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。     

Angioplasty of unprotected left main coronary stenosis: Real world experience of a single-operator group from eastern India

BackgroundCoronary artery bypass graft surgery is the standard treatment of unprotected left main coronary stenosis (ULMCA). However, in the real world scenario, many of these patients are unfit for CABG or prefer angioplasty as an alternative when offered the choice.MethodsA total of 86 clinically stable patients with ULMCA stenosis who were unfit or unwilling for CABG underwent PCI with DES at two tertiary care centers in Kolkata. Patients were followed up prospectively for a median of 34.6 months for major adverse cardiovascular events. Angiographic follow-up was done after 1 year of index procedure or earlier, if indicated.ResultsFifty-five patients (64%) had distal left main stenosis. Two-stent technique was used in 19 patients (22%) and single-stent technique in 36 patients (42%) with distal left main lesion. Thirteen patients (15.1%) had left ventricular ejection fraction (LVEF) of ≤45%. There was no in-hospital death, MI, or stent thrombosis. During follow-up, major adverse cardiac event (MACE) occurred in 9 patients (10.5%). Our study revealed significantly greater MACE in patients with distal left main lesion with LVEF ≤45% (50% vs 6.38%, p = 0.0002), high SYNTAX score (36.36% vs 6.82%, p = 0.008), and diabetes (17.95% vs 0.00%, p = 0.07). Overall, also patients with Diabetes, LVEF ≤ 45%, and SYNTAX score >32 had significantly higher MACE. Use of IC Stent, IVUS, or procedural strategy in distal lesion did not affect MACE.ConclusionIn selective patients with low-intermediate SYNTAX score and without diabetes and LV dysfunction, ULMCA PCI with DES is feasible.     

无保护左主干病变冠状动脉搭桥术与雷帕霉素洗脱支架治疗的对比研究

目的:回顾性分析无保护左主干病变患者使用雷帕霉素洗脱支架(DES)的经皮冠状动脉介入治疗(PCI)与冠状动脉旁路移植手术(CABG)治疗的中、远期疗效,并探讨应用SYNTAX SCORE来评估病变风险与临床事件的相关性。方法:本研究回顾性收集了176例无保护左主干病变患者,其中CABG组80例,PCI-DES组96例。收集患者的基本情况、左主干病变特点及SYNTAX评分、CABG和PCI手术情况,随访患者术后3年的主要不良心脑血管事件(MACCE)的发生率。结果:术后3年随访,PCI-DES组与CABG组的MACCE发生率及无MACCE生存率比较差异无统计学意义,但PCI组靶血管再次血运重建率(TVR)明显高于CABG组(P<0.05)。用SYNTAX SCORE把PCI-DES和CABG两组患者分为高积分组(≥30.0)和低积分组(<30.0):高积分组,术后3年PCI-DES亚组MACCE事件发生率高于CABG亚组(23.53%∶18.05%,P<0.05),无MACCE事件生存率低于CABG亚组(51.47%∶70.83%,P<0.05)。低积分组,术后3年MACCE事件发生率CABG亚组高于PCI-DES亚组(12.50%∶7.14%,P>0.05),而无MACCE事件生存率低于PCI-DES亚组(75.00%∶82.14%,P<0.05)。结论:PCI-DES与CABG治疗无保护左主干病变患者总体疗效相似。用SYNTAX SCORE指导无保护左主干病变血管重建方式的选择有重要价值,但在不同的患者人群中,仍应结合临床特征和冠状动脉病变特点选择恰当的血运重建术。     

64排螺旋CT冠状动脉成像在无保护左主干冠脉病变PCI中的应用价值

目的 探讨64排螺旋CT冠状动脉成像（CTA）在冠状动脉无保护左主干病变（UPLM）介入治疗中的应用价值.方法 随机选取25例2012年1月至2014年1月在粤北人民医院心血管内科临床诊断为冠心病,并进行经导管冠脉造影（CAG）,确诊为UPLM的患者.其中12例患者术前进行了CTA检查;13例患者术前未进行CTA检查,而直接进行CAG及PCI.结果 12例介入诊疗前进行CTA检查的患者,CTA检查阳性预测值为100％,介入治疗均成功,手术成功率100％,术中未出现低血压及慢血流等并发症情况,PCI平均操作时间（30±5）min.13例术前未进行CTA检查的患者,有11例选择行PCI并成功,PCI成功率100％.但其中有6例患者在CAG及PCI术中出现低血压（46％）,2例患者术中出现冠脉慢血流（15％）,整体并发症发生率为61％,与CTA组比较差异有统计学意义（P＜0.01）;PCI平均操作时间（50±9）min,较CTA组明显增加（P＜0.01）.另外2例患者术前未行CTA检查,行CAG后放弃PCI治疗,择期行CABG（15％）.结论 冠心病患者术前行CTA检查,有助于提前发现UPLM,从而提高UPLM患者介入手术成功率,减少术中并发症.     

