Long-term clinical and angiographic outcomes of treatment of unprotected left main coronary artery stenosis with sirolimus-eluting stents

Favorable early results of percutaneous drug-eluting stents in unprotected left main (LM) disease are available, but outcome data beyond 6 to 10 months are lacking. We evaluated the long-term results of sirolimus-eluting stents (SESs) in patients with LM disease. From November 2002 to December 2004, consecutive patients with LM disease, without contraindications to double antiplatelet therapy and undergoing SES implantation, were enrolled prospectively. The primary end point of the study was occurrence of major adverse cardiovascular events. In total 85 patients were treated with 118 SES and followed for 595 +/- 230 days. Event-free survival rates at 1 year and 2 years were 85.5% and 78.6%, respectively. Only 2 deaths occurred overall (2.4%), the first in-hospital in a very high-risk patient according to the European System for Cardiac Operative Risk Evaluation and the second in a patient with severe systolic dysfunction already at the index procedure). Myocardial infarction was adjudicated in 3 patients (3.6%), 2 occurring periprocedurally and 1 during follow-up for a de novo nontarget lesion. There were 7 (10.8%) target lesion revascularizations at 24 months, with all but 1 percutaneous and in a subject with bifurcation LM disease at baseline. At 9-month angiography, late loss was 0.15 +/- 0.81 mm and restenosis rate was 8.2%. An increased incidence of adverse events was noted in patients undergoing SES after dilation with extremely oversized balloons. No case of stent thrombosis was reported. In conclusion, this single-center experience suggests that percutaneous use of SESs to treat LM disease in unselected high-risk patients is safe and effective even 1 year after implantation.     

Long-term outcomes of sirolimus-eluting stents vs. paclitaxel-eluting stents in unprotected left main coronary artery bifurcation lesions

Background:

The treatment of unprotected left main coronary artery (uLMCA) bifurcation lesions remains challenging.

Hypothesis:

We hypothesized that the type of drug‐eluting stent would correlate with clinical outcomes for the treatment of uLMCA bifurcation lesions.

Methods:

One hundred fifteen patients who underwent stent implantation using a provisional T‐stenting technique with sirolimus‐eluting stents (SES) or paclitaxel‐eluting stents (PES) for uLMCA bifurcation lesions were enrolled. A major adverse cardiac event (MACE) was defined as a composite of cardiac death, myocardial infarction, or target lesion revascularization.

Results:

Ninety‐four patients were treated with SES and 21 patients with PES. Baseline characteristics were similar between the 2 groups. Angiographic follow‐up was performed in 99 (86%) patients. Late loss in the LMCA to the left anterior descending coronary artery was significantly lower in the SES group than in the PES group (0.28 ± 0.54 mm vs 1.03 ± 0.45 mm, P<0.001). One case of stent thrombosis occurred in the SES group. During follow‐up with a median of 712 days, the SES group had a lower MACE compared with the PES group (10.6% vs 28.6%, P = 0.032). Cox proportional hazards models including age, sex, diabetes, acute coronary syndrome, true bifurcation, stenting strategy, and type of drug‐eluting stent used (SES vs PES) demonstrated that stent type was the only predictor of MACE (hazard ratio of PES vs SES: 3.88, 95% confidence interval: 1.29–11.67, P = 0.016).

Conclusions:

According to the results of the present study, SES may be associated with more favorable outcomes than PES for stenting of uLMCA bifurcation, which should be further studied by larger trials. © 2011 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose.     

无保护左主干病变血运重建的临床评价

冠脉旁路移植术为无保护左主干病变的首选治疗。随着经皮冠脉介入治疗技术的进步,在有选择的无保护左主干患者中,PCI与CABG的疗效相当。本文对无保护左主干病变几种血运重建方法进行综述。     

无保护左主干病变支架介入治疗后冠状动脉造影随访结果分析

目的观察无保护左主干病变,应用药物洗脱支架介入治疗后冠状动脉造影随访结果,并分析其影响因素。方法选择无保护左主干病变患者150例,其中48例在平均(10.0±7.5)个月进行了冠状动脉造影复查,根据冠状动脉造影显示有无狭窄分为:再狭窄组12例和无再狭窄组36例。结果与无再狭窄组比较,再狭窄组患者随访时最小管腔直径明显减小[(2.7±1.0)mm vs (3.5±0.4)mm,P=0.0001]、直径狭窄率明显升高[(31.4±26.4)% vs (8.3±5.3)%,P=0.0000]、晚期管腔丢失明显升高[(0.8±0.7)mm vs (0.2±0.3)mm,P=0.0000];双支架置入术的再狭窄率明显高于单支架置入术[(75.0% vs 13.9%),P=0.0011]。结论左主干远端分叉病变双支架置入术的疗效较差,冠状动脉旁路移植术应作为首选。     

Kissing sirolimus-eluting stents for the treatment of left main coronary artery stenosis.

