Predictors of long-term major adverse cardiac events and clinical restenosis following elective percutaneous coronary stenting

Limited data exist regarding the predictors of long-term clinical outcomes following elective percutaneous coronary intervention (PCI) in the current era of stenting. The authors investigated the predictors of major adverse cardiac events (MACE) and clinical restenosis in 740 consecutive patients who underwent successful elective PCI with bare metal stents (BMSs) or drug-eluting stents (DESs). At 30-month follow-up, compared with BMS recipients, DES recipients had a significantly lower rate of MACE, which was mainly driven by a decreased repeat target vessel PCI. The rate of 30-month clinical restenosis was significantly lower in DES recipients. The authors conclude that baseline clinical, angiographic, and procedural characteristics determine long-term MACE and clinical restenosis after elective PCI, with DES being the independent predictor for both.     

药物洗脱支架在老年急性心肌梗死患者治疗中疗效观察

目的评价药物洗脱支架治疗老年ST段抬高型急性心肌梗死（AMI）患者的安全性和有效性。方法连续性收集2005年1月-12月行直接介入治疗的105例60岁及以上的老年ST段抬高型AMI患者，其中，49例接受药物洗脱支架植入，56例接受金属裸支架植入，对两组患者术后30d和240d的主要心血管不良事件（包括死亡、非致死性再梗死和靶血管血运重建）进行随访、分析。结果药物洗脱支架组和金属裸支架组的手术成功率差异无统计学意义（96％与95％，P〉0．05）。术后30d内，药物洗脱支架组和金属裸支架组的心脏不良事件发生率差异无统计学意义（8、2％与12．5％，P〉0.05），两组由冠状动脉造影证实的早期支架内血栓发生率差异无统计学意义（2．0％与1．8％，P〉0.05）。术后240d随访，与金属裸支架植入比较，药物洗脱支架植入能明显减少心脏不良事件发生率[12．2％与30、0％，相对危险比为0、38，95％可信限（CI）：0、12～0、96，P〈0.053，靶血管血运重建率显著降低[2.0％与25．0％，相对危险比为0．08（95％CI：0．01～0.63），P〈0．01]。术后30～240d，两组未发生晚期支架内血栓。结论与金属裸支架比较，药物洗脱支架应用于老年ST段抬高型AMI患者可能并不增加支架内血栓的中期发生率，同时可以降低患者8个月靶血管再次血运重建率。     

Treatment of saphenous vein graft lesions with drug-eluting stents: immediate and midterm outcome

OBJECTIVES: The purpose of the present report was to evaluate clinical and angiographic outcomes of drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions. BACKGROUND: The safety and efficacy of DES implantation for the treatment SVG lesions remains uncertain. METHODS: We evaluated in-hospital and six-month outcomes in 61 consecutive patients treated with DES in SVG lesions from March 2002 to March 2004 (DES group), as compared to 89 consecutive patients treated with bare-metal stents (BMS) in the 24 months immediately before the introduction of DES (BMS group). Major adverse cardiac events (MACE) including death, myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR) were recorded in-hospital and at six-month follow-up. RESULTS: The rate of in-hospital MACE was similar between the two groups (6.6% vs. 5.6%, p = 1.0). Cumulative MACE at six months was 11.5% in the DES group and 28.1% in the BMS group (p = 0.02). The DES group had a significantly lower incidence of in-segment restenosis (10.0% vs. 26.7%, p = 0.03), TLR (3.3% vs. 19.8%, p = 0.003), and TVR (4.9% vs. 23.1%, p = 0.003). By Cox regression analysis, diabetes (hazard ratio [HR]: 3.03; 95% confidence interval [CI]: 1.33 to 6.90; p = 0.008), usage of BMS (HR: 2.53; 95% CI: 1.07 to 5.97; p = 0.03), and age of SVG (HR: 1.10; 95% CI: 1.02 to 1.19; p = 0.02) were identified as predictors of MACE at six-month follow-up. CONCLUSIONS: Compared to BMS implantation, DES implantation in SVG lesions appears safe with favorable and improved mid-term outcomes.     

