The short‐ and long‐term outcomes of percutaneous intervention with drug‐eluting stent vs bare‐metal stent in saphenous vein graft disease: An updated meta‐analysis of all randomized clinical trials

The use of drug‐eluting stents (DES) vs bare‐metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta‐analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short‐ and long‐term clinical outcomes of the following: all‐cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target‐vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short‐term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35–0.91, P = 0.02; OR: 0.43, 95% CI: 0.19–0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22–0.95, P = 0.04, respectively). However, there were no different outcomes for all‐cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long‐term follow‐up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all‐cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short‐term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long‐term follow‐up.     

Drug-Eluting Stents Versus Bare-Metal Stents in Large Coronary Artery Revascularization: Systematic Review and Meta-Analysis

ObjectivesWe aim to determine if drug eluting stents (DES) are better than bare-metal stents (BMS) in large coronary artery (diameter ≥ 3 mm) percutaneous coronary intervention (PCI).BackgroundDES have become the standard of care for PCI in coronary artery disease (CAD). However, the superiority of DES over BMS in large vessel CAD is not clear and previous studies have shown conflicting results.MethodsRandomized controlled trials (RCTs) comparing outcomes of PCI with BMS and DES for large vessel CAD were identified from the year 2000 to August 2019. The outcomes were studied individually and included all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR), and stent thrombosis. Aggregated odds ratio and 95% CI were calculated using a random-effects model.ResultsEight RCTs were included (4 with data for first-generation DES, 3 with data for second-generation DES, and 1 with data for both first- and second-generation DES). Compared to BMS, second generation DES had a significantly lower rate of all-cause mortality (2.4% vs. 3.9%, OR 0.74, 95% CI 0.56–0.98, P 0.04), TLR (3.5% vs. 8.6% OR 0.38 95% CI 0.28–0.53, P < 0.001), and MI (2.1% vs. 2.9% OR 0.73 95% CI 0.53–1.0, P 0.05). The difference in all-cause mortality was not seen with first-generation DES.ConclusionNewer DES are associated with a lower mortality, TLR, and MI and thus should be preferred over BMS for large coronary artery PCI.     

Safety and efficacy of drug eluting stents compared with bare metal stents for saphenous vein graft interventions: A comprehensive meta‐analysis of randomized trials and observational studies comprising 7,994 patients

Background: Saphenous vein graft (SVG) lesions remain amongst the most challenging lesions for percutaneous coronary intervention (PCI). It is unknown whether drug eluting stents (DES) are superior to bare metal stents (BMS) for such lesions. Our objective is to determine the safety and efficacy of DES compared with BMS for SVG lesions by performing a meta‐analysis of clinical trials and observational studies. Data Sources: PubMed, Cochrane Register of Controlled Trials, conference proceedings, and internet‐based resources of clinical trials. Study Selection: Studies comparing DES vs. BMS for SVG lesions with at least > 30 patients in each study reporting the outcomes of interest [death, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis (ST), and the composite of death, TVR and MI (major adverse cardiac events; MACE)] with at least 6 months clinical follow‐up. The primary outcome of interest was death. Results: Two randomized trials, one subgroup analysis of a randomized trial and 26 observational studies comprising a total of 7,994 patients (4,187 patients in DES and 3,807 patients in BMS group) were included in the analysis .Mean follow‐up duration was 21 ± 11 months (6–48 months). In the overall population, MACE events were 19% in DES and 28% in BMS with a risk ratio (RR) of 0.7 (0.6, 0.8) P < 0.00001. This effect of MACE was sustained in studies with >2 years follow‐up with RR of 0.77 (0.65, 0.91) P = 0.003. Death rate was 7.8% in DES and 9% in BMS with a RR of 0.82 (0.7, 0.97) P = 0.02. MI rate was 5.7% in DES and 7.6% in BMS with RR of 0.72 (0.57, 0.91) P = 0.007. TVR was 12% in DES and 17% in BMS with RR of 0.71 (0.59, 0.85) P = 0.0002. ST was 1% in DES and 1.7 % in BMS RR of 0.61 (0.35, 1.06) P = 0.08. Specifically in randomized controlled trials, DES were associated with no significant differences in overall mortality [RR = 1.97; 95% confidence interval (CI), 0.17–23; P = 0.58] or MI (RR = 1.24; 95% CI, 0.3–5.5; P = 0.78) compared with BMS. Conclusions: Based on the results of this meta‐analysis, DES may be considered as a safe and efficacious option for the percutaneous intervention of SVG lesions. © 2010 Wiley‐Liss, Inc.     

