Ten-year clinical outcomes after sirolimus-eluting stent implantation: Impact of an in-stent restenosis target lesion

doi:10.1016/j.ahj.2016.02.005

American Heart Journal

Volume 175, May 2016, Pages 47-55

https://doi.org/10.1016/j.ahj.2016.02.005 Get rights and content

Background

Little is known about the long-term outcomes after first-generation sirolimus-eluting stent (SES) implantation. We aimed to investigate the clinical outcomes up to 10 years after SES implantation.

Methods

The study population comprised 342 patients (504 lesions) who underwent SES implantation between January 2002 and December 2004. The median duration of follow-up was 3816 days (interquartile range [Q1-Q3], 3,705-3,883 days).

Results

The cumulative event rate of definite stent thrombosis was 3.9%. The cumulative rate of target lesion revascularization (TLR) at 1, 5, and 10 years was 8.7%, 18.8%, and 31.1%, respectively, and the annual rate of TLR was 3.1%. Clinically driven TLR occurred at relatively constant rate during 10 years (2.0% per year). In a multivariate analysis, higher body mass index, hemodialysis, in-stent restenosis (ISR) target lesion, and total stent length >30 mm were independent risk factors of TLR within 5 years. An independent risk factor of TLR beyond 5 years was ISR target lesion.

Conclusions

Late TLR after SES implantation is a long-term hazard, lasting up to 10 years. The ISR target lesion is a risk factor of TLR during 10 years.

Section snippets

Patient population

This study was designed as a retrospective, single-arm, single-center registry to evaluate clinical outcomes after the implantation of SES (Cypher, Cordis, Johnson & Johnson, Miami, FL). From January 2002 to December 2004, 395 consecutive patients (568 lesions) who underwent the first SES implantation were enrolled in this study. Of these, we excluded 53 patients (64 lesion) treated with SES and other type of stent. Finally, we analyzed 342 patients (504 lesions) treated exclusively with SES.

Baseline characteristics

The study population included 12.6% patients of advanced age (>80 years) and 45.3% patients with diabetes mellitus (DM). Furthermore, the proportions of in-stent restenosis (ISR) target lesion and chronic total occlusion were 36.0% and 14.0%, respectively (Table I). All the stents that previously implanted were BMSs.

Clinical outcomes of 10-year follow-up

The cumulative event rate of all-cause death and cardiac death was 42.1% and 18.4%, respectively (Table II and Figure 1). The annual rate of all-cause death and cardiac death

Discussion

In the present study, we analyzed the long-term clinical outcomes after the first SES implantation. The main findings of this analysis are as follows: (1) TLR after SES implantation occurred at a relatively constant rate up to 10 years, and (2) SES implantation for ISR target lesions was a risk factor of TLR through 10 years.

Several long-term follow-up studies up to 5 years after SES implantation have demonstrated the benefit of DESs and low rates of TLR.12, 13 However, the clinical and lesion

Conclusions

Late TLR after SES implantation is a continuous hazard, lasting up to 10 years. In-stent restenosis target lesion is an independent risk factor of TLR through 10 years.

References (30)

P. Wenaweser et al.
Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice. 4-year results from a large 2-institutional cohort study
J Am Coll Cardiol
(2008)
Y. Nakagawa et al.
Incidence and risk factors of late target lesion revascularization after sirolimus-eluting stent implantation (3-year follow-up of the j-Cypher Registry)
Am J Cardiol
(2010)
G. Weisz et al.
Five-year follow-up after sirolimus-eluting stent implantation results of the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) Trial
J Am Coll Cardiol
(2009)
N. Palhais et al.
Ten-year clinical follow-up after sirolimus-eluting stent implantation
Am Heart J
(2014)
A. Caixeta et al.
5-Year clinical outcomes after sirolimus-eluting stent implantation
J Am Coll Cardiol
(2009)
R. Koster et al.
Nickel and molybdenum contact allergies in patients with coronary in-stent restenosis
Lancet
(2000)
G. Niccoli et al.
The evolving role of inflammatory biomarkers in risk assessment after stent implantation
J Am Coll Cardiol
(2010)
D.H. Steinberg et al.
Outcome differences with the use of drug-eluting stents for the treatment of in-stent restenosis of bare-metal stents versus drug-eluting stents
Am J Cardiol
(2009)
S. Habara et al.
Late restenosis after paclitaxel-coated balloon angioplasty occurs in patients with drug-eluting stent restenosis
J Am Coll Cardiol
(2015)
J.M. de la Torre-Hernandez et al.
Drug-eluting stent thrombosis: results from the multicenter Spanish registry ESTROFA (Estudio ESpanol sobre TROmbosis de stents FArmacoactivos)
J Am Coll Cardiol
(2008)

G. Barone-Rochette et al.

Stent-related cardiac events beyond three years after implantation of the sirolimus-eluting stent (from the EVASTENT Patients)

Am J Cardiol

(2011)

M.B. Leon et al.

Late clinical events after drug-eluting stents: the interplay between stent-related and natural history-driven events

J Am Coll Cardiol Interv

(2009)

U. Sigwart et al.

Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty

N Engl J Med

(1987)

R. Mehran et al.

Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome

Circulation

(1999)

M.C. Morice et al.

