Cases Of Definite Stent Thrombosis Research Articles

Ultrathin, biodegradable polymer-coated everolimus-eluting stents for patients undergoing percutaneous coronary intervention: Final three-year results of the PERFORM-EVER registry

The registry reports 3-year safety and clinical performance of the ultrathin strut (60 μm) biodegradable polymer-coated Tetrilimus, an everolimus-eluting stent (EES) (Sahajanand Medical Technologies Limited, India), in ‘real-world’ patients with coronary artery disease. A total of 815 Tetrilimus EES were implanted in 735 lesions in 594 patients. At 3-year follow-up, primary endpoint (target lesion failure, TLF) was reported in 8.6 % patients, including 2.6 % cardiac deaths, 3.5 % myocardial infarction and 2.6 % target lesion revascularization. At three-year, no cases of definite stent thrombosis were reported. The final three-year results of PERFORM-EVER registry endorse the continuous safety and effectiveness Tetrilimus EES.

Clinical performance of a dedicated self-apposing stent for the treatment of left main stem disease. Results of the left Main AngioplasTy wIth a Self-apposing StEnt - the MATISSE study.

In the recent years percutaneous treatment of the left main stem (LM) has gained a precise role as a result of consistent scientific evidence vs. coronary artery bypass. A self-apposing stent offers an improved adaptation to the vessel wall, especially in case of tapered vessels; aim of this study was to investigate the role of a novel self-apposing, sirolimus-eluting stent (Stentys, France) for the treatment of LM coronary artery disease. MATISSE is a retrospective, multicenter registry, which enrolled 151 patients treated with the device at 17 international centers. Primary study endpoint was the occurrence of major adverse cardiovascular events (MACE), a composite endpoint of cardiac death, target lesion revascularization (TLR) and target-vessel myocardial infarction, at 9months clinical follow-up. Secondary endpoints included procedural success, the single determinants of MACE and stent thrombosis. Lesions were located in distal LM bifurcation in 84% of the patients. Procedural success was achieved in 150 patients. The average follow-up length was 348±52days. MACE occurred in 14 (9.3%) patients with 2 (1.3%) cardiac deaths. TLR occurred in 8 patients (5.3%). There were 2 cases of definite stent thrombosis, 1 acute and 1 very late. A self-apposing stent, when used for LM PCI in a real world, high risk population, showed good immediate procedural results with low rates of adverse events at mid-term follow-up.

Immediate and 1-year follow-up with the novel nanosurface modified COBRA PzF stent

The COBRA PzF coronary stent, which has a unique nano-coating of Polyzene-F, was developed to reduce the risk of stent thrombosis. To report procedural and 1-year clinical outcomes following COBRA PzF coronary stent implantation in a real-world percutaneous coronary intervention (PCI) registry. All patients assigned to treatment with the COBRA PzF in the GCS Axium Rambot Center, Aix-en-Provence, France between February 2013 to June 2014 were prospectively enrolled. Among 100 patients (71% men, mean±standard error age 71.4±11.0 years), 38% had acute coronary syndromes. The population was consistent with real-world experience and included patients with multiple co-morbidities and 26% with diffuse multivessel disease. A total of 151 lesions were treated with 166 stents, including 26% of lesions with a type B2 or C classification. Pre- and post-procedural quantitative coronary angiography analyses showed a mean acute gain of 2.2±0.2mm. Angiographic success was achieved in all cases. One-year follow-up was available for all patients and the target vessel failure (composite of all-cause mortality, myocardial infarction or target vessel revascularization) rate was 12%, including 2% mortality (end-stage cardiomyopathy), 5% myocardial infarction (five periprocedural myocardial infarctions with isolated troponin elevation without chest pain or Q waves) and 5% target lesion revascularization. There were no cases of definite stent thrombosis. The COBRA PzF stent was safe and effective in routine practice. One-year follow-up was associated with excellent clinical outcomes and compared favourably with current devices. These results are very promising in a real-world population of complex patients, and further study is warranted.

