Periprocedural myocardial infarction is associated with increased mortality in patients with coronary artery bifurcation lesions after implantation of a drug-eluting stent
http://onlinelibrary.wiley.com/doi/10.1002/ccd.25857/abstract
Abstract
Objectives: The present study aimed to investigate the association between periprocedural myocardial infarction (PMI)， defined by creatine kinase (CK)-MB or troponin I (TNI) level elevations >5 times the 99th percentile of the upper reference limit (URL) within 48 h after implantation of a drug-eluting stent (DES)， and one-year mortality in patients with coronary bifurcation.
Background: PMI is reported to be associated with increased one-year mortality after DES implantation. However， the prevalence and association of PMI with mortality after stenting bifurcation lesions remains unclear.
Methods: We prospectively followed 1971 patients with true coronary bifurcations who underwent DES implantation as part of the multicenter DEFINITION study. These patients were grouped into categories based on PMI outcome: Non-PMI， CKMB-PMI， TNI-PMI， and CKMB/TNI-PMI. The primary endpoint was the rate of all-cause mortality at one year.
Results: PMI occurred in 11.4% of patients by CK-MB criteria and 41.3% of patients by TNI criteria. At one-year follow-up， the mortality rate was 2.3% in the entire patient population. However， mortality was significantly higher in the CKMB-PMI (6.4%) and CKMB/TNI-PMI (6.1%) groups compared to the Non-PMI (1.7%) and TNI-PMI (2.1%) groups (all p<0.05). A 10-fold increase in TNI levels resulted in similar PMI rate (5.2%) and mortality risk (adjusted HR 2.7， 95% CI 3.0-5.2) as a 5-fold increase in CKMB levels.
Conclusions: PMI， as defined by CK-MB elevations following coronary bifurcation lesion stenting， was associated with increased one-year mortality. Additionally， to attain an equal frequency of PMI， the elevation in TNI levels needed to be twice as high as the elevation in CKMB levels. This article is protected by copyright. All rights reserved.
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围术期心肌梗死可增加冠状动脉分叉病变患者置入药物洗脱支架后的死亡率
围术期心肌梗死（PMI）可增加置入药物洗脱支架（DES）后的一年死亡率，但分叉病变置入DES后的PMI患病率及其与死亡率的相关性尚不清楚。本研究前瞻性入选1971例置入DES治疗的冠状动脉分叉病变患者，根据其PMI结局将其分为非PMI组、CKMB-PMI组、TNI-PMI组及CKMB/TNI-PMI。结果发现，CK-MB及TNI所诊断的PMI发生率分别为11.4%和41.3%。随访1年结束时，受试患者的总死亡率为2.3%，与非PMI组及TNI-PMI组相比，CKMB-PMI组及CKMB/TNI-PMI组的死亡率更高。TNI增加10倍对PMI发生率及死亡风险的影响才能与CKMB增加5倍的影响相当。综上可见，根据CK-MB增高所诊断的PMI可显著增加分叉病变支架置入后的一年死亡率。
How bifurcation angle impacts the fate of side branch after main vessel stenting: A retrospective analysis of 1200 consecutive bifurcation lesions in a single center
http://onlinelibrary.wiley.com/doi/10.1002/ccd.25858/abstract
Abstract
Objectives: We aimed to investigate the effect of bifurcation angle (BA) on side branch (SB) occlusion after main vessel (MV) stenting.
Background: BA is thought to impact the risk of SB occlusion in coronary bifurcation patients undergoing percutaneous coronary intervention (PCI).
Methods: A total of 1171 consecutive patients with 1200 bifurcation lesions undergoing one stent or provisional two stent techniques were studied. The lesions were divided into low angle and high angle groups using the median BA (52°). Multivariate logistic regression analysis was performed to identify independent predictors of SB occlusion.
Results: SB occlusion occurred in 88 (7.33%) of 1200 bifurcation lesions treated with the one stent technique or MV stenting first strategy. The rate of SB occlusion was significantly higher in the high angle group (63/600， 10.5%) than the low angle group (25/600， 4.2%) (p<0.001). The rate of SB occlusion increased significantly across quartiles of BA as follows: from 3.63% in the first quartile of BA， to 4.71% in quartile II， to 8.14% in quartile III to 12.97% in quartile IV (p<0.001). Multivariable analysis showed that high angle was an independent predictor of SB occlusion (odds ratio: 1.026， 95% confidence intervals: 1.014-1.037， p<0.001). Plaque distribution at the same side of SB， MV TIMI flow grade before stenting， pre-procedural diameter stenosis of bifurcation core， diameter ratio between MV/SB and diameter stenosis of SB before MV stenting were also independent predictors of SB occlusion.
