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)     

Drug-eluting stents versus bare metal stents in ST elevation myocardial infarction: from evidence to practice

In 2001, drug-eluting stents (DES) were introduced as a strategy to decrease restenosis and need for re-intervention. As the utilization of DES grew in general practice, there was considerable use of DES in "off-label" patients not evaluated in the initial randomized clinical trials. Single-center and large registry studies were able to demonstrate that the clinical efficacy of DES persisted even in patient subgroups not included in the initial clinical trials. These observations provided support for evaluating DES in STEMI patients. We will consider the evidence that evaluates the relative safety and efficacy of DES compared to BMS in STEMI patients, as well as address practical issues faced in the routine clinical care of these patients.     

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.     

药物洗脱支架与金属裸支架在急性ST段抬高心肌梗死急诊介入治疗中应用长期随访结果的比较

目的 探讨与金属裸支架(BMS)相比,Cypher支架(Cordis公司,美国)在急性ST段抬高心肌梗死(STEMI)急诊经皮冠状动脉介入治疗(PCI)中应用的安全性和长期有效性.方法 连续选择2002年12月至2005年3月间STEMI患者407例,均于发病12 h内行急诊PCI治疗,于梗死相关血管靶病变置入Cypher支架或BMS.对所有病例随访1.5～4.0年(平均28.7±11.7个月),比较两类支架院内及出院后严重心脏不良事件(MACE,包括死亡、再发心肌梗死、靶病变重建等)发生的差异.结果 407例患者中置入Cypher支架者131例,置入BMS者276例.Cypher支架组所置入支架的直径明显小于BMS组(3.0 mm与3.2 mm,P=0.00).两组在随访期间心因性死亡(1.5%与6.9%,P=0.02)以及随访期间总的主要不良心脏事件(MACE)(6.1%与12.7%,P=0.04)差异均有统计学意义.应用Cox回归比例风险模型计算Cypher支架组在随访期间发生总MACE的相对危险度为0.45(P＜0.05).两组的支架内血栓形成发生率差异无统计学意义,支架内再狭窄发生率以及靶病变重建率差异亦无统计学意义,但Cypher支架较之BMS有明显降低的趋势.结论 在STEMI的急诊PCI治疗时,置入Cypher支架具有较好的安全性和长期有效性,与BMS相比可以降低远期复合MACE以及心因性死亡的发生率. 2)以及随访期间总的主要不良心脏事件(MACE)(6.1%与12.7%,P=0.04)差异均有统计学意义.应用Cox回归比例风险模型计算Cypher支架组在随访期间发生总MACE的相对危险度为0.45(P＜0.05).两组的支架内血栓形成发生率差异无统计学意义,支架内再狭窄发生率以及靶病变重建率 异亦无统计学意义,但Cypher支架较之BMS有明显降低的趋势.结论 在STEMI的急诊PCI治疗时,置人Cypher支架具有较好的安全性和长期有效性,与BMS相比可以降低远期复合MACE以及心因性死亡的发生率. 2)以及随访期间总的主要不良心脏事件(MACE)(6.1%与12.7%,P=0.04)差异均有统计学意义.应用Cox回归比例风险模型计算Cypher支架组在随访期间发生总MACE的相对危险度为0.45(P＜0.     

Early readmissions after percutaneous coronary intervention in a rural tertiary care center (from the Guthrie Health Off-label Stent [GHOST] Registry)

Early readmissions (ERs) impose a huge cost to the health care system, lower patients' quality of life, and may be an indicator of quality of initial care. We performed this single-center study to assess the incidence, predictors, and implications of 30-day readmission after percutaneous coronary intervention (PCI) in a tertiary care rural setting. In 4,262 consecutive patients who underwent PCI, we evaluated 30-day readmission rates and assessed demographic, clinical, and angiographic correlates of ER. Using Cox regression analyses, we estimated the multivariable impact of an ER on 1-year all-cause mortality and major adverse events (MACEs; death, myocardial infarction, target vessel revascularization, stent thrombosis). ER occurred in 486 patients (11.4%) including 366 (8.6%) for cardiac reasons and 120 (2.8%) for noncardiac reasons. Multivariable models predicting any readmission, cardiac readmission, and noncardiac readmission had c-statistic values of 0.63, 0.63, and 0.68, respectively. One-year mortality and MACEs were higher in the readmitted versus not readmitted patients (7.9% vs 3.2%, 18 vs 9.7%, p <0.0001 for the 2 comparisons). ER had a significant and independent impact on 1-year mortality (adjusted hazards ratio 2.2, 95% confidence interval 1.4 to 3.4) and MACEs (hazards ratio 2.2, 95% confidence interval 1.8 to 2.8). In conclusion, readmission within 30 days after PCI is common and frequently related to cardiac causes. Patients who require an ER after PCI have higher 1-year mortality and MACEs.     

