Abstract 5954: Does Sirolimus-Eluting Stent Implantation Lead to an Increased Risk of Stent Fracture?

Stent fracture (SF) of sirolimus-eluting stents (SES) has emerged recently in literature and shown to be associated with an increased risk of restenosis. We sought to assess whether the use of SES increases the frequency of SF compared with bare-metal stents (BMS). A consecutive series of 499 lesions of 434 patients undergoing SES implantation (total stent length: 10 to 40 mm) followed by coronary angiography at 6 to 9 months were compared with 137 consecutive patients (147 lesions) treated with BMS (total stent length: 10 to 40 mm) which consists of stent platform of SES. SF was defined as single or multiple stent strut fracture as well as complete separation of stent segments. There were no significant differences in total stent length and the angulation of the lesion between the 2 groups. At follow up, SF occurred in 21 lesions (4.2%) in the SES group and 2 lesions (1.4%) in the BMS group (P=0.129). In-stent restenosis rates were 34.8% (SES; 33.3%, BMS; 50.0%) in lesions with SF and 7.7% (SES; 3.8%, BMS; 20.7%) in lesions without SF (P<0.001). As a result, cumulative rate of major adverse cardiac events at 1 year (death, myocardial infarction, or target lesion revascularization) was higher in patients with SF than in patients without SF (27.3% vs. 12.0%, P=0.035, SES; 25.0% vs. 8.2%, P=0.035, BMS; 50.0% vs. 23.7%, P=0.425). Figure summarizes multivariable predictors of SF. In this model, SES use was not associated with a significantly increased risk of SF at 6 to 9 months. The implantation of stents in tortuous lesion and/or longer lesions covered with longer stents rather than the use of SES may increase the likelihood of SF in this population subset.

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Abstract 1926: The Incidence, Predictors, and Outcome of Delayed Stent Fracture After Successful Implantation of Sirolimus-Eluting Stents

Circulation ◽

10.1161/circ.116.suppl_16.ii_414-c ◽

2007 ◽

Vol 116 (suppl_16) ◽

Author(s):

Hisashi Umeda ◽

Tomoko Gochi ◽

Mitsunori Iwase ◽

Ryoji Ishiki ◽

Hideo Izawa ◽

...

Keyword(s):

Single Point ◽

Target Lesion ◽

Stent Fracture ◽

Consecutive Series ◽

Cardiac Events ◽

Stent Restenosis ◽

Late Lumen Loss ◽

Increased Risk ◽

Adverse Cardiac Events ◽

Stent Length

Background: Recently, stent fracture (SF) of sirolimus-eluting stents (SES) has been shown to be associated with an increased risk of restenosis after SES implantation. We sought to assess the incidence, predictors, and clinical outcome of SF after implantation of SES. Methods: A consecutive series of 430 lesions of 382 patients treated with SES followed by coronary angiography at 6 to 9 months were analyzed. SF was defined as complete transverse liner separation or single or multiple stent strut fracture. Results: At follow up, SF occurred in 33 of 430 lesions (7.7%), and 32 of 382 patients (8.4%). In 23 of 33 lesions (69.7%), SF was found in a single point, whereas SF occurred in 2 or more points per lesion in 10 lesions (30.3%). Minimal lumen diameter was significantly smaller in patients with SF (2.11±0.64 mm vs. 2.52±0.60 mm, P <0.001), presumably due to greater late lumen loss (0.36±0.57 mm vs. 0.08±0.50 mm, P =0.005). Consequently, in-stent restenosis in lesions with SF was observed more frequently than non-SF lesions (15.2% vs. 4.0%, P =0.004). At 450 days, however, the cumulative rate of major adverse cardiac events (death, myocardial infarction, or target lesion revascularization) was similar in patients with and without SF (9.1% vs. 7.1%, P =0.722). Multivariable predictors of SF were shown in Figure . Conclusions: The occurrence of SF 6 to 9 months after implantation of SES in consecutive “real-world” patients was relatively common, which did not lead to an increased risk of adverse cardiac events at 450 days. Total stent length, the reduction in the lesion angle by stenting, and lesions located on the right coronary artery were identified as predictors of SF after implantation of SES.