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。     

Biodegradable-Polymer Versus Polymer-Free Drug-Eluting Stents for the Treatment of Coronary Artery Disease

Background/purposeBiodegradable-polymer (BP) and polymer-free (PF) drug eluting stents (DES) were developed to reduce the risk of delayed arterial healing observed with durable-polymer (DP) platforms. Although trials demonstrate BP-DES and PF-DES are non-inferior to DP-DES, there is limited data directly comparing these technologies. We performed a meta-analysis to assess the efficacy and safety of BP-DES versus PF-DES for the treatment of coronary artery disease.Methods/materialsElectronic searches were performed identifying randomized trials comparing BP-DES with PF-DES. Co-primary efficacy endpoints were target vessel revascularization (TVR), target lesion revascularization (TLR) and angiographic in-stent late lumen loss (LLL). Co-secondary safety endpoints were all-cause death, myocardial infarction (MI) and stent thrombosis (ST).ResultsOf 208 studies, 5 met inclusion criteria including 1975 patients. At mean follow-up (14 ± 5 months), BP-DES were associated with significantly reduced rates of TVR (OR 0.58, 95%CI 0.37–0.92, p = 0.02), TLR (4.7% vs 9.5%) (OR 0.48, 95%CI 0.31–0.75, p = 0.001) and in-stent LLL (pooled mean difference ?0.20 mm, 95%CI ?0.24 to ?0.16, p < 0.001). There was no difference in safety, including all-cause death (OR 1.24, 95%CI 0.68–2.28, p = 0.48), MI (OR 0.92, 95%CI 0.54–1.56, p = 0.75) or ST (OR 1.58, 95%CI 0.67–3.73, p = 0.30).ConclusionsThese data suggests that BP-DES are more efficacious when compared with PF-DES for the treatment of CAD.     

A comparison of drug-eluting stents versus bare metal stents in saphenous vein graft PCI outcomes: a meta-analysis

Aims: Studies demonstrate that percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) is associated with reduced revascularization and major adverse cardiac events (MACE) rates compared to bare metal stents (BMS) in native coronary vessels. Optimal PCI treatment of saphenous vein graft (SVG) lesions remains unclear despite SVG procedures representing up to 10% of PCI cases. We therefore performed a meta‐analysis to compare outcomes between BMS and DES in SVG PCI. Methods and Results: A search (2004–2009) of MEDLINE and conference proceedings for all relevant studies comparing mortality and MACE outcomes in DES versus BMS in SVG PCI and meta‐analysis of the data was performed. Twenty studies were identified from 2005 to 2009 enrolling a total of 5,296 patients. Meta‐analysis revealed a decrease in mortality associated with DES use, odds ratio (OR) 0.68; 95% confidence interval (CI) 0.53–0.88; P = 0.004. Similarly, MACE (OR 0.64; 95% CI 0.51–0.82; P < 0.001), total lesion revascularization (OR 0.60; 95% CI 0.43–0.83; P = 0.002), and total vessel revascularization (OR 0.57; 95% CI 0.41–0.80; P = 0.001) were significantly decreased in the patients in which DES were used compared to BMS. This reduction in mortality and MACE events associated with DES use appears to be limited to registry studies and not randomized controlled studies. Conclusions: Our meta‐analysis suggests DES use to be safe in SVG PCI and associated with reduced mortality and MACE rates with reductions in revascularization also observed. (J Interven Cardiol 2011;24:172–180)     

