Female vs male complex PCI by sirolimus-eluting stenting: one-year NAGOMI COMPLEX study outcome
A Aminian, G Stankovic, M Mamas, B Chevalier, R ByrneAbstract
Background/Introduction
Percutaneous coronary interventions (PCI) are increasingly performed in complex settings, influenced by lesion characteristics, procedural strategies, and patient-related factors. The impact of sex differences on PCI risk and outcomes remains uncertain. Prior evidence indicates that women more frequently present with higher bleeding risk (HBR), which may influence procedural strategy and outcomes.
Purpose
The NAGOMI COMPLEX study evaluates the safety and effectiveness of a new-generation sirolimus-eluting stent in complex PCI. This analysis assesses the impact of sex-based differences in clinical outcomes at one-year follow-up.
Methods
NAGOMI COMPLEX is a prospective, multicentre, observational study enrolling more than 3000 patients undergoing complex PCI across 52 European sites. Patients were eligible if they met at least one of the predefined procedural complexity criteria. Following completion of enrolment, this analysis includes patients with available one-year follow-up data, in which clinical outcomes were assessed by sex. The primary endpoint is one-year target lesion failure (TLF), defined as a composite of cardiovascular death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (CD-TLR).
Results
Among 3031 patients, 72.9% had chronic coronary syndrome and 20.9% were women (n=633). Women were older (71.1 ± 9.66 vs 68.6 ± 10.29 years; p<0.0001) and more frequently HBR patients (51.1% vs 41.6%; p<0.0001). Prior PCI (32.2% vs 37.0%; p=0.0264) and CABG (6.0% vs 8.3%; p=0.0595) were less frequent in women. Complex procedural features such as left main stenting (20.6%), complex bifurcations (15.4%), chronic total occlusion (22.3%), and multivessel PCI (41.3%) did not differ between genders, nor did the number of implanted stents per lesions. Women had lower use of radial access (75.0% vs 84.0%; p<0.0001) and intravascular imaging (24.1% vs 29.5%; p=0.0006, at lesion level). At one year, TLF was comparable (7.4% vs 8.9%; p=0.3104), including cardiovascular death (3.0% vs 2.0%), TVMI (4.0% vs 5.6%), and CDTLR (2.8% vs 3.6%). Access site bleeding (BARC 1–5) (5.8% vs 2.0%; p<0.0001) and major bleeding (BARC 3–5) (5.0% vs 2.5%; p=0.0085) were both higher in women, without differences in all-cause mortality (4.2% vs 4.5%; p=0.821). Rates of MI were 5.2% in men and 6.5% in women (p=0.2766), TLR 3.9% vs 5.6% (p=0.1447), stent thrombosis 1.2% vs 1.8% (p=0.3783), and stroke 1.1% vs 2.3% (p=0.0664).
Conclusion(s)
In this large multicentre cohort of patients undergoing complex PCI with new-generation sirolimus-eluting stents, female patients more frequently presented with HBR features and had higher postprocedural bleeding events, while overall procedural performance was similar between sexes. These results highlight the need for sex-specific approaches to bleeding risk minimization in complex PCI.