ORLANDO, Fla. — Women undergoing transcatheter aortic valve replacement had more vascular complications than men, but they had a better mortality rate at 1 year, according to findings reported at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
Roxana Mehran, MD, FAHA, FACC, FSCAI, professor of medicine, population evidence and health policy at Icahn School of Medicine at Mount Sinai and associate medical editor of Cardiology Today’s Intervention, and colleagues studied in-hospital and 1-year outcomes of 23,652 patients (49.9% women) who underwent TAVR between 2012 and 2014 and were included in the Society of Thoracic Surgeons/American College of Cardiology TVT Registry.
Jaya Chandrasekhar, MBBS, MRCP, FRACP, postdoctoral research fellow at Icahn School of Medicine at Mount Sinai, said during a presentation that compared with men, women were somewhat older (82 years vs. 81 years), were more likely to have porcelain aorta (7.7% vs. 6%) and had a higher STS predicted risk of mortality (9% vs. 8%), but were less likely to have comorbidities such as CAD (prior PCI: 29.5% vs. 41.9%; prior CABG: 16.4% vs. 46.1%), diabetes (35% vs. 39.5%) or atrial fibrillation (38.9% vs. 42.7%).
Women were more likely than men to be treated with non-transfemoral access (45% vs. 36%) and with smaller sheaths and devices, she said.
Women had a higher rate of in-hospital vascular complications than men (8.27% vs. 4.39%; adjusted HR = 1.7; 95% CI, 1.34-2.14), according to the results. These included device-related complications related to coronary obstruction or compression (0.7% vs. 0.1%; crude OR = 4.92; P = .0001) and unplanned cardiac surgery (2.4% vs. 1.6%; crude OR = 1.53; P = .0001),
There also was a trend toward women having a higher rate of in-hospital Valve Academic Research Consortium (VARC) major bleeding (adjusted OR = 1.19; 95% CI, 0.99-1.44), Chandrasekhar said.
Despite these factors, in-hospital mortality was similar between the sexes (adjusted OR = 0.89; 95% CI, 0.71-1.11) and 1-year mortality was lower for women (21.3% vs. 24.5%; adjusted HR = 0.73; 95% CI, 0.63-0.85).
At 1 year, stroke (adjusted HR = 1.3; 95% CI, 0.95-1.9) and bleeding (adjusted HR = 1.1; 95% CI, 0.96-1.2) were similar between women and men, Chandrasekhar said.
“Women undergoing TAVR in a U.S. national registry for significant aortic valve disease had a different risk profile compared to men; nevertheless, they had a higher incidence of procedural complications. Yet, at 1 year, survival and death or stroke were superior in women compared to men,” Chandrasekhar said during the presentation. “Perhaps this is due to women having fewer systemic baseline risks, including [CAD] and a higher cover index, as well as a testament to management of major vascular complications at the time of the procedure.”
Mehran told Cardiology Today’s Intervention that “perhaps the time has come to evaluate safety and efficacy of TAVR vs. [surgical] AVR in an all-female prospective randomized trial.”– by Erik Swain
Chandrasekhar J, et al. Late-Breaking Clinical Trials – Part 3. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 4-7, 2016; Orlando, Fla.
Disclosure: Chandrasekhar reports no relevant financial disclosures. Mehran reports receiving institutional research support from AstraZeneca, Bayer, Bristol-Myers Squibb, Eli Lilly/Daiichi Sankyo and The Medicines Company; serving on advisory boards for Abbott, Janssen Pharmaceuticals and Osprey Medical; and receiving consultant fees/honoraria from Medscape.