Drug-eluting stents are associated with similar cardiovascular outcomes when compared to bare metal stents in the setting of acute myocardial infarction

BACKGROUND: Recent randomized trials have demonstrated conflicting results regarding the use of drug-eluting stents (DESs) as compared to bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI). We compared outcomes among patients presenting with acute ST-elevation myocardial infarction (STEMI) who received DES with those who received BMS. METHODS: In-hospital, 30-day, 6-month, and 1-year outcomes of a cohort of 122 patients who underwent primary or facilitated PCI and received a BMS were compared to 122 propensity-matched patients who received a DES. Seventy-two patients received sirolimus-eluting stents, and 50 received paclitaxel-eluting stents. RESULTS: Baseline demographics were similar among groups. One-, 6-, and 12-month outcomes, including reinfarction, death, stent thrombosis, and target vessel revascularization (TVR), were similar among groups. At 1 year, all-cause mortality was 13.3% in the BMS group and 9.2% in the DES group [P=not significant (ns)], recurrent MI was 5.3% in the BMS group vs. 4.4% in the DES group (P=ns), and TVR was 7% in the BMS group vs. 8.7% in the DES group (P=ns). CONCLUSIONS: Our data do not support the general use of DES in the setting of STEMI given similar cardiovascular outcomes among patients receiving BMS or DES, the need for long-term dual antiplatelet therapy with DES, and the possible repercussions of very late stent thrombosis.     

Two-year clinical outcome after coronary stenting of small vessels using 2.25-mm sirolimus- and paclitaxel-eluting stents: insight into the RESEARCH and T-SEARCH registries.

OBJECTIVES: To evaluate long-term outcomes after drug-eluting stents (DES) implantation in small coronary vessels. BACKGROUND: Sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) have been reported to improve both the angiographic and clinical outcomes compared with bare metal stents even in 'real world' settings. Currently, no data is available on long-term outcomes after DES implantation in small vessels. METHODS: Since April 2002, our institution has implanted DES, either SES or PES, as a default strategy in all patients irrespective of their clinical presentation. Between October 2002 and September 2003, 197 consecutive patients were enrolled: 107 consecutive patients received at least one 2.25-mm SES (SES group) and 90 consecutive patients received at least one 2.25-mm PES (PES group). RESULTS: The two cohorts presented with high-risk characteristics. At 2 years, the cumulative incidence of major adverse cardiac events (MACE) in the SES group was significantly lower than that in the PES group (10.3% vs. 23.3%, P=0.02). There were two subacute angiographic stent thromboses in the PES group and none in the SES group. By multivariate analysis, PES utilization (HR 2.37, 95% CI 1.07-5.26), presentation with acute coronary syndromes (ACS) (HR 3.34, 95% CI 1.44-7.70) and multi-vessel disease (MVD) (HR 3.91, 95% CI 1.27-12.0) were identified as independent predictors of MACE. CONCLUSIONS: In an unselected population treated for small vessel disease, SES were associated with significantly better 2-year clinical outcomes than PES. The use of PES and the presentation with ACS and MVD were identified as independent predictors of MACE.     

The present and future of drug-eluting stents.

The only widely accepted way to reduce restenosis rate after percutaneous balloon angioplasty has been the use of coronary bare metal stents, and the last decade has witnessed a prompt and widespread adoption of bare metal stents that has revolutionized the field of interventional cardiology. The new millennium has seen the recent development of drug-eluting stents (DES), allowing controlled release of a drug directly to the injured artery, which seem to have prevented by large the problem of in-stent restenosis. The goal of this review was to summarize recent laboratory and clinical investigations concerning the effects of DES in various settings relevant to coronary heart disease. In the experimental setting, we examine the intracellular signaling and the role of smooth muscle cells after vascular injury. We also discuss recent observations from our laboratory showing the effects of coating per se on cell apoptosis and proliferation. In the clinical setting, the effects of DES in patients with stable or unstable angina pectoris is examined in detail for the relevant implications both in the treatment and prognosis. The results of a meta-analysis on the effects that have been overlooked in individual studies are reported which show a striking reduction in bypass surgery after DES implantation. Finally, we discuss the potential role of new materials and technologies (i.e., nanotechnology) that will improve DES performance allowing other future clinical applications in patients with ST-elevation myocardial infarction, vulnerable plaques, insulin-dependent diabetes mellitus, etc.     

