, Humanitas University, 20072, Pieve Emanuele, Milan, Italy.
Insights
Complex percutaneous coronary interventions (PCI) using drug-coated balloons (DCB) are common and linked to higher target lesion failure (TLF) risk. However, this increased risk is mainly observed in in-stent restenosis cases, not de novo lesions.
Area of Science:
- Interventional Cardiology
- Cardiovascular Research
- Medical Device Technology
Background:
- Procedural complexity in percutaneous coronary interventions (PCI) with drug-eluting stents (DES) correlates with adverse events, particularly with long or multiple stent implantations.
- Understanding procedural complexity is crucial for optimizing outcomes in various PCI techniques, including those employing drug-coated balloons (DCB).
Purpose of the Study:
- To validate established complex PCI criteria within the context of DCB-based PCI.
- To assess the prognostic impact of complex DCB-PCI on clinical outcomes, specifically target lesion failure (TLF).
Main Methods:
- Retrospective analysis of 1279 patients undergoing DCB angioplasty across two Italian centers (2018-2023).
- Complex DCB-PCI defined by criteria including: ≥3 vessels/lesions treated, ≥3 devices used, complex bifurcation treatment, total device length >60 mm, or chronic total occlusion (CTO) target lesion.
- Primary endpoint: 2-year incidence of TLF (composite of target lesion revascularization, target vessel-myocardial infarction, cardiac death).
Main Results:
- Over half (50.2%) of patients met complex PCI criteria, most commonly due to long device length (>60 mm).
- Complex DCB-PCI was associated with a higher 2-year TLF incidence (16.7% vs. 11.4%) compared to non-complex PCI, particularly in cases of in-stent restenosis (ISR).
- No significant difference in TLF was observed between complex and non-complex DCB-PCI for de novo coronary lesions.
Conclusions:
- Contemporary complex PCI criteria are frequently applicable to DCB angioplasty in real-world settings.
- Complex DCB-PCI is associated with an increased risk of TLF, but this association is primarily driven by outcomes in ISR patients.
- The prognostic significance of complex PCI criteria appears limited for de novo lesions treated with DCB.
Background:
Procedural complexity during percutaneous coronary interventions (PCI) with drug-eluting stent (DES) has been associated with adverse events, especially in case of long and multiple stents implantation.
Objective:
This study aims to validate contemporary complex PCI criteria for drug coated balloon (DCB)-based PCI.
Methods:
Consecutive patients undergoing DCB angioplasty at 2 Italian centers from 2018 to 2023 were retrospectively enrolled. Complex DCB-PCI was defined as the presence of at least 1 of the 6 following features: 3 vessels treated; ≥ 3 lesions treated; ≥ 3 devices (DES or DCB) used; bifurcation treated with 2 devices; total device length (DES + DCB) > 60 mm; CTO as target lesion. The primary endpoint was the 2 year incidence of target lesion failure (TLF), a composite of target lesion revascularization (TLR), target vessel-myocardial infarction and cardiac death, at time-to-first event analysis.
Results:
A total of 1279 patients were included, of whom 642 (50.2%) met complex PCI criteria. The most frequently met criteria was "total device length > 60 mm" (71.6% in the complex PCI group). The proportion of in-stent restenosis (ISR) was 30.8% in the complex DCB-PCI group and 43.8% in the non-complex PCI group (p < 0.001). After adjusting for relevant clinical covariates and for the presence of ISR, patients undergoing complex PCI had a higher incidence of TLF at 2 years as compared to those undergoing non-complex PCI (16.7 vs. 11.4%; adj. hazard ratio 1.73, 95% confidence interval 1.16-2.59, p = 0.007). However, such difference was significant only in the ISR subgroup, while outcomes of complex and non-complex PCI for de novo lesions were similar.
Conclusions:
In a real-world cohort of patients undergoing DCB angioplasty, complex PCI criteria were frequently met and associated with higher risk of TLF. However, their prognostic impact was limited in patients with de novo coronary lesions treated with DCB.
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