Clinical results of drug eluting stents compared to bare metal stents for patients with ST elevation acute myocardial infarction

OBJECTIVE: To investigate the clinical outcomes in patients with ST segment elevation acute myocardial infarction (STEMI) treated with drug eluting stents (DES) versus a matched control group of patients with STEMI treated with bare metal stents (BMS). METHODS: This registry included 122 patients with STEMI undergoing primary coronary angioplasty with DES implantation at our institution. The control group consisted of 506 patients implanted with BMS, who were matched for age, infarct location, and diabetic status. The incidences of major adverse cardiac events (MACE) including target vessel/lesion revascularization (TVR/TLR) and stent thrombosis were assessed up to 12 months. RESULTS: Twelve months follow up showed a non-significant trend towards reduced deaths (3.3% versus 7.1%, P=0.1), significantly reduced recurrent MI (0.0% versus 6.1%, P=0.02), TVR (5.7% versus 15.2%, P=0.006) and TLR (2.5% versus 14.0%, P=0.004) events in the DES group as compared to BMS group. The composite incidences of MACE at 12 months follow-up was lower in the DES group (11.5%) as compared to the BMS group (21.3%, P=0.01). CONCLUSION: According to our experiences, the use of DES in STEMI is safe and effective as compared to BMS. DES was effective in reducing the incidence of restenosis outcomes and overall adverse cardiac events up to 12 months.     

Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents.

OBJECTIVES: We sought to define the incidence of late clinical events and late stent thrombosis in patients treated with drug-eluting (DES) versus bare-metal stents (BMS) after the discontinuation of clopidogrel as well as their timing and outcome. BACKGROUND: There is growing concern that delayed endothelialization after DES implantation may lead to late stent thrombosis and related myocardial infarction (MI) or death. However, event rates and outcomes after clopidogrel discontinuation versus BMS are unknown. METHODS: A consecutive series of 746 nonselected patients with 1,133 stented lesions surviving 6 months without major events were followed for 1 year after the discontinuation of clopidogrel. Patients were assigned randomly 2:1 to DES versus BMS in BASKET (Basel Stent Kosten Effektivit?ts Trial). The primary focus of this observation was cardiac death/MI. RESULTS: Rates of 18-month cardiac death/MI were not different between DES and BMS patients. However, after the discontinuation of clopidogrel (between months 7 and 18), these events occurred in 4.9% after DES versus 1.3% after BMS implantation. Target vessel revascularization remained lower after DES, resulting in similar rates of all clinical events for this time period (DES 9.3%, BMS 7.9%). Documented late stent thrombosis and related death/target vessel MI were twice as frequent after DES versus BMS (2.6% vs. 1.3%). Thrombosis-related events occurred between 15 and 362 days after the discontinuation of clopidogrel, presenting as MI or death in 88%. CONCLUSIONS: After the discontinuation of clopidogrel, the benefit of DES in reducing target vessel revascularization is maintained but has to be balanced against an increase in late cardiac death or nonfatal MI, possibly related to late stent thrombosis.     

Late outcomes of drug‐eluting versus bare metal stents in saphenous vein grafts: Propensity score analysis

Objective : To compare late outcomes with the routine use of drug‐eluting stents (DES) compared with bare‐metal stents (BMS) during percutaneous intervention (PCI) of saphenous vein grafts (SVGs). Background : Safety concerns >1 year from stent implantation have been raised about DES used for PCI of SVGs in a small randomized clinical trial. However, there are few studies comparing late outcomes of DES and BMS in routine clinical practice. Methods : Clinical outcomes (nonfatal MI, cardiac mortality) were assessed in 74 consecutive patients who received BMS and 74 consecutive propensity score matched patients that received DES for PCI of SVGs. Clinical follow‐up was censored at 2 years ± 30 days for both stent groups. Results : At 2 years, the hazard ratio for DES compared with BMS for PCI of SVGs for target vessel revascularization was 0.54 (0.21–1.36), nonfatal MI or cardiac death was 0.68 (0.27–1.68), cardiac mortality 1.19 (0.32–4.45), and stent thrombosis 0.49 (0.09–2.66). Similar outcomes were observed stratified by propensity score quintile. Conclusions : The routine clinical use of DES for PCI of SVGs was associated with a safety profile that was similar to that of bare metal stents with a clear trend toward a less frequent need for reinterventions. © 2008 Wiley‐Liss, Inc.     