Comparison of coronary DES and BMS in octogenarians: A systematic review and meta-analysis

Objective Uncertainty exists regarding the relative performance of drug-eluting stents (DES) versus bare-metal stents (BMS) in octogenarians undergoing percutaneous coronary intervention (PCI). We undertook a meta-analysis to assess outcomes for DES and BMS in octogenarians undergoing PCI. Methods Electronic data bases of PubMed, Cochrane, and EMBASE were searched. We included randomized, controlled clinical trials (RCT) and observational studies comparing DES and BMS in octogenarians receiving PCI. The methodological qualities of eligible trials were assessed using a “risk of bias” tool. The endpoints included all-cause death, major adverse cardiac events (MACE), myocardial infarction (MI), target vessel revascularization (TVR), major bleeding, and stent thrombosis (ST). Odds ratios (OR) and 95% confidence intervals (95% CI) were calculated for each endpoint. Results A total of one RCT and six observational studies were included and analyzed in this meta-analysis. All trials were of acceptable quality. At 30 days, compared with DES-treated patients, BMS-treated patients had a higher incidence of mortality (OR: 3.91, 95% CI: 1.10–13.91; P = 0.03). The OR for MACE (1.52, 95% CI: 0.56–4.17; P = 0.13), MI (0.81, 95% CI: 0.37–2.17; P = 0.23), TVR (0.75, 95% CI: 0.17–3.41; P = 0.41), major bleeding (0.77, 95% CI: 0.35–1.68; P = 0.43), and ST (1.44, 95% CI: 0.32–6.45; P = 0.33) did not reach statistical significance. At one year follow-up, the OR did not favor BMS over MACE (MACE, defined as the composite of death, myocardial infarction, and TVR) (1.87; 95% CI: 1.22–2.87; P < 0.01), MI (1.91, 95% CI: 1.22–2.99; P < 0.01), TVR (3.08, 95% CI: 1.80–5.26; P < 0.01) and ST (3.37, 95% CI: 1.12–10.13; P < 0.01). The OR for mortality (1.51; 95% CI: 0.92–2.47; P = 0.10) and major bleeding (0.85, 95% CI: 0.47–1.55; P = 0.60) did not reach statistical significance. At > 1 year follow-up, the OR for all endpoints, including mortality, MACE, MI, TVR, major bleeding, and ST, did not reach statistical significance. Conclusions Our meta-analysis suggests that DES is associated with favorable outcomes as compared with BMS in octogenarians receiving PCI.     

Meta-Analysis of Provisional Versus Systematic Double-Stenting Strategy for Left Main Bifurcation Lesions

ObjectiveWe sought to compare the clinical outcomes with provisional versus double-stenting strategy for left main (LM) bifurcation percutaneous coronary intervention (PCI).BackgroundDespite two recent randomized controlled trials (RCTs) and several observational reports, the optimal LM bifurcation PCI technique remains controversial.MethodsPubMed, Cochrane Central Register of Controlled-Trials (CENTRAL), Clinicaltrials.gov, International Clinical Trial Registry Platform were leveraged for studies comparing PCI bifurcation techniques for LM coronary lesions using second-generation drug eluting stents (DES). The primary outcome was major adverse cardiovascular events (MACE). Secondary outcomes of interest were all-cause mortality, cardiovascular mortality, myocardial infarction (MI), target vessel or lesion revascularization, and stent thrombosis.ResultsTwo RCTs and 10 observational studies with 7105 patients were included. Median follow-up duration was 42 months (IQR: 25.7). Double stenting was associated with a trend towards higher incidence of MACE (odds ratio [OR] 1.20; 95 % confidence interval [CI] 0.94 to 1.53) compared with provisional stenting. This was mainly driven by higher rates of target lesion revascularization (TLR) (OR 1.50; 95 % CI 1.07 to 2.11). There were no statistically significant differences in the incidence of all-cause mortality, cardiovascular mortality, MI, or stent thrombosis. On subgroup analysis according to the study type, provisional stenting was associated with lower MACE and TLR in observational studies, but not in RCTs.ConclusionFor LM bifurcation PCI using second-generation DES, a provisional stenting strategy was associated with a trend towards lower incidence of MACE driven by statistically significant lower rates of TLR, compared with systematic double stenting. These differences were primarily driven by observational studies. Further RCTs are warranted to confirm these findings.     

