Drug-eluting devices for lower limb peripheral arterial disease: a focus on safety and efficacy
Peripheral arterial disease (PAD) is a significant cause of cardiovascular morbidity, particularly affecting patients with femoropopliteal and below-the-knee (BTK) arterial lesions. These patients, often presenting with symptoms ranging from intermittent claudication to chronic limb-threatening ischemia (CLTI), face an elevated risk of limb loss if left untreated.
Over the years, endovascular interventions have become the preferred revascularisation strategy for these patients, with drug-eluting devices playing a critical role.
Why this study?
This study provides a thorough review of the current evidence on drug-eluting stents (DES) and drug-coated balloons (DCBs), focusing on their safety and efficacy in treating PAD, especially in complex lesions where restenosis remains a challenge.
As the use of these devices becomes more widespread, particularly in challenging clinical settings, it is essential to understand their comparative effectiveness and long-term safety.
Key findings:
1 - Efficacy of drug-eluting stents (DES):
- For patients undergoing treatment of femoropopliteal lesions, drug-eluting stents have shown to be highly effective. Notably, the Eluvia DES, which utilises a polymer-based system to deliver paclitaxel, has demonstrated superior results in maintaining vessel patency.
In the EMINENT trial, a 1-year follow-up revealed that the primary patency rate for patients treated with Eluvia was 83.2 %, significantly higher than the 74.3 % observed in those treated with bare metal stents (BMS) (p = 0.0077).
This suggests that, in this patient population, polymer-based DES can offer enhanced outcomes, particularly in preventing restenosis and the need for repeat interventions. - Furthermore, the SPORTS trial provided additional evidence supporting the use of Eluvia DES, showing that it outperforms both BMS and paclitaxel DCBs in terms of freedom from target lesion revascularization (TLR) over a 12-month period.
2 - Challenges with drug-coated balloons (DCBs):
- DCBs, particularly those coated with paclitaxel, have been explored as an alternative to DES, especially in patients with BTK lesions. However, the results have been less consistent.
The IN.PACT DEEP study examined the effectiveness of paclitaxel-coated balloons in BTK arteries and found no significant difference in primary patency or TLR when compared to plain old balloon angioplasty (POBA).
This raises important considerations for clinicians when choosing between DCBs and other revascularisation options for patients with BTK lesions, where the risk of restenosis and other complications is high.
Clinical relevance:
The study's findings have substantial implications for clinical practice. In patients with PAD affecting the femoropopliteal arteries, drug-eluting stents, particularly polymer-based options like Eluvia, have proven to be a superior choice in reducing the need for further interventions and improving long-term outcomes. The choice of DES over traditional BMS is supported by evidence from trials like EMINENT and SPORTS, which highlight better primary patency and reduced reintervention rates.
However, for BTK lesions, the decision is more nuanced. While DCBs offer the potential advantage of a "leave nothing behind" strategy, their inconsistent results in clinical trials, as seen in the IN.PACT DEEP study, suggest that they may not always be the best option, particularly in complex cases with extensive calcification or long lesion lengths. In such scenarios, DES may still be the preferred choice due to their ability to provide sustained drug release and structural support, which are crucial for maintaining patency in the challenging BTK territory.
Moreover, the ongoing discussion regarding the safety of paclitaxel-coated devices underscores the importance of individualized patient assessment. The recent FDA reversal of previous restrictions on paclitaxel-coated devices reflects a growing confidence in their safety, yet it also emphasizes the need for careful patient selection and close monitoring of long-term outcomes.
Visual insights:
Figure 1 from the study illustrates the comparison of primary patency and freedom from target lesion revascularization (TLR) rates among different drug-eluting devices in femoropopliteal interventions. This figure highlights the superior performance of Eluvia DES compared to BMS and other devices. Source: EuroIntervention Journal
If this article piqued your interest in the original paper, hold off until you’ve watched the videos below! The authors themselves dive into the chapters they contributed to, highlighting the value of this state-of-the-art publication—you won’t want to miss it!
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