老年多支血管病变患者置入药物洗脱支架与冠状动脉旁路移植术后近远期临床结果

目的:本研究旨在比较老年(年龄≥75岁)稳定性冠心病合并多支血管病变患者行经皮冠状动脉介入治疗(PCI)置入药物洗脱支架(DES)与冠状动脉旁路移植术(CABG)的近远期临床结果。方法:本研究于2003年7月至2006年12月,连续入选年龄≥75岁稳定性冠心病合并多支血管病变患者363例,在我院行PCI置入DES(n=269)或CABG(n=94)治疗。主要终点为24个月时主要不良心脑血管事件(MACCE),次要终点为24个月时全因死亡及非致死性心肌梗死(MI)、脑血管事件和再次血运重建以及全因死亡、非致死性MI和脑血管事件复合终点事件。结果:住院期间,CABG组的病死率(7.4%vs.1.9%,P=0.023)和非致死性MI的发生率(3.2%vs.0,P=0.023),明显高于DES组,CABG组的MACCE的发生率也明显高于DES组(10.6%vs.1.9%,P=0.001)。多因素回归分析结果显示:24个月时,CABG组和DES组的主要终点事件的风险未见明显差异[22.3%vs.15.2%,风险比(HR)=1.62,95%CI 0.63～3.31,P=0.379],两组的全因死亡、心源性死亡、非致死性MI、脑血管事件和再次血运重建的风险也没有明显差异;CABG组全因死亡、非致死性MI和脑血管事件复合终点事件的风险明显高于DES组(19.1%vs.8.2%,HR 3.87,95%CI:1.24～12.37,P=0.009)。结论:本研究提示,与DES相比,CABG可能会增加75岁以上多支血管病变患者的远期全因死亡、非致死性MI和脑血管事件复合终点事件的风险,而未降低再次血运重建和MACCE。     

Immediate procedural and long-term clinical outcomes following drug-eluting stent implantation to ostial saphenous vein graft lesions

BACKGROUND: Ostial saphenous vein graft (OSVG) lesions were excluded from all the clinical trials demonstrating significantly lower restenosis rates with drug-eluting stents (DES) compared to bare metal stents (BMS). This study aimed to evaluate the efficacy of DES in OSVG lesions by assessing angiographic and 12-month clinical outcomes. METHODS: 70 consecutive patients (70 OSVG lesions) underwent coronary stent implantation between May 2003 and April 2006: 37 lesions received DES and 33 lesions BMS. Endpoints were all cause and cardiovascular mortality, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), examined separately and as a combined end-point (major adverse cardiac events, MACE). RESULTS: Procedural (94.6% for DES and 87.9% for BMS) and angiographic (100% for DES and 100% for BMS) success did not differ between the two groups. The only in-hospital events were non-Q wave MI (DES 8.1% versus BMS 12.1%, P=0.69). At 30-day follow-up, there were no other events. Overall, at 1-year follow-up, the BMS group had a higher TLR (30.3% versus 5.4%, P=0.015), TVR (33.3% versus 10.8%, P=0.045) and MACE rate (36.4% versus 10.8%, P=0.024) compared to the DES group. CONCLUSIONS: Drug-eluting stent implantation to OSVG lesions achieves better clinical results than BMS but is still associated with a relatively high incidence (10.8%) of revascularization at 1-year follow-up.     

