Comparison of drug-eluting stents with bare metal stents in unselected patients with acute myocardial infarction.

OBJECTIVES: The aim of this study was to compare the procedural characteristics and outcomes of patients with acute myocardial infarction treated with drug-eluting stents (DES) vs. bare metal stents (BMS). BACKGROUND: DES have been shown to reduce the incidence of restenosis and target vessel revascularization (TVR) in clinical randomized studies when compared with BMS in patients undergoing elective percutaneous intervention. Limited data are available with the use of DES in patients with acute ST-segment elevation myocardial infarction. METHODS: Two hundred and sixty-one consecutive patients who presented with myocardial infarction between 7/2001 and 8/2005 were studied. The procedural characteristics, 30-day and 12-month outcomes of 131 patients treated with DES were compared with 130 patients treated with BMS. RESULTS: At 12-months follow-up DES therapy was associated with a substantial decrease in major adverse cardiovascular events (MACE) (HR 0.33; P =0.002), TVR (HR 0.19; P =0.002), and recurrent myocardial infarction (HR 0.23; P =0.051) vs. BMS therapy. Coronary interventions utilizing DES were characterized by a marked increase in the number of stent per target vessel (DES: 1.9 +/- 0.9 vs. BMS: 1.38 +/- 0.6, P < 0.0001), treatment of bifurcation (DES: 21% vs. BMS: 5%, P =0.0004), and multivessel intervention (DES: 22% vs. BMS: 8%, P =0.003). CONCLUSION: The routine use of DES in acute myocardial infarction is associated with reduced rates of MACE at 12 months vs BMS, despite a higher rate of complex procedures in the DES treated patients. In addition to its anti-restenosis effect, the improved outcome of patients treated with DES may be linked to a more complete revascularization in association with prolonged clopidogrel therapy.     

多支冠状动脉病变患者1911例PCI二年疗效

目的评价多支冠状动脉病变（MVD）通过经皮冠状动脉介入（PCI）进行血运重建的长期疗效。方法1995年6月2003年12月连续2028例在我院成功接受PCI的MVD患者,对其心绞痛复发率、造影复查再狭窄率和主要不良心脏事件（MACE）的发生率进行回顾分析。结果2028例MVD患者,完全性血运重建率86.2%（1748/2028）,住院期间共死亡26例（总病死率1.3%）,对存活出院的2002例患者中的1911例随访24个月,随访率95.5%,其心绞痛复发率、造影复查再狭窄率和MACE发生率分别为10.7%、14.6%、25.4%,其中1754例植入普通金属支架（BMS）,157例植入药物洗脱支架（DES）。尽管DES组患者冠心病危险因素多、病变程度复杂,不稳定心绞痛占61.8%、糖尿病占41.4%、慢性完全闭塞病变（CTO）占37.6%、3支病变占58.0%,但心绞痛复发率、造影复查再狭窄率和MACE发生率均显著低于BMS组（分别为4.5%vs11.2%,3.2%vs15.7%,8.9%vs26.9%,均P<0.01）。结论PCI进行血运重建是治疗MVD的有效方法,但仍存在BMS支架术后不良事件发生率高,DES用于治疗MVD具有更好的长期疗效。     

Safety and efficacy with drug-eluting stent in ST-segment elevation and non-ST-segment elevation myocardial infarction

BACKGROUND: Drug-eluting stents (DES) have been shown to reduce the need for repeat revascularization compared with bare metal stents (BMS). However, there is little information regarding the safety and long-term efficacy of DES in patients with acute myocardial infarction (AMI). HYPOTHESIS: The aim of this study was to evaluate the safety and efficacy of DES in patients with AMI. METHODS: Data from 211 consecutive patients with AMI treated with DES were compared with those from 228 consecutive patients with AMI treated with BMS. All patients were treated within 7 days of symptom onset. The incidence of major adverse cardiovascular events ([MACE]: death, reinfarction, and target vessel revascularization) was evaluated at 30 days and 1 year. RESULTS: Baseline clinical and angiographic characteristics were similar for both stent groups. However, patients who received DES had longer lesion lengths (23.0 +/- 12.7 vs. 18.8 +/- 10.6 mm, respectively; p < 0.001) and smaller reference diameters (2.97 +/- 0.52 vs. 3.19 +/- 0.63 mm, respectively, p < 0.001). At 30 days, the incidence rates of MACE (DES vs. BMS: 2.2 vs. 1.9%, p = 1.000) and stent thrombosis (BMS vs. DES: 0.9 vs. 1.7%; p = 0.434) did not differ significantly between the groups. At 1 year, patients with DES had a lower rate of MACE (BMS vs. DES: 14.0 vs. 6.6%; p = 0.011) primarily due to a lower target vessel revascularization rate (BMS vs. DES: 9.6 vs. 4.8%; p = 0.028). CONCLUSIONS: The DES appear to be superior to the BMS in reducing the risk of MACE in patients with AMI.     