Outcomes of intravascular ultrasound-guided percutaneous coronary intervention with drug-eluting stents versus bare metal stents for acute coronary syndrome in octogenarians

The number of percutaneous coronary interventions (PCI) performed for octogenarians with acute coronary syndrome (ACS) continue to increase. The short- and long-term outcomes of intravascular ultrasound (IVUS)-guided PCI with drug-eluting stents (DES) or bare metal stents (BMS) for ACS in octogenarians, however, remain largely unknown. We analyzed clinical outcomes of octogenarians undergoing IVUS-guided PCI for ACS with either DES or BMS. During the study period, a total of 776 patients with ACS underwent IVUS-guided PCI and 75 of them were octogenarians. In-hospital mortality tended to be lower in the DES group than in the BMS group. Between 6 months and 1 year of follow up, treatment with DES compared with BMS tended to result in fewer target lesion revascularizations. Major adverse cardiac events were similar between patients receiving DES and BMS. In octogenarians with ACS treated with IVUS-guided PCI, DES appears as safe as BMS, providing similar short- and long-term outcomes.     

A comparative analysis of major clinical outcomes using drug‐eluting stents versus bare‐metal stents in a large consecutive patient cohort

Objectives : To ascertain the long‐term safety, efficacy, and pattern of use of drug‐eluting stents (DES) in routine clinical practice. Methods : We analyzed a registry of 6,583 consecutive patients undergoing percutaneous coronary intervention (PCI), of whom 2,633 were treated using DES (DES group) and 3,950 were treated using bare‐metal stents (BMS group). Propensity score was used for stratified analysis of outcomes and for matching. Outcomes were total mortality, myocardial infarction (MI), repeat target vessel revascularization (TVR) rates, and risk‐adjusted event‐free survival. Results : Follow‐up time was 6 months to 5.18 years (mean: 3 years). Patients in the DES group were more likely to be diabetic and had use of longer or more stents, treatment of more lesions and of more proximal main vessels. After propensity score matching, the cumulative mortality was 12.85% in the DES group versus 14.14% in the BMS group (P = 0.001). Use of DES reduced the occurrence of MI (5.17% vs.5.83%, P = 0.046), of clinically driven TVR (9.76% vs. 12.28%, P < 0.001) and of the composite endpoint of death/MI/TVR (23.38% vs. 26.07%; P < 0.001). Conclusions : Our risk‐adjusted event‐free survival analysis indicates a prognostic benefit for DES utilization that sustains up to 5 years following PCI. © 2010 Wiley‐Liss, Inc.     

Drug eluting stents for ST-elevation myocardial infarction: risk and benefit

Drug-eluting stents have been a major advance in percutaneous coronary revascularization. Widespread use of these stents has been spurred by substantial reductions in restenosis rates when compared with bare metal stents. The use of drugeluting stents during ST-segment elevation myocardial infarction has been a common practice and is associated with lower revascularization rates in various studies. Unfortunately, significant concerns regarding the occurrence of late stent thrombosis with this technology persist. A clinical dilemma exists as to whether the benefits of reduced repeat revascularization with DES outweigh the harm caused by a possible increased occurrence of the infrequent but devastating complication of late stent thrombosis. This review with discuss the theoretical risks and benefits of DES for STEMI, the available data regarding their use, and the areas where future studies are needed.     

Outcomes of stenting with overlapping drug-eluting stents versus overlapping drug-eluting and bare-metal stents for the treatment of diffuse coronary lesions

Introduction

We investigated the outcomes of stenting with overlapping drug-eluting stents (DES) versus overlapping stenting with a combination of drug-eluting and bare metal stents (BMS) in very long ≥(≥ 25 mm).

Methods and Results

Fifty-two patients treated with either overlapping DES-DES (n = 22) or DES-BMS (n = 30) were selected from a registry of 588 patients with very long coronary lesions. Patients with acute myocardial infarction (MI) within the preceding 48 hours were excluded. The DES-DES combination was more frequently used for longer lesions compared with the DES-BMS group (47.95 ± 9.25 vs 39.98 ± 9.15 mm, p = 0.003). Left anterior descending artery lesions were also more frequently treated with the DES-DES combination (95.5 vs 66.7%, p = 0.02). In four patients in the DES-BMS group, overlapping stents were used for the coverage of dissections. Peri-procedural non-Q-wave MI occurred in one patient in the DES-BMS group. On follow up, only one case of non-fatal MI occurred in a patient with overlapping DES-DES.