Clinical outcomes of percutaneous interventions in saphenous vein grafts using drug-eluting stents compared to bare-metal stents: a comprehensive meta-analysisof all randomized clinical trials

Background:

Clinical outcomes of percutaneous coronary intervention (PCI) in patients with saphenous vein grafts (SVGs) remain poor despite the use of drug‐eluting stents (DES). There is a disparity in clinical outcomes in SVG PCI based on various registries, and randomized clinical data remain scant. We conducted a meta‐analysis of all existing randomized controlled trials (RCTS) comparing bare‐metal stents (BMS) and DES in SVGPCIs.

Hypothesis:

PCI in patients with SVG disease using DES may reduce need for repeat revascularization without an excess mortality when compared to BMS.

Methods:

An aggregate data meta‐analysis of clinical outcomes in RCTs comparing PCI with DES vs BMS for SVGs reporting at least 12 months of follow‐up was performed. A literature search between Janurary 1, 2003 and September 30, 2011 identified 4 RCTs (812 patients; DES = 416, BMS = 396). Summary odds ratio (OR) and 95% confidence interval (CI) were calculated using the random‐effects model. The primary endpoint was all‐cause mortality. Secondary outcomes included nonfatal myocardial infarction (MI), repeat revascularization, and major adverse cardiac events (MACE). These outcomes were assessed in a cumulative fashion at 30 days, 18 months, and 36 months.

Results:

There were no intergroup differences in baseline clinical and sociodemographic characteristics. At a median follow‐up of 25 months, patients in the DES and BMS group had similar rates of death (OR: 1.63, 95% CI: 0.45–5.92), MI (OR; 0.83, 95% CI: 0.27‐2.60), and MACE (OR: 0.58, 95% CI: 0.25–1.32). Patients treated with DES had lower rates of repeat revascularization (OR: 0.40, 95% CI: 0.22–0.75).

Conclusions:

In this comprehensive meta‐analysis of all RCTs comparing clinical outcomes of PCI using DES vs BMS in patients with SVG disease, use of DES was associated with a reduction in rate of repeat revascularization and no difference in rates of all‐cause death and MI. Clin. Cardiol. 2012 DOI: 10.1002/clc.21984 Dr. Virani is supported by a Department of Veterans Affairs Health Services Research and Development Service (HSR&D) Career Development Award (CDA‐09‐028), and has research support from Merck and National Football League Charities (all grants to the institution and not individual). The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs. The authors have no other funding, financial relationships, or conflicts of interest to disclose.     

Comparison of long-term clinical and angiographic outcomes following implantation of bare metal stents and drug-eluting stents in aorto-ostial lesions

Percutaneous coronary intervention (PCI) to aorto-ostial (AO) lesions is technically demanding and associated with high revascularization rates. The aim of this study was to assess outcomes after bare metal stent (BMS) compared to drug-eluting stent (DES) implantation after PCI to AO lesions. A retrospective cohort analysis was conducted of all consecutive patients who underwent PCI to AO lesions at 2 centers. Angiographic and clinical outcomes in 230 patients with DES from September 2000 to December 2009 were compared to a historical control group of 116 patients with BMS. Comparison of the baseline demographics showed more diabetics (32% vs 16%, p = 0.001), lower ejection fractions (52.3 ± 9.7% vs 55.0 ± 11.5%, p = 0.022), longer stents (17.55 ± 7.76 vs 14.37 ± 5.60 mm, p <0.001), and smaller final stent minimum luminal diameters (3.43 ± 0.53 vs 3.66 ± 0.63 mm, p = 0.001) in the DES versus BMS group. Angiographic follow-up (DES 68%, BMS 66%) showed lower restenosis rates with DES (20% vs 47%, p <0.001). At clinical follow-up, target lesion revascularization rates were lowest with DES (12% vs 27%, p = 0.001). Cox regression analysis with propensity score adjustment for baseline differences suggested that DES were associated with a reduction in target lesion revascularization (hazard ratios 0.28, 95% confidence interval 0.15 to 0.52, p <0.001) and major adverse cardiac events (hazard ratio 0.50, 95% confidence interval 0.32 to 0.79, p = 0.003). There was a nonsignificantly higher incidence of Academic Research Consortium definite and probable stent thrombosis with DES (n = 9 [4%] vs n = 1 [1%], p = 0.131). In conclusion, despite differences in baseline characteristics favoring the BMS group, PCI with DES in AO lesions was associated with improved outcomes, with lower restenosis, revascularization, and major adverse cardiac event rates.     

