Benefits of drug eluting stents versus bare metal stents in ST-elevation myocardial infarction: a contemporary review

The efficacy of drug-eluting stents (DES) in reducing the rates of in-stent restenosis after percutaneous coronary intervention (PCI) compared to bare metal stents (BMS) in stable coronary artery disease has been well demonstrated. Thus, the Food and Drug Administration has approved the utilization of DES for stable coronary disease. However, there is still much debate surrounding the implantation of DES for patients with ST-segment elevation myocardial infarction (STEMI) given safety concerns about the possibility of increased rates of stent thrombosis with DES. The review of the current body of evidence comparing DES with BMS is consistent with results from previous trials in stable coronary disease and reveals lower rates of revascularization with DES in STEMI patients. The ultimate decision regarding the appropriate stent during PCI needs to be individualized as patients' compliance with dual antiplatelet therapy is critical. The data suggest that PCI with DES in STEMI patients who adhere to long-term dual antiplatelet therapy is safe and effective. Randomized trials with longer-term follow-up are necessary to better elucidate the safety and efficacy of DES versus BMS in patients with STEMI.     

Bare-Metal Stents Versus Drug-Eluting Stents for Primary Angioplasty: Long-Term Outcome

Percutaneous transluminal coronary intervention (PCI) is the most used myocardial revascularization technique for patients with coronary artery disease. Primary PCI with stent implantation is widely considered the gold standard for the treatment of ST-elevation myocardial infarction patients. Coronary stents, compared with balloon angioplasty, have reduced focal lesion restenosis. To reduce in-stent restenosis, drug-eluting stents (DES) were designed to locally release drugs inhibiting neointimal growth. Recent concerns have emerged on the potential higher risk of stent thrombosis with DES that might be even more pronounced among myocardial infarction patients. For these reasons, DES for primary PCI remains an “off-label” use. In the last several years, a number of randomized trials and registries have tested the safety and efficacy of DES in primary PCI. Data from these studies were analyzed in several meta-analyses, reasonably consistently demonstrating that the use of DES significantly decreased the need for revascularization without an increase in the incidence of death, recurrent infarction, or stent thrombosis at long-term follow-up.     

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

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

Single-center randomized evaluation of paclitaxel-eluting versus conventional stent in acute myocardial infarction (SELECTION)

OBJECTIVES: To evaluate the superiority of the paclitaxel-eluting stent (PES) in reducing neointimal hyperplasia (NIH) over its corresponding bare metal stent (BMS) during primary percutaneous coronary intervention (PCI). BACKGROUND: Primary PCI with stent implantation is the repercussion strategy of choice for ST-elevation myocardial infarction (STEMI); nonetheless restenosis rate is still high. Drug-eluting stents have been proven to reduce restenosis rate in many settings, but their use during primary PCI is still controversial. METHODS: Consecutive patients with STEMI <12 hours were randomized to receive PES or BMS. The primary end-point was the percentage of the stent volume obstructed by neointimal proliferation (NIH) measured by intravascular ultrasound (IVUS) at a 7-month angiographic follow-up. Secondary end-points were binary restenosis rate and major adverse cardiac events (MACE, i.e., death, nonfatal myocardial infarction, and target lesion revascularization). RESULTS: Eighty patients with STEMI were randomized into the PES or BMS group. Patients were well matched for baseline characteristics and the index procedure was always successful. In-hospital and 1-month MACE were 2.5% per group. NIH at 7 months was 4.6% versus 20% (P< 0.01), late lumen loss 0.1 versus 1.01 mm (P = 0.01). MACE were 7.5% versus 42.5% (P = 0.001) with no difference in death and recurrent myocardial infarction rates. Late-acquired incomplete stent apposition (ISA) rate was 5.1% versus 2.7% (P = 0.65). One subacute stent thrombosis was reported in each group. CONCLUSIONS: PES was superior to its corresponding BMS in reducing NIH in the STEMI setting without any increase in early and long-term clinical adverse events.     

Long-term Outcomes of Drug-eluting versus Bare-metal stent for ST-elevation Myocardial Infarction

Background

Long-term outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain uncertain.

Objective

To investigate long-term outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI).

