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.     

A randomized trial of polytetrafluoroethylene-membrane-covered stents compared with conventional stents in aortocoronary saphenous vein grafts

We compared a conventional stent (Jostent Flex, Jomed GmbH, Rangendingen, Germany) with a polytetrafluoroethylene (PTFE)-membrane-covered stent (Jostent Stentgraft) in patients undergoing intervention of a stenosis in an obstructed vein graft.The use of stents improved results of percutaneous revascularization of obstructed vein grafts, but did not demonstrate the reduced elevated restenosis rate. In addition, long-term clinical event rate is still high compared with intervention in native vessels. Observational studies suggested that stents covered with a PTFE membrane might be associated with a low complication and restenosis rate in venous bypass grafts.This prospective multicenter study included a total of 211 patients who were randomly assigned to receive either a Flex stent or Stentgraft. The primary end point was binary restenosis rate at six months by core lab quantitative coronary angiography.Acute success and procedural events were comparable between the two groups. Restenosis rate was not significantly different between the Flex (20%) and the Stentgraft (29%) groups (p = 0.15), although there was a nonsignificant trend toward a higher late occlusion rate in the Stentgraft group (7% vs. 16%, p = 0.069) at follow-up. Likewise, after a mean observation period of 14 months, cumulative event rates (death, myocardial infarction, or target lesion revascularization) were comparable in the two groups (31% vs. 31%, p = 0.93).This controlled trial does not indicate a superiority of the PTFE-membrane-covered Stentgraft compared with a conventional stent with respect to acute results, restenosis, or clinical event rates.     

Meta-analysis of long-term outcomes for drug-eluting stents versus bare-metal stents in primary percutaneous coronary interventions for ST-segment elevation myocardial infarction

The use of drug-eluting stents (DESs) in primary percutaneous coronary intervention (PPCI) has shown early benefit over bare-metal stents (BMSs) in decreasing adverse cardiac events. However, there are concerns regarding the increased risk of late and very late stent thrombosis (ST) after DES use. With the paucity of ST events individual trials may have been underpowered to detect significant differences. We sought to perform a meta-analysis to evaluate the available literature examining the outcomes of DESs and BMSs in PPCI after ≥3 years of follow-up. We analyzed 8 randomized clinical trials (RCTs) and 5 observational studies comparing DESs to BMSs in PPCI. Clinical end-point data were analyzed for RCTs and observational studies separately using random-effect models. RCTs included 5,797 patients in whom first-generation DESs (sirolimus- or paclitaxel-eluting stents) were compared to BMS control arms. Patients receiving DESs had a significantly lower risk of target lesion revascularization (odds ratio [OR] 0.48, confidence interval [CI] 0.37 to 0.61), target vessel revascularization (OR 0.53, CI 0.42 to 0.66), and accordingly major adverse cardiac events (OR 0.69; CI 0.56 to 0.84). Incidence of ST was not different between groups (OR 1.02, CI 0.76 to 1.37). There was no significant difference in mortality (OR 0.88, CI 0.68 to 1.12) or recurrent myocardial infarction (OR 0.97; CI 0.61 to 1.54). Among observational studies (n = 4,650) fewer studies reported on target lesion revascularization and target vessel revascularization, but the trend remained in favor of DESs. A small but statistically significant increase in ST was noted with DES use (OR 1.62, CI 1.18 to 2.21) at ≥3 years of follow up, without evidence of recurrent myocardial infarction. Those receiving DESs had a significantly lower mortality compared to those receiving BMSs (OR, 0.65, 95% CI 0.53 to 0.80, p <0.001). In conclusion, this meta-analysis of RCTs examining the long-term outcomes of first-generation DESs versus BMSs in PPCI, DES use resulted in decreased repeat revascularization with no increase in ST, mortality, or recurrent myocardial infarction.     

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

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

Increased late mortality after sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts: results from the randomized DELAYED RRISC Trial.