Drug-eluting stenting is superior to bare metal stenting in saphenous vein grafts.

This study compared the outcomes of percutaneous coronary intervention (PCI) of saphenous vein grafts (SVGs) with drug-eluting stents (DES) with bare metal stents (BMS). PCI of degenerated SVG is associated with worse outcomes and high incidence of in-stent restenosis compared with PCI of native coronary arteries. There is a paucity of data on the outcomes of PCI of SVG with DES. Data from 223 consecutive patients who underwent PCI of SVG were imputed into a dedicated clinical database. We assessed the clinical outcomes at a mean follow-up of 9.1+/-2.1 months. A total of 139 patients underwent PCI of SVG with DES and 84 patients with BMS. The mean age of the SVG was 7.6+/-3.8 years in the DES group and 7.7+/-2.8 years in the BMS group (P=0.38). Procedural success was achieved in all patients except for one patient in the BMS group who underwent emergent coronary artery bypass graft surgery for SVG dissection. There were no other in-hospital cardiac events in both groups. There was one cardiac death in the DES group and three deaths in the BMS group (P=0.03). When compared to the BMS, PCI of SVG with DES was associated with a lower incidence of myocardial infarction (4.3% vs. 20.2%; P=0.04) and target vessel revascularization (10.1% vs. 36.9%; P=0.035). When compared with BMS, PCI of SVG with DES was associated with a lower incidence of death, myocardial infarction, and target vessel revascularization.     

Comparison of drug-eluting versus bare metal stents in cardiac allograft vasculopathy

Although not a definitive treatment, percutaneous coronary intervention offers a palliative benefit to patients with cardiac allograft vasculopathy. Given the superior outcomes with drug-eluting stents (DESs) over bare metal stents (BMSs) in native coronary artery disease, similar improvements might be expected in transplant patients; however, the results have been mixed. Consecutive cardiac transplantation recipients at a single center receiving a stent for de novo cardiac allograft vasculopathy from 1997 to 2009 were retrospectively analyzed according to receipt of a DES versus a BMS. The angiographic and clinical outcomes were subsequently evaluated at 1 year. The baseline clinical and procedural characteristics were similar among those receiving DESs (n = 18) and BMSs (n = 16). Quantitative coronary angiography revealed no difference in the reference diameter, lesion length, or pre-/postprocedural minimal luminal diameter. At the 12-month angiographic follow-up visit, the mean lumen loss was significantly lower in the DES group than in the BMS group (0.19 ± 0.73 mm vs 0.76 ± 0.97 mm, p = 0.02). The DES group also had a lower rate of in-stent restenosis (12.5% vs 33%, p = 0.18), as well as a significantly lower rate of target lesion revascularization (0% vs 19%, p = 0.03). At 1 year, DESs were associated with a lower composite rate of cardiac death and nonfatal myocardial infarction (12% vs 38%, p = 0.04). In conclusion, DESs are safe and effective in the suppression of neointimal hyperplasia after percutaneous coronary intervention for cardiac allograft vasculopathy, resulting in significantly lower rates of late lumen loss and target lesion revascularization, as well as a reduced combined rate of cardiac death and nonfatal myocardial infarction.     

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.     

