Table 2

Effectiveness Outcomes at 24 Months

IN.PACT (n = 220)PTA (n = 111)p Value
Primary patency78.9 (42)50.1 (54)<0.001
CD-TLR§9.1 (18/198)28.3 (30/106)<0.001
Time to first CD-TLR, days351.9 ± 165.9261.7 ± 139.00.049
All TLR10.1 (20/198)29.2 (31/106)<0.001
Primary sustained clinical improvement76.9 (133/173)59.2 (61/103)0.003
ABI/TBI#0.924 ± 0.2610.938 ± 0.1840.611

Values are % (n), % (n/N), or mean ± SD.

CD-TLR = clinically driven target lesion revascularization; TLR = target lesion revascularization; TVR = target vessel revascularization; other abbreviations as in Table 1.

  • Unless otherwise indicated, all tests were for superiority using the Fisher exact test for binary variables and Student t test for continuous variables.

  • Freedom from clinically driven TLR or freedom from restenosis as determined by Duplex ultrasound peak systolic velocity ratio ≤2.4 within 24 months. The 24-month primary patency was calculated based on Kaplan-Meier estimate, and the number of primary patency failure subjects are displayed in the parentheses.

  • Log rank p value.

  • § Any reintervention at the target lesion due to symptoms or drop of ABI of ≥20% or >0.15 when compared with post-procedure baseline ABI/TBI.

  • Includes clinically driven and incidental or duplex-driven TLR.

  • Freedom from target limb amputation, TVR, and increase in Rutherford class.

  • # TBI allowed/used in case of incompressible vessels in phase II.