国产可降解涂层雷帕霉素洗脱支架的中期有效性和安全性

目的:评估第二代国产生物可降解涂层雷帕霉素洗脱支架(EXCELTM,JWMS,China)的中期有效性和安全性.方法:连续观察71例住院的冠心病患者,常规冠状动脉造影及支架植入.主要观察术后平均18个月的无主要不良心脏事件(MACE,包括心源性死亡、心肌梗死、靶血管再次介入治疗)生存率、术后急性、亚急性及晚发血栓的发生率.结果:71例患者90支血管的104处病变共植入了113枚支架.1例患者手术后3 d死亡,70例患者完成了随访.随访期间未发生支架内再狭窄.术后18个月无MACE生存率为98.6%,术后亚急性血栓发生率1.4%.结论:国产第二代生物可降解涂层雷帕霉素洗脱支架有良好的中期效果和安全性.     

EXCEL支架治疗冠心病合并2型糖尿病患者的临床观察

目的比较国产载雷帕霉素可降解聚合物涂层支架(EXCEL支架)和进口载雷帕霉素涂层支架(CY-PHER支架)在冠心病合并2型糖尿病患者中应用的安全性和临床效果。方法选择2008年6月～2010年2月在我科住院并且行PCI治疗的冠心病合并2型糖尿病患者316例。按植入支架类型分为EXCEL组(120例)和CY-PHER组(196例),对2组患者住院期间,术后30 d及术后1 a的主要心血管不良事件(MACE)和支架内血栓的发生情况进行随访和对比分析。结果住院期间、术后30 d及术后随访1 a期间EXCEL组无急性、亚急性及晚期血栓形成,CYPHER组发生1例亚急性血栓形成。2组MACE的发生率差异均无统计学意义。结论 EXCEL支架应用于冠心病合并2型糖尿病患者,与CYPHER支架一样安全有效,没有增加MACE发生率及支架内血栓形成事件。     

生物可降解涂层雷帕霉素洗脱支架的中长期有效性和安全性

第一代药物洗脱支架的有效性已得到大量临床研究的充分证实,但其晚发血栓等不良反应亦引起广泛关注[1,2].支架表面不可降解的多聚涂层所造成的局部过敏、炎症反应可能是诱发血栓的原因之一[3].本研究旨在观察第二代国产可降解涂层雷帕霉素洗脱支架(EXCELTM,JWMS,China)植入后的中长期有效性和安全性.     

进口与国产雷帕霉素洗脱支架一年临床疗效比较

目的对因冠状动脉粥样硬化性心脏病接受择期经皮冠状动脉介入治疗（PCI）的患者,对比接受国产雷帕霉素药物洗脱支架（Firebird）和进口雷帕霉素药物洗脱支架（CypherSelect）治疗后1年的临床疗效。方法连续入选2004年1月至2006年12月于北京安贞医院接受介入治疗置入国产和进口雷帕霉素药物洗脱支架（SES）的冠心病患者2000例,根据置入支架类型,分为国产Firebird组（Firebird;1004例）和进口Cypher组（Cypher;996例）。随访1年的临床疗效。初级终点为两组患者支架术后主要心血管不良事件（MACE）的发生率,包括全因死亡、非致死性心肌梗死及靶血管重建。次级终点为1年内的支架内血栓发生率。结果 1年的随访结果显示,国产和进口雷帕霉素药物洗脱支架（SES）组的MACE发生率差异无统计学意义（17.8%比18.6%,P=0.666）。两组患者的死亡（4.7%比5.1%,P=0.649）、心肌梗死（4.2%比4.8%,P=0.493）和靶血管重建率（9.0%比8.6%,P=0.795）均相近。两组患者12个月确定/可能性支架内血栓的发生率亦差异未见统计学意义（1.1%比1.0%,P=0.841）。多因素回归分析表明,DES类型不是1年内MACE的独立预测因素。结论国产FirebirdSES和进口CypherSES在术后1年内具有相同的临床疗效和安全性。     

