Table 3.
Key efficacy and safety outcomes at 24‐months
| MDT‐2113 DCB | PTA | P‐value | |
|---|---|---|---|
| 24‐month efficacy outcomes | |||
| Clinically driven TLRa | 9.1% (6/66) | 20.7% (6/29) | 0.117 |
| All TLRb % (N/n) | 9.1% (6/66) | 20.7% (6/29) | 0.117 |
| Time to 1st CD‐TLR | 470.2 ± 199.8 | 168.2 ± 65.4 | 0.012 |
| Primary sustained clinical improvementc | 75.8% (47/62) | 71.4% (20/28) | 0.795 |
| 24‐month safety outcomes | |||
| Primary safety composited | 89.4% (59/66) | 79.3% (23/29) | 0.207 |
| 30‐day device‐ and proc.‐related death | 0.0% (0/68) | 0.0% (0/32) | > 0.999 |
| Major adverse evente | 15.2% (10/66) | 24.1% (7/29) | 0.384 |
| Target limb major amputation | 0.0% (0/66) | 0.0% (0/29) | > 0.999 |
| Clinically‐driven TVR | 10.6% (4/66) | 20.7% (6/29) | 0.207 |
| All‐cause death | 6.1% (4/66) | 3.4% (1/29) | 1.000 |
| Thrombosis | 0.0% (0/66) | 0.0% (0/29) | > 0.999 |
Abbreviations: TLR, target lesion revascularization; TVR, target lesion revascularization; DCB, drug‐coated balloon; N, numbers in category; n, number of available values; PTA, percutaneous transluminal angioplasty; CD‐TLR, clinically‐driven TLR.
Clinically driven TLR is defined as any re‐intervention within the target vessel due to symptoms or drop of ABI/TBI of ≥20% or >0.15 when compared to post‐procedure baseline ABI/TBI.
All TLR includes clinically driven and incidental or duplex‐driven TLR.
Primary sustained clinical improvement defined as freedom from target limb amputation, TVR, and increase in Rutherford class at 12 months post‐procedure.
Primary safety composite is defined as freedom from device and procedure‐related 30‐day death and freedom from target limb major amputation and clinically‐driven TVR through 24 months.
MAE is defined as a composite of target limb major amputation, clinically‐driven TVR, all‐cause death, and thrombosis within 24 months.