Conclusion

Overlapping a BMS in the proximal part of a long DES instead of exclusive deployment of two or more overlapped DES seems to be a safe and feasible therapeutic strategy in our practice.     

Safety of drug-eluting stents in the coronary artery in ST-elevation myocardial infarction at a single high-volume medical center

Several trials have shown the effectiveness of drug-eluting stents (DES) in reducing restenosis. Acute ST-elevation myocardial infarction (STEMI) has been an exclusion criterion in most trials evaluating the safety and efficacy of DES. There is recent randomized trial data evaluating the use and safety of DES for acute myocardial infarction. However, there is a need for "real world" data on the efficacy and safety of DES in STEMI. A single-center retrospective analysis was performed on 188 consecutive patients with STEMI treated with primary or rescue coronary angioplasty between March 2004 and July 2005. The study consisted of 3 groups: 115 patients treated with paclitaxel-eluting stents, 55 with sirolimus-eluting stents, and 18 with bare metal stents. Outcomes were assessed from 12 to 28 months (mean 20, median 19) for major adverse cardiac events (MACEs) including myocardial infarction, in-stent thrombosis, clinical restenosis, and death. There were 4 in-stent thromboses in the paclitaxel group (3.4%) and 2 in-stent thromboses in the sirolimus group (3.6%). The thromboses ranged from acute (within 24 hours) to as late as 8 months. Clinical restenosis occurred in 4 patients (3.4%) in the paclitaxel group and in 2 patients (3.6%) in the sirolimus. None of the 18 patients with bare metal stents had thrombosis or clinical restenosis. There were 7 total deaths, all related to complications from the index STEMI: 1 in the bare metal group, 1 in the sirolimus group, and 5 in the paclitaxel group. The postdischarge MACE rate was 7% with no deaths. In conclusion, the use of DES in acute STEMI is associated with a low postdischarge MACE rate and a 3.5% in-stent thrombosis rate, which is similar to reported rates in earlier randomized trials.     

Late loss of early benefit from drug-eluting stents when compared with bare-metal stents and coronary artery bypass surgery: 3 years follow-up of the ERACI III registry.

Aims: Long-term benefit from coronary revascularization with drug-eluting stents (DES) relative to bare metal stents (BMS) and coronary artery bypass grafting (CABG) has not been established. One year follow-up of the ERACI III registry study showed better outcome with DES. To compare major adverse cardiac and cerebrovascular event (MACCE) rates in patients with multivessel cardiovascular disease (CVD) who received DES with those patients treated with BMS or CABG in the ERACI II trial. METHODS AND RESULTS: Patients with multivessel CVD who met the ERACI II trial, clinical and angiographic inclusion criteria were treated with DES and enrolled in the ERACI III registry. The primary endpoint was 3-year MACCE. ERACI III-DES patients (n = 225) were compared with the BMS (n = 225) and CABG (n = 225) arms of ERACI II. Patients treated with DES were older, more often smokers, more often high risk by euroSCORE and less frequently had unstable angina. They also had higher incidence of type C lesions and received more stents than the BMS-treated cohort. Three year MACCE was lower in ERACI III-DES (22.7%) than in ERACI II-BMS (29.8%, P = 0.015), mainly reflecting less target vessel revascularization (14.2 vs. 24.4%, P = 0.009). MACCE rates at 3 years were similar in DES and CABG-treated patients (22.7%, P = 1.0), in contrast to results at 1 year (12 vs. 19.6%, P = 0.038). MACCE rates in ERACI III-DES were higher in diabetics (RR 0.81, 0.66-0.99; P = 0.018). Death or non-fatal MI at 3 years trended higher in the DES (10.2%) than BMS cohort (6.2%, P = 0.08) and lower than in CABG patients (15.1%, P = 0.07). Sub-acute late-stent thrombosis (LST) (>30 days) occurred in nine DES patients and no BMS patients (P = 0.008). CONCLUSION: In patients with multivessel CVD, the initial advantage for PCI with DES over CABG observed at 1 year was not apparent by 3 years. Furthermore, despite continued lower incidence of MACCE, initial advantage over BMS appeared to decrease with time. LST occurred more frequent in DES-treated patients.     

