EMPOWER CAD

The first prospective, multi-center, single-arm, all-female, all-comers study to generate real-world clinical evidence associated with an IVL-first* treatment strategy in a patient population with calcified coronary artery disease (CAD).1

EMPOWER CAD logo
Empower CAD logo

Study leadership

This section contains attributions including profile pictures, titles, descriptions, and Twitter handles.

  • Dr. Margaret McEntegart headshot
    Margaret McEntegart, MD, PhD
    Director of Complex Percutaneous Coronary Intervention Program Columbia University Medical Center/New York-Presbyterian Hospital
  • Dr. Alexandra Lansky headshot
    Alexandra Lansky, MD, FACC, FAHA, FSCAI, FESC
    Professor of Medicine, Section of Cardiovascular Medicine and Director, Heart and Vascular Clinical Research Program Yale University School of Medicine
  • Dr. Nieves Gonzalo headshot
    Nieves Gonzalo, MD, PhD
    Consultant Interventional Cardiologist Hospital Clinico San Carlos, Madrid, Spain

Drs. McEntegart, Lansky and Gonzalo are paid consultants of Shockwave Medical.

EMPOWER CAD Study Design

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 399
    Patients
  • 103
    Patient OCT sub study
  • 45
    Global sites

Objective

Prospective, multi-center, single-arm used to generate real-world clinical evidence for coronary IVL in a population of female patients with calcified CAD.

Key Inclusion Criteria

  • Nonpregnant female aged 18 years or older
  • Meets indications for percutaneous coronary intervention (PCI) and stent
  • Scheduled to undergo PCI with coronary IVL & stenting per standard of care for non-stented lesion

Key Exclusion Criteria

  • Patients with in-stent restenosis
  • Patients actively in cardiogenic shock

Primary Safety Endpoint

Target lesion failure (TLF) defined as a composite of cardiac death, myocardial Infarction (per fourth universal definition) attributable to target vessel (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR) at 30 days.

Primary Effectiveness Endpoint

Procedure success defined as stent delivery with a residual in-stent stenosis ≤30% in all target lesions (core laboratory assessed) and without in-hospital TLF (CEC adjudicated).

This all-comers study was designed to include female patients who have severely calcified coronary artery disease
Patients followed up to 30 days, 1 year, 2 years & 3 years

The Growing Need to EMPOWER

Underdiagnosed. Underrepresented. Underwhelming outcomes. Coronary artery disease in female patients has historically been under investigated in the clinical setting. The rationale for exclusion was based on females being a more high-risk patient population and presenting with atypical symptoms. This, coupled with more tortuous anatomy and complex plaque patterns, frequently leads to worse outcomes.2, 3, 5

Testimonial

Previous reports with atherectomy have shown that females with calcified CAD are more susceptible to adverse procedural outcomes compared to males. Despite often being more challenging to treat, female patients are under-represented in published data, and there have been no dedicated prospective studies performed on this population. EMPOWER CAD will be an extremely valuable study to better inform interventional cardiologists on the optimal treatment strategy for these complex patients.

Dr. Margaret McEntegart
The Importance of EMPOWER CAD

The Importance of EMPOWER CAD

It’s Time to EMPOWER: Real-World Data in All-Comer Patient Population. Watch as Dr. Margaret McEntegart and Dr. Alexandra Lansky discuss the importance of Shockwave IVL in a complex real-world, female-only patient population with EMPOWER CAD.

EMPOWER CAD is the first study to utilize ​an IVL-first* Strategy​

EMPOWER CAD is the first coronary, all-comers Shockwave-sponsored study to implement an IVL-first* treatment algorithm. The DISRUPT CAD Pooled analysis suggested that an ​IVL-first* approach can potentially bridge the disparity in clinical outcomes between the genders4. In the EMPOWER ​study over 90% of lesions were treated with an IVL-first* treatment algorithm.​

Testimonial

Information that will be gathered in EMPOWER CAD will be immensely valuable, as it will provide more robust data with longer-term outcomes in a larger, all-comers patient cohort to determine whether Shockwave coronary IVL should be considered the front-line calcium modification approach in female patients.

Dr. Alexandra Lansky

Graphic outlining a Shockwave IVL-first algorithm for treating coronary artery disease.

Actuals

Enrollment

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This section presents key statistical information with numbers and descriptions.

  • 399
    Patients
  • 449
    Site Reported Target Lesions Treated**

Pre-Shockwave IVL

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This section presents key statistical information with numbers and descriptions.

  • 2.0
    %
    Cutting/scoring balloon
  • 68.4
    %
    Dilatation
  • 7.3
    %
    Atherectomy

Shockwave IVL

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This section presents key statistical information with numbers and descriptions.

  • 90.6
    %
    IVL-first approach

Stenting

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This section presents key statistical information with numbers and descriptions.

  • 98.4
    %
    Stent implanted

Post-stent

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This section presents key statistical information with numbers and descriptions.

  • 91.9
    %
    Dilatation

High-risk, complex real-world patient cohort

 

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  • 32
    %
    Prior myocardial infarction
  • 26
    %
    Acute coronary syndrome
  • 28
    %
    Chronic kidney disease
  • 37
    %
    Bifurcation and trifurcation lesions

Effectiveness Endpoint

Shockwave IVL proved to be an effective calcium modification strategy in an all-comers female population​.

