李佳，徐晗，竇克非，徐波，尤士杰，吳永健，喬樹賓，顏紅兵，楊躍進(jìn)

冠心病研究

經(jīng)橈動(dòng)脈和經(jīng)股動(dòng)脈路徑同期進(jìn)行冠狀動(dòng)脈三支病變介入治療患者住院期間及長(zhǎng)期臨床結(jié)果比較

李佳，徐晗*，竇克非，徐波，尤士杰，吳永健，喬樹賓，顏紅兵，楊躍進(jìn)

目的：通過與經(jīng)股動(dòng)脈（TF）徑路比較，評(píng)價(jià)經(jīng)橈動(dòng)脈（TR） 徑路同期進(jìn)行經(jīng)皮冠狀動(dòng)脈（冠脈）介入治療冠脈三支病變的安全性、可行性、住院期間及長(zhǎng)期隨訪期間臨床結(jié)果。

方法：4 974例冠脈造影診斷為左主干未受累的冠脈三支病變并接受單次經(jīng)皮血運(yùn)重建治療的患者入選了本項(xiàng)研究。分為TR組3 856例，TF組1 118例。手術(shù)和臨床結(jié)果通過數(shù)據(jù)庫和隨訪獲得。本研究應(yīng)用傾向評(píng)分匹配方法得到基線資料均衡的930對(duì)患者來比較TR組和TF組的住院期間和長(zhǎng)期隨訪期間臨床結(jié)果，用Cox比例風(fēng)險(xiǎn)模型評(píng)估兩組間所有臨床結(jié)果的風(fēng)險(xiǎn)差異，用Kaplan-Meier法估算兩組安全性和有效性相關(guān)事件的累積發(fā)生率，并用logrank法進(jìn)行比較。

結(jié)果：傾向評(píng)分匹配后，兩組的臨床和血管造影特征無統(tǒng)計(jì)學(xué)意義。TR組較TF組住院時(shí)間更短[（7.49±4.46）天vs（8.63±6.23）天，P＜0.0001]、出血事件更少（1.1%vs 2.9%，P=0.003）外，其余手術(shù)結(jié)果差異無統(tǒng)計(jì)學(xué)意義。臨床隨訪顯示TR組全因死亡率明顯降低（TR組1.8%，TF組4.2%，P=0.0014；風(fēng)險(xiǎn)比0.44，95%可信區(qū)間0.25～0.79），而兩組間其他長(zhǎng)期隨訪期間臨床結(jié)果差異無統(tǒng)計(jì)學(xué)意義。

結(jié)論：TR進(jìn)行冠脈三支病變患者的同期介入治療是安全、可行的，并具有與TF介入治療相似的手術(shù)成功率，具更短的住院時(shí)間、更低的出血風(fēng)險(xiǎn)、更低的死亡率，長(zhǎng)期療效不亞于TF介入治療。

冠狀動(dòng)脈疾?。粯飫?dòng)脈；股動(dòng)脈；安全性

Methods: A total of 4974 consecutive patients with triple vessel lesion CAD without LM disease who received onestage PCI were enroll in this study. The patients were divided into 2 groups: TR group, n=3856 and TF group, n=1118. The procedural and clinical results were obtained from data base and follow-up study. There were 930 pairs of patients with comparable baseline data obtained from propensity score matching method served as control subjects for both TR and TF groups. The risk diversity between 2 groups was evaluated by Cox’s proportional-hazards model, the cumulative incidences for the safety and efficacy were estimated by Kaplan-Meier method and meanwhile compare by log-rank test.

Results: With propensity score matching, the clinical and angiographic characteristics were similar between 2 groups. TR group had the shorter in-hospital time than TF group (7.49 ± 4.46) days vs (8.63 ± 6.23) days, P＜0.0001 and less incidence of bleeding 1.1% vs 2.9%, P＜0.003; the other procedural feathers were similar between 2 group. The follow-up study presented that TR group had obviously lower all cause mortality than TF group (1.8% vs 4.2%,

P=0.0014; HR=0.44, 95% CI 0.25-0.79); the other longer term follow-up outcomes were similar between 2 groups.

