Clinical impact of sirolimus‐eluting stent in ST‐segment elevation myocardial infarction: A meta‐analysis of randomized clinical trials

Objectives: To evaluate outcome of patients undergoing sirolimus‐eluting stent (SES) as compared to bare‐metal stent (BMS) implantation during primary angioplasty for ST‐segment elevation myocardial infarction (STEMI). Background: The role of SES in primary percutaneous coronary intervention setting is still debated. Methods: We searched Medline, EMBASE, CENTRAL, scientific session abstracts, and relevant Websites for studies in any language, from the inception of each database until October 2008. Only randomized clinical trials with a mean follow‐up period >6 months and sample size >100 patients were included. Primary endpoint for efficacy was target‐vessel revascularization (TVR) and primary endpoint for safety was stent thrombosis. Secondary endpoints were cardiac death and recurrent myocardial infarction (MI). Results: Six trials were included in the meta‐analysis, including 2,381 patients (1,192 randomized to SES and 1,189 to BMS). Up to 12‐month follow‐up, TVR was significantly lower in patients treated with SES as compared to patients treated with BMS (4.53% vs. 12.53%, respectively; odds ratio [OR] 0.33; 95% confidence interval [CI] 0.24–0.46; P < 0.00001). There were no significant differences in the incidence of stent thrombosis (3.02% vs. 3.70%, OR = 0.81 [95% CI, 0.52–1.27], P = 0.81), cardiac death (2.77% vs. 3.28%, OR = 0.84 [95% CI, 0.52–1.35], P = 0.47), and recurrent MI (2.94% vs. 4.04%, OR = 0.71 [95% CI, 0.45–1.11], P = 0.13) between the two groups. Conclusion: SES significantly reduces TVR rates as compared to BMS in STEMI patients up to 1 year follow‐up. Further studies with larger population and longer follow‐up time are needed to confirm our findings. © 2009 Wiley‐Liss, Inc.     

A randomized study of prourokinase during primary percutaneous coronary intervention in acute ST‐segment elevation myocardial infarction

Objectives

To evaluate the efficacy and safety of intracoronary administration of prourokinase via balloon catheter during primary percutaneous coronary interventions (PCI) in patients with acute ST‐segment elevation myocardial infarction (STEMI).

Methods

Acute STEMI patients underwent primary PCI were randomly divided into two groups: intracoronary prourokinase (IP) group (n = 118) and control group (n = 112). During primary PCI, prourokinase or saline were injected to the distal end of the culprit lesion via balloon catheter after balloon catheter dilatation. Demographic and clinical characteristics, infarct size, myocardial reperfusion, and cardiac functions were evaluated and compared between two groups. Hemorrhagic complications and MACE occurred in the 6‐months follow up were recorded.

Results

No significant differences were observed between two groups with respect to baseline demographic, clinical, and angiographic characteristics (P > 0.05). In IP group, more patients had complete ST segment resolution (>70%) compared with control group (P < 0.05). Patients in IP group showed lower levels of serum CK, CK‐MB and TnI, and a much higher myocardial blood flow (MBF) than those in control group (P < 0.05). No significant differences of TIMI major or minor bleeding complications were observed between the two groups (P > 0.05). At 6‐months follow‐up, there was a trend that patients in the IP group had a less chance to have MACE, though it was not statistically different (8.5% vs 12.5%, P > 0.05).

Conclusions

Intracoronary administration of prourokinase via balloon catheter during primary PCI effectively improved myocardial perfusion in STEMI patients.     