We present a case of kissing drug-eluting stent deployment in the left main coronary artery in a 43-year-old male with failed previous bypass grafting. We discuss the technique used for stent deployment and the rationale for using this technique in the drug-eluting stent era.     

第二代药物洗脱支架治疗无保护左主干病变的疗效及安全性分析

目的探讨第二代药物洗脱支架（DES）置入治疗无保护左主干（ULM）病变患者的疗效及安全性。方法回顾性研究南京医科大学附属南京医院诊断为ULM病变并接受DES治疗的患者216例。接受第一代DES的患者121例为F组,接受第二代DES的患者95例为S组。患者术后常规服用阿司匹林100 mg,每日一次;氯吡格雷150 mg,每日一次（维持至少1年）。主要研究终点为主要不良心血管事件（MACE）,包括心源性死亡、非致死性心肌梗死和再次靶血管血运重建（TVR）;次要终点为12个月时定量冠状动脉造影（CAG）参数。结果在（342±23）d随访期内,总体复合MACE 22例（10.2%）,主要构成为TVR 16例（7.4%）。S组复合MACE为5.3%显著低于F组14.0%（χ2=4.491,P=0.034,RR 2.669,95%CI 1.022~6.975）。S组复合MACE的减少主要表现为TVR减少（χ2=4.465,P=0.035,RR 3.402,95%CI 0.998~11.60）。随访血管造影再狭窄F组与S组分别为17例（14.5%）和8例（8.4%）,差异无统计学意义（χ2=1.647,P=0.199）。血管内超声提示的晚期获得性支架贴壁不良于F组和S组分别为7例（5.8%）和1例（1.1%）,F组有增加趋势,但差异无统计学意义（χ2=3.342,P=0.068）。结论与第一代DES相比较,使用第二代DES治疗ULM病变MACE发生率低,主要表现为TVR减少;第二代DES治疗ULM病变具有更好的疗效和安全性。     

Comparison of drug-eluting stents versus surgery for unprotected left main coronary artery disease

This study was conducted to compare the clinical outcomes of drug-eluting stents (DESs) with those of standard bypass surgery for the treatment of patients with left main lesions in a single-center experience. From January 2000 to October 2005, a total of 96 patients with significant unprotected left main disease were treated with DES implantation, and 245 with bypass surgery. Baseline features, such as Euroscore, were similar between groups, except for diabetes and hypertension, which were more frequent in the surgical group. The combination of death, Q-wave myocardial infarction, stroke, and repeated revascularization (major adverse cardiac and cerebrovascular events [MACCEs]) at 30 days occurred in 2.1% after DES implant and 9.0% after surgery (p=0.03). At 1 year, DES-treated patients more frequently needed repeat revascularization (5.2% vs 0.8%; p=0.02), although combined MACCE rates were similar (10.4% for DES, 11.4% for surgery; p=0.50). Moreover, after a mean follow-up of 1.3+/-0.8 and 3.2+/-1.6 years for the DES and surgical groups, there were no significant differences in MACCEs, respectively. In conclusion, in our experience, percutaneous treatment of patients with unprotected left main disease with DESs provided similar clinical results compared with surgical revascularization at a midterm follow-up.     

药物洗脱支架和冠状动脉旁路移植术治疗无保护左主干病变的疗效分析

背景冠状动脉无保护左主干病变(ULMCA)在冠脉病变患者中风险最高,预后最差,冠状动脉旁路移植术(CABG)能显著降低死亡率,延长患者生存期,故一直被认为是治疗冠脉无保护左主干病变的金标准。但随着冠脉介入技术的进步,药物洗脱支架(DES)能显著降低支架置入后再狭窄的风险和再介入的比例,因此也成为无保护左主干病变的治疗方法之一,而冠脉搭桥作为左主干病变治疗金标准的的地位正日益受到挑战。目的比较药物洗脱支架(DES)置入与冠状动脉旁路移植术(CABG)对冠状动脉无保护左主干病变患者的近期及远期疗效。方法回顾性收集2006年12月到2009年12月在苏州大学附属第一人民医院接受治疗的49例冠状动脉左主干狭窄患者的临床资料,其中26例置入药物洗脱支架(DES组),23例患者接受了冠脉旁路移植术(CABG组),记录两组患者围手术期、术后6月到3年的主要心脑血管不良事件(MAC-CE)发生率。结果 (1)两组患者一般临床特征比较无统计学意义;(2)平均随访(16.4±8.8)个月,DES组与CABG组的MACCE发生率分别为11.5%及13.0%,P>0.05;(3)DES组与CABG组术后2年无事件生存率分别为78.8%及85.0%,P>0.05。结论药物洗脱支架置入对于无保护左主干病变患者是安全、有效、可行的,有着与冠脉搭桥相似的近、远期疗效,但对于左主干累及分叉病变者,DES组因较高的血运重建率而疗效略差于CABG。     

Elective sirolimus-eluting stent implantation for left main coronary artery disease: six-month angiographic follow-up and 1-year clinical outcome.