Drug‐eluting stents versus bare‐metal stents for treatment of bare‐metal in‐stent restenosis

Objectives : We compared the long‐term outcomes of drug‐eluting stents (DES) versus bare‐metal stents (BMS) for treatment of bare‐metal in‐stent restenosis (ISR). Background : There are no randomized trials or observational studies directly comparing the safety and efficacy of DES versus BMS for treatment of bare‐metal ISR. Methods : We examined data on all patients who underwent percutaneous coronary intervention (PCI) for ISR at Cleveland Clinic between 05/1999 and 06/2007. We compared the efficacy and safety of DES to BMS for treating bare‐metal ISR. The primary end point was a composite of death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were individual components of the primary endpoint. Results : Of the 931 patients identified over 8 years, 706 had bare‐metal ISR and met our study criteria. Of the 706 patients with bare‐metal ISR, 362 were treated with DES and 344 with BMS. There were 230 cumulative events for a median follow‐up of 3.2 years. After adjusting for 27 variables, DES were associated with lower primary endpoint compared to BMS for treatment of bare‐metal ISR (21% vs. 45%, adjusted hazard ratio [HR] 0.63; 95% confidence interval [CI], 0.42–0.95; P = 0.03). The individual secondary endpoint of death (8% vs. 24%, P = 0.005) favored DES, but MI (3% vs. 8%, P = 0.31), and TLR (13% vs. 20%, P = 0.23) failed to reach statistical significance. Conclusions : In our multivariate analysis of patients with bare‐metal ISR, DES use was associated with significantly lower death, MI, or TLR when compared to BMS. © 2010 Wiley‐Liss, Inc.     

Differential healing response attributed to culprit lesions of patients with acute coronary syndromes and stable coronary artery after implantation of drug-eluting stents: An optical coherence tomography study

Background

Pathology studies have shown delayed arterial healing in culprit lesions of patients with acute coronary syndrome (ACS) compared with stable coronary artery disease (CAD) after placement of drug-eluting stents (DES). It is unknown whether similar differences exist in-vivo during long-term follow-up. Using optical coherence tomography (OCT), we assessed differences in arterial healing between patients with ACS and stable CAD five years after DES implantation.

Methods and results

A total of 88 patients comprised of 53 ACS lesions with 7864 struts and 35 stable lesions with 5298 struts were suitable for final OCT analysis five years after DES implantation. The analytical approach was based on a hierarchical Bayesian random-effects model. OCT endpoints were strut coverage, malapposition, protrusion, evaginations and cluster formation. Uncovered (1.7% vs. 0.7%, adjusted p = 0.041) or protruding struts (0.50% vs. 0.13%, adjusted p = 0.038) were more frequent among ACS compared with stable CAD lesions. A similar trend was observed for malapposed struts (1.33% vs. 0.45%, adj. p = 0.072). Clusters of uncovered or malapposed/protruding struts were present in 34.0% of ACS and 14.1% of stable patients (adj. p = 0.041). Coronary evaginations were more frequent in patients with ST-elevation myocardial infarction compared with stable CAD patients (0.16 vs. 0.13 per cross section, p = 0.027).

Conclusion

Uncovered, malapposed, and protruding stent struts as well as clusters of delayed healing may be more frequent in culprit lesions of ACS compared with stable CAD patients late after DES implantation. Our observational findings suggest a differential healing response attributable to lesion characteristics of patients with ACS compared with stable CAD in-vivo.     

