Stent thrombosis after sirolimus- and paclitaxel-eluting stent implantation in daily clinical practice: analysis of a single center registry.

OBJECTIVES: To evaluate stent thrombosis (ST) rate after sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation in daily clinical practice. BACKGROUND: The safety profile of drug-eluting stents (DES) was predominantly determined in randomized clinical trials with narrow inclusion criteria. Concerns about ST have been raised in unselected patients treated with DES. METHODS: We prospectively evaluated 867 patients undergoing DES implantation, 618 patients with SES, and 249 with PES, in a single academic center. RESULTS: Multivessel disease was present in 72% of patients, multivessel stenting was performed in 17%, long (>18 mm) lesions were treated in 30%, and multiple stents per lesion were needed in 31%. On average, 1.7 +/- 0.8 stents per patient were implanted (stented segment length: 32 +/- 25 mm/vessel). IIb/IIIa inhibitors were used in 7.5%. Intravascular ultrasound (IVUS) guidance was employed in 65% of SES and 50% of PES implantations, and the procedural success rate was 100% in SES and 99% in PES cases. Six-month follow-up was performed in all patients, whereas one-year follow-up was completed in 87% patients of the SES group and in 95% of the PES group. We considered that ST occurred when angiographic evidence of thrombus was available, or when patients experienced sudden cardiac death or either ST-elevation or non-ST-elevation myocardial infarction (MI) through the 12-month follow-up period. The overall incidence of ST was 0.9% (0.4% in SES and 2% in PES, P = 0.03). Of the eight ST, two (25%) were acute, four (50%) subacute, one (12.5%) was a late event, and one (12.5%) a very late event. Seven ST were confirmed by angiography. No IVUS guidance was used in 4/8 (50%) ST patients, while antiplatelet therapy was prematurely discontinued in 3/8 (37.5%). Among ST patients, mortality and nonfatal MI rates were 25% and 37.5%, respectively. No ST was diagnosed between 6 and 12 months, while one very late thrombosis occurred at 15 months. CONCLUSIONS: The incidence of ST after DES use in daily clinical practice is low and similar to that observed in randomized clinical trials.     

Stent thrombosis following drug-eluting stent implantation. A single-center experience

BACKGROUND: The risk of stent thrombosis (ST) following drug-eluting stent (DES) implantation may extend beyond the initial period after successful implantation. METHODS: We evaluated the incidence, timing, and clinical outcomes of patients who presented with DES-related early (30 days) angiographic ST. Between 1/2004 and 9/2006, a total of 1339 patients underwent DES implantation (90% using Cypher stents) at our institution. Dual antiplatelet therapy was recommended for 3 to 12 months. Clinical follow-up was obtained and adjudicated at 1 and 6 months following any ST event. RESULTS: We identified eight patients (0.6% of the total patients treated with DES) with definite ST. Their mean age was 67+/-13 years. Six patients (75%) were male and 37.5% (3/8) had diabetes. Acute myocardial infarction (AMI) was the clinical presentation in 87.5% of patients. Time to ST was 4 days in two (25%) of eight patients. The other six patients (75%) had late ST (>30 days). The median time to late ST was 480 days (range: 90-1080 days). Two patients had recurrent events of late ST. All cases of late ST, except one, occurred after clopidogrel treatment was discontinued. Median time from clopidogrel withdrawal to late ST was 18 months (range: 0.5-35 months). At 6 months' follow-up from the time of ST, the subsequent major adverse cardiac event (MACE) rate (including death, re-infarction, recurrent ST or need for emergent CABG) was 62.5% and overall and/or cardiac mortality rate was 12.5%. CONCLUSION: We found that ST occurred infrequently (0.6%) and the majority (75%) of patients developed ST late (>30 days) and beyond the period recommended for dual anti-platelet pharmacotherapy. Major adverse cardiac events following ST are substantial at 6 months and thus deserve careful clinical attention.     

