Women fare better than men after Impella-assisted HR PCI

Women undergoing high-risk percutaneous coronary intervention (HR PCI) appear to have better survival outcomes following hospital discharge compared with men, despite being older and having a more complex coronary artery disease, according to data from the IMPELLA-PL registry.

In a cohort of 253 consecutive patients, the 12-month mortality rate postdischarge trended lower in women than in men (9.4 percent vs 19.5 percent; hazard ratio [HR], 1.99, 95 percent confidence interval [CI], 0.97–5.12; p=0.053), reported one of the study authors Dr Aleksandra Gasecka of the Medical University of Warsaw in Warsaw, Poland.  

Of the patients, 32 were women and 221 were men. Women were significantly older (mean age 75.2 vs 70.1 years; p=0.006) and had lower haemoglobin levels (mean 11.4 vs 13.2 g/dL). [TCT 2023, abstract 770]

In addition, women more often had a multivessel coronary artery disease (including left main disease) than men (81.3 percent vs 61.1 percent; p=0.043), with lower left ventricular end-diastolic diameter (52.0 vs 61.0 mm; p<0.001), higher ejection fraction (39.0 vs 25.0; p<0.001), and higher SYNTAX score II (46.0 vs 42.5; p=0.038).

The in-hospital mortality rates were similar, being 9.4 percent in women and 8.1 percent in men (p=0.736). However, complication profiles differed by sex (combined complication rates, 75.0 percent in women vs 56.6 percent in men; p=0.046), according to Gasecka.

For example, systemic complications, specifically acute kidney injury and major bleeding, were more common in women (68.8 percent vs 35.7 percent; p<0.001). On the other hand, device-related complications, such as access-site bleeding, haemolysis, and limb ischemia, occurred more frequently in men (17.9 percent vs 6.3 percent; p=0.049).

“Impella is the least invasive mechanical circulatory support device,” which is advocated by the American College of Cardiology to prevent haemodynamic compromise in selected patients undergoing HR PCI, Gasecka said.

“Data on sex-[related] differences during Impella-assisted HR PCI are limited and controversial,” she noted.

In PROTECT III and CVAD trials, mortality and major adverse cardiac and cerebrovascular event rates were similar, but PCI-related complications and major bleeding events were more common in women than in men. The IMP-IT trial, on the other hand, found comparable complication rates but higher mortality rate in women vs men. [JACC Cardiovasc Interv 2023;16:1721-1729; Catheter Cardiovasc Interv 2020;96:536-544; JACC Cardiovasc Interv 2023;16:124-126]

The mixed data, nevertheless, the IMPELLA-PL registry and the previous studies drive home the message that more women should be included in mechanical circulatory support registries and trials to be able to provide tailored care to female and male patients in the setting of HR PCI, according to Gasecka.