Rotational atherectomy for fibro‐calcific coronary artery disease in drug eluting stent era: Procedural outcomes and angiographic follow‐up results

Objectives: The aim of this study was to examine the binary re‐stenosis rates, procedural success, and in hospital outcomes following treatment of fibro‐calcified coronary lesion with rotational atherectomy in drug eluting stent era. Background: Binary restenosis rates have remained high with the use of bare metal stents following rotational atherectomy in calcified lesions. There is limited data available following rotational atherectomy in drug eluting stent era. Methods: We evaluated the procedural and angiographic outcomes following a consecutive series of 516 procedures treated with rotational atherectomy followed by stenting. We compared the results between Rota + Drug eluting stent (DES) and Rota + bare metal stent (BMS) groups. Results: Procedural success was achieved in 97.1% of the lesions with overall low in hospital adverse events (death in 1.1%, Q MI in 1.3%, Non Q MI in 5.3%, and urgent repeat PCI in 0.4%). There was significant reduction in the binary restenosis rates following Rota + DES use as compared to Rota + BMS use (11% vs. 28.1%, P < 0.001; OR = 3.17, 95% CI: 1.76–5.93) and similar reduction was seen in the target lesion revascularization (10.6% vs. 25%, P = 0.001; OR = 2.81, 95% CI: 1.53–5.14). We have identified ostial lesions, chronic total occlusion lesions, and use of bare metal stents as independent predictors of restenosis in this group of patients. Conclusions: Rotational atherectomy can be performed with high success rates and low complications, and rotational atherectomy followed by drug eluting stent implantation significantly reduces binary restenosis rates in fibrocalcific lesions as compared to rotational atherectomy and bare metal stents. © 2010 Wiley‐Liss, Inc.     

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.     

Drug-eluting stent restenosis the pattern predicts the outcome.

OBJECTIVES: We sought to determine if the angiographic pattern of in-stent restenosis in drug-eluting stents (DES) maintains its prognostic importance. BACKGROUND: The pattern of restenosis in the bare-metal stent era had a significant impact on therapeutic outcomes. METHODS: We identified a total of 250 consecutive restenotic lesions in 203 patients (66.4% sirolimus-eluting stents and 33.6% paclitaxel-eluting stents). We divided these lesions into two groups: focal, defined as < or =10 mm, 163 lesions (65.2%); and nonfocal, which were diffuse, proliferative, or obstructive, 87 lesions (34.8%). The end points analyzed were angiographic restenosis and target lesion revascularization (TLR). RESULTS: Diabetes was the only clinical variable associated with the pattern of restenosis (28.8% focal compared with 52.9% diffuse; p = 0.0001). Angiographic follow-up of the treatment of restenosis was available in 61.2% of the lesions and was similar between the two groups. The rate of angiographic restenosis was 17.8% in the focal group and 51.1% in the nonfocal group (p = 0.0001). The incidence of TLR also increased with the type of restenosis treated (9.8% and 23%, respectively; p = 0.007). An adjusted multivariate analysis revealed that the pattern of restenosis remained associated with both the occurrence of restenosis and TLR (odds ratio [OR] 5.1 [95% confidence interval (CI) 1.1 to 23], p = 0.03; and OR 3.61 [95% CI 1.2 to 10.9], p = 0.02; respectively). CONCLUSIONS: Similar to bare-metal stent data, the angiographic pattern of restenosis following DES implantation is prognostically important. Diabetes is a significant predictor of the pattern of restenosis in the DES era.     

Meta-analysis of long-term outcomes of drug-eluting stent implantations for chronic total coronary occlusions

Background

In the treatment of chronic total occlusions (CTOs), some uncertainty exists regarding the effect of drug-eluting stents (DESs) compared with the effects of bare mental stents (BMSs). We reviewed outcomes of DES vs. BMS implantation for CTO lesions, to evaluate the risk-benefit ratio of DES implantation.

Methods

Relevant studies of long-term clinical outcomes or angiographic outcomes of both BMS and DES implantation were examined. The primary endpoint comprised major adverse cardiovascular events (MACEs), including all-cause deaths, myocardial infarctions (MIs), and target lesion revascularizations (TLRs). A fixed-effect model and random-effect model were used to analyze the pooling results.

