Directional Atherectomy Prior to Drug-Coated Balloons in Femoropopliteal Arteries: My Evidence-Based Best Practices

Despite its established role as a vessel preparation tool, direct atherectomy (DA) remains underutilized in many healthcare systems. This was one of the core messages of Theodosios Bisdas, MD, from Athens Medical Centre in Greece, who took to the podium this afternoon to share his own evidence-based practices in how DA use before drug-coated balloons (DCBs) can benefit the femoropopliteal arteries. 

What specific lesion characteristics do you consider when deciding to use DA before DCB?

Based on the current body of evidence and the availability of dedicated devices, I employ DA for 2 primary lesion types: eccentric lesions, whether calcified or not; and recoils following angioplasty of long chronic total occlusions (CTOs) when aiming to leave nothing behind (focal atherectomy). Additionally, I use DA in cases of isolated popliteal artery disease to avoid placing any scaffold.

How does vessel preparation with DA impact the efficacy of drug delivery from DCBs in your experience?

The cutter of the DA removes plaque, creating a pathway for paclitaxel to be delivered directly to the smooth muscle cells of the media. Furthermore, DA reduces dissection rates, making the use of DCBs more effective. This translates to less need for scaffolding and reinforces the value of vessel preparation before DCB application.

Can you elaborate on the technical aspects of performing DA that you find crucial for optimal outcomes?

It is a powerful tool for luminal gain and vessel preparation but requires adherence to specific technical principles for safe and effective outcomes:

1. Crossing test: confirm that the device can cross the lesion without resistance before initiating debulking

2. Distal protection device: Always use one, regardless of operator experience.

3. Avoid over-debulking: Aim for a residual stenosis of <30% to prevent perforation or late aneurysm formation.

4. CO2 injection: Use the side port of the device to perform angiographic controls for luminal gain, especially in patients with chronic kidney disease. 

What are the key differences in outcomes you’ve observed between using DCB alone vs DA followed by DCB? 

Directional atherectomy serves as an effective vessel preparation tool, minimizing dissection, enhancing luminal gain, and improving vessel compliance. When combined with DCBs, DAART (DA and anti-restenotic therapy) has shown to offer: 

-    Less scaffolding and greater acute luminal gain
-    A trend toward improved long-term patency rates, particularly when achieving a residual stenosis of <30%. 

What are your thoughts on the potential for reducing bailout stenting rates when using DA before DCB?

In the DEFINITIVE-AR trial, DA achieved low rates of flow-limiting dissection and bailout stenting. In the REALITY registry, which included real-world lesion characteristics (mean lesion length: 17.9 cm, PACCS grade 4: 68%), the bailout stenting rate was 8.8%. This compares favorably to the 33.3% provisional stenting rate reported in the IN.PACT Global Study for long lesions treated with DCB angioplasty as the primary therapy. 

How do you approach heavily calcified lesions in the femoropopliteal segment? Is there a calcification threshold where you prefer atherectomy? 

While there is no specific calcification threshold for employing DA, lesion morphology often dictates the choice. I prefer DA for:
-    Eccentric lesions 
-    Focal atherectomy in cases where circumferentially calcified lesions are unresponsive to intravascular lithotripsy or scoring-balloon angioplasty.

Are there any specific patient subgroups that seem to benefit more from the combined DA and DCB approach?

Currently, there is insufficient data or subgroup analysis to definitively identify specific patient groups. However, I prioritize young patients and those with lesions in ‘no-stenting zones’ for DA to avoid scaffolding. Additionally, long and calcified lesions appear to benefit from the DAART approach, as identified in the DEFINITIVE AR trial and confirmed by the REALITY registry. 

How do you balance the potential benefits of DA with the added procedural time and cost?

Although procedural time is a limitation, increased operator experience reduces it. Additionally, I favor focal atherectomy, which involves performing DA after gentle angioplasty of a long lesion. This reduces significantly the procedural time. From a cost perspective, the long-term benefits—such as reduced bailout stenting, lower rates of in-stent restenosis, and fewer target lesion revascularizations—justify the initial investment. 

Based on your experience, what future research directions would you suggest to further refine the use of DA with DCBs? 

Despite its established role as a vessel preparation tool, DA remains underutilized due to a lack of reimbursement in many healthcare systems and the additional cost of adjunctive devices such as distal protection. Future research should focus on:
1. Cost-effectiveness analyses comparing DAART to standalone DCB therapies to highlight long-term savings
2. Comparative studies of DAART versus alternative vessel preparation methods (e.g., lithotripsy) for calcified lesions to determine the optimal approach or to define specific lesion characteristics that respond adequately to the one or the other type of treatment.