https://doi.org/10.1007/s00392-024-02526-y
1Herzzentrum Dresden GmbH an der TU Dresden Klinik für Innere Medizin, Kardiologie und Intensivmedizin Dresden, Deutschland; 2Helios Park-Klinikum Leipzig Klinik für Innere Medizin I - Kardiologie, Angiologie Leipzig, Deutschland
Background: Females are generally underrepresented in cardiovascular clinical trials. Specifically, data are limited for women undergoing high-risk percutaneous coronary interventions (HRPCI) with mechanical circulatory support. We investigated sex-specific outcomes in patients undergoing microaxial flow pump (mAFP)-supported HRPCI.
Methods: We used a prospective single-center registry to examine 65 (28%) female and 169 (72%) male patients undergoing mAFP-supported HRPCI. The primary outcomes were 30-day and 3-year survival. Safety was assessed according to ARC-2 and VARC-3 definitions.
Results: Female and male patients were comparable with regard to age (81 (IQR 76; 84) vs 79 (IQR 71; 84) years, p=0.286), median left ventricular ejection fraction (LV-EF 41% (IQR 30; 54) vs 39% (IQR 29; 50), p=0.294) and the rate of relevant comorbidities. The STS score was significantly higher in females compared to males (6.6 (4.4; 12.4) vs 5.3 (IQR 3.1; 10.3), p=0.023). There were no significant differences with regard to ischemic (CCS 3/4: 46.2% vs 34.5%) and heart failure symptoms (NYHA III/IV: 63.1% vs 53.0%). The rate for 3-vessel (80.0% vs 78.7%) and left main disease (80.0% vs 78.1%) was also comparable between females and males leading to a comparable median Syntax score (33 (IQR 23; 40) vs 32 (IQR 24; 41), p=0.907).
A median of 3 lesions was treated in both groups without significant differences (p=0.234). The median residual Syntax-Score was 7 in both groups without statistical significance (p=0.904). Complete revascularization defined by a residual Syntax-Score ≤8 was achieved in 54.8% and 55.7% of female and male patients (p=0.908). The time of mAFP-support was also not different between groups. There was a numerically higher rate of VARC-defined vascular access site complications in females (38.5% vs 28.6%, p=0.144), mainly minor complications. The rates of myocardial infarction, VARC-defined bleeding, stroke and acute kidney injury were not significantly different.
The Kaplan-Meier estimated 30-day (83.5% (95%-CI 74.6; 93.5) vs. 83.5% (95%-CI 77.8; 89.6), p=0.909) and 3-year survival (48.6% (95%-CI 34.6; 68.2) vs. 49.8% (95%-CI 41.6; 59.7), p=0.651) was not different between female and male patients. In a multivariate Cox regression analysis, sex was not associated with early and late mortality whereas a higher residual Myocardial Jeopardy Score (per 1-point increase HR 1.10 (95%-CI 1.01; 1.19)), atrial fibrillation (HR 1.83 (95%-CI 1.10; 3.06)), chronic dialysis (HR 2.23 (95%-CI 1.14; 4.35), and a reduced LV-EF (per 10% decrease HR 1.23 (95%-CI 1.04; 1.45)) were independently associated with a higher 3-year mortality.
Conclusion: In patients undergoing mAFP-supported HRPCI, no significant safety and survival differences were detected between female and male patients indicating equipoise in the outcome between both sexes. Consequently, those therapies should not be withheld from women if indicated. Increased long-term mortality was predicted by baseline comorbidities and incomplete revascularization.