OBJECTIVES: We sought to provide long-term follow-up data of sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in saphenous vein grafts (SVG) from the RRISC (Reduction of Restenosis In Saphenous vein grafts with Cypher) trial. BACKGROUND: We have previously shown that, in SVG, the use of SES reduces 6-month restenosis and repeated revascularization procedures versus the use of BMS. These data are consistent with trials in native coronary arteries. However, recently published long-term follow-up data of these trials have revealed an increased risk of adverse events (particularly very late stent thrombosis) after SES. METHODS: A total of 75 patients with 96 SVG lesions were randomized to SES versus BMS. All patients underwent clinical follow-up up to 3 years. Specific outcomes assessed in this secondary post-hoc analysis were all-cause mortality, myocardial infarction, and target vessel revascularization. RESULTS: Thirty-eight patients received 60 SES for 47 lesions, whereas 37 patients received 54 BMS for 49 lesions. At a median follow-up time of 32 months (interquartile range 26.5 to 36 months), 11 deaths (7 cardiac, of which 1 was caused by very late stent thrombosis and, 3 were sudden) occurred after SES (29% [95% confidence interval (CI) 17% to 45%]) versus 0 after BMS (0% [95% CI 0% to 9%]) with an absolute difference of 29% ([95% CI 14% to 45%], p < 0.001). The rates of myocardial infarction and target vessel revascularization were not different: 18% and 34% after SES, respectively, versus 5% and 38% after BMS, respectively (p = 0.15 and p = 0.74, respectively). CONCLUSIONS: In this secondary post-hoc analysis, BMS were associated with lower long-term mortality than SES for SVG disease. Also, the 6-month reduction in repeated revascularization procedures with SES was lost at longer-term follow-up. (RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent; http://clinicaltrials.gov/ct/show/NCT00263263?order=1; NCT00263263).     

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)     

Outcomes of drug-eluting stents compared to bare-metal stents in ST-segment elevation acute myocardial infarction

IntroductionPrimary percutaneous coronary intervention (PPCI) has become the treatment of choice in patients with ST-segment elevation myocardial infarction (STEMI). Drug-eluting stents (DES) reduce restenosis compared to bare-metal stents (BMS) but there is conflicting data concerning their use in the setting of STEMI. We aimed to evaluate the influence of the type of stent on the outcomes of PPCI.MethodsThis was a single-center longitudinal study including 213 consecutive patients (76% men, mean age 60±12 years) with STEMI undergoing PPCI between 2003 and 2007, divided into two groups: BMS (43.7%) and DES (56.3%). We assessed clinical and demographic features as well as angiographic and electrocardiographic signs of myocardial reperfusion. The composite outcome of death, myocardial infarction (MI) or target-lesion revascularization (TLR) was evaluated.ResultsAt a median follow-up of 26 months there were no differences in the composite outcome of death/MI/TLR (BMS 18.3% vs DES 15.8%) or in the incidence of stent thrombosis. Angiographic results of the procedure were also similar. Independent predictors of the composite outcome were age (HR=1.06, 95% CI [1.02-1.11], left anterior descending artery as infarct-related vessel (HR=2.69, 95% CI [1.17-6.19]) and use of glycoprotein IIb/IIIa inhibitors (HR=0.33, 95% CI [0.13-0.83]).ConclusionsThere was no benefit in angiographic outcomes or major cardiac events after treatment with drug-eluting stents compared to bare-metal stents in this group of patients with STEMI.     

Effectiveness of drug-eluting stents in patients with bare-metal in-stent restenosis: meta-analysis of randomized trials.