旁路移植术和介入治疗无保护左主干病变的疗效分析

目的:分析无保护左主干病变(ULMCA)经外科旁路移植术(CABG)和冠状动脉介入术(PCI)治疗的临床效果。方法:回顾性分析ULMCA196例,其中PCI95例,CABG105例,比较2组围术期并发症,左心室大小和心功能,主要心血管事件(MACE)。结果:围术期死亡:PCI组4例,占4.4%,CABG组8例,占7.6%;主动脉球囊反搏使用:PCI组12例(13.2%),CABG组23例(22.0%);MACE:PCI组15例(16.5%),CABG组22例(21.0%),P<0.05;平均随访(13±5)个月,PCI组死亡3例,免于MACE77.6%,MACE19例(22.4%),CABG组死亡3例,免于MACE87.6%,MACE12例(12.4%),射血分数改变PCI组1.2%±0.7%,CABG组2.3%±1.1%,P<0.05;左心室舒张末期直径大小变化PCI组(3.5±0.2)mm,CABG组(4.6±0.7)mm,P<0.03,纽约心功能分级PCI组(2.5±0.6)级,CABG组(1.5±0.3)级,P<0.02。结论:PCI和CABG术对ULMCA治疗都有较好的近、远期结果,但围术期PCI疗效优于CABG,对左主干累及分叉病变,CABG则优于PCI。     

Invasive assessment modalities of unprotected left main stenosis

Among all coronary lesions, the decision-making process for the treatment of unprotected left main (ULM) stem lesions is still challenging. Indeed, the optimal therapeutic strategy for patients with ULM disease remains controversial: coronary artery bypass grafting was established as the gold standard, but it is without doubt that percutaneous coronary intervention (PCI) performed by experienced operators achieves good results at long term follow up, especially in cases where the ostium and/or shaft of ULM are treated. Thanks to the widespread use of invasive assessment of atherothrombotic ULM stenosis, improved selection of PCI cases and techniques of stenting, better outcomes are now possible. This review seeks to define the place of PCI in ULM disease by describing the different modalities of ULM stenosis assessment.     

Percutaneous coronary intervention in unprotected left main coronary artery stenosis: Mid-term outcomes of a single-center observational study

BackgroundPercutaneous coronary intervention (PCI) is an appropriate alternative to coronary artery bypass grafting (CABG) for revascularization of unprotected left main coronary artery (ULMCA) disease in patients with low-to–intermediate anatomic complexity or when the patient refuses CABG even after adequate counselling by heart team. We assessed the safety, in-hospital and mid-term outcomes of ULMCA stenting with drug-eluting stents (DES) in Indian patients.MethodsOur study was a retrospective analysis of patients who had undergone ULMCA PCI at a tertiary center, between March 2011 and February 2020. Clinical characteristics, procedural data, and follow-up data were analyzed. The primary outcome was a composite of major adverse cardiovascular and cerebrovascular events (MACCE) during the hospital stay and at follow-up. The median follow-up was 2.8 years (interquartile range: 1.5–4.1 years).Results661 patients (mean age, 63.5 ± 10.9 years) had undergone ULMCA PCI. The mean SYNTAX score was 27.9 ± 10.4 and the mean LVEF was 58.0 ± 11.1%. 3-vessel disease and distal lesions were noted in 54% and 70.6% patients, respectively. The incidence of in-hospital MACCE was 1.8% and the MACCE during follow-up was 11.5% (including 48 [8.4%] cardiac deaths). The overall survival rates after one, three, five, and nine years were 94%, 88%, 84%, and 82%, respectively. The multivariate analysis revealed that age >65 years and high SYNTAX scores were independent predictors of mid to long-term mortality.ConclusionULMCA PCI with DES is safe and has acceptable in-hospital and mid-term outcomes among patients with low-to–intermediate SYNTAX score.     

Radiation-induced stenosis of the left main coronary artery

Isolated left main coronary artery stenosis induced by mediastinal radiation is a well-documented but rare entity. Its clinical manifestations can be latent for many years, but its ominous sequela cannot be ignored. We report here such a patient presenting 16 yr postmediastinal radiation, the longest documented latency to date.     

