scholarly journals Clinical Outcomes from Unselected “Real-World” Patients with Long Coronary Lesion Receiving 40 mm Biodegradable Polymer Coated Sirolimus-Eluting Stent

Scientifica ◽  
2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Anurag Polavarapu ◽  
Raghava Sarma Polavarapu ◽  
Jayesh Prajapati ◽  
Kamlesh Thakkar ◽  
Asif Raheem ◽  
...  
Keyword(s):  
Real World ◽  
Biodegradable Polymer ◽  
Cardiac Death ◽  
Target Lesion ◽  
Cardiac Events ◽  
Target Vessel Revascularization ◽  
Primary Endpoints ◽  
Coronary Lesions ◽  
Sirolimus Eluting Stent

Background. Long lesions being implanted with drug-eluting stents (DES) are associated with relatively high restenosis rates and higher incidences of adverse events.Objectives. We aimed to examine the safety and efficacy of the long (40 mm) biodegradable polymer coated Indolimus sirolimus-eluting stent (SES) in real-world patients with long coronary lesions.Methods. This study was observational, nonrandomized, retrospective, and carried out in real-world patients. A total of 258 patients were enrolled for the treatment of long coronary lesions, with 40 mm Indolimus. The primary endpoints in the study were incidence of major adverse cardiac events (MACE), a miscellany of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) or target vessel revascularization (TVR), and stent thrombosis (ST) up to 6-month follow-up.Results. The study population included higher proportion of males (74.4%) and average age was 53.2 ± 11.0 years. A total of 278 lesions were intervened successfully with 280 stents. The observed MACE at 6-month follow-up was 2.0%, which included 0.8% cardiac death and 1.2% MI. There were no TLR or TVR and ST observed during 6-month follow-up.Conclusions. The long (40 mm) Indolimus stent demonstrated low MACE rate and was proven to be safe and effective treatment for long lesions in “real-world” patients.

scholarly journals Two-year safety and efficacy of Indigenous Abluminus Sirolimus Eluting Stent. Does it differ amongst diabetics? – Data from en-ABLe- REGISTRY

2021 ◽  
Vol 13 (2) ◽  
pp. 162-168
Author(s):  
Kamal Sharma ◽  
Sameer Dani ◽  
Devang Desai ◽  
Prathap Kumar ◽  
Nirav Bhalani ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Real World ◽  
Safety Profile ◽  
Target Lesion ◽  
Target Vessel ◽  
Open Label ◽  
Safety And Efficacy ◽  
Target Vessel Revascularization ◽  
Sirolimus Eluting Stent

Introduction: To evaluate the efficacy/safety profile of the Abluminus DES+ over 2-years follow-up in the "real-world" scenario in diabetics as compared to non-diabetics. Methods: In prospective, all-comers, open-label registry conducted at 31 sites, patients were analyzed for 1 & 2-year outcomes with the primary endpoint defined as 3P-MACE of CV death, target vessel related myocardial infarction (TV-MI), ischemia-driven target lesion revascularization (TLR)/target vessel revascularization (TVR) apart from Stent thrombosis (ST). Results: Of 2500 patients of PCI with 3286 Abluminus-DES+, 1641 (65.64%) were non-diabetics while859 (34.36%) were diabetics. The 3-P MACE for the cohort at 1 & 2 years were 2.9%, and 3.16%; TLR/TVR - 1.4% at both the intervals for 2493 patients at 2 yrs. follow-up. TV-MI & ST were 0.36% and0.56% at 1st and 2nd year respectively. The 3P-MACE was lower in non-diabetics at 1 & 2 years (2.3%vs 4.2%; 2.4% vs 4.7% respectively). For components of MACE, CV mortality (0.9 vs 1.9% at 1 yr ; 1.0vs 2.1% at 2 years) was significant (P < 0.05) while TLR (1.1 vs 1.9% at 1 yr. & 1.1 vs 2.1% at 2 yrs.) and TV-MI (0.9 vs 1.9% at 1 yr. & 1 vs 2.1% at 2 years) were similar for diabetics and non-diabetics so was ST (P > 0.05). Conclusion: Abluminus-DES+ showed excellent 2-year safety and efficacy with low 3-P MACE which was higher in diabetics driven by higher CV death but similar TLR, TV-MI and ST.

