Percutaneous Coronary Intervention Stent Research Articles

Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel Meeting on the Endeavor Zotarolimus-Eluting Coronary Stent

Initial trials comparing stenting with balloon angioplasty demonstrated improved angiographic and clinical outcomes with the former.1–3 The main clinical problem with bare metal stents (BMS) became the development of in-stent restenosis.4–6 Early data suggested that drug-eluting stents (DES) could mitigate, if not abolish, this problem.7–9 Since the approval of DES, these devices have become the predominant stents used in percutaneous coronary interventions, regardless of indication. As of September 2007, the Cypher sirolimus-eluting stent (SES) (Cordis Johnson & Johnson, Miami Lakes, Fla) had been deployed in >3 million patients worldwide,10 and the millionth Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Mass) was implanted as of January 2005.11 Over the past 2 years, numerous reports of very late stent thrombosis (ST) with first-generation DES have surfaced. This highly morbid complication and data suggesting that death and myocardial infarction (MI) may be more common with DES12,13 have altered the focus of trials and registries working to determine optimal DES use. There is a hope that second-generation DES will be less prone to ST as a result of differences in drug, stent design, and polymer. Medtronic, Inc (Minneapolis, Minn) presented safety and efficacy data to a public meeting of the US Food and Drug Administration (FDA) Circulatory System Devices Panel (CSDP) in October 2007 on its Endeavor zotarolimus-eluting stent (ZES), seeking approval for the indication of treating de novo native coronary lesions ≤27 mm with reference vessel diameters of 2.5 to 3.5 mm. The FDA asked the CSDP to determine whether the data presented demonstrated a reasonable level of safety and effectiveness, with clinical benefits clearly outweighing short- and long-term risks of ZES use. Important efficacy end points included ischemia-driven target lesion revascularization (TLR) or target vessel revascularization (TVR); safety end points included death, MI, and ST. The …

Drug-eluting stents: a systematic review and economic evaluation

To assess the effectiveness and cost-effectiveness of the use of drug-eluting coronary artery stents in percutaneous coronary intervention (PCI) in patients with coronary artery disease. Bibliographic databases, including MEDLINE, EMBASE and the Cochrane Library, were searched from December 2002 to August 2005. Hand-searching was also done. A systematic literature review of effectiveness was conducted focusing primarily on randomised controlled trials (RCTs). Full economic evaluations that compared two or more options and considered both costs and consequences were eligible for inclusion in the economics review. A critique of manufacturer submissions to the National Institute for Health and Clinical Excellence and an economic evaluation in the form of cost-utility analysis were also carried out. In the 17 RCTs of drug-eluting stents (DES) versus bare metal stents (BMS), no statistically significant differences in mortality or myocardial infarction (MI) were identified up to 3 years. Significant reductions in repeat revascularisations were determined for DES compared with BMS [for example, at 1 year: target lesion revascularisation (TLR) relative risk 0.24; 95% confidence interval (CI) 0.19 to 0.31; and target vessel revascularisation (TVR) relative risk 0.43; 95% CI 0.33 to 0.55]. This estimated benefit appears to be stable from 1 to 3 years. Binary restenosis and late luminal loss also favoured DES. In the eight RCTs of DES versus DES, no statistically significant differences in mortality or MI were detected between DES designs. In meta-analyses of TLR, TVR and composite event rate, marginal improvement in efficacy of Cypher trade mark over Taxus trade mark was observed. These results await confirmation beyond 1 year and differences in study design may have influenced reporting of outcomes. Ten full economic evaluations were included in the review and the balance of evidence indicated that DES are more cost-effective in higher risk patients. The review of submitted models confirmed the view that DES may be cost-effective only under very limited circumstances when realistic assumptions and data values were used. In the cost-utility analysis of DES versus BMS, the use of DES appears to reduce the rate of repeat revascularisations; benefit estimates used in the economic assessment are defined as 'broad' (i.e. cases involving any TLR/TVR irrespective of any other lesions/vessels undergoing revascularisation) and 'narrow' (i.e. cases involving TLR/TVR only). The incremental benefit to the patient is therefore described as the loss of quality-adjusted life-years (QALYs) avoided by not having to undergo a repeat revascularisation. Univariate sensitivity analysis and extreme values analysis indicate that the price premium, numbers of stents used in the index procedure and absolute risk reduction in repeat interventions most significantly influence the cost-effectiveness ratios. Sensitivity analyses also permit a range of values for efficacy and effectiveness to be considered for individual designs of DES. The cost-effectiveness results reveal that, all patients considered together, the calculated cost per QALY ratios are high (183,000-562,000 pounds) and outside the normal range of acceptability. Cost-effectiveness is only achieved for those non-elective patients who have undergone a previous coronary artery bypass graft and have small vessels. 'Real-world' data show that patient numbers in this latter group are very small (one in 3100 of all patients treated with PCI). The conclusions of the assessment are that the use of DES would be best targeted at the subgroups of patients with the highest risks of requiring reintervention, and could be considered cost-effective in only a small percentage of such patents. This is similar to the conclusion of our previous assessment. Trials of DES compared with new generation BMS and with DES would be useful, as would further evaluation of newer BMS in combination with drug administration.