经桡动脉行无保护左主干病变介入治疗

目的:回顾性总结29例冠状动脉造影发现为无保护左主干开口及体部狭窄病例的冠脉介入治疗(PCI)资料,以探讨手术的安全性和可行性。方法:术前给予常规药物治疗,经桡动脉途径行PCI,观察桡动脉穿刺成功率、PCI即刻成功率、手术时间、支架扩张时间和扩张压力、住院期间严重并发症发生率、出院前心绞痛发作情况评估及术前心电图(ECG)特点分析。结果:29例患者桡动脉穿刺成功率和PCI即刻成功率均为100%,手术时间25～50(38±8)min,支架扩张时间3～7(5±1.3)s,支架扩张压力14～20(16.0±1.9)atm(1atm=101.325kPa),住院期间无严重并发症发生,前臂肿胀3例,术后心绞痛显著缓解。术前胸痛发作时ECG特点:典型"左主干"心电图17例,胸前导联ST-T改变者10例,间歇性左束支阻滞2例。结论:经桡动脉途径对无保护左主干开口和体部病变行PCI治疗,成功率高,安全有效。     

Long-term outcomes of PCI vs. CABG for ostial/midshaft lesions in unprotected left main coronary artery

Background There are limited data on long-term (> 5 years) outcomes of drug-eluting stent (DES) implantation compared with coronary artery bypass grafting (CABG) for ostial/midshaft left main coronary artery (LMCA) lesions. Methods Of the 259 consecutive patients in Beijing Anzhen Hospital with ostial/midshaft LMCA lesions, 149 were treated with percutaneous coronary intervention (PCI) with DES and 110 were with CABG. The endpoints of the study were death, repeat revascularization, myocardial infarction (MI), stroke, the composite of cardiac death, and major adverse cardiac and cerebrovascular events (MACCE, the composite of cardiac death, MI, stroke or repeat revascularization).The duration of follow-up is 7.1 years (interquartile range 5.3 to 8.2 years). Results There is no significant difference between the PCI and CABG group during the median follow-up of 7.1 years (interquartile range: 5.3–8.2 years) in the occurrence of death (HR: 0.727, 95% CI: 0.335–1.578; P = 0.421), the composite endpoint of cardiac death, MI or stroke (HR: 0.730, 95% CI: 0.375–1.421; P = 0.354), MACCE (HR: 1.066, 95% CI: 0.648–1.753; P = 0.801), MI (HR: 1.112, 95% CI: 0.414–2.987; P = 0.833), stroke (HR: 1.875, 95% CI: 0.528–6.659; P = 0.331), and repeat revascularization (HR: 1.590, 95% CI: 0.800–3.161; P = 0.186). These results remained after multivariable adjusting. Conclusion During a follow-up up to 8.2 years, we found that DES implantation had similar endpoint outcomes compared with CABG.     

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。     

介入治疗在无保护左主干病变中的应用——对不能耐受旁路移植术或手术高危患者的疗效

目的　探讨经皮冠状动脉介入治疗 (PCI)在不能耐受冠状动脉旁路移植术 (CABG)或手术高危的无保护左主干病变 (UPL MT)患者中的应用及近、远期疗效。方法　自 1993年 2月至 2 0 0 2年 8月期间 ,对 85例被列为不能耐受 CABG或手术高危的 UPL MT进行了 PCI治疗 ,其中定向斑块旋切术 (DCA) 4 8例 ,支架术 37例。术后半年内每月至少门诊复查一次 ,以后定期随诊、电话随访。术后 3、6、12月行冠状动脉造影复查。结果　 PCI术均获技术成功(术后残余直径狭窄 <5 0 % ,且获得 TIMI3级血流 )。住院期间主要不良心脏事件 (MACE)共 12例 (14 .1% ) :死亡9例 (10 .6 % ) ,其中心源性死亡 3例 (3.5 % ) ;再次 PCI术 3例 (3.5 % ) ;无 Q波心肌梗死、急诊 CABG。术后半年随访发现死亡共 15例 (17.6 % ) ,其中心源性死亡 8例 (9.4 % ) ;半年内共有 71例患者接受冠状动脉造影复查 ,其中对19例 (2 6 .8% )进行了靶血管重建 ;对资料完整的 6 4例患者作左心室射血分数 (L VEF)对比分析 ,结果显示 :PCI术后 (3或 /和 6个月 ) L VEF较术前显著改善 (5 .5± 8.7% ,P<0 .0 5 )。Kaplan- Meier生存分析显示 :PCI术后 1年、3年 (免于死亡 )的生存率为 81.2 %、76 .5 % ,免于心源性死亡的生存率为 90 .6 %、89.4 % ,免于心脏事件的生     