Comparison of one-year outcome of patients aged <75 years versus ≥75 years undergoing "rescue" percutaneous coronary intervention

The influence of age on the clinical results after rescue angioplasty (percutaneous coronary intervention [PCI]) has been poorly investigated. In the present study, we evaluated the outcome of 514 consecutive patients undergoing rescue PCI who were divided into 2 groups according to age: <75 years (n = 469) and ≥75 years (n = 45). The primary end point of the study was the incidence of death at 1 year of follow-up. The secondary end point was the 1-year incidence of major cardiac adverse events (MACE) defined as a composite of death, recurrent acute myocardial infarction, and target vessel revascularization. The predictors of death and MACE at 1 year were also investigated. At 1 year of follow-up, the <75-year-old group had a significantly lower incidence of death (7% vs 24%, p = 0.0001) and MACE (14% vs 28%, p = 0.01) compared to the ≥75-year-old group. The Cox proportional hazards model identified age (adjusted hazard ratio 0.2665, 95% confidence interval 0.1285 to 0.5524, p = 0.0004), cardiogenic shock (hazard ratio 0.1057, 95% confidence interval 0.0528 to 0.2117, p <0.000001), Thrombolysis In Myocardial Infarction flow grade 2 to 3 after PCI versus 0 to 1 (hazard ratio 3.8380, 95% confidence interval 1.7781 to 8.2843, p = 0.0006), multi- versus single-vessel disease (hazard ratio 0.3716, 95% confidence interval 0.1896 to 0.7284, p = 0.0039) as independent predictors of survival at 1 year of follow-up. In conclusion, at 1 year of follow-up after rescue PCI, the patients aged ≥75 years had a greater incidence of death and MACE compared to patients aged <75 years. Age, cardiogenic shock, Thrombolysis In Myocardial Infarction flow grade 0-1 after PCI, and multivessel coronary disease were predictors of survival and freedom from MACE at 1 year of follow-up.     

Safety and efficacy with drug-eluting stent in ST-segment elevation and non-ST-segment elevation myocardial infarction

BACKGROUND: Drug-eluting stents (DES) have been shown to reduce the need for repeat revascularization compared with bare metal stents (BMS). However, there is little information regarding the safety and long-term efficacy of DES in patients with acute myocardial infarction (AMI). HYPOTHESIS: The aim of this study was to evaluate the safety and efficacy of DES in patients with AMI. METHODS: Data from 211 consecutive patients with AMI treated with DES were compared with those from 228 consecutive patients with AMI treated with BMS. All patients were treated within 7 days of symptom onset. The incidence of major adverse cardiovascular events ([MACE]: death, reinfarction, and target vessel revascularization) was evaluated at 30 days and 1 year. RESULTS: Baseline clinical and angiographic characteristics were similar for both stent groups. However, patients who received DES had longer lesion lengths (23.0 +/- 12.7 vs. 18.8 +/- 10.6 mm, respectively; p < 0.001) and smaller reference diameters (2.97 +/- 0.52 vs. 3.19 +/- 0.63 mm, respectively, p < 0.001). At 30 days, the incidence rates of MACE (DES vs. BMS: 2.2 vs. 1.9%, p = 1.000) and stent thrombosis (BMS vs. DES: 0.9 vs. 1.7%; p = 0.434) did not differ significantly between the groups. At 1 year, patients with DES had a lower rate of MACE (BMS vs. DES: 14.0 vs. 6.6%; p = 0.011) primarily due to a lower target vessel revascularization rate (BMS vs. DES: 9.6 vs. 4.8%; p = 0.028). CONCLUSIONS: The DES appear to be superior to the BMS in reducing the risk of MACE in patients with AMI.     