Usefulness of Drug Eluting Stent in Percutaneous Coronary Intervention—A Single Center Experience in Taiwan

Drug eluting stents (DES) have been shown to reduce in-stent restenosis rate and target vessel revascularization in large clinical trials. However, the safety and efficacy of DES use in the Taiwanese population has not been reported. We designed this trial to analyze the clinical results in patients using DES in a single tertiary center. We retrospectively analyzed the clinical data of all patients treated at National Taiwan University Hospital, Taipei, Taiwan, with sirolimus- or paclitaxel-eluting stents between September 2003 and January 2005. A total of 585 patients (466 men, 119 women; mean age, 64.5 +/- 11.2 years) were enrolled. Meanwhile, 205 sirolimus- and 717 paclitaxel-eluting stents were implanted, with a mean of 1.6 stents per patient. Half (50.2%) of the stents were placed in the left anterior descending artery. Among the enrolled patients, 41.8% had diabetes mellitus, 25% had a diagnosis of acute coronary syndrome, and 10.7% was treated with primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Overall 8-month target vessel revascularization, major adverse cardiac event rate, and cardiac death rate were 8.8%, 9.7% and 2.5%, respectively. There was no difference in clinical events between sirolimus- and paclitaxel-eluting stents. The overall subacute stent thrombosis rate was 1.36%, significantly lower than that in patients who presented with acute coronary syndrome (4%). The use of DES in the Taiwanese population yielded comparable results as those in large clinical trials. Subacute stent thrombosis rate was higher in acute coronary syndrome. The safety of DES in these situations should be further clarified.

Comparison of Effectiveness of Bare Metal Stents Versus Drug-Eluting Stents in Large (≥3.5 mm) Coronary Arteries

Drug-eluting stents (DESs) are superior to bare metal stents (BMSs) in decreasing restenosis rates across a wide range of patient and lesion subsets. However, widespread utilization of DESs raises concerns with regard to risks of prolonged dual antiplatelet therapy, the potential for late adverse events such as late thrombosis, and cost. Vessel diameter and lesion length have been previously identified as predictors for restenosis for DESs and BMSs. This study compared the clinical outcomes of DESs versus BMSs in large coronary arteries (> or =3.5 mm). A cohort of 233 patients who underwent single-vessel angioplasty with DES implantation in large vessels was compared with 233 propensity-matched patients who received BMSs in vessels with similar reference vessel diameters. Clinical outcomes at 30 days, 6 months, and 1 year were compared between groups. Baseline clinical and procedural characteristics were similar. Target lesion revascularization and target vessel revascularization rates and the incidence of major adverse cardiac events were low and comparable between the 2 groups at all follow-up intervals. At 1 year, the primary outcome occurred in 8.5% of patients with DESs and 7.7% of patients with BMSs (p = 0.80). There were no episodes of subacute stent thrombosis or late thrombosis in either group. In conclusion, implantation of DESs in large coronary arteries confers no additional benefit compared with BMSs, and the 2 approaches are associated with equally favorable clinical outcomes at 1 year.