The effectiveness of sirolimus-eluting stent (SES) implantation in patients treated electively for left main (LM) stenoses has not been yet ascertained. The present study reports on the clinical and angiographic outcome of 16 consecutive patients treated electively for de novo stenoses in the LM. The impact of SES implantation on major adverse cardiac events was evaluated. Mean age was 65 +/- 11 years. Unprotected LM was present in nine (56%), and eight patients (50%) received stents extending into both the left anterior descending and circumflex arteries for stenoses of the distal left main bifurcation. In-house mortality and reintervention rate was zero. One patient developed a non-Q-wave myocardial infarction related to the index procedure. At 1-year clinical follow-up, there were no deaths or further myocardial infarctions; one (6%) patient required target lesion revascularization. A total of 12 patients (75%) underwent 6-month angiographic follow-up with a late lumen loss of 0.04 +/- 0.65 mm and one focal restenosis (8% of patients). Elective SES implantation for LM disease was associated with zero mortality and a very low incidence of additional major adverse events at 1 year.     

一站式复合血管重建技术治疗无保护左主干病变

目的 评价一站式复合血管重建技术治疗无保护左主干病变的可行性和安全性.方法 2007年6月至2009年4月共有14例左主干病变患者接受一站式复合血管重建技术再血管化.其中男性13例,女性1例,平均年龄(60.4±15.4)岁,冠状动脉造影显示左主干开口或体部病变5例,远端或分叉病变11例.手术在一站式复合手术室内进行.通过胸骨下段小切口在心脏不停跳状态下行微创冠状动脉旁路移植术(左乳内动脉至前降支旁路移植),同期对左主干病变和(或)其他非前降支病变行经皮冠状动脉介入治疗.结果 14例患者均顺利进行一站式复合手术.即刻冠状动脉造影显示左乳内动脉桥均通畅.共有25处非前降支病变接受经皮冠状动脉介入治疗,其中23处病变置入支架(药物洗脱支架27枚,金属裸支架2枚),其余2处病变仅行冠状动脉球囊扩张术.围术期及随访期间无死亡、围术期心肌梗死、脑卒中或再次再血管化等发生.平均随访7.9个月(1～15个月),所有患者均存活且无再发心绞痛.5例患者术后1年再次接受冠状动脉造影,证实左乳内动脉桥及支架均通畅.结论 一站式复合血管重建技术治疗经选择的无保护左主干病变尤其是合并高危因素者安全可行.     

Comparison of coronary artery bypass surgery with percutaneous coronary intervention with drug-eluting stents for unprotected left main coronary artery disease.

OBJECTIVES: This study evaluated the clinical outcomes of consecutive, selected patients treated with coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for unprotected left main coronary artery (ULMCA) disease. BACKGROUND: Although recent data suggest that PCI with DES provides better clinical outcomes compared to bare-metal stenting for ULMCA disease, there is a paucity of data comparing PCI with DES to CABG. METHODS: Since April 2003, when DES first became available at our institution, 123 patients underwent CABG, and 50 patients underwent PCI with DES for ULMCA disease. RESULTS: High-risk patients (Parsonnet score >15) comprised 46% of the CABG group and 64% of the PCI group (p = 0.04). The 30-day major adverse cardiac and cerebrovascular event (MACCE) rate for CABG and PCI was 17% and 2% (p < 0.01), respectively. The mean follow-up was 6.7 +/- 6.2 months in the CABG group and 5.6 +/- 3.9 months in the PCI group (p = 0.26). The estimated MACCE-free survival at six months and one year was 83% and 75% in the CABG group versus 89% and 83% in the PCI group (p = 0.20). By multivariable Cox regression, Parsonnet score, diabetes, and CABG were independent predictors of MACCE. CONCLUSIONS: Despite a higher percentage of high-risk patients, PCI with DES for ULMCA disease was not associated with an increase in immediate or medium-term complications compared with CABG. Our data suggest that a randomized comparison between the two revascularization strategies for ULMCA may be warranted.     

A randomized comparison of paclitaxel-eluting stents versus bare-metal stents for treatment of unprotected left main coronary artery stenosis.