Long-term outcomes of drug-eluting stents versus bare metal stents in saphenous vein graft interventions. Evidence from a meta-analysis of randomized controlled trials

BackgroundThe optimal stent for use in saphenous vein graft (SVG) intervention is still debatable. Multiple randomized trials have compared drug-eluting stents (DES) to bare metal stents (BMS) in SVG interventions with conflicting results.MethodsAuthors searched the online databases for randomized controlled trials (RCTs) comparing DES to BMS in SVG percutaneous coronary interventions (PCI). We performed a meta-analysis using a random effects model to calculate the odds ratio for outcomes of interest.ResultsAuthors studied six RCTs that included 1592 patients undergoing PCI of SVG. The mean follow up was 42 months. Patients mean age was the same in both groups: 70.3 years in the DES group (approximately 93.3% male) and 70.3 years in the BMS group (approximately 93.8% male). Vein graft age was 13.4 years in the DES PCI arm vs. 13.4 years in the BMS PCI arm. Four of the six trials reported data on embolic protection device use: 67% (303/452) in the DES arm vs. 67.9% (309/455) in the BMS arm. The primary outcome of long-term all-cause mortality was not different between DES vs. BMS (15.2% vs. 14.1%, OR 1.12, 95% CI 0.67–1.88; P = 0.66). Secondary outcomes were also similar between DES and BMS: major adverse cardiovascular events (31.6% vs. 33.1%, OR 0.79, 95% CI 0.45–1.38; P = 0.41); cardiac death (9% vs. 8.6%, OR 1.12, 95% CI 0.55–2.30; P = 0.75); myocardial infarction (8% vs. 9.5%, OR 0.84, 95% CI 0.47–1.51; P = 0.57); target lesion revascularization (16.4% vs. 14.4%, OR 0.98, 95% CI 0.50–1.92; P = 0.95); and target vessel revascularization (19% vs. 19.4%, OR 0.75, 95% CI 0.41–1.34; P = 0.33).ConclusionAt a mean follow-up of 42 months, no difference was observed in clinical outcomes between DES and BMS in SVG interventions.     

Outcomes With Drug-Coated Balloons vs. Drug-Eluting Stents in Small-Vessel Coronary Artery Disease

BackgroundThe use of drug-coated balloons (DCBs) in small-vessel coronary artery disease (SVD) remains controversial.MethodsWe performed a meta-analysis of all randomized controlled trials (RCTs) reporting the outcomes of DCB vs. DES in de-novo SVD. We included a total of 5 RCTs (1459 patients), with (DCB n = 734 and DES n = 725).ResultsOver a median follow-up duration of 6 months, DCB was associated with smaller late lumen loss (LLL) compared with DES (mean difference −0.12 mm) (95% confidence intervals (CI) [−0.21, −0.03 mm], p = 0.01). Over a median follow-up of 12 months, both modalities had similar risk of major adverse cardiovascular events (MACE) (8.7% vs. 10.2%; odds ratio (OR): 0.94, 95% CI [0.49–1.79], p = 084), all-cause mortality (1.17% vs. 2.38%; OR: 0.53, 95% CI [0.16–1.75], p = 0.30), target lesion revascularization (TLR) (7.9% vs. 3.9%; OR: 1.26, 95% CI [0.51–3.14], p = 0.62), and target vessel revascularization (TVR) (8.2% vs. 7.8%; OR: 1.06, 95% CI [0.40–2.82], p = 0.91). DCBs were associated with lower risk of myocardial infarction (MI) compared with DES (1.55% vs. 3.31%; OR: 0.48, 95% CI [0.23–1.00], p = 0.05, I2 = 0%).ConclusionPCI of SVD with DCBs is associated with smaller LLL, lower risk of MI, and similar risk of MACE, death, TLR, and TVR compared with DES over one year. DCB appears as an attractive alternative to DES in patients with de-novo SVD, but long-term clinical data are still needed.     