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.     

Comparison of outcomes for patients receiving drug-eluting versus bare metal stents for non-ST-segment elevation myocardial infarction

The outcomes for patients undergoing percutaneous coronary interventions (PCI) with drug-eluting stents (DESs) and bare metal stents (BMSs) have been compared in many studies for patients with ST-segment elevation myocardial infarction. However, little is known about the relative outcomes for patients with non-ST-segment elevation myocardial infarction (NSTEMI). The aim of the present study was to compare the NSTEMI outcomes for PCI with DESs and BMSs. New York's PCI registry was used to propensity-match 4,776 pairs of patients with NSTEMI who had received DESs and BMSs from January 1, 2003 to December 31, 2007. These patients were followed up through December 31, 2008 to test for differences in mortality, target vessel revascularization, and total repeat revascularization. The outcomes were also compared for various patient subsets. At a median follow-up period of 3.68 years, the patients receiving DESs had significantly lower mortality (16.58% vs 14.52%, difference 2.06%, p<0.001), target vessel revascularization (13.08% vs 11.04%, p=0.009), and total repeat revascularization (22.16% vs 18.77%, p<0.001). The patients receiving paclitaxel-eluting and sirolimus-eluting stents both experienced superior outcomes compared to patients receiving BMSs. The patients receiving DESs had significantly lower mortality rates than their propensity-matched counterparts receiving BMSs when they were ≥65 years (difference 2.29%, p=0.01) and male (difference 2.77%, p=0.003). In conclusion, patients with NSTEMI undergoing PCI experienced lower 4-year mortality, target vessel revascularization, and repeat revascularization rates when they had received DESs than when they had received BMSs, and patients who were >65 years old, and men received notable benefits.     

Clinical outcomes following drug-eluting versus bare metal stent implantation for lesion subsets excluded from pivotal clinical trials: findings from the GHOST Study (Guthrie Health System Off-Label StenT Study)

Objectives: We assessed outcomes of patients undergoing drug-eluting stent (DES) vs. bare metal stent (BMS) implantation for complex lesions excluded from pivotal clinical trials of DES.
Background: Although DES improve target vessel revascularization (TVR) and major adverse cardiovascular events (MACE) compared to BMS in randomized trials, data on safety and efficacy of DES in complex lesions are insufficient.
Methods: In a single-center registry of 1,354 patients who underwent stent implantation for complex lesions between July 2001 and December 2005, we compared the incidence of death, death or myocardial infarction (MI), stent thrombosis [definite or probable by the Academic Research Consortium (ARC) criteria], TVR, and MACE between patients who received DES (n = 483) versus those who received BMS (n = 871). Mean duration of follow-up was 494 versus 838 days in DES and BMS groups, respectively.
Results: Clinical outcomes in DES versus BMS groups were as follows: death 5.2% versus 11.5% (log-rank P = 0.042); death/MI 11.2% versus 16.7% (P = 0.47), stent thrombosis 2.9% versus 2.6% (P = 0.61), TVR 6.6 versus 18.5% (P < 0.0001), MACE 14.9% versus 29.7% (P = 0.0002), respectively. After adjustment for baseline differences, DES implantation was associated with lower TVR (adjusted hazards ratio HR = 0.38, 95% CI 0.26–0.56, P < 0.0001) and MACE (HR = 0.56, CI 0.42–0.74, P < 0.0001) without significant impact on other outcomes. In 933 patients who underwent DES (n = 483) or BMS (n = 450) implantation in the year 2003 or later, DES implantation similarly lowered TVR and MACE without affecting other outcomes.
Conclusions: Our findings support the safety and efficacy of DES in patient subsets excluded from pivotal randomized clinical trials of DES.     

