New data confirming one-year outcomes with coronary intravascular lithotripsy (IVL, Shockwave Medical) in both women and men were presented at the 2022 Scientific Sessions of the Society for Cardiovascular Angiography & Interventions (SCAI 2022; 19–22 May, Atlanta, USA).
A pooled analysis of the Disrupt CAD III & IV studies showed that IVL was equally safe and effective in men (n=342) and women (n=106). Despite the smaller vessel size in women (2.8mm vs. 3.1mm, p=<0.001), the primary effectiveness endpoint of procedural success for women and men was similar (90.6% vs. 93%, p=0.47), Shockwave Medical reported in a press release. The primary safety endpoint of 30-day major adverse cardiovascular events (MACE) for women and men was also similar (9.4% vs. 7%, p=0.55). Notably, there were also consistently low rates of post-IVL serious angiographic complications in women and men (2.2% vs. 2.6%, p=0.85), which differs from similar analyses in an atherectomy population.
At one year, women and men had similar rates of MACE (12.7% vs. 13.3%, p=0.83) and target lesion failure (TLF, 10.4% vs. 11.2%, p=0.85), respectively. The components of target lesion revascularisation (TLF) were low in both women and men and numerically favoured females, including target vessel-myocardial infarction (MI, 8.5% vs. 9.7%), target lesion revascularisation (2.9% vs. 4.2%) and stent thrombosis (0% vs. 1.2%).
“Given the established safety profile of IVL and the high rates of acute and long-term adverse events in women undergoing PCI, with or without atheroablation of calcified lesions, coronary IVL is an attractive treatment option for optimising outcomes in our female patients,” said Alexandra Lansky (Yale University School of Medicine, New Haven, USA). “While this is the first one-year analysis of its kind for coronary IVL, the sustained benefit in MACE at one year suggests that IVL should be considered first-line therapy for plaque modification in women with calcified lesions.”
The presentation follows the recent publication of SCAI’s “Expert Consensus Statement on Sex-Specific Consideration in Myocardial Revascularization” in JSCAI, which referenced the role of IVL in female patients. The SCAI statement concluded, “while additional evidence is needed, these results taken in the context of outcomes with atherectomy devices suggest that IVL may emerge as a first-line therapy for plaque modification of calcified lesions in women specifically.”
“As someone who is dedicating her career to addressing the needs of the most complex patients, I find these results very encouraging,” said Katherine Kunkel (Piedmont Heart Institute, Atlanta, USA), one of the sites that participated in Disrupt CAD III. “Thanks to an increasing focus on the challenges of female patients, which often include atypical symptoms, later presentation with smaller and more tortuous vessels, and possibly an unconscious bias that may be associated with under-treatment, I am confident that we are heading in the right direction to improve outcomes in female patients. Additionally, tools like IVL are helping level the playing field for safely and effectively treating all types of patients with calcified disease.”