DISRUPT CAD POOLED

The largest systematic assessment of Shockwave coronary Intravascular Lithotripsy (IVL) to date based on individual patient data from the DISRUPT CAD I–IV clinical programs.

DISRUPT CAD IV DISRUPT CAD Pooled OCT Subgroup Analysis EMPOWER CAD
DISRUPT CAD POOLED logo
DISRUPT CAD Pooled logo

DISRUPT CAD Pooled Key Findings  

  • CAD pooled is the largest systematic assessment of Shockwave coronary IVL to-date based on individual patient data from the DISRUPT CAD I–IV clinical programs. 
  • Shockwave coronary IVL achieved high procedural success in a cohort of one of the most severe and longest calcified vessel segments reported for any percutaneous coronary intervention (PCI) trial to date. Shockwave IVL was delivered largely via transradial approach. ​ 
  • Shockwave coronary IVL was safe with low rates of major adverse cardiac events (MACE) and very low rates of severe angiographic complications in these complex target lesions across multiple trials, centers and patient subgroups.​ 
  • Shockwave coronary IVL was consistently effective in achieving high acute gain and low residual stenosis across multiple trials, centers and patient subgroups. ​ 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 628
    Patients
  • 72
    Sites in 12 countries
  • 97
    %
    Severe Ca++
  • 42
     mm
    Calcium length
  • 99
    %
    Shockwave IVL crossing & therapy delivery
  • 63
    %
    Transradial access
  • 0.2
    %
    Major dissections*
  • 0.2
    %
    Perforations*
  • 0.2
    %
    Abrupt closure*
  • 0
    %
    Slow flow/no reflow*
  • 12
    %
    Residual stenosis*
  • 1.7
     mm
    Acute luminal gain

*Procedural angiographic outcomes post stent. Independent angiographic core lab assessment.

Pooled Analysis Study Design 

  • Individual patient-data (IPD) pooled analysis of the DISRUPT CAD I-IV studies 
  • Uniform study criteria, endpoints, adjudication, follow-up 
  • Multivariate analysis: Predictors of MACE and procedural success 
  • Safety and effectiveness sub-group analysis 
  • 30-day follow-up 
  • ITT Population: N=628, 72 global sites in 12 countries 
  • Countries included: Australia, Belgium, Switzerland, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom, United States 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 60
    N for DISRUPT CAD I
  • 120
    N for DISRUPT CAD II
  • 384
    N for DISRUPT CAD III
  • 64
    N for DISRUPT CAD IV

Shockwave IVL Has Very Low Rates of Angiographic Complications Despite Lesion Complexity 

Accordion Section

Core Lab Analysis Immediately Post-IVL Final Post-Stent
Any serious angiographic complication 2.1% 0.3%
Severe dissection (Type D-F)  1.8% 0.2%
Perforation 0.0% 0.2%
Abrupt closure 0.0% 0.2%
Slow flow 0.4% 0.0%
No-flow 0.0% 0.0%

*Per protocol: CK-MB level >3x ULN at discharge (peri-procedural MI): 97% of NQWMI occurred prior to discharge

See All Clinical Evidence
See All Clinical Evidence
  • DISRUPT CAD I
    Single-arm, pre-market study demonstrating the safety and performance of Shockwave IVL in heavily calcified  coronary lesions.
    Coronary IVL
  • DISRUPT CAD II
    European post-market study confirming DISRUPT CAD I results and showing strong safety and procedural success with Shockwave coronary IVL.
    Coronary IVL
  • DISRUPT CAD III
    Largest and most rigorous Shockwave study showcasing the safety, effectiveness and ease of use of Shockwave coronary IVL .
    Coronary IVL