Conclusion: TR intervention is safe and feasible for treating the patients with triple vessel lesion CAD, the procedural success rate and long term outcomes are similar to TF intervention, while it has shorter in-hospital time, lower risks for bleeding and death.

(Chinese Circulation Journal, 2015,30:311.)

經(jīng)股動(dòng)脈（TF）徑路是冠狀動(dòng)脈（冠脈）血管成形術(shù)常選取的徑路，但常導(dǎo)致血管徑路并發(fā)癥增多和住院時(shí)間延長(zhǎng)[1,2]。因經(jīng)橈動(dòng)脈（TR）徑路已被證實(shí)具有減少出血并發(fā)癥、術(shù)后無需臥床并提高患者舒適度等優(yōu)點(diǎn)[3-7]，在行冠脈介入治療時(shí)[甚至包括急性心肌梗死（AMI）、無保護(hù)的左主干病變和老年患者等復(fù)雜情況]可以選擇TR徑路替代標(biāo)準(zhǔn)的TF徑路[2,8,9]。然而目前還少見對(duì)經(jīng)TR和TF介入治療冠脈三支病變住院期間和長(zhǎng)期隨訪期間臨床結(jié)果的比較研究[10,11]。

1 對(duì)象與方法

研究對(duì)象：本研究選取了2004-04至2010-10期間我院行冠脈造影確診為冠脈三支病變并接受經(jīng)皮冠脈介入治療（PCI）的連續(xù)5 798例患者，評(píng)價(jià)其住院期間的結(jié)果和長(zhǎng)期臨床結(jié)果。冠脈三支病變定義為冠脈三支主要的血管狹窄均大于50%。排除了急診PCI、分次PCI以及經(jīng)TR和TF雙徑路介入治療的患者后，本研究最終入選了4 974例患者（TR組3 856例，TF組1 118例）。

手術(shù)的實(shí)施及術(shù)后的干預(yù)血管徑路、介入治療策略由心臟專科介入醫(yī)生決定。支架的類型和品牌由術(shù)者選擇，研究中涉及的支架品牌有：Cypher雷帕霉素洗脫支架（Cordis Europa N.V.，荷蘭LJ.Roden），Taxus紫杉醇洗脫支架（Boston scientific，愛爾蘭戈?duì)栱f），F(xiàn)irebird雷帕霉素洗脫支架（Microport，中國(guó)上海）和Excel雷帕霉素洗脫支架（JW Medical Co.Ltd，中國(guó)山東）。

術(shù)前所有患者均服用阿司匹林300 mg每日1次，術(shù)前至少提前1天服用氯吡格雷300 mg的負(fù)荷劑量。術(shù)中均予每公斤體重100 U的普通肝素。術(shù)后3個(gè)月服用阿司匹林300 mg每日1次，后改為100 mg每日1次長(zhǎng)期服用。服用氯吡格雷75 mg每日1次，至少1年。

隨訪資料的采集和主要監(jiān)測(cè)指標(biāo)：手術(shù)成功判定標(biāo)準(zhǔn)為血管造影成功，介入治療后心肌梗死溶栓治療臨床試驗(yàn)（TIMI）血流3級(jí)、目測(cè)殘余狹窄＜30%，且術(shù)后未發(fā)生住院期間死亡、心肌梗死（MI）或急診行冠脈旁路移植術(shù)（CABG）。評(píng)價(jià)住院期間的出血事件，并根據(jù)所有記錄的出血事件特點(diǎn)應(yīng)用TIMI出血分級(jí)標(biāo)準(zhǔn)（嚴(yán)重、輕微） 進(jìn)行分級(jí)[12,13]。

隨訪數(shù)據(jù)通過術(shù)后第1、3、6、12個(gè)月及其后每年一次的門診或電話隨訪完成。平均隨訪時(shí)間21個(gè)月，主要監(jiān)測(cè)指標(biāo)包括支架內(nèi)血栓形成 （肯定、肯定/可能、早期、晚期及極晚期） 、全因死亡率、心肌梗死、靶病變血運(yùn)重建（TVR）和主要不良心臟事件（MACE，即死亡、心肌梗死和TVR復(fù)合發(fā)生率）。所有終點(diǎn)均按照學(xué)術(shù)研究聯(lián)合會(huì)（ARC） 的定義進(jìn)行界定。

