Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany.
Department of Cardiology, Vivantes Klinikum im Friedrichshain and Am Urban, Berlin, Germany.
Lancet. 2016 Jan 2;387(10013):31-9. doi: 10.1016/S0140-6736(15)00447-X. Epub 2015 Oct 12.
Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions.
We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504.
Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm(2) [SD 1·15] post-procedure vs 6·21 mm(2) [1·22] at 6 months) with a low mean neointimal area (0·08 mm(2) [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed.
Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease.
Biotronik AG.
可吸收支架旨在克服传统不可吸收金属药物洗脱支架的局限性。到目前为止，只有聚合物可吸收支架在商业上可用。我们旨在评估新型第二代药物洗脱可吸收金属支架（DREAMS 2G）在初发冠状动脉病变患者中的安全性和性能。
我们在比利时、巴西、丹麦、德国、新加坡、西班牙、瑞士和荷兰的 13 个经皮冠状动脉介入治疗中心进行了这项前瞻性、多中心、非随机、首例人体试验。入选患者有稳定或不稳定型心绞痛或有记录的无症状性缺血，最大病变数量为 2 处，参考血管直径为 2.2-3.7mm。临床随访安排在第 1、6、12、24 和 36 个月。患者安排在第 6 个月进行血管造影随访，部分患者安排进行血管内超声、光学相干断层扫描和血管舒缩评估。所有患者均建议至少服用 6 个月双联抗血小板治疗。主要终点是 6 个月时的节段内晚期管腔丢失。我们进行了意向治疗分析。该试验在 ClinicalTrials.gov 注册，编号为 NCT01960504。
在 2013 年 10 月 8 日至 2015 年 5 月 22 日期间，我们纳入了 123 名患有 123 处冠状动脉靶病变的患者。在 6 个月时，平均节段内晚期管腔丢失为 0.27mm（标准差 0.37），25 名患者中有 20 名（80%）经血管造影检查发现可识别的血管舒缩。血管内超声评估显示支架区域得到保留（术后平均 6.24mm²[标准差 1.15] vs 6 个月时的 6.21mm²[1.22]），新生内膜面积较低（0.08mm²[0.09]），光学相干断层扫描未检测到腔内任何肿块。4 名（3%）患者发生靶病变失败：1 名（<1%）患者死于心源性死亡，1 名（<1%）患者发生围手术期心肌梗死，2 名（2%）患者需要临床驱动的靶病变血运重建。未观察到明确或可能的支架血栓形成。
我们的发现表明，在初发冠状动脉病变中植入 DREAMS 2G 装置是可行的，6 个月时安全性和性能结果良好。这种新型可吸收金属支架可能是治疗阻塞性冠状动脉疾病的可吸收聚合物支架的替代方法。
百多力公司。