中国冠心病患者接受不同支架治疗预后的荟萃分析

目的比较中国冠心病患者置入药物洗脱支架(DES)和裸支架(BMS)或西罗莫司洗脱支架(SES)和紫杉醇洗脱支架(PES)之间,临床预后的差别。方法检索数据库,纳入随访时间≥6个月的、比较DES和BMS或SES和PES的临床研究。用STATA 10.0作荟萃分析,比较不同类型支架的临床预后,包括主要心血管不良事件(MACE)、靶病变血运重建(TLR)、靶血管血运重建(TVR)、支架内血栓形成和心肌梗死的发生情况。结果共纳入文献11篇(3780例),随访时间从6个月至3年。与BMS相比,DES可减少MACE(OR=0.471,95%CI0.336～0.662,P<0.001)、减少TVR(OR=0.250,95% CI0.148～0.422,P<0.001),但支架内血栓形成在两组间差异无统计学意义。而SES与PES相比,在MACE、TLR、TVR、支架内血栓、心肌梗死方面差异均无统计学意义。结论药物洗脱支架有效性、安全性高,药物支架中,西罗莫司支架和紫杉醇支架差异无统计学意义。     

Clinical and angiographic outcome after sirolimus-eluting stent implantation in aorto-ostial lesions.

OBJECTIVES: This observational study evaluated the clinical and angiographic outcomes of patients with aorto-ostial coronary artery disease treated with sirolimus-eluting stents (SESs) or with bare metal stents (BMSs). BACKGROUND: The safety and effectiveness of SESs for the treatment of aorto-ostial lesions have not been demonstrated. METHODS: We identified 82 consecutive patients who underwent percutaneous coronary interventions in 82 aorto-ostial lesions using the SES (32 patients) or BMS (50 patients) and compared the two groups of patients. The incidence of major adverse cardiac events (MACE), including death or Q-wave myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR), were recorded in-hospital and at a 10-month follow-up. RESULTS: All stents were implanted successfully. There were no statistically significant differences regarding major in-hospital complications between the two groups. At 10-month follow-up, two (6.3%) patients in the SES group and 14 (28%) patients in the BMS group underwent TLR (p = 0.01); MACE were less frequent in the SES group compared to the BMS group (19% vs. 44%, p = 0.02). Angiographic follow-up showed lower binary restenosis rates (11% vs. 51%, p = 0.001) and smaller late loss (0.21 +/- 0.31 mm vs. 2.06 +/- 1.37 mm, p < 0.0001) in the SES group. CONCLUSIONS: The main finding of our study is that, compared to the BMS, implantation of the SES in aorto-ostial lesions appears safe and effective, with no increase in major in-hospital complications and a significant improvement in restenosis and late event rates at 10-month follow-up.     

Impact of three or more sirolimus-eluting stents versus paclitaxel-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention.

OBJECTIVES: The purpose of this study was to examine the clinical outcomes of patients who underwent stenting with > or =3 sirolimus-eluting stents (SES) when compared with those treated with > or =3 paclitaxel-eluting stents (PES). BACKGROUND: Drug-eluting stent (DES) implantation for single coronary lesions is proven to be effective and durable. METHODS: A total of 126 patients who received DES were identified, of which 66 patients received > or =3 SES (SES group) and 60 patients received > or =3 PES (PES group). RESULTS: The baseline clinical and angiographic characteristics were compatible between the two study groups. During the index hospitalization, all clinical outcomes were similar between the two groups. There were no deaths or Q-wave myocardial infarctions (MIs) in either group. At 30 days' and 6 months' follow-up, all clinical outcomes, including death, Q-wave MI, non-Q-wave MI, target lesion revascularization, target vascular revascularization, and major adverse cardiac events, were compatible between both groups. There were 2 patients (3.0%) with subacute thrombosis in the SES group and 1 patient (1.7%) in the PES group, but there was no statistical significance. There was no late thrombosis from either group. In addition, patients in the SES group had similar event-free survival rates as compared with those in the PES group (P = 0.56). CONCLUSIONS: Patients who require > or =3 DES implantations experienced increased adverse clinical events as compared with historical single stent implantation. However, there were no differences in safety and efficacy among the patients treated with SES as compared with those treated with PES.     