Comparison of drug-eluting versus bare metal stents on later frequency of acute myocardial infarction and death

In clinical trials of highly selected patients, drug-eluting stents (DESs) decreased restenosis but not the rate of acute myocardial infarction (AMI) or death. Whether DES use has an affect on the rate of AMI or death in unselected patients is uncertain. Bare metal stents (BMSs) were placed in 1,164 consecutive patients in the year before the introduction of DESs. DESs were subsequently placed in 1,285 consecutive comparable patients at Wake Forest Baptist Medical Center. Early and late clinical outcomes were compared. Propensity score analysis was used to adjust outcomes for baseline differences. Patient and procedural characteristics of the 2 groups were similar, with an overall incidence of 72% for acute coronary syndromes (p = NS). At 9 months, target vessel revascularization (2.8% vs 8.6%, p <0.001), AMI (3.7% vs 4.7%, p = 0.257), and death (4.9% vs 7.1%, p = 0.030) were lower in the DES group than in the BMS group. Propensity score-adjusted Cox proportional hazard ratios for DES versus BMS at 9 months were 0.71 (95% confidence interval 0.42 to 1.19) for AMI, 0.56 (95% confidence interval 0.36 to 0.87) for death, and 0.60 (95% confidence interval 0.42 to 0.86) for the combined end point of AMI or death. In conclusion, in this single-center observational study, use of DESs in consecutive unselected patients, most of whom would not have been eligible for inclusion in the randomized trials of DES versus BMS, was associated with lower AMI and death rates than in a comparable group of patients treated with BMSs in mid-term (9-month) follow-up.     

Frequency of coronary arterial late angiographic stent thrombosis (LAST) in the first six months: outcomes with drug-eluting stents versus bare metal stents

Concerns have been raised about the long-term safety of drug-eluting stent (DES) implantation due to late angiographic stent thrombosis (LAST). We investigated the incidence and 6-month clinical and angiographic outcomes of LAST after DES versus bare metal stent (BMS) implantation. This study comprised 6,551 patients treated with BMSs (n = 4,104) or DESs (n = 2,447). LAST was defined as angiographically proved stent thrombotic occlusion with acute ischemic symptoms >30 days after stenting. Major adverse cardiac events were defined as death, Q-wave myocardial infarction, and target lesion revascularization. Patients treated with DESs had a significantly higher risk profile than did patients treated with BMSs. There were 8 cases (0.33%) of LAST in the DES group and 7 (0.17%) in the BMS group, showing similar event rates after risk adjustment (adjusted hazard ratio 1.2, 95% confidence interval 0.1 to 18.4, p = 0.9). Four patients with LAST treated with DESs (50%) and 1 treated with BMSs (14%) were associated with discontinuation of antiplatelet therapy. Two cases (25%) of LAST with DESs occurred in patients on aspirin monotherapy and another 2 cases (25%) occurred in patients on dual antiplatelet therapy. There was no case of in-hospital death associated with LAST events. At 6-month follow-up after LAST events, major adverse cardiac events occurred in only 3 patients (43%) in the BMS group. In conclusion, the incidence of LAST was similar after DES and BMS implantations. LAST treated with DESs was associated with antiplatelet therapy discontinuation in a significant number of patients, and LAST events also developed on dual antiplatelet therapy. Patients with LAST and DESs showed favorable outcomes during follow-up.     

Comparison of frequency of major adverse events in patients with atrial fibrillation receiving bare-metal versus drug-eluting stents in their coronary arteries

In patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with drug-eluting stent (DES) implantation, the available evidence from clinical trial data are inconclusive. We evaluated the safety and efficacy of the use of DESs versus bare-metal stents (BMSs) in a consecutive real-world cohort of patients with AF. Of 8,962 unselected patients with AF seen in our institution from 2000 through 2010, 833 (9%) had undergone percutaneous coronary intervention with stent implantation. BMSs were used for 678 patients (81%) and DESs for 155 (19%). During follow-up (median 688 days, interquartile range 1,114), all bleeding episodes, thromboembolism, and major adverse cardiac events (MACEs; i.e., death, acute myocardial infarction, target lesion revascularization) were recorded. Incidence of MACEs was similar in the 2 groups as was incidence of all-cause mortality. Results remained similar even after adjustment for age and other confounding factors. Factors independently associated with an increased risk of MACEs were older age (hazard ratio 1.024, 95% confidence interval 1.004 to 1.044, p = 0.02), implantation of stent during acute ST-segment elevation myocardial infarction (hazard ratio 1.81, 95% confidence interval 1.10 to 2.99, p = 0.02), and stent diameter (hazard ratio 1.09, 95% confidence interval 1.01 to 1.18, p = 0.03). Implantation of DESs was not significantly associated with a higher risk of major bleeding and we observed a similar ratio of serious events at follow-up after DES compared to BMS implantation. In conclusion, in our cohort, systematic use of DESs does not seem to be justified in most patients with AF because it was not associated with any clear advantage compared to BMSs.     

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)     

Comparison of long-term clinical and angiographic outcomes following implantation of bare metal stents and drug-eluting stents in aorto-ostial lesions

Percutaneous coronary intervention (PCI) to aorto-ostial (AO) lesions is technically demanding and associated with high revascularization rates. The aim of this study was to assess outcomes after bare metal stent (BMS) compared to drug-eluting stent (DES) implantation after PCI to AO lesions. A retrospective cohort analysis was conducted of all consecutive patients who underwent PCI to AO lesions at 2 centers. Angiographic and clinical outcomes in 230 patients with DES from September 2000 to December 2009 were compared to a historical control group of 116 patients with BMS. Comparison of the baseline demographics showed more diabetics (32% vs 16%, p = 0.001), lower ejection fractions (52.3 ± 9.7% vs 55.0 ± 11.5%, p = 0.022), longer stents (17.55 ± 7.76 vs 14.37 ± 5.60 mm, p <0.001), and smaller final stent minimum luminal diameters (3.43 ± 0.53 vs 3.66 ± 0.63 mm, p = 0.001) in the DES versus BMS group. Angiographic follow-up (DES 68%, BMS 66%) showed lower restenosis rates with DES (20% vs 47%, p <0.001). At clinical follow-up, target lesion revascularization rates were lowest with DES (12% vs 27%, p = 0.001). Cox regression analysis with propensity score adjustment for baseline differences suggested that DES were associated with a reduction in target lesion revascularization (hazard ratios 0.28, 95% confidence interval 0.15 to 0.52, p <0.001) and major adverse cardiac events (hazard ratio 0.50, 95% confidence interval 0.32 to 0.79, p = 0.003). There was a nonsignificantly higher incidence of Academic Research Consortium definite and probable stent thrombosis with DES (n = 9 [4%] vs n = 1 [1%], p = 0.131). In conclusion, despite differences in baseline characteristics favoring the BMS group, PCI with DES in AO lesions was associated with improved outcomes, with lower restenosis, revascularization, and major adverse cardiac event rates.     

Early outcome of treatment of ostial de novo left anterior descending coronary artery lesions with drug-eluting stents

We investigated early and mid-term clinical and angiographic outcomes of patients who had de novo ostial left anterior descending coronary artery (LAD) lesions that were treated with drug-eluting stents (DESs) or bare metal stents (BMSs). We identified 43 consecutive patients who underwent percutaneous intervention for isolated de novo ostial LAD lesions with implantation of DESs and compared them with 43 patients who had similar lesions that were treated with BMSs. All stents were successfully implanted. There were no significant differences with respect to major in-hospital complications between the 2 groups. One patient in the BMS group died during hospitalization. Non-Q-wave myocardial infarction occurred in 2 patients (4.7%) in the DES and in 1 patient (2.3%) in the BMS group. At 9-month follow-up, 3 patients (7%) in the DES group and 11 (25.6%) in the BMS group underwent target lesion revascularization (p = 0.038); major adverse cardiac events were less frequent in the DES than in the BMS group (9.3% vs 32.6%, p = 0.015). Angiographic follow-up was available in 82% of patients in the DES group and 75% of those in the BMS group (p = 0.6) and showed lower binary restenotic rates (5.7% vs 31.3%, p = 0.01) and smaller late loss (0.30 +/- 0.81 vs 1.23 +/- 0.93 mm, p = 0.0001) in the DES group. In conclusion, DES implantation in de novo ostial LAD lesions appears safe and effective and is associated with a significant decrease in restenotic rates compared with historical experience with BMSs.     

