Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.
JACC Cardiovasc Interv. 2015 Jun;8(7):889-99. doi: 10.1016/j.jcin.2015.01.033. Epub 2015 May 20.
This study assessed clinical events and patient-reported chest pain 2 years after treatment of all-comers with Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, California) and Promus Element everolimus-eluting stents (Boston Scientific, Natick, Massachusetts).
For both drug-eluting stents (DES), no all-comer outcome data from >12 months of follow-up have been published. Although there is increasing interest in patient-reported chest pain following stenting, data with novel DES are scarce.
The DUTCH PEERS multicenter trial (TWENTE II) (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial [TWENTE II]) randomized 1,811 all-comer patients to treatment with 1 type of DES. Monitoring and event adjudication were performed by independent contract research organizations.
The 2-year follow-up of 1,810 patients (99.9%) was available. The primary composite endpoint target vessel failure occurred in 8.6% and 7.8% of patients treated with zotarolimus- and everolimus-eluting stents, respectively (p = 0.55). Rates of components of target vessel failure were: cardiac death (2.4% vs. 1.9%, p = 0.42); target vessel-related myocardial infarction (2.4% vs. 1.8%, p = 0.33); clinically-indicated target vessel revascularization (4.6% vs. 4.9%, p = 0.83). At 1- and 2-year follow-up, >80% of patients were free from chest pain (no between-stent difference). In addition, >87% of patients were either free from chest pain or experienced pain only at maximal physical exertion, but not during normal daily activities. Patients with chest pain after 12 months at no more than moderate physical effort had a higher risk of target vessel revascularization during the following year (hazard ratio: 1.89 [95% confidence interval: 1.05 to 3.39], p = 0.03).
During the second year of follow-up, the incidence of adverse clinical endpoints remained similar and low for both DES. The vast majority of patients were free from chest pain.
本研究评估了所有接受 Resolute Integrity 佐他莫司洗脱支架（美敦力血管，加利福尼亚州圣罗莎）和 Promus Element 依维莫司洗脱支架（波士顿科学，马萨诸塞州纳提克）治疗的患者在治疗后 2 年的临床事件和患者报告的胸痛情况。
对于这两种药物洗脱支架（DES），均未发表超过 12 个月随访的所有患者结局数据。尽管人们对支架置入后患者报告的胸痛越来越感兴趣，但新型 DES 的数据却很少。
DUTCH PEERS 多中心试验（TWENTE II）（基于耐用聚合物的支架挑战 Promus Element 与 Resolute Integrity）随机试验[TWENTE II]）将 1811 名所有患者随机分为 1 种 DES 治疗。通过独立合同研究组织进行监测和事件裁决。
1810 名患者（99.9%）的 2 年随访结果可用。佐他莫司洗脱支架和依维莫司洗脱支架治疗患者的主要复合终点靶血管失败发生率分别为 8.6%和 7.8%（p=0.55）。靶血管失败的组成部分发生率为：心源性死亡（2.4%比 1.9%，p=0.42）；靶血管相关心肌梗死（2.4%比 1.8%，p=0.33）；临床指示的靶血管血运重建（4.6%比 4.9%，p=0.83）。在 1 年和 2 年的随访中，超过 80%的患者无胸痛（支架间无差异）。此外，超过 87%的患者无胸痛或仅在最大体力活动时感到胸痛，但在日常活动中没有胸痛。在 12 个月时仅在中等体力活动时出现胸痛的患者在接下来的一年中靶血管血运重建的风险更高（风险比：1.89[95%置信区间：1.05 至 3.39]，p=0.03）。
在随访的第二年，两种 DES 的不良临床终点发生率仍然相似且较低。绝大多数患者无胸痛。