Clinical Outcomes Following Percutaneous Coronary Intervention With Drug‐Eluting Stents Versus Bare Metal Stents in Patients on Chronic Hemodialysis

Background

Patients on chronic hemodialysis (HD) are recognized as a high‐risk group for adverse events after percutaneous coronary intervention, and whether drug‐eluting stents (DES) are associated with improved outcomes over bare metal stents (BMS) is still uncertain. The purpose of this study was to assess the efficacy of DES compared with BMS at short‐ and long‐term follow‐up (FU) in an unselected sample of HD patients.

Methods and Results

In the time period 2005–2010, consecutive patients on chronic HD treated with percutaneous coronary intervention (PCI) and stent implantation were retrospectively selected and analyzed. A total of 169 patients were selected, 77 treated exclusively with BMS and 92 exclusively with DES. Baseline clinical characteristics were similar in the 2 groups as well as the number of treated vessels, treated lesions, and the stent per patient ratio. At longest available FU, no difference between the 2 study groups was found in terms of cardiac death (18.2% vs 16.3%, P = 0.83), myocardial infarction (2.5% vs 8.6%, P = 0.09), cerebrovascular accidents (0% vs 1.1%, P = 0.98), and target vessel revascularization (TVR) (9.1% vs 16.3%, P = 0.17). Major adverse cardiac and cerebrovascular events‐free survival at 1,500 days in the BMS and DES groups was 57.6% and 50.9% (P = 0.11), respectively.

Conclusions

PCI in patients on chronic HD treatment is associated with a high incidence of adverse events at FU, mainly represented by death. In our study, the use of DES was not associated with a reduction of target lesion revascularization (TLR) and TVR.

     

Treatment of saphenous vein graft lesions with drug-eluting stents: immediate and midterm outcome

OBJECTIVES: The purpose of the present report was to evaluate clinical and angiographic outcomes of drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions. BACKGROUND: The safety and efficacy of DES implantation for the treatment SVG lesions remains uncertain. METHODS: We evaluated in-hospital and six-month outcomes in 61 consecutive patients treated with DES in SVG lesions from March 2002 to March 2004 (DES group), as compared to 89 consecutive patients treated with bare-metal stents (BMS) in the 24 months immediately before the introduction of DES (BMS group). Major adverse cardiac events (MACE) including death, myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR) were recorded in-hospital and at six-month follow-up. RESULTS: The rate of in-hospital MACE was similar between the two groups (6.6% vs. 5.6%, p = 1.0). Cumulative MACE at six months was 11.5% in the DES group and 28.1% in the BMS group (p = 0.02). The DES group had a significantly lower incidence of in-segment restenosis (10.0% vs. 26.7%, p = 0.03), TLR (3.3% vs. 19.8%, p = 0.003), and TVR (4.9% vs. 23.1%, p = 0.003). By Cox regression analysis, diabetes (hazard ratio [HR]: 3.03; 95% confidence interval [CI]: 1.33 to 6.90; p = 0.008), usage of BMS (HR: 2.53; 95% CI: 1.07 to 5.97; p = 0.03), and age of SVG (HR: 1.10; 95% CI: 1.02 to 1.19; p = 0.02) were identified as predictors of MACE at six-month follow-up. CONCLUSIONS: Compared to BMS implantation, DES implantation in SVG lesions appears safe with favorable and improved mid-term outcomes.     

Early outcome of treatment of ostial de novo left anterior descending coronary artery lesions with drug-eluting stents