scholarly journals Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months’ results from the S-FLEX UK registry

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e026578 ◽  
Author(s):  
Anirban Choudhury ◽  
Scot Garg ◽  
Jamie Smith ◽  
Andrew Sharp ◽  
Sergio Nabais de Araujo ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Biodegradable Polymer ◽  
Cardiac Death ◽  
Target Lesion ◽  
Performance Outcomes ◽  
Target Vessel ◽  
Cardiac Events ◽  
All Cause Mortality ◽  
Secondary Endpoints ◽  
Sirolimus Eluting Stent

ObjectiveTo prospectively evaluate safety and efficacy of the ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent (S-SES) in ‘real world’ patient population requiring percutaneous coronary intervention (PCI).MethodsNational, prospective, multicentre, single-arm, all-comers, observational registry of 469 patients treated with S-SES from July 2015 and November 2016 in 11 centres in UK. Primary endpoint was target lesion failure (TLF) at 12 months (cardiac death, target vessel myocardial infarction (MI) or clinically driven target lesion revascularisation (TLR)). Secondary endpoints included safety and performance outcomes at 12 months—overall stent thrombosis (ST), all-cause mortality, any MI, target vessel failure (TVF) and major adverse cardiac events (MACE—composite of cardiac death, MI, emergent or repeat revascularisation).ResultsAt 12 months, the primary endpoint occurred in 11 (2.4%) of 466 patients, consisting of 4 (0.9%) cardiac deaths, 3 (0.6%) target vessel MI and 7 (1.5%) TLR. Secondary endpoints findings included all-cause mortality in 6 (1.3%), TVF of 14 (3%), no definite ST, 1 (0.2%) probable ST and 3 (0.6%) possible ST. Overall MACE was observed in 18 (3.9%).ConclusionsThe S-FLEX UK registry showed that the S-SES is safe with a low incidence of TLF in routine clinical practise in patients with coronary artery disease being treated by PCI.

scholarly journals Favorable Outcomes after Implantation of Biodegradable Polymer Coated Sirolimus-Eluting Stents in Diabetic Population: Results from INDOLIMUS-G Diabetic Registry

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Anurag Polavarapu ◽  
Raghava Sarma Polavarapu ◽  
Jayesh Prajapati ◽  
Asif Raheem ◽  
Kamlesh Thakkar ◽  
...  
Keyword(s):  
Biodegradable Polymer ◽  
Clinical Performance ◽  
Target Lesion ◽  
Diabetic Patients ◽  
Cardiac Events ◽  
Target Vessel Revascularization ◽  
Kaplan Meier ◽  
Diabetic Population ◽  
Male Patients ◽  
Sirolimus Eluting Stent

Objective. The main aim is to evaluate safety, efficacy, and clinical performance of the Indolimus (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) sirolimus-eluting stent in high-risk diabetic population with complex lesions.Methods. It was a multicentre, retrospective, non-randomized, single-arm study, which enrolled 372 diabetic patients treated with Indolimus. The primary endpoint of the study was major adverse cardiac events (MACE), which is a composite of cardiac death, target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), and stent thrombosis (ST). The clinical follow-ups were scheduled at 30 days, 6 months, and 9 months.Results. The mean age of the enrolled patients was 53.4 ± 10.2 years. A total of 437 lesions were intervened successfully with 483 stents (1.1 ± 0.3 per lesion). There were 256 (68.8%) male patients. Hypertension and totally occluded lesions were found in 202 (54.3%) and 45 (10.3%) patients, respectively. The incidence of MACE at 30 days, 6 months and 9 months was 0 (0%), 6 (1.6%), and 8 (2.2%), respectively. The event-free survival at 9-month follow-up by Kaplan Meier method was found to be 97.8%.Conclusion. The use of biodegradable polymer coated sirolimus-eluting stent is associated with favorable outcomes. The results demonstrated in our study depict its safety and efficacy in diabetic population.