6例PCI术后支架内血栓形成患者的原因分析及防治

目的分析PCI术后支架内血栓形成的病理生理机制、影响因素及防治策略。方法回顾性分析2012年1-7月我院心内科冠心病住院患者行PCI术后6例发生支架内血栓的基础病史、好发部位及危险因素。结果2012年1～7月,我院心内科共完成PCI术570例,6例患者（男性5例,女性1例）术后发生急性支架内血栓2例,亚急性支架内血栓4例,发生率1．0％。6例患者根据临床特点均行冠脉造影术＋PCI术,其中1例术中发生低复流,冠脉内注人硝普钠、硝酸甘油、替罗非班,可见远段血栓影,予替罗非班强化治疗,出现心率、血压下降,予以临时起搏器治疗。术后6例患者均出现胸痛,除1例未予采集心电图外,其余5例心电图示相关血管支配的心肌sT段抬高。对临床高度疑诊患者均紧急行再次PCI术,其中4例造影证实支架内血栓（3例经血栓抽吸术后症状消失,TIMI达到3级,存活出院,1例因反复发生心力衰竭而最终死亡）,余2例突发胸痛来不及行PCI术而死于心跳骤停。结论支架内血栓形成与患者临床特点、病变因素、支架因素、介人手术相关因素、药物因素相关,急诊介入手术是治疗支架内血栓的首选。     

Recurrent atherosclerosis complications as a mechanism for stent failure

Stents are an indispensable tool in the percutaneous treatment of symptomatic coronary artery disease. Yet, stent failure due to restenosis or thrombosis may compromise their clinical benefit, carrying substantial morbidity and mortality. Despite improvements in device design and adjunctive medical treatment, stent failure still occurs during long-term follow-up, suggesting that this may be an issue that persists for many years, perhaps indefinitely. Numerous studies during the last decade have highlighted the previously underappreciated pivotal role of atherosclerosis in stent failure. We review evolving evidence on the role of atherosclerosis in stent restenosis and thrombosis, differentiating between de novo in-stent atherosclerosis development (i.e., neoatherosclerosis) and progression of pre-existing underlying atherosclerosis (i.e., paleoatherosclerosis), a distinction with potentially important clinical implications. We conclude with a concept that provides a unifying pathophysiology for these significant problems in the field of interventional cardiology based on the progression and destabilization of atherosclerosis.     

非体外循环冠状动脉搭桥术治疗介入术后再狭窄的临床经验

目的:探讨非体外循环冠状动脉搭桥术治疗冠状动脉介入术后再狭窄的临床应用及效果。方法:回顾性分析我院心外科自2008年7月至2009年6月对109例冠状动脉介入术后再狭窄患者实施非体外循环冠状动脉搭桥术前后的影像学资料及临床资料,总结手术方法选择和手术效果。结果:109例非体外循环冠状动脉搭桥平均远端吻合口(3.01±0.80)个,全部病例围术期无心绞痛发作,7例出现心力衰竭(心衰),无围术期死亡。全部患者出院前无心绞痛复发,活动量增加,心功能改善。结论:冠状动脉介入治疗术后再狭窄应积极实施非体外循环冠状动脉搭桥手术。     

Stent thrombosis

Intense investigation continues on the pathobiology of stent thrombosis (ST) because of its morbidity and mortality. Because little advance has been made in outcomes following ST, ongoing research is focused on further understanding predictive factors as well as ST frequency and timing in various patient subsets, depending upon whether a drug-eluting stent or bare-metal stent has been implanted. Although the preventive role of antiplatelet therapies remains unchallenged, new data on genomics and variability in response to antiplatelet therapy, as well as the effects of novel therapeutic agents and duration of therapy, have become available. The goal remains identification of patients at particularly increased risk of ST so that optimal prevention strategies can be developed and employed.     

Application of drug-coated balloon in coronary artery intervention: challenges and opportunities

In recent decades, the outcomes of coronary heart disease (CHD) have markedly improved, which can be partly attributed to the use of novel drugs (especially statins and antiplatelet drugs) and partly to the evolution of percutaneous coronary intervention (PCI). From percutaneous transluminal coronary angioplasty to bare-metal stent and then to drug-eluting stent, every step of PCI is attractive to interventional cardiologist, great progress has been made for patients with CHD. In the past few years, some successor devices for treating CHD have emerged. Undoubtedly, drug-coated balloon (DCB), which was recommended by 2014 ESC Guidelines on myocardial revascularization, is a “shining star” among them. DCB involves a semi-compliant angioplasty balloon coated with an anti-proliferative agent that can exert antirestenotic efficacy by permeating into the vessel wall during balloon contact. This review discusses the conception and merits, preclinical data, emerging clinical indications, and results from clinical trials of this novel interventional technology. Although DCB has shown authentic efficacy in the treatment of in-stent restenosis, its use in de novo coronary lesions is still in dispute. Hence, concerns and the future direction of DCB are also covered in this paper.     