Results

Ten studies were included according to the selection criteria. Eight were nonrandomized controlled trials, and two consisted of a randomized controlled comparison between DES and BMS implantation. No significant difference was evident for in-hospital MACE rates between the two groups (odds ratio [OR], 1.07; 95% confidence interval [CI], .53 to 2.13), but the long-term MACE rates in the DES group were significantly lower than in the BMS group (OR, .22; 95% CI, .13 to .38; P < .00001). The rates of stent restenosis and reocclusions were also significantly lower in the DES group (OR, .14; 95% CI, .09 to .20; and OR, .23; 95% CI, .12 to .41, respectively).

Conclusion

Implantation of the DES improves long-term angiographic and clinical outcomes compared with BMS in the treatment of CTO lesions.     

Drug‐eluting stents in patients with end‐stage renal disease: Meta‐analysis and systematic review of the literature

Objective : The study sought to examine the total weight of evidence regarding the use of drug eluting (DES) and bare metal stents (BMS) in patients with end stage renal disease (ESRD). Background : The potential superiority of DES over BMS in reducing target lesion or vessel revascularization (TLR or TVR) in patients with ESRD on dialysis has not been established. Small studies comparing DES to BMS in this population have yielded inconclusive results mainly due to the small sample size. Methods : We searched MEDLINE, EMBASE, Science Citation Index, CINAHL, and the Cochrane CENTRAL database of controlled clinical trials (December 2009) for controlled trials comparing DES to BMS in ESRD patients. We conducted a fixed‐effects meta‐analysis across seven eligible studies (n = 869 patients). Results : Compared with BMS‐treated patients, DES‐treated patients had significantly lower TLR/TVR (OR 0.55 CI: 0.39–0.79) and major adverse cardiac events (MACE) (OR 0.54; CI: 0.40–0.73). The absolute risk reduction (ARR) with DES in TLR/TVR was ?0.09 (CI: ?0.14 to ?0.04; NNT 11) and in MACE was ?0.13 (CI: ?0.19 to ?0.07; NNT 8). A trend towards lower incidence of all cause mortality was also noted with DES (OR 0.68; CI: 0.45–1.01). No significant differences were noted between both groups in the relative or absolute risk of myocardial infarction. Conclusion : The use of DES in patients with ESRD is safe and yields significant reduction in the risk of TLR/TVR and MACE. Larger randomized studies are needed to confirm the results of this meta‐analysis and establish the appropriate stent choice in this high risk population. © 2010 Wiley‐Liss, Inc.     

Clinical safety and efficacy of a novel thin‐strut cobalt–chromium coronary stent system: Results of the real world Coroflex Blue Registry

Objectives : The aim of this registry was to evaluate the clinical efficacy and safety of the Coroflex Blue cobalt–chromium stent in real‐world practice. Background: The development of cobalt–chromium bare‐metal stents (BMS) with thinner struts has lead to better deliverability and lower target‐lesion revascularization rates compared with stainless steel BMS. Methods: The Coroflex Blue Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease attributable to single de novo or restenotic nonstented lesions of a single vessel amenable for percutaneous stenting. The primary end point was clinically driven target‐lesion revascularisation (TLR) 6 months after enrolment, secondary endpoints were technical/procedural success, in‐hospital outcome, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) after 6 months. Results: The registry included 2,315 patients (mean age 64.3 ± 11.1 years, 19.8% diabetes, 37.3% acute myocardial infarction). Although a complex lesion cohort with 60.3% Typ B₂/C‐lesions, the technical success rate was 99.1% and the procedural success rate 98.5%. The incidence of TLR after 6 months was 5.5% and the cumulative 6‐month acute/subacute stent thrombosis rate was 1.6%. After 6 months cumulative event‐free survival was 90.8% in all patients and 87% in patients with acute PCI for acute myocardial infarction. Conclusions: This registry demonstrates the safety and efficacy of the Coroflex Blue cobalt–chromium stent platform in real‐world practice. In the era of drug‐eluting stents (DES), these results raise the serious question if the use of DES for primary prevention of restenosis and TLR is really justified.     