Abstract 5992: Comparison of 4 Years Efficacy and Durability of Sirolimus-Eluting Stent and Paclitaxel- Eluting Stent Deployment in Patients with Very Long Coronary Lesions: Multicenter Registry in Asia

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Sunao Nakamura ◽  
Hisao Ogawa ◽  
Jang-Ho Bae ◽  
Yeo Hans Cahyadi ◽  
Wasan Udayachalerm ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Stent Thrombosis ◽  
Late Stent Thrombosis ◽  
Cardiac Events ◽  
Stent Deployment ◽  
Very Late Stent Thrombosis ◽  
Coronary Lesion ◽  
Coronary Lesions ◽  
Sirolimus Eluting Stent

Aim : The aim of this study is to compare the 4 years safety and durability of Sirolimus-eluting stent (SES) and Paclitaxel-eluting stent (PES) deployment on the outcome of patients with very long coronary lesions (VLL). Methods : A prospective analysis of 656 patients 730 lesions (male 70.4%, mean age 66.9 yrs) with very long coronary lesion (≥40mm) (368 SES and 288 PES) in five high volume Asian centers after successful stenting in VLL was performed. Lesion locations of VLL were LAD 48.2% (SES 50.2%, PES 45.7%), LCX 18.5%, RCA 33.3%. Complete clinical follow-up to 4 years is being analyzed for all patients. Results : The baseline clinical characteristics between 2 groups were similar. At 4 years overall cardiac events of SES (16.3%) were lower than PES (24.0%) (p=0.03). See table for clinical results. Conclusion : The use of SES and PES in patients with very long coronary lesion was safe and feasible with low acute complication and low incidence of restenosis. SES showed lesser incidence of cardiac events (death, myocardial infarction, CABG and PCI) at 4 years clinical follow-up. SAT (sub acute stent thrombosis), LAST (late stent thrombosis: ~1year), VLAST (very late stent thrombosis: 1year~ 4years) MACE (death, myocardial infarction, CABG and PCI).

scholarly journals Clinical Outcomes Following Large Vessel Coronary Artery Perforation Treated with Covered Stent Implantation: Comparison between Polytetrafluoroethylene- and Polyurethane-Covered Stents (CRACK-II Registry)

2021 ◽  
Vol 10 (22) ◽  
pp. 5441
Author(s):  
Jerzy Bartuś ◽  
Rafał Januszek ◽  
Damian Hudziak ◽  
Michalina Kołodziejczak ◽  
Łukasz Kuźma ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Clinical Outcomes ◽  
Cardiac Death ◽  
Real Life ◽  
Target Lesion ◽  
Covered Stents ◽  
Cardiac Events ◽  
Coronary Artery Perforation ◽  
One Year

Data on the clinical outcomes comparing synthetic fluorocarbon polymer polytetrafluoroethylene- (PTFE, GraftMaster) and polyurethane- (Papyrus) covered stents (CSs) to seal coronary artery perforations (CAPs) are limited. We aimed to evaluate 30-day and 1-year clinical outcomes after PCI complicated by CAP and treated with CS. We assessed 106 consecutive patients with successful CAP sealing (122 CSs): GraftMaster (51 patients, 57 CSs) or Papyrus CS (55 patients, 65 CSs). The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined as the composite of cardiac death, target lesion revascularisation (TLR), and myocardial infarction (MI). The mean age of subjects was 69 ± 9.6 years (53.8% males). No significant differences were identified between the GraftMaster and Papyrus groups at the 30-day follow-up for MACE, cardiac death, MI and stent thrombosis (ST), while significantly lower rate of TLR and TVR (p = 0.02) were confirmed in the Papyrus group. At one year, differences remained similar between stents for MACE, a trend towards a lower rate of TLR (p = 0.07), MI (p = 0.08), and ST (p = 0.08), and higher for cardiac death (p = 0.07) was observed in the Papyrus group. This real-life registry of CAP illustrated that the use of Papyrus CS is associated with lower rates of TLR and TVR at 30-day follow-up in comparison to the GraftMaster CSs and no significant differences between both assessed CS at one year of follow-up.

scholarly journals Ultrathin-strut biodegradable polymer versus durable polymer drug-eluting stents: a meta-analysis

Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001394 ◽  
Author(s):  
Mohammad Riashad Monjur ◽  
Christian F Said ◽  
Paul Bamford ◽  
Michael Parkinson ◽  
Richard Szirt ◽  
...  
Keyword(s):  
Biodegradable Polymer ◽  
Cardiac Death ◽  
Primary Outcome ◽  
Second Generation ◽  
Meta Analysis ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Durable Polymer ◽  
Drug Eluting

ObjectivesDetermine whether an ultrathin biodegradable polymer sirolimus-eluting stent (‘Orsiro’—BP-SES) has clinical benefits over second-generation durable polymer drug-eluting stents (DP-DES).MethodsWe conducted a prospective systematic review and meta-analysis of randomised clinical trials comparing Orsiro BP-SES against DP-DES (PROSPERO Registration: CRD42019147136). The primary outcome was target lesion failure (TLF): composite of cardiac death, target vessel myocardial infarction (TVMI) and clinically indicated target lesion revascularisation (TLR)) evaluated at the longest available follow-up.ResultsNine trials randomised 11 302 patients to either Orsiro BP-SES or DP-DES. At mean weighted follow-up of 2.8 years, the primary outcome (TLF) occurred in 501 of 6089 (8.2%) participants with BP-SES compared with 495 of 5213 (9.5%) participants with DP-DES. This equates to an absolute risk reduction of 1.3% in TLF in favour of Orsiro BP-SES (OR 0.82; 95% CI 0.69 to 0.98; p=0.03). This was driven by a reduction in TVMI (OR 0.80; 95% CI 0.65 to 0.98; p=0.03). There were no significant differences in other clinical endpoints: cardiac death, TLR and stent thrombosis.ConclusionThe Orsiro BP-SES shows promising clinical outcomes in patients undergoing percutaneous coronary intervention compared with contemporary second-generation DES at a short to medium term follow-up. More research is warranted to evaluate performance over a longer follow-up period and in different clinical and lesion subsets.

P2804Initial experience with the novel BioMime Morph 40–60 mm long sirolimus-eluting tapered stent in long coronary lesions

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Premawardhana ◽  
A Choudhury ◽  
B Sekar ◽  
H Hussain
Keyword(s):  
Primary Endpoint ◽  
Biodegradable Polymer ◽  
Cardiac Death ◽  
Positive Family History ◽  
Composite Endpoint ◽  
The Novel ◽  
Cobalt Chromium ◽  
Coronary Lesions ◽  
Procedural Success

Abstract Aims Aims: Long lesions treated with overlapping stents has been reported to be associated with healing problems and/or adverse events. The novel BioMime Morph is a 40, 50 and 60 mm long sirolimus-eluting cobalt chromium stent (65 μm strut thickness, biodegradable polymer) with a tapered design (0.5 mm taper from proximal to distal end) and is available in the following proximal and distal diameters (2.75–2.2 5mm, 3–2.5 mm and 3.5–3 mm). It can be a novel alternative for treatment of long coronary lesions, overcoming the limitations of overlapping stents. Methods and results Methods: Data was evaluated from our centre's prospective BioMime Morph database from August 2016 - January 2019. Primary endpoint was device oriented composite endpoint (DOCE: cardiac death, TV-MI, TLR and TVR). Secondary endpoints were technical (successful Morph implantation) and procedural success (successful procedure with Morph without in-hospital MACE). Results 103 patients had BioMime Morph stents implanted, with mean follow up of 411 (±214) days and a mean age of 66 (±11) years. Co-morbidities included hypertension (58%), hypercholesterolemia (38%), diabetes mellitus (28%), PVD (2%), CVD (5%), CKD (12%), previous MI (17%), smoking (40%) and positive family history (20%). There was history of previous PCI in 18% and CABG in 4%. Indication for PCI was predominantly ACS (78% including 13% STEMI), 15% were CTOs. 80% of the procedures were performed via radial access using 5–6F sheath in 73%. Vessels treated included LAD (43%), Cx (12%) and RCA (45%). Pre-dilatation was performed in 96% including use of non-complaint balloons in 51%, scoring balloons in 12% and rotablation in 4%. Post-dilatation was performed in 99%. Buddy wire was used in 41% while a guideliner used in 13%. Technical success (secondary endpoint) was achieved in 100 whilst procedural success was achieved in 96% (4 cases of contrast induced nephropathy). Cumulative DOCE (primary endpoint) was % (cardiac death 1%, TV-MI 1%, definitive ST 0%, possible ST 1%, TLR 2% and TVR 2%). OCT follow up at 1 month, 3 month and 6 months in 2 patients showed endothelialisation even at 1 month. Conclusions Our initial experience of the use of the novel BioMime Morph tapered DES for treatment of long coronary lesions exhibit promising results in short to medium follow-up. Elution of the drug in 1 month along with biodegradable polymer and ultra thin struts potentially helps early healing and raises the possibility of short DAPT even in these complex long lesions. BioMime Morph stents can potentially be an alternative to overlapping conventional stents for treating long coronary lesions.

