Table 3

Effectiveness and Safety Results in the 3 Study Subgroups Stratified by Diagnostic Versus Interventional Procedure

Effectiveness MeasuresRoll-InsVCDMCΔVCD-MC (95% CI)p Value
Diagnostic procedures(n = 58)(n = 134)(n = 66)
 Time to (mean ± SD)
  Hemostasis (min)2.7 ± 2.83.3 ± 4.914.8 ± 5.9 (n = 65)−11.5 (−13.0 to −9.9)<0.0001
  Ambulation (h)1.4 ± 0.81.6 ± 1.2 (n = 133)6.6 ± 18.4−5.0 (−8.2 to −1.9)0.0295
 Eligibility for hospital discharge (h)5.4 ± 14.8 (n = 57)4.9 ± 7.4 (n = 131)11.9 ± 35.4 (n = 64)−7.0 (−13.3 to −0.6)0.1257
 Hospital discharge (h)9.7 ± 21.48.7 ± 20.2 (n = 132)14.8 ± 38.8 (n = 65)−6.1 (−14.3 to 2.2)0.2402
 Device deployment (min)1.0 ± 1.31.2 ± 2.9 (n = 131)
 30-day major adverse events composite0000 (0 to 1.99)0.0091
Interventional procedures(n = 29)(n = 133)(n = 68)
 Time to (mean ± SD)
  Hemostasis (min)8.6 ± 33.45.4 ± 15.625.2 ± 30.5 (n = 66)19.8 (−26.2 to −13.4)<0.0001
  Ambulation (h)3.10 ± 4.173.5 ± 6.9 (n = 131)5.8 ± 3.5 (n = 63)−2.3 (−4.1 to −0.5)0.0022
 Eligibility for hospital discharge (h)18.4 ± 6.9 (n = 28)20.5 ± 14.7 (n = 126)20.6 ± 15.2 (n = 64)−0.2 (−4.7 to 4.3)0.9460
 Hospital discharge (h)21.6 ± 5.124.8 ± 15.8 (n = 132)23.7 ± 14.41.1 (−3.4 to 5.6)0.6270
 Device deployment (min)0.9 ± 0.80.8 ± 0.8 (n = 129)
 30-day major adverse events composite0000 (0 to 2.00)0.0093

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

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

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

  • 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.