We investigated early and mid-term clinical and angiographic outcomes of patients who had de novo ostial left anterior descending coronary artery (LAD) lesions that were treated with drug-eluting stents (DESs) or bare metal stents (BMSs). We identified 43 consecutive patients who underwent percutaneous intervention for isolated de novo ostial LAD lesions with implantation of DESs and compared them with 43 patients who had similar lesions that were treated with BMSs. All stents were successfully implanted. There were no significant differences with respect to major in-hospital complications between the 2 groups. One patient in the BMS group died during hospitalization. Non-Q-wave myocardial infarction occurred in 2 patients (4.7%) in the DES and in 1 patient (2.3%) in the BMS group. At 9-month follow-up, 3 patients (7%) in the DES group and 11 (25.6%) in the BMS group underwent target lesion revascularization (p = 0.038); major adverse cardiac events were less frequent in the DES than in the BMS group (9.3% vs 32.6%, p = 0.015). Angiographic follow-up was available in 82% of patients in the DES group and 75% of those in the BMS group (p = 0.6) and showed lower binary restenotic rates (5.7% vs 31.3%, p = 0.01) and smaller late loss (0.30 +/- 0.81 vs 1.23 +/- 0.93 mm, p = 0.0001) in the DES group. In conclusion, DES implantation in de novo ostial LAD lesions appears safe and effective and is associated with a significant decrease in restenotic rates compared with historical experience with BMSs.     

Safety and effectiveness of drug eluting stent in patients with ST elevation myocardial infarction undergoing primary angioplasty

Background : Drug eluting stents (DES) have recently been proven to further reduce restenosis and revascularization rate in comparison to bare metal stents in elective procedures. Most early DES trials did not include patients undergoing primary percutaneous coronary intervention (PCI) for ST‐segment elevation MI, because these patients tend to have lower restenosis rates than other patient groups and delayed endothelization of these stents raises concern about a possible increase of thrombotic complications in the setting of STEMI. Aim : To confirm the safety and effectiveness of DES in patients with STEMI in a real‐world scenario. Methods : From January 2004 to December 2006, clinical and angiographic data of 370 patients with STEMI treated with primary PCI have been analyzed. Patients were retrospectively followed for the occurrence of major adverse cardiac events (MACE): death, reinfarction and target vessel revascularization (TVR). Results : Overall, 120 patients received DES (32%, DES group) and 250 received bare metal stents (68%, BMS group) in the infarct related artery. Compared with the BMS group, DES patients were younger, (mean age 56 ± 12 vs. 65 ± 10; P < 0.001) had more often diabetes mellitus (47% vs. 14% P < 0.001), anterior localization (65% vs. 45%; P < 0.0011) and less cardiogenic shock at admission (4% vs. 7%; P < 0.001). The angiographic characteristics in the DES group showed longer lesions (23 mm vs. 19 mm) and smaller diameter of vessels (2.5 mm vs. 3.0 mm). After a median follow‐up of 24 ± 9 months, there was no significant difference in the rate of stent thrombosis (1.6% in the DES group vs. 1.2% in the BMS group, P = ns). The incidence of MACE was significantly lower in the DES group compared with the BMS group (HR 0.56 [95% CI: 0.3–0.8]; P = 0.01), principally due to the lower rate of TVR (HR 0.41 [95% CI: 0.2–0.85]; P = 0.01). Conclusions : Utilization of DES in the setting of primary PCI for STEMI, in our “real world,” was safe and improved the 3‐year clinical outcome compared with BMS reducing the need of TVR. © 2008 Wiley‐Liss, Inc.     

Targeted stent use in clinical practice based on evidence from the Basel Stent Cost Effectiveness Trial (BASKET).

AIM: It is unknown which patients benefit most from drug-eluting stents (DES) against bare-metal stents (BMS) in a long-term clinical outcome. METHODS AND RESULTS: To address this question, data from 826 consecutive patients with angioplasty, randomized 2:1 to DES vs. BMS, with an 18-month follow-up for cardiac death/myocardial infarction (MI) and non-MI-related target-vessel revascularization (TVR) were analysed for interactions between stent type and patient/vessel characteristics predicting events. Rates of 18-month TVRs were lower with DES vs. BMS use (7.5 vs. 11.6%, P = 0.05), but similar for both stents regarding cardiac death/MI (DES, 8.4%; BMS, 7.5%; P = 0.70). Significant interactions between stent type and two multivariable event predictors were identified: small stents (<3.0 mm) and bypass graft stenting. In these patient groups together (n = 268, 32%), DES reduced non-MI-related TVR (HR = 0.44; P = 0.02) and cardiac death/MI (HR = 0.44; P = 0.04), whereas in the other 558 patients (68%) TVR rate was similar (HR = 0.75; P = 0.38) and cardiac death/MI rate increased after DES (HR = 2.07; P = 0.05). CONCLUSION: Patients with angioplasty of small vessels or bypass grafts seem to benefit from DES use, in long-term outcome, in contrast to patients with large native vessel stenting where there might even be late harm. Still, this hypothesis needs to be tested prospectively.     

