Mijin Kim
Nationality
Korea
Current Position
Teaching staff
Organization
Presbyterian Medical Center, Jeon-ju, Div. of Vascular And Endovascular Surgery Dept. of surgery
Peripheral Artery Session

Topic: Clinical Outcomes Comparison of drug coated balloon

Abstract

IN.PACT global study is real-world, prospective, multicenter, single arm study

Final result of This study. 5 year were like this.

  • The IN.PACT Global Study remains the largest and only reported real-world drug-coated balloon (DCB) study with independent CEC adjudication through 5 years
  • Results demonstrate sustained effectiveness of the IN.PACT Admiral DCB through five years with a freedom from CD-TLR = 69.4%
  • Long-term safety through five years demonstrated;
    • low amputation (1.7%) and thrombosis (5.7%) rates
    • freedom from all-cause mortality of 78.9% with a known vital status rate of 96.4% through 5 years
  • Robust, real-world data continues to demonstrate durable results indicating the IN.PACT Admiral DCB as a viable solution for the treatment of femoropopliteal disease

 

Four subgroup analysis that have never been reported in Asia.

  1. PACT Global : ISR , long lesion (>15cm), CTO (>5cm)
  • High 5-year freedom from clinically driven TLR was demonstrated in all three pre-specified cohorts,
    but it was slightly lower in the de novo ISR cohort highlighting the challenging nature of ISR lesions.
  • No safety issues were reported in any of the cohorts. All-Cause Mortality with vital status at 5 years:

 

  1. PACT Global Study : Stented vs Non-stented Analysis
  • Stented group had longer lesions, more total occlusions, more severe calcification and higher diameter stenosis at baseline
  • In the event of sub-optimal angioplasty results (i.e., persistent residual stenosis >50%, flow limiting dissection), the IN.PACT Admiral DCB can be safely followed by provisional BMS with the expectation of similar outcomes through 5 years compared to lesions treated with DCB alone
  1. PACT Global Study : Female vs Male
  • No differences in reintervention rates demonstrate consistent, long-term effectiveness in both females and diabetics
  • No difference in mortality between the male and female subgroups through five-year although mean age was significantly higher in females.
  1. PACT Global Study : Claudicant vs CLI
  • Long-term effectiveness and safety through 5 years supports the strong performance of the IN.PACT Admiral DCB in a clinically complex CLI subgroup;
  • Freedom from CD-TLR: 5% (RCC 2-3) versus 60.7% (RCC 4-5)
  • Freedom from all-cause mortality: 2% (RCC 2-3) versus 60.0% (RCC 4-5)

 

Conclusion

DCB showing excellent results with regard to efficacy and safety in the most complicated patient subgroups.

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