2 結(jié)果

2.1 傾向評(píng)分匹配前后臨床特點(diǎn)、冠狀動(dòng)脈病變特點(diǎn)和處理情況

傾向評(píng)分匹配前，TF組患者年齡、女性、既往心肌梗死病史、既往PCI病史、既往CABG病史、糖尿病、高血壓、高脂血癥、不穩(wěn)定性心絞痛均顯著高于TR組，左心室射血分?jǐn)?shù)、平均病變數(shù)量低于TR組，差異均有統(tǒng)計(jì)學(xué)意義（P均＜0.05～0.001）。其余差異無統(tǒng)計(jì)學(xué)意義（表1）。TF組再狹窄病變、完全閉塞病變、B2-C型病變、開口病變、中重度鈣化病變均顯著高于TR組，TF組前降支病變及直接支架置入術(shù)的患者比例低于TR組，差異均有統(tǒng)計(jì)學(xué)意義（P均＜0.01）。TR組使用6F指引導(dǎo)管大于TF組（P＜0.01）。表2

表1 傾向評(píng)分匹配前患者臨床特點(diǎn)

表2 傾向評(píng)分匹配前患者冠狀動(dòng)脈病變特點(diǎn)及處理情況

共有930例TR組患者與930例TF組患者相匹配進(jìn)入后續(xù)統(tǒng)計(jì)學(xué)分析。相對(duì)標(biāo)準(zhǔn)差小于10%。對(duì)傾向評(píng)分有很好的預(yù)測(cè)價(jià)值（C-statistic值為0.783）和校準(zhǔn)能力（Hosmer-Lemeshow檢驗(yàn)，P=0.26）。

傾向評(píng)分匹配后兩組基線資料差異無統(tǒng)計(jì)學(xué)意義（表3）。在TF組中使用6號(hào)指引導(dǎo)管的比例顯著低于TR組（6F：82.7%比97.1%，P＜0.0001）。表4

表3 傾向評(píng)分匹配后患者臨床特點(diǎn)

表4 傾向評(píng)分匹配后患者冠狀動(dòng)脈病變特點(diǎn)及處理情況

2.2 傾向評(píng)分匹配后的住院期間及長(zhǎng)期隨訪期間臨床結(jié)果

兩組患者在住院期間手術(shù)成功率、死亡率或心肌梗死的發(fā)生率、造影劑用量及X線暴露時(shí)間、TIMI嚴(yán)重出血及輸血差異無統(tǒng)計(jì)學(xué)意義（P＞0.05）。 TR組比TF組患者住院時(shí)間及術(shù)后在院時(shí)間顯著縮短； TIMI輕微出血事件顯著降低； PCI術(shù)后血紅蛋白下降幅度更小，差異均有統(tǒng)計(jì)學(xué)意義（P均＜0.01）。表5

表5 傾向評(píng)分匹配后患者住院期間及隨訪臨床結(jié)果

本研究進(jìn)行了15～38個(gè)月的臨床隨訪。TR組全因死亡率及心原性死亡率顯著低于TF組，差異有統(tǒng)計(jì)學(xué)意義（P均＜0.05～0.01）。其他各項(xiàng)差異無統(tǒng)計(jì)學(xué)意義（表5）。兩組患者肯定的和可能的支架內(nèi)血栓形成發(fā)生率和血栓形成的時(shí)間（早期、晚期、極晚期） 差異無統(tǒng)計(jì)學(xué)差異。表6

表6 傾向評(píng)分匹配后患者支架內(nèi)血栓形成事件累積發(fā)生率[例(%)]

傾向評(píng)分匹配后校正的臨床結(jié)果的比較顯示，TR組全因死亡風(fēng)險(xiǎn)較TF組顯著降低（風(fēng)險(xiǎn)比0.44，95%可信區(qū)間0.25～0.79），其他臨床事件的風(fēng)險(xiǎn)比在兩組間無統(tǒng)計(jì)學(xué)意義。根據(jù)Kaplan-Meier法估計(jì)及l(fā)og-rank檢驗(yàn)的結(jié)果（圖1），也證實(shí)了TR組的全因死亡率（2.7%）比TF組（5.9%）顯著降低（P=0.0049）。兩組間心肌梗死、靶病變（原支架內(nèi)或支架兩端5 mm內(nèi)的病變）血運(yùn)重建、靶血管（包括因靶病變以外區(qū)域或自身原發(fā)病變進(jìn)展或新形成的病變）血運(yùn)重建、主要不良心臟事件以及支架內(nèi)肯定/可能的血栓形成等事件的長(zhǎng)期累積發(fā)生率沒有統(tǒng)計(jì)學(xué)意義。