Selective drug‐eluting stent implantation for high‐risk patients with acute ST‐elevation myocardial infarction: Rationale and safety

Background : A selective policy of drug‐eluting stent (DES) implantation in ST‐elevation myocardial infarction (STEMI) patients at high risk of restenosis may maximize the benefit from restenosis reduction and minimize risk from late stent thrombosis (LaST). Objectives : We sought to prospectively determine the safety of selective DES implantation for long lesions (>20 mm), small vessels (<2.5 mm) and diabetic patients in patients with STEMI using a prospective single‐center registry. Methods : A total of 252 patients who underwent primary PCI between January 2005 and December 2006 were included: 126 consecutive patients receiving DES were compared with 126 age‐, sex‐, and vessel‐matched controls with STEMI who received bare‐metal stents. Composite major adverse cardiovascular events (MACE) (death, AMI, and target vessel revascularization) were used as the primary outcome measure. Results : Baseline clinical and angiographic characteristics and outcomes were similar between groups except for the prespecified diabetes, lesion length, and maximum stent diameter. Long‐term outcomes at a median follow up of 34 ± 6 months showed significant reductions in reinfarction (2% vs. 11%, P = 0.03), target vessel revascularization (TVR) (10% vs. 24%, P = 0.02), and composite MACE (18% vs. 31%, P = 0.03) with DES, with no excess of death (9% vs. 7%, P = NS) or LaST (2% vs. 1%, P = NS). In a Cox multivariate model, clopidogrel cessation at long‐term follow‐up was the most powerful predictor of hierarchical MACE (HR: 5.165; 95%CI: 2.019–13.150, P = 0.001). Conclusions : Selective DES implantation in patients with high‐risk STEMI appears safe, and exposes fewer patients to the risk of LaST. A randomized comparison of selective versus routine DES use in patients with STEMI should be considered. © 2010 Wiley‐Liss, Inc.     

Clinical impact of complete atrioventricular block in patients with ST‐segment elevation myocardial infarction

Complete atrioventricular block (CAVB) is a common complication of ST‐segment elevation myocardial infarction (STEMI). Although STEMI patients complicated with CAVB had a higher mortality in the thrombolytic era, little is known about the impact of CAVB on STEMI patients who underwent primary percutaneous coronary intervention (PCI). The study aimed at evaluating the clinical impact of CAVB on STEMI patients in the primary PCI era. We consecutively enrolled 1295 STEMI patients undergoing primary PCI within 24 hours from onset. Patients were divided into two groups according to the infarct location: anterior STEMI (n = 640) and nonanterior STEMI (n = 655). The outcomes were all‐cause death and major adverse cardiocerebrovascular events (MACCE) with a median follow‐up period of 3.8 (1.7–6.6) years. Eighty‐one patients (6.3%) developed CAVB. The incidence of CAVB was lower in anterior STEMI patients than in nonanterior STEMI (1.7% vs 10.7%, p < .05). Anterior STEMI patients with CAVB had a higher incidence of all‐cause deaths (82% vs 20%, p < .05) and MACCE (82% vs 25%, p < .05) than those without CAVB. Although higher incidence of all‐cause deaths was found more in nonanterior STEMI patients with CAVB compared with those without CAVB (30% vs 18%, p < .05), there was no significant difference in the incidence of MACCE (24% vs 19%). Multivariate analysis showed that CAVB was an independent predictor for all‐cause mortality and MACCE in anterior STEMI patients, but not in nonanterior STEMI. CAVB is rare in anterior STEMI patients, but remains a poor prognostic complication even in the primary PCI era.     

A randomized comparison of manual versus mechanical thrombus removal in primary percutaneous coronary intervention in the treatment of ST‐segment elevation myocardial infarction (TREAT‐MI)

