Shockwave Versus Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Design and Rationale of
Sameh Sayfo1, Mohamad Bader Abo Hajar2, Taylor Pickering2
1Department of Cardiology, Baylor Scott & White The Heart Hospital - Plano, Plano, Texas.
Insights
Intravascular lithotripsy (IVL) with drug-coated balloons (DCB) may be a safe alternative to surgical endarterectomy for common femoral artery (CFA) stenosis. The SHOCKIFY trial compares these treatments to evaluate long-term efficacy and patient outcomes.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Devices
Background:
- Calcified atherosclerotic disease in lower extremities causes severe symptoms like claudication and chronic limb-threatening ischemia.
- Surgical endarterectomy is the gold standard for common femoral artery (CFA) stenosis, but intravascular lithotripsy (IVL) with drug-coated balloons (DCB) is a potential alternative.
- Long-term data on the efficacy of IVL with DCB for CFA stenosis is limited.
Purpose of the Study:
- To assess if IVL with DCB is a noninferior alternative to surgical endarterectomy for CFA stenosis.
- To evaluate the safety and efficacy of IVL with DCB compared to surgical endarterectomy.
- To provide robust randomized data for potential future treatment guidelines for CFA stenosis.
Main Methods:
- The SHOCKIFY trial is a prospective, randomized clinical trial comparing IVL with DCB to surgical endarterectomy for severe calcified CFA stenosis.
- Participants are randomized 1:1 to receive either IVL with DCB or endarterectomy.
- Primary endpoints are 6-month safety and 1-year primary patency; secondary endpoints include ankle-brachial index, Rutherford classification, and patient-reported outcomes at 30 days, 6 months, and 1 year.
Main Results:
- Primary safety endpoint: freedom from perioperative death, major adverse cardiovascular events, and major adverse limb events at 6 months.
- Primary efficacy endpoint: primary patency at 1 year.
- Secondary endpoints include ankle-brachial index, Rutherford classification, patient satisfaction, and quality of life metrics.
Conclusions:
- IVL with DCB may offer a safer, minimally invasive option for CFA stenosis.
- The study aims to determine if IVL with DCB is a viable, noninferior alternative to surgical endarterectomy.
- Results could influence future treatment guidelines for managing complex vascular calcification in the CFA.
Background:
Calcified atherosclerotic disease in the lower extremities can lead to severe symptoms, including lifestyle-limiting claudication and chronic limb-threatening ischemia. Although surgical endarterectomy remains the gold standard treatment for symptomatic common femoral artery (CFA) stenosis, intravascular lithotripsy (IVL) combined with a drug-coated balloon (DCB) has shown potential as a safe and effective alternative. However, the long-term efficacy of this approach is not well-established.
Methods:
The SHOCKwave angioplasty versus surgical endarterectomy for severe calcified common femoral artery stenosis: effIcacy/saFetY (SHOCKIFY) trial is a single-site, prospective, randomized clinical trial comparing IVL with DCB to surgical endarterectomy in the management of CFA stenosis. Eligible subjects will be randomized in a 1:1 manner to receive either IVL with DCB treatment or endarterectomy. The primary end points include 6-month safety, defined as freedom from perioperative death, major adverse cardiovascular events, and major adverse limb events, along with 1-year efficacy, measured by primary patency. Secondary end points include follow-up assessments at 30 days, 6 months, and 1 year for ankle-brachial index, Rutherford chronic limb-threatening ischemia classification, patient satisfaction, and quality of life metrics. Specifically, patency will be evaluated at 30 days and 6 months as part of the secondary end points. These metrics will be assessed through the Short Form-36 quality of life survey, the peripheral artery questionnaire, and the walking impairment questionnaire. Patient-reported outcomes will be analyzed at these follow-up intervals.
Conclusions:
This trial aimed to assess whether IVL with DCB is a viable, noninferior alternative to the traditional surgical endarterectomy, potentially offering a safer, minimally invasive option for CFA stenosis. The results may reform the future of CFA treatment guidelines by providing robust, randomized data on the clinical utility of IVL in managing complex vascular calcification.
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