The cost-effectiveness of drug-eluting stents: a systematic review

Drug-eluting stents have been seen as an attractive alternative to bare-metal stents for percutaneous coronary interventions (PCIs) because of the decreased need for revascularization. However, comparative clinical trials have shown no difference in patient outcomes, and drug-eluting stents are considerably more expensive than their bare-metal counterparts. We conducted a systematic review of all published comparative cost-effectiveness analyses to identify the factors contributing to the heterogeneity of their conclusions. We retrieved all articles published between Jan. 1, 2000, and July 31, 2006, in which the cost-effectiveness, from a third-party payer perspective, of drug-eluting stents was compared with that of bare-metal stents for PCI in unrestricted patient populations. Electronic databases, Web sites from health technology assessment groups and references of identified articles were searched. Our outcome variable was whether the study's conclusions favoured widespread use of drug-eluting stents, as assessed by 4 independent reviewers. Study characteristics such as quality, funding source, country and year of publication were extracted. Two-by-2 tables and Fisher's exact test were used to study the association between covariates and the outcome variable. A classification and regression tree (CART) model was used for multivariate analysis. We identified 19 cost-effectiveness analyses. Ten were in favour of widespread use of drug-eluting stents, and 9 favoured more restrained use. Only 1 of 9 high-quality studies supported widespread use, as compared with 9 of 10 lower quality studies (p < 0.001). All of the 7 sponsored studies argued in favour of widespread use, as compared with 3 of the 12 studies without sponsorship (p = 0.003). Studies from the United States were more likely than those from other countries to endorse unlimited use (p = 0.032). A CART model with 2 covariates--study quality and sponsorship--provided the best fit (error rate 10.5%). Conclusions drawn by cost-effectiveness analyses of drug-eluting stents for PCI are associated with the study's quality, funding source and country of origin. Vigilance regarding these study characteristics is required when interpreting findings from cost-effectiveness analyses.

Effect of hospital ownership status and payment structure on the adoption and use of drug-eluting stents for percutaneous coronary interventions

The impact of the use of drug-eluting stents in percutaneous coronary intervention (PCI) on cardiac care is still uncertain. We examined the influence of systemic factors, such as hospital ownership status, organizational characteristics and payment structure, on the use of drug-eluting stents in PCI and the effect on cardiac surgery volume. We conducted a cross-sectional analysis of drug-eluting stent use in 12 993 patients undergoing PCI with stenting (drug-eluting or bare-metal) and time-series regression analyses of the monthly number of cardiac surgery and PCI procedures performed using data collected from 1998 to 2004 at 13 public and private hospitals in the Emilia-Romagna region of Italy. Public hospitals used drug-eluting stents more selectively than private hospitals, targeting the new device to patients at high risk of adverse events. The time-series regression analyses showed that the number of PCI procedures performed per year increased during this period, both in public (slope coefficient 36.4, 95% confidence interval [CI] 30.2 to 43.1) and private centres (slope coefficient 6.4, 95% CI 3.1 to 9.2 ). Concurrently, there was a reduction in the number of isolated coronary artery bypass graft (CABG) surgeries, although the degree of change was higher in public than in private hospitals (coefficient -16.1 v. -6.2 respectively ). The number of CABG procedures associated with valve surgery decreased in public hospitals (coefficient -5.0, 95% CI -6.1 to -3.8) but increased in private hospitals (coefficient 4.1, 95% CI 2.0 to 6.1). Public and private hospitals behaved differently in adopting drug-eluting stents and in using PCI with drug-eluting stents as a substitute for surgical revascularization.

