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Impact of sirolimus-eluting stent fracture on 4-year clinical outcomes
Hisashi Umeda1, Tomoko Kawai, Naoki Misumida
1Division of Cardiology, Toyota Memorial Hospital, 1-1 Heiwa-cho, Toyota, Japan. hisashi_umeda_aa@mail.toyota.co.jp
Insights
Stent fracture (SF) after sirolimus-eluting stent (SES) implantation increases major adverse cardiac events (MACE) within the first year. However, SF did not significantly impact MACE rates between 1 and 4 years post-procedure.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomedical Engineering
Background:
- Stent fracture (SF) is a known complication of sirolimus-eluting stent (SES) implantation.
- The association between SF and long-term major adverse cardiac events (MACE) after SES remains unclear, particularly beyond one year.
Purpose of the Study:
- To evaluate the impact of stent fracture (SF) versus non-fracture on 4-year clinical outcomes in patients treated with sirolimus-eluting stents (SES).
- To assess the temporal relationship between SF and MACE, specifically examining outcomes within the first year and between years 1 and 4.
Main Methods:
- Analysis of 874 lesions in 793 patients who underwent SES implantation and 6- to 9-month angiographic follow-up.
- Identification of stent fracture (SF) at follow-up and comparison of clinical outcomes (MACE, target-lesion revascularization, stent thrombosis, death, myocardial infarction) between SF and non-SF groups over 4 years.
Main Results:
- Stent fracture (SF) was identified in 8.0% of lesions.
- SF lesions showed significantly higher in-stent late loss and in-stent restenosis rates compared to non-SF lesions.
- At 4 years, SF was associated with significantly higher MACE (23.2% vs. 12.6%, P=0.014) and target-lesion revascularization (18.8% vs. 10.2%, P=0.029) rates.
- The adverse impact of SF on MACE was primarily observed within the first year (17.4% vs. 6.6%, P=0.001), with similar MACE rates between 1 and 4 years (5.8% vs. 5.9%, P=0.611).
- No significant differences were found in very late stent thrombosis, death, or myocardial infarction between SF and non-SF groups.
Conclusions:
- Stent fracture (SF) of sirolimus-eluting stents (SES) is linked to increased MACE, predominantly driven by target-lesion revascularization, within the first year post-implantation.
- Beyond the first year, stent fracture (SF) did not show a significant association with major adverse cardiac events (MACE) in this cohort.
Background:
Although stent fracture (SF) after sirolimus-eluting stent (SES) implantation has been recognized as one of the predisposing factors of in-stent restenosis, it remains uncertain whether SF can increase the risk of major adverse cardiac events (MACE), especially beyond 1 year after SES implantation. The aim of this study was to assess the impact of SF relative to non-SF on 4-year clinical outcomes after treatment with SES of comparable unselected lesions.
Methods And Results:
A total of 874 lesions in 793 patients undergoing SES implantation and subsequent angiography 6 to 9 months after index procedure were analyzed. At 6- to 9-month angiographic follow-up, SF was identified in 70 of 874 lesions (8.0%). In-stent late loss was significantly higher in SF lesions versus non-SF lesions (0.42±0.59 mm versus 0.13±0.49 mm, P<0.001), resulting in a significantly higher in-stent restenosis rate (21.4% versus 4.1%, P<0.001). At 4 years, SF versus non-SF was associated with a significantly higher MACE rate (23.2% versus 12.6%, P=0.014), mainly driven by significantly higher target-lesion revascularization (18.8% versus 10.2%, P=0.029) rate. Adverse effects of SF on clinical outcomes occurred mostly within the first year (17.4% versus 6.6%, P=0.001), with similar MACE rate between 1 and 4 years (5.8% versus 5.9%, P=0.611). No significant differences between SF versus non-SF patients were observed in the cumulative frequency of very late stent thrombosis (2.9% versus 1.4%, P=0.281), death (0% versus 2.1%, P=0.252), or myocardial infarction (5.8% versus 2.9%, P=0.165).
Conclusions:
SF of SES was associated with higher MACE rate up to 1 year, mainly driven by higher target-lesion revascularization, whereas no significant association was evident between years 1 and 4.
