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.     

药物洗脱支架在冠心病无保护左主干病变中的应用

目的评价药物洗脱支架治疗经选择冠心病无保护左主干病变的安全性和有效性。方法2003年1月~2005年6月间,共有48例经选择的冠心病患者,年龄39~81岁,经冠状动脉造影证实为无保护左主干病变(左主干狭窄均≥75%)行介入治疗置入药物洗脱支架。结果48例患者介入治疗均获得成功,共置入药物洗脱支架75枚(51 Cypher,18 Taxus,6 Firebird)。其中左主干开口部狭窄5例(10.4%,5/48),体部狭窄6例(12.5%,6/48),远端分叉部位狭窄37例(77.1%,37/48)。37例远端分叉部位狭窄患者中,主支支架加边支经皮冠状动脉介入治疗(PCI)10例,双支架术27例,最后成功对吻球囊扩张30例(81.1%,30/37)。所有患者治疗后临床症状明显缓解或消失,住院及6个月随访期间无严重心血管事件发生,43例患者术后6个月行冠状动脉造影随访,2例患者再狭窄(均为分叉病变)行冠状动脉旁路移植术(CABG),冠状动脉造影随访率89.6%,再狭窄率4.7%。结论药物洗脱支架介入治疗冠心病无保护左主干病变安全有效,近中期效果良好。     

Prolonged effectiveness of coronary artery bypass surgery versus drug-eluting stents in diabetics with multi-vessel disease: An updated systematic review and meta-analysis

Background

Currently, the appropriateness of percutaneous coronary intervention (PCI) using drug-eluting stents (DES) versus coronary artery bypass grafting (CABG) for patients with diabetes (DM) and multi-vessel disease (MVD) is uncertain due to limited evidence from few randomised controlled trials (RCTs). We aimed to compare the clinical effectiveness of CABG versus PCI-DES in DM-MVD patients using an evidence-based approach.

Methods

A systematic review and meta-analyses were conducted to compare the risk of all-cause mortality, myocardial infarction (MI), repeat revascularisation, cerebrovascular events (CVE), and major adverse cardiac or cerebrovascular events (MACCE).

Results

A total of 1,837 and 3,052 DM-MVD patients were pooled from four RCTs (FREEDOM, SYNTAX, VA CARDS, and CARDia) and five non-randomised studies. At mean follow-up of 3 years, CABG compared with PCI-DES was associated with a lower risk of all-cause mortality and MI in RCTs. By contrast, no significant differences were observed in the mean 3.5-year risk of all-cause mortality and MI in non-randomised trials. However, the risk of repeat revascularisations following PCI-DES compared with CABG was 2.3 (95% CI = 1.8–2.8) and 3.0 (2.3–4.2)-folds higher in RCTs and non-randomised trials, respectively. Accordingly, the risk of MACCE at 3 years following CABG compared with PCI-DES was lower in both RCTs and non-randomised trials [0.65 (: 0.55–0.77); and 0.77 (0.60–0.98), respectively].

Conclusions

Based on our pooled results, we recommend CABG compared with PCI-DES for patients with DM-MVD. Although non-randomised trials suggest no additional survival-, MI-, and CVE- benefit from CABG over PCI-DES, these results should be interpreted with care.     

Late stent malapposition with marked positive vascular remodeling observed only at the site of drug-eluting stents after multivessel coronary stenting

A 74-year-old woman presented with effort-induced chest pain. Diagnostic coronary angiography revealed three-vessel disease. A successful angioplasty was performed with two sirolimus-eluting stents placed in the left anterior descending artery (LAD) and left circumflex artery (LCX). The right coronary artery (RCA) was treated with a bare-metal stent. Follow-up angiography and intravascular ultrasound (IVUS) assessment were performed 8 months later, which showed late stent malapposition (LSM) with marked positive vascular remodeling around the drug-eluting stents (DES) in both LAD and LCX lesions, but there was no evidence of ectatic area around the BMS in the RCA lesion. Compared with the baseline IVUS, a significant increase in external elastic membrane (EEM) cross-sectional area was found. Twenty-seven months later, we performed repeat follow-up angiography. Intravascular ultrasound still showed vessel malapposition. A previous report showed that aneurysmal dilatation of the stented segment with severe localized hypersensitivity reaction could be a potential cause of late thrombosis after DES implantation. If LSM is related to hypersensitivity of the DES, it may have a potential risk of adverse events. Although there is a paucity of data regarding malapposition as the cause of adverse events, careful long-term follow-up of patients with vessel enlargement after DES placement is recommended.     