Use of drug‐eluting stents for chronic total occlusions: A systematic review and meta‐analysis

Aim: To perform a systematic review and meta‐analysis of studies reporting outcomes after drug‐eluting stent (DES) implantation in chronic total occlusions (CTOs). Methods: A review of publications and online databases in January 2010 retrieved 17 published studies that reported outcomes after DES implantation in CTOs: eight uncontrolled studies, seven nonrandomized comparative studies with bare‐metal stents (BMS), one post‐hoc analysis of a randomized trial, and one randomized trial. Data were pooled using random‐effects meta‐analysis models. Results: All published studies evaluated sirolimus‐ or paclitaxel‐eluting stents. All studies reporting comparative angiographic outcomes revealed less binary angiographic restenosis with DES implantation compared to BMS (odds ratio: 0.15, 95% CI: 0.08, 0.26). Over a mean follow‐up period of 18.9 ± 16.5 months, the cumulative incidence of death, myocardial infarction, or stent thrombosis was similar between DES and BMS in all studies. Target lesion revascularization (odds ratio: 0.13, 95% CI: 0.06, 0.26) and target vessel revascularization (odds ratio 0.18, 95% CI: 0.11, 0.31) at 6–12 months were consistently lower among DES‐treated patients. Similar patterns of safety and efficacy event rates were also observed in studies reporting >12 month outcomes. Conclusions: Compared with BMS, treatment of chronic total coronary occlusions with DES is associated with significant reductions in angiographic and clinical restenosis with similar safety. The consistency and magnitude of treatment effect across both individual trials and the pooled analysis establish DES as the preferred therapy for percutaneous revascularization of CTOs. © 2010 Wiley‐Liss, Inc.     

药物洗脱支架和金属裸支架治疗弥漫病变的比较研究

目的比较冠心病患者弥漫病变采用药物洗脱支架和金属裸支架治疗的近期和远期预后,分析影响这类病变介入治疗预后的危险因素。方法研究对象为我院2004年4月至2005年8月接受置入单个长度>25.0mm支架治疗并且进行冠状动脉造影随访的205例患者,排除支架置入失败及支架置入位置不理想者。分为置入药物洗脱支架(DES)组(n=128)和置入金属裸支架(BMS)组(n=77)。所有的患者术后均接受阿司匹林300mg、氯吡格雷75mg等规范药物治疗。手术成功判定标准为至少用相互垂直的两个投照体位行冠状动脉造影,肉眼判定残余狭窄<20%和前向血流TIMI3级。再狭窄判定标准以复查冠状动脉造影定量分析支架内或支架邻近血管管腔直径狭窄程度≥50%。患者在支架术后6个月左右接受冠状动脉造影随访。结果共205例患者(男性181例,女性24例)227个靶病变置入382枚支架完成造影随访。其中C型病变占总数的93.8%,B2型病变为6.2%。双支或双支以上血管病变的患者比例达到86.8%。平均术前参考血管直径(2.88±0.43)mm。平均每个病变支架长度(40.09±12.94)mm,54.2%的病变接受了重叠置入支架。比较置入DES组和置入BMS组,两组的患者基本条件差异无统计学意义,在病变基本条件方面,DES组术前参考血管直径明显小于BMS组[(2.80±0.37)mm比(3.10±0.48)mm,P=0.005]。6个月随访结果显示再狭窄率DES组(15.4%)小于BMS组(48.4%),P<0.001。晚期支架内腔径丢失BMS组明显大于DES组[(0.94±0.76)mm比(0.39±0.53)mm,P<0.001]。靶病变血管重建率DES要明显好于BMS(11.6%比38.5%,P<0.001)。支架内再狭窄在置入DES组的局限性再狭窄比例大于置入BMS组(33.3%比18.2%,P=0.029)。对影响复杂弥漫病变支架再狭窄因素的多元logistic回归分析发现,采用支架重叠置入(OR=2.82,P=0.017)和支架类型(OR=5.71,P<0.001)是对复杂弥漫病变支架内再狭窄影响最大的危险因素。结论我们的研究发现对于复杂弥漫病变的治疗,药物洗脱支架有着良好的治疗效果,较金属裸支架能明显减低再狭窄率。对于弥漫病变,我们应该使用长支架,尽可能减少支架重叠置入的数量。     

Immediate procedural and long-term clinical outcomes following drug-eluting stent implantation to ostial saphenous vein graft lesions

