Abstract
IntroductionIn recent years, the new third-generation ultrathin bioresorbable-polymer sirolimus-eluting stent (BP-SES), characterized by some of the thinnest struts among commercially available devices (60–80 μm) and an amorphous silicon carbide coating, has been introduced for the treatment of coronary artery disease (CAD). The present study aimed to assess different clinical outcomes and safety of this drug-eluting stent in male and female patients in a real-world setting.MethodsThe present study is a retrospective analysis including all patients treated with BP-SES between January 2017 and December 2019 at a single high-volume center. Follow-up data, including stress test results and clinical setting, were collected during outpatient visits or by telephone contact. Patients symptomatic for angina or with a positive stress test were addressed to CT scan/coronary angiogram. The main study outcome was target lesion failure (TLF), defined as a composite of cardiovascular death, target vessel myocardial infarction, or target lesion revascularization.ResultsOverall, 66 (15.9%) female and 349 (84.1%) male patients were included; women were older (median age 70 vs. 66, P = 0.003) and with a lower body mass index (BMI) (25.0 vs. 26.1, P = 0.010) compared to men, with no other relevant differences in baseline characteristics. Indication for percutaneous coronary intervention (PCI) was acute coronary syndrome in 86 (20.7%) of the cases, with no significant differences between male and female patients. A total of 558 lesions were treated with BP-SES stents, 90 in women and 468 in men (1.36 vs. 1.34 lesions per patient, P = 0.83); cumulative stent length (33.6 vs. 38.4 mm, P = 0.078), and mean stent diameter (2.92 vs. 3.0 mm, P = 0.39) did not differ in women compared to men. Technical and clinical successes were achieved in all patients. Stent thrombosis (ST) occurred in 2 (0.5%) patients, both men. TLF occurred in 10 (2.9%) men and 2 (3.0%) women after a median follow-up of 402 days, without significant differences at log-rank analysis (2.34 events per 100 patient-years in men, 2.53 in women; P = 0.80).ConclusionUltrathin struts BP-SES showed to be a safe and effective option for the treatment of CAD in both women and men, with a very low ST rate and favorable long-term outcomes.
Highlights
In recent years, the new third-generation ultrathin bioresorbable-polymer sirolimus-eluting stent (BP-SES), characterized by some of the thinnest struts among commercially available devices (60–80 μm) and an amorphous silicon carbide coating, has been introduced for the treatment of coronary artery disease (CAD)
Introduction of bioresorbable polymers (BP), which progressively disappear after implantation, has led to the development of drug-eluting stents (DES) transforming over time into biologically less active bare-metal stents (BMS), with a potential reduction of long-term thrombogenicity [9]
The present study aims to evaluate the short and midterm outcomes in women and men treated with the implantation of ultrathin BP sirolimus-eluting stent (BP-SES) during routine clinical practice
Summary
The new third-generation ultrathin bioresorbable-polymer sirolimus-eluting stent (BP-SES), characterized by some of the thinnest struts among commercially available devices (60–80 μm) and an amorphous silicon carbide coating, has been introduced for the treatment of coronary artery disease (CAD). Developed medical devices and drugs are too often tested in unbalanced populations in terms of gender in controlled studies, which are hardly representative of the real-world populations in which such devices are used [1] This limitation applies as well to stent technology, a field in which the evolution from bare-metal stents (BMS) to first and second-generation drug-eluting stents (DES) has led to significant prognostic improvements in women in terms of adverse cardiovascular events at follow-up [2]. Introduction of bioresorbable polymers (BP), which progressively disappear after implantation, has led to the development of DES transforming over time into biologically less active BMS, with a potential reduction of long-term thrombogenicity [9] These technological improvements have guided the creation of a recently distributed ultrathin BP sirolimus-eluting stent (BP-SES), with some of the thinnest struts among commercially available devices (60–80 μm based on stent diameter) and an amorphous silicon carbide coating, which has shown promising results in early randomized clinical trials (RCT) [10]
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