Potential shift from coronary bypass surgery to percutaneous coronary intervention for multivessel disease and its economic impact in the drug-eluting stent era

BACKGROUND: Drug-eluting stents (DES) may promote percutaneous coronary intervention (PCI) procedures in patients traditionally referred for coronary artery bypass graft (CABG) surgery and may save money. OBJECTIVES: The purpose of the present study was to quantify the potential shift from CABG surgery to multivessel PCI in the DES era and to model the economic consequences. METHODS: Based on predefined criteria, the feasibility of PCI was evaluated in patients with multivessel coronary artery disease who underwent CABG surgery before the availability of DES at the Centre Hospitalier de l'Université de Montréal's Notre-Dame Hospital (Montreal, Quebec). Modelling was used to evaluate the potential cost savings using multivessel PCI instead of CABG surgery. Equal one-year outcomes in both groups were assumed, with the exception of a 10% repeat revascularization (RR) rate in the DES group and a 4% RR rate in the CABG group. The impact of those assumptions was evaluated using 1000 Monte Carlo simulations. RESULTS: The authors retrospectively evaluated that, of 289 patients who underwent CABG without concomitant valve surgery between January and December 2003, only 22 patients (8%) were good candidates for multivessel DES implantation. The procedures would have involved an average of 3.6 DES per patient. The average cost per revascularization procedure was $14,402 with surgery and $11,220 for multivessel DES implantation (using $2,200 DES), leading to a savings of $3,182 per patient. However, after including RR procedures, PCI would only have been associated with savings of $812 per surgery avoided. Monte Carlo analysis revealed that surgery may be less expensive than PCI in 36% of patients. CONCLUSIONS: Most patients who underwent CABG surgery in 2003 were retrospectively judged to be ineligible for multivessel PCI with DES. In the rare eligible patient, multivessel PCI with DES is not expected to produce savings to health care costs in Canada unless the DES purchase cost continues to decrease.     

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.     

Duration of dual antiplatelet treatment in the era of next generation drug-eluting stents

Current percutaneous coronary intervention guidelines recommend dual antiplatelets(aspirin 100 mg + clopidogrel 75 mg daily) for at least 12 mo following drugeluting stent(DES) implantation if patients are not at high risk of bleeding.Several reports have tried to shorten the dual antiplatelet therapy to 3-6 mo,especially following next-generation DES implantation,for cost-effectiveness.However,the clinical results are inconsistent and the data regarding next-generation DESs limited.In this report,recently published important pivotal reports regarding the optimal duration of dual antiplatelets following DES implantation are summarized.     

Effects of drug-eluting stents on systemic inflammatory response in patients with unstable angina pectoris undergoing percutaneous coronary intervention

Inflammatory markers are elevated in acute coronary syndromes, and are also known to play a crucial role in the pathogenesis of neointimal proliferation and stent restenosis. Drug-eluting stents (DESs) have been shown to decrease stent restenosis in different studies. In this study, we aimed to investigate the effect of treatment with DESs on systemic inflammatory response in patients with unstable angina pectoris who underwent percutaneous coronary intervention (PCI). We compared plasma high-sensitivity C-reactive protein (hsCRP), human tumor necrosis factor α (Hu TNF-α), and interleukin 6 (IL-6) levels after DES (dexamethasone-eluting stent [DEXES], and sirolimuseluting stent [SES]) implantation with levels after bare metal stent (BMS) implantation. We performed PCI with a single stent in 90 patients (62 men; 59 ± 9 years of age; n = 30 in the BMS group, n = 30 in the DEXES group, n = 30 in the SES group) who had acute coronary syndrome. Plasma hsCRP, Hu TNF-α, and IL-6 levels were determined before intervention and at 24 h, 48 h, and 1 week after PCI. The results were as follows. Plasma hsCRP levels at 48 h (11.19 ± 4.54, 6.43 ± 1.63 vs 6.23 ± 2.69 mg/l, P = 0.001) after stent implantation were significantly higher in the BMS group than in the DES group; this effect persisted for 7 days (P = 0.001). Plasma Hu TNF-α levels at each time point were higher in the SES group than in the BMS and DEXES groups (P < 0.05). The time course of Hu TNF-α values was similar in all groups. Although IL-6 levels at baseline and at 24 and 48 h showed no statistically significant difference between the study groups, postprocedural values at 7 days were slightly statistically significant in the SES group (P = 0.045). Drug-eluting stents showed significantly lower plasma hsCRP levels after PCI compared with BMSs. This may reflect the potent effects of DESs on acute inflammatory reactions induced by PCI.     