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Stent Fracture after Everolimus-Eluting Stent Implantation

Cardiology Research and Practice ◽

10.4061/2011/320983 ◽

2011 ◽

Vol 2011 ◽

pp. 1-5 ◽

Cited By ~ 4

Author(s):

Ali S. Almasood ◽

Xavier Freixa ◽

Sohail Q. Khan ◽

Peter H. Seidelin ◽

Vladimír Džavík

Keyword(s):

Bare Metal Stents ◽

Metal Stents ◽

Stent Fracture ◽

Potential Mechanism ◽

Cardiac Events ◽

Stent Restenosis ◽

Stent Type ◽

Drug Eluting ◽

New Generation ◽

In Stent Restenosis

Compared with bare-metal stents, drug-eluting stents (DES) have greatly reduced the risk of in-stent restenosis (ISR) by inhibiting neointimal growth. Nevertheless, DES are still prone to device failure, which may lead to cardiac events. Recently, stent fracture (SF) has emerged as a potential mechanism of DES failure that is associated with ISR. Stent fracture is strongly related to stent type, and prior reports suggest that deployment of sirolimus eluting stents (SES) may be associated with a higher risk of SF compared to other DES. Everolimus eluting stents (EESs) represent a new generation of DES with promising results. The occurrence of SF with EES has not been well established. The present paper describes two cases of EES fracture associated with ISR.

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Effect of Coronary Target Lesion Revascularization on Late Cardiac Events After Insertion of Sirolimus-Eluting or Bare Metal Stents

The American Journal of Cardiology ◽

10.1016/j.amjcard.2010.04.039 ◽

2010 ◽

Vol 106 (6) ◽

pp. 774-779 ◽

Cited By ~ 3

Author(s):

Victor Novack ◽

Michael C. Nguyen ◽

Meredith Rooney ◽

Riya Chacko ◽

Lena Novack ◽

...

Keyword(s):

Bare Metal Stents ◽

Target Lesion ◽

Target Lesion Revascularization ◽

Metal Stents ◽

Bare Metal ◽

Cardiac Events

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Abstract 2161: Impact of Target Lesion Revascularization During the First Year After Bare-Metal or Sirolimus-Eluting Stenting on Five-Year Cardiac Outcomes

Circulation ◽

10.1161/circ.116.suppl_16.ii_469 ◽

2007 ◽

Vol 116 (suppl_16) ◽

Author(s):

Meredith Mulhearn ◽

Victor Novack ◽

Riya S Chacko ◽

Lena Novack ◽

Laura Mauri ◽

...

Keyword(s):