Objectives : The objective of this study was to compare the efficacy and long‐term clinical outcome of manual thrombus aspiration with the Export catheter (Medtronic, Minneapolis, MN) versus mechanical thrombus cutting/aspiration with the X‐sizer system (eV3, White Bear Lake, MN) in primary percutaneous coronary intervention (PPCI). Background : In PPCI for acute ST‐segment elevation myocardial infarction (STEMI), markers of myocardial reperfusion are improved with adjunctive thrombectomy. Previous studies of different devices showed a variability in performance, suitability, and short‐term clinical outcome. In current literature, no direct comparison is available. Methods : We prospectively randomized 201 patients admitted for PPCI for STEMI to either the Export catheter or the X‐sizer prior to stent deployment. Technical success in advancing to and across the lesion, improvement of flow, reduction of thrombus, and the effect on ST‐segment resolution were examined. The primary endpoint of the follow‐up study was the combined endpoint of cardiac death, recurrent myocardial infarction (MI), or target‐vessel revascularization (TVR) at 3 years. Results : Although the Export catheter was more successfully deployed, other procedural parameters were similar with a trend toward better ST‐segment resolution (56.6% vs. 44%; P = 0.06) as compared to the X‐sizer system. The occurrence of the primary clinical endpoint at 3 years was 22.2% and 18.6%, respectively (HR 1.20; 95% CI 0.65–2.22; P = 0.35). Conclusion : Despite shorter procedural times, better lesion crossing, and fewer complications, both surrogate endpoints as well as 3‐year clinical follow‐up were similar with the use of the Export catheter as compared to the X‐sizer system. © 2011 Wiley‐Liss, Inc.     

Safety and efficacy of drug‐eluting stent for ST‐segment elevation myocardial infarction in an unselected consecutive cohort

Objective: The objective of this study is to investigate the clinical outcome of a large cohort of patients with ST‐segment elevation myocardial infarction (STEMI) treated with drug‐eluting stents (DES) compared to bare metal stents (BMS). Background: Several randomized controlled trials have demonstrated that PCI with the routine use of DES is safe and effective in patients with STEMI. However as randomized trials have strict inclusion criteria, further studies in unselected patient populations are needed. Methods: We performed a retrospective cohort analysis of the Mayo Clinic PCI database. A total of 552 consecutive STEMI patients who underwent a DES implantation between May 2003 and April 2006 were included in the study and compared to 557 who had BMS for STEMI earlier. No specific patient subsets were excluded. Results: Procedural success was achieved in 532 patients (96%). During initial hospitalization, 16 patients (2.9%) died and 8 (1.5%) suffered from a recurrent myocardial infarction. The median follow‐up was 23 months (IQR: 13–27 months). At 12 months post discharge, the rate of target lesion revascularization and death were 2.9% and 3.7%, respectively, and survival free of major adverse cardiac events (MACE) was 90.9%. These rates were similar to or lower than those of patients treated for STEMI with BMS prior to the availability of DES. Conclusion: DES are safe and effective in the treatment of STEMI in an unselected cohort; 90.9% of patients are free of MACE at 12 months post discharge. © 2008 Wiley‐Liss, Inc.     

ST段抬高的急性心肌梗死急诊置入药物洗脱支架与普通金属裸支架的比较

目的对比观察雷帕霉素药物洗脱支架（Cypher）与普通金属支架（Bx-sonic）在急性ST段抬高心肌梗死（STEAMI）急诊冠脉介入（PCI）治疗中应用的安全性和临床疗效。方法选择我院急诊住院的82例STEAMI患者,在发病时间12h内急诊行直接PCI治疗,其中50例于梗死相关血管的靶病变植入Cypher支架（Cypher支架组）,32例植入Bx-sonic支架（普通支架组）。并对其临床资料,病变特征,术后住院期间及随访期间再梗死、死亡、靶血管再成形等心脏不良事件发生率进行分析。结果两组支架术患者住院期间心脏不良事件发生率无显著差异。平均随访（6.2±2.3）个月,Cypher支架组心绞痛发生率较普通支架组显著减低（5%vs21%,P<0.01）。Cy-pher支架组无心脏事件生存率显著高于普通支架组（95%vs78%,P<0.01）。普通支架组支架内再狭窄率较Cy-pher支架组高。再梗死、心源性死亡、中风等不良事件发生率无显著差异。结论雷帕霉素药物洗脱支架与普通支架一样在STEAMI急诊PCI中是安全有效的。