Conclusions: High BA was an independent predictor of SB occlusion after MV stenting. The occlusion risk of SB with a high BA should not be ignored. This article is protected by copyright. All rights reserved.
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分叉角度对主支支架置入术后分支闭塞的影响
分叉角度（BA）被认为可影响行PCI治疗的冠状动脉分叉病变患者的分支（SB）闭塞风险。为评估分叉角度（BA）对主支（MV）支架置入术后分支（SB）闭塞的影响，本研究连续入选1171例涉及1200处分叉病变行单支架或临时双支架治疗的患者。以BA为52°为界，将其分为低BA组与高BA组。结果发现，与低BA组相比，高BA组的SB闭塞发生率更高。将BA进行四分位可见，随着患者所处BA四分位分组的增加，SB闭塞发生率增高。多因素Logistic回归分析发现，BA较高是MV支架置入术后发生SB闭塞的独立预测因素。临床医生不应忽视行MV支架置入术的BA较高患者SB闭塞风险。
PLATINUM China: A prospective， randomized investigation of the platinum chromium everolimus-eluting stent in?de novo coronary artery lesions
http://onlinelibrary.wiley.com/doi/10.1002/ccd.25859/abstract
Abstract
Objectives: The PLATINUM China clinical trial evaluated the safety and effectiveness of the thin-strut， everolimus-eluting， platinum-chromium PROMUS Element stent (PtCr-EES) (Boston Scientific， Marlborough， MA) for the treatment of patients in China.
Background: Clinical outcomes from the PtCr-EES have not been evaluated in patients from China， nor has it been directly compared with the second-generation stainless steel paclitaxel-eluting TAXUS Liberté stent (PES) in a randomized head-to-head trial.
Methods:In this prospective， multicenter， single-blind， superiority trial， patients with a single de novo atherosclerotic coronary artery lesion were randomized 1:3 to receive either the PES or PtCr-EES (Boston Scientific， Marlborough， MA). The primary endpoint was in-stent late loss at 9 months.
Results: Among 127 PES and 373 PtCr-EES patients (71.2% male; mean age 57.3 years)， the primary endpoint of 9-month in-stent late loss was 0.40±0.45mm for PES versus 0.11±0.36mm for PtCr-EES (P<0.001). In-stent % diameter stenosis was 22.20±16.00% for PES versus 11.06±13.86% for PtCr-EES (P<0.001) at 9 months. The 1-year rate of death/MI was 1.6% (2/127) for PES versus 0% (0/371) for PtCr-EES (P=0.06) and target vessel revascularization was 4.7% (6/127) for PES versus 2.7% (10/371) for PtCr-EES (P=0.26). No stent thromboses occurred at12 months in either group.
Conclusions: In the largest prospective angiographic evaluation conducted to date with this stent， the PROMUS Element PtCr-EES was superior to the TAXUS Liberté PES for the primary endpoint of late loss at 9 months， with low rates of clinical events at 1 year. Clinical follow-up will continue to 2 years. This article is protected by copyright. All rights reserved.
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PLATINUM 中国：铂铬合金依维莫司药物洗脱支架治疗原发冠状动脉病变
为探讨铂铬合金依维莫司药物洗脱支架（PtCr-EES）治疗中国原发冠状动脉病变患者的安全性及有效性， PLATINUM 中国这项前瞻性、多中心、单盲、随机、优效性研究入选单支原发冠状动脉病变患者，将其随机分为紫杉醇药物洗脱支架（PES）组与PtCr-EES组。结果发现，与PES组相比，PtCr-EES组PCI治疗后9个月时支架内晚期腔径丢失更小，管腔直径狭窄百分比更低；术后1年时的死亡/心肌梗死、靶血管血运重建发生率呈降低趋势，且无支架内血栓发生。综上可见，与PES相比，PtCr-EES在减少PCI术后9个月支架内晚期腔径丢失及降低术后1年临床事件发生率方面更具优势。
Association of mean platelet volume with angiographic thrombus burden and short-term mortality in patients with st-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention
http://onlinelibrary.wiley.com/doi/10.1002/ccd.25860/abstract
Abstract
Objectives: The aim of this study was to evaluate the impact of mean platelet volume (MPV) on the intracoronary thrombus burden and short-term mortality in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).
Backgroud: Platelets play a crucial role in the pathophysiology of coronary artery disease. MPV has been reported to be an indicator of platelet reactivity.