Multivessel drug‐eluting stenting and impact of diabetes mellitus—A report from the EVENT registry

Objectives: To compare clinical outcomes in patients with and without diabetes after multivessel percutaneous coronary intervention (PCI). Background: Diabetes is associated with significantly worse outcomes after multivessel PCI and coronary bypass surgery is recommended as the preferred option for these patients. Methods and Results: The Evaluation of Drug Eluting Stents and Ischemic Events registry is a multicenter evaluation of acute and 1 year outcomes in unselected patients undergoing PCI since approval of drug‐eluting stents (DES). Major adverse cardiac events (MACE) were defined as all cause mortality, myocardial infarction, or repeat revascularization and rate was estimated by Kaplan‐Meier method and compared using log‐rank. The independent correlates of MACE were determined using Cox proportional hazards regression. Of 4,819 nonemergency native coronary DES procedures, 1,595 (33.1%) were in patients with diabetes and 722 (11.7%) involved >1 vessel. Of patients undergoing multivessel procedures, diabetes was present in 256 (35.5%). One year after multivessel PCI, MACE was similar for patients with or without diabetes (22.3% versus 21.2%, log‐rank test P = 0.85). The independent correlates of 1 year MACE were female sex (Hazard ratio [HR], 1.58, 95% CI 1.14–2.20), ejection fraction (HR 0.74 per group [<25%, 26–35%, 36–50%, and >50%], 95%CI 0.59–0.94) and number of stents (HR 1.20 per stent, 95%CI 1.04–1.38) but not diabetes (HR 1.00, 95% CI 0.71–1.39). Conclusions: Multivessel DES is performed commonly in patients with diabetes with outcomes at 1 year similar to patients without diabetes. Longer follow‐up is required to more fully evaluate the safety and effectiveness of this strategy. © 2009 Wiley‐Liss, Inc.     

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)     

Short- and long-term benefits of drug-eluting stents compared to bare metal stents even in treatment for large coronary arteries

Although drug-eluting stents (DES) for percutaneous coronary intervention (PCI) have dramatically reduced the incidence of in-stent restenosis, their deployment for large-size coronary lesions is still controversial because of problems such as late in-stent thrombosis and late catch-up in DES. We aimed to evaluate the long-term outcome beyond 2 years of bare metal stents (BMS) as compared with DES in large vessels. Consecutive 228 patients who underwent PCI with large-size stents (>3.5 mm in diameter) in our hospital were enrolled in this study. The end points of this study are target lesion revascularization (TLR) and occurrence of major adverse cardiac events (MACE) for subject patients. We analyzed 183 patients (152 men, mean age 65.8 ± 10.5 years) whose outcome could be followed up for at least 2 years. At the first 8-month follow-up, clinically driven TLR rate was significantly higher in patients who received BMS than those who received DES (17.2 vs. 2.2 %, p < 0.05), although the rate of TLR was not different between the 2 groups beyond 8 months. Thus, overall rate of TLR was higher in BMS than in DES (22.7 vs. 5.4 %, p < 0.05). Under these conditions, the higher rate of TLR for BMS was observed in simple as well as complex lesions with or without diabetes, although there were no significant differences in MACE between BMS and DES. Multivariate analysis showed that BMS was an only independent factor of TLR at the 8 month follow-up period [p = 0.004, odds ratio 9.58, 95 % confidence interval (2.10–43.8)]. These results demonstrate that the rate of in-stent restenosis in large-size coronary lesions was transiently higher in the first 8 months for patients implanted with BMS compared with DES in which no in-stent thrombosis and TLR beyond 2 years were observed. We suggest using the DES even in large-size coronary lesions in terms of short- and long-term outcomes.     

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.     