Clinical impact of drug-eluting stents in an unselected population of diabetic patients

BACKGROUND: Drug-eluting stents (DES) have been shown in randomized trials to reduce clinical events in diabetic patients. Our aim was to determine whether these clinical results are applicable in an unselected population of patients with non-insulin-dependent diabetes mellitus (NIDDM) and insulin-dependent diabetes mellitus (IDDM). METHODS: We studied 440 consecutive patients (271 NIDDM and 169 IDDM) who underwent percutaneous coronary intervention, divided into 2 cohorts: Group A (1998-2000): 220 patients with bare metal stents, and Group B (2002-2004): 220 patients with drug-eluting stents. We analyzed major coronary adverse events (death, nonfatal acute myocardial infarction, and target lesion revascularization) over a mean follow-up of 18+/-15 months. RESULTS: Group B had more patients who were insulin-dependent (44.5 versus 32.3% p<0.001) or had hypertension (64.5 versus 54.1%; p=0.02), a lower left ventricular ejection fraction (53.89 versus 56.8%; p=0.04), more complex lesions (B2/C) (82.7 versus 62.3%; p<0.001), more treated lesions (1.40 versus 1.26; p<0.001), more stents implanted (1.69 versus 1.15; p<0.0001), and more patients treated with abciximab (76.8 versus 42.7%; p<0.0001). During the follow-up, Group B had fewer major adverse coronary events (11.7 versus 27.9%; p<0.001) and a reduction in target lesion revascularization (3.9 versus 17.2%; p<0.001), with no differences in death or myocardial infarction. Both groups experienced a significant reduction in events (NIDDM: 8.1 versus 26.7%; p<0.001 and IDDM: 16 versus 31.9%; p=0.016). Multivariate regression analysis showed the use of drug-eluting stents to be in direct relation with event-free survival (odds ratio [OR]: 3.37; 95% confidence interval [CI], 1.44-7.90; p=0.005). CONCLUSION: Despite the worse angiographic characteristics, the use of DES reduced clinical events, particularly target lesion revascularization.     

Mid-Term Clinical Outcomes of ACS and Non-ACS Patients Treated With Everolimus-Eluting Stents

Drug-eluting stents (DES) have proven to be effective for reducing the rate of restenosis, whereas stent thrombosis (ST) after DES implantation has raised safety concerns. Everolimus-eluting stents (EES) are a new generation of DES that have demonstrated safety and efficacy compared with first-generation DES. However, the use of EES in patients presenting with acute coronary syndrome (ACS) has not been adequately investigated. We compared the clinical outcomes between the ACS and non-ACS groups treated with EES. A total of 335 consecutive patients who received EES implantation between January 2010 and January 2011 were investigated (ACS; n = 172, non-ACS; n = 163). Clinical outcome data were obtained for 94.3% of the patients. Follow-up angiography was performed in 58.5% of all patients. The median follow-up period was 8 months in both groups. Clinical outcomes were not statistically different between the groups. The rate of target lesion revascularization (TLR) was 2.5% in the ACS group and 3.8% in the non-ACS group (P = 0.37). MACE occurred in 8.2% of the ACS group and 10.2% of the non-ACS group (P = 0.54). A definite ST was identified in one patient in each group (P = 0.75). The unadjusted cumulative event rates estimated by the Kaplan-Meier method and the log-rank test showed no significant difference between the groups for TLR, target vessel revascularization (TVR), all-cause death, or MACE. In conclusion, EES was safe and efficacious for patients presenting with ACS, as well as for those with non-ACS during a mid-term follow-up period.     

Long-term clinical outcomes of drug-eluting stents vs. bare-metal stents in Chinese geriatric patients

Background & Objective Little is known about the relative efficacies of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and bare-metal stents (BMS) in elderly patients. The objective of this study was to evaluate the clinical outcome for geriatric patients who received either DES or BMS. Methods From January 2002 to October 2005, 199 consecutive Chinese geriatric patients (≥ 75 years old) underwent PCI with coronary DES or BMS implantation at our institution. We analyzed the major clinical end points that included all-cause mortality, cardiovascular death, myocardial infarction, target lesion revascularization (TLR), stent thrombosis, and bleeding complications. Results The three-year cumulative rates of all-cause mortality, cardiovascular death, and myocardial infarction were significantly lower in the DES group (6.3%, 3.6%, 5.4%) compared with the BMS group (16.2%, 11.5%, 14.9%; P < 0.05). No significant differences were found in the three-year cumulative rate for target lesion revascularization (6.3% vs. 4.6%, P = 0.61) or stent thrombosis (3.6% vs. 2.3%, P = 0.70). Likewise, there were no statistically significant differences in the cumulative rate for intracranial hemorrhage, or major and minor hemorrhage at three years. Conclusions DES-based PCI was associated with a significant reduction in the three-year cumulative rate of all-cause mortality, cardiovascular death, and myocardial infarction compared with BMS, without increased risk of TLR, stent thrombosis, or bleeding complications at three years in this group of Chinese geriatric patients.     

