University Heart Center Graz, Medical University Graz, Graz, Austria.
Piedmont Heart Institute, Atlanta, GA, United States of America.
Cardiovasc Revasc Med. 2024 Jan;58:60-67. doi: 10.1016/j.carrev.2023.07.016. Epub 2023 Jul 24.
Patients with high bleeding risk (HBR) are often treated with abbreviated dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) to reduce bleeding risk, however this strategy is associated with an increase in ischemic events, especially if the acute PCI result is suboptimal. We compared clinical outcomes among patients with HBR treated with 1-month DAPT who underwent intravascular ultrasound (IVUS)- or optical coherence tomography (OCT)-guided PCI versus those who underwent angiography-guided PCI without intravascular imaging.
The Onyx ONE Clear study includes patients with HBR from the Onyx ONE US/Japan and Onyx ONE randomized studies who were treated with the Resolute Onyx zotarolimus-eluting stent. The primary endpoint was the composite of cardiac death (CD) or myocardial infarction (MI) between 1 month and 2 years after PCI. Propensity-score adjustments and matching were performed for differences in baseline and procedural characteristics between groups.
Among the 1507 patients in Onyx ONE Clear, 271 (18.0 %) had IVUS or OCT used during PCI (Imaging-guided group) and 1236 (82.0 %) underwent Angiography-guided PCI (Angio-guided group). Imaging-guided patients were less likely to present with atrial fibrillation, acute coronary syndrome, and left ventricle ejection fraction ≤35 %. Conversely, Imaging-guided patients were more likely to have complex (ACC/AHA type B2/C), longer, and heavily calcified lesions. Between 1 month and 2 years, the composite rate of CD or MI was similar between Imaging-guided and Angio-guided patients (9.9 % vs. 12.4 %, P = 0.33). There was also no difference between groups after adjustment; (P = 0.56). However, CD was significantly lower among Imaging-guided patients (2.7 % vs. 6.1 %, P = 0.048). There were no between-group differences in MI or stent thrombosis. Propensity score matching results were similar.
Despite higher lesion complexity, using intravascular imaging guidance for PCI between 1-month and 2-years follow-up had comparable outcomes with angiographic guidance alone in patients with HBR treated with 1-month DAPT. (ClinicalTrials.gov: Identifier: NCT03647475 and NCT03344653).
NON-STANDARD ABBREVIATIONS AND ACRONYMS: BARC: Bleeding Academic Research Consortium; DAPT: dual antiplatelet therapy; DES: drug-eluting stent; HBR: high bleeding risk; IVUS: intravascular ultrasound; OCT: optical coherence tomography; SAPT: single antiplatelet therapy.
经皮冠状动脉介入治疗（PCI）后，高出血风险（HBR）患者常接受短程双联抗血小板治疗（DAPT）以降低出血风险，但这种策略与缺血事件的增加相关，尤其是如果急性 PCI 结果不理想。我们比较了 HBR 患者接受 1 个月 DAPT 治疗，行血管内超声（IVUS）或光相干断层扫描（OCT）指导 PCI 与行血管造影指导 PCI 而不进行血管内成像患者的临床结局。
Onyx ONE Clear 研究纳入了来自 Onyx ONE US/Japan 和 Onyx ONE 随机研究的 HBR 患者，这些患者接受 Resolute Onyx 佐他莫司洗脱支架治疗。主要终点是 PCI 后 1 个月至 2 年时的心脏死亡（CD）或心肌梗死（MI）的复合终点。对两组间基线和操作特征的差异进行倾向评分调整和匹配。
在 Onyx ONE Clear 研究的 1507 例患者中，271 例（18.0%）在 PCI 时使用 IVUS 或 OCT（影像指导组），1236 例（82.0%）行血管造影指导 PCI（血管造影指导组）。影像指导组患者发生心房颤动、急性冠脉综合征和左心室射血分数≤35%的可能性较低。相反，影像指导组患者的病变更复杂（ACC/AHA 类型 B2/C）、更长和重度钙化。在 1 个月至 2 年期间，影像指导组和血管造影指导组的 CD 或 MI 复合发生率相似（9.9% vs. 12.4%，P=0.33）。调整后两组间也无差异（P=0.56）。然而，影像指导组的 CD 明显较低（2.7% vs. 6.1%，P=0.048）。两组间 MI 或支架血栓形成无差异。倾向评分匹配结果相似。
尽管病变复杂性较高，但在接受 1 个月 DAPT 治疗的 HBR 患者中，与单纯血管造影指导相比，1 个月至 2 年随访期间进行血管内成像指导 PCI 具有相当的结果。（临床试验.gov：标识符：NCT03647475 和 NCT03344653）。
BARC：出血学术研究联合会；DAPT：双联抗血小板治疗；DES：药物洗脱支架；HBR：高出血风险；IVUS：血管内超声；OCT：光学相干断层扫描；SAPT：单抗血小板治疗。