Two-year outcomes following unprotected left main stenting with first vs. new-generation drug-eluting stents: the FINE registry

To assess two-year outcomes following first vs. new-generation drug-eluting stent (DES) implantation in unprotected left main (ULMCA) percutaneous coronary intervention. All eligible patients from our two-centre registry treated with first and new-generation DES from October 2006 to November 2010 were analysed. The study objective was major adverse cardiac events (MACE), defined as all-cause mortality, target vessel revascularisation (TVR) and myocardial infarction (MI) at two years. In total, 186 patients were included: 93 (50.0%) treated with first vs. 93 (50.0%) with new-generation DES. No differences were observed in baseline clinical characteristics except for higher EuroSCORE with new-generation DES (3.6±2.5 vs. 4.6±2.7; p=0.007). No significant difference was observed in stenting techniques; two stents were used respectively in 53.8% vs. 44.1% (p=0.187). Notably, intravascular ultrasound guidance was more frequent with new-generation DES (46.2% vs. 61.3%; p=0.040). At 730.0 (interquartile range 365.5-1,224.5) days, there was a trend towards improved MACE with new-generation DES (31.2% vs. 19.6%; p=0.070) and a significant reduction in TVR (23.7% vs. 12.0%; p=0.038) and MI (4.3% vs. 0%; p=0.044). Notably, there were four cases of definite stent thrombosis (ST) with first vs. none with new-generation DES (p=0.044). In our study, new-generation DES had a trend for less MACE and improved results with regard to MI, TVR and definite ST at two-year follow-up.

Acute procedural and six-month clinical outcome in patients treated with a dedicated bifurcation stent for left main stem disease: the TRYTON LM multicentre registry

Tryton side branch (SB) reverse culotte stenting has been employed for the treatment of left main (LM) stem bifurcations in patients at high risk for bypass surgery. The aim of this study was to assess acute angiographic results and six-month clinical outcome after implantation of the Tryton stent in the LM. We studied 52 consecutive patients with LM disease treated in nine European centres. Angiographic and clinical data analysis was performed centrally. Fifty-one of 52 patients (age 68±11 yrs, 75% male, 42% unstable angina, SYNTAX score 20±8) were successfully treated with the Tryton stent. Medina class was 1,1,1 in 33 (63%), 1,0,1 in 7 (13%), 1,1,0 in 3 (6%), 0,1,1 in 8 (4%) and 0,0,1 in 1 (2%). The Tryton stent on a stepped balloon (diameter 3.5-2.5 mm) was used in 41/51 (80%) of cases. The mean main vessel stent diameter was 3.4±0.4 mm with an everolimus-eluting stent employed in 30/51 (59%) of cases. Final kissing balloon dilatation was performed in 48/51 (94%). Acute gain was 1.52±0.86 mm in the LM and 0.92±0.47 mm in the SB. The angiographic success rate was 100%; the procedural success rate reached 94%. Periprocedural MI occurred in three patients. At six-month follow-up, the TLR rate was 12%, MI 10% and cardiac death 2%. The hierarchical MACE rate at six months was 22%. No cases of definite stent thrombosis occurred. The use of the Tryton stent for treatment of LM bifurcation disease in combination with a conventional drug-eluting stent is feasible and achieves an optimal angiographic result. Safety of the procedure and six-month outcome are acceptable in this high-risk lesion PCI. Further safety and efficacy studies with long-term outcome assessment of this strategy are warranted.

Lower risk of stent thrombosis and restenosis with unrestricted use of ‘new-generation’ drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

To compare the long-term outcome after percutaneous coronary intervention with 'new-generation' drug-eluting stents (n-DES) to 'older generation' DES (o-DES), and bare-metal stents (BMS) in a real-world population. We evaluated 94 384 consecutive stent implantations (BMS, n = 64 631; o-DES, n = 19 202; n-DES, n = 10 551) in Sweden from November 2006 to October 2010. All cases of definite stent thrombosis (ST) and restenosis were documented in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Older generation DES were classified as: Cypher and Cypher Select (Cordis Corporation, Miami, FL, USA), Taxus Express and Taxus Liberté (Boston Scientific Corporation), and Endeavor (Medtronic Inc.) and n-DES as: Endeavor Resolute (Medtronic Inc.), XienceV, Xience Prime (Abbott Laboratories) and Promus, Promus Element (Boston Scientific Corporation). The Cox regression analyses unadjusted and adjusted for clinical and angiographic covariates showed a statistically significant lower risk of restenosis in n-DES compared with BMS [adjusted hazard ratio (HR) 0.29; 95% confidence interval (CI): 0.25-0.33] and o-DES (HR 0.62; 95% CI: 0.53-0.72). A lower risk of definite ST was found in n-DES compared with BMS (HR 0.38; 95% CI: 0.28-0.52) and o-DES (HR, 0.57; 95% CI: 0.41-0.79). The risk of death was significantly lower in n-DES compared with o-DES (adjusted HR: 0.77; 95% CI: 0.63-0.95) and BMS (adjusted HR: 0.55; 95% CI: 0.46-0.67). Percutaneous coronary intervention with n-DES is associated with a 38% lower risk of clinically meaningful restenosis, a 43% lower risk of definite ST, and a 23% lower risk of death compared with o-DES in this observational study from a large real-world population.