Clinical Impact of Drug-Coated Balloon–Based Percutaneous Coronary Intervention in Patients With Multivessel Coronary Artery Disease

BackgroundData on drug-coated balloon (DCB) treatment in the context of multivessel coronary artery disease (CAD) are limited.ObjectivesThe purpose of this study was to investigate the impact of DCB-based treatment on percutaneous coronary intervention for multivessel CAD.MethodsA total of 254 patients with multivessel disease successfully treated with DCBs or in combination with drug-eluting stents (DES) were retrospectively enrolled (DCB-based group) and compared with 254 propensity-matched patients treated with second-generation DES from the PTRG-DES (Platelet Function and Genotype-Related Long-Term Prognosis in Drug-Eluting Stent-Treated Patients With Coronary Artery Disease) registry (n = 13,160) (DES-only group). Major adverse cardiovascular events (MACE) comprised cardiac death, myocardial infarction, stroke, stent thrombosis, target vessel revascularization, and major bleeding at 2 years.ResultsBaseline clinical characteristics were comparable between the groups. In the DCB-based group, 34.3% of patients were treated with DCBs only and 65.7% were treated with the DES hybrid approach. The number of stents and total stent length were significantly reduced by 65.4% and 63.7%, respectively, in the DCB-based group compared with the DES-only group. Moreover, the DCB-based group had a lower rate of MACE than the DES-only group (3.9% and 11.0%; P = 0.002) at 2-year follow-up. The DES-only group had a higher risk for cardiac death and major bleeding.ConclusionsThe DCB-based treatment approach showed a significantly reduced stent burden for multivessel percutaneous coronary intervention and led to a lower rate of MACE than the DES-only treatment. This study shows that DCB-based treatment approach safely reduces stent burden in multivessel CAD, and improved long-term outcomes may be expected by reducing stent-related events. (Impact of Drug-Coated Balloon Treatment in De Novo Coronary Lesion; NCT04619277)     

Cardiac events after non-cardiac surgery in patients with previous coronary intervention in the drug-eluting stent era

The peri-operative risk for patients with coronary drug-eluting stents (DES) who subsequently have non-cardiac surgery (NCS) is unclear. We performed this retrospective study of all patients in our institution who had coronary intervention and subsequent NCS from 2003 through December 2008 to evaluate the incidence of major adverse cardiac events (MACE) in patients who received DES compared to those who received bare-metal stents (BMS) or had percutaneous transluminal coronary angioplasty (PTCA) during the same time period. The main outcome measures were 30-day post-operative myocardial infarction, stent thrombosis, target vessel revascularization (TVR) and cardiac death. During the 6-year study period, 1,770 coronary interventions were performed and 238 patients subsequently had NCS in 8 days to 49 months. Eighteen patients had PTCA, 79 BMS and 141 DES. Acute myocardial infarction occurred in 1 patient who had PTCA, 2 who had BMS and 14 who had DES (p = 0.10). Stent thrombosis occurred in 6 patients who had DES and none who had BMS (p = 0.09). Seven patients who had DES had TVR compared to 1 patient who had BMS and none who had PTCA (p = 0.41). Cardiac mortality occurred in 2 patients who had DES and none who had PTCA or BMS (p = 0.35). In conclusion, the 30-day MACE in patients who received coronary DES and undergone NCS were not significantly different compared to those who received BMS or had PTCA only, with a trend toward higher stent thrombosis in the DES group.     

The Cobalt chromium STent with Antiproliferative for Restenosis II (COSTAR II) trial study design: advancing the active-control evaluation of second-generation drug-eluting stents

BACKGROUND: Randomized clinical trials have demonstrated the superiority of drug-eluting stents (DESs) compared with bare-metal stents in reducing the need for revascularization and major adverse cardiac events (MACEs) in low-risk patients with single-vessel lesions. Rapid DES uptake has necessitated shifting the paradigm to active DES-controlled noninferiority study models with most studies using surrogate angiographic measurements to attain adequate statistical power. No previous prospective trial has specifically compared a new DES with an active-control DES in a high-risk patient population using primary clinical end points. OBJECTIVE: COSTAR II is designed to compare use of the investigational Costar stent (Conor MedSystems, Palo Alto, CA) with the Taxus (Boston Scientific, Maple Grove, MN) stent in single- and multivessel percutaneous coronary intervention. The primary end point is the clinical composite of MACE at 8 months supported by consistent results in the evaluation of 8-month MACE rates in the single- and multivessel cohorts and of in-segment late loss in a small angiographic substudy at 9 months. METHODS: A total of 1700 patients, 50% with single-vessel and 50% with multivessel disease, are randomized in a 3:2 ratio to receive either Costar or Taxus stent(s) in this prospective, multicenter, noninferiority study design. Because no prior data were available to determine control multivessel MACE rates, an imputed placebo statistical analysis plan incorporating a variable delta based on actually observed control DES MACE rates will be implemented. The results of COSTAR II will provide information about a novel coronary stent device as well as unique data regarding both control and test DES use in more complex "real-world" patients.     