scholarly journals Midterm Clinical Impacts of Biodegradable Polymer Everolimus-Eluting Stents Compared with Durable Polymer Everolimus-Eluting Stents: A 3-Year Propensity-Matched Study

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Hiroaki Matsuda ◽  
Ai Kagase ◽  
Takahiro Tokuda ◽  
Yusuke Ochiumi ◽  
Akira Murata ◽  
...  
Keyword(s):  
Biodegradable Polymer ◽  
Cumulative Incidence ◽  
Cardiac Death ◽  
Group Versus ◽  
Target Lesion ◽  
Target Vessel ◽  
Target Vessel Revascularization ◽  
Durable Polymer ◽  
The Individual ◽  
Few Data

Objectives. Our aim was to evaluate the safety and efficacy of biodegradable polymer everolimus-eluting stents (BP-EES) compared with durable polymer everolimus-eluting stents (DP-EES) in midterm. Background. There are few data about midterm clinical outcomes of BP-EES compared with DP-EES. Methods and Results. Between January 2016 and December 2017, 395 consecutive patients were treated with BP-EES and 391 consecutive patients were treated with DP-EES in Nagoya Heart Center. The primary endpoint was a 3-year cumulative incidence of target lesion failure (TLF) defined as cardiac death, target vessel myocardial infarction (MI), and clinical indicated target lesion revascularization (TLR). Moreover, clinical indicated target vessel revascularization (TVR) and definite stent thrombosis (ST) were also evaluated as the secondary endpoints. After propensity score matching, 327 patients were selected in each group. At 3 years, the cumulative incidence of TLF was 4.5% in the BP-EES group versus 6.5% in DP-EES (adjusted HR 0.67 (95% CI 0.33–1.30), log-rank P=0.23). Regarding the individual components of the TLF at 3 years, the cumulative incidence of target vessel MI was significantly lower in BP-EES than in DP-EES (0% versus 1.9%: adjusted HR 0.83 (95% CI 0.71–0.97), log-rank P=0.01), but there was no difference between BP-EES and DP-EES in the incidence of cardiac death and clinically indicated TLR. The cumulative 3-year incidence of definite ST was significantly lower in BP-EES than in DP-EES (0% versus 1.6%, log-rank P=0.02). Conclusions. There were no significant differences of TLF between BP-EES and DP-EES within 3 years. In this study, BP-EES seems to prevent definite ST and be safer than DP-EES in midterm.

Abstract 2150: A European and Canadian Multicenter Randomized, Double-Blind Trial of the Sirolimus-Eluting Stent (SES) in Patients with De Novo Native Coronary Artery Lesions (NEW-SIRIUS): 5-Year Clinical Outcomes

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Eric Schampaert ◽  
Joachim Schofer ◽  
Guenther Breithardt ◽  
Eric A. Cohen ◽  
Michael Schlüter ◽  
...  
Keyword(s):  
De Novo ◽  
Target Lesion ◽  
Diabetic Patients ◽  
Restenosis Rate ◽  
Cardiac Events ◽  
Double Blind ◽  
Significant Difference ◽  
Catch Up ◽  
Sirolimus Eluting Stent

