Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2): a multicentre, participant-masked, registry-based, randomised controlled trial.

Summary

In a pragmatic, participant-masked RCT of 1,136 claudication patients, paclitaxel-coated infrainguinal devices did not improve 1-year disease-specific quality of life and showed a higher 5-year mortality signal versus uncoated devices. Routine use for intermittent claudication is not supported.

Key Findings

• No difference in 1-year VascuQoL-6 between paclitaxel-coated and uncoated devices (mean difference −0.02; 95% CI −0.66 to 0.62; p=0.96).
• Overall all-cause mortality was not different over a median 7.1 years (HR 1.18; 95% CI 0.94–1.48), but 5-year mortality incidence was higher with paclitaxel-coated devices (HR 1.47; 95% CI 1.09–1.98).
• Femoropopliteal interventions comprised 96% of cases; most patients had Rutherford category 3 claudication.

Clinical Implications

For intermittent claudication, prioritize symptom-guided care and supervised exercise; if endovascular therapy is chosen, consider uncoated devices given lack of QoL benefit and mortality signal with paclitaxel-coated devices.

Limitations

• Device heterogeneity and evolving technology may influence generalizability
• Trial powered for QoL primary endpoint; mortality analyses may be exploratory

Future Directions

Mechanistic and device-level studies to understand mortality signals; head-to-head comparisons with alternative technologies and stratified analyses by lesion and patient risk.