圖1 傾向評(píng)分匹配后Kaplan-Meier法評(píng)價(jià)長(zhǎng)期隨訪臨床結(jié)果

3 討論

近20年來，隨著介入診治器械制作技術(shù)的進(jìn)步，TR路徑行PCI術(shù)已逐漸成為首選路徑。與TF路徑相比，橈動(dòng)脈入路穿刺處發(fā)生出血、血腫、假性動(dòng)脈瘤并發(fā)癥相對(duì)較低、患者術(shù)后無需絕對(duì)臥床、制動(dòng)24 h，且避免了TF穿刺后，長(zhǎng)時(shí)間的壓迫止血

極易引起反射嘔吐等不良癥狀，近十余年該術(shù)式得到廣泛的推廣和普及，目前國(guó)內(nèi)一些醫(yī)學(xué)中心，如我院TR介入治療（TRI）已成為主要術(shù)式。

TRI治療，隨著介入器械的不斷發(fā)展適應(yīng)證范圍也不斷拓展。TRI手術(shù)已不僅僅局限于簡(jiǎn)單冠脈病變，TR處理無保護(hù)左主干病變、TR處理慢性閉塞性病變（CTO）病變、TR對(duì)急性心肌梗死、分叉病變等均有國(guó)內(nèi)外文獻(xiàn)報(bào)道[26-29]，臨床應(yīng)用中已成為普遍接受的事實(shí)。然而目前還少有TR和TF介入治療冠脈三支病變的住院期間和長(zhǎng)期臨床結(jié)果進(jìn)行比較研究[10,11]。

從本研究可以看出TR組和TF組比較兩組在手術(shù)成功率、X線曝露時(shí)間、造影劑用量等方面無統(tǒng)計(jì)學(xué)意義。此外，兩組患者術(shù)后血腫的發(fā)生因程度不同，未納入統(tǒng)計(jì)范疇。橈動(dòng)脈位置表淺，周圍無關(guān)節(jié)活動(dòng)，也無肌肉、大血管及靜脈伴行，可降低動(dòng)靜脈瘺的發(fā)生，且易于壓迫，易于止血控制，術(shù)后出血并發(fā)癥與TF組比較明顯減少。同時(shí)因橈動(dòng)脈是肌性動(dòng)脈，交感神經(jīng)興奮性高，易發(fā)生痙攣，血管穿刺及導(dǎo)管操作難度相對(duì)較大，對(duì)手術(shù)操作者要求較高。目前多主張?jiān)谘軛l件允許的情況下采用TR途徑。對(duì)于部分患者造影中出現(xiàn)痙攣、過度迂曲，或上肢動(dòng)脈閉塞的不建議采用TRI治療。

本研究是目前最大的針對(duì)冠脈三支病變患者同期進(jìn)行介入治療時(shí)TR和TF住院期間及和長(zhǎng)期臨床結(jié)果的觀察性隊(duì)列研究。本研究的主要發(fā)現(xiàn)：對(duì)于冠狀三支病變患者進(jìn)行同期介入治療時(shí)，TR PCI是安全可行的；TR PCI出血并發(fā)癥明顯減少；TR PCI可縮短住院時(shí)間；與TF PCI相比，傾向評(píng)分匹配后TR PCI治療冠脈三支病變患者的死亡率顯著降低。盡管兩組患者近期及遠(yuǎn)期臨床結(jié)果相似，這些發(fā)現(xiàn)讓我們更有信心通過TR PCI對(duì)三支病變同期進(jìn)行處理。