冠状动脉旁路移植术后行PCI患者特点分析

目的:探讨冠状动脉旁路移植术后行经皮介入治疗(PCI)患者的临床及造影特点,为冠脉旁路移植术后患者治疗策略的选择提供参考. 方法:分析150例搭桥术后行PCI患者的临床及造影特点. 结果:患者平均年龄(62.3±9.3)岁,左室射血分数(59.1±6.6)％.150例患者均为冠状动脉多支血管病变,共处理罪犯病变197处,其中自身血管153处,动脉桥血管2处,静脉桥血管42处.所有患者均行PCI治疗,无再流发生率为12.7％,其中16例为桥血管病变,3例自身冠状动脉病变,桥血管介入治疗较自身血管介入治疗后其心肌标志物升高明显,无术中死亡病例. 结论:PCI是冠状动脉搭桥术后心肌缺血患者的有效治疗手段,心功能和血管病变造影特点是成功治疗的关键.     

One-year clinical outcomes in patients with very small coronary artery disease treated with drug-eluting stents: An observational study in the Indian population

Percutaneous coronary intervention (PCI) in very small vessel coronary arteries is challenging due to adverse short-term as well as long-term outcomes. This single-arm, open-label, observational study assessed 1-year clinical outcomes of drug-eluting stents (DES) in Indian patients undergoing PCI for symptomatic very small-calibre coronary artery disease. It enrolled 66 Indian patients with 74 very small coronary artery lesions (reference vessel diameter: ≥2.0 and ≤ 2.25 mm); eligible for implantation with 2.25 mm DES. The primary endpoint of major adverse cardiovascular events (MACE) was 3.0% indicating favourable 1-year clinical outcomes of DES in very small coronary artery lesions in Indian patients.     

Safety and effectiveness of percutaneous coronary intervention using rotational atherectomy and new-generation drug-eluting stents for calcified coronary artery lesions in patients with chronic kidney disease

AimCoronary artery calcification is an important factor influencing revascularisation outcomes in patients with chronic kidney disease (CKD). Lesion preparation using rotational atherectomy (RA) may help adequately modify calcified plaques and facilitate the achievement of optimal clinical outcomes in these patients. In this study, we assessed the safety and effectiveness of percutaneous coronary intervention (PCI) using RA followed by new-generation drug-eluting stent (DES) implantation in patients with CKD and calcified coronary artery disease (CAD).Methods and resultsFrom November 2014 to October 2019, a total of 203 patients with calcified CAD who underwent RA followed by second- or third-generation DES implantation at our centre were included in the study. Mild, moderate, and severe CKD was present in 38%, 55.5%, and 6.5% of the patients, respectively. Diffused coronary calcifications were present in 85%. Procedural success was 97.5% with minimal periprocedural complications. In-stent restenosis occurred in one patient (0.5%); major adverse cardiovascular and cerebrovascular events were reported in 22 patients (10.8%); cardiac death occurred in eight patients during follow-up.ConclusionPercutaneous coronary intervention using RA followed by second- or third-generation DES implantation is feasible and safe with high procedural success and low in-stent restenosis in CKD patients with calcified coronary lesions.     

国产长药物支架治疗冠脉长病变的疗效评估

目的评价国产药物长支架治疗冠状动脉长病变的临床疗效。方法对60例冠心病冠脉长病变患者置入药物涂层长支架(66枚,长度均≥29mm),随机选择同期60例接受短支架治疗的患者(70枚,长度均≤18mm),所有患者均于术后6～9个月复查冠脉造影,比较两组支架置入情况、近远期临床效果以及事件发生率。结果两组手术成功率相似(98.3%和100%,P>0.05),随访6～9个月,两组患者死亡率、支架再狭窄率及心血管事件发生率差异均无统计学意义。结论国产药物涂层支架治疗冠状动脉长病成功率高,其近期及远期效果均满意,故安全可行。     