BACKGROUND: Ostial saphenous vein graft (OSVG) lesions were excluded from all the clinical trials demonstrating significantly lower restenosis rates with drug-eluting stents (DES) compared to bare metal stents (BMS). This study aimed to evaluate the efficacy of DES in OSVG lesions by assessing angiographic and 12-month clinical outcomes. METHODS: 70 consecutive patients (70 OSVG lesions) underwent coronary stent implantation between May 2003 and April 2006: 37 lesions received DES and 33 lesions BMS. Endpoints were all cause and cardiovascular mortality, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), examined separately and as a combined end-point (major adverse cardiac events, MACE). RESULTS: Procedural (94.6% for DES and 87.9% for BMS) and angiographic (100% for DES and 100% for BMS) success did not differ between the two groups. The only in-hospital events were non-Q wave MI (DES 8.1% versus BMS 12.1%, P=0.69). At 30-day follow-up, there were no other events. Overall, at 1-year follow-up, the BMS group had a higher TLR (30.3% versus 5.4%, P=0.015), TVR (33.3% versus 10.8%, P=0.045) and MACE rate (36.4% versus 10.8%, P=0.024) compared to the DES group. CONCLUSIONS: Drug-eluting stent implantation to OSVG lesions achieves better clinical results than BMS but is still associated with a relatively high incidence (10.8%) of revascularization at 1-year follow-up.     

冠状动脉支架置入术后不同类型支架再狭窄形式分析

目的通过分析冠状动脉支架置入后造影复查的影像资料,寻找不同支架再狭窄的特点。方法入选行冠状动脉病变介入治疗后造影复查的846处病变,对再狭窄病变行再狭窄形式分析。结果裸支架和药物支架再狭窄中支架近端局限性再狭窄分别占5.69%和33.67%(P=0.000),而支架内弥漫性再狭窄分别占29.27%和9.18%(P=0.000),弥漫性狭窄累及支架两端的分别为20.33%和6.12%(P=0.003),闭塞性再狭窄发生率分别为9.76%和10.20%(P=0.912)。雷帕霉素及其衍生物释放支架和紫杉醇释放支架再狭窄支架边缘局限性再狭窄分别为47.06%和25.00%(P=0.037),支架内弥漫性狭窄分别为1.96%和16.67%(P=0.018)。结论药物支架改变了支架再狭窄模式,弥漫型转为局限型;闭塞性再狭窄时药物支架以支架近端闭塞为主,裸支架以支架内闭塞为主;紫杉醇药物释放支架弥漫性再狭窄发生率较雷帕霉素释放支架有所增加。     

Drug‐eluting stents versus bare‐metal stents for treatment of bare‐metal in‐stent restenosis

Objectives : We compared the long‐term outcomes of drug‐eluting stents (DES) versus bare‐metal stents (BMS) for treatment of bare‐metal in‐stent restenosis (ISR). Background : There are no randomized trials or observational studies directly comparing the safety and efficacy of DES versus BMS for treatment of bare‐metal ISR. Methods : We examined data on all patients who underwent percutaneous coronary intervention (PCI) for ISR at Cleveland Clinic between 05/1999 and 06/2007. We compared the efficacy and safety of DES to BMS for treating bare‐metal ISR. The primary end point was a composite of death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were individual components of the primary endpoint. Results : Of the 931 patients identified over 8 years, 706 had bare‐metal ISR and met our study criteria. Of the 706 patients with bare‐metal ISR, 362 were treated with DES and 344 with BMS. There were 230 cumulative events for a median follow‐up of 3.2 years. After adjusting for 27 variables, DES were associated with lower primary endpoint compared to BMS for treatment of bare‐metal ISR (21% vs. 45%, adjusted hazard ratio [HR] 0.63; 95% confidence interval [CI], 0.42–0.95; P = 0.03). The individual secondary endpoint of death (8% vs. 24%, P = 0.005) favored DES, but MI (3% vs. 8%, P = 0.31), and TLR (13% vs. 20%, P = 0.23) failed to reach statistical significance. Conclusions : In our multivariate analysis of patients with bare‐metal ISR, DES use was associated with significantly lower death, MI, or TLR when compared to BMS. © 2010 Wiley‐Liss, Inc.     

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.     

The short‐ and long‐term outcomes of percutaneous intervention with drug‐eluting stent vs bare‐metal stent in saphenous vein graft disease: An updated meta‐analysis of all randomized clinical trials

The use of drug‐eluting stents (DES) vs bare‐metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta‐analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short‐ and long‐term clinical outcomes of the following: all‐cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target‐vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short‐term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35–0.91, P = 0.02; OR: 0.43, 95% CI: 0.19–0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22–0.95, P = 0.04, respectively). However, there were no different outcomes for all‐cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long‐term follow‐up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all‐cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short‐term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long‐term follow‐up.     