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.     

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.     

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.     

Long-term safety and effectiveness of drug-eluting stents compared to bare metal stents in ST elevation myocardial infarction: findings from the Guthrie Health Off-label Stent (GHOST) Registry

Background: Multiple randomized trials and observational studies have shown drug‐eluting stents (DES) to be safe and effective at 3‐year follow‐up in stent thrombosis (ST)‐segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). However, outcomes data beyond 3–4 years after DES implantation are sparse. Methods: We studied 554 STEMI patients who underwent successful PCI with either DES or bare metal stent (BMS). Primary study end‐points were time to occurrence of ST and the composite of death or myocardial infarction (MI). Secondary end‐points were time to occurrence of major adverse cardiac events (MACEs) and discrete events that comprise MACE (death, MI, and target vessel revascularization [TVR]). Outcomes of the DES and BMS groups were assessed by survival analysis and multivariable Cox regression. Results: There were 205 (37%) patients who received DES and 349 (63%) patients who received BMS. At a median follow‐up of 41.4 months after PCI, there were no differences in the unadjusted incidence of ST (ST, 3.4 vs. 4.3%, log‐rank P = 0.61) and MI (6.8% vs. 8%, P = 0.61) between DES versus BMS groups, respectively. However, DES implantation was associated with lower unadjusted incidence of death or MI (11% vs. 23.5%, P = 0.0002), MACE (16% vs. 34%, P < 0.0001), death (6.3% vs. 17%, P = 0.0004), and TVR (9.8% vs. 18%, P = 0.008) than BMS implantation. In multivariable analyses, DES implantation was associated with significantly lower incidence of MACE (adjusted HR = 0.47 [95% CI: 0.31–0.76], P = 0.0007) than BMS implantation. Conclusion: In our study of STEMI patients, DES implantation was safer than BMS implantation and was associated with lower MACE at long‐term follow‐up. (J Interven Cardiol 2012;25:118–125)     

Long-term safety and effectiveness of drug-eluting stents compared to bare metal stents following successful PCI in non-ST-elevation myocardial infarction: findings from the Guthrie Health Off-Label StenT (GHOST) Registry

Background: The long‐term safety and effectiveness of drug‐eluting stents (DES) versus bare metal stents (BMS) in non‐ST‐segment elevation myocardial infarction (NSTEMI) beyond 2 years after percutaneous coronary intervention (PCI) is unknown. Methods: We studied 674 NSTEMI patients who underwent successful PCI with DES (n = 323) or BMS (n = 351). The primary study end‐points were time to occurrence of death or nonfatal recurrent myocardial infarction (MI), and stent thrombosis (ST). Secondary end‐points included time to occurrence of target vessel revascularization (TVR) and any major adverse cardiovascular event (MACE, defined as the composite of death, MI, ST, TVR). Results: The DES and BMS groups were well matched except that DES patients received dual antiplatelet therapy for a longer duration and had smaller final vessel diameter. In survival analysis, at a mean follow‐up of 1333 ± 659 days after PCI, the DES group had similar incidence of death/myocardial infarction (24% vs. 27%, log rank p = 0.23) and ST (4.0% vs. 2.6%, p = 0.18) as the BMS group. The DES patients had lower incidence of TVR (8.1% vs. 17%, p = 0.0018) but similar MACE (26% vs. 37%, p = 0.31). In multivariable analysis, DES vs. BMS implantation showed no significant impact on death/myocardial infarction [adjusted hazards ratio (HR) 1.0, 95% confidence intervals (CI) 0.7–1.4], ST (HR 1.7; CI 0.7 – 4.0), or MACE (HR 0.8; CI 0.6 – 1.1). However, TVR was lower in the DES group (HR 0.4; CI 0.3 – 0.7). Conclusion: In patients presenting with NSTEMI, DES implantation appears to be as safe as BMS implantation at long‐term follow‐up. In addition, DES are effective in reducing TVR compared to BMS. (J Interven Cardiol 2012;25:28–36)     

Comparison between drug-eluting and bare metal stent on ST-elevation myocardial infarction outcome: Should second-generation drug-eluting stent be preferred?

