967 THIRD GENERATION, ULTRATHIN STRUTS STENT IN WOMEN COMPARED TO MEN: A GENDER-RELATED ANALYSIS
Authors: Gili Sebastiano , Galli Stefano , Teruzzi Giovanni , Baldi Giulia Santagostino , Ravagnani Paolo , Calligaris Giuseppe , Montorsi Piero , Trabattoni Daniela 
Published: December 2022

Abstract

Introduction
Female patients underrepresentation in clinical trials is a well known issue in clinical research, especially harming the assessment of interventional cardiovascular devices. Limited inclusion of women in such studies might lead to suboptimal care, as results derived from predominantly male populations might not hold true for female patients. In recent years, third generation drug-eluting stents have become the standard of care for percutaneous coronary interventions (PCI). Among them, the Orsiro sirolimus-eluting stent carries some promising features such some of the thinnest struts among commercially available devices (60-80 µm), a bioresorbable-polymer and an amorphous silicon carbide coating. We performed the presents study with the aim to assess if use of this stent in a real-world setting might lead to differential clinical outcomes in women compared to men.

Methods
This is a retrospective study conducted at a single, high-volume center, including all patients undergoing PCI with the implantation of at least one Orsiro for acute or chronic coronary syndromes between January 2017 and December 2019. Main clinical and procedural features were collected, as well as in hospital outcomes. Follow-up data were collected by outpatient visit or by telephone interview. Target lesion failure (TLF), a composite of cardiovascular death, target vessel myocardial infarction or target lesion revascularization, was the main outcome.

Results
Out of a total of 416 patients treated with at least an Orsiro stent, 66 (15.9%) were women and 349 (84.1%) men. No significant differences were observed at baseline, excepted for a higher age (median age 70 vs. 66, P=0.003) and a lower BMI (25.0 vs. 26.1, P=0.010) in women compared to men. No gender-related differences were observed in the indication for PCI, with most of the patients presenting with chronic coronary syndrome (329, 79.3%), rather than acute coronary syndrome in (86, 20.7%). The global number of treated lesions was 558 (90 in women, 468 in men); frequency of left main (5.3% vs. 3.0%) and left anterior descending (34.9% vs. 42.4%) PCI was similar (P=0.28). Treated vessels number of treated lesion per patients (1.36 vs. 1.34, P=0.83), cumulative stent length (33.6 mm vs. 38.4, P=0.078) and mean stent diameter (2.92 vs. 3.0 mm, P=0.39) was not different between men and women. Technical and clinical success was achieved in all cases. Two cases (0.5%) of stent thrombosis, one early and one late, were documented, all in men. After a median follow-up of 402 days, the main outcome of TLF was observed in 10 (2.9%) men and 2 (3.0%) women, with no significant differences at log-rank analysis (2.34 events per 100 patient-years in males, 2.53 in females; P=0.80). In the subgroup of patients undergoing small-vessel PCI (stent diameter ≤ 2.5 mm) no differences were observed in terms of TLF at follow-up between women and men (3.2% vs. 4.9%; P = 0.68). Similar findings emerged in the subgroup of patients presenting with acute coronary syndrome (6.3% vs. 4.3%, P = 0.74)

Conclusions
Ultrathin struts Orsiro stent did not show significant differences in terms of procedural, short-term and long-term outcomes in women compared to men in a real-world setting. This device may represent a viable option for female and male patients undergoing PCI.