Trends in percutaneous versus surgical revascularization of unprotected left main coronary stenosis in the drug‐eluting stent era—a report from the American College of Cardiology‐National Cardiovascular data registry (ACC‐NCDR)

We sought to determine how practice patterns for unprotected left main stenosis have changed with the advent of drug-eluting stents (DES). Percutaneous coronary intervention (PCI) of unprotected left main coronary stenosis has been controversial. We analyzed data submitted to the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) between January 1, 2002 and December 31, 2004 from 1,276,582 cardiac catheterizations at 417 institutions. Of these, 53,548 (4.2%) had left main stenosis >50% and no prior CABG. After excluding the unrevascularized, the patient sample (N = 32,562) was analyzed for PCI vs. CABG. Data was stratified by year/quarter, bare metal stent vs. DES, elective vs. urgent/emergent situations, LVEF < or > or =40%, and %left main and RCA stenosis. Of unprotected left main revascularizations from 2002 to 2004, PCI increased from 17.0% to 21.9%, while CABG decreased from 83.0% to 78.1% (P < 0.0001). In 2002, bare metal stents were used for all PCIs; in 2004, bare metal stent use was only 25.5%, while DES use was 74.5% (P < 0.0001). Of elective procedures, PCI rose from 19.1% to 27.5% while CABG fell from 80.9% to 72.5% (P < 0.0001). Similar trends, all significant, were seen in every clinical situation. In the era of DES, the rate of PCI for unprotected left main stenosis has risen, while CABG has declined. These findings are seen across varying clinical situations, including elective procedures. DES have rapidly and largely replaced bare metal stents for PCI of unprotected left mains. However, PCI is still chosen less frequently than CABG for unprotected left main revascularization.

Large and small vessel vasoconstriction following coronary artery stenting: Effect of intra coronary nitroglycerine and relation to LDL cholesterol

Percutaneous coronary intervention (PCI) with stent placement induces epicardial coronary vasoconstriction, which is resolved by intracoronary (IC) nitroglycerine (NTG). The effect of stenting on microvascular coronary circulation and coronary blood flow (CBF) is less well established, and the effect of NTG on CBF following stenting is unknown. We examined the time course, extent, and influence of NTG, on PCI induced coronary vasoconstriction. Secondarily we also did an explorative analysis to evaluate the effect of increased levels of low density lipoprotein cholesterol (LDL-Cholesterol) on CBF after stenting. Methods Single vessel PCI stent was performed in 19 patients (age 62 ± 10 years). Immediately after PCI, a 0.014 Doppler flow-wire was positioned distal to the stent, and IC NTG 0.2 mg was given. Quantitative coronary angiography (QCA) and CBF measurements were taken at baseline, and at 10, 20 and 30 min following PCI. Further IC NTG 200 μg was given after the measurement at 30 min, and the measurements were repeated at 31 and 33 min. Coronary flow velocity reserve (CFVR) was measured with adenosine IC bolus. Results Compared to baseline, there were significant reductions in CBF (24.5 ± 18.3%), (35 ± 30 vs. 28 ± 25 ml/min, p = 0.001) and coronary arterial diameter (5.1 ± 5.4%) (2.63 ± 0.54 vs. 2.50 mm ± 0.53, p = 0.008) within 30 min following PCI. Subsequent IC NTG reversed both small (28 ± 25 vs. 44 ± 30 ml/min, p < 0.001) and large (2.50 ± 0.53 vs. 2.80 ± 0.59 mm, p = 0.001) vessel PCI induced vasoconstriction. LDL-cholesterol was significantly correlated to the percent reduction of blood-flow within 30 min ( r = 0.515, p = 0.024, n = 19) and to the maximal CBF after NTG ( r = 0.520, p = 0.022, n = 19). Conclusion Following PCI, both large and small vessel vasoconstriction are seen as manifest by a reduction in coronary conduit vessel diameter and in CBF. These effects are reversed by NTG. Serum levels of LDL are modestly related to the reduction of CBF and to the degree of NTG induced vasodilatation of coronary micro-vasculature.

