Incidence Of Late Stent Thrombosis Research Articles

Biofunctionalization of cardiovascular stents to induce endothelialization: Implications for in- stent thrombosis in diabetes.

Stent thrombosis remains one of the main causes that lead to vascular stent failure in patients undergoing percutaneous coronary intervention (PCI). Type 2 diabetes mellitus is accompanied by endothelial dysfunction and platelet hyperactivity and is associated with suboptimal outcomes following PCI, and an increase in the incidence of late stent thrombosis. Evidence suggests that late stent thrombosis is caused by the delayed and impaired endothelialization of the lumen of the stent. The endothelium has a key role in modulating inflammation and thrombosis and maintaining homeostasis, thus restoring a functional endothelial cell layer is an important target for the prevention of stent thrombosis. Modifications using specific molecules to induce endothelial cell adhesion, proliferation and function can improve stents endothelialization and prevent thrombosis. Blood endothelial progenitor cells (EPCs) represent a potential cell source for the in situ-endothelialization of vascular conduits and stents. We aim in this review to summarize the main biofunctionalization strategies to induce the in-situ endothelialization of coronary artery stents using circulating endothelial stem cells.

Capturing Endothelial Cells by Coronary Stents - From Histology to Clinical Outcomes

Abstract Introduction of drug-eluting stents (DES) in the therapy of patients with coronary artery disease resulted in the significant reduction of in-stent restenosis compared to bare-metal stent (BMS) treatment. However, the high incidence of late stent thrombosis with DES emerged as one of the safety concerns after their implantation. Enhancing stent endothelization by improved early healing and neointimal strut coverage emerged as possible solution for this late complication. Endothelial progenitor cells (EPC) capturing stents are designed to promote in situ endothelization with immobilized, antihuman, anti-CD34 antibodies attached to the luminal stent surface. Anti-CD34 antibodies target and capture EPC from circulation, which further differentiate into vascular endothelial cells and form functional endothelial layer on the stent surface. These cells are also capable of secreting pro-angiogenic factors that stimulate local endothelial cells to proliferate and migrate. Preclinical and clinical studies proved feasibility, efficacy and safety of EPC capturing stents in stable and high-risk patients with coronary artery disease. Rapid and extensive endothelization of EPC capturing stents translated into favorable profile of clinical outcomes, comparable to efficacy of BMSs and DESs. Therefore, we here present the most important results from the experimental and clinical studies that explored ECP capturing strategy to enhance endothelization, reduce the incidence of instent thrombosis and improve outcomes of patients with coronary artery disease, along with the future perspectives in this promising therapeutic approach.

A prospective, multicenter, randomized OCT study of early neointimal condition at first and second months after BuMA Supreme stent versus XIENCE stent implantation in high-bleeding-risk coronary artery disease patients: study protocol for a randomized controlled trial

BackgroundEarlier vascular healing after drug-eluting stent (DES) implantation may reduce the incidence of late stent thrombosis and provide theoretical evidence to shorten dual antiplatelet therapy duration in patients with high bleeding risks. The BuMA supreme stent is a newly developed DES-coated with the sirolimus by using the international patent electronic grafted eG™ technology. Previous randomized trials showed that BuMA stents had better stent-strut coverage at 3-month follow-ups, which were evaluated by optical coherence tomography (OCT). However, there have been a limited number of studies that are directly evaluating the extent of neointima formation at the first and second months after stent implantation in high-bleeding-risk patients with coronary artery disease. This clinical trial is designed to demonstrate the non-inferiority of the BuMA supreme stent compared to the XIENCE stent in early neointimal formation.Methods/designThis is a prospective, multicenter, randomized trial. Forty patients will be assigned into the first-month OCT group, and another 40 patients into the second-month OCT group. The patients in each cohort will be randomized again into two groups in a 1:1 ratio, either being implanted with the BuMA Supreme stent or the Xience V/Prime/Xpedition stent. The primary endpoint is stent-strut neointimal coverage rate (%) at the first and second months, respectively. Secondary endpoints include neointimal hyperplasia area/volume, neointimal hyperplasia thickness, stent-strut malapposition rate, late lumen loss (LLL), restenosis rate, device/lesion/clinical success rate, device-oriented composite endpoints at the first and second months, stent thrombosis and other serious adverse events and bleeding events at follow-up.DiscussionThe results will provide the first accurate imaging evidence on neointimal formation of the BuMA Supreme stent and the Xience stent at 1–2 months post PCI. The result should inspire further exploration and adjustment of DAPT treatments.Trial registrationClinicalTrials.gov, ID: NCT02747329. Registered on 21 April 2016. Last updated 17 May 2018.

