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Published on: May 14, 2013
Drug-Coated Balloon Versus Drug-Eluting Stent for Coronary Revascularization in Patients With Chronic Kidney Disease:
Filippo Luca Gurgoglione1, Marco Frazzetto2, Mauro Gitto3
1DCB Academy, Milan, Italy; Division of Cardiology, Parma University Hospital, Parma, Italy.
Insights
Drug-coated balloons (DCB) show similar effectiveness to drug-eluting stents (DES) for percutaneous coronary intervention in chronic kidney disease (CKD) patients. DCB treatment significantly reduced major bleeding events compared to DES.
Area of Science:
- Cardiology
- Nephrology
- Interventional Cardiology
Background:
- Chronic kidney disease (CKD) patients face higher risks post-percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
- Drug-coated balloons (DCB) offer a stentless alternative for PCI, particularly in complex cases.
Purpose of the Study:
- To compare the clinical outcomes of DCB-only PCI versus current-generation DES in patients with CKD.
- To evaluate the safety and efficacy of DCB in a high-risk CKD population.
Main Methods:
- Pooled analysis of seven observational studies including 1,732 CKD patients (eGFR <60 mL/min/1.73 m²).
- Comparison between DCB (765 patients) and DES (967 patients) cohorts.
- Propensity score matching was used to balance baseline characteristics, creating matched groups of 460 patients each for analysis.
Main Results:
- Major adverse cardiovascular events (MACE) rates were similar between DCB and DES groups in the matched population (HR: 1.09, 95% CI: 0.71-1.66).
- DCB treatment demonstrated a significantly lower incidence of BARC major bleeding (HR 0.13; 95% CI 0.03-0.48; p < 0.001).
- DCB-PCI showed reduced MACE risk in small-vessel disease (HR: 0.54) and long lesions (HR: 0.44).
Conclusions:
- DCB-only PCI offers comparable mid-term MACE rates to current-generation DES in CKD patients.
- DCB treatment significantly reduces major bleeding risk compared to DES in this population.
- These findings support DCB as a viable option for personalized revascularization strategies in CKD patients.
Abstract:
Chronic kidney disease (CKD) is associated with adverse outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Drug-coated balloons (DCB) have emerged as a promising stentless alternative. This study aimed to compare the clinical outcomes of DCB-only PCI versus current-generation DES in patients with CKD. This pooled analysis integrated data from seven observational studies. The DCB cohort included the EASTBOURNE, Milan-DCB, RISE, and DRAGON registries. The DES cohort comprised the ULISSE, ASTUTE, RUDI-FREE, and DRAGON registries. The study population included 1.732 patients with CKD (eGFR <60 ml/min/1.73 m²), of whom 765 were treated with DCB and 967 with DES. The primary endpoint was major adverse cardiovascular events (MACE). Propensity score matching was applied to balance clinical and angiographic features. In the matched population (460 patients per group), the rate of MACE was similar between the two groups (hazard ratio [HR]: 1.09, 95% confidence interval: 0.71 to 1.66) at a mean follow-up of 564 days. DCB treatment was associated with a significantly lower incidence of Bleeding Academic Research Consortium major bleeding (HR 0.13; 95% confidence interval 0.03 to 0.48; p < 0.001). DCB-based PCI was associated with a lower risk of MACE in small-vessel disease (HR: 0.54; p for interaction = 0.04) and long (≥30 mm) lesions (HR: 0.44; p for interaction = 0.02). DCB treatment was associated with comparable rates of MACE at mid-term follow-up and a significantly lower incidence of major bleeding compared to current-generation DES in patients with CKD. These insights may facilitate a personalized revascularization approach in CKD patients.
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