Safety and efficacy of drug-eluting stents and bare metal stents in acute coronary syndrome

Compared with medical therapy, percutaneous coronary intervention has been shown to reduce the rates of death and recurrent ischemia in patients presenting with acute coronary syndromes (ACS). In the current interventional era, both drug-eluting stents (DES) and bare-metal stents (BMS) have been widely used, despite the fact that the use of DES in the context of ACS was initially an “off-label” indication and that ACS has been associated with stent thrombosis (ST). In contrast to the wealth of data available for the use of DES in patients with ST-elevation myocardial infarction, data regarding the performance of DES in non–ST-elevation ACS is restricted to a handful of registries with conflicting data. The aim of this review was to summarize the safety and efficacy of DES in the entire spectrum of ACS.     

Comparison of bare metal stents versus drug-eluting stents on clinical decision making in patients with previous percutaneous coronary intervention admitted for suspected acute coronary syndrome

To determine whether the decreased rate of restenosis observed with drug-eluting stents (DES) has changed the treatment of patients with recurrent symptoms after stent placement, we compared patients hospitalized with presumed cardiac symptoms within 1 year after placement of either a DES or a bare metal stent (BMS). In this retrospective, single-center study, cases were identified from consecutive patients who received a DES from March 2003 to July 2004 or a BMS from August 2001 to June 2002. No differences were noted in the rate of hospitalization, hospitalization for presumed cardiac symptoms, use of coronary angiography in patients hospitalized for presumed cardiac symptoms, or average interval to hospitalization. In contrast, restenosis and the need for additional revascularization procedures were higher in the BMS group. The primary indication for additional revascularization was restenosis in the BMS group and progression of coronary artery disease in the DES group. In the DES group, the need for revascularization was significantly higher in patients with multi- versus single-vessel coronary artery disease (26% vs 7%, p < 0.05). In conclusion, the rate of hospitalization and use of coronary angiography in patients with recurrent symptoms were similar in patients who received a BMS or DES, despite the decreased rates of restenosis and additional revascularization procedures observed with DESs.     

Initial impact of drug-eluting stents on coronary artery bypass grafting

The impact of drug-eluting stents (DES) on the characteristics and operative results of patients referred for coronary artery bypass grafting (CABG) was studied. We reviewed data from isolated CABG patients 24 months before (group A, n = 134) and 24 months after (group B, n = 98) the introduction of DES for clinical use at Teikyo University Hospital in Tokyo. Group B patients were significantly older than those of group A (66 +/- 9 versus 69 +/- 9 years old). The number of diseased vessels was significantly larger in group B (2.5 +/- 0.6 versus 2.7 +/- 0.5) and left main trunk disease decreased in group B (27% versus 17%). Preoperative IABP support was more frequent in group B (9% versus 17%) and beating heart surgery was significantly more frequent in group B (26% versus 59%). The number of grafts was similar in the 2 groups (3.2 +/- 1.4 versus 3.0 +/- 1.1). The operative mortality rates were 0.7% and 4.1% in group A and B, respectively. Incomplete revascularization followed by postoperative percutaneous coronary intervention (PCI) was performed in 11% and 12%, respectively, and all the patients survived surgery. The operative mortality rates for arrested heart and beating heart surgery were 2% and 2%, respectively. In conclusion, after the introduction of DES, more clinically ill patients were referred to CABG. Combination therapy consisting of CABG and PCI (Hybrid) may be a treatment of choice in critical patients.     