药物洗脱支架治疗冠状动脉小血管病变的疗效分析

目的通过分析比较裸金属支架(BMS)与药物洗脱支架[DES,包括雷帕霉素(Cypher)支架和紫杉醇(TAXUS)支架]治疗冠状动脉小血管病变疗效的差异,为DES治疗多支及单支小血管病变冠心病提供依据。方法连续入选2002年12月至2005年5月沈阳军区总医院首次接受经皮冠状动脉介入治疗(PCI)、靶血管为小血管病变且达到完全血运重建的486例患者,其中多支小血管病变(多支)150例。分为BMS组214例(多支63例)、Cypher组140例(多支46例)和TAXUS组132例(多支41例),对比分析各组患者住院期间及随访6个月的临床情况。结果3组患者冠脉病变特点、PCI成功率及住院期间主要不良心脏事件(MACE)发生率等指标差异均无显著性(P>0·05)。冠脉造影随访显示,两个DES组再狭窄率均明显低于BMS(Cypher组4·9%,TAXUS组7·5%对BMS组29·2%,P<0·05),随访期间MACE发生率亦明显低于BMS(Cypher组2·9%,TAXUS组3·9%对BMS组12·0%,P<0·01)。进一步分析多支小血管病例,发现两个DES组的再狭窄率及随访期间MACE发生率仍然明显低于BMS组(再狭窄率Cypher组6·7%,TAXUS组7·1%对BMS组37·5%,P<0·05;MACE发生率Cypher组4·1%,TAXUS组4·8%对BMS组21·0%,P<0·05)。结论Cypher和TAXUS支架治疗小血管病变安全可行,疗效显著,治疗多支小血管病变可得到相同的疗效。     

Unrestricted use of drug-eluting stents compared with bare-metal stents in routine clinical practice: findings from the National Heart, Lung, and Blood Institute Dynamic Registry.

OBJECTIVES: We investigated the effectiveness and safety of drug-eluting stents (DES) as used in routine clinical practice. BACKGROUND: Randomized trials have shown that DES prevent target vessel revascularization in selected patients, but whether this translates into superior outcomes, compared with bare-metal stents (BMS), for the full spectrum of patients treated with DES in North America is unknown. METHODS: Patients in the National Heart, Lung, and Blood Institute Dynamic Registry enrolled in 2004 who received at least 1 DES (n = 1,460) were compared with 1,763 patients enrolled in the recruitment period immediately preceding the approval of DES (2001 to 2002) who received at least 1 BMS. RESULTS: Patients receiving DES more often had diabetes mellitus and less often presented with an acute myocardial infarction (MI). At 1 year, cumulative death and MI was 7.6% in DES- and 8.7% in BMS-treated patients (adjusted hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.68 to 1.15; p = 0.34). The 1-year rate of target vessel revascularization was 5.0% in DES and 9.2% in BMS patients (p < 0.001), and the risk of any repeat revascularization by percutaneous coronary intervention or coronary bypass was lower in DES patients (adjusted HR 0.38, 95% CI 0.25 to 0.60; p < 0.001). Patients with both simple and complex lesion characteristics benefited from DES with lower risk of repeat target vessel revascularization by percutaneous coronary intervention compared with BMS (any complex lesion: adjusted HR 0.57, 95% CI 0.39 to 0.83; absence of any complex lesion: adjusted HR 0.44, 95% CI 0.28 to 0.71). The 1-year incidence of stent thrombosis was 1.0% in DES patients. CONCLUSIONS: The generalized use of DES resulted in better outcomes than BMS, with fewer clinically driven revascularization procedures and similar rates of death and MI at 1 year.     

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.     