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.     

Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention

BackgroundThe majority of stent-related major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI) are believed to occur within the first year. Very-late (>1-year) stent-related MACE have not been well described.ObjectivesThe purpose of this study was to assess the frequency and predictors of very-late stent-related events or MACE by stent type.MethodsIndividual patient data from 19 prospective, randomized metallic stent trials maintained at a leading academic research organization were pooled. Very-late MACE (a composite of cardiac death, myocardial infarction [MI], or ischemia-driven target lesion revascularization [ID-TLR]), and target lesion failure (cardiac death, target-vessel MI, or ID-TLR) were assessed within year 1 and between 1 and 5 years after PCI with bare-metal stents (BMS), first-generation drug-eluting stents (DES1) and second-generation drug-eluting stents (DES2). A network meta-analysis was performed to evaluate direct and indirect comparisons.ResultsAmong 25,032 total patients, 3,718, 7,934, and 13,380 were treated with BMS, DES1, and DES2, respectively. MACE rates within 1 year after PCI were progressively lower after treatment with BMS versus DES1 versus DES2 (17.9% vs. 8.2% vs. 5.1%, respectively, p < 0.0001). Between years 1 and 5, very-late MACE occurred in 9.4% of patients (including 2.9% cardiac death, 3.1% MI, and 5.1% ID-TLR). Very-late MACE occurred in 9.7%, 11.0%, and 8.3% of patients treated with BMS, DES1, and DES2, respectively (p < 0.0001), linearly increasing between 1 and 5 years. Similar findings were observed for target lesion failure in 19,578 patients from 12 trials. Findings were confirmed in the network meta-analysis.ConclusionsIn this large-scale, individual patient data pooled study, very-late stent-related events occurred between 1 and 5 years after PCI at a rate of ∼2%/year with all stent types, with no plateau evident. New approaches are required to improve long-term outcomes after PCI.     

Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes

Patients still present with drug-eluting stent (DES) failure despite an angiographically successful implantation. The aim of the present study was to investigate the relation between the fractional flow reserve (FFR) measured after DES implantation and the clinical outcomes at 1 year. A total of 80 patients (mean age 62 years, 74% men, 99 DESs) underwent coronary pressure measurement at maximum hyperemia after successful DES implantation. The composite of major adverse cardiac events (MACE), including death, myocardial infarction, and ischemia-driven target vessel revascularization was evaluated at 1 year. The patients were divided into 2 groups (low-FFR group, FFR ≤0.90 and high-FFR group, FFR >0.90) according to the median FFR. The mean poststent percent diameter stenosis was 11 ± 5% in the low-FFR group and 12 ± 3% in the high-FFR group (p = 0.31). Left anterior descending coronary artery lesions were more frequent in the low-FFR group than in the high-FFR group (82% vs 55%, p = 0.02). The mean stent length was greater in the low-FFR group than in the high-FFR group (38 ± 18 vs 28 ± 13 mm, p = 0.01). Six cases (7.5%) of MACE occurred during the 1-year follow-up. The rate of MACE was 12.5% in the low-FFR group and 2.5% in the high-FFR group (p <0.01). Receiver operating characteristic curves revealed 0.90 as the best cutoff of FFR after DES implantation for the prediction of 1-year MACE. In conclusion, a poststent FFR of ≤0.90 correlated with a greater adverse event rate at 1 year.     