Methods

We performed search of MEDLINE, EMBASE, the Cochrane library, and ISI Web of Science (until February 2013) for randomized trials comparing more than 12-month efficacy or safety of DES with BMS in patients with STEMI. Pooled estimate was presented with risk ratio (RR) and its 95% confidence interval (CI) using random-effects model.

Results

Ten trials with 7,592 participants with STEMI were included. The overall results showed that there was no significant difference in the incidence of all-cause death and definite/probable stent thrombosis between DES and BMS at long-term follow-up. Patients receiving DES implantation appeared to have a lower 1-year incidence of recurrent myocardial infarction than those receiving BMS (RR = 0.75, 95% CI 0.56 to 1.00, p= 0.05). Moreover, the risk of target vessel revascularization (TVR) after receiving DES was consistently lowered during long-term observation (all p< 0.01). In subgroup analysis, the use of everolimus-eluting stents (EES) was associated with reduced risk of stent thrombosis in STEMI patients (RR = 0.37, p=0.02).

Conclusions

DES did not increase the risk of stent thrombosis in patients with STEMI compared with BMS. Moreover, the use of DES did lower long-term risk of repeat revascularization and might decrease the occurrence of reinfarction.     

Effect of coronary endothelial function on outcomes in patients undergoing percutaneous coronary intervention

Numerous studies have documented the association between endothelial dysfunction and adverse cardiovascular events. For example, coronary artery disease is associated with functional and structural changes of the coronary arteries, resulting in ischemia or plaque rupture, and is highly associated with endothelial dysfunction. Recent data suggest that implantation of drug-eluting stents (DES) can induce coronary artery endothelial dysfunction at follow-up when compared with bare-metal stents (BMS) and that this endothelial dysfunction may be associated with late stent thrombosis. Indeed, despite the superiority of DES in preventing restenosis, the incidence of death and myocardial infarction is similar when comparing DES with BMS. Medical treatment, such as statins, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers, can improve endothelial dysfunction. Thus, administration of these drugs along with percutaneous coronary intervention (PCI) may be a low-risk strategy to provide therapeutic benefit by stabilizing unstable plaque or by suppressing new lesion formation in patients undergoing PCI.     

Factors Associated With the Use of Bare Metal Stents in Patients With ST Elevation Myocardial Infarction

BackgroundDrug eluting stents (DES) are used in the majority of patients undergoing percutaneous coronary intervention (PCI). Factors associated with the use of bare metal stents (BMS) for patients undergoing primary PCI for ST elevation myocardial infarction (STEMI) have not been adequately explored. The objective of this study was to evaluate factors associated with BMS use in STEMI patients undergoing primary PCI.MethodsPatients undergoing primary PCI for STEMI between January 2008 and February 2015 were retrospectively identified. Patients who received both a DES and BMS were included in the DES group and patients receiving balloon angioplasty only were excluded. Baseline demographics, angiographic variables, procedure related variables and in-hospital events were collected. Multivariate analysis was performed to identify factors associated with BMS use.ResultsEight hundred and sixty-five patients underwent primary PCI for STEMI during the study period. Seventy-two patients (8.3%) received balloon angioplasty only and were excluded, yielding 793 patients for the study cohort. Three hundred fifty-two patients (44%) received BMS and 441 patients (56%) received DES. Patients receiving DES had a higher prevalence of diabetes mellitus, prior myocardial infarction, prior PCI, left anterior descending artery culprit location and Medicaid Insurance compared to those receiving BMS. Patients receiving BMS had a higher prevalence of cardiogenic shock and right coronary artery culprit location. Unadjusted in-hospital mortality was significantly higher for patients receiving BMS compared to patients receiving DES, 11.1% vs 3.2%, respectively, p < 0.0001. Multivariate predictors of BMS use were cardiogenic shock (OR 30.3; 95% CI 11.25 to 81.73) and diabetes mellitus (OR 2.99; 95% CI 1.04 to 8.64).ConclusionIn a contemporary series of patients undergoing primary PCI for STEMI, BMS were used in 44% of patients and independent factors associated with BMS use were cardiogenic shock and diabetes mellitus.     