Successful Retrieval of Dislodged Paclitaxel-eluting Stent with a Nitinol Loop Snare: A Case Report

Coronary stent dislodgment or embolization before deployment is a rare but challenging complication in interventional cardiology. Intracoronary embolization of the dislodged stent is associated with a high risk of coronary occlusion, due to thrombus formation and subsequent myocardial infarction. Furthermore, systemic embolization may cause severe cerebrovascular events. Nonsurgical retrieval strategies for this complication have been suggested, but bailout cardiac surgery may be indicated if percutaneous retrieval attempts fail. To our knowledge, this is the first case report of intracoronary drug-eluting stent dislodgment, and successful retrieval was accomplished by a loop snare technique. With the increasing trend of using drug-eluting stents in percutaneous coronary intervention, the likelihood of stent dislodgment or embolization may increase. It should be kept in mind, especially by coronary interventionists, how to manage this complication.

Improved long-term survival associated with stent deployment during percutaneous coronary interventions: Results from a registry of 3399 patients

The use of stents in percutaneous coronary intervention (PCI) improves procedural success and reduces restenosis. However, few studies have had a sufficient sample size or adequate follow-up to determine whether this advantage results in a positive effect on mortality. A total of 3399 patients undergoing PCI (stented [with dual antiplatelet therapy]: n = 2456, nonstented [balloon PCI or rotational atherectomy]: n = 942) at a single institution from 1994 to 2001 were followed up prospectively (43 +/- 22 and 54 +/- 25 months, respectively) for acute and long-term clinical outcomes. Angiographic success (< 50% residual stenosis) (99.7% vs 97.7%, P < .001) and acute gain (3.02 +/- 0.55 vs 2.08 +/- 0.62 mm, P < .001) were both greater for stented lesions. Likewise, procedural complications of death (0.04% vs 0.4%, P = .02) and dissection (4.9% vs 8.0%, P = .001) were lower in the stent group, as were rates of 6-month clinical restenosis (10.3% vs 16.3%, P < .001). Eight-year mortality (12.0% vs 18.2%, hazard ratio = 0.78, P = .009) was lower among the stent group, as was long-term major adverse cardiac events (36.2% vs 50.6%, P < .001), but no difference in long-term myocardial infarction was found (6.5% vs 7.6%, P = .28). In multivariable Cox regression, stent use (hazard ratio = 0.76, 95% CI [0.58-0.99], P = .04) remained associated with significantly reduced mortality. This large prospective study demonstrates that, in addition to a general improvement in procedural success and a reduced need for repeat revascularization, the use of stents with dual antiplatelet therapy was associated with a significant reduction in long-term mortality. Consideration should be given for the use of stents whenever feasible during PCI.

What Is the Risk of Stent Thrombosis Associated With the Use of Paclitaxel-Eluting Stents for Percutaneous Coronary Intervention? A Meta-analysis

What Is the Risk of Stent Thrombosis Associated With the Use of Paclitaxel-Eluting Stents for Percutaneous Coronary Intervention? A Meta-analysis

Comparison of Effectiveness of Sirolimus-Eluting Stents Versus Bare Metal Stents for Percutaneous Coronary Intervention in Patients at High Risk for Coronary Restenosis or Clinical Adverse Events

We evaluated the clinical effect of selective use of sirolimus-eluting stents (SESs) in real-world, high-risk patients. A total of 4,237 consecutive patients who underwent percutaneous coronary intervention (SES, n = 872, bare metal stents [BMSs], n = 3,365) was enrolled in a prospective regional survey. A prespecified high-risk subset of patients was selected on the basis of clinical and angiographic characteristics. A propensity score analysis was performed to compare patients who received SESs with those who received BMSs. Patients in the SES group more often had diabetes and more frequently had previous myocardial infarction or coronary revascularization, type C lesions, and multivessel procedures. Patients who presented with acute myocardial infarction were treated more often with BMSs. At 9 months, the use of SESs was associated with fewer major adverse cardiac events (death, myocardial infarction, or target lesion revascularization; hazard ratio 0.56, 95% confidence interval 0.37 to 0.85) and target lesion revascularizations (hazard ratio 0.43, 95% confidence interval 0.20 to 0.91). This decrease was more evident in a prespecified high-risk subgroup of patients (major adverse cardiac events, 8.0% SES vs 15.6% BMS, hazard ratio 0.45, 95% confidence interval 0.29 to 0.72). We conclude that selective SES use in real-world patients who have high-risk clinical and angiographic characteristics is associated with significant decreases in major adverse cardiac events and repeat revascularizations compared with BMS use.