药物洗脱支架治疗糖尿病多支冠脉病变

目的 探讨药物洗脱支架治疗糖尿病多支冠脉病变患者的安全性和可行性,并与冠脉旁路移植术的疗效进行比较.方法 150例糖尿病多支冠脉病变患者,84例行药物洗脱支架置入术(DES组),66例行冠脉旁路移植术(CABG组).比较两组住院期和随访期不良心血管事件(死亡、心肌梗死、再次血管重建术和脑血管意外)的发生情况.结果 两组的大多数临床和冠脉病变特征相似,CABG组左主干病变(30%比4%,P=0.001)和三支病变(70%比54%,P=0.045)显著增多,完全血管重建化率更高(82%比67%,P=0.037).住院期CABG组术后病死率显著增高(6.1%比0%,P=0.022),但两组总体不良心血管事件发生率仍相似(2.4%比9.1%,P=0.069).在平均(18±8)个月随访期,DES组再次血管重建化率显著增加(13.1%比3.0%,P=0.03),导致总体不良心血管事件发生率增高(21.4%比9.1%,P=0.041),其中相当部分(45%)由于病变进展所致.结论 药物洗脱支架置入术应用在糖尿病多支冠脉病变患者中安全可行,缩小了再次血管重建化发生率上与冠脉旁路移植术的差距.     

药物洗脱支架置入与冠状动脉旁路移植术治疗糖尿病合并多支病变的近中期疗效分析

目的比较药物洗脱支架(DES)置入与冠状动脉旁路移植术(CABG)治疗糖尿病合并多支病变患者住院时和12个月的临床效果。方法入选2003年7月至2005年12月北京安贞医院645例糖尿病合并多支病变进行血运重建的患者,比较CABG和置入DES组全因死亡、非致死性心肌梗死(M I)、脑血管事件、再次血运重建以及总的心脑血管不良事件(MACCE)发生率。结果 CABG组更多合并有左主干病变、慢性闭塞病变、C型病变和3支病变,完全血运重建较高(P均<0.001);DES组和CABG组总死亡率(P=0.460)、心脏性死亡和非致死性M I复合终点事件(P=0.076)的发生率差异无统计学意义;DES组MACCE、再次血运重建发生率明显增高(P均<0.001)。结论糖尿病合并多支病变患者12个月时CABG有较低MACCE,与再次血运重建发生率较低有关;DES有较高的再次血运重建发生率,与糖尿病较高的再狭窄率和PC I较低的完全血运重建率有关。     

Comparison of sirolimus-, paclitaxel-, and everolimus-eluting stent in unprotected left main coronary artery percutaneous coronary intervention

ObjectivesThis retrospective study evaluated the outcomes of patients who underwent unprotected left main coronary artery (ULMCA) percutaneous coronary intervention (PCI) with different types of drug-eluting stents (DES).BackgroundThe standard of care for patients with ULMCA is coronary artery bypass surgery. However, current guidelines recommend PCI in clinical conditions where there is an increased risk of adverse surgical outcomes. Clinical outcomes of patients undergoing ULMCA PCI with different types of drug-eluting stents (DES) are unknown.MethodsData from a multicenter international registry, which included 239 consecutive patients from four institutions who ULMCA PCI with DES, were collected.ResultsThere were 42 patients receiving paclitaxel-eluting stent (PES), 158 patients receiving sirolimus-eluting stent (SES), and 39 patients receiving everolimus-eluting stent (EES). There was no statistical difference in major adverse cardiovascular events, cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis among PES, SES, and EES at 30 days and 1 year.ConclusionsThere are no differences in clinical events among patients receiving PES, SES, and EES for ULMCA disease.     

女性冠心病患者冠状动脉介入治疗长期预后

目的:了解女性冠心病患者在接受冠状动脉介入治疗(PCI)后的长期临床疗效.方法:584例经PCI治疗的患者,被分为女性组(122例)和男性组(462例),收集其一般临床资料及PCI治疗情况,并进行长期(3～49个月)临床随访,详细记录患者临床主要不良事件的发生情况.结果:男性患者的全因性死亡率(0:3.03%,P＞0.05)及心因性死亡率(0:2.98%,P＞0.05)有增高趋势,女性患者因心脏病再住院率(15.57%:9.96%,P＜0.05)显著增加,但2组患者其他临床主要不良事件差异无统计学意义.经过校正不匹配因素的偏相关分析显示,男性与心因性死亡(r=0.0874,P＜0.05)及全因性死亡(r=0.0970,P＜0.05)呈正相关.结论:女性患者PCI治疗的长期临床预后良好.     