Safety and Efficacy of Clopidogrel Reloading in Patients on Chronic Clopidogrel Therapy Who Present With an Acute Coronary Syndrome and Undergo Percutaneous Coronary Intervention

The clinical safety and efficacy of clopidogrel reloading in patients receiving long-term clopidogrel therapy who present with acute coronary syndromes and undergo percutaneous coronary intervention have not yet been evaluated. The study cohort comprised 1,368 consecutive patients receiving long-term clopidogrel therapy (75 mg/day) who had presented with acute coronary syndromes and underwent coronary artery stent implantation. In total, 926 patients were given a 600-mg clopidogrel loading dose (reload cohort) before cardiac catheterization, while 442 patients were not reloaded (no-reload cohort). Patients who had presented with cardiogenic shock or stable angina were excluded. The 2 cohorts were well matched for the conventional risk factors for coronary artery disease. The analyzed clinical end points of death (1.1% vs 0.9%, p = 0.77), death or Q-wave myocardial infarction (0.9% vs 0.9%, p = 1.0), target lesion revascularization (0.2% vs 0.8%, p = 0.45), target vessel revascularization (1.1% vs 1.1%, p = 1.0), and major adverse cardiac events (2.0% vs 1.8%, p = 0.8) were similar between the no-reload and reload groups at 30 days. The in-hospital rates of major bleeding and gastrointestinal bleeding were also similar between the 2 cohorts. There were no cases of definite stent thrombosis. In conclusion, patients receiving long-term clopidogrel therapy who present with acute coronary syndromes do not gain any clinical benefit from additional reloading with clopidogrel.

Six‐month clinical follow‐up of the tryton side branch stent for the treatment of bifurcation lesions

Treatment of bifurcation lesions with the Tryton Sidebranch stent has been shown to be feasible with an acceptable clinical outcome and low side branch late loss in the first in man trial. To report acute procedural and six month clinical follow-up after the use of the Tryton Sidebranch stent in an "all comer" registry. The first 100 coronary bifurcation lesions assigned for treatment with the Tryton stent were included in a prospective registry. Procedural and angiographic success rates were determined from patient charts and pre- and postprocedural quantitative coronary angiography. Totally, 96 patients with 100 lesions were included in the study. Seventy-two percent presented with stable angina, 25% with unstable angina/NSTEMI, and 3% STEMI. The bifurcation was located in the left main in 8%. Two lesions were chronic total occlusions. Sixty-nine percent were true bifurcation lesions. One failure of stent delivery occurred. Acute gain in SB was 0.76 ± 0.64 mm and three patients had residual stenosis of >30%. Angiographic success rate was 95%; procedural success rate reached 94%. Peri-procedural MI occurred in two and there was one cardiac death during hospitalization. At a median six months follow-up, TLR rate was 4%, MI 3%, and cardiac death 1%. The percentage MACE-free survival at six months was 94%. No cases of definite stent thrombosis occurred. In a real world the use of the Tryton Sidebranch stent is associated with good procedural safety and angiographic success rate and acceptable outcome at six months of follow-up.

Stent com liberação de everolimus vs. stent com liberação de zotarolimus na prática clínica do mundo real

Everolimus-Eluting Stent versus Zotarolimus-Eluting Stent in the Real Word Clinical Practice Background: The use of drug-eluting stents (DES) has proven to be effective in different angiographic scenarios. However, recent concerns with the occurrence of very late stent thrombosis with the first DES generation, probably related to delayed or incomplete endothelization, have led to the development of new safer and more effective devices. Method: Retrospective, single center study, including patients undergoing percutaneous coronary intervention between January 2006 and December 2008, treated with everolimuseluting stent (EES) (Xience VTM/PromusTM) and zotarolimuseluting stent (ZES) (EndeavorTM). Our objective was to compare the rates of major adverse cardiac events between EES and ZES patients after 12 months of follow-up. Results: Overall, 198 patients with 266 lesions were included in the study. Mean age was 60 + 10 years and 39% had diabetes mellitus, without significant differences between groups. The reference diameter (2.3 + 0.5 mm vs. 2.38 + 0.2 mm; P = 0.14), as well as lesion length (16.3 + 9.4 mm vs. 16.1 + 11.3 mm; P = 0.89), were also not significantly different between groups. After 12 months of follow-up, the rate of major adverse cardiac events was 8.16% in the EES group vs. 8% in the ZES group (P = 0.96), with a global rate of target-lesion revascularization of 2% (1% EES and 3% ZES; P = 0.32). There were no cases of definite stent thrombosis. Conclusion: In this study of non-selected patients, the rates of major adverse cardiac events were similar between patients treated in the EES and ZES groups, with low target-lesion revascularization rates and excellent safety profile after 12 months of follow-up.

