A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries

The EQ-5D assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) of health-related quality of life responses assigned by the participants. The values are anchored at 1 (best) to 0 (worst). The vales for the visual analog score takes values from 100 (best) to 0 (worst). The index value is comparable across the baseline, 12- and 24-Months timepoints.

Improvement was calculated by comparing the scores from 12- and 24-Months to the baseline scores and presenting the number of participants that showed improvement at 12- and 24-Months. The WIQ measures the improvement as reported by participants in their walking distance, walking speed, stair-climbing ability and improvement in their PAD symptoms pre-procedure (baseline) compared to 12 months and compared to 24 months. The improvement at those time points is measured as percent improvement.

The Rutherford Classification describes the different stages of peripheral artery disease (PAD) from a score of 0 (no PAD) to 6 (critical limb ischemia with major tissue loss). The percentages represent the percent of participants that had sustained clinical improvement from baseline to 12 months and baseline to 24 months. Sustained clinical improvement means their Rutherford Class improved by one or more categories compared with baseline.

Number of participants with improved Rutherford Classification at 12- and 24-Months when compared to baseline.

Primary Sustained Clinical Improvement is improvement in Rutherford Classification of one or more categories as compared to baseline without the need for repeat target lesion revascularization (TLR).

Secondary Sustained Clinical Improvement is improvement in Rutherford classification of one or more categories as compared to baseline including those participants with repeat TLR.

Number of participants with improvement in Ankle-Brachial Index (ABI) at 12- and 24-Months compared to baseline.

Hemodynamic Improvement is defined as an increase in ABI of >= 0.10 or to an ABI >= 0.90 as compared to baseline without the need for repeat TLR. The ABI measures the arterial pressure in the leg compared to the arterial pressure in the arm. The higher the value, the better the blood flow. Improvement is defined as an increase in the ABI by greater than or equal to 0.10 compared with baseline or to an ABI greater than or equal to 0.90. The percentages in the table represent the patients that demonstrated an improvement in their ABI from baseline to 12 months and baseline to 24-months.

Changes in healthcare utilization over time

Number of participants that successfully received Eluvia stent. Technical success defined as implanted and achieving residual angiographic stenosis no greater than 30% assessed visually.

Number of participants with successful procedures. Procedural success defined as technical success with no major adverse events (MAEs) noted within 24 hours of the stenting procedure.

Number of participants with Clinical Events Committee (CEC) adjudicated MAEs at 12- and 24-Months cumulatively. The MAEs are defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization rate. A participant can be present in more than one sub-category.

The numbers represent the percentage of patients that were event free at 12 and 24 months (i.e. didn't have a TLR).

The cumulative number of participants that received a clinically-driven target lesion revascularization after the stenting procedure.

The cumulative number of participants that received a clinically-driven target vessel revascularization after the stenting procedure.

Rutherford Classification:

• Asymptomatic - Normal Treadmill /stress test

• Mild claudication - Completes treadmill exercise; ankle pressure (AP) after exercise <50mm Hg, but >25 mm Hg less than blood pressure (BP)
• Moderate claudication - Between categories 1 and 3
• Severe claudication - Cannot complete treadmill exercise and AP after exercise <50 mm Hg
• Ischemic rest pain - Resting AP <40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); toe pressure (TP) <30 mm Hg
• Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal edema - Resting AP <60 mm Hg, ankle or metatarsal (MT) PVR flat or barely pulsatile; TP <40 mm Hg
• Major tissue loss-extending above MT level - Same as Category 5