Outcomes of intravascular ultrasound-guided percutaneous coronary intervention with drug-eluting stents versus bare metal stents for acute coronary syndrome in octogenarians

The number of percutaneous coronary interventions (PCI) performed for octogenarians with acute coronary syndrome (ACS) continue to increase. The short- and long-term outcomes of intravascular ultrasound (IVUS)-guided PCI with drug-eluting stents (DES) or bare metal stents (BMS) for ACS in octogenarians, however, remain largely unknown. We analyzed clinical outcomes of octogenarians undergoing IVUS-guided PCI for ACS with either DES or BMS. During the study period, a total of 776 patients with ACS underwent IVUS-guided PCI and 75 of them were octogenarians. In-hospital mortality tended to be lower in the DES group than in the BMS group. Between 6 months and 1 year of follow up, treatment with DES compared with BMS tended to result in fewer target lesion revascularizations. Major adverse cardiac events were similar between patients receiving DES and BMS. In octogenarians with ACS treated with IVUS-guided PCI, DES appears as safe as BMS, providing similar short- and long-term outcomes.     

Direct versus conventional stent implantation in patients with acute coronary syndrome just before the era of drug-eluting stents

BACKGROUND: Direct stent implantation in patients, who undergo elective percutaneous coronary intervention (PCI) can be performed with a high success rate and clinical results that are comparable to those after predilatation. It was the aim of this prospective study to compare clinical, angiographic and procedural parameter of direct stent implantation (DS) and conventional stent implantation (CS) in patients with acute coronary syndrome (ACS). PATIENTS AND METHODS: We analysed 194 patients with ACS (ST-elevation myocardial infarction 66%, non-ST-elevation myocardial infarction 18%, unstable angina 16%), in whom primary PCI was performed between January and December 2002. In 156 (80%) patients glycoprotein IIb/IIIa inhibitors were administered during the procedure. In 73 patients (38%) direct stent implantation could be performed successfully. In 12 patients (6%) direct stent implantation failed due to the inability to pass the stenosis. In 121 patients (62%) the stent was implanted after predilatation. RESULTS: The clinical parameters were comparable in both groups. Reference luminal diameter before stent implantation did not differ in both groups (DS 3.01+/-0.54 vs. CS 2.84+/-0.43 mm). The final minimal luminal diameter was significantly higher in the DS group (DS 2.95+/-0.45 vs. CS 2.77+/-0.47 mm, p=0.01). The procedural time (DS 41.0+/-14.1 vs. CS 46.8+/-16.9 min, p=0.02), radiation exposure time (DS 7.3+/-4.6 vs. CS 8.9+/-4.6 min, p=0.002) and the amount of contrast agent (DS 216+/-90 vs. CS 235+/-79 ml, p=0.03) could be decreased by the technique of direct stent implantation. The incidence of major adverse cardiac events (death, myocardial infarction, CABG) during hospitalization was 4.1% in the DS group and 11.5% in the CS group (p=0.11). CONCLUSIONS: Direct stent implantation is safe and feasible in patients with acute coronary syndromes. The procedural time, radiation exposure time and the amount of contrast agent can be significantly decreased using the technique of direct stent implantation. The incidence of major adverse cardiac events was not significantly different in this subset of patients.     

Early and long-term outcomes after percutaneous coronary intervention of unprotected left main coronary disease with drug-eluting stents in patients with non-ST-elevation acute coronary syndrome

Background

Patients presenting with non-ST-elevation acute coronary syndrome (NSTE-ACS) and unprotected left main coronary disease (ULMCD) are among the highest risk patients but current consensus guidelines do not address the optimal timing and mode of revascularization for these individuals.

Methods

In this single-centre registry, we evaluated the clinical outcomes of 151 consecutive patients with NSTE-ACS and ULMCD who underwent percutaneous coronary intervention with drug-eluting stents from 2005 to 2009.

Results

Overall in-hospital major adverse cardiac event (MACE) rate was 5.3%, mortality rate was 0.7%. At 30 months ± 15 months, 30 patients (19.9%) experienced MACE. The 4-year cumulative survival rate of no MACE was 73.2% and cumulative survival rate was 90.6%. Left ventricular ejection fraction (hazard ratio [HR] 0.947; 95% confidence interval [CI], 0.898-0.998; P = 0.043) and SYNTAX [SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery] score ≥ 33 (HR 1.28; 95% CI, 1.025-1.433; P = 0.029) were associated with MACE, while only left ventricular ejection fraction (HR 0.82; 95% CI, 0.69-0.973; P = 0.023) was associated with mortality.

