Table 3

Safety Outcomes at 24 Months

IN.PACT (n = 220)PTA (n = 111)p Value
Primary safety composite87.4% (173/198)69.8% (74/106)<0.001
Major adverse events19.2% (38/198)31.1% (33/106)0.023
All-cause death§8.1% (16/198)0.9% (1/106)0.008
Device- and procedure-related death0.0% (0/198)0.0% (0/106)>0.999
Clinically driven TVR12.6% (25/198)30.2% (32/106)<0.001
Target limb major amputation0.0% (0/198)0.0% (0/106)>0.999
Thrombosis1.5% (3/198)3.8% (4/106)0.243

Values are % (n/N).

PTA = percutaneous transluminal angioplasty; other abbreviations as in Tables 1 and 2.

  • p values are based on Fisher exact test for superiority with significance level of 0.05.

  • Freedom from 30-day device- and procedure-related death and target limb major amputation and clinically driven TVR within 24 months.

  • Composite of death, clinically-driven TVR, target limb major amputation, and thrombosis.

  • § No deaths were adjudicated as device- or procedure-related by the clinical events committee. Median post-index days to death: 564.5 days in DCB versus 397 days in PTA.