Table 2

Effectiveness and Safety Results in the 3 Study Groups

Roll-Ins (n = 87)VCD (n = 267)MC (n = 134)ΔVCD-MC (95% CI)p Value
Effectiveness measures
 Time to (mean ± SD)
  Hemostasis (min)4.7 ± 19.44.4 ± 11.620.1 ± 22.5 (n = 131)−15.7 (−19.0 to −12.3)<0.0001
  Ambulation (h)2.0 ± 2.62.5 ± 5.0 (n = 264)6.2 ± 13.3 (n = 129)−3.7 (−5.5 to −1.9)0.0028
 Eligibility for hospital discharge (h)9.7 ± 14.2 (n = 85)12.6 ± 13.9 (n = 257)16.3 ± 27.5 (n = 128)−3.7 (−7.8 to 0.5)0.1540
 Hospital discharge (h)13.6 ± 18.516.8 ± 19.8 (n = 264)19.4 ± 29.2 (n = 133)−2.6 (−7.5 to 2.3)0.3612
 Device deployment (min)0.9 ± 1.11.0 ± 2.1 (n = 260)
Safety measures to 30 days(n = 84)(n = 256)(n = 126)
 Major adverse events composite0000 (0 to 1.05)0.0005
 Secondary safety composite end point7 (8.3)22 (8.5)5 (4.0)4.6 (−1.1 to 9.2)0.1360
 Rebleeding after initial hemostasis3 (3.6)14 (5.4)3 (2.4)3.1 (−1.8 to 6.9)0.1989
 Access site hematoma ≥6 cm3 (3.6)6(2.4)1 (0.8)1.6 (−2.2 to 4.3)0.4334
 Access site-related bleeding requiring >30 min for hemostasis1 (1.2)1 (0.4)1 (0.8)−0.4 (−4.0 to 1.5)0.5503
 Transient access site-related nerve injury01 (0.4)00.4 (−2.6 to 2.2)1.0000
 Retroperitoneal bleeding02 (0.8)00.8 (−2.2 to 2.8)0.3298
 Ecchymosis ≥6 cm1 (1.2)01 (0.8)−0.8 (−4.4 to 0.8)
 Decreased pedal pulse1 (1.2)00
Death000

Unless specified otherwise, values indicate n (%) of patients.

CI = confidence interval; other abbreviations as in Table 1.

  • The p value for primary safety end point was calculated from the noninferiority test between VCD and MC with a pre-specified noninferiority margin of 4.0%. The p values for the secondary end points were from Fisher exact test;

  • primary safety end point includes: 1) need for surgical or nonsurgical vascular repair; 2) access site-related: a) bleeding requiring transfusion, b) infection requiring antibiotics or extended hospitalization, c) nerve injury requiring surgery, d) >30 days nerve injury; and 3) new ipsilateral lower extremity ischemia.