Seven-year clinical outcomes in patients undergoing percutaneous coronary intervention with biodegradable polymer coated sirolimus-eluting stent: Results from a single-center real-world experience

ObjectiveThe aim of the present study was to assess seven-year clinical outcomes of biodegradable polymer coated Supralimus sirolimus-eluting stent (S-SES) [Sahajanand Medical Technologies Pvt. Ltd., Surat, India] in real-world patients with coronary artery disease. MethodsThis observational, retrospective study was carried out in all 346 consecutive enrolled patients who underwent percutaneous coronary intervention (PCI) with the S-SES, between April 2008 and December 2009, at a single center. We analyzed major adverse cardiac events (MACE) [a composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and target vessel revascularization (TVR)] as primary outcomes at seven-year follow-up. ResultsOut of 346 patients, seven-year follow-up was obtained in 327 (94.5%) patients and hence results were analyzed for 327 patients. At seven-year, MACE occurred in 41 (12.5%) patients, consisting of 23 (7.0%) cardiac deaths, 14 (4.3%) TLR, and 4 (1.2%) TVR. The incidence of late stent thrombosis was observed in 3 (0.9%) patients. At follow-up of seven-year, the cumulative event-free survival was found to be 84.7% by Kaplan-Meier method. ConclusionsThe present study demonstrated satisfactory and sustained seven-year clinical outcomes as evidenced by the low rates of MACE and ST for the biodegradable polymer coated S-SES.

Nine-month angiographic and two-year clinical follow-up of polymer-free sirolimus-eluting stent versus durable-polymer sirolimus-eluting stent for coronary artery disease: the Nano randomized trial.

First generation drug-eluting stents (DES) were associated with a high incidence of late stent thrombosis (ST), mainly due to delayed healing and re-endothelization by the durable polymer coating. This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent (SES) in the treatment of patients with de novo coronary artery lesions. The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES (Lepu Medical Technology, Beijing, China) in the treatment of patients with de novo native coronary lesions. The primary endpoint was in-stent late lumen loss (LLL) at 9-month follow-up. The secondary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction or target lesion revascularization. A total of 291 patients (Nano group: n = 143, Partner group: n = 148) were enrolled in this trial from 19 Chinese centers. The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months (P < 0.001). The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES (0.34 ± 0.42) mm vs. (0.30 ± 0.48) mm, P = 0.21). The incidence of MACE in the Nano group were 7.6% compared to the Partner group of 5.9% (P = 0.75) at 2 years follow-up. The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES (0.8% vs. 0.7%, 0.8% vs. 1.5%, both P = 1.00). In this multicenter randomized Nano trial, the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions. Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES.

ASSA13-10-19 The Optimal Duration of Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention: A Meta-Analysis