Conclusions

Our study demonstrates the feasibility of percutaneous coronary intervention with drug-eluting stents in patients with NSTE-ACS and ULMCD. The early and long-term outcomes were acceptable. Left ventricular ejection fraction and SYNTAX score ≥ 33 predict MACE and only left ventricular ejection fraction predicts mortality.     

Clinical outcome of patients with chronic total occlusion treated with drug-eluting stents

BACKGROUND: There is limited evidence on the medium-term prognosis of patients with chronic total occlusion successfully treated with drug-eluting stent (DES) implantation. METHODS: We compared the medium-term outcome of 111 patients with chronic total occlusion (CTO) successfully treated with implantation of sirolimus-or paclitaxel-eluting stents versus 112 patients treated with bare metal stents. RESULTS: During an overall follow-up period of 18 months, the composite endpoint of death, myocardial infarction or target lesion revascularization was significantly lower in the drug-eluting stent than in the bare metal stent group: 8.1% vs. 21.6%, respectively (p=0.005). The difference was due to the reduction of target lesion revascularization with DES compared to bare metal stents: 3.6% vs. 18.9%, respectively (p<0.001). The Cox proportional hazards model identified DES as an independent predictor of adverse cardiac events (adjusted hazard ratio, 0.16; 95% confidence interval 0.05 to 0.52, p=0.002). CONCLUSIONS: During medium-term follow-up use of DES is associated with improved outcome compared to use of bare metal stents in patients with CTO.     

Relationship between symptom-onset-to-balloon time and long-term mortality in patients with acute myocardial infarction treated with drug-eluting stents

Background

Time from hospital arrival to reperfusion in ST-segment elevation myocardial infarction (STEMI) has been predictive of in-hospital mortality. The purpose of this study was to evaluate the relationship between symptom-onset-to-balloon time and long-term mortality in patients with STEMI in the drug-eluting stent (DES) era.

Methods

A series of 393 patients with STEMI treated with DES from 2005 to 2007 was stratified according to risk profile and preprocedural Thrombolysis In Myocardial Infarction (TIMI) flow grade, and clinical, angiographic, and follow-up data were collected.

Results

A total of 98 (24.9%) low-risk patients and 295 (75.1%) non-low-risk patients were identified. Three-year mortality rate was 3.1% for low-risk patients and 10.2% for non-low-risk patients (p = 0.034), respectively; however it did not differ according to symptom-onset-to-balloon time in either low-risk (p = 0.333) or non-low-risk patients (p = 0.881). Similarly, symptom-onset-to-balloon time and mortality were not related to preprocedural TIMI flow (p = 0.474 for TIMI 0–1; p = 0.428 for TIMI 2–3). In multivariate analysis, final TIMI flow 0–2, systolic blood pressure <100 mmHg at admission, age ≥70 years, anterior infarction, C-reactive protein level, and peak creatine kinase myocardial band isoenzyme level were identified as independent predictors of 3-year mortality while symptom-onset-to-balloon time and preprocedural TIMI flow were not.

Conclusions

In STEMI patients treated with DES, symptom-onset-to-balloon time does not affect long-term outcomes even in individuals at non-low risk and with poor preprocedural TIMI flow grade.     

药物洗脱支架植入术联合氯吡格雷治疗冠心病的临床疗效

目的探讨药物洗脱支架(DES)植入术联合氯吡格雷治疗冠心病的临床疗效。方法回顾性分析2007年1月至2011年12月,该院收治的73例接受经皮冠状动脉介入治疗(PCI)的患者,对照组(DES治疗术后,除了常规二级预防以外,服用氯吡格雷12个月)28例,观察组(DES治疗术后,除了常规二级预防外,服用氯吡格雷18个月)45例。比较两组治疗2年后急性心血管事件的再发生率、再次住院率、死亡率的差别。结果对照组与观察急性心血管事件发生率(10.7%vs 4.4%,P=0.001)、再次住院率(14.3%vs 4.4%,P=0.001)、晚期血栓发生率(14.3%vs 6.3%,P=0.001)比较差异显著,有统计学意义;死亡率(0%vs 0%,P=0.95)比较差异无统计学意义(P>0.05)。两组患者治疗后血液流变学指标显著优于治疗前,差异有统计学意义(P<0.05);观察组治疗后血液流变学指标明显优于对照组,差异有统计学意义(P<0.05)。远期观察疗效良好。结论 DES植入联合氯吡格雷对冠心病治疗效果良好,值得推广。     