A propensity score matched analysis to determine if second-generation drug-eluting stents outperform first-generation drug-eluting stents in a complex patient population

Background

Drug-eluting stents (DES) are routinely used in complex patients, but the impact of 1st- versus 2nd-generation DES on clinical outcomes has not been well described. This study aimed to assess the efficacy and safety of 2nd-generation (everolimus-eluting) DES compared to 1st-generation (sirolimus- and paclitaxel-eluting) DES in a selected, higher-risk population with complex clinical and angiographic features.

Methods

The study included 5693 consecutive patients with the presence of ≥ 1 predefined complex clinical and angiographic characteristic treated with either generation DES. Using propensity score matching, the clinical outcomes of 1076 patients treated with 2nd-generation DES were compared with the outcomes of a matched population treated with 1st-generation DES over 1-year follow-up.

Results

After matching, baseline clinical and angiographic characteristics were similar between groups. At 1-year follow-up, the rate of major adverse cardiac events was 9.4% with 2nd-generation DES and 11.3% with 1st-generation DES (p = 0.16). There were no significant differences in the rates of death (3.2 vs. 4.0%, p = 0.30), myocardial infarction (1.6 vs. 1.3%, p = 0.57), target vessel revascularization (5.9 vs. 7.3%, p = 0.17) or target lesion revascularization (4.4 vs. 5.0%, p = 0.50). Definite stent thrombosis was less frequent with 2nd-generation DES (0.1 vs. 0.8%, p = 0.011), as was definite or probable stent thrombosis (0.7 vs. 1.6%, p = 0.040).

Conclusion

In this propensity score matched patient population with complex features undergoing percutaneous coronary intervention, the use of 2nd-generation DES was associated with lower rates of stent thrombosis, and similar 1-year major adverse cardiac events compared to 1st-generation DES.     

Drug-eluting stents: a critique

Despite advances in the design of balloons and stents, restenosis remains a major drawback of coronary angioplasty. Multiple randomised trials have demonstrated that drug-eluting stents (DES) can significantly reduce rates of restenosis by 60-75% across both lesion and patient subsets. In recent years there has been an exponential increase in the worldwide use of DES. This expansion has occurred as a result of an enthusiastic extrapolation of results from randomised trials leading to "off-label" use of DES in anatomical or clinical high-risk scenarios, or both. However, emerging medium- to long-term follow-up data have raised concerns about the safety of DES. A number of analyses have recently shown increased rates of late stent thrombosis in patients with DES. The exact mechanisms leading to stent thrombosis remain unclear. This article critically reviews the available efficacy and safety data on DES and discusses the factors influencing our current practice and perception of the net value of DES.     

Drug eluting stents for saphenous vein graft interventions

Drug eluting stents (DES) have improved percutaneous coronary intervention (PCI) outcomes for most coronary lesion subsets and have gained widespread acceptance. This practice is supported by large-scale clinical trials. Evidence for DES use for treatment of saphenous vein graft (SVG) lesions is less well defined and often conflicting. Most SVG interventions are performed in the setting of an acute coronary syndrome (ACS), in large caliber vascular conduits with soft and friable plaque with inflammatory debris, without a fibrous cap. In this review, we provide an up to date assessment of the published evidence on DES use in PCI of SVG lesions.     

A comparative study of restenosis rates in bare metal and drug-eluting stents

BACKGROUND:

Various studies have been performed throughout the world on the rate of restenosis using bare metal stents (BMS) and drug-eluting stents (DES). The prohibitive costs associated with DES generally dictate the type of stent used, especially in developing countries. Therefore, there was a need for a study to assess the effect of various risk factors on restenosis in BMS and DES in the Indian context. A study was performed in the premier institution of the Indian Armed Forces, the Army Hospital (Research and Referral), New Delhi, India, under the aegis of the Indian Council of Medical Research (New Delhi). The profile of patients in the armed forces is inherently diverse in terms of demography, ethnicity, genetics, etc, which reflects the diverse and varied nature of the population in India.