Primary Endpoint ◽

Cardiac Death ◽

Bare Metal Stents ◽

Target Lesion ◽

Adverse Outcomes ◽

Target Lesion Revascularization ◽

Metal Stents ◽

Bare Metal ◽

Cardiac Outcomes ◽

Increased Risk

Background: The association of restenosis requiring target lesion revascularization (TLR) and late cardiac outcomes after drug-eluting versus bare metal stents (BMS) has not been previously assessed. Methods: We hypothesized that restenosis requiring TLR within 1 year after stenting would be associated with increased risk of adverse cardiac outcomes during the next 4 years. Of 1058 patients randomized to sirolimus-eluting (SES) or BMS in the SIRIUS trial, 37 were excluded due to multivessel (6) or SVG (1) stenting or the occurrence of TLR within the first 30 days (30), leaving 515 SES and 506 BMS. Patients with TLR for restenosis indication between 31–360 days after the index procedure (TLR group) were compared with all others (Non TLR group) for outcomes during years 2–5. The primary endpoint was a composite of cardiac death, any MI or any repeat revascularization. The secondary endpoint was cardiac death or any MI. All events were adjudicated by an independent committee. Event rates were estimated using Kaplan-Meier (KM) method and compared using log rank. The correlates of the primary and secondary endpoints were tested using Cox proportional hazards regression. Results: TLR occurred in 120 (11.8%) patients. TLR patients had lower frequency of SES (24.2% vs. 53.9%, p<0.001), more diabetes (35.8% vs. 25.2%, p=0.02) and smaller diameter vessels (2.7±0.5 vs. 2.8±0.5 mm, p=0.04). TLR presented with MI in 7 (5.8%) patients, including CKMB >5 times normal in 6 (5.0%) patients. The primary endpoint occurred in 42 (36.1%) TLR and 211 (24.3%) Non TLR patients (log-rank p = 0.002). Cardiac death or MI occurred in 16 (13.8%) TLR patients and 57 (6.6%) Non TLR patients (log-rank p = 0.005). TLR was an independent predictor of the primary endpoint (Hazard ratio [HR] 1.6, 95% CI 1.2–1.9) and of cardiac death or MI (HR 1.9, 95% CI 1.3–2.4). Other independent predictors of cardiac death or MI were diabetes (HR 2.2, 95% CI = 1.7–2.6) and prior MI (HR 1.9, 95% CI 1.3–2.4). SES compared with BMS was not significantly associated with the primary endpoint or cardiac death or MI. Conclusions: Restenosis requiring TLR during 31–360 days after successful stenting is associated with an increased risk of adverse outcomes, including cardiac death or MI, in subsequent years.

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Real-World Three-Year Clinical Outcomes of Biolimus-Eluting Stents versus Other Contemporary Drug-Eluting Stents in Patients with Acute Myocardial Infarction Patients: Data from the Korea Acute Myocardial Infarction Registry (KAMIR)

Journal of Interventional Cardiology ◽

10.1155/2021/6698582 ◽

2021 ◽

Vol 2021 ◽

pp. 1-7

Author(s):

Ji Young Park ◽

Seung-Woon Rha ◽

Yung-Kyun Noh ◽

Byoung Geol Choi ◽

Ji Yeon Hong ◽

...

Keyword(s):

Myocardial Infarction ◽

Acute Myocardial Infarction ◽

Cardiac Death ◽

Bare Metal Stents ◽

Target Lesion ◽

Drug Eluting Stents ◽

Metal Stents ◽

Cardiac Events ◽

Total Death ◽

Drug Eluting

Introduction. Biolimus-eluting stents (BES) are known to be superior to bare-metal stents. This study aims to evaluate the safety and efficacy of BES compared to other drug-eluting stents (DES) based on big data from the Korea Acute Myocardial Infarction Registry (KAMIR). Methods. The study analyzed a total of 9,759 acute myocardial infarction (AMI) patients who underwent percutaneous coronary intervention (PCI) with DES. Total death, cardiac death, recurrent MI, revascularization, stent thrombosis, target lesion failure (TLF, composite of cardiac death, recurrent myocardial infarction (MI), and target lesion revascularization), and major adverse cardiac events (MACE, composite of total death, recurrent MI, and revascularization) were analyzed in patients with AMI up to three years. Study populations were divided into BES (n = 2,020), everolimus-eluting stents (EES, n = 5,293), and zotarolimus-eluting stents (ZES, n = 2,446) groups. Results. To adjust baseline potential confounders, an inverse probability weighting (IPTW) analysis was performed. After IPTW, at three years, total death (7.2%, 8.6%, and 9.5%, P < 0.001 ), cardiac death (4.1%, 5.3%, and 6.6%, P < 0.001 ), recurrent MI (1.6%, 2.6%, and 3.2%, P < 0.001 ), TLF (6.5%, 8.1%, and 9.1%, P < 0.001 ), and MACE (15.8%, 17.5%, and 18.2%, P < 0.001 ) were lowest in the BES group compared with the other DES groups in AMI patients. During the 3-year clinical follow-up, the BES group showed better outcomes of MACE (hazard ratio (HR), 0.773; 95% confidence interval (CI), 0.676–0.884; P < 0.001 ), TLF (HR, 0.659; 95% CI, 0.538–0.808; P < 0.001 ), total death (HR, 0.687; 95% CI, 0.566–0.835; P < 0.001 ), and cardiac death (HR,0.593; 95% CI, 0.462–0.541; P < 0.001 ) than the EES groups. Conclusions. In this study, BES was superior to EES or ZES in reducing total death, cardiac death, TLF, and MACE in AMI patients.