Methods: A total of 649 consecutive STEMI patients who underwent primary PCI between January 2008 and December 2013 were enrolled and divided into two groups based on the thrombus burden: the large thrombus burden (LTB) group and the small thrombus burden (STB) group. The primary endpoint was all-cause mortality at 30 days.
Results：The LTB group had significantly higher admission MPV compared with the STB group (10.77±1.22 vs 9.95±1.03，p<0.001). The cumulative 30-day all-cause mortality rate was significantly higher in the groups with high MPV and LTB (9.8% vs 2.5%，p<0.001， 8.6% vs 4.1%，p=0.036， respectively). In a receiver operating characteristic analysis， MPV≥10.2 predicted LTB with 73.5% sensitivity and 68.9% specificity. Multivariate logistic regression analysis demonstrated MPV was an independent predictor of large intracoronary thrombus burden (OR 1.794， 95% CI 1.533 to 2.100，p<0.001) and 30-day all-cause mortality (HR 1.408， 95% CI 1.040 to 1.906，p=0.027).
Conclusions: An increased MPV on admission is an independent predictor of large intracoronary thrombus burden and short-term mortality. It may be a useful biomarker for risk stratification in patients with STEMI undergoing primary PCI. This article is protected by copyright. All rights reserved.
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行PCI治疗的STEMI患者中MPV与造影所示血栓负荷及短期死亡率相关性
血小板在冠状动脉疾病发病的病理生理过程中发挥了重要作用，为探讨血小板反应性指标——平均血小板体积（MPV）对行PCI治疗的STEMI患者冠状动脉内血栓负荷及短期死亡率的影响，研究连续入选649例行急诊PCI的STEMI患者，根据冠状动脉内血栓负荷情况将其分为血栓负荷较大（LTB）组与血栓负荷较小（STB）组。结果发现，与STB组相比，LTB组入院时MPV更高；MPV较高及LTB患者PCI术后30天累积全因死亡率更高；MPV是冠状动脉血栓负荷较大及PCI术后30天全因死亡率的独立预测因素，MPV≥10.2预测LTB的敏感性及特异性分别为73.5%和68.9%。综上可见，MPV有望成为对行急诊PCI治疗的STEMI患者进行危险分层的有用生物标志物。
Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: Two-Year results from a prospective patient-level pooled analysis of TARGET trials
http://onlinelibrary.wiley.com/doi/10.1002/ccd.25861/abstract
Abstract
Objectives:
We aimed to evaluate the safety and effectiveness of the novel abluminal groove-filled biodegradable polymer-coated sirolimus-eluting FIREHAWK stent (MicroPort Medical， Shanghai， China) in a large cohort of patients.
Background:
Trials on the FIREHAWK stent allowing targeted sirolimus release were not individually powered to reliably estimate low-frequency safety endpoints such as stent thrombosis (ST) or to examine long-term safety and efficacy. Additionally， the China Food and Drug Administration requires an objective performance criterion (OPC) study for new drug-eluting stents.
Methods:
The primary endpoint， target lesion failure (TLF)， was defined as the composite of cardiac death， target vessel myocardial infarction (MI)， or clinically indicated target lesion revascularization at 12 months. Patient-level data from 1007 patients with de novo native coronary lesions exclusively treated with the FIREHAWK stent in the TARGET serial studies (I and II) were prospectively collected， pooled and analyzed throughout a 2-year follow-up.
Results:
The 12-month rate of TLF in 1003 patients (follow-up rate， 99.6%) was 3.9% (upper 95% confidence interval (CI): 5.3%)， which was significantly lower than the performance goal of 9.0% (P<0.0001). The 24-month rates of TLF， PoCE (a composite of all-cause death， all MI， or any revascularization)， and ARC definite or probable ST were 4.6%， 7.8% and 0.1%， respectively. In subgroup analysis， long lesion (≥30mm) was an independent predictor of TLF within 2 years (hazard ratio [95%CI]: 2.44 [1.32， 4.53]， P<0.01).
Conclusions:
This pooled， patient-level analysis indicates that the FIREHAWK stent exhibits a promising 2-year efficacy and safety profile. This article is protected by copyright. All rights reserved.