Current management of unprotected left main coronary artery disease: Run-in survey of the RITMO (Registro Italiano sul Trattamento del tronco coMune non protettO) study

The optimal approach for a significant unprotected left main coronary stenosis (ULM) is debated, in light of the recent progresses of percutaneous coronary intervention (PCI). However, coronary artery bypass grafting (CABG) is still considered the first choice treatment. Randomized trials comparing PCI and CABG are ongoing, yet patient selection will considerably limit their clinical applicability. We thus designed a prospective multicenter registry which will include patients with ULM disease independently from the subsequent medical, interventional or surgical treatment: the RITMO Study (Registro Italiano sul Trattamento del tronco coMune non protettO). During the RITMO run-in phase, we conducted a systematic survey of Italian catheterization laboratories to define current management strategies for ULM. A total of 240 Italian catheterization laboratory were sent an email questionnaire on current practices for ULM, with 45 (19%) detailed replies, for a total of 61,370 annual coronary angiographies. Data provided from responders showed a 5% (95% interval: 2–16) prevalence of ULM, with 50% (9–99) of ULM treated surgically and 10% (0–81) treated percutaneously. In conclusion, treatment of ULM in Italy remains prevalently surgical, even if PCI is performed in a sizable portion of patients with ULM.     

Ten-year outcomes of early generation sirolimus- versus paclitaxel-eluting stents in patients with left main coronary artery disease

To compare 10-year outcomes after implantation of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) for left main coronary artery (LMCA) stenosis. Very long-term outcome data of patients with LMCA disease treated with drug-eluting stents (DES) have not been well described. In 10-year extended follow-up of the MAINCOMPARE registry, we evaluated 778 patients with unprotected LMCA stenosis who were treated with SES (n = 607) or PES (n = 171) between January 2000 and June 2006. The primary composite outcome (a composite of death, myocardial infarction [MI] or target-vessel revascularization [TVR]) was compared with an inverse-probability-of-treatment-weighting (IPTW) adjustment. Clinical events have linearly accumulated over 10 years. At 10 years, there were no significant differences between SES and PES in the observed rates of the primary composite outcome (42.0% vs. 47.4%; hazard ratio [HR] 0.85; 95% confidence interval [CI] 0.66–1.10), and definite stent thrombosis (ST) (1.9% vs. 1.8%; HR 1.02, 95% CI 0.28–3.64). In the IPTW-adjusted analyses, there were no significant differences between SES and PES in the risks for the primary composite outcome (HR 0.89, 95% CI 0.65–1.14) or definite ST (adjusted HR 1.05, 95% CI 0.29–3.90). In patients who underwent DES implantation, high overall adverse clinical event rates (with a linearly increasing event rate over time) were observed during extended follow-up. At 10 years, there were no measurable differences in outcomes between patients treated with SES vs. PES for LMCA disease. The incidence of stent thrombosis was quite low and comparable between the groups.     

One-year results of unprotected left main disease treatment with paclitaxel-eluting stents: results of a multicenter registry.

BACKGROUND: Preliminary data suggest that drug-eluting stents might have a role in selected cases of unprotected left main stenosis (ULMS). The purpose of this study was to determine the rates of death, myocardial infarction, and repeated revascularization in a multicenter, prospective series of patients with ULMS treated with paclitaxel-eluting stents. METHODS: A prospective registry was initiated in March 2003 through December 2004 in five tertiary centers including all patients with a significant (>50%) stenosis in ULMS treated with at least one paclitaxel-eluting stent. There were no clinical or angiographic exclusion criteria. Clinical follow-up was obtained at 6 and 12 months. RESULTS: A total of 100 patients were included. Mean age was 67.6 +/- 11.4 years and 36% were diabetics. Distal left main was affected in 53% of patients. Implantation of two stents was required in only 15%. Angiographic success was achieved in all cases. Significant periprocedural CK-MB elevation occurred in 5 patients and there was 1 intraprocedural death. At a median 9 months follow-up, cardiac death occurred in 7%, the majority of which (4%) in patients with ST-elevation myocardial infarction and cardiogenic shock before stent implantation. Only 3 patients (3%) required repeated target-vessel revascularization, all repeated angioplasty procedures. CONCLUSION: Percutaneous treatment of unprotected left main lesions with paclitaxel-eluting stents is associated with acceptable mid-term results in selected patients, with very low rates of repeated revascularization.     