Efficacy and safety of drug-eluting stents in patients with acute ST-segment-elevation myocardial infarction: a meta-analysis of randomized controlled trials

We compared the efficacy and safety of drug-eluting stents with that of bare-metal stents in patients who experienced acute ST-segment-elevation myocardial infarction (STEMI) and underwent primary percutaneous coronary intervention. To do this, we performed a meta-analysis of 13 randomized controlled trials in which drug-eluting stents were compared with bare-metal stents in STEMI patients. The trials involved 6,769 patients (4,246 received drug-eluting stents and 2,523 received bare-metal stents) and follow-up periods of 6 to 48 months. In comparison with bare-metal stents, drug-eluting stents significantly reduced the incidence of major adverse cardiac events, with a risk ratio (RR) of 0.59 (95% confidence interval [CI], 0.47-0.73; P < 0.00001). Drug-eluting stents were not associated with a significant reduction in overall death (RR = 0.94; 95% CI, 0.74-1.20; P = 0.64), but were associated with significant reductions in recurrent myocardial infarction (RR = 0.76; 95% CI, 0.58-0.98; P = 0.03), target-vessel revascularization (RR = 0.47; 95% CI, 0.39-0.56; P <0.00001), and in-stent restenosis (RR = 0.32; 95% CI, 0.25-0.39; P < 0.00001). Moreover, no significant difference was found in the comparative risk of stent thrombosis (RR = 0.85; 95% CI, 0.63-1.14; P = 0.27).On the basis of risk ratio, we conclude that using drug-eluting stents in STEMI patients who undergo primary percutaneous coronary intervention is safe with regard to stent thrombosis within 48 months, and that drug-eluting stents improve clinical outcomes by reducing the risks of major adverse cardiac events, recurrent myocardial infarction, reintervention, and in-stent restenosis, compared with bare-metal stents. However, in order to investigate possible very late stent thrombosis, follow-up of these trials beyond 48 months is warranted.     

Late and very late thrombosis of drug-eluting stents: evolving concepts and perspectives

Coronary stents are the mainstay of percutaneous coronary revascularization procedures and have significantly decreased the rates of acute vessel closure and restenosis. Stent thrombosis (ST) after percutaneous coronary intervention is an uncommon and potentially catastrophic event that might manifest as myocardial infarction and sudden death. Optimization of stent implantation and dual antiplatelet therapy have markedly reduced the occurrence of this complication. Bare-metal stent (BMS) thrombosis occurs in <1% of the cases, usually within the first month after implantation. The advent of drug-eluting stents (DES) has raised concerns regarding later occurrence of ST, beyond the traditional 1-month timeframe, especially in complex lesion subsets that were excluded from randomized trials that compared BMS to DES. There is widespread controversy regarding the actual incremental risk associated with DES. Recent studies suggest a 0.5% increased long-term thrombosis risk with DES; however, the clinical significance of these events remains under debate. The degree of protection achieved by dual antiplatelet therapy and optimal duration of treatment are under investigation. Novel stent designs might potentially decrease the incidence of this event. In this review, we will describe the current knowledge of the pathophysiology of late DES thrombosis, although many aspects remain incompletely understood.     

Late and very late thrombosis of drug-eluting stents: evolving concepts and perspectives.

Coronary stents are the mainstay of percutaneous coronary revascularization procedures and have significantly decreased the rates of acute vessel closure and restenosis. Stent thrombosis (ST) after percutaneous coronary intervention is an uncommon and potentially catastrophic event that might manifest as myocardial infarction and sudden death. Optimization of stent implantation and dual antiplatelet therapy have markedly reduced the occurrence of this complication. Bare-metal stent (BMS) thrombosis occurs in <1% of the cases, usually within the first month after implantation. The advent of drug-eluting stents (DES) has raised concerns regarding later occurrence of ST, beyond the traditional 1-month timeframe, especially in complex lesion subsets that were excluded from randomized trials that compared BMS to DES. There is widespread controversy regarding the actual incremental risk associated with DES. Recent studies suggest a 0.5% increased long-term thrombosis risk with DES; however, the clinical significance of these events remains under debate. The degree of protection achieved by dual antiplatelet therapy and optimal duration of treatment are under investigation. Novel stent designs might potentially decrease the incidence of this event. In this review, we will describe the current knowledge of the pathophysiology of late DES thrombosis, although many aspects remain incompletely understood.     

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.     

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.     