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Impact of neoatherosclerosis observed at very late phase after coronary stent implantation on subsequent adverse events

European Heart Journal ◽

10.1093/ehjci/ehaa946.0310 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

Y Sumino ◽

T Yonetsu ◽

H Ueno ◽

K Nogami ◽

T Misawa ◽

...

Keyword(s):

Clinical Outcomes ◽

Stent Implantation ◽

Plaque Rupture ◽

Late Phase ◽

Bare Metal Stents ◽

Metal Stents ◽

Cardiac Events ◽

Stent Restenosis ◽

Coronary Stent Implantation

Abstract Background Despite the reduction in late thrombotic events with newer generation coronary stents, late stent failure remains a concern following stent implantation. Neoatherosclerosis (NA) is a cause of in-stent restenosis and acute thrombotic occlusion originating from the stented segment by disruption of the in-stent atheroma. Although the clinical impact of NA at 1 year has been reported, clinical significance of NA observed at very later phase remains to be determined. We sought to investigate the association between optical coherence tomography (OCT) findings at very late phase after stenting and subsequent clinical outcomes. Methods A total of 195 patients with 316 stents (including 74 bare metal stents, 48 first-generation DES, and 194 second-generation DES) without stent failure who underwent OCT examination at >3 years (4.9 [3.9- 5.8] years) after stent implantation according to the prespecified protocol were investigated. OCT analysis included the presence of lipid-laden neointima, macrophage, malapposition, thrombus, and plaque rupture within the stents. NA was defined as having lipid-laden neointima. The criteria for the diagnosis of NA were signal-poor region in continuous flames, lipid length longer than 0.3 mm, and invisible stent strut at NA site. Quantitative OCT measurement included lipid length (LL), lipid arc, minimum lumen area (MLA) at the stented segment and minimum stent area (MSA). Major adverse cardiac events (MACE) including all-cause death, non-fatal myocardial infarction, and clinically driven revascularization were assessed. MACE-free survival rate was compared between patients with stent showing NA (NA group) and those without NA (non-NA group). Furthermore, in per-stent basis analysis, stent failure including remote revascularization and stent thrombosis of the stent after follow-up OCT examination was assessed. Results NA was identified in 50 stents (15.8%) in 38 patients (19.5%). During the median follow-up period of 2.1 [1.0- 2.8] years after OCT examination, 15 MACEs (7.7%) were captured in the total cohort, of which stent failure was observed in 5 stents (5/316, 1.6%). In patient-based analysis, patients with NA had more frequent MACE than those without (18.0% vs 5.1%, p=0.01). Kaplan-Meier analysis revealed that significantly higher MACE rate was detected in NA group than in non-NA group (χ2=5.4, Log-rank p=0.02). In stent-based analysis, NA stents had more frequent stent failure than those without (8.0% vs 0.4%, p=0.002) Conclusions NA observed by OCT at >3 years after implantation were associated with subsequent worse clinical outcomes in both patient and stent-based analysis. NA at the very late phase after stenting might be the therapeutic target of secondary prevention and OCT examination at very late phase after stenting may help identify high risk patients of subsequent MACE. Funding Acknowledgement Type of funding source: None

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Drug-coated Balloons for Small Coronary Vessel Interventions: A Literature Review

Interventional Cardiology Review ◽

10.15420/icr.2019.06.r3 ◽

2019 ◽

Vol 14 (3) ◽

pp. 131-136 ◽

Cited By ~ 4

Author(s):

Thomas Nestelberger ◽

Raban Jeger

Keyword(s):