Background : NEW-SIRIUS is the pooled analysis of the E-SIRIUS (n=352) and C-SIRIUS (n=100) studies, respectively, performed in Europe and Canada. Identical in design, these are multicenter randomized, double-blind trials examining the safety and efficacy of the sirolimus-eluting stent (SES) vs. an identical bare-metal stent (BMS) in 452 patients to treat de novo native long lesions in small coronary arteries, with adjunctive clopidogrel for only 2 months. Methods : The primary endpoint was in-stent minimum lumen diameter (MLD) at 8-month follow-up. Among the secondary endpoints were major adverse cardiac events(MACE) at 1, 6, 9 and 12 months, and annually up to 5 years post-procedure, as well as target lesion revascularization (TLR), target vessel revascularization (TVR) and protocol-defined stent thrombosis. Results : At 8 months, the MLD was 2.27±0.47mm in the SES vs. 1.36±0.66 mm in the BMS (p < 0.001). The binary in-lesion restenosis rate was 5.1% in the SES vs. 44.2% in the BMS (p < 0.001). At 4 years, there was a significantly lower incidence of MACE (SES: 15.1% vs BMS: 33.9%, p < 0.001), primarily driven by a significant difference in clinically-driven TLR rates (SES: 7.1% vs. BMS: 26.0%, p < 0.001). A subgroup analysis in diabetic patients (45 SES, 60 BMS) demonstrated that the in-stent MLD was larger in SES than in BMS (2.20±0.47 vs 1.14±0.64 mm, p < 0.001) and the binary in-lesion restenosis rate was reduced from 56.1% (BMS) to 10.0% (RRR: 82.2%, p < 0.001) at 8 months. At 4 years, the freedom from MACE in diabetic patients was 80.0% in the SES vs. 61.7% in the BMS (p = 0.031), again mainly driven by an improved freedom from clinically driven-TLR (SES: 90.8% vs. BMS: 66.9%, p=0.005), with no evidence of a late catch-up effect. Conclusion : Up to 4 years, SES were superior to BMS in the total cohort as well as in the diabetic subgroup without evidence of a late catch-up. Five-year follow-up data, including antiplatelet therapies utilization and a diabetic subgroup analyses will be available by July 2007 and presented.

Abstract 18600: Very Long-term Clinical Outcome After Sirolimus-eluting Stent Implantation

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Shoichi Kuramitsu ◽  
Hiroaki Matsuda ◽  
Hiroyuki Jinnouchi ◽  
Takashi Hiromasa ◽  
Takenori Domei ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Cumulative Incidence ◽  
Cardiac Death ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Cardiac Events ◽  
Important Concern ◽  
Adverse Cardiac Events ◽  
Sirolimus Eluting Stent

Background: Late adverse events such as stent thrombosis (ST) or late target-lesion revascularization (TLR) after sirolimus-eluting stents (SES) implantation remain an important concern. However, there is little data regarding clinical outcome beyond 5 years after SES implantation. We sought to assess very long-term clinical outcome after SES implantation. Methods: Between April 2004 and December 2006, a total of 686 patients with 894 lesions underwent percutaneous coronary intervention only with SES. We assessed the major adverse cardiac events (MACE), defined as a composite of cardiac death, TLR, definite ST. Results: At 10 years, cumulative incidence of MACE and cardiac death were 50.8% and 8.2%, respectively. Cumulative incidence of TLR within 1 year was 12.6%. However, late TLR beyond 1 year continued to occur without attenuation up to 10 years (2.3%/year) (5 years, 22.8%; 10 years, 33.3%). Cumulative incidence of definite ST was low (30 days, 0.3%; 1 year, 0.9%; 5 years, 1.8%; and 10 years, 3.3%), whereas definite ST also continued to occur without attenuation (0.27%/year). The predictors of MACE were hemodialysis (hazard ratio [HR] 2.87, 95% confidence intervals [CI]:1.76-4.53, p <0.001) and age ≥75 years (HR 1.72, 95% CI: 1.31-2.26, p <0.001). Conclusions: Late catch-up phenomenon regarding ST and TLR continued up to 10 years without attenuation. Careful clinical follow-up is required in patients treated with SES beyond 5 years.

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