85岁及以上老年冠心病患者经皮冠状动脉支架治疗的临床观察

目的 探讨85～94岁冠心病患者经皮冠状动脉支架治疗的疗效和预后.方法 回顾性分析90例85岁以上冠心病患者经皮冠状动脉支架治疗的临床和造影特点、住院期间和长期疗效.结果 90例中,21例应用金属裸支架(BMS),69例应用药物洗脱支架(DES).三支病变41例,2支病变21例,单支病变28例.手术成功率为94.4%,术前与术后TIMI-3级血流比例分别为72.2%和94.4%.手术相关并发症为15.6%,主要为冠脉夹层(11.1%).住院期间主要心血管不良事件(MACE)为7.8%,其中DES组住院期间MACE为5.8%,BMS组为14.3%.DES组出现2例严重出血.86例患者随访1年时,总的MACE为4.6%,其中DES组为6.0%,BMS组没有任何MACE.DES组出现]例脑卒中和1例严重出血.47例患者随访2年时,总的MACE为14.9%,其中DES组MACE为19.4%,BMS组无任何MACE.DES组1例发生严重出血,BMS组1例发生脑卒中.多因素COX回归分析表明,肌酐水平和高血压是影响长期预后的重要因素.结论 85岁以上冠心病患者经皮冠状动脉支架治疗手术成功牢较高,住院期间和长期的MACE事件发生率较低,并存高血压和严重.肾功能不全的患者MACE的发生率相对较高.     

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 stent-supported percutaneous coronary intervention for chronic total coronary occlusion.

OBJECTIVES: This study sought to determine the clinical and angiographic outcomes after drug-eluting stent (DES)-supported percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO). BACKGROUND: There are few data about the efficacy of DES-supported PCI for CTO. METHODS: All consecutive patients who had a sirolimus-eluting stent or a paclitaxel-eluting stent implanted for CTO from December 2003 to December 2004 were analyzed. Clinical and angiographic outcomes of patients treated with DES were compared with a case-matched control group of patients treated with bare metal stents (BMS) in the 12 months before the routine use of DES. RESULTS: Successful DES-supported PCI was performed in 92 patients and 104 CTO. The case-matched control group consisted of 26 patients and 27 CTO successfully treated with BMS. There were no differences between groups in baseline clinical and angiographic characteristics. Stent length in the DES group was higher as compared with that of BMS group (51+/-28 mm vs. 40+/-19 mm, P=0.073). The 6-month major adverse cardiac event (MACE) rate was lower in the DES group as compared with that of BMS group (9.8% vs. 23%, P=0.072). The angiographic follow-rate was 80% in the DES group and 81% in the BMS group. The 6-month restenosis rate was 19% in the DES group and 45% in the BMS group (P<0.001). By multivariate analysis, it was found that in the DES group, the only predictors of restenosis were stented segment length (OR 1.031, 95% CI 1.01-1.06, P=0.009) and a target vessel reference diameter<2.5 mm (OR 6.48, 95% CI 1.51-27.83, P=0.012), while the only predictor of MACE was stent length (OR 1.04, 95% CI 1.01-1.08, P=0.006). CONCLUSIONS: DES implantation for CTO decreases the risk of mid-term restenosis and MACE. Small vessels and diffuse disease requiring the implantation of multiple stents and very long stents for full coverage of the target lesion are still associated with a relatively high risk of restenosis.     