Long-term outcomes following coronary drug-eluting- and bare-metal-stent implantation

BackgroundAlthough drug-eluting stents (DES) reduce restenosis rates relative to bare-metal stents (BMS), recent reports have indicated that the use of DES may be associated with an increased risk of stent thrombosis. Our study focused on the effect of stent type on clinical outcomes in a “real world” setting. Methods889 patients undergoing percutaneous coronary intervention (PCI) with either DES (Cypher or Taxus; n=490) or BMS (n=399) were enrolled in a prospective single center registry. The outcome analysis covered a period of up to 3.2 years (mean 2.7 years±0.5 years) and was based on 65 deaths, 27 myocardial infarctions, 76 clinically driven target lesion revascularizations (TLR), and 15 angiographically confirmed cases of definite stent thrombosis and was adjusted for differences in baseline characteristics. ResultsIn total 1277 stents (613 BMS and 664 DES) were implanted in 1215 lesions. Despite a significantly different unadjusted death rate (10.1% and 5.1% in BMS and DES patients, respectively; p<0.05), the patient groups did not differ significantly in the risk of myocardial infarction during 2.7 years of follow-up. After adjustment for differences in baseline characteristics between groups, the difference in the cumulative incidence of death did not remain statistically significant (p=0.22). Target lesion revascularizations occurred significantly less frequently in patients with DES compared to individuals after BMS implantation (5.9% and 11.8% in patients with DES and BMS, respectively; p<0.05). The rate of angiographically confirmed stent thrombosis was 2.1% in patients with DES and 1.1% in BMS patients (p=0.31).There was a significantly lower unadjusted event rate (including deaths, myocardial infarction, target lesion revascularization, and stent thrombosis) in patients with drug-eluting stents than in those with bare-metal stents (16.4% and 25.8%, respectively), with 9.4 fewer such events per 100 patients (unadjusted hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.46 to 0.87). After adjustment, the relative risk for all outcome events in patients with drug-eluting stents was 0.79 (95% CI, 0.67 to 0.95). However, the adjusted relative risk for death and myocardial infarction did not differ significantly between groups (adjusted relative risk in patients with drug-eluting stents 0.94 (95% CI, 0.77 to 1.37)). ConclusionsIn this real-world population, the beneficial effect of first generation DES in reducing the need for new revascularization compared with BMS extends to more than 2.5 years without evidence of a worse safety profile. The minor risk of stent thrombosis and myocardial infarction within this period after implantation of DES seems unlikely to outweigh the benefit of these stents.

Long-term safety and efficacy are observed after implantation of Zotarolimus-Eluting Stent in real-world clinical practice

Zotarolimus-eluting stents (ZESs) have been shown to be safe and effective in randomised trials. We sought to report the clinical outcomes after implantation of ZES in real-world clinical practice. ZES have been approved for clinical use in Singapore since April 2005. Until December 31, 2007, a total of 219 patients had undergone implantation of ZES. After excluding 11 foreign patients with whom contact was lost, 208 patients (246 lesions, 305 stents) formed the study cohort. A high-proportion of diabetic patients (n=90, 43.3%) was included. Recommended dual antiplatelet therapy was at least 3 months (n=147) for patients treated before or 12 months (n=61) after January 2007. As of January 2008, the median follow-up duration was 19 months (range: 1 to 33 months). There were 10 (4.8%) deaths, including 7 (3.4%) cardiac deaths. Myocardial infarction occurred in 11 (5.3%) patients. The numbers of patients requiring target vessel revascularisation and target lesion revascularisation were 10 (4.8%) and 5 (2.4%) respectively. Using the ARC definition, there were two cases of definite stent thrombosis on days 7 and 17, and one case of probable stent thrombosis on day 15. In this real-world clinical experience, ZES was associated with a low incidence of adverse cardiac events at a medium follow-up of one and half years.