Procedural success 87.4%
Stent delivered 98.5%7
≤ 30% residual stenosis 98.5%
Without in-hospital TLF 89.2%

graphs comparing Effectiveness Endpoints

 

Primary Safety Endpoint

In a real-world female patient population with challenging calcium Shockwave IVL had strong safety outcomes.

Parameter Rate
Target lesion failure within 30-days 11.6%
Cardiac death 1.0%
MI

Peri-procedural MI (<48hrs)

Spontaneous MI (>48hrs)

 10.6%
9.6%
1.5%
ID-TLR 1.3%

 

SCAI definition used for periprocedural MI. The Fourth Universal definition (Type 4a) used for spontaneous MI beyond discharge.

  • Protocol required systematic biomarker collection in all patients.
  • MI rate reflective of complex patient population
  • Majority of MIs were biomarker elevation alone without clinical symptoms

Angiographic Complications

IVL has been proven to have consistently low angiographic complications across both male and female patients.6

EMPOWER CAD

  • 0.2% (1/420) serious angiographic complication at final
  • All complications were resolved at final imaging without further clinical sequelae
Parameter Post-IVL
(N=233)		 Post Stent
(N=410)		 Final
(N=420)
Any serious angiographic complications 2.6% 1.2% 0.2%
Severe dissection (Type D to F) 2.6% 0.4% 0.0%
Perforation 0.0% 0.7% 0.2%
Abrupt closure 0.0% 0.5% 0.0%
Slow flow 0.0% 0.0% 0.0%
No-reflow 0.0% 0.0% 0.0%

 

DISRUPT CAD Pooled Sex-Specific Analysis, Male Patients

Parameter Post-IVL (N=435) Final (N=484)
Any serious angiographic complications 2.3% 0.4%
Severe dissection (Type D to F) 1.8% 0.2%
Perforation 0% 0.2%
Abrupt closure 0% 0.2%
Slow flow 0.5% 0%
No-reflow 0% 0%

EMPOWER CAD had 233 lesions, and DISRUPT CAD Pooled Sex-Specific Male Analysis had 435 lesions with available angiography for post-IVL angiographic complication analysis.

Quality of Life at 30 Days

Shockwave IVL was shown to significantly improve quality of life at 30 days in a challenging, complex female patient cohort​.

 

Shockwave IVL-first* Strategy Successful in a Female Population​​

In a high-risk patient population that has typically seen underwhelming results with other calcium modification modalities, EMPOWER CAD demonstrates first-in-class safety and effectiveness utilizing an IVL-first* strategy.5

​

 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 90.6
    %
    Lesions in which Shockwave IVL-first* approach was used

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 87.4
    %
    Procedural success
  • 98.5
    %
    Stent delivery7
  • 98.5
    %
    With less or equal to 30% residual stenosis
  • 2.6
    %
    Post IVL serious angiographic complication rate

Drs. Baron and Croce are paid consultants of Shockwave Medical.

See All Coronary Studies
See All Coronary Studies
  • DISRUPT CAD Pooled
    The largest systematic assessment of Shockwave coronary Intravascular Lithotripsy (IVL) to date based on individual patient data from DISRUPT CAD I–IV.
    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
  • DISRUPT CAD IV
    Shockwave coronary study demonstrating the safety and effectiveness of Shockwave IVL within a Japanese patient population.
    Coronary IVL

Additional Resources

*Shockwave IVL-first algorithm: the utilization of a non-compliant balloon first, and subsequently if the lesion was found to need additional therapy, and Shockwave IVL could pass, it was the front-line calcium modification tool used. Additional tools were used only if needed after IVL at the operator’s discretion.​
**449 target lesions treated is the number of site reported lesions. 430 is the number of core lab reported lesions for EMPOWER CAD.

 

1. McEntegart, Margaret et al. Treating Women With Calcified Coronary Arteries Using Intravascular Lithotripsy: Primary Results of the EMPOWER CAD Study, Journal of the Society for Cardiovascular Angiography & Interventions, 2026, 104191
2. Lansky, Alexandra et al. SCAI Expert Consensus Statement on Sex-Specific Considerations in Myocardial Revascularization. Journal of the Society for Cardiovascular Angiography & Interventions. 2022; 100016
3. Shaw, Leslee et al., Sex differences in calcified plaque and long-term cardiovascular mortality: observations from the CAC Consortium, European Heart Journal. 2018; 101093
4. Hussain, Yasin et al. Sex-Specific Outcomes After Coronary Intravascular Lithotripsy: A Patient-Level Analysis of the Disrupt CAD Studies., Journal of the Society for Cardiovascular Angiography & Interventions, 2002; 100011
5. Ford, Thomas et al., Sex differences in procedural and clinical outcomes following rotational atherectomy, Catheterization & Cardiovascular Interventions, 2019; 101002
6. Hill, J., et al., Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease, Journal of the American College of Cardiology, 2020; 101016
7. M. McEntegart et al. Women with Calcified Coronary Arteries Treated With Intravascular Lithotripsy. Presented at EuroPCR 2025. May 20, 2025