紫杉醇微孔载药支架与进口雷帕霉素药物洗脱支架治疗冠心病的临床效果比较

目的:比较紫杉醇微孔载药支架和进口雷帕霉素药物洗脱支架在经皮冠状动脉介入治疗中的临床疗效。方法: 筛选73例行经皮冠状动脉介入治疗术的冠心病患者,随机分为两组,紫杉醇微孔载药支架组（紫杉醇组,35例）和进口雷帕霉素药物洗脱支架组（雷帕霉素组,38例）。支架植入术后6个月复查冠状动脉造影（CAG）。随访6个月,对比两组支架内血栓形成、主要心血管不良事件（包括心源性死亡、非致死性心肌梗死、靶病变血运重建）和支架内再狭窄发生率。结果: 随访6个月,两组均未出现急性、亚急性和晚期支架内血栓形成、非致死性心肌梗死和心源性死亡。心绞痛、支架内再狭窄和靶病变血运重建发生率均无统计学差异。结论: 紫杉醇微孔载药支架与进口雷帕霉素药物洗脱支架在治疗冠状动脉简单病变时具有相同的近、中期临床疗效和安全性。     

国产西罗莫司洗脱支架治疗急性心肌梗死的安全性和有效性

目的:评估国产西罗莫司药物洗脱支架Firebird2TM治疗急性心肌梗死的安全性和有效性. 方法:连续入选2010年9月至2011年12月因急性心肌梗死在我院行介入治疗的120例患者.观察并分析所有患者冠状动脉的靶血管特点、支架植入情况、住院期间和支架植入术后6个月的主要心脏不良事件(MACE,包括死亡、再发心梗、靶血管的再次血运重建)发生率和支架内血栓发生率. 结果:120例急性心肌梗死患者靶血管共植入支架152枚,术后即刻TIMI3级获得率95.8％,住院期间死亡1例.术后6个月临床随访总MACE事件的发生率为5％,死亡2例,靶血管的再次血运重建4例,无再发心梗和支架内血栓发生. 结论:国产西罗莫司洗脱支架Firebird2TM对急性心肌梗死患者具有良好的安全性和疗效.     

国产雷帕霉素药物洗脱支架治疗冠心病1年临床随访——多中心注册研究

目的:多中心、前瞻性评估国产Firebird雷帕霉素洗脱支架在冠心病患者中应用的安全性及1年临床随访结果.方法:2004年6月至9月,入选上海地区6家医院接受国产雷帕霉素药物洗脱支架治疗的冠心病患者360例.记录各例基础临床、介入治疗情况及1年临床随访结果,并与RESEARCH研究结果进行比较.结果:与RESEARCH研究资料比较,本研究组中患者高胆固醇血症(24.2%对56%)、既往接受CABG(0.3%对9%)或PCI(7.2%对19%)、多支冠脉病变(27.2%对54%)、复杂病变(B2型病变:30%对49%,C型病变:36.4%对43%)及支架术后行后扩张者(13.1%对55%)较少,P均＜0.001.本研究介入治疗成功率高于RE-SEARCH研究(99.2%对97%,P=0.03).术后1年临床随访率93.9%,严重心脏不良事件(MACE,包括死亡、非致命性心梗及靶血管再次血运重建)发生率为8.3%,与RESEARCH研究中药物支架组相似(9.7%,P=0.58),显著低于普通支架组(14.8%,P=0.001).Firebird支架术后1年血栓事件发生率为0.9%. 结论:国产Firebird雷帕霉素洗脱支架治疗冠心病安全、有效,术后1年MACE发生率与RE-SEARCH研究Cypher支架组相似.     

