EMPOWER CAD

A prospective, multi-center, single-arm, female-only, all-comers study to generate real-world clinical evidence associated with coronary Intravascular Lithotripsy (IVL) in a patient population with calcified coronary artery disease (CAD).

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
    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.

  • 400
    Patients
  • 200
    Patient OCT sub study
  • 50
    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

IVL-First Treatment Algorithm

EMPOWER CAD is the first coronary, all-comers Shockwave-sponsored observational study to implement an IVL-first treatment algorithm. Early retrospective analyses (DISRUPT CAD III/IV) have suggested that an IVL-first approach can potentially bridge the disparity in clinical outcomes between the genders. EMPOWER CAD provides additional insight into an IVL-first strategy for an historically underrepresented patient population in clinical trials.

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.

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.1

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
Announcing EMPOWER CAD

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 Video Highlights

  • Image for Complex PCI in Women

    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
  • Image for Consistency Across the Sexes: IVL is Safe & Effective in Modifying Nodular Calcium in Men & Women*

    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
  • Image for Consistent Results Regardless of Complex Anatomy

    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.

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

1: Equity in Modifying Plaque of Women With Undertreated Calcified Coronary Artery Disease: Design and Rationale of EMPOWER CAD study McEntegart, Margaret et al. Journal of the Society for Cardiovascular Angiography & Interventions, Volume 3, Issue 11, 102289.
2: Ali ZA, Shin D, Singh M, Malik S, Sakai K, Honton B, Kereiakes DJ, Hill JM, Saito S, Mario CD, Gonzalo N, Riley RF, Maehara A, Matsumura M, Hokama J, West NEJ, Stone GW, Shlofmitz RA. Outcomes of coronary intravascular lithotripsy for the treatment of calcified nodules: a pooled analysis of the Disrupt CAD studies. EuroIntervention. 2024 Dec 2;20(23):e1454-e1464. doi: 10.4244/EIJ-D-24-00282. PMID: 39618263; PMCID: PMC11586657.
3: Equity in Modifying Plaque of Women With Undertreated Calcified Coronary Artery Disease: Design and Rationale of EMPOWER CAD study McEntegart, Margaret et al. Journal of the Society for Cardiovascular Angiography & Interventions, Volume 3, Issue 11, 102289
*Hill, J, Kereiakes, D, Shlofmitz, R. et al. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. JACC. 2020 Dec, 76 (22) 2635-2646. https://doi.org/10.1016/j.jacc.2020.09.603