Risk of Thrombosis With the Use of Sirolimus-Eluting Stents for Percutaneous Coronary Intervention (from Registry and Clinical Trial Data)

We conducted a meta-analysis on 6 studies in 2,963 patients who had coronary artery disease and received a sirolimus-eluting stent or a bare metal stent for revascularization. Compared with bare metal stents, sirolimus-eluting stents did not appear to increase the risk for thrombosis up to 13.5 months after coronary intervention (risk ratio 0.49, 95% confidence interval 0.22 to 1.12, p = 0.09).

Coronary Artery Surgery

Coronary Artery Surgery

Stability and dynamic deforming process for structure of coronary artery stents

Abstract Coronary stent is of a micro cylindrical net structure. In this paper stability and dynamic deforming process for structure of coronary artery stents in percutaneous coronary intervention (PCI) was studied by measurements of stent deformation under pressure and theoretical analysis. In PCI, a stent has two stages of loading (1) the stage stent in inflated, and (2) the stage stent is left, and is under the pressure of the shrinkage of the artery. For the first stage, the change of the stent diameter was measured by the observation with a microscope. Load–displacement curves of the stent in the inflation process were got. The maximum deformation rate of the inflating stent was 2.0 mm/s at the right end of the stent at the inflating time 15.5 s. In the second stage, the buckling behavior of the stent was studied. An “Intelligent Electronic Measurement Apparatus” was used for the buckling test of stents. Some new buckling phenomena of multi-buckling were revealed in the tests. These results will be important for the research of the stent properties.

What is the risk of stent thrombosis associated with the use of paclitaxel-eluting stents for percutaneous coronary intervention?: A meta-analysis

This study investigated the risk of stent thrombosis associated with the use of paclitaxel-eluting stents (PES) compared to bare-metal stents (BMS).Clinical experience with coronary drug-eluting stents (DES) is relatively limited. There is concern that DES used for percutaneous coronary intervention may result in subsequent thrombosis.We conducted a meta-analysis on eight trials (total of 13 study arms) in 3,817 patients with coronary artery disease who were randomized to either PES or BMS.As compared with BMS, PES do not increase the hazard for thrombosis up to 12 months (risk ratio [RR] = 1.06, 95% confidence interval [CI] 0.55 to 2.04, p = 0.86]). There was no evidence of heterogeneity among the studies (chi-square value for Q-statistic = 5.90 [10 degrees of freedom], p = 0.82). Similar results were obtained when the analysis was restricted to trials with a polymeric stent platform (Treatment of de novo coronary disease using a single pAclitaXel elUting Stent [TAXUS]-I, -II, -IV, and -VI) (RR = 1.01, 95% CI 0.40 to 2.53, p = 0.99), trials with longer lesions (TAXUS-IV and -VI) (RR = 0.62, 95% CI 0.2 to 1.91, p = 0.41), and trials that used a higher dose of paclitaxel (ASian Paclitaxel-Eluting Stent Clinical trial [ASPECT], European evaLUaTion of paclitaxel Eluting Stents [ELUTES], and DELIVER-I) (RR = 1.87, 95% CI 0.52 to 6.81, p = 0.34).Current evidence suggests that standard dose PES do not increase the hazard of stent thrombosis compared to BMS.