Safety and efficacy of the Yukon Choice Flex sirolimus-eluting coronary stent in an all-comers population cohort

Aims

The use of biodegradable-polymer drug-eluting stents has been shown to provide favorable results when compared with durable polymer drug-eluting stents and long-term follow up data have recently shown significant reductions in terms of very late stent thrombosis.Aim of the present study was to assess the safety and efficacy profile of a novel biodegradable polymer DES, the Yukon Choice Flex sirolimus-eluting stent.

Methods

We report here the one-year clinical outcomes associated with the use of the Yukon Choice Flex sirolimus-eluting stent in an all-comers patient population. The present stent represents a further refinement of the stent platform tested in the ISAR TEST 3 and 4 randomized clinical trials. A total of 778 consecutive patients undergoing implantation of this stent were enrolled in the present observational study and prospectively followed for one year.

Results

The use of the Yukon Choice Flex stent in a patient population with complex coronary lesion morphology was associated with optimal immediate angiographic results. At one year follow up the rates of death, myocardial infarction, definite stent thrombosis and ischemia-driven target lesion revascularization were respectively 2.4%, 1.9%, 0.3% and 11.3%.

Conclusions

The use of the sirolimus-eluting biodegradable polymer Yukon Choice Flex stent in an all-comers population of patients with complex coronary artery disease is associated with a favorable safety and efficacy profile up to one year follow up.     

Comprehensive Meta-Analysis on Drug-Eluting Stents versus Bare-Metal Stents during Extended Follow-up

Background

Several observational reports have documented both increased and decreased cardiac mortality or Q-wave myocardial infarction with drug-eluting stents compared with bare-metal stents.

Methods

We sought to evaluate the safety and efficacy of drug-eluting stents compared with bare-metal stents early after intervention (<1 year) and late (>1 year) among a broad population of patients, using a meta-analysis of randomized clinical trials.

Results

We identified 28 trials with a total of 10,727 patients and a mean follow-up of 29.6 months. For early outcomes (<1 year), all-cause mortality for drug-eluting stents versus bare-metal stents was 2.1% versus 2.4% (risk ratio [RR] 0.91, [95% confidence interval (CI), 0.70-1.18]; P = .47), non-Q-wave myocardial infarction was 3.3% versus 4.4% (RR 0.78 [95% CI, 0.61-1.00]; P = .055), target lesion revascularization was 5.8% versus 18.4% (RR 0.28 [95% CI, 0.21-0.38]; P <.001), and stent thrombosis was 1.1% versus 1.3% (RR 0.87 [95% CI, 0.60-1.26]; P = .47). For late outcomes (>1 year), all-cause mortality for drug-eluting stents versus bare-metal stents was 5.9% versus 5.7% (RR 1.03 [95% CI, 0.83-1.28]; P = .79), target lesion revascularization was 4.0% versus 3.3% (RR 1.22 [95% CI, 0.92-1.60]; P = .16), non-Q-wave myocardial infarction was 1.6% versus 1.2% (RR 1.36 [95% CI, 0.74-2.53]; P = .32) and stent thrombosis was 0.7% versus 0.1% (RR 4.57 [95% CI, 1.54-13.57]; P = .006).

Conclusions

There was no excess mortality with drug-eluting stents. Within 1 year, drug-eluting stents appear to be safe and efficacious with possibly decreased non-Q-wave myocardial infarction compared with bare-metal stents. After 1 year, drug-eluting stents still have similar mortality, despite increased stent thrombosis. The reduction in target lesion revascularization with drug-eluting stents mainly happens within 1 year, but is sustained thereafter.     

药物洗脱支架:如何平衡再狭窄减少与支架内血栓

药物先脱支架通过抑制平滑肌细胞的增殖减少了支架内再狭窄,但也因此而出现了支架内血栓的不良反应,现综述其临床益处及局限性,并分析其导致支架内血栓的相习因素.     