OBJECTIVES: To optimize percutaneous coronary intervention (PCI) strategy for unprotected left main (LM) disease, we performed a randomized study: intravascular ultrasound (IVUS)-guided bare-metal stent (BMS) or paclitaxel-eluting stent (PES) implantation after lesion pre-treatment with cutting balloon (CB) for unprotected LM lesions. BACKGROUND: Recent studies have shown promising results in terms of safety and feasibility for patients with LM disease who underwent PCI with stent implantation. However, comparison of BMS and PES for LM lesions has not yet been evaluated. METHODS: One hundred three patients were randomly assigned to receive BMS (n = 50) or PES (n = 53) implantation. All interventions were IVUS guided, and CB pre-treatment before stenting was performed in all patients. All patients were scheduled for 6-month follow-up. RESULTS: Baseline clinical characteristics were comparable in both cohorts. Stent implantation was successful in all lesions. Follow-up analysis showed binary restenosis in 11 (22%) BMS and in 3 (6%) PES patients (p = 0.021). By IVUS, percentage of neointimal volume obstruction at 6 months was reduced from 25.20 +/- 22.02% with BMS to 16.60 +/- 17.25% with PES (p = 0.02). At 6 months, the major adverse cardiac event-free survival rate was 70% in BMS and 87% in PES patients (p = 0.036). CONCLUSIONS: This study demonstrates that PCI of LM with IVUS guidance and CB pre-treatment is safe and effective. No serious procedure-related complications were observed, and clinical outcomes appeared to be good. Finally, the findings demonstrate that implantation of PES may be superior to BMS in the large-diameter LM vessel at 6 months, warranting the performance of a large-scale randomized trial.     

Percutaneous coronary intervention for unprotected left main coronary artery stenosis

Hemodynamically significant left main coronary artery stenosis (LMCA) is found in around 4% of diagnostic coronary angiograms and is known as unprotected LMCA stenosis if the left coronary artery and left circumflex artery has no previous patent grafts. Previous randomized studies have demonstrated a significant reduction in mortality when revascularization by coronary artery bypass graft (CABG) surgery was undertaken compared with medical treatment. Therefore, current practice guidelines do not recommend percutaneous coronary intervention (PCI) for such a lesion because of the proven benefit of surgery and high rates of restenosis with the use of bare metal stents. However, with the advent of drug-eluting stents (DES), the long term outcomes of PCI with DES to treat unprotected LMCA stenoses have been acceptable. Therefore, apart from the current guidelines, PCI for treatment of unprotected LMCA stenosis is often undertaken in individuals who are at a very high risk of CABG or refuse to undergo a sternotomy. Future randomized studies comparing CABG vs PCI using DES for treatment of unprotected LMCA stenosis would be a great advance in clinical knowledge for the adoption of appropriate treatment.     

Rapamycin-eluting stents for the treatment of unprotected left main coronary disease

Background

Conventional bare stents have been used to treat unprotected left main (LM) coronary artery stenosis. However, restenosis remains the main limitation. Since rapamycin-eluting stents (RES) appear to inhibit neointimal proliferation, their application to this specific site seems promising.

Methods

Since May 2002, we have studied a series of 52 patients with LM lesions treated with RES. Forty-seven patients presented with de novo stenoses, and 5 had in-stent restenosis; 19 patients required combined stent treatment for other remote lesions in the coronary tree, 6 of them at the level of proximal right coronary artery. The RES was implanted directly at the LM in 39 patients; 13 others needed predilation. Once deployed, the RES was overexpanded with short balloons adjusted to the LM length in 44 patients. Quantitative coronary angiograms were analyzed in the same view before and immediately after treatment and at follow-up. Patients were followed-up closely and new cardiac catheterization was scheduled at 6-month evaluation or earlier in the presence of symptoms. At follow-up study, quantitative coronary angiography and motorized intravascular ultrasound analyses were performed in 35 (67%) patients.

Results

Primary success was obtained in 50 patients (96%). Two patients (4%) developed a non-Q-wave myocardial infarction. All patients were symptom-free at discharge. After a mean follow-up of 12 ± 4 months, 50 patients (96%) remain asymptomatic. No late death or acute thrombosis have been recorded. Two patients became symptomatic 2 and 4 months after treatment, respectively. One had restenosis at a remote site, while the other had in-segment restenosis. None of the remaining 33 angiographically evaluated patients developed restenosis at any site. Target lesion revascularization was 1/52 (2%).

Conclusions

Although longer-term follow-up studies are needed, the tailored treatment of coronary lesions located at the LM by overexpanded RES is feasible and safe. Midterm results seem promising, which might help to shift the orientation of patient management from surgical to percutaneous revascularization.