同种和不同种药物洗脱支架治疗冠状动脉药物洗脱支架内再狭窄有效性的系统评价

目的评价同种药物洗脱支架和不同种药物洗脱支架治疗冠状动脉药物洗脱支架内再狭窄的有效性。方法计算机检索Pub Med、OVID、Embase、Cochrane图书馆、万方数据库、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、维普数据库(VIP),收集同种和不同种药物洗脱支架治疗冠状动脉药物洗脱支架内再狭窄的临床资料,共纳入10项研究,1680名患者,使用Rev Man5.2软件进行系统评价。检索时间为各大数据库建库至2015年10月。结果在治疗冠状动脉药物洗脱支架内再狭窄时,采用不同药物洗脱支架可降低靶病变血运重建率(OR=0.73,95%CI为0.55~0.96,P=0.02)和主要不良心血管事件发生率(OR=0.72,95%CI为0.54~0.96,P=0.03)。两组间的病死率(OR=1.03,95%CI为0.49~2.16,P=0.95)和心肌梗死发生率(OR=0.59,95%CI为0.24~1.41,P=0.23)无统计学差异。结论对于药物洗脱支架内再狭窄患者,再次植入不同药物洗脱支架比植入同种支架更获益。     

Variable histological and ultrasonic characteristics of restenosis after drug-eluting stents

Bare-metal stents have undergone intense pathological and clinical examination, but histological characterization of drug-eluting stent (DES) restenosis (ISR) remains unknown. We report a series of cases (n = 6) with intravascular ultrasound (IVUS) and pathological examinations over 8 months after DES deployment. Tissue samples were obtained using atherectomy devices in 5 cases and a thrombectomy catheter in 1 case. Histology revealed not only smooth muscle cell proliferation, which correlated with homogeneous hypoechoic tissue by IVUS in one case, but also demonstrated delayed healing features such as organized fibrin deposition in 3 cases (one with homogeneous echolucent tissue by IVUS), macrophage and T-lymphocyte infiltration in others. IVUS appearance of ISR components varied from echolucent to echodense images. This report suggests a variable histological and IVUS pattern of ISR after DES implantation. Further investigations are necessary to define the potentially pro-thrombotic histological features of ISR after DES implantation, and the relationship between the molecular mechanisms of thrombosis and DES restenosis.     

Long-term clinical outcomes of drug-eluting stents vs. bare-metal stents in Chinese geriatric patients

Background & Objective Little is known about the relative efficacies of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and bare-metal stents (BMS) in elderly patients. The objective of this study was to evaluate the clinical outcome for geriatric patients who received either DES or BMS. Methods From January 2002 to October 2005, 199 consecutive Chinese geriatric patients (≥ 75 years old) underwent PCI with coronary DES or BMS implantation at our institution. We analyzed the major clinical end points that included all-cause mortality, cardiovascular death, myocardial infarction, target lesion revascularization (TLR), stent thrombosis, and bleeding complications. Results The three-year cumulative rates of all-cause mortality, cardiovascular death, and myocardial infarction were significantly lower in the DES group (6.3%, 3.6%, 5.4%) compared with the BMS group (16.2%, 11.5%, 14.9%; P < 0.05). No significant differences were found in the three-year cumulative rate for target lesion revascularization (6.3% vs. 4.6%, P = 0.61) or stent thrombosis (3.6% vs. 2.3%, P = 0.70). Likewise, there were no statistically significant differences in the cumulative rate for intracranial hemorrhage, or major and minor hemorrhage at three years. Conclusions DES-based PCI was associated with a significant reduction in the three-year cumulative rate of all-cause mortality, cardiovascular death, and myocardial infarction compared with BMS, without increased risk of TLR, stent thrombosis, or bleeding complications at three years in this group of Chinese geriatric patients.     

PCI对冠心病合并糖尿病行冠状动脉旁路移植的影响

目的 评价术前PCI对冠心病合并2型糖尿病患者行冠状动脉旁路移植术的影响.方法 回顾性分析2003年1月至2013年1月,上海交通大学医学院附属仁济医院心血管外科1848例冠状动脉旁路移植术患者,合并糖尿病352例.患者分为2组,术前PCI组106例,术前无PCI组246例.结果 围术期死亡率6.2%,PCI组死亡率16.04%,非PCI组死亡率2.03%.运用x2、t试验,logistic多因素回归分析表明,术前PCI史是影响围术期心功能、术后死亡、术后并发症发生的重要因素.结论 术前PCI是冠心病合并2型糖尿病行冠状动脉旁路移植围术期死亡、术后心血管不良事件发生的危险因素.