OBJECTIVES: We sought to synthesize the available evidence on the effectiveness of drug-eluting stents for bare-metal in-stent restenosis. BACKGROUND: Although there is clinical evidence that drug-eluting stents are associated with better results than other treatments for in-stent restenosis, they are not yet approved for this indication. Meta-analysis of randomized trials may yield more precise estimates of treatment effects and enable a rapid adoption of effective treatments in clinical practice. METHODS: Data sources included PubMed and conference proceedings. Prespecified criteria were met by 4 randomized studies comparing sirolimus- or paclitaxel-eluting stents versus balloon angioplasty or vascular brachytherapy in 1,230 patients with bare-metal in-stent restenosis. Studies reported the clinical outcomes of efficacy and safety during a minimum of 9 months. The primary outcome was target lesion revascularization. RESULTS: No significant heterogeneity was found across trials, thus showing a similar effect size regardless of the use of balloon angioplasty or vascular brachytherapy as comparators. The risk of target lesion revascularization (odds ratio 0.35, 95% confidence interval [CI] 0.25 to 0.49; p < 0.001) and that of angiographic restenosis (odds ratio 0.36, 95% CI 0.27 to 0.49; p = 0.001) were markedly lower in patients treated with drug-eluting stents. There were no differences between patients treated with drug-eluting stents and those treated with other techniques with respect to the composite of death or myocardial infarction (odds ratio 1.04, 95% CI 0.54 to 2.03; p = 0.55). CONCLUSIONS: Drug-eluting stents are markedly superior to conventional techniques (balloon angioplasty and vascular brachytherapy) and should be considered as first-line treatment for patients with bare-metal in-stent restenosis.     

Short- and long-term outcomes after stent-assisted percutaneous treatment of saphenous vein grafts in the drug-eluting stent era

Percutaneous treatment of saphenous vein graft (SVG) lesions has been associated with higher rates of periprocedural complications and restenosis compared with non-SVG lesions. Whether these outcomes are similar in contemporary clinical practice, particularly when drug-eluting stents are used, is unknown. We evaluated outcomes of 110 consecutive patients who were treated with stent-assisted percutaneous coronary intervention for 145 SVG lesions (drug-eluting stents used in 91.0% of lesions). Embolic protection devices were used in 52.1% of treated grafts. Adverse events were recorded up to 1 year. Major or minor periprocedural myocardial necrosis occurred in 11 patients (10.9%). At 1-year clinical follow-up, we observed 13 myocardial infarctions (13.7%), 8 target lesion revascularizations (8.4%), 18 target vessel revascularizations (19.0%), 2 stent thromboses (2.1%), and 7 deaths (7.4%). The incidence of major adverse cardiac events, defined as death, myocardial infarction, or target vessel revascularization, was 30.5% at 1 year. By multivariable analysis, the presence of thrombus inside the graft before the procedure and the length of the stented segment were independent predictors of major adverse cardiac events at 1 year (hazard ratio for thrombus 4.07, 95% confidence interval 1.90 to 8.68, p = 0.0003; hazard ratio per millimeter of stented length 1.02, 95% confidence interval 1.01 to 1.03, p = 0.025). In conclusion, our data show that patients with SVG lesions remain a high-risk subgroup with worse outcomes after percutaneous coronary intervention compared with native vessel disease even in the era of drug-eluting stents.     

Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials

Purpose

Drug-eluting stents are commonly used for percutaneous coronary intervention. Despite excellent clinical efficacy, the association between drug-eluting stents and the risk for late thrombosis remains imprecisely defined.

Methods

We performed a meta-analysis on 14 contemporary clinical trials that randomized 6675 patients to drug-eluting stents (paclitaxel or sirolimus) compared with bare metal stents. Eight of these trials have reported more than a year of clinical follow-up.

Results

The incidence of very late thrombosis (>1 year after the index procedure) was 5.0 events per 1000 drug-eluting stent patients, with no events in bare metal stent patients (risk ratio [RR] = 5.02, 95% confidence interval [CI], 1.29 to 19.52, P = .02). Among sirolimus trials, the incidence of very late thrombosis was 3.6 events per 1000 sirolimus stent patients, with no events in bare metal stent patients (RR = 3.99, 95% CI, .45 to 35.62, P = .22). The median time of late sirolimus stent thrombosis was 15.5 months, whereas with bare metal stents it was 4 months. Among paclitaxel trials, the incidence of very late thrombosis was 5.9 events per 1000 paclitaxel stent patients, with no events in bare metal stent patients (RR = 5.72, 95% CI, 1.08 to 32.45, P = .049). The median time of late paclitaxel stent thrombosis was 18 months, whereas it was 3.5 months in bare metal stent patients.