<h3>Objective</h3> To assess the efficiency and safety of the use of different dual antiplatelet therapy in patients undergoing percutaneous coronary intervention. <h3>Methods</h3> Cochrane Library, MEDLINE, EMBASE, CBM, CNKI, and VIP, were searched up to October 2011. Randomized controlled trials comparing the efficiency and safety with short duration of treatment (≤6months) versus long duration of treatment ( &gt; 6months) of dual antiplatelet therapy on percutaneous coronary intervention which have been reported were enrolled. No language restriction was enforced. The quality of the included studies was critically evaluated. Data analyses were performed using the Cochrane Collaboration’s RevMan 5.1 software. <h3>Results</h3> Eight trials were included. Three randomised controlled trials and five observational study trials met the inclusion criteria and were incorporated into the primary analysis. Meta-analysis showed that the incidence of death or myocardial infarction in long duration treatment group was lower than short duration treatment group in randomised controlled trials [<i>OR</i> = 0.74, 95% confidence interval [CI] 0.56 to 0.98, <i>P</i> &lt; 0.0001]. Meanwhile, Combined observational studies showed that incidence of death or myocardial infarction in long duration treatment group was lower than short treatment group [<i>OR</i> = 0. 7, 95% confidence interval [CI]0. 45 to 1. 08, <i>P</i> = 0. 11]. We also explored the heterogeneity between the randomised controlled studies and observational studies. In randomised controlled trials, the incidence of major bleeding events of short treatment group was lower than long treatment group [<i>OR</i> = 1.29, 95% confidence interval [CI] 0.99 to 1.69, <i>P</i> = 0.06]. Meta-analysis of observational studies showed that the incidence of late stent thrombosis in long treatment group was lower than short treatment group [<i>OR</i> = 0.40, 95% confidence interval [CI] 0.15 to 1.07, <i>P</i> = 0.07]. <h3>Conclusions</h3> The long duration of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention can reduce the incidence of death or myocardial infarction. There is a trend of decreasing the rate of late stent thrombosis in long treatment group. The incidence of bleeding does not increase obviously in the long treatment group.

A novel platinum chromium everolimus-eluting stent for the treatment of coronary artery disease.

The development of coronary stents represents a major step forward in the treatment of obstructive coronary artery disease since the introduction of percutaneous coronary intervention. The initial enthusiasm for bare metal stents was, however, tempered by a significant incidence of in-stent restenosis, the manifestation of excessive neointima hyperplasia within the stented vessel segment, ultimately leading to target vessel revascularization. Later, drug-eluting stents, with controlled local release of antiproliferative agents, consistently reduced this need for repeat revascularization. In turn, the long-term safety of first-generation drug-eluting stents was brought into question with the observation of an increased incidence of late stent thrombosis, often presenting as myocardial infarction or sudden death. Since then, new drugs, polymers, and platforms for drug elution have been developed to improve stent safety and preserve efficacy. Development of a novel platinum chromium alloy with high radial strength and high radiopacity has enabled the design of a new, thin-strut, flexible, and highly trackable stent platform, while simultaneously improving stent visibility. Significant advances in polymer coating, serving as a drug carrier on the stent surface, and in antiproliferative agent technology have further improved the safety and clinical performance of newer-generation drug-eluting stents. This review will provide an overview of the novel platinum chromium everolimus-eluting stents that are currently available. The clinical data from major clinical trials with these devices will be summarized and put into perspective.

Accelerating endothelialization of coronary stents by capturing circulating endothelial progenitor cells

Drug-eluting stents (DES) have become the standard of care for the treatment of coronary artery disease. However, late stent thrombosis has emerged as a major concern, especially in ‘off-label’ use. Pathologic studies of patients dying from late DES thrombosis demonstrate delayed arterial healing, characterized by persistent fibrin deposition and poor endothelialization. In recent years, a novel prohealing device was developed that captures circulating endothelial progenitor cells (EPCs) by immobilized antihuman-CD34 antibody as a surface coating. EPCs have the ability to migrate to areas of vascular injury and aid in the regeneration of damaged and dysfunctional endothelium. Preclinical results of the EPC-capture stent have shown promise in accelerating endothelialization as compared with bare metal and DES. Clinically, the safety and efficacy of the EPC-capture stent has been proven in numerous clinical trials with low incidence of late stent thrombosis. In this article, we discuss the relevance of the ...

Use of Endothelial Progenitor Capture Cell Stent During Percutaneous Treatment of Coronary Bifurcations