EXCEL支架在冠状动脉分叉病变应用的研究

目的:探讨EXCEL雷帕霉素洗脱支架治疗冠状动脉分叉病变的安全性和有效性。方法:共56例病人有57处冠状动脉真性分叉病变(其中前降支/对角支30例,左回旋支/钝缘支17例,右冠脉/后降支8例,前降支/回旋支1例)接受主支血管EXCEL雷帕霉素洗脱支架和分支血管球囊扩张术,回顾性分析其结果。结果:手术即刻成功率100%,住院期间无主要不良心脏事件(MACE)发生。6~18个月随访[临床随访率100%,造影随访38例(67.9%)]结果显示:MACE发生1例(1.8%,1/56),为造影证实的支架内再狭窄70%,并实施了再次PCI。造影再狭窄率为5.3%(2/38)。结论:EXCEL雷帕霉素洗脱支架治疗冠状动脉分叉病变安全,有效。     

EXCEL可降解涂层雷帕霉素洗脱支架长期临床应用的安全性和有效性

目的:评估EXCEL可降解涂层雷帕霉素洗脱支架置入3年后的安全性和有效性。方法:连续入选我院100例冠心病住院患者,均单一置入EXCEL支架。术后接受双联抗血小板治疗(氯吡格雷和阿司匹林)6个月,随后单用阿司匹林。术后平均8个月实施造影随访及冠状动脉内超声检测。观察术后3年主要不良心脏事件(MACE)、全因死亡和血栓事件发生率。结果:100例患者均完成3年临床随访。1年时发生4例(4.0%)靶病变血运重建,无死亡和非致死性心肌梗死发生,1年MACE发生率为4.0%。3年随访时共6例(6.0%)MACE发生,包括靶病变血运重建4例(4.0%)和心性死亡2例(2.0%)。3年累计全因死亡率4%,包括心性死亡2例(2.0%),脑卒中和肺癌导致的非心性死亡各1例(2.0%),术后3年共发生支架内血栓事件2例(2.0%),其中很可能的支架内血栓事件仅1例(1.0%)。造影随访支架内再狭窄率3.6%(4/112),支架内晚期管腔丢失(0.12±0.34)mm。冠状动脉内超声检查共发现4处晚期支架贴壁不良(发生率6.3%,4/64),但随访期间无任何临床事件发生。结论:EXCEL支架置入术后患者的靶病变血运重建及MACE发生率一直处于较低水平,提示其早期临床获益可持续至术后3年。这一结论有待大规模、随机对照及随访期更长的临床研究证实。     

可降解与不可降解涂层雷帕霉素洗脱支架植入后高敏C反应蛋白和白细胞介素6水平变化

目的 观察可降解涂层与不可降解涂层雷帕霉素药物洗脱支架植入后循环与局部高敏C反应蛋白和白细胞介素6水平变化.方法 连续入选118例接受PCI治疗植入1枚支架的不稳定型心绞痛患者,分为不可降解涂层组(n=65)和可降解涂层组(n=53).于术前、术后即刻、48 h、7天及9月时抽取静脉血,术前、术后即刻及术后9月冠状动脉造影随访时以微导管抽取冠状动脉局部血液,测定高敏C反应蛋白和白细胞介素6水平.结果 两组基本临床资料、PCI术情况无明显差异.两组术后即刻支架局部血清白细胞介素6水平较术前显著升高;术后48 h和7天循环高敏C反应蛋白和白细胞介素6水平明显高于术前.两组间比较,PCI术前、术后即刻、48 h、7天和9月时循环及局部高敏C反应蛋白和白细胞介素6水平均无明显差异.结论 可降解涂层与不可降解涂层雷帕霉素洗脱支架对术后循环与局部炎症反应的影响可能相似.     