METHODS AND RESULTS:

A total of 130 patients were included in the present study. Follow-up after stent implantation was scheduled for six to nine months following the procedure to assess symptoms, drug compliance, and treadmill test and coronary angiography results, and to ascertain the incidence of restenosis. However, only 80 patients returned for follow-up and, therefore, the final analysis was based on these patients. They were segregated into BMS (n=41) and DES (n=39) groups. Restenosis occurred in 29 patients (36.3%). Nine of 39 patients with DES (23.1%) and 20 of 41 patients with BMS (48.8%) developed restenosis. There was a statistically significant relationship between restenosis and female sex, clinical presentation before intervention and at the time of follow-up evaluation (unstable angina), hypertension, positive stress test and compliance with medical therapy (P<0.05). No statistically significant relationship was observed between restenosis and age, diabetes, smoking, obesity and diet (P>0.05).

CONCLUSIONS:

DES appear to reduce the restenosis rate and clinical end points, and appear to be more cost effective than BMS. Patient-related factors (eg, sex, hypertension and unstable angina) are important variables that affect the restenosis rate. Noninvasive stress testing had high positive and negative predictive values. Therefore, based on the present study, noninvasive stress testing is suggested before routine angiography at follow-up, which will reduce the need for repeat coronary angiography.     

Safety of drug eluting stents in patients on chronic anticoagulation using long‐term single antiplatelet treatment with clopidogrel

Background: Use of triple therapy with aspirin, clopidogrel, and anticoagulants significantly increases bleeding, thus drug eluting stents (DES) are usually avoided in patients requiring anticoagulation. We tested use of DES vs. BMS using a long‐term therapy with clopidogrel only and anticoagulants in this group of patients. Methods: We enrolled 165 consecutive patients, 79 receiving DES (age 67 ± 9 years, 84% with atrial fibrillation) and 86 receiving bare metal stents (BMS) (age 70 ± 11 years, 71% with atrial fibrillation). All patients received aspirin + clopidogrel + oral anticoagulants for 4 weeks, then aspirin was stopped and clopidogrel was continued during the 12‐month follow‐up. Primary end point was the combined incidence of major adverse coronary events and major bleedings. Results: Incidence of the primary endpoint was 10.1% in patients with DES and 26.7% in patients with BMS (P = 0.01). There was a large difference in incidence of target vessel revascularization (8.1% for DES, 23.3% for BMS, P = 0.01), whereas incidence of myocardial infarction (3.8% in DES vs. 8.1% in BMS) and major bleeding (1.3% vs. 2.3%, respectively) were not significantly different. There were no cases of stent thrombosis. On multivariate Cox regression analysis, the only factor associated with a reduced risk of the primary endpoint was use of DES (hazard ratio 0.35 with 95% confidence interval 0.14–0.85, P = 0.02). Conclusions: Results of our cohort study suggest that use of DES associated with a treatment with clopidogrel only may be safe and significantly reduce the need for new revascularization in patients requiring chronic anticoagulation.© 2009 Wiley‐Liss, Inc.     

Drug-eluting stents and vulnerable plaque

Coronary artery disease with acute coronary syndromes (ACS) is the leading cause of death worldwide in both men and women. ACS mostly occur as a result of rupture of “vulnerable plaque” with a superimposed thrombus formation, which ultimately leads to distal cessation of blood flow. Vulnerable plaque mostly occurs in mildly obstructive coronary lesions rather than severely stenosed (< 50%) lesions. Support for this conclusion comes from studies of patients with ACS who had a recent prior coronary angiogram; the artery involved in the subsequent ACS was usually only moderately diseased. Whether early treatment of these mildly obstructive lesions with percutaneous coronary interventions may lead to prevention of this deadly malady remains unknown. The long-term efficacy of percutaneous coronary intervention for mildly obstructive coronary narrowing is limited by the occurrence of restenosis, which limits the applicability of this therapy for these lesions. However, use of drug-eluting stents has significantly reduced the incidence of in-stent restenosis, yielding much better long-term outcomes. This article reviews the available data for possible early treatment of mildly obstructive coronary lesions with drug-eluting stents for prevention of ACS.