A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization

N Engl J Med

(2002)

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Very long-term serial luminal changes after sirolimus-eluting stent implantation and progression process of very late stent failure
2018, Cardiovascular Revascularization Medicine
Citation Excerpt :
This observation indicates a persistent risk even after newer-generation DES implantation. Despite the continuous risk of late TLR after 1st-generation DES implantation in the previous studies [4,5], the annual risk of TLR has been reported to decrease beyond 5 years in another study [16]. This difference potentially depends on the compliance of antiatherosclerotic drugs such as statin therapy, which prevents the occurrence of neoatherosclerosis and reduce late TLR after DES implantation [17,18].
Very long-term angiographic results after sirolimus-eluting stent (SES) implantation have not been clarified. This study investigated serial angiographic results of early (< 1 year), late (1–5 years), and very late (> 5 years) follow-up after SES implantation and the progression process to very late SES failure.
We analyzed 631 lesions undergoing serial coronary angiography at early, late, and very late follow-up after SES implantation. The results of 205 lesions undergoing very late target lesion revascularization (VL-TLR; TLR beyond 5 years) for acute coronary syndrome (ACS; 83) and non-ACS (122) were evaluated in comparison with 426 non-TLR lesions as a control group.
Non-TLR lesions showed no attenuated decline of minimum lumen diameter from postprocedure (2.51 ± 0.47 mm), early (2.37 ± 0.58 mm), late (2.22 ± 0.60 mm), up to very late (2.01 ± 0.63 mm) follow-up. In VL-TLR lesions, compared to non-TLR lesions, late lumen loss (LLL) from postprocedure to early follow-up was similar, but delayed LLL from early to late follow-up was significantly larger (0.25 ± 0.48 mm vs. 0.15 ± 0.46 mm, p = 0.01). Although the delayed LLL was significantly larger in non-ACS lesions (0.29 ± 0.44 mm) than in non-TLR lesions (p < 0.01), it was similar in ACS (0.19 ± 0.52 mm) and non-TLR lesions (p = 0.54). Very delayed LLL from late to very late follow-up was 1.65 ± 0.82 mm in ACS lesions and 1.10 ± 0.76 mm in non-ACS lesions.
Progression of in-stent luminal narrowing did not attenuate beyond 5 years after SES implantation. In very late SES failure, stent-related ACS lesions showed gradual luminal narrowing and subsequent rapid progression beyond 5 years, whereas non-ACS lesions had progressive luminal narrowing within 5 years.
Difference in clinical presentations and related angiographic findings among early, late, and very late sirolimus-eluting stent failures requiring target lesion revascularization
2017, International Journal of Cardiology
Citation Excerpt :
Drug-eluting stents (DES) have reduced in-stent restenosis and target lesion revascularization (TLR) compared to bare-metal stents [1–3]. However, late DES failure including TLR and stent thrombosis has been reported to continue occurring beyond 5 years after sirolimus-eluting stent (SES) implantation [4,5]. The stent failure presents with acute coronary syndrome (ACS) which is a critical problem of percutaneous coronary intervention (PCI) with stents.
The difference in clinical presentations (acute coronary syndrome [ACS] and stable coronary artery disease [SCAD]) and related angiographic morphologies of sirolimus-eluting stent (SES) failure requiring target lesion revascularization (TLR) during early-term (< 1 year), late-term (1–5 years), and very late-term periods (> 5 years) remains unknown.
Among 4484 lesions undergoing SES implantation, clinically-driven TLR was performed on 105 lesions during early-term, 169 lesions during late-term, and 147 lesions during very late-term period. Angiographic morphological patterns were divided into focal or non-focal patterns and stent-edge or stent-body patterns.
The proportion of ACS substantially increased in very late TLR lesions (57.1%) from early (40.0%, p = 0.01) and late TLR lesions (36.7%, p < 0.001). The proportions of both stent-edge and non-focal patterns were higher in very late TLR lesions than in early and late TLR lesions. Although the stent-edge pattern tended to be more prevalent in SCAD lesions than in ACS lesions during the early- and late-term periods, it was more frequently observed in ACS lesions than in SCAD lesions during the very late-term period (65.5% vs. 47.6%, p = 0.04). The non-focal pattern was more frequent in ACS lesions than in SCAD lesions during all 3 periods. However, the proportion of the non-focal pattern in ACS lesions was extremely high during the very late-term (90.5%) compared with the early- (47.6%, p < 0.001) and late-term periods (48.4%, p < 0.001).
Stent-related ACS became more common beyond 5 years after SES implantation. Stent-edge and non-focal patterns were the main angiographic morphologies of very late SES failure, particularly causing ACS.
Hybrid coronary revascularization (HCR) versus coronary artery bypass grafting (CABG) in multivessel coronary artery disease (MVCAD): A meta-analysis of 14 studies comprising 4226 patients
2022, Catheterization and Cardiovascular Interventions
Very long-term clinical outcomes after percutaneous coronary intervention for complex vs non-complex lesions: 10-year outcomes following sirolimus-eluting stent implantation
2022, Nagoya Journal of Medical Science
JCS/JSCVS 2018 Guideline on Revascularization of Stable Coronary Artery Disease
2022, Circulation Journal
Predictors of 10-Year Stent-Related Adverse Outcomes after Coronary Drug-Eluting Stent Implantation: The Importance of Stent Size
2021, Cardiology (Switzerland)

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Clinical InvestigationTen-year clinical outcomes after sirolimus-eluting stent implantation: Impact of an in-stent restenosis target lesion

Background

Methods

Results

Conclusions

Section snippets

Patient population

Baseline characteristics

Clinical outcomes of 10-year follow-up

Discussion

Conclusions

J Am Coll Cardiol

Am J Cardiol

J Am Coll Cardiol

Am Heart J

J Am Coll Cardiol

Lancet

J Am Coll Cardiol

Am J Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Am J Cardiol

J Am Coll Cardiol Interv

Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty

N Engl J Med

Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome

Circulation

A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization

N Engl J Med

Clinical Investigation
Ten-year clinical outcomes after sirolimus-eluting stent implantation: Impact of an in-stent restenosis target lesion