二代支架时代数据中糖尿病对无保护左主干患者不同血运重建术预后的影响

目的:在二代支架时代,糖尿病对不同血运重建策略治疗无保护左主干冠状动脉疾病患者的影响尚未可知。方法:回顾性入选823例无保护左主干冠状动脉疾病的患者,其中接受二代药物洗脱支架(DES)置入治疗的患者331例(糖尿病患者,n=99;非糖尿病患者,n=232),接受冠状动脉旁路移植术(CABG)患者492例(糖尿病患者,n=127;非糖尿病患者,n=365)。我们根据不同的血运重建策略比较了糖尿病对临床结果的影响。结果:在接受血运重建的无保护左主干病变患者中,糖尿病患者占27.5%(226/823)。经过平均25.3个月的随访后发现,在接受DES治疗的人群中,糖尿病患者与非糖尿病患者的全因死亡率、心源性死亡率、血运重建发生率、卒中和主要不良心脑血管事件的发生率没有显著差异。然而,在全因死亡/心肌梗死/卒中联合终点(糖尿病组21.5%vs.非糖尿病7.2%,P=0.001)及心肌梗死发生率(糖尿病组15.4%vs.非糖尿病组1.6%,P<0.001)中,糖尿病患者明显高于非糖尿病患者。在接受CABG治疗的群体中,糖尿病组和非糖尿病组所有临床终点发生率相似。结论:在二代药物洗脱支架治疗无保护左主干病变的患者中,合并糖尿病的患者较非糖尿病组预后较差,在接受CABG的患者中,糖尿病和非糖尿病组预后相似。     

Long term outcomes of drug-eluting stent versus coronary artery bypass grafting for left main coronary artery disease: a meta-analysis

Background It is still controversial whether percutaneous coronary intervention with drug-eluting stent (DES) is safe and effective compared to coronary artery bypass graft surgery (CABG) for unprotected left main coronary artery (ULMCA) disease at long-term follow up (≥ 3 years). Methods Eligible studies were selected by searching PubMed, EMBASE, and Cochrane Library up to December 6, 2016. The primary endpoint was a composite of death, myocardial infarction (MI) or stroke during the longest follow-up. Death, cardiac death, MI, stroke and repeat revascularization were the secondary outcomes. Results Four randomized controlled trials and twelve adjusted observational studies involving 14,130 patients were included. DES was comparable to CABG regarding the occurrence of the primary endpoint (HR = 0.94, 95% CI: 0.86-1.03). Besides, DES was significantly associated with higher incidence of MI (HR = 1.56, 95% CI: 1.09-2.22) and repeat revascularization (HR = 3.09, 95% CI: 2.33-4.10) compared with CABG, while no difference was found between the two strategies regard as the rate of death, cardiac death and stroke. Furthermore, DES can reduce the risk of the composite endpoint of death, MI or stroke (HR = 0.80, 95% CI: 0.67-0.95) for ULMCA lesions with SYNTAX score ≤ 32. Conclusions Although with higher risk of repeat revascularization, PCI with DES appears to be as safe as CABG for ULMCA disease at long-term follow up. In addition, treatment with DES could be an alternative interventional strategy to CABG for ULMCA lesions with low to intermediate anatomic complexity.     

Revascularization of unprotected left main coronary artery disease: Strategy selection and systematic risk assessment

Refinement of interventional techniques, adjunctive pharmacological therapy, and the introduction of drug eluting stents have fostered new interest for the percutaneous treatment of unprotected left main coronary artery (ULMCA) stenosis. Several observational registries, some randomized controlled trials and several meta‐analyses have consistently shown no difference in mortality and myocardial infarction between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery in patients with ULMCA stenosis, but a higher rate of target vessel revascularization in patients treated with PCI. As a consequence, PCI of ULMCA stenosis has been upgraded to class IIa or IIb indication in the current European or American College of Cardiology/American Heart Association practice guidelines. Although these results are promising, they do not still represent enough evidence for extending PCI of ULMCA stenosis to current clinical practice. The EXCEL trial will address the value of PCI in relation to CABG for the treatment of ULMCA stenosis in more than 2000 patients. A major breakthrough of the SYNTAX trial has been the demonstration of an interaction between the coronary complexity and the revascularization strategy, suggesting that optimal risk stratification is a key element when deciding the best strategy of revascularization in this high‐risk group of patients. Multidisciplinary team approach remains essential to provide a balanced information to the patient and to offer the beast treatment option. © 2012 Wiley Periodicals, Inc.