雷帕霉素洗脱支架对糖尿病患者经皮冠状动脉介入治疗的远期影响

目的分析雷帕霉素洗脱支架(SES)对糖尿病患经皮冠状动脉介入治疗后的远期影响。方法采用回顾性研究方法,在1004．例接受冠状动脉内支架术治疗的冠心病患中,84例糖尿病和250例非糖尿病患置入SES;168例糖尿病和502例非糖尿病患置入普通支架。记录并比较一般临床资料、冠状动脉造影及冠状动脉内支架术情况、远期心脏事件发生率和1年无心脏事件生存率。结果随访期间(平均16．2个月),SES组中糖尿病亚组和非糖尿病亚组的远期心脏事件发生率为4．8％比3．6％,P=0．744;1年无心脏事件生存率为95．0％比96．7％,P=0．602,两亚组差异均无统计学意义。但BMS组中,糖尿病亚组的远期心脏事件发生率显高于非糖尿病组(31.0%比21．7％,P=0．015);两亚组的1年无心脏事件生存率分别为74．2％比86．8％(P=0．001)。结论SES能显改善糖尿病患冠状动脉支架术的远期疗效,降低靶病变再狭窄和远期心脏事件的发生率,提高1年无心脏事件生存率。     

Are drug-eluting stents safer and more effective than bare-metal stents in patients with acute myocardial infarction?

Questions about the long-term safety over the beneficial effects of drug-eluting stents (DES) have grown. We compared the long-term safety and efficacy of DES and bare-metal stents (BMS) in patients with acute myocardial infarction (AMI). A total of 1,017 AMI patients treated with stent implantation were followed for 3 years; 660 (64.9%) patients were treated with at least one DES and 357 (35.1%) patients were treated with at least one BMS. The primary endpoints were total mortality and the composite of major adverse cardiac events (MACE) including total mortality, re-MI, target lesion revascularization (TLR), and coronary artery bypass graft. At 3-years, the overall risks of cardiac and all-cause mortality were not different between the groups. However, the use of DES significantly decreased TLR (17.4% versus 7.1%, adjusted hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.30 to 0.65) and the composite of MACEs (27.2% versus 19.5%, adjusted HR 0.65, 95% CI 0.48 to 0.87) with no differences in MI. The risk of MACE up to 1 year (HR 0.56, 95% CI 0.39 to 0.80) was higher in BMS patients, whereas from 1 year to 2 years (HR 0.55, 95% CI 0.27 to 1.10) and from 2 years to 3 years (HR 1.13, 95% CI 0.56 to 2.28), it was similar between the groups. The use of DES does not have a significant effect on overall long-term clinical survival compared with that of BMS in AMI patients. However, the use of DES reduced the need for re-intervention and the risk of MACE, mostly within 1 year.     

Five-Year Outcomes in Patients With Chronic Total Coronary Occlusion Treated With Drug-Eluting vs Bare-Metal Stents: A Case-Control Study

Background

Limited data exist on long-term safety and effectiveness of drug-eluting stents (DESs) in true chronic total coronary occlusion (CTO) settings. We evaluated 5-year clinical outcomes of patients with CTO treated successfully with DES vs bare-metal stent (BMS).

Methods

We compared the 5-year clinical outcomes of 156 patients treated with DES implantation with outcomes of a historical cohort of 159 patients treated with BMS. Primary end point was freedom from major adverse cardiac events (MACEs; defined as death, myocardial infarction [MI], and target lesion revascularization [TLR]); secondary end points were freedom from target vessel failure (TVF; combination of target vessel revascularization, MI, and cardiac death) and TLR at 5 years.

Results

After 5 years, the DES group had significantly superior event-free survival from MACE (84% vs 69%; log rank P < 0.001), TVF (71% vs 84%; P = 0.002), and TLR (77% vs 92%; P = 0.0001), compared with the BMS group. The Cox proportional hazards model identified BMS vs DES (adjusted hazard ratio [HR] = 3.37; 95% confidence interval [CI], 1.85-6.17; P = 0.001), final minimal lumen diameter (HR, 0.27; 95% CI, 0.14-0.52; P = 0.0001), and stent length (HR, 1.01; 95% CI, 1.00-1.03; P = 0.03) as independent predictors of MACE at 5-year follow-up. Twelve (7%) and 7 (4%) stent thromboses occurred in the DES and BMS groups (P = 0.23), respectively.

Conclusions

After 5 years, DESs were superior to BMSs in reducing MACE, TVF, and TLR in patients with CTO and should be the preferred strategy.