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TARGET研究两年结果：新型生物可降解支架聚合物雷帕霉素靶向洗脱支架治疗原发冠状动脉病变的安全性及疗效
鉴于既往有关新型生物可降解支架聚合物雷帕霉素靶向洗脱支架（火鹰支架）的研究均无足够效力可靠评估发生率较低的安全性终点如支架血栓形成（ST）或是评估其长期安全性及有效性，且CFDA要求对这种新型支架开展OPC研究。TARGET研究对其中接受火鹰支架治疗的1007例原发冠状动脉病变患者数据进行了分析。结果发现，完成随访的1003例患者中，12个月时靶病变失败（TLF）发生率为3.9%，显著低于预期目标值；24个月时TLF、ARC定义的明确及可能ST以及全因死亡、心肌梗死及任何血运重建复合终点发生率分别为4.6%、7.8%和0.1%。亚组分析显示，≥30 mm的长病变是支架置入后两年内发生TLF的独立预测因素。综上可见，火鹰支架置入两年后的疗效及安全性较好。
First-in-Man study evaluating the safety and efficacy of a second generation biodegradable polymer sirolimus-eluting stent in the treatment of patients with?de novocoronary lesions: Clinical， angiographic， and OCT outcomes of CREDIT-1
http://onlinelibrary.wiley.com/doi/10.1002/ccd.25862/abstract
Abstract
Objective:To evaluate the preliminary safety and efficacy of the EXCEL II stent system.
Background:Although the first biodegradable polymer drug-eluting stent (BP-DES)， EXCEL， was launched nearly a decade ago， in-stent restenosis and stent thrombosis remain pertinent clinical problems in practice. A new cobalt-chromium BP-DES EXCEL II has been developed with the aim of improving stent safety and efficacy.
Methods:Forty-five patients with single de novo native coronary lesions were enrolled and randomized to two groups in a 2:1 ratio， the 4-month follow-up group (n=30) and the 12-month follow-up group (n=15). All patients underwent percutaneous coronary intervention (PCI) with the EXCEL II stent system. Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were used to assess coronary vasculature at the designated 4- or 12-month follow-up. The primary outcome was major adverse cardiac events (MACE) at 30 days post-PCI.
Results:No MACE， thrombotic events， or target lesion failure was found in the 45 patients during the 12-month follow up. There was no significant difference (P>0.05) between the two groups in terms of in-stent and in-segment late lumen loss (LLL). No in-stent and in-segment restenosis was found in either groups. At follow-up， the ratio of >10% uncovered struts per lesion was 26.67% in the 4-month group and 0% in the 12-month group (P<0.05). Neointimal coverage in the 12-month group was significantly better than in the 4-month group (98.58% vs. 93.51%， P<0.01).
Conclusions:This first-in-man (FIM) study demonstrates promising feasibility， safety， and efficacy of EXCEL II stents. These stents were found to have rapid endothelialization and low LLL rates at 4 and 12 months after implantation. This article is protected by copyright. All rights reserved.
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CREDIT-1研究的临床、血管造影及OCT结局
已推出近十年的第一代生物可降解聚合物药物洗脱支架（BP-DES）EXCEL，存在支架内再狭窄及支架内血栓形成问题。为提高其安全性及有效性，人们研发了第二代钴铬BP-DESEXCELⅡ。为评估EXCEL II的初步安全性及有效性，本研究入选45例单支原发冠状动脉病变患者，采用EXCELⅡ行PCI，随访4个月及12个月，采用定量冠状动脉造影（QCA）及光学相干断层扫描（OCT）评估冠状动脉血管。结果发现，随访12个月期间，有45例患者未出现MACE、血栓性时间或靶血管病变失败。随访4个月及12个月时均未见支架内及节段内再狭窄，支架内及节段内晚期管腔丢失（LLL）无明显差异。此外，与置入4个月后相比，置入12个月时支架贴壁及新生内膜覆盖情况更好。综上可见，EXCELⅡ具有良好的可行性、安全性及有效性，可快速实现内皮化，置入4个月及12个月后LLL发生率较低。
Morphological characteristics of severe aortic stenosis in China: Imaging corelab observations from the first Chinese transcatheter aortic valve trial
http://onlinelibrary.wiley.com/doi/10.1002/ccd.25863/abstract
Abstract
Objectives
We sought to describe the morphological characteristics of aortic valve disease in a Chinese population presenting for Transcatheter Aortic Valve Replacement (TAVR).
Background
Racial and regional differences are known to exist in aortic stenosis (AS) but limited data exists comparing the specific anatomical variations between populations.
Methods
Patients were prospectively evaluated in a Chinese population presenting for TAVR in the Venus A-Valve trial， the first trial evaluating TAVR in China. A systematic anatomical assessment protocol employed contrast computed tomography (CT) in all cases.