Comparison of safety and efficacy of sirolimus-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction

Sirolimus-eluting stents (SESs) are superior to bare metal stents (BMSs) for percutaneous coronary intervention, but data regarding SESs in ST-segment elevation myocardial infarction (STEMI) are limited. We investigated the clinical outcomes of patients with STEMI who were treated with SESs. We measured clinical characteristics and acute and long-term outcomes in 306 consecutive patients with STEMI who received a SES (n = 156) or a BMS (n = 150). Patients were followed for death, nonfatal reinfarction, and target vessel revascularization. Patients with SESs had a 0.6% in-hospital mortality rate versus 5.3% in patients with BMSs (p = 0.015). Six-month mortality rates were 1.9% (SES) and 10.1% (BMS, p = 0.003). At 6 months, patients with SESs were less likely to have target vessel revascularization (1.3% vs 8.1%, p = 0.005) and achieve the composite end point (3.2% vs 16.1%, p = 0.0001). No subacute thrombosis or clinical restenosis occurred in the SES group. Patients who received BMSs were older, received more stents, and had more myocardial damage, worse renal function, and lower ejection fractions than did those in the SES group. By multivariate discriminant analysis, stent type (SES vs BMS) was the most significant determinant of the 6-month composite end point (p = 0.01) and the need for target vessel revascularization (p = 0.02). In conclusion, SESs are safe and effective in STEMI at 6 months.     

ST-segment elevation: Distinguishing ST elevation myocardial infarction from ST elevation secondary to nonischemic etiologies

The benefits of early perfusion in ST elevation myocardial infarctions(STEMI) are established; howeverearly perfusion of non-ST elevation myocardial infarctions has not been shown to be beneficial. In additionST elevation(STE) caused by conditions other thanacute ischemia is common. Non-ischemic STE may beconfused as STEMI, but can also mask STEMI on electrocardiogram(ECG). As a result, activating the primarypercutaneous coronary intervention(pPCI) protocooften depends on determining which ST elevation patterns reflect transmural infarction due to acute coronary artery thrombosis. Coordination of interpreting theECG in its clinical context and appropriately activatingthe pPCI protocol has proved a difficult task in borderline cases. But its importance cannot be ignored, asreflected in the 2013 American College of CardiologyFoundation/American Heart Association guidelines concerning the treatment of ST elevation myocardial infarction. Multiples strategies have been tested and studiedand are currently being further perfected. No mattethe strategy, at the heart of delivering the best care lies rapid and accurate interpretation of the ECG. Here, we present the different patterns of non-ischemic STE and methods of distinguishing between them. In writing this paper, we hope for quicker and better stratification of patients with STE on ECG, which will lead to be bet-ter outcomes.     

Are drug-eluting stents superior to bare metal stents when compared to coronary artery bypass surgery? Show me the data

Recent randomized trials comparing coronary artery bypass surgery (CABG) versus drug eluting stents (DES) observed better survival, survival free of myocardial infarction (MI) and free from death, MI and stroke in patients with 3-vessel disease and diabetics if they were treated with DES. In the past, when we used bare metal stent (BMS) and meta-analysis of randomized trials with BMS and CABG, patients with 3-vessel disease and those with diabetes at 5 years of follow up had similar incidence of death, MI and stroke with CABG and BMS. The results reported recently by the SYNTAX and FREEDOM trials suggested a lack of clinical benefit with DES compared to BMS. The author in the article compared these recent results with the above meta-analysis and made an indirect comparison among DES, BMS and CABG. Reasons for these intriguing findings were discussed, and also a search for potential solutions was conducted.     

Long-term prognosis of first myocardial infarction according to the electrocardiographic pattern (ST elevation myocardial infarction, non-ST elevation myocardial infarction and non-classified myocardial infarction) and revascularization procedures