Six-month results of a biodegradable polymer and rapamycin-coating stent for coronary artery disease

Objective To assess the safety and efficacy of a novel biodegradable polymer and rapamycin-coating stent, the EXCEL stent, in the treatment of coronary artery disease (CAD), as compared with the Cypher?stent. Methods In this prospective, non-randomized study, 60 consecutive patients with symptomatic CAD received either an EXCEL stent (n=32), or a CypherTM stent(n=28),according to their respective treatment intention. Follow-up angiography was performed at a mean of 180±40 days. The primary endpoint of the study was the occurrence of a major adverse cardiac event (MACE), including death, myocardial infarction, or target-vessel revascularization during the 6 months after stenting. The secondary end points included the in-stent late luminal loss (LLL), percentage of in-stent stenosis of the luminal diameter, and the rate of restenosis (luminal narrowing of 50 percent or more) at 6 months. Results There were no significant differences between the two groups in baseline characteristics, including the distribution of target vessel and lesion types. During the follow up period of 6 months, there were no occurrences of MACE in either group. Twenty-seven patients (84%) in the EXCEL group and 10 (36 %) in the Cypher?group underwent quantitative coronary angiography at 6 months. For these patients, no restenosis occurred, and there were no differences in the in-stent stenosis of the luminal diameter (5.98±5.52 % vs 5.21±6.3%, P>0.05) and the LLL (-0.02±0.09 mm vs -0.01±0.07 mm, P>0.05). Conclusions Compared with the CypherTM stent, the EXCEL Stent with biodegradable polymer and rapamycin-coating showed similar efficacy in the prevention of neointimal proliferation, restenosis, and associated clinical events in CAD patients.     

可生物降解涂层药物洗脱支架介入治疗的近期疗效

目的 评估国产新型西罗莫司可生物降解涂层支架在急性心肌梗死患者介入治疗(percutaneous coronary intervention,PCI)中的疗效及安全性.方法 急性心肌梗死患者56例,其中ST段抬高性心肌梗死48例,非ST段抬高性心肌梗死8例,均置人西罗莫司可生物降解涂层洗脱支架,观察手术成功率、支架内血栓等并发症及主要不良心脏事件(main adverse coronary events,MACE)发生率,术后随访1～14个月,6～9个月行冠状动脉造影复查.结果 成功行PCI 55例,手术即刻成功率98%.82处病变共置入西罗莫司支架98枚,其中17枚(17.3%)为直接支架术.4例出现无复流现象,1例使用主动脉气囊反搏.1例术后6 h猝死,考虑急性支架内血栓.术中及住院期间无其他严重并发症发生.50例(89.3%)随访1～14个月,无晚期支架内血栓发生,无MACE;复查冠状动脉造影19例,1例发生支架内再狭窄,无需血运重建.结论 国产西罗莫司可生物降解涂层支架在急性心肌梗死患者行PCI治疗有较好疗效及安全性.     

Effectiveness and safety of the sirolimus-eluting stents coated with bioabsorbable polymer coating in human coronary arteries.

BACKGROUND: Although the sirolimus-eluting stent (CYPHER, Cordis, USA) has shown a dramatic reduction of restenosis, there are still some concerns about its efficacy and safety. Its durable polymer coating may enhance neointimal proliferation and residual sirolimus, which cannot be released from polymer, may result in incomplete reendothelization. As a drug reservoir, bioabsorbable polymer (polylactic acid, PLA) is more rational. OBJECTIVE: We aimed to determine the safety and efficacy of sirolimus-eluting stent coated with PLA (EXCEL, JW Medical Systems, China) in the treatment of human coronary arterial diseases. METHODS: The study included 31 patients with de novo coronary lesions, with vessels 2.5-3.5 mm in diameter. The primary end points included the percentage of in-stent restenosis of the luminal diameter and in-stent late luminal loss at 6 months, as determined by quantitative angiography. The secondary end point was the major adverse cardiac events (MACE) 30 days and 6 months after the index procedure. RESULTS: Forty-eight EXCEL stents were successfully delivered in the 34 lesions, and multiple stents were implanted in 35.3% of lesions. All patients were discharged without clinical complications and completed clinical follow-up at 1 and 6 months. No MACE had occurred. Twenty patients (30 stents) completed 6 months of angiographic follow-up. No in-stent or in-lesion restenosis (diameter stenosis > or =50%) was observed. In-stent late loss was (0.07 +/- 0.17) mm. CONCLUSIONS: The implantation of EXCEL stent is feasible and safe and elicits minimal neointimal proliferation. This new stent has potential advantages regarding the long-long-term result over the commercially stent as the new stent has no sustained stimulation to the local tissue.     