Results
A total of 120 consecutive patients were studied. Of these， 61 were tricuspid (50.7%)， 57 bicuspid (47.5%) and 2 unicuspid (1.7%). Of the 57 bicuspid cases， 31 (54.4%) had no raphe (Sievers classification type 0) and 26 (45.6%) were of raphe type. Although the incidence of bicuspid valve morphology was more than a third of the Northern Chinese population， this was lower than the Eastern Chinese (p=0.035)， in whom the incidence was more than half. A comparison of tricuspid morphologies in China vs a Western series of 229 consecutive patients undergoing TAVR assessed with CT showed a three-fold excess of leaflet calcium burden in China， with a leaflet calcium volume of 421mm3?(IQR 188-688) vs 142mm3?(IQR 58-267).
Conclusions
Patients presenting for TAVR in China have a very high frequency of bicuspid valve morphology. Even in tricuspid disease， there are clear differences to Western patients， with a high calcium burden， which presents challenges for TAVR in this population.
(ClinicalTrials.gov http://clinicaltrials.gov/NCT01683474). This article is protected by copyright. All rights reserved.
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中国严重主动脉瓣狭窄的形态学特征
主动脉狭窄（AS）存在种族及地区差异，但各人群AS间的解剖学变异数据相对缺乏。为确定中国主动脉瓣膜病变患者的形态学特征，研究连续入选120例行经导管主动脉瓣置换术（TAVR）的中国AS患者，采用增强CT系统评估其解剖特征。结果发现，三叶型、二叶型及单叶型患者各占50.7%、47.5%和1.7%。双叶型患者中，有嵴和无嵴者分别占54.4%和45.6%。该地区二叶型主动脉瓣的比例高于中国北部地区，低于东部地区。与西方人群相比，中国三叶型主动脉瓣钙化更严重。综上可见，中国行TAVR治疗的AS患者主动脉瓣更多为二叶型，即使是三叶型也与西方AS患者存在差异，钙化更严重。
Peri-procedural use of tirofiban in elective percutaneous coronary intervention for long coronary lesions with overlapping drug-eluting stents - the PETITION study
http://onlinelibrary.wiley.com/doi/10.1002/ccd.25864/abstract
Abstract
Methods: A total of 748 stable angina patients with long lesions (≥ 40 mm in length) treated with overlapping stent implantation were randomly assigned to receive tirofiban (tirofiban group; n=373) or conventional therapy (control group; n=375). Intravenous tirofiban was initiated before PCI and maintained for 12 h after the procedure. The primary endpoint was PMI， defined as an elevation in CK-MB?>3 times the upper limit of normal 12 h after the index procedure. The secondary endpoint was major adverse cardiac events (MACE)， including cardiac death， target vessel revascularization (TVR) and recurrent MI (re-MI)， at one-year of clinical follow-up. The safety end-points included Thrombolysis in Myocardial Infarction (TIMI) major bleeding and stent thrombosis.
Results: Despite comparable angiographic and procedural characteristics， in the intention-to-treatment analysis， the primary endpoint was significantly reduced in the tirofiban group (4.0% vs. 11.5%， P<0.001). Multivariate analysis revealed that the adjunctive use of tirofiban was the only negative predictor of PMI (OR 0.41， 95% CI 0.28 0.81， P<0.01). At one-year of clinical follow-up， the overall occurrence of MACE was significantly lower in the tirofiban group (13.4% vs. 22.7%， P=0.001). The rate of TIMI major bleeding and stent thrombosis did not differ significantly between the two groups.
Conclusion: Our results show that the adjunctive use of tirofiban reduces the occurrence of PMI and MACE at one year in stable coronary artery disease patients undergoing elective PCI for long lesions with overlapping stent implantation. This article is protected by copyright. All rights reserved.
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聚焦PETITION 研究，关注冠状动脉长病变串联置入药物洗脱支架择期介入治疗围术期替罗非班应用
PETITION研究入选748例串联置入药物洗脱支架的冠状动脉长病变稳定性心绞痛患者，将其随机分为替罗非班组与常规治疗组（对照组），前者在PCI前开始静脉应用替罗非班，并持续至术后12小时。意向性治疗分析发现，与对照组相比，替罗非班组随访1年时主要终点PMI（即术后12h内CK-MB升高大于正常上限3倍）发生率及总MACE发生率均更低，TIMI大出血及支架内血栓发生率无显著差异。多因素分析显示，辅助应用替罗非班是PMI发生风险降低的唯一预测因素。综上可见，对串联置入药物洗脱支架的冠状动脉长病变稳定性冠心病患者而言，PCI围术期应用替罗非班可减少术后1年时PMI及MACE的发生。