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).

Study leadership

Margaret McEntegart, MD, PhD

Director of Complex Percutaneous Coronary Intervention Program Columbia University Medical Center/New York-Presbyterian Hospital
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
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

399

Patients
200

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 pbatterns, frequently leads to worse outcomes.^{1, 2, 4}

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

Study Details: EMPOWER CAD

Co-principal investigators Dr. Alexandra Lansky and Dr. Margaret McEntegart discuss the importance of addressing unmet needs and female inequality in calcified lesions.

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 genders³. In the EMPOWER study over 90% of lesions were treated with an IVL-first* treatment algorithm.

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

Actuals

Enrollment

399

Patients
449

Site Reported Target Lesions Treated**

Pre-Shockwave IVL

2.9

%

Cutting/scoring balloon
68.4

%

Dilatation
7.3

%

Atherectomy

Shockwave IVL

90.6

%

IVL-first approach

Stenting

98.4

%

Stent implanted

Post-stent

91.9

%

Dilatation

High-risk, complex real-world patient cohort

32

%

Prior myocardial infarction
23

%

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	86.9% (339/390)
Stent delivered	98.5% (384/390)
≤ 30% residual stenosis	98.5% (384/390)
Without in-hospital TLF	88.7% (346/390)

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	12.1% (48/397)
Cardiac death	1.3% (5/397)
MI Peri-procedural MI (<48hrs) Spontaneous MI (>48hrs)	10.6% (42/397) 9.6% (38/397) 1.5% (6/397)
ID-TLR	1.3% (5/397)

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.⁵

EMPOWER CAD

0.2% (1/419) serious angiographic complication at final
All complications were resolved at final imaging without further clinical sequelae

Parameter	Post-IVL (N=233)	Post Stent (N=409)	Final (N=419)
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 III***

Core Lab Analysis	Immediately Post-IVL (N=384)	Final (N=384)
Any serious angiographic complications	2.6%	0.5%
Severe dissection (Type D to F)	2.1%	0.3%
Perforation	0.0%	0.3%
Abrupt closure	0.0%	0.3%
Slow flow	0.6%	0.0%
No-reflow	0.0%	0.0%

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.⁴

90.6

%

Lesions in which Shockwave IVL-first* approach was used

86.9

%

Procedural success
98.5

%

Stent delivery
98.5

%

With less or equal to 30% residual stenosis
2.6

%

Post IVL serious angiographic complication rate

EMPOWER Video Highlights

Complex PCI in Women

Dr. Suzanne Baron outlines the growing need to EMPOWER, highlighting the studies that detail the discrepancies in PCI between females and males.
Watch Video
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Consistency Across the Sexes: IVL is Safe & Effective in Modifying Nodular Calcium in Men & Women^†

Nodular calcium poses a big clinical problem that is predominantly represented in female patients. Calcified nodules have worse long-term outcomes than any other presentation of calcium.² Dr. Kevin Croce’s patient presented with a challenging tortuous nodular calcified lesion in the right coronary artery. A Shockwave C2 + IVL catheter was used to successfully treat the nodular calcium safely and effectively.
Watch the Case Review
Consistent Results Regardless of Complex Anatomy

The main challenges for calcific lesion treatment in women are related with vessel size and tortuosity.³ Dr. Nieves Gonzalo’s patient presented with both challenges in the left anterior descending artery and the circumflex artery. After visualizing how severe the calcium was in both arteries, a 2.5 Shockwave C2+ catheter was used to modify the calcium. IVL has proven to be impactful and safe for the treatment of calcific coronary disease in females.
Watch the Case Review

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

More Coronary Clinical 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 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.
***DISRUPT CAD III was a 76.6% (294/384) male population. The DISRUPT CAD III exclusion criteria and primary endpoints differ from that of EMPOWER CAD.

1. 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
2. Shaw, Leslee et al., Sex differences in calcified plaque and long-term cardiovascular mortality: observations from the CAC Consortium, European Heart Journal. 2018; 101093
3. 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
4. Ford, Thomas et al., Sex differences in procedural and clinical outcomes following rotational atherectomy, Catheterization & Cardiovascular Interventions, 2019; 101002
5. Hill, J., et al., Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease, Journal of the American College of Cardiology, 2020; 101016
6. M. McEntegart et al. Women with Calcified Coronary Arteries Treated With Intravascular Lithotripsy. Presented at EuroPCR 2025. May 20, 2025

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).

Study leadership

EMPOWER CAD Study Design

Statistics Callout

The Growing Need to EMPOWER

Testimonial

Study Details: EMPOWER CAD

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

Testimonial

Actuals

Enrollment

Statistics Callout

Pre-Shockwave IVL

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Shockwave IVL

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Stenting

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Post-stent

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High-risk, complex real-world patient cohort

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Effectiveness Endpoint

Primary Safety Endpoint

Angiographic Complications

EMPOWER CAD

DISRUPT CAD III***

Quality of Life at 30 Days

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

Statistics Callout

Statistics Callout

Complex PCI in Women

Consistency Across the Sexes: IVL is Safe & Effective in Modifying Nodular Calcium in Men & Women†

Consistent Results Regardless of Complex Anatomy

More Coronary Clinical Studies

Additional Resources

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

Shockwave IVL-first* Strategy Successful in a Female Population

Consistency Across the Sexes: IVL is Safe & Effective in Modifying Nodular Calcium in Men & Women^†