Drug-Eluting Versus Bare Metal Stents in Saphenous Vein Graft Intervention: An Updated Comprehensive Meta-Analysis of Randomized Trials

BackgroundDrug eluting stents (DES) are preferred over bare metal stents (BMS) for native coronary artery revascularization unless contraindicated. However, the preferred stent choice for saphenous venous graft (SVG) percutaneous coronary interventions (PCI) is unclear due to conflicting results.MethodsPubMed, Clinical trials registry and the Cochrane Center Register of Controlled Trials were searched through June 2018. Seven studies (n = 1639) comparing DES versus BMS in SVG-PCI were included. Endpoints were major adverse cardiac events (MACE), cardiovascular mortality, all-cause mortality, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), in-stent thrombosis, binary in-stent restenosis, and late lumen loss (LLL).ResultsOverall, during a mean follow up of 32.1 months, there was no significant difference in the risk of MACE, cardiovascular mortality, all-cause mortality, MI, stent thrombosis, TVR and TLR between DES and BMS. However, short-term follow up (mean 11 months) showed lower rate of MACE (OR 0.66 [0.51, 0.85]; p = 0.002), TVR (OR 0.47 [0.23, 0.97]; p = 0.04) and binary in-stent restenosis (OR 0.14 [0.06, 0.37]; p < 0.0001) in DES as compared with BMS. This benefit was lost on long-term follow up with a mean follow up 35.5 months.ConclusionIn this meta-analysis of SVG-PCI, DES use was associated with similar MACE, cardiovascular mortality, all-cause mortality, MI, in-stent thrombosis, TVR and TLR compared with BMS during long-term follow up. There was high incidence of MACE noted in both DES and BMS suggesting a need for exploring novel strategies to treat SVG disease to improve clinical outcomes.     

Long-term effect of stenting in unprotected left main coronary artery disease in the elderly

Objective To evaluate the feasibility, safety and efficacy of percutaneous stent implantation for treating left main coronary artery (LMCA) stenosis. Methods Consecutive patients with unprotected left main coronary artery disease treated by stent-based percutaneous intervention (PCI) at 6 medical centers in China were enrolled. Procedural data and clinical outcomes were obtained from all patients. Results From January 2001 to December 2004, 138 patients (79 males and 59 females; mean age: 69.7±5.8 years) underwent PCI for LMCA stenosis. Bare metal stents (BMS) were implanted in 51 patients with non-bifurcational lesions and in 5 patients with bifurcational lesions from January of 2001 to June of 2003 (BMS group);. drug eluting stents (DES) were used unselectively to cover both bifurcational and non-bifurcational lesions in 86 patients from July of 2003 to December of 2004 (DES group). Procedural success rate of the 138 cases was 98% (135/138). One patient (0.7%) with bifurcation lesion who was treated with DES died from severe heart failure 2 weeks after the procedure. During a mean follow up period of 21.3±5.6 months, one patient died from renal failure, one from sudden cardiac death, 4 underwent target lesion revascularization (TLR) in the BMS group, which all occurred in patients with bifurcational lesions; whereas in the DES group no deaths occurred and only one patient with bifurcational lesion had TLR. Conclusions (1) PCI is feasible and relatively safe to treat unprotected left main coronary artery disease in elderly patients at medical centers with experienced professionals. (2) BMS and DES have similar immediate and long-term efficacy in the treatment of ostium and shaft lesions of the LMCA. (3) DES are strongly suggested in the therapy of distal bifurcation lesion of unprotected LMCA.     

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.     

Provisional stenting for multivessel PCI

Background: Bare stents reduce acute complications and repeat revascularization following percutaneous coronary intervention (PCI), but are costly and may lead to in‐stent restenosis. It remains unclear whether stents should be universally implanted or whether provisional stenting mainly to suboptimal balloon dilatation results is an acceptable approach for multivessel PCI. Objective: To compare the long‐term clinical restenosis and target lesion revascularization (TLR) of stented and non‐stented coronary artery lesions in patients who had multivessel PCI. Methods: We performed retrospective analysis of matched data from 129 consecutive patients who underwent multivessel PCI (at least optimal balloon angioplasty to one coronary artery segment and balloon angioplasty plus stenting to another coronary artery in the same patient, all lesions are de novo native coronary artery lesions with vessel diameter ?2.5?mm). The study endpoint was restenosis and repeat revascularization at one‐year follow‐up. Results: Baseline characteristics were similar in both groups. Low in‐hospital MACE (3.1%). Acute myocardial infarction, emergency revascularization via either PCI or CABG was detected and angiographic success was achieved in 99.3% of lesions in both groups. The rate of clinically driven angiographic restenosis and TLR at one‐year (follow‐up?100%) was similar (17.1% versus 18.6%, P?=?0.871, and 13.9% versus 16.3%, P?=?0.728, for optimal balloon angioplasty versus provisional stenting. Conclusions: The main findings from this study are that long‐term angiographic restenosis and TLR was comparable for optimal balloon angioplasty and provisional stenting, suggesting that provisional stenting is an acceptable approach for multivessel PCI.     