药物洗脱支架对完全闭塞性病变介入治疗预后影响的评估

目的比较对于完全性闭塞病变采用药物洗脱支架和金属裸支架的近期和远期预后。方法选择我院近期连续接受置入药物洗脱支架(DES)或金属裸支架(BMS)治疗,并且进行冠状动脉造影随访的155例存在完全闭塞病变的冠心病患者。患者在支架术后6个月左右接受冠状动脉造影随访。结果共155例患者(138名男性,17名女性)159处靶病变置入232枚支架完成造影随访,其中慢性完全性闭塞65例,占41.9%。其中C型病变占总数的85.4%。在患者基本条件方面,DES组2型糖尿病比例要多于BMS组(33.8%比18.5%,P=0.030)。在病变基本条件方面,DES组和BMS组C型病变分别占89.6%和72.0%(P=0.005),DES组病变更为复杂。DES组慢性完全闭塞病变比例明显高于BMS组(60.3%比24.4%,P<0.001)。DES组和BMS组的支架长度和病变长度没有差别。DES组参考血管直径小于BMS组[(2.72±0.36)mm比(2.96±0.52)mm,P=0.001]。6个月随访结果显示支架再狭窄DES组明显低于BMS组(15.6%比41.5%,P<0.001)。DES组支架再狭窄更多为局限性(58.3%比17.6%,P<0.001)。DES组的靶病变血管重建率明显低于BMS组(5.8%比19.9%,P=0.001)。病变内晚期腔径丢失DES明显小于BMS[(0.36±0.63)mm比(1.04±0.70)mm,P<0.001]。晚期支架内血栓DES有2例,BMS为0。DES组有1例死亡。术后主要心脏不良事件发生率两组分别是1.4%和11.1%,DES组显著低于BMS组(P=0.032)。结论我们的研究发现对于完全闭塞性病变的治疗,DES有着良好的治疗效果,比BMS有着明显减低的再狭窄率、靶病变血管重建率,并且在随访期间患者有着更少的心血管事件。     

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.     

Funneling: enhancing results of small-vessel stenting

Until October 2008, coronary drug-eluting stents with a diameter of ≤2.5 mm were not approved by the FDA. Target vessels of ≤2 mm in diameter pose a major challenge in view of high restenosis rates when stented bare metal stents (BMS) are used and distal edge dissection when oversized stents are deployed. Described is a method (“funneling”) to optimize stenting of small vessels. This strategy combines stenting the distal part of the lesion with short (8–12 mm length) 2-mm bare metal stent while stenting with a larger-diameter (≥2.5 mm) drug-eluting stent (DES) with considerable DES–BMS overlap (leaving only the distal 4–6 mm of the BMS not overlapped by a DES). The two stents create a funnel that is for the most part drug eluting. With funneling, both drug elution and larger diameter are attained, minimizing both edge dissection and restenosis.     

Registry data evaluating the effectiveness of drug-eluting stents for the treatment of symptomatic in-stent restenosis

BACKGROUND: In this new-era of drug-eluting stents (DES) the impact of symptomatic in-stent restenosis (ISR) is diminishing. However, world wide bare-metal stents remain widely used and therefore, it is imperative to establish a simple and effective form of treatment. The objective of this registry database was to evaluate the 'real-world' effectiveness of DES for the treatment of symptomatic bare-metal stent ISR. METHODS: All patients presenting with symptomatic ISR were evaluated between February 2003 and February 2005. Patients had 9-month angiographic follow-up with primary endpoint evaluation of binary restenosis (>50%). Secondary endpoints included in-segment late loss, target lesion revascularization (TLR) and the difference in late loss between sirolimus (n=23) and paciltaxel (n=36) eluting stents. RESULTS: Fifty eight patients with fifty nine ISR lesions were evaluated, 36% of patients had diabetes mellitus. All procedures were performed safely with no adverse peri-procedural events documented. At 9-month follow-up the median in-segment late loss was 0.24 mm (IQR 0.1, 0.53), with a binary restenosis rate of 17%. At long-term follow-up greater than 1 year, the incidence of TLR was 10%. No difference in the angiographic parameter of in-segment late loss was seen between the sirolimus and paclitaxel-eluting stents. CONCLUSIONS: In this cohort of patients with long-term angiographic and clinical follow-up, DES is an effective and safe treatment for symptomatic bare-metal stent ISR.     

