DISRUPT CAD Pooled OCT Subgroup Analysis

Explore the OCT sub-analysis of individual patient data pooled from four coronary studies to see Shockwave Intravascular Lithotripsy (IVL) outcomes, fracture analysis and stent expansion predictors across various calcium arcs and nodule presence.

DISRUPT CAD POOLED OCT Analysis logo
DISRUPT CAD Pooled OCT Subgroup analysis logo

DISRUPT CAD Pooled OCT Analysis Conclusions

  • The present individual patient data pooled analysis of four studies (N=262) represents the largest evaluation of Shockwave IVL by OCT 
  • OCT demonstrated extensive calcium fracture after Shockwave IVL treatment with excellent stent expansion of severely calcified lesions 
  • Visible calcium fracture and calcium characteristics were not predictors of stent expansion following treatment with Shockwave IVL 

Moderated Poster, TCT 120: OCT Characterization of Shockwave IVL for Treatment of Calcified Coronary Lesions: Patient-level Pooled Analysis of the DISRUPT CAD OCT Sub-studies, Ziad A. Ali, TCT 2021. 

DISRUPT CAD I DISRUPT CAD II DISRUPT CAD III DISRUPT CAD IV DISRUPT CAD Pooled
Enrollment Dec 2015 – Sep 2016  May 2018 – Mar 2019  Jan 2019 – Mar 2020  Nov 2019 – Apr 2020 Dec 2015 – Apr 2020 
Study Design Prospective, multi-arm, single-arm
ITT (N) 601 1203  3844 645 6286
OCT Analysis* 282 57 106* 71* 262
OCT Core Laboratory Cardiovascular Research Foundation, New York, NY 
Target Lesions Severely calcified**, de novo coronary artery lesions 

*Patient enrollment in OCT sub-studies was open to all sites participating in the DISRUPT CAD studies that routinely perform OCT imaging.
** Includes patients from DISRUPT CAD III and IV. 

1: Brinton et al. Circulation 2019;139:834-836
2: Ali et al. J Am Coll Cardiol Img 2017;10:897-906
3: Ali et al. Circ Cardiovasc Interv 2019;12:e008434
4: Hill et al. J Am Coll Cardiol 2020;76:2635-46
5: Saito et al. Circ J 2021;85(6):826-33
6:Kereiakes et al., J Am Coll Cardiol Intv 2021;14:1337-48

Accordion Section

Pre-IVL
N=248		 Post-Stent
N=245
MLA, mm2 2.1 ± 1.0  6.2 ± 1.9* 
Area stenosis at MLA site, %  72 ± 12  18 ± 20 
Calcium arc at max calcium site, °  270 ± 81 
Calcium thickness at max calcium site, mm  0.96 ± 0.25 
MSA, mm2  6.0 ± 1.9
Mean stent area, mm2  7.9 ± 2.3 
Stent expansion at max calcium site, %  103 ± 29 
Mean stent expansion, %  107 ± 29 
Any malapposition strut, %  3.9 ± 4.6 

*MLA was never co-localized with the pre-IVL maximum calcification 

Moderated Poster, TCT 120: OCT Characterization of Shockwave IVL for Treatment of Calcified Coronary Lesions: Patient-level Pooled Analysis of the DISRUPT CAD OCT Sub-studies, Ziad A. Ali, TCT 2021.

VISIBLE CALCIUM FRACTURE ANALYSIS

AVERAGE OF 3.2 FRACTURES PER LESION DEMONSTRATED BY OCT

Moderated Poster, TCT 120: OCT Characterization of Shockwave IVL for Treatment of Calcified Coronary Lesions: Patient-level Pooled Analysis of the DISRUPT CAD OCT Sub-studies, Ziad A. Ali, TCT 2021. 

MicroCT Allows for Microfracture Visualization Post-Shockwave IVL 

Moderated Poster, TCT 163: OCT Characterization of Eccentric Versus Concentric Calcium Treated With Shockwave IVL: Patient-level Pooled Analysis of the DISRUPT CAD OCT Sub-studies. Ziad A. Ali, TCT 2021

Review the full CAD Pooled OCT presentation

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