载雷帕霉素可降解聚合物涂层支架治疗冠心病的临床观察

目的以Cypher支架为标准,评价载雷帕霉素可降解聚合物涂层支架(EXCEL支架)治疗冠心病(CAD)的安全性和临床效果。方法采用前瞻性、非随机对比研究方法,根据入选和剔除标准入选60例CAD患者,根据所置入支架分为EXCEL组(n=32)和Cypher组(n=28);相同方法进行冠状动脉造影(CAG)和支架置入;以6个月主要不良心脏事件(MACE)、再狭窄率、直径狭窄程度和晚期管腔丢失(LLL)为研究终点评价EXCEL支架治疗CAD的安全性和临床效果。结果平均随访(6.04±2.12)个月,两组MACE发生率均为0;EXCEL组27例(84.38%)和Cypher组10例(35.71%)于术后平均(6.04±2.12)个月接受了定量冠状动脉造影随访。各组再狭窄率均为0;直径再狭窄率分别为(5.98±5.52)%和(5.21±6.3)%,LLL分别为-(0.02±0.09)mm和-(0.01±0.07)mm,上述各项指标差异均无统计学意义(P>0.05)。两组均未发现与雷帕霉素及其聚合物相关的不良反应。结论EXCEL支架治疗CAD安全有效。在降低主要心脏不良事件、预防再狭窄和LLL方面可获得与Cypher支架同样满意的临床效果。     

EXCEL支架在慢性闭塞病变介入治疗中的应用及疗效观察

目的总结冠状动脉性心脏病(冠心病)慢性完全闭塞(chronic total occlusion,CTO)病变经皮冠状动脉介入(percutaneous coronary intervention,PCI)治疗中EXCEL生物降解药物涂层支架的应用及3年随访结果,评价其在CTO病变的疗效及安全性。方法2006年1月至2009年3月入住成都军区昆明总医院,冠状动脉造影确诊CTO病变并行PCI治疗患者185例,靶病变均植入EXCEL支架,常规二联抗血小板治疗至少6个月。术后6个月、1年、2年、3年临床及冠状动脉造影随访,以主要心血管事件(major adverse cardiac events,MACE)发生率、再狭窄率(in-stent restenosis,ISR)、血运重建率为研究终点,同时了解亚急性及晚期支架内血栓发生率。结果共147例CTO病变血管开通,即刻血管开通率为79.5%(147/185);共201处闭塞病变中,26处导丝无法通过,8处导丝通过闭塞病变后球囊无法跨越病变部位,靶血管开通率83.1%;闭塞时间12个月以内及超过12个月的靶血管开通率分别为87.5%、62.4%,有桥侧支存在者PCI治疗成功率低于无桥侧支者,断端呈刀切状的成功率低于鼠尾状(P0.05)。术中无死亡病例;术后6个月、1年、2年、3年冠状动脉造影复查率分别为30.8%、19.5%、15.1%、10.3%,MASE发生率分别为3.2%、2.3%、1.95、4.0%,再狭窄率分别为8.8%、8.3%、7.1%、5.3%;发生亚急性、晚期支架内血栓各1例,发生率分别为0.6%、0.1%,无急性支架内血栓事件。结论EXCEL支架应用于CTO病变PCI治疗中安全有效,没有增加MACE发生率及支架内血栓事件。     