The treatment of bifurcation lesions remains a challenge with poor immediate results and higher restenosis rate than in nonbifurcated lesions. Drug-eluting stents improve the outcome after coronary stenting, but are associated with a small but statistically significant increase in late and very late stent thrombosis. Thus, aim of the present study was to evaluate the angiographic and clinical results of a new type of stent (coated with murine monoclonal antihuman CD34 antibodies designed to attract circulating endothelial progenitor cells to rapidly establish a functional endothelial layer and promote healing stent implantation) in a cohort of consecutive patients with coronary bifurcation lesions. Between December 2007 and July 2008, a total of 43 consecutive patients were enrolled and 47 consecutive bifurcation lesions were treated with endothelial progenitor capture cell stents. The angiographic end points binary restenosis rate inside the stent (within 5 mm of the stent edges or in the segments treated with balloon angioplasty) was 5% (2.1% in the main branch and 10.5% in the side branch). No stent thrombosis was observed. Clinical follow-up was completed in all patients at mean time of 34.5 days after percutaneous coronary interventions by clinical evaluation and 12.3 months with a telephone contact. Angina at rest was present in 3 patients (7.9%). No in-hospital, 30-days, or 12-months major adverse cardiac events (death, myocardial infarction, and repeat revascularization coronary artery bypass graft or percutaneous coronary angioplasty) were reported. The use of endothelial progenitor capture cell in the setting of coronary bifurcation appears to be feasible and safe with no incidence of late stent thrombosis and a very low rate of repeated revascularization.

In-stent thrombosis after 68 months of implantation inspite of continuous dual antiplatelet therapy: a case report

Lately, there has been an increased incidence of late stent thrombosis; especially following Drug eluting stent (DES) implantation. Several factors are associated with an increased risk of stent thrombosis, including the procedure itself, patient and lesion characteristics, stent design, and premature cessation of anti-platelet drugs. We present a case of late stent thrombosis (LST) following DES implantation after a period of 68 months, making it the longest reported case of LST reported in the literature, despite the use of dual anti-platelet therapy.

Pre-clinical and Clinical Study Results for the Coracto™ Rapamycin-eluting Stent – A New-generation Drug-eluting Stent

First- and second-generation drug-eluting stents (DES) have successfully decreased the rate of restenosis compared with bare-metal stents (BMS); however, the incidence of late stent thrombosis, which mostly occurs after the implantation of DES, and chronic restenosis are still important medical problems. A new generation of DES, the Coracto™ rapamycin-eluting stent (RES), has the potential to reduce late stent thrombosis and the risk of chronic restenosis due to the totally biodegradable polymer providing a controlled drug release. In brief, the results of the two pre-clinical studies proved the safety and efficacy of the Coracto RES. In addition, in a clinical study comparing the Coracto RES and the Constant BMS, patients receiving the Coracto RES with chronic total occlusion (CTO) had a 71% decrease in the relative risk of restenosis after six months and an 82% reduction in target vessel revascularisation (TVR) after 24 months. The late stent thrombosis of the Coracto RES was 0% at 24-month follow-up. This article provides an overview of the data obtained from pre-clinical animal experiments using a porcine and rabbit model of stenting and a recently conducted clinical study demonstrating the safety and efficacy of the Coracto RES.

040 Is it long-term (> 12 months) dual antiplatelet treatment necessary in diabetic patients treated with drug-eluting stents?

Despite encouraging short-term results with drug-eluting stents (DES) in diabetes mellitus (DM) patients (pts) with coronary artery disease, the long-term safety is not clear. We investigated the influence of long-term (> 12 months) dual antiplatelet treatment (APLT) with aspirin and clopidogrel on clinical outcome in DM pts treated with DES. The study included 552 consecutive DM pts (male 81%, mean age 65+9 years) that had been treated with DES and received dual APLT treatment for 12 months. Long-term clinical follow-up (FU) (mean time 30.4 + 11.6 months), obtained in 545/552 (99%) of them; 419 (77%) pts were on dual APLT (group A) and 126 (23%) on single APLT (group B). Major adverse cardiovascular event (MACE) on clinical FU was considered death (D), myocardial infarction (MI), percutaneous or surgical revascularization (REV), cerebrovascular accident (CVA), and hard end-points (HDP) was considered D, MI and CVA. Late stent thrombosis (LST) was defined as angiographic documentation of stent occlusion associated with an acute ischemic event, unexplained sudden D or MI not clearly attributable to another coronary lesion > 12 months post-procedure. Unstable angina at presentation was more frequent in group A pts (36% vs. 26%, p<0.05).The incidence of LST was 2.1% in group A and 0.8% in group B pts (p:ns); no difference was observed according to diabetic treatment (insulin vs. non-insulin dependent). At FU D was observed in 4.8% vs. 2.4%, MI 1.9% vs. 0.8%, and HDP in 8.4% vs. 4% between pts in group A and B respectively (p:ns). The rate of any REV and MACE was higher in pts in group A (20.3% vs. 6.3%, and 26.7% vs. 11.1%, p<0.001); this difference was only observed in non-insulin-dependent pts. In a multivariate model ejection fraction <40% was predictor for LST (HR 14.5, 95% CI 3.9-49.4, p<0.001), and D/MI (HR 3.61, 95% CI 1.7-7.5, p=0.001), and multivessel disease for MACE (HR 2.0,95% CI 1.27-3.15, p=0.003). Dual APLT > 12 months in DM pts treated with DES implantation is not associated with better clinical outcome or lower risk of LST.