Percutaneous coronary intervention of moderate to severe calcified coronary lesions: Insights from the National Heart,Lung, and Blood Institute Dynamic Registry

Objectives: To evaluate the efficacy and safety of drug eluting stents (DES) when compared with bare metal stents (BMS) in patients with moderate to severe calcified coronary lesions. Background: Calcified coronary lesions present unique technical challenges during percutaneous coronary intervention (PCI) and it is not known if DES are as safe and as effective in the presence of calcium, as randomized trials typically exclude this common patient subset. Methods: We evaluated patients with PCI of a single calcified lesion enrolled across five recruitment waves in the National Heart, Lung, and Blood Institute Dynamic Registry between 1997 and 2006. Patients were divided into two groups based on the stent type‐ BMS and DES. The primary efficacy outcome was the need for repeat revascularization at 1 year and the primary safety outcome was a composite of death and myocardial infarction at 1 year. Results: Among the 1,537 patients included in the analysis, 884 (57%) underwent PCI with BMS and 653 (43%) with DES. DES use was associated with a significant reduction in the risk of repeat revascularization (10.0% vs. 15.3%; P = 0.003) with no significant higher risk of primary safety outcome (9.3% vs. 10.5%; P = 0.45) when compared to the BMS group. In a propensity score adjusted analysis, DES use was associated with a significantly lower risk in repeat revascularization (HR = 0.57; 95% CI 0.40–0.82; P = 0.002) and no significant difference in the risk of death and myocardial infarction (HR = 0.78; 95% CI 0.53–1.15; P = 0.20) compared to BMS group. Conclusion: In this large multicenter registry of patients with a moderate to severe calcified coronary lesion, use of DES compared to BMS was associated with significant reduction in the risk of repeat revascularization without any increase in death and myocardial infarction. © 2010 Wiley‐Liss, Inc.     

Long-term outcomes following coronary drug-eluting- and bare-metal-stent implantation

Background

Although drug-eluting stents (DES) reduce restenosis rates relative to bare-metal stents (BMS), recent reports have indicated that the use of DES may be associated with an increased risk of stent thrombosis. Our study focused on the effect of stent type on clinical outcomes in a “real world” setting.

Methods

889 patients undergoing percutaneous coronary intervention (PCI) with either DES (Cypher or Taxus; n = 490) or BMS (n = 399) were enrolled in a prospective single center registry. The outcome analysis covered a period of up to 3.2 years (mean 2.7 years ± 0.5 years) and was based on 65 deaths, 27 myocardial infarctions, 76 clinically driven target lesion revascularizations (TLR), and 15 angiographically confirmed cases of definite stent thrombosis and was adjusted for differences in baseline characteristics.

Results

In total 1277 stents (613 BMS and 664 DES) were implanted in 1215 lesions. Despite a significantly different unadjusted death rate (10.1% and 5.1% in BMS and DES patients, respectively; p < 0.05), the patient groups did not differ significantly in the risk of myocardial infarction during 2.7 years of follow-up. After adjustment for differences in baseline characteristics between groups, the difference in the cumulative incidence of death did not remain statistically significant (p = 0.22). Target lesion revascularizations occurred significantly less frequently in patients with DES compared to individuals after BMS implantation (5.9% and 11.8% in patients with DES and BMS, respectively; p < 0.05). The rate of angiographically confirmed stent thrombosis was 2.1% in patients with DES and 1.1% in BMS patients (p = 0.31).There was a significantly lower unadjusted event rate (including deaths, myocardial infarction, target lesion revascularization, and stent thrombosis) in patients with drug-eluting stents than in those with bare-metal stents (16.4% and 25.8%, respectively), with 9.4 fewer such events per 100 patients (unadjusted hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.46 to 0.87). After adjustment, the relative risk for all outcome events in patients with drug-eluting stents was 0.79 (95% CI, 0.67 to 0.95). However, the adjusted relative risk for death and myocardial infarction did not differ significantly between groups (adjusted relative risk in patients with drug-eluting stents 0.94 (95% CI, 0.77 to 1.37)).

Conclusions

In this real-world population, the beneficial effect of first generation DES in reducing the need for new revascularization compared with BMS extends to more than 2.5 years without evidence of a worse safety profile. The minor risk of stent thrombosis and myocardial infarction within this period after implantation of DES seems unlikely to outweigh the benefit of these stents.     

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.