De Novo ◽

Small Vessel Disease ◽

Bare Metal Stents ◽

Standard Of Care ◽

Target Lesion ◽

Small Vessel ◽

Current Evidence ◽

Metal Stents ◽

Vessel Disease ◽

Stent Restenosis

Newer-generation drug-eluting stents (DES) are the standard of care for the treatment of symptomatic coronary artery disease. However, some lack of efficacy has been reported in small coronary arteries based on higher rates of target lesion restenosis, thrombosis and MI resulting in repeated interventions. Drug-coated balloons (DCBs) are an established treatment option for in-stent restenosis in both bare metal stents and DES and they can deliver an anti-proliferative drug into the vessel wall without implanting a stent. DCBs are a promising technique for selected de novo coronary lesions, especially in small vessel disease. In this article, the current evidence for the treatment of small vessel disease with DCBs will be reviewed.

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Drug-eluting stents for treatment of focal infrapopliteal lesions

VASA ◽

10.1024/0301-1526/a000170 ◽

2012 ◽

Vol 41 (2) ◽

pp. 90-95 ◽

Cited By ~ 10

Author(s):

Rastan ◽

Noory ◽

Zeller

Keyword(s):

Limb Salvage ◽

Bare Metal Stents ◽

Target Lesion ◽

Drug Eluting Stents ◽

Metal Stents ◽

Target Lesion Revascularisation ◽

Randomized Studies ◽

Drug Eluting ◽

The Mean

We have investigated the role of drug-eluting stents on patency rates after treatment of focal infrapopliteal lesions in patients with intermittent claudication and critical limb ischemia. Reports indicate that drug-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. A Pub Med, EMBASE, Cochrane database review search of non-randomized studies investigating patency rates, target lesion revascularisation rates, limb salvage rates and mortality rates in an up to 3-year follow-up period after drug-eluting stent placement was conducted. In addition, preliminary results of randomized studies comparing drug-eluting stents with bare-metal stents and plain balloon angioplasty in treatment of focal infrapopliteal lesions were included in this review. A total of 1039 patients from 10 non-randomized and randomized studies were included. Most commonly used drug-eluting stents were sirolimus-eluting. The mean follow-up period was 12.6 (range 8 - 24). The mean 1-year primary patency rate was 86 ± 5 %. The mean target lesion revascularization rate and limb salvage rate was 9.9 ± 5 % and 96.6 %±4 %, respectively. Results from non-randomized and preliminary results from prospective, randomized trials show a significant advantage for drug-eluting stents in comparison to plain balloon angioplasty and bare-metal stents concerning target lesion patency and in parts target lesion revascularisation. No trial reveals an advantage for drug-eluting stents with regard to limb salvage and mortality.

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Percutaneous Coronary Intervention in Patients with Diabetes and Multivessel or Left Main Disease – a Review

Interventional Cardiology Review ◽

10.15420/icr.2012.7.1.37 ◽

2012 ◽

Vol 7 (1) ◽

pp. 37

Author(s):

Donald E Cutlip ◽

Keyword(s):

Percutaneous Coronary Intervention ◽

Coronary Artery ◽

Statistical Significance ◽

Bare Metal Stents ◽

Coronary Intervention ◽

Metal Stents ◽

Increased Risk ◽

Percutaneous Coronary ◽

Patients With Diabetes ◽

The Impact

Coronary artery disease in patients with diabetes is frequently a diffuse process with multivessel involvement and is associated with increased risk for myocardial infarction and death. The role of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) in patients with diabetes and multivessel disease who require revascularisation has been debated and remains uncertain. The debate has been continued mainly because of the question to what degree an increased risk for in-stent restenosis among patients with diabetes contributes to other late adverse outcomes. This article reviews outcomes from early trials of balloon angioplasty versus CABG through later trials of bare-metal stents versus CABG and more recent data with drug-eluting stents as the comparator. Although not all studies have been powered to show statistical significance, the results have been generally consistent with a mortality benefit for CABG versus PCI, despite differential risks for restenosis with the various PCI approaches. The review also considers the impact of mammary artery grafting of the left anterior descending artery and individual case selection on these results, and proposes an algorithm for selection of patients in whom PCI remains a reasonable strategy.

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