Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Division of Angiology, Medical University, Graz, Austria.
EuroIntervention. 2022 Dec 2;18(11):e940-e948. doi: 10.4244/EIJ-D-21-01098.
Numerous randomised controlled trials (RCTs) have demonstrated the superiority of paclitaxel drug-coated balloons (DCBs) over non-coated angioplasty balloons for treatment of femoropopliteal peripheral arterial disease (PAD). There is a paucity of clinical evidence in more complex patients who are often excluded from RCTs and long-term data up to 5 years are very limited in PAD revascularisation studies.
This is a report of the 5-year outcomes from the prospective, single-arm, international IN.PACT Global Study. The IN.PACT Admiral DCB was evaluated for femoropopliteal atherosclerotic disease treatment in a real-world patient population.
In total, 1,535 patients were enrolled at 64 international sites. The prespecified clinical cohort included 1,406 patients with claudication or rest pain. Patients were evaluated up to 5 years for the occurrence of adverse events and clinically driven target lesion revascularisations (CD-TLR).
The mean lesion length was 12.1±9.5 cm in 1,774 lesions, 18.0% had in-stent restenosis, 35.5% were total occlusions and 68.7% were calcified. Per independent clinical events committee adjudication, the Kaplan-Meier estimate of freedom from CD-TLR up to 5 years was 69.4%, and the restricted mean survival time to first CD-TLR was 1,470.1 days. Outcomes were similar for males and females; freedom from CD-TLR was 69.1% in females and 69.6% in males (p=0.602). The cumulative incidence of major adverse events for the clinical cohort was 45.9% and freedom from all-cause mortality with the vital status update was 78.9% up to 5 years.
The IN.PACT Admiral DCB demonstrated safe and durable outcomes in real-world participants with complex femoropopliteal disease.
gov: NCT01609296.
大量的随机对照试验（RCT）已经证明，紫杉醇药物涂层球囊（DCB）在治疗股腘外周动脉疾病（PAD）方面优于非涂层球囊。在 RCT 中经常排除的更为复杂的患者中，临床证据较少，在 PAD 血运重建研究中，长达 5 年的长期数据非常有限。
这是前瞻性、单臂、国际 IN.PACT Global 研究 5 年结果的报告。IN.PACT Admiral DCB 在真实世界的患者人群中用于股腘动脉粥样硬化疾病的治疗。
共在 64 个国际站点招募了 1535 名患者。预设的临床队列包括 1406 名有跛行或静息痛的患者。患者在 5 年内接受了不良事件和临床驱动的靶病变血运重建（CD-TLR）的评估。
1774 处病变的平均病变长度为 12.1±9.5cm，18.0%有支架内再狭窄，35.5%为完全闭塞，68.7%为钙化。根据独立临床事件委员会的裁决，Kaplan-Meier 估计 5 年内 CD-TLR 无复发的比例为 69.4%，首次 CD-TLR 的限制性平均生存时间为 1470.1 天。男性和女性的结果相似；女性 CD-TLR 无复发率为 69.1%，男性为 69.6%（p=0.602）。临床队列的主要不良事件累积发生率为 45.9%，根据生命状态更新，5 年内全因死亡率无复发率为 78.9%。
IN.PACT Admiral DCB 在复杂股腘动脉疾病的真实世界参与者中显示出安全和持久的结果。
gov：NCT01609296。
