Table 11.2.
Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL-2), Balloon vs Stenting in Severe Ischaemia of the Leg (BASIL-3), and Best Endovascular vs Best Surgical Therapy for Patients with Critical Limb Ischemia (BEST-CLI) trial end points
End points | BASIL-2 and BASIL-3 | BEST-CLI |
---|---|---|
| ||
Primary | AFS | MALE-free survival |
Secondary | Freedom from all-cause mortality In-hospital and 30-day morbidity and mortality MALE MACE Relief of ischemic pain Psychological morbidity HRQL: generic and disease-specific instruments Reintervention and crossover intervention rates Healing of tissue loss (ulcers, gangrene) Extent and healing of minor amputations Hemodynamic changes; absolute APs and TPs, ABI, TBI HRQL (VascuQoL and EQ-5D) Health economic analysis |
Freedom from all-cause mortality RAFS Freedom from MALE and POD AFS Freedom from myocardial infarction Freedom from stroke Freedom from reinterventions (major and minor) in index leg No. of reinterventions (major and minor) per limb salvaged Freedom from hemodynamic failure Freedom from clinical failure Freedom from CLTI HRQL (VascuQoL and EQ-5D) Health economic analysis |
ABI, Ankle-brachial index; AFS, amputation-free survival; APs, ankle pressures; CLTI, chronic limb-threatening ischemia; EQ-5D, EuroQol-5 Dimension questionnaire; HRQL, health-related quality of life; MACE, major adverse cardiac event; MALE, major adverse limb event; POD, perioperative death; RAFS, reintervention- and amputation-free survival; TBI, toe-brachial index; TPs, toe pressures; VascuQoL, Vascular Quality of Life questionnaire.