Percutaneous Coronary Intervention in Perspective

Since the United States Food and Drug Administration (FDA) approval of drug-eluting stents (DES) in 2003 as a treatment for coronary artery disease (http://www.fda.gov/bbs/topics/NEWS/2003/NEW00896.html), physicians have extended the use of these devices to patient and lesion complexities beyond those studied in pivotal randomized trials that compared their outcomes with bare metal stents. During the early period of enthusiastic adoption of DES, clinical decisions regarding DES implantation often exceeded the supportive evidence for a specific indication and instead were based on extrapolations of DES use in less complex patients, positive reports from subgroup analyses of subsequent trials, and anecdotal experience. Application of DES beyond the studied (and approved) indications, termed “off-label,” represents at least 60% of clinical practice patterns in contemporary percutaneous coronary intervention.1 In parallel with the increasing use of sirolimus- and paclitaxel-eluting stents, there emerged concern that DES may be associated with an increased incidence of late stent thrombosis (ST) and possibly increased rates of myocardial infarction (MI) and death.2–7 Although the pivotal trials evaluating DES were not statistically powered to identify differences in rare adverse events between DES and bare metal stents, the observation that ST, in particular late ST, was often associated with death or MI3,8–13 raised concerns among clinicians and regulators. In many instances, the limited data available obscured the differentiation of “evidence-based” medicine from clinical opinion and raised questions about the risk–benefit equation of DES use. The result was a return to increased use of bare metal stents and a relative decline in DES use from ≈90% of coronary stent revascularization procedures in 2006 to 60% by mid-2007.14 Because of these safety concerns, the FDA convened an expert advisory panel in December 2006 resulting in an updated statement that although the approved DES were associated with a small but measurable increase …

Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): Randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation

Drug-eluting stents (DES) reduce restenosis rates compared to bare-metal stents. Most trials using DES enrolled selected patient and lesion subtypes, and primary endpoint focused on angiographic metrics or relatively short-term outcomes. When DES are used in broader types of lesions and patients, important differences may emerge in long-term outcomes between stent types, particularly the incidence of late stent thrombosis. PROTECT is a randomized, open-label trial comparing the long-term safety of the zotarolimus-eluting stent and the sirolimus-eluting stent. The trial has enrolled 8,800 patients representative of those seen in routine clinical practice, undergoing elective, unplanned, or emergency procedures in native coronary arteries in 196 centers in 36 countries. Indications for the procedure and selection of target vessel and lesion characteristics were at the operator's discretion. Procedures could be staged, but no more than 4 target lesions could be treated per patient. Duration of dual antiplatelet therapy was prespecified to achieve similar lengths of treatment in both study arms. The shortest predefined duration was 3 months, as per the manufacturer's instructions. The primary outcome measure is the composite rate of definite and probable stent thrombosis at 3 years, centrally adjudicated using Academic Research Consortium definitions. The main secondary end points are 3-year all-cause mortality, cardiac death, large nonfatal myocardial infarction, and all myocardial infarctions. This large, international, randomized, controlled trial will provide important information on comparative rates of stent thrombosis between 2 different DES systems and safety as assessed by patient-relevant long-term clinical outcomes.