Long‐term clinical,angiographic, and intravascular ultrasound outcomes of biodegradable polymer‐coated sirolimus‐eluting stents

Background: The residual drug carriers on drug‐eluting stents (DES) surfaces are considered to be one of the most significant reasons causing late thrombosis. There is no documented data currently available on the safety/benefit profile beyond 6 months of EXCEL stent, a novel sirolimus‐eluting stent with biodegradable polymer coating, in treating patients with coronary artery disease (CHD). Objective: To evaluate the long‐term efficacy and safety of EXCEL stent on treating CHD patients. Methods: Between February and March 2006, a consecutive cohort of complex patients treated with the EXCEL stent was prospectively enrolled in this single‐center registry. Antiplatelet protocol was 6‐month dual antiplatelet therapy with clopidogrel and aspirin followed by aspirin alone indefinitely. The primary outcome was major adverse cardiac events (MACE) at 12 months. Secondary outcomes included in‐segment and in‐stent late lumen loss and binary restenosis rate measured by quantitative coronary angiography (QCA) analysis at 8 months postindex PCI procedure. Results: A total of 100 patients with 153 lesions were included in this analysis. Most lesions (83.0%) were classified as complex (B2/C). At 12 months, four patients (4.0%) experienced MACE, which were four target‐lesion revascularizations due to in‐stent restenosis (ISR). All patients received follow‐up up to 24 ± 0.4 months and no cardiac death, MI, and in‐stent thrombosis occurred during the 6 months of dual antiplatelet therapy or the subsequent 15 months of aspirin treatment alone. QCA analysis of 112 lesions from 75 patients showed 3.6% (4/112) in‐stent lesion restenosis, 5.4% (6/112) in‐segment lesion restenosis, 0.12 ± 0.34 mm in‐stent late lumen loss, and 0.08 ± 0.35 mm in‐segment late lumen loss. Conclusions: In this single‐center experience with complex patients and lesions, the EXCEL^TM stent implantation with 6‐month dual antiplatelet treatment proved to markedly reduce the incidence of 24‐month ISR and MACE. These preliminary findings require further validation by large scale, randomized trials. © 2008 Wiley‐Liss, Inc.     

Cypher~(TM)支架治疗冠心病的疗效观察

目的评价雷帕霉素洗脱冠状动脉支架(CypherTM)应用于冠心病的临床疗效及再狭窄情况。方法选择接受CypherTM支架治疗的348例冠心病患者,观察术后即刻效果、术后6个月心脏性死亡、心肌梗死、再次血管重建及冠状动脉造影复查情况。病例中包括ST段抬高的急性心肌梗死86例,非ST段抬高的急性心肌梗死21例,不稳定型心绞痛149例,稳定型心绞痛92例。结果支架植入成功率99.3%,住院期间无死亡,术后出现急性和亚急性血栓各1例,1例晚期血栓致心肌梗死,1例心衰死亡,另有5例随访中进行了血管重建术,术后6个月主要心脏不良事件发生率2.9%。术后6个月56例冠状动脉造影复查的再狭窄率为7.1%(支架内为1.8%),支架内平均晚期管腔丢失为0.16mm(病变段内为0.20mm),靶病变重建率为5.4%。结论应用CypherTM支架治疗冠心病是安全和有效的,主要心脏不良事件发生率低,支架内再狭窄率和靶病变重建率明显低于普通金属支架。     

Three-year follow-up after rotational atherectomy for the treatment of diffuse in-stent restenosis: predictors of major adverse cardiac events.

