Abstract

As the first prospective randomized three-arm study comparing drug-coated balloons (DCB), drug-eluting stents (DES), and bare-metal stents (BMS) for TASC C/D femoropopliteal lesions, the SPORTS trial demonstrated superior 12-month angiographic and clinical outcomes with DES (Eluvia™). DCB (SeQuent Please™) showed high bailout stenting rates (58%) impacting long-term patency. This article integrates device characteristics to guide complex lesion management.

Introduction

Treatment selection for TASC C/D femoropopliteal lesions has long lacked high-level evidence. Conventional interventions face challenges including high restenosis rates. The SPORTS trial, with randomized data from 224 patients (mean lesion length 22.3cm), provides critical decision-making insights.

Key Findings: SPORTS Trial Outcomes

1. Study Design

Three-arm RCT: 224 patients (Rutherford 2-4, lesions ≥13cm) randomized to:

DCB: SeQuent Please™ OTW (B.Braun)

DES: Eluvia™ (Boston Scientific)

BMS: Bare nitinol stent

Primary endpoint: Core lab-assessed angiographic stenosis at 12 months

2. Critical Results

Subgroup analysis:

DCB bailout cause: 58% required stenting for dissections

Calcification impact: DES advantage amplified in moderate-severe calcification (38-41%)

3. Clinical Implications

DES superiority: Eluvia™ achieved 34.7% lower stenosis vs BMS in long lesions

DCB limitations: SeQuent Please™ non-inferior to BMS but 60% required bailout

Lesion-specific: DES showed greater lumen gain in occlusions (MLD 4.2±0.7mm)

Technological Advances: DCB Optimization

Data from Medtronic's Prevail DCB highlight evolutionary directions:

Delivery enhancement:

Pushability: Next-gen DCBs reach 210g (vs 148g in SeQuent Please™ NEO)

Trackability: Tapered tip + ultrathin balloon material reduce resistance

Drug delivery:

Urea excipient: Rapid drug transfer in 30-60s (similar to SeQuent Please™)

Paclitaxel dose: 3.5μg/mm² (aligned with IN.PACT series)

Evidence base:

SCAAR study: 0.8% thrombosis rate at 2 years in 1,797 patients

Complex lesion efficacy: Strong performance in bifurcation (22.8%) and ISR (28%)

Conclusion

For TASC C/D lesions, SPORTS evidence supports:

First-line strategy: DES (Eluvia™) for lesions >15cm, especially calcified/occluded;

DCB role: SeQuent Please™ for stent-averse patients, with bailout stents available;

Technology evolution: Next-gen DCBs must overcome delivery limitations (e.g., Prevail's 210g pushability).

Future studies require >1-year data to validate DES durability and explore DCB-stent hybrid approaches.