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

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

An angiographic evaluation of restenosis rate at a six-month follow-up of patients with ST-elevation myocardial infarction submitted to primary percutaneous coronary intervention

BACKGROUND: Percutaneous coronary intervention (PCI) is considered to be the optimal type of revascularization in patients with ST-segment elevation myocardial infarction (STEMI). However, the long-term effectiveness of this procedure can be reduced by restenosis. This investigation was aimed at a prospective evaluation, in a group of STEMI patients of "the real world" (not involved in randomised trials), of the angiographic restenosis rate at a 6-month follow-up, and at identifying the relationship between restenosis and the patients' characteristics. MATERIALS AND METHODS: Our study population consisted of 123 patients with STEMI submitted to primary PCI to then undergo stress echocardiography 3 months after PCI and an angiographic evaluation at a 6-month follow-up. RESULTS: a) In real life the restenosis rate is quite high (42.3%); b) no correlation was found between patients' clinical characteristics and restenosis; c) restenosis rate was higher in patients with bare metal stents than in those with drug-eluting stents (55.8% vs. 11.1%; p<0.001); in patients with longer stents (21.6+/-8.62 vs 18.1+/-6.34 mm, p=0.015) and when more than one stent was implanted. Moreover, a consistent number of patients showed restenosis though asymptomatic. CONCLUSIONS: Our data suggest that primary PCI is associated with a high incidence of angiographic restenosis. No correlation was found between patients' clinical characteristics and restenosis. The length and the number of implanted stents seem to be associated with a more probable restenosis at six-month angiographic evaluation. Drug-eluting stent implantation seems to be associated with a lower incidence of restenosis even in STEMI patients.     

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.     

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.     

Short and long-term benefits of sirolimus-eluting stent in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials

Background Recent concerns have emerged on the potential higher risk of stent thrombosis after DES implantation, that might be even more pronounced among STEMI patients. The aim of the current study was to perform a meta-analysis to evaluate the benefits and safety of Sirolimus-Eluting Stent (SES) as compared to BMS in patients undergoing primary angioplasty for STEMI. Methods The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of DES for STEMI. The following keywords were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, sirolimus-eluting stent (SES), Cypher. Information on study design, type of stent, inclusion and exclusion criteria, primary endpoint, number of patients, angiographic and clinical outcome, were extracted by two investigators. Disagreements were resolved by consensus. Results A total of 9 trials were included in the meta-analysis, involving 2,769 patients (1389 or 50.2% randomized to DES and 1,380 or 49.8% randomized to BMS). At 12 months follow-up, SES was associated with a significant reduction in TVR (4.9% vs. 13.6%, p < 0.0001), with a trend in benefits in mortality (2.9% vs. 4.2%, p = 0.08) and reinfarction (3.0% vs. 4.3%, p = 0.06), without any significant difference in stent thrombosis (1.9% vs. 2.5%, p = 0.36). Safety and efficacy of DES were confirmed at 2–3 years follow-up (data available from 4 trials including 569 patients). Conclusions This meta-analysis shows that among selected STEMI patients undergoing primary angioplasty, SES as compared to BMS is safe and associated with a significant reduction in TVR at 1 and 2–3 years follow-up.     

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)     

雷帕霉素药物洗脱支架治疗急性心肌梗死六个月随访结果

目的探讨雷帕霉素药物洗脱支架（Cypher）在急性ST段抬高心肌梗死急诊经皮冠状动脉介入治疗（PCI）中应用的安全性和有效性.方法选择2002年11月至2004年12月间的急性ST段抬高心肌梗死患者168例,于发病12 h内行急诊PCI治疗,于梗死相关血管的靶病变置入Cypher支架.记录1个月和6个月随访终点时的主要心脏不良事件（包括死亡、再发心肌梗死、靶血管再成形等）发生率、支架内血栓发生率、支架内再狭窄发生率.结果 168例患者急诊PCI治疗均获得成功.168支梗死相关血管的171处罪犯病变共置入175枚Cypher支架,未发生与介入治疗有关的并发症.1个月随访终点时死亡3例（死亡率1.8%）;支架内亚急性血栓1例;主要心脏不良事件发生率2.4%.6个月随访终点时死亡4例（死亡率2.4%）;主要心脏不良事件发生率4.2%;支架内血栓发生率1.2%;支架内再狭窄发生率1.8%.结论药物洗脱支架（Cypher）在急性ST段抬高心肌梗死急诊PCI中应用与普通支架一样有较强的安全性和有效性,并可以明显降低再狭窄率.