Antiplatelet therapy discontinuation following drug‐eluting stent placement: Dangers, reasons, and management recommendations

Drug-eluting stents (DES) have several advantages over bare-metal stents (BMS), including significantly lower target vessel revascularization. However, DES is associated with a higher incidence of late stent thrombosis (ST). Although late ST after DES placement is uncommon (approximately 0.4-0.6%/year), it is catastrophic clinical consequences make it a concern. Dual antiplatelet therapy (DAT) with aspirin and clopidogrel is the standard of care for prevention of ST, and DAT discontinuation is associated with a marked increase in ST risk. These guidelines recommend continuing DAT for > or = 12 months after DES implantation in patients not at high risk for bleeding. Premature DAT discontinuation is common in clinical practice. Therefore, it is imperative that physicians be aware of factors contributing to discontinuation, including cost, patient education, and actual bleeding events, so as to educate their patients about the risks and benefits of continued DAT. This review highlights the risks of premature DAT discontinuation, discusses common reasons for discontinuation, and offers potential solutions to improve adherence.

AS-267: The Impact of Intravascular Ultrasound for Late Stent Thrombosis after Drug-Eluting Stent Implantation

Background: Stent thrombosis (ST) is a serious complication of drugeluting stent (DES) implantation, regardless of the timing (acute, subacute, or late). The US Food and Drug Administration (FDA) panel accepts ST but rejects increased death/myocardial infarction (MI) risk for on-label DES use. To date, the safety and efficacy of intravascular ultrasound (IVUS) use in DES implantation has been well evaluated, but there are few data regarding IVUS for ST. We evaluated the impact of IVUS for ST in DES implantation. Methods: A total 1,448 patients with DES implantation were included from January 2006 to February 2008 and were divided into a phase I group (from January 2006 to December 2006; before IVUS use; n 731) and a phase II group (from March 2007 to February 2008; after IVUS use; n 717). ST was defined by the Academic Research Consortium (ARC) as reported at the Transcatheter Cardiovascular Therapeutics 2006 meeting. Results: The median follow-up duration was 6 months in both phases. In all, 31 (2.1%) ST occurred: 21 (2.9 %) in phase I (4 subacute, 17 late ST) and 10 (1.4%) in phase II (4 subacute, 6 late ST). The incidence of ST in phase I was higher than in phase II (2.9% vs 1.4 %, p 0.052) but was not significant. Subacute ST in phase I was not higher than phase II (0.5% vs 0.6 %, p 0.978). Late ST in phase I was significantly higher than in phase II (2.3% vs 0.8 %, p 0.023). The univariate logistic regression showed the hazard ratio (HR) for late ST was 0.376 (95% confidence interval [CI], 0.146–0.971) for IVUS use and 0.959 (95% CI, 0.936–0.981) for high-density lipoprotein (HDL). After adjustment for age, sex, and HDL, IVUS use showed a trend for predicting late ST (HR, 0.223; 95% CI, 0.049–1.003; p 0.050). Conclusion: The incidence of late ST was higher in phase I before IVUS use compared with phase II after IVUS use. The use of IVUS showed the trend for decreasing late ST, but a large-scale study is needed for the evaluation of the impact of IVUS use in DES implantation. AS-268

More Fuel for the Drug-Eluting vs. Bare-Metal Stent Debate

Drug-eluting stents (DES) have been associated with an increased incidence of late stent thrombosis, but the consequences of late stent thrombosis were

All-cause mortality after drug-eluting stent implantation in African–Americans

Recent studies have questioned the safety of drug-eluting stents because of a higher incidence of late stent thrombosis, raising the possibility that drug-eluting stents may be associated with an increased mortality. The effect of drug-eluting stents on mortality in African-Americans is unknown. We evaluated 628 African-American patients (354 patients treated with drug-eluting stents and 274 patients treated with bare metal stents) between January 2003 and August 2005, using data from our bolus-only platelet glycoprotein IIb/IIIa inhibitor database. The primary end point was all-cause mortality obtained using social security death index. After a mean follow-up of 3+/-0.9 years, the mortality rate in the bare metal stents group was 12.8% compared with 7.1% in the drug-eluting stents group [adjusted P value=0.19; hazard ratio (HR) for bare metal stents group compared with drug-eluting stents group for death=1.4; 95% confidence interval (CI): 0.8-2.4]. In a subgroup analysis, patients presenting with acute coronary syndrome had a higher mortality when treated with bare metal stents compared with drug-eluting stents (17.1 vs. 6.3%, P=0.022; HR=2.2; 95% CI: 1.1-4.4). Patients with chronic kidney disease (all patients with creatinine >1.5 mg/dl) also had a higher mortality with bare metal stents compared with drug-eluting stents (36.7 vs. 20.4%, P=0.044; HR=2.3; 95% CI: 1.02-5.2). Drug-eluting stents seem to be safe in African-Americans and may improve survival in certain subgroups such as patients with acute coronary syndromes and chronic kidney disease.

