Reijnen Michel M P J, van Wijck Iris, Brodmann Marianne, Micari Antonio, Torsello Giovanni, Rha Seung-Woon, Menk Jeremiah, Zeller Thomas
Department of Vascular Surgery, Rijnstate, Arnhem, The Netherlands.
Multi-Modality Medical Imaging Group, TechMed Centre, University of Twente, Enschede, The Netherlands.
Cardiovasc Intervent Radiol. 2023 Oct;46(10):1329-1345. doi: 10.1007/s00270-023-03478-y. Epub 2023 Aug 1.
To summarize the 5-year outcomes of drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with diabetes mellitus (DM) or chronic limb-threatening ischemia (CLTI) compared to non-DM and intermittent claudication (IC).
The IN.PACT Global study was a real-world prospective, multicenter, international, single-arm study that enrolled 1535 participants. Post hoc analyses were conducted for participants with DM (n = 560) versus non-DM (n = 842) and CLTI (n = 156) versus IC (n = 1246). Assessments included freedom from clinically driven target lesion revascularization (CD-TLR) through 60 months, a composite safety outcome (freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and freedom from CD-target vessel revascularization within 60 months), and major adverse events (MAEs).
Kaplan-Meier estimates of 60-month freedom from CD-TLR were 67.7% and 70.5% (p = 0.25) in the DM and non-DM cohorts; and 60.7% and 70.5% (p = 0.006) in the CLTI and IC cohorts. The Kaplan-Meier 60-month composite safety outcomes were 65.1% DM versus 68.9% non-DM (p = 0.12); 53.2% CLTI versus 69.1% IC (p < 0.001). Between DM and non-DM, MAE rates were not significantly different through 60 months except for all-cause mortality which was higher in DM (23.8% versus 16.6%; p < 0.001). Participants with CLTI had a higher cumulative incidence of major target limb amputation (6.8% versus 1.1%; p < 0.001) and all-cause mortality (37.4% versus 17.4%; p < 0.001) through 60 months compared to IC.
In this real-world study, 5-year reintervention rates following DCB angioplasty were similar between DM and non-DM, but mortality rates were expectedly higher in patients with DM. Reintervention, mortality, and amputation rates were all higher in CLTI patients compared to IC, which is consistent with the known frailty of this patient population.
Level 3, Non-randomized controlled cohort/follow-up study.
总结药物涂层球囊（DCB）治疗糖尿病（DM）或慢性肢体威胁性缺血（CLTI）患者股腘动脉病变与非糖尿病和间歇性跛行（IC）患者相比的5年结局。
IN.PACT Global研究是一项真实世界的前瞻性、多中心、国际性、单臂研究，纳入了1535名参与者。对DM患者（n = 560）与非DM患者（n = 842）以及CLTI患者（n = 156）与IC患者（n = 1246）进行事后分析。评估包括60个月内无临床驱动的靶病变血运重建（CD-TLR）、复合安全结局（30天内无器械和手术相关死亡、60个月内无主要靶肢体截肢以及无CD靶血管血运重建）和主要不良事件（MAE）。
DM组和非DM组60个月无CD-TLR的Kaplan-Meier估计值分别为67.7%和70.5%（p = 0.25）；CLTI组和IC组分别为60.7%和70.5%（p = 0.006）。Kaplan-Meier 60个月复合安全结局在DM组为65.1%，非DM组为68.9%（p = 0.12）；CLTI组为53.2%，IC组为69.1%（p < 0.001）。在DM组和非DM组之间，60个月内MAE发生率除全因死亡率在DM组较高（23.8%对16.6%；p < 0.001）外无显著差异。与IC患者相比，CLTI患者60个月内主要靶肢体截肢的累积发生率更高（6.8%对1.1%；p < 0.001），全因死亡率也更高（37.4%对17.4%；p < 0.001）。
在这项真实世界研究中，DCB血管成形术后5年再次干预率在DM组和非DM组相似，但DM患者死亡率预期更高。与IC患者相比，CLTI患者的再次干预率、死亡率和截肢率均更高，这与该患者群体已知的虚弱状况一致。
3级，非随机对照队列/随访研究。