Background and purposeAlthough several studies reported that drug-eluting stents (DES) are able to reduce restenosis incidence without increasing mortality, concerns still exist about their safety in ST-segment elevation myocardial infarction (STEMI) patients mainly for a possible higher rate of in-stent thrombosis. Recent evidence suggests a better safety profile of second-generation DES, but data on their outcome in STEMI are still poor. In this study we evaluated the impact on mortality and target lesion revascularization (TLR) of DES or bare metal stent (BMS) implantation in STEMI patients submitted to primary angioplasty.Methods and subjectsWe analyzed mortality and TLR in 1150 STEMI patients during a mean 43-month follow-up after DES (44.6%) or BMS (55.4%) implantation. A propensity score method was used to minimize bias. During follow-up, 223 deaths occurred.Essential resultsUnadjusted for potential confounders, DES implantation was associated with a significant reduction in all-cause mortality [hazard ratio (HR) 0.40; 95%CI 0.30–0.54] and TLR (HR 0.55; 95%CI 0.36–0.86); this latter was confirmed after propensity score analysis (HR 0.39; 95%CI 0.21–0.67). Second- (n = 179) vs. first- (n = 337) generation DES showed a further reduction in TLR (HR 0.17; 95%CI 0.05–0.57). Adjusted analyses showed a significant reduction in the combined end-point of all-cause mortality or TLR after both first- and second-generation DES vs. BMS implantation with a trend to a lower risk for second- vs. first-generation DES.Principal conclusionsDES implantation in STEMI patients showed a significant reduction in TLR and in the combined endpoint of TLR or mortality. Second-generation DES showed a more protective effect on the combined endpoint, suggesting that they would be preferred in this setting.     

Drug‐eluting stents in patients with end‐stage renal disease: Meta‐analysis and systematic review of the literature

Objective : The study sought to examine the total weight of evidence regarding the use of drug eluting (DES) and bare metal stents (BMS) in patients with end stage renal disease (ESRD). Background : The potential superiority of DES over BMS in reducing target lesion or vessel revascularization (TLR or TVR) in patients with ESRD on dialysis has not been established. Small studies comparing DES to BMS in this population have yielded inconclusive results mainly due to the small sample size. Methods : We searched MEDLINE, EMBASE, Science Citation Index, CINAHL, and the Cochrane CENTRAL database of controlled clinical trials (December 2009) for controlled trials comparing DES to BMS in ESRD patients. We conducted a fixed‐effects meta‐analysis across seven eligible studies (n = 869 patients). Results : Compared with BMS‐treated patients, DES‐treated patients had significantly lower TLR/TVR (OR 0.55 CI: 0.39–0.79) and major adverse cardiac events (MACE) (OR 0.54; CI: 0.40–0.73). The absolute risk reduction (ARR) with DES in TLR/TVR was ?0.09 (CI: ?0.14 to ?0.04; NNT 11) and in MACE was ?0.13 (CI: ?0.19 to ?0.07; NNT 8). A trend towards lower incidence of all cause mortality was also noted with DES (OR 0.68; CI: 0.45–1.01). No significant differences were noted between both groups in the relative or absolute risk of myocardial infarction. Conclusion : The use of DES in patients with ESRD is safe and yields significant reduction in the risk of TLR/TVR and MACE. Larger randomized studies are needed to confirm the results of this meta‐analysis and establish the appropriate stent choice in this high risk population. © 2010 Wiley‐Liss, Inc.     