Cost-Effectiveness of Drug-Eluting Stents Including the Economic Impact of Late Stent Thrombosis

Recent studies examining the effectiveness of drug-eluting stents (DES) have found that the use of DES is associated with a significant increase in the incidence of late stent thrombosis (LST). Previous cost-effectiveness analyses of DES have not accounted for the costs associated with LST. In this study, published research was reviewed to identify studies that compared the cost-effectiveness of DES with that of bare-metal stents and to identify the incidence of LST. Probable costs were assigned to LST-related myocardial infarction and death on the basis of the treatment costs for these outcomes. These costs as well as those of extended clopidogrel therapy were then incorporated into the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) and TAXUS-IV cost-effectiveness data. This review found that the incidence of LST ranged from 0.2% to 0.7%. Assuming a base case LST incidence of 0.5%, a cost per death of $20,000, a cost per myocardial infarction of $20,000, and a cost of an additional 2 years of clopidogrel therapy of $2,428 per patient, the costs per revascularization avoided were $15,056 for the SIRIUS trial and $25,210 for the TAXUS-IV trial. The costs per quality-adjusted life-year gained were $250,935 and $257,591, respectively. Sensitivity analyses revealed that the costs per revascularization avoided varied from $14,618 to $15,830 for the SIRIUS trial and from $24,540 to $26,396 for the TAXUS-IV trial. Similarly, the cost per quality-adjusted life-year gained varied from $243,638 to $263,840 for the SIRIUS trial and from $250,739 to $269,708 for the TAXUS-IV trial. In conclusion, LST-related adverse events and the need for extended clopidogrel therapy substantially increase the costs associated with the implementation of DES. The inclusion of these costs renders the widespread use of DES not cost effective in the United States in terms of cost per quality-adjusted life-year gained and cost per revascularization avoided.

2-Year Outcome of Patients Treated for Bifurcation Coronary Disease With Provisional Side Branch T-Stenting Using Drug-Eluting Stents

Our goal was to determine whether the deployment of drug-eluting stents (DES) in bifurcation lesions, according to a uniform provisional side-branch T-stenting strategy (PTS), is a safe and effective treatment in the immediate and long term. In comparison with simple stenoses, successful percutaneous intervention for coronary bifurcation lesions is limited by a higher incidence of procedural complications and need for repeat revascularization. The ideal strategy to overcome these limitations remains to be demonstrated while recent controversy surrounds the long-term safety of DES in bifurcations. Consecutive patients treated for bifurcation lesions using DES were studied in a prospective single-center registry. Between 2003 to 2005, 477 procedures were performed. The PTS strategy was used in 92%, with a side-branch stent in 28% and final kissing balloon inflation in 95%. Angiographic success was achieved in 99% with 2.5% in-hospital major adverse cardiac events. The cumulative rate of major adverse cardiac events was 10.7% at 1 year and 13.6% at 2 years, including 6.9% and 8.9% target vessel revascularization. Deviation from the PTS strategy independently predicted 2-year mortality (odds ratio: 5.5 [95% confidence interval: 1.63 to 18.3], p < 0.01). The rate of definite or probable stent thrombosis at 2 years was 2.5% with half of all events occurring before hospital discharge. The PTS strategy for the treatment of bifurcation lesions is applicable to over 90% of patients in the real world. With DES, both safety and efficacy have been demonstrated in the long-term with <10% need for repeat revascularization in the first 2 years and a low incidence of late stent thrombosis.