Optimal Duration of Antiplatelet Therapy in Recipients of Coronary Drug-Eluting Stents

Four weeks' therapy with clopidogrel, in addition to aspirin (acetylsalicylic acid), is currently standard care after percutaneous coronary intervention (PCI) with stent implantation. The recent availability of drug-eluting stents (DES), which dramatically reduce restenosis at the site of PCI, has again raised the issue of stent thrombosis. In clinical trials, the risk of stent thrombosis appeared unrelated to the presence of the drug eluting from the stent and was documented within the usual range of < or =1% at 9 months after DES implantation. However, these devices feature delayed strut endothelialisation and there are reports describing late DES thrombosis up to 18 months after PCI, in most cases after clopidogrel has been discontinued. Although infrequent after bare-metal stenting (0.4-2.8%), stent thrombosis is a catastrophic event. Before DES availability, adjunctive intravascular brachytherapy significantly reduced in-stent neointimal proliferation, at the price of a higher-than-expected rate of late stent occlusion (6-8%). In such setting, a 12-month aspirin plus clopidogrel regimen showed a beneficial effect on long-term adverse events. An additional consideration is that, among patients undergoing bare-metal stent PCI, combined antithrombotic therapy with aspirin and clopidogrel has been recently associated with favourable effects on cardiovascular outcome beyond stent thrombosis in two large-scale clinical trials. Therefore, we propose that prolonged combination therapy with aspirin and clopidogrel be mandatory up to 1 year after PCI in all patients receiving DES.

Polymer‐Based Paclitaxel‐Eluting Stents in Percutaneous Coronary Intervention:

Drug-eluting stents have altered the practice of interventional cardiology by dramatically reducing the risk of angiographic and clinical restenosis following percutaneous coronary intervention. Based on extensive preclinical study and clinical trial data, the polymer-based, slow rate-release paclitaxel-eluting TAXUS stent has recently received Food and Drug Administration approval for sale in the United States. In the current article, we review the available data from the TAXUS trials that have demonstrated that implantation of the slow rate-release TAXUS stent is safe and, in terms of restenosis, markedly superior to bare metal stenting for the treatment of de novo lesions <28 mm in length in arteries 2.5-3.75 mm in diameter. Additional trials in the TAXUS program are currently examining the role of slow and moderate rate-release polymer-based, paclitaxel-eluting stents in a broader range of clinical settings and lesion subsets.

Left ventricular function in the stent or surgery trial one year after randomization to coronary artery bypass graft surgery or stent percutaneous coronary intervention

Left ventricular function in the stent or surgery trial one year after randomization to coronary artery bypass graft surgery or stent percutaneous coronary intervention

The effects of contemporary use of coronary stents on in-hospital mortality

OBJECTIVESThis study was designed to determine the effect of coronary stents on in-hospital mortality.BACKGROUNDDespite extensive use of stents for percutaneous coronary interventions (PCIs), their effect on serious in-hospital events, especially mortality, is not well defined.METHODSA cohort study was performed using 16,811 consecutive native-vessel PCI procedures performed on patients in the Society for Cardiac Angiography & Interventions Registry from July 1, 1996, through December 31, 1998. Patients undergoing balloon-only angioplasty were compared with those receiving a planned or unplanned stent. Procedures with other devices were excluded. Multivariable analyses adjusted for detailed clinical characteristics and for individual laboratory.RESULTSStents were associated with a significant reduction in in-hospital mortality (0.3%) compared with balloon procedures (0.6%; multivariable odds ratio [OR] 0.55; 95% confidence interval [CI] 0.34, 0.89; p = 0.014). The risk of emergency coronary bypass also was reduced by stenting (0.3% vs. 0.7%; multivariable OR 0.47; 95% CI: 0.29, 0.76; p = 0.002). Adjustment for the use of glycoprotein IIb/IIIa inhibitors did not change the results, and the effects of stenting relative to balloon procedures were similar in those procedures with and without glycoprotein IIb/IIIa blockade (p = 0.94).CONCLUSIONSThis study suggests that coronary stenting, compared with balloon procedures, reduces in-hospital mortality, independent of the clinical setting.