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Published on: November 19, 2020
Sirolimus-Coated Balloon Versus Drug-Eluting Stent in Elderly Patients With Coronary Artery Disease: A Matched-based
Filippo Luca Gurgoglione1, Sylwia Iwańczyk2, Wojciech Wańha3
1Division of Cardiology, Parma University Hospital, Parma, Italy; DCB Academy, Milano, Italy.
Insights
Sirolimus-coated balloons (SCB) offer comparable safety and efficacy to drug-eluting stents (DES) for elderly patients with coronary artery disease (CAD). SCB significantly reduced major bleeding events, presenting a promising alternative for this vulnerable population.
Area of Science:
- Cardiology
- Interventional Cardiology
- Geriatric Medicine
Background:
- Coronary artery disease (CAD) is a major cause of mortality in elderly individuals (≥75 years).
- Percutaneous coronary intervention (PCI) with second-generation drug-eluting stents (DES) is a common treatment for elderly CAD patients.
- Drug-coated balloons (DCB) are emerging as a potential alternative to DES.
Purpose of the Study:
- To compare the safety and efficacy of PCI using Sirolimus-Coated Balloons (SCB) versus second-generation DES in elderly patients with CAD.
- To evaluate key cardiovascular outcomes and bleeding events at 2-year follow-up.
Main Methods:
- A comparative study utilizing data from the EASTBOURNE study (SCB) and the Complex Registry (DES).
- Inclusion of elderly patients (≥75 years) who underwent PCI.
- Application of propensity score matching and Cox regression analysis for outcome assessment.
- Primary endpoint: net adverse cardiovascular events (NACE) at 2 years.
- Secondary endpoint: Bleeding events (BARC 3-5).
Main Results:
- After matching, 220 patients were analyzed in each group (SCB vs. DES).
- No significant difference in NACE incidence between SCB and DES groups (p=0.239).
- Similar rates of nonfatal myocardial infarction and target lesion revascularization were observed.
- The SCB group showed a significantly lower rate of major bleeding events (BARC 3-5) compared to the DES group (p=0.030).
Conclusions:
- PCI with SCB demonstrates comparable safety and efficacy to second-generation DES in elderly patients with CAD at 2-year follow-up.
- SCB therapy is associated with a significantly reduced risk of major bleeding in this population.
- SCB represents a viable and potentially safer alternative for treating elderly patients with CAD.
Abstract:
Coronary artery disease (CAD) is the leading cause of mortality in elderly patients (≥75 years). While percutaneous coronary intervention (PCI) with second-generation drug-eluting stents (DES) is commonly used in elderly patients with CAD, drug-coated balloons (DCB) have emerged as a promising alternative. The aim of this study was to compare the safety and efficacy of PCI with Sirolimus-Coated Balloons (SCB) and second-generation DES in this population. We included elderly patients who underwent PCI from the prospective, investigator-driven EASTBOURNE study (n= 534 patients treated with Magic Touch SCB) and the Complex Registry (n = 234 patients treated with second-generation DES). The primary endpoint was net adverse cardiovascular events (NACE), a composite of all-cause death, target lesion revascularization (TLR), nonfatal myocardial infarction (MI), and major bleedings at the 2-year follow-up. The cardinality score matching and Cox regression analysis were employed. After matching, 220 patients were included in each group. The incidence of NACE was similar between groups (HR 1.28; 95% CI: 0.85-1.93; p = 0.239). No significant differences were observed in the rates of nonfatal MI, or TLR. However, the SCB group exhibited a significantly lower rate of the secondary BARC 3-5 bleeding endpoint compared to the DES group (HR 0.17; 95% CI: 0.04-0.77; p = 0.030). In conclusion, CI with SCB demonstrated comparable safety and efficacy to second-generation DES in elderly patients with CAD at 2-year follow-up, with a notable reduction in major bleeding risk in the SCB group.