本研究結(jié)果提示TR介入治療冠脈三支病變是安全可行的。一些隨機(jī)觀察性研究表明與TF相比，TR可減少出血并發(fā)癥及血液制品的輸注[1,4,7,16,17]。與之前的研究結(jié)果一致，我們發(fā)現(xiàn)對(duì)于冠脈三支病變患者，TR 介入治療可以顯著減少出血并發(fā)癥P=0.0207）及PCI術(shù)后血紅蛋白的降低（P=0.0003）。TF組中術(shù)后出血引起的輸血更為常見，盡管兩組間比較無統(tǒng)計(jì)學(xué)差異。較多的出血及血管并發(fā)癥會(huì)從而導(dǎo)致潛在的住院時(shí)間延長(zhǎng)及住院費(fèi)用的增加。事實(shí)上，本研究表明TR PCI顯著縮短了住院時(shí)間及術(shù)后在院期間。從而減少各種費(fèi)用[18-21]。

除死亡率外，兩組的長(zhǎng)期臨床結(jié)果相似，在靶血管血運(yùn)重建中已統(tǒng)計(jì)包含了再次CABG的發(fā)生，兩組的靶血管血運(yùn)重建發(fā)生率相似。這一有利的結(jié)果可能部分歸功于后擴(kuò)張、高壓釋放、新成像模式、新設(shè)備等技術(shù)改進(jìn)在TR徑路時(shí)依然可以應(yīng)用[1,4,22,23]。一些大規(guī)模的比較研究已經(jīng)指出了低死亡率與TR PCI間的聯(lián)系，可能是因?yàn)門R PCI減少了出血和（或）輸血的發(fā)生所致[4,16,25]。與之類似，本研究發(fā)現(xiàn)對(duì)于冠脈三支病變的患者，TR組全因死亡率及心原性死亡率顯著減低。TR PCI容易止血、血管徑路并發(fā)癥更少、指引導(dǎo)管尺寸更小、血紅蛋白下降程度更小使得出血事件減少、死亡率降低。然而，我們需要注意的是有關(guān)死亡率的數(shù)據(jù)是基于一項(xiàng)回顧性、非隨機(jī)性的研究，其只能推論出一個(gè)假說而不是證明這一觀點(diǎn)。TR和TF PCI治療冠脈三支病變死亡率是否存在差異還需要進(jìn)一步的大規(guī)模隨機(jī)行試驗(yàn)來證明。

研究的局限性：本研究為回顧性非隨機(jī)化研究，隱藏的混雜因素和其他來源的偏倚不可避免。盡管期望通過傾向評(píng)分來校正可觀測(cè)到的潛在的無法測(cè)量的混雜因素，但仍有一些殘余的混雜因素的影響無法排除。另外傾向評(píng)分匹配可能檢驗(yàn)效能降低。因此，未來還需要大規(guī)模隨機(jī)試驗(yàn)來比較經(jīng)兩種通路介入治療冠脈三支病變的手術(shù)和長(zhǎng)期臨床結(jié)果。

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Comparison of In-hospital and Long Term Clinical Outcomes Between Trans-radial and Trans-femoral Approaches in Patients of Triple Vessel Lesion CAD With Percutaneous Coronary Intervention

LI Jia, XU Han, DOU Ke-fei, XU Bo, YOU Shi-jie, WU Yong-jian, QIAO Shu-bin, YAN Hong-bing, YANG Yue-jin.
Department of Cardiology, Cardiovascular Institute and Fu Wai Hospital, CAMS and PUMC, Beijing (100037), China

Objectives: To evaluate the safety, feasibility, in-hospital and long-term follow-up period outcomes by trans-radial (TR) approach for treating the patients of triple vessel lesion coronary artery disease (CAD) with one-stage percutaneous coronary intervention (PCI) in comparison with trans-femoral (TF) access.

Coronary artery disease; Radial artery; Femoral artery; safety

2014-11-04）

（編輯：常文靜）

100037 北京市， 中國(guó)醫(yī)學(xué)科學(xué)院 北京協(xié)和醫(yī)學(xué)院 國(guó)家心血管病中心 阜外心血管病醫(yī)院 冠心病診治中心

李佳 主治醫(yī)師 主要從事心血管內(nèi)科相關(guān)疾病治療 Email：litdoctorlij@163.com*為共同第一作者 通訊作者：竇克非Email：drdoukefei@sohu.com

R54

A

1000-3614（2015）04-0311-06

10.3969/j.issn.1000-3614.2015.04.003