Five-Year Outcomes in Patients With Chronic Total Coronary Occlusion Treated With Drug-Eluting vs Bare-Metal Stents: A Case-Control Study

Background

Limited data exist on long-term safety and effectiveness of drug-eluting stents (DESs) in true chronic total coronary occlusion (CTO) settings. We evaluated 5-year clinical outcomes of patients with CTO treated successfully with DES vs bare-metal stent (BMS).

Methods

We compared the 5-year clinical outcomes of 156 patients treated with DES implantation with outcomes of a historical cohort of 159 patients treated with BMS. Primary end point was freedom from major adverse cardiac events (MACEs; defined as death, myocardial infarction [MI], and target lesion revascularization [TLR]); secondary end points were freedom from target vessel failure (TVF; combination of target vessel revascularization, MI, and cardiac death) and TLR at 5 years.

Results

After 5 years, the DES group had significantly superior event-free survival from MACE (84% vs 69%; log rank P < 0.001), TVF (71% vs 84%; P = 0.002), and TLR (77% vs 92%; P = 0.0001), compared with the BMS group. The Cox proportional hazards model identified BMS vs DES (adjusted hazard ratio [HR] = 3.37; 95% confidence interval [CI], 1.85-6.17; P = 0.001), final minimal lumen diameter (HR, 0.27; 95% CI, 0.14-0.52; P = 0.0001), and stent length (HR, 1.01; 95% CI, 1.00-1.03; P = 0.03) as independent predictors of MACE at 5-year follow-up. Twelve (7%) and 7 (4%) stent thromboses occurred in the DES and BMS groups (P = 0.23), respectively.

Conclusions

After 5 years, DESs were superior to BMSs in reducing MACE, TVF, and TLR in patients with CTO and should be the preferred strategy.     

Impact of increased transmitral gradients after undersized annuloplasty for chronic ischemic mitral regurgitation

Introduction

It is unknown whether drug-eluting stents (DES), in comparison with bare-metal stents (BMS), improve clinical outcomes of ST-elevation myocardial infarction (STEMI) patients with renal insufficiency. We aimed to compare the clinical outcomes of BMS versus DES, as well as sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES), in STEMI patients with renal insufficiency.

Methods

From the Korea Acute Myocardial Infarction Registry, 874 STEMI patients with renal insufficiency (glomerular filtration rate < 60 ml/min) comprising 116 patients with BMS and 758 patients with DES (430 SES and 328 PES) implantation were selected. Major adverse cardiac events (MACE) within 1 year, defined as composite of all-cause mortality, nonfatal myocardial infarction and target lesion revascularization were compared. In addition to multivariate adjusted analysis, propensity analysis for stent choice was performed.

Results

With a median follow-up of 342 days, 116 MACE occurred. MACE was more frequent in the BMS group than in the DES group before (HR [95% CI] = 2.3 [1.3-3.8]) and after propensity score matching (HR [95% CI] = 2.0 [1.0-3.8]). The difference of MACE was mainly driven by a higher rate of target lesion revascularization rate in the BMS group. In comparison between SES and PES, there was no significant difference between the 2 groups in propensity score-matched populations (HR [95% CI] = 0.7 [0.4-1.1]).

Conclusions

In STEMI patients with renal insufficiency, DES implantation exhibits a favorable 1 year clinical outcomes than BMS implantation, however, no difference was found between SES and PES.