Restenosis remains the major limitation of coronary stent implantation, especially in diffuse forms of in-stent restenosis. In this study, rotablation (RA) with adjunct angioplasty of in-stent restenosis was performed in 84 patients. Clinical follow-up and control angiography were obtained 6-month postprocedure. The rate of recurrent restenosis after rotablation for in-stent restenosis at 6-month angiographic follow-up was 45%, resulting in a rate of major adverse cardiac events of 35%. At 3-year follow-up, the cumulative event-free survival rate was 57% for the entire population. The only predictor of MACE at 3-year clinical follow-up by multivariate logistic regression analysis was in-stent lesion length. RA for the treatment of diffuse in-stent restenosis is thereby characterized by high procedural success rates and recurrent angiographic restenosis in 45% of patients with diffuse lesions. Major adverse cardiac events occur most likely within the first 6 months postprocedure. Three years after rotablation of in-stent restenosis, 43% of patients had experienced at least one major adverse cardiac event. Cathet Cardiovasc Intervent 2001;53:334-340.     

雷帕霉素药物洗脱支架治疗急性心肌梗死六个月随访结果

目的探讨雷帕霉素药物洗脱支架（Cypher）在急性ST段抬高心肌梗死急诊经皮冠状动脉介入治疗（PCI）中应用的安全性和有效性.方法选择2002年11月至2004年12月间的急性ST段抬高心肌梗死患者168例,于发病12 h内行急诊PCI治疗,于梗死相关血管的靶病变置入Cypher支架.记录1个月和6个月随访终点时的主要心脏不良事件（包括死亡、再发心肌梗死、靶血管再成形等）发生率、支架内血栓发生率、支架内再狭窄发生率.结果 168例患者急诊PCI治疗均获得成功.168支梗死相关血管的171处罪犯病变共置入175枚Cypher支架,未发生与介入治疗有关的并发症.1个月随访终点时死亡3例（死亡率1.8%）;支架内亚急性血栓1例;主要心脏不良事件发生率2.4%.6个月随访终点时死亡4例（死亡率2.4%）;主要心脏不良事件发生率4.2%;支架内血栓发生率1.2%;支架内再狭窄发生率1.8%.结论药物洗脱支架（Cypher）在急性ST段抬高心肌梗死急诊PCI中应用与普通支架一样有较强的安全性和有效性,并可以明显降低再狭窄率.     

Safety and performance of the EverProTM everolimus-eluting coronary stent system with biodegradable polymer in a real-world scenario

BACKGROUNDThe EverPro^TM (Sahajanand Laser Technology Ltd., India) everolimus-eluting coronary stent system (EES) is a second-generation drug-eluting stent with a biodegradable polymer.AIMTo determine the safety and performance of the EverPro^TM EES in patients with coronary artery disease (CAD) during a 1-year clinical follow-up.METHODSThis observational, retrospective, single-center study enrolled patients who had been implanted with the EverPro^TM stent between June 1, 2018 and January 31, 2019, and had completed a 1-year follow-up period after the index procedure. The primary clinical endpoint was major adverse cardiac events (MACE) at 6 mo defined as the composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Secondary endpoints were the incidence of TLR at 1, 6 and 12 mo follow-up, MACE at 1 and 12 mo follow-up, and stent thrombosis up to 1 year after the index procedure.RESULTSThe study population comprised 77 patients (98 lesions). A total of 37 (48.1%) patients had comorbid hypertension. In total, 26 (33.8%) patients presented with ST segment elevation MI and 10.4% patients with non-ST segment elevation MI. Treated lesions were located mainly in the left anterior descending artery (49%) followed by the right coronary artery (29.6%), left circumflex (12.2%) and obtuse marginal (9.2%) arteries. The majority of patients were with single-vessel disease (79%), 22.2% of lesions had a mild to severe thrombus load, and 94.9% were American College of Cardiology/American Heart Association type B or C. De novo stenting was performed in 96.9% of patients and 3% were treated for in-stent restenosis. Procedural success was attained in all patients. In-hospital or follow-up MACE and stent thrombosis were not reported during the 1-year follow-up period.CONCLUSIONThese findings suggest that the EverPro^TM EES is a safe and effective treatment option with no MACE or stent thrombosis reported during the 1-year study period in patients with CAD.