Contemporary clinical characteristics,treatment, and outcomes of angiographically confirmed coronary stent thrombosis: Results from a multicenter California registry

Objectives : To describe the contemporary treatment and outcomes for patients with angiographically confirmed (definite) stent thrombosis (ST). Background : Limited data are available on contemporary treatment patterns and outcomes of patients with ST in the United States. Methods : In this multicenter California registry, consecutive cases of definite ST over 5 years were identified. Clinical characteristics, in‐hospital outcomes, and long‐term survival are reported. Results : One hundred and sixty five consecutive episodes of ST were identified in 153 patients from January 2005 to February 2010. The distribution of acute (≤24 hr), subacute (24 hr to 30 days), late (30 days to 1 year), and very late (≥1 year) ST was 3.9%, 21.8%, 17.6%, and 50.3%, respectively. Only 41.2% of patients were on dual antiplatelet therapy at the time of presentation, while 22.4% of patients were on none. Of the 61.4% of patients treated with restenting, 71.1% of them received a drug‐eluting stent. Procedural success was 88.1%, and in‐hospital death, stroke, and CABG occurred in 5.5%, 0.6%, and 6.1% of subjects, respectively. All‐cause mortality at 1 year was 14.3%. Although female gender, diabetes mellitus (DM), bifurcation disease, ejection fraction <40%, and cardiogenic shock at the time of presentation were associated with an increased risk of in‐hospital mortality, only DM (P = 0.047) and bifurcation disease (P = 0.027) remained independent predictors of in‐hospital death. Conclusion : In‐hospital mortality from definite ST is lower than previously reported, but long‐term mortality remains high. DM and bifurcation disease, but not type of percutaneous therapy, are independently associated with in‐hospital mortality. © 2011 Wiley Periodicals, Inc.     

IVUS-Guided Stent Implantation to Improve Outcome: A Promise Waiting to be Fulfilled

The use of intravascular ultrasound (IVUS) to improve acute angiographic results was already shown in the prestent era. Various studies demonstrated the efficacy of IVUS in balloon sizing and estimating the extent of positive remodeling. With the introduction of drug-eluting stents (DES) the rate of restenosis has been significantly reduced but a new concern, the risk of stent thrombosis, has emerged. The association of stent underexpansion with stent thrombosis was observed for bare metal stents (BMS) and DES. Until now, the criteria for IVUS optimization used in different studies have relied on distal reference or on mean reference vessel for stent or postdilatation balloon sizing. Furthermore, an important recent innovation not available in previous studies is the use of noncompliant balloons to perform high pressure post-dilatation. Universal and easily applicable IVUS criteria for optimization of stent implantation as well as randomized studies on IVUS-guided DES implantation are necessary to minimize stent malapposition and underexpansion, which in turn can positively influence the rates of stent restenosis and thrombosis.     

血脂控制水平与冠状动脉支架置入术后支架内再狭窄的相关性研究

目的:探讨血脂控制水平与经皮冠状动脉介入治疗(PCI)术后支架内再狭窄(ISR)的相关性。方法:收集2012-01至2012-12在兰州大学第一医院心脏中心住院首次行PCI的冠心病患者211例,所有患者均常规口服双联抗血小板、他汀类药物,并于术后3~12个月再次入院行冠状动脉造影,根据造影结果分为两组,其中ISR组25例,无ISR组186例,所有入选患者于PCI术前及复查造影时采集外周静脉血,全自动生化分析仪检测总胆固醇、甘油三酯、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇,定量分析两次血脂水平,探讨其与冠状动脉ISR的关系。结果:两组患者中年龄、性别、高血压患病率、冠心病家族史、术前诊断急性冠状动脉综合征、吸烟、饮酒比例等方面的差异均无统计学意义(P0.05),PCI术前总胆固醇、甘油三酯、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇水平差异均无统计学意义(P0.05);ISR组合并2型糖尿病的患者比例(36.0%)较无ISR组(17.7%)差异有统计学意义(P=0.03)。Logistic多因素逐步回归分析显示,PCI术后总胆固醇未下降(比值比=1.07,95%可信区间:0.38~2.62,P=0.04)、低密度脂蛋白胆固醇未控制在1.8 mmol/L以下或较PCI术前未下降50%(比值比=11.33,95%可信区间:3.62~35.52,P0.01)以及合并2型糖尿病(比值比=3.00,95%可信区间:1.04~8.67,P=0.04)与ISR呈正相关。结论:PCI术后总胆固醇未下降、低密度脂蛋白胆固醇未达标是后期ISR发生的高危因素,合并2型糖尿病的患者PCI术后发生ISR的风险明显增高。