The efficacy of everolimus-eluting stent implantation in patients with ST-segment elevation myocardial infarction: outcomes of 2-year clinical follow-up

First-generation drug-eluting stents (DES) demonstrated delay in vascular healing and increase in incidence of late and very late stent thrombosis compared with bare-metal stents (BMS). Second-generation DES, however, have shown a reduction of late and very late stent thrombosis compared with first-generation DES. Thus, we decided to evaluate whether the second-generation everolimus-eluting stent (EES) has an advantage over BMS in Japanese patients with ST-segment elevation myocardial infarction (STEMI). This study was conducted in two centers, retrospective, non-randomized and observational design in patients with STEMI. Three-hundred eighty patients were randomly selected to receive EES (198 patients) or cobalt-chromium BMS (182 patients). The primary endpoints were cardiac death, recurrent myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis (ST). At 2 years, the rates of TLR, TVR, and recurrent MI were significantly lower in the EES group than in the BMS group (TLR 1.5 vs. 8.3 %, p < 0.05; TVR 2.5 vs. 9.4 %, p < 0.05; recurrent MI 1.0 vs. 4.1 %, p < 0.05), and the rate of ST was also significantly lower in the EES group than in the BMS group (0.5 vs. 4.3 %, p < 0.05). Thus, major adverse cardiac events defined at the composite cardiac death, MI, TLR, TVR, or ST were significantly lower in EES group than in BMS group (3.0 vs. 9.9 %, p = 0.008). The rate of cardiac death, however, did not differ between both groups. In STEMI patients, EES may be associated with improved outcomes—specifically, a significant reduction in TVR, ST, and recurrent MI compared to BMS throughout 2 years.     

Lack of clinical long‐term benefit with the use of a drug eluting stent compared to use of a bare metal stent in saphenous vein grafts

Background: Small randomized trials have shown short‐term improved outcome with drug‐eluting stents (DES) over bare metal stent (BMS) in saphenous vein graft (SVG) interventions by reducing in‐stent restenosis and target vessel revascularization (TVR). It is not clear, however, if these benefits are maintained long term. The aim of this study is to compare the outcome in a larger cohort of patients undergoing SVG stent implantation with DES or BMS, at 2 years. Methods: From among 250 patients who underwent SVG stenting, 225 patients with available follow‐up were selected from data bases at the three participating institutions. One‐hundred‐six patients had DES (sirolimus, paclitaxel or tacrolimus eluting stent) and 119 patients had any available BMS from April 2002 to December 2006. The primary endpoint was MACE rate, a combination of cardiac death, S‐T elevation myocardial infarction (STEMI) and target lesion revascularization. Secondary end points were the individual components of the primary endpoint. Follow‐up was obtained by mailed interviews or telephone calls and review of the hospital chart. Results: The DES and BMS groups had similar age (71 ± 8 years vs. 70 ± 7 years, P = 1.0), diabetes (45% vs. 36%, P = 0.3), history of MI (58% vs. 51%, P = 0.6), EF (44% vs. 47%, P = 0.2) and previous PCI (40% vs. 35%, P = 0.4). Reference vessel diameter (3.15 ± 0.5 mm vs. 3.5 ± 0.5 mm. P = 0.001) and stent size (3.3 ± 0.4 mm vs. 3.9 ± 0.5 mm, P = 0.001) were smaller in the DES group; however, the BMS were longer (24 ± 10 mm vs. 21 ± 6 mm, P = 0.05). At one year there was a trend (P = 0.1) for lower MACE rate in the DES group, but at two years there was no difference in MACE free survival between the DES and BMS groups (81 % vs. 82%, P = 0.9). The death rate was similar (6% each) with three patients having STEMI (two in the DES and one in the BMS). TVR was also similar (14% in each group). Conclusion: In patients undergoing treatment of SVG disease with a stent, the marginal benefit of DES seen at 1 year was lost at 2‐year follow‐up. © 2008 Wiley‐Liss, Inc.     

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.