冠心病合并2型糖尿病患者置入药物洗脱支架的疗效评价

目的 评价冠心病合并2型糖尿病患者冠状动脉病变置入药物洗脱支架后的疗效。方法 选择我院2004年4月至2005年8月连续接受置入药物洗脱支架（DES）或金属裸支架（BMS）治疗并且进行了冠状动脉造影随访的139例的冠心病合并2型糖尿病患者。所有患者在支架术后6个月后接受冠状动脉造影随访。结果共139例患者（男性114例,女性25例）221处病变完成随访。其中C型病变94处（42．5％）,完全闭塞病变42处（19．0％）,平均每个病变支架长度（26．53±14．72）mm,平均参考血管直径（2．80±0．43）mm。两组患者在性别比例和年龄方面差异无统计学意义。两组在冠心病的危险因素如：高血压病、高脂血症、吸烟等方面差异无统计学意义。两组病变的复杂程度基本相当。DES组的参考血管直径比BMS组小[（2．71±0．41）mm比（2．98±0．53）mm,P〈0．001]。6个月后随访,DES组的支架内再狭窄率（10．6％比38．6％,P〈0．001）和病变内晚期腔径丢失[（0．24±0．56）mm比（0．91±0．77）mm,P〈0．001]明显低于BMS组。DES组的靶病变血管重建率显著低于BMS组（8．6％比30．0％,P〈0．001）。DES组有4例晚期支架内血栓。结论 本研究显示药物洗脱支架对于冠心病合并2型糖尿病患者冠状动脉病变的介入治疗有着良好的治疗效果,明显优于金属裸支架。     

Outcomes with Drug-Coated Balloons in Percutaneous Coronary Intervention in Diabetic Patients

BackgroundPercutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains associated with inferior clinical outcomes and an increased risk of restenosis compared with non-diabetics even in the era of drug-eluting stents (DES). The outcomes with drug-coated balloons (DCBs) in diabetic patients have received limited study.MethodsWe performed a meta-analysis of all studies published between January 2000 and January 2019 reporting the outcomes with DCB vs. DES after PCI of de-novo coronary lesions in diabetic patients. Outcomes included major adverse cardiovascular events (MACE), target lesion revascularization (TLR), binary restenosis by quantitative coronary angiography (QCA), and late lumen loss (LLL).ResultsThree studies with 378 patients (440 lesions) were included in the meta-analysis. During 17.3 ± 11.3 months follow-up, DCB were associated with a similar risk of MACE (OR: 0.63, 95% CI [0.36, 1.12], p = 0.11), TLR (OR: 0.51, 95% CI [0.25, 1.06] p = 0.07), binary restenosis (OR: 0.42, 95% CI [0.09, 1.92], p = 0.26), and LLL (mean difference: −0.13 mm, 95% CI [−0.41, 0.14], p = 0.34) compared with DES.ConclusionIn diabetic patients with de-novo coronary lesions undergoing PCI, DCBs are associated with similar outcomes compared with first-generation DES, with a signal toward potential benefit in lowering target lesion revascularization. Further randomized studies are needed to compare the newer-generation DCBs and DES in this setting.     

The efficacy of bare metal stent implantation for patients with acute myocardial infarction in the drug-eluting stent era

BACKGROUND: Although several trials have demonstrated the safety of drug-eluting stent (DES) implantation for acute myocardial infarction (AMI) patients, care must be exercised when DES are implanted in AMI cases because of the risk of in-stent thrombosis or adverse side effects of antiplatelet agents. On the other hand, recently, there has been much improvement in bare metal stents (BMSs), and thus, the efficacy of BMS implantation should be reevaluated. METHODS: We investigated the primary and long-term outcome of BMS implantation for AMI patients in the DES era (July 2004 to December 2006; n=97 [Group 1]) and compared the results with those in the pre-DES era (January 2002 to June 2004; n=81 [Group 2]), retrospectively. RESULTS: The most frequently used BMS in Group 1 was the Driver stent (63.9%) and in Group 2 the Duraflex stent (44.4%). Stent length and diameter were not significantly different between Group 1 and Group 2. The rates of in-stent restenosis, and target lesion revascularization were lower in Group 1 than in Group 2. Restenosis frequently occurred in small vessel lesions and in lesions that had required more than 10atm fully to dilate the pre-dilatation balloon at the primary PCI. CONCLUSIONS: Currently available BMSs are much more effective than old-type BMSs. However, DES implantation may be considered for small vessel diseases and lesions that need high pressure to dilate.