The aim of this study was to describe differences in the characteristics and short- and long-term prognoses of patients with first acute myocardial infarction (MI) according to the presence of ST-segment elevation or non-ST-segment elevation. From 2001 and 2003, 2,048 patients with first MI were consecutively admitted to 6 participating Spanish hospitals and categorized as having ST-segment elevation MI (STEMI), non-ST-segment elevation MI (NSTEMI), or unclassified MI (pacemaker or left bundle branch block) according to electrocardiographic results at admission. The proportions of female gender, hypercholesterolemia, hypertension, and diabetes were higher among NSTEMI patients than in the STEMI group. NSTEMI 28-day case fatality was lower (2.99% vs 5.26%, p = 0.02). On multivariate analysis, the odds ratio of 28-day case fatality was 2.23 for STEMI patients compared to NSTEMI patients (95% confidence interval 1.29 to 3.83, p = 0.004). The multivariate adjusted 7-year mortality for 28-day survivors was higher in NSTEMI than in STEMI patients (hazard ratio 1.31, 95% confidence interval 1.02 to 1.68, p = 0.035). However, patients with unclassified MI presented the highest short- and long-term mortality (11.8% and 35.4%, respectively). The excess of short-term mortality in unclassified and STEMI patients was mainly observed in those patients not treated with revascularization procedures. In conclusion, patients with first NSTEMI were older and showed a higher proportion of previous coronary risk factors than STEMI patients. NSTEMI patients had lower 28-day case fatality but a worse 7-year mortality rate than STEMI patients. Unclassified MI presented the worst short- and long-term prognosis. These results support the invasive management of patients with acute coronary syndromes to reduce short-term case fatality.     

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.     

Meta-analysis comparing the effect of drug-eluting versus bare metal stents on risk of acute myocardial infarction during follow-up

The only clinical benefit of drug-eluting stents (DESs) over bare metal stents (BMSs) is a significant decrease in the need for new revascularization procedures. We evaluated whether DESs also decrease the incidence of myocardial infarction at midterm. We performed a meta-analysis from 25 randomized trials comparing commercially available DESs with BMSs that included 9,791 patients overall. There was no heterogeneity across the trials included (Q test for heterogeneity, p = 0.68). Of the 9,791 patients included in all the trials, 364 developed an acute myocardial infarction during follow-up (6 to 12 months). The risk of myocardial infarction was significantly lower in patients allocated to DESs (3.3% vs 4.2% in those allocated to BMSs, odds ratio 0.79, 95% confidence interval 0.64 to 0.97, p = 0.03). In conclusion, the significant decrease in angiographic restenosis associated with the use of DESs leads not only to a decreased need for subsequent revascularization procedures but also a decreased incidence of myocardial infarction during the first 12 months after stent implantation.     

Comparison of late (3-year) registry data outcomes using bare metal versus drug-eluting stents for treating ST-segment elevation acute myocardial infarctions

Clinical trial data have supported the safety and efficacy of drug-eluting stents (DES) in the treatment of patients with ST-segment elevation myocardial infarctions (STEMIs), but contemporary "real-world" registry data regarding the late safety profiles of DES are limited. This prospective registry-based study included 1,569 consecutive unselected patients with STEMIs who underwent emergency primary percutaneous coronary intervention from January 2001 to December 2009. Of the study cohort, 200 patients (12.7%) received DES, while 1,369 patients (87.3%) underwent bare-metal stent (BMS) placement. The primary end points of the study were all-cause mortality and target vessel revascularization at 1, 2, and 3 years. Survival status was assessed by municipal civil registries. Repeat revascularization procedures were prospectively collected in the hospital database. All-cause mortality was significantly lower in the DES group at 3 years (4.2% vs 13.5%, p = 0.007) compared to BMS-treated patients, but DES use was not an independent predictor of all-cause mortality (adjusted odds ratio 0.5, 95% confidence interval 0.2 to 1.2, p = 0.10). Target vessel revascularization was significantly lower in the DES group compared to the BMS group at 3 years (10.5% vs 21%, p = 0.001). DES use was an independent predictor of reduced target vessel revascularization (adjusted odds ratio 0.44, 95% confidence interval 0.25 to 0.77, p = 0.004). Late definite stent thrombosis occurring after 1 year occurred in 4 (2.5%) patients in the DES group compared to 6 (0.7%) in the BMS group (p = 0.05). DES use was an independent predictor of late stent thrombosis (adjusted odds ratio 8.6, 95% confidence interval 1.9 to 38, p = 0.004). In conclusion, this contemporary registry-based study of patients who underwent primary percutaneous coronary intervention for STEMI demonstrated improved revascularization rates without increased 3-year hazard of adverse clinical outcomes in DES-treated patients.