药物洗脱支架对开通冠状动脉慢性完全闭塞病变患者预后的影响

目的:评价经皮冠状动脉介入治疗(PCI)成功开通冠状动脉慢性完全闭塞病变(CTO),对患者长期预后的影响。方法:连续选取2010年1月至2012年1月,在首都医科大学附属北京安贞医院心内科一病房,经冠状动脉造影检查证实CTO病变,并PCI试行开通CTO病变患者为研究对象。记录患者临床资料、冠状动脉造影情况、手术并发症及PCI结果,根据手术是否成功分为PCI成功组(n=583)和PCI失败组(n=101)。院外随访入选患者,随访截止至2015年1月。随访主要终点事件为全因死亡率,次要终点事件为非致死性心肌梗死、再次血运重建及总MACE发生率,比较PCI成功组与失败组长期预后的差别。结果:研究共入选CTO患者684例,583例经PCI成功开通并置入药物涂层支架,开通率(85.2%)。随访时间4.6(3,5)年,其中成功开通CTO组失访60例(失访率10.3%),失败组失访10例(失访率9.9%)。校正前PCI成功组总MACE(23.3%vs.48.5%,P0.05)、全因死亡率(5.2%vs.17.8%,P0.05)、TVR率(11.2%vs.21.8%,P0.05)低于失败组,非致死性MI发生率与失败组差异无统计学意义(7.0%vs.8.9%,P0.05)。Cox模型多因素分析显示,PCI成功组总MACE发生率(HR:1.421,95%CI:1.079~1.870)、全因死亡率(HR:0.324,95%CI:0.165~0.637)、TVR率(HR:2.077,95%CI:1.459~2.761)仍明显低于失败组(P0.05)。结论:对慢性闭塞病变行成功的PCI术,可以降低全因死亡率和再次血运重建率,降低MACE的发生率,改善患者长期预后。     

Long-term prognosis of patients with acute coronary syndrome and moderate coronary artery stenosis

We evaluated the clinical outcome and the prognostic factors at 6-year follow-up of patients with acute coronary syndrome without critical coronary arterial narrowing. The mean follow-up was 73 +/- 19 months. Mortality rate was 13%, and 20 patients (12%) had major cardiac event, 8 patients (5%) had stroke and 10 patients (6%) underwent revascularization. Multivariate analysis matched for age and ejection factor showed that moderate disease (stenosis 40-59%) (OR = 2.713, p < 0.024) was an independent predictive factor of major cardiac event.     

药物洗脱支架对冠心病合并2型糖尿病患者的临床疗效

目的：评价药物洗脱支架在冠心病合并2型糖尿病患者中的临床疗效。方法：68例冠心病合并2型糖尿病患者接受冠脉内原发病变药物洗脱支架置入(SES组)；对照组(BS组)是从我科资料库中抽取的原发病变置入普通支架的56例冠心病合并2型糖尿病患者。结果：术后1年内随访结果SES组与BS组手术成功率相似(分别为97．1%与98．2%,P=1．00)。SES组与BS组累计1年内主要不良心脏事件发生率分别为19．1%与35．7%(P=0．037,OR=0．425,95%CI：0．188～0．961),再次血运重建率为10．3%与25．0%(P=0．03,OR=0．344,95%CI：0．128～0．925),死亡、急性心肌梗死无差异。结论：药物洗脱支架较普通支架显著降低糖尿病患者冠脉介入治疗的1年主要不良心脏事件。