Conclusions

Although the incidence of very late stent thrombosis more than 1 year after coronary revascularization is low, drug-eluting stents appear to increase the risk for late thrombosis. Although more of this risk was seen with paclitaxel stents, it remains possible that sirolimus stents similarly increase the risk for late thrombosis compared with bare metal stents.     

Long-term clinical outcomes in patients treated with drug-eluting compared to bare-metal stents for the treatment of transplant coronary artery disease

Objective : We aimed to compare the long‐term clinical outcomes of first‐vessel percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) and bare metal stents (BMS) for the treatment of transplant coronary artery disease (TCAD). Background : TCAD is the leading cause of late death in orthotopic heart transplantation (OHT) recipients. PCI is associated with worse clinical outcomes compared with non‐OHT patients. Our institution previously reported superior angiographic outcomes with DES compared with BMS in OHT patients. However, long‐term clinical outcomes comparing PCI with DES versus BMS are lacking. Methods : The data on 105 OHT recipients who underwent first‐vessel PCI with DES (n = 58) or BMS (n = 47) at UCLA Medical Center between 1995 and 2009 were retrospectively analyzed. Results : Five‐year clinical outcomes were not significantly different with DES and BMS in terms of the composite of death, myocardial infarction (MI), or target vessel revascularization (TVR) [(40.8 ± 7.2)% vs. (59.6 ± 7.2)%, log‐rank P = 0.33], death [(31.8 ± 7.8)% vs. (40.4 ± 7.2)%, log‐rank P = 0.46], MI [(12.2 ± 6.2)% vs. (11.3 ± 5.4)%, log rank P = 0.98], TVR [(25.5 ± 6.9)% vs. (26.5 ± 7.3)%, log rank P = 0.76], and time to repeat OHT [(2.27 ± 1.79) vs. (3.22 ± 3.34), P = 0.98]. Conclusions : At long‐term follow‐up, PCI with DES and BMS provided similar clinical outcomes in OHT. Long‐term mortality remains high in OHT recipients after PCI with either DES or BMS. Randomized clinical trials are required to determine the optimal treatment strategy for OHT recipients with TCAD. © 2012 Wiley Periodicals, Inc.     

Long-term outcomes of drug-eluting stents versus bare-metal stents in large coronary arteries

Background

Long-term (> 3 years) outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in large coronary arteries were not conclusive. In addition, large coronary vessels were defined using a wide size range (≥ 3.0 mm) in previous studies. The aim of this study was to assess the long-term efficacy of DES versus BMS in subgroups of different vessel sizes.

Methods

A total of 1096 patients (1342 lesions) who underwent either DES or BMS implantation in large coronary vessels was followed for a mean duration of 4.5 years. Patients were divided into 4 subgroups by the reference vessel diameters (Q1: 3.0–3.25 mm, Q2: 3.26–3.50 mm, Q3: 3.51–3.75 mm, and Q4: 3.76–4.50 mm). The primary endpoint was major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target vessel revascularization, and stent thrombosis. The propensity score-adjusted Cox regression method was applied.

Results

In the 3 subgroups with smaller vessel sizes, the adjusted risk of MACE in DES recipients was reduced by 82% in Q1 (hazard ratio [HR]: 0.18, 95% confidence interval [CI]: 0.09–0.38), 49% in Q2 (HR: 0.51, 95% CI: 0.26–0.98), and 67% in Q3 (HR: 0.33, 95% CI: 0.15–0.73). However, in the largest vessel subgroup (> 3.75 mm), all clinical outcomes were not significantly different irrespective of the stent type used.

Conclusions

The incidence of MACE in 3.0–3.75 mm vessels was significantly reduced by the use of DES than by the use of BMS during a long-term follow-up. However, DES lost its benefit in > 3.75 mm vessels.