For an older adult (>65) with symptomatic femoropopliteal peripheral artery disease and comorbidities (diabetes, hypertension, chronic kidney disease), does atherectomy combined with drug‑coated balloon angioplasty improve primary patency and reduce clinically driven target‑lesion revascularization compared with drug‑coated balloon alone?

Drug-Coated Balloon Plus Atherectomy vs. Drug-Coated Balloon Alone for Femoropopliteal Angioplasty

For older adults with symptomatic femoropopliteal PAD and multiple comorbidities, drug-coated balloon (DCB) angioplasty should be the first-line endovascular strategy, with atherectomy reserved only as an adjunct when technically necessary for lesion preparation—not as a routine combination therapy—because current evidence shows no consistent improvement in primary patency or target lesion revascularization rates, and some data suggest increased adverse limb events with atherectomy. 1

Guideline-Based Treatment Framework

Primary Endovascular Strategy

• Drug-eluting treatment (DCB) should be considered as the first-choice strategy for femoropopliteal lesions (Class IIa, Level A), according to the 2024 ESC guidelines. 1

• Endovascular therapy should be the first choice even for complex lesions, especially in surgical high-risk patients like your described population with diabetes, hypertension, and chronic kidney disease. 1

• The 2017 AHA/ACC guidelines support endovascular procedures as reasonable for lifestyle-limiting claudication with hemodynamically significant femoropopliteal disease (Class IIa, Level B-R). 1

Role of Atherectomy: Limited and Conditional

• No guideline recommends routine atherectomy plus DCB as superior to DCB alone for femoropopliteal disease. 1

• Atherectomy should be viewed as a lesion preparation tool when balloon angioplasty alone cannot adequately dilate heavily calcified or complex lesions, not as a standalone therapeutic modality. 1

Evidence Analysis: Atherectomy Outcomes

Recent Large-Scale Registry Data (Mixed Results)

• A 2024 VQI registry analysis of 60,794 patients showed atherectomy was associated with a 13% reduction in major adverse limb events (MALE) compared to standard treatment (aOR 0.87; 95% CI 0.77-0.98), primarily driven by decreased major amputation rates (aOR 0.69; 95% CI 0.52-0.91). 2

• However, complication rates were higher with atherectomy (6.2% vs 5.9%, p<0.0001), and there were no differences in 30-day mortality, primary patency, or target vessel revascularization. 2

Long-Term Outcomes Show Concern

• A 2019 Medicare-linked VQI study of 16,838 patients found that atherectomy patients had worse 5-year outcomes: higher risk of any amputation (HR 1.51; 95% CI 1.08-2.13) compared to PTA alone, and significantly worse outcomes compared to stenting—higher major amputation (HR 3.66; 95% CI 1.72-7.81), any amputation (HR 2.73; 95% CI 1.60-4.76), and MALE (HR 1.61; 95% CI 1.10-2.38). 3

• The 5-year MALE rate was 38% for atherectomy versus 33% for PTA and 32% for stenting. 3

Systematic Review: No Procedural Advantage

• A 2014 meta-analysis of 6 RCTs (287 patients, 328 lesions) found debulking atherectomy conferred no procedural advantage or improvement in clinical outcomes over balloon angioplasty alone. 4

• Technical success was similar (93.6% vs 96.2%), bail-out stenting rates were comparable, and primary patency at median 9-month follow-up showed no difference (RR 0.90; 95% CI 0.56-1.46). 4

Clinical Decision Algorithm for Your Patient Population

When to Use DCB Alone (Preferred Approach)

• Short to moderate-length lesions (TASC A/B) with mild to moderate calcification. 1

• Lesions amenable to adequate balloon dilation without significant recoil or dissection. 1

• Patients at high bleeding risk where minimizing procedural complexity is paramount. 1

When Atherectomy May Be Considered as Adjunct

• Heavily calcified lesions (PACSS score ≥2) where balloon angioplasty cannot achieve adequate luminal gain. 5

• Long, complex TASC C/D lesions where plaque debulking may facilitate subsequent DCB delivery and apposition. 5

• In-stent restenosis where balloon angioplasty alone has very high failure rates. 6, 7

• The Phoenix atherectomy study showed acceptable safety in complex lesions (82% TASC C/D, 80% moderate-severe calcification) with only 1% perforation rate and 4% bail-out stenting in femoropopliteal segments. 5

Critical Contraindications to Atherectomy

• Do not use atherectomy prophylactically to prevent progression to critical limb ischemia in claudication patients—progression rates are only 10-15% over 5 years, and procedural risks outweigh hypothetical benefits. 1, 8

• Avoid in patients with poor runoff or extensive infrapopliteal disease where distal embolization risk is heightened. 4

Essential Adjunctive Management

Antithrombotic Therapy Post-Procedure

• Single antiplatelet therapy (aspirin 75-100 mg or clopidogrel 75 mg daily) is recommended after femoropopliteal intervention (Class I). 1

• For high-risk limb presentations (your patient with diabetes, CKD, and multiple comorbidities), consider aspirin plus rivaroxaban 2.5 mg twice daily (Class IIa). 1

• Short-term DAPT for 1-3 months may be considered in patients without high bleeding risk, followed by single antiplatelet therapy. 1

Risk Factor Modification

• Target LDL-C <55 mg/dL with intensive statin therapy, adding ezetimibe or PCSK9 inhibitor as needed. 6

• Aggressive blood pressure control, particularly with ACE inhibitors. 6

• Optimal glycemic control in diabetic patients is crucial for improved limb-related outcomes. 6

Critical Pitfalls to Avoid

• Do not assume atherectomy plus DCB is superior to DCB alone—the evidence is conflicting, with some studies showing harm and none showing consistent benefit in primary patency or TLR. 2, 4, 3

• Do not perform revascularization solely to prevent CLI progression in claudication patients—mortality in PAD is primarily from cardiovascular events, not limb-related complications. 1, 8

• Do not use bare-metal stents if stenting is required—drug-eluting stents show superior patency. 8

• Do not neglect surveillance—perform duplex ultrasound at 1 month, 6 months, then annually to detect restenosis early. 6

• Durability is diminished with greater lesion length, occlusion rather than stenosis, multiple diffuse lesions, poor runoff, diabetes, CKD, and smoking—discuss realistic expectations about restenosis and repeat intervention risk. 1

Surgical Bypass Consideration

• For your high-risk patient population, surgical bypass should be reserved for cases where autologous vein (great saphenous vein) is available, surgical risk is acceptable despite comorbidities, and complex lesions have failed endovascular approaches after interdisciplinary team discussion. 1

• Operative mortality for CABG in patients ≥80 years with comorbidities ranges 5-8% (11% for urgent cases), with longer hospital stays and less frequent discharge to home. 1