PMID- 36052430 OWN - NLM STAT- MEDLINE DCOM- 20240314 LR - 20240411 IS - 1545-1550 (Electronic) IS - 1526-6028 (Linking) VI - 31 IP - 2 DP - 2024 Apr TI - Incidence of Acute Thrombotic Occlusion and Its Predictors After Contemporary Femoropopliteal Endovascular Therapy in Patients With Peripheral Artery Disease. PG - 263-273 LID - 10.1177/15266028221120519 [doi] AB - PURPOSE: This study investigated the incidence of acute thrombotic occlusion (ATO) and its predictors after contemporary femoropopliteal (FP) endovascular therapy (EVT) for peripheral artery disease. MATERIALS AND METHODS: We retrospectively examined 763 limbs (chronic limb-threatening ischemia [CLTI]: 44%, involving popliteal lesion: 44%) in 644 patients (mean age: 75+/-9 years, male: 71%, hemodialysis: 34%) who successfully underwent EVT with contemporary FP devices (drug-coated stent: n=220, stent graft: n=158, drug-eluting stent: n=150, drug-coated balloon [DCB]: n=235) from June 2012 to July 2020. The outcome measure was ATO defined as acute onset of claudication and/or signs of CLTI in combination with angiographic evidence of occlusive thrombus formation within the treated segment. Cox proportional hazards regression models were used to identify baseline characteristics associated with the incidence of ATO after EVT treated with scaffold. To determine the impact of ATO occurrence and creatine phosphokinase (CPK) elevation on the subsequent composite outcome of mortality or major amputation, we developed the Cox model in which the trichotomous variable (free from ATO, ATO without CPK elevation, and ATO with CPK elevation) was a time-dependent covariate. RESULTS: The 24-month incidence of ATO in the overall population was 4.3%+/-0.8% (DCB: 1.0%+/-0.7% vs scaffold: 5.8%+/-1.1%, p<0.01). Hemodialysis (hazard ratio [HR]: 2.63, p=0.02) and involving popliteal lesion (HR: 8.22, p<0.01) were independently associated with an increased risk of ATO in patients treated with scaffold. Both ATO without CPK elevation and ATO with CPK elevation were significantly associated with a composite outcome of mortality or major amputation comparing free from ATO, with an HR of 2.39 and 9.87, respectively (p=0.02 and p<0.01). CONCLUSION: We found a substantial incidence of ATO after contemporary FP-EVT, particularly with scaffold. Hemodialysis and involving popliteal lesion were significantly associated with ATO risk in patients treated with scaffold. The occurrence of ATO, particularly with CPK elevation, was associated with an increased risk of a subsequent composite outcome of mortality or major amputation. The scaffold was safely used in patients without those risk factors of ATO, but a non-scaffolding strategy should be considered for patients with more risk factors. CLINICAL IMPACT: The scaffold was safely used in patients without hemodialysis and involving popliteal lesion, but a non-scaffolding strategy should be considered for patients with those risk factors. The occurrence of ATO, particulary with CPK elevation, was of high risk of mortality or amputation. FAU - Nakao, Sho AU - Nakao S AUID- ORCID: 0000-0002-1339-0226 AD - Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan. FAU - Iida, Osamu AU - Iida O AUID- ORCID: 0000-0001-6829-7304 AD - Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan. FAU - Takahara, Mitsuyoshi AU - Takahara M AD - Department of Diabetes Care Medicine, Osaka University Graduate School of Medicine, Suita, Japan. FAU - Okamoto, Shin AU - Okamoto S AUID- ORCID: 0000-0002-9178-5514 AD - Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan. FAU - Ishihara, Takayuki AU - Ishihara T AD - Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan. FAU - Tsujimura, Takuya AU - Tsujimura T AUID- ORCID: 0000-0002-3128-1357 AD - Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan. FAU - Hata, Yosuke AU - Hata Y AUID- ORCID: 0000-0001-5482-3502 AD - Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan. FAU - Toyoshima, Taku AU - Toyoshima T AD - Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan. FAU - Higashino, Naoko AU - Higashino N AD - Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan. FAU - Mano, Toshiaki AU - Mano T AD - Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan. LA - eng PT - Journal Article DEP - 20220901 PL - United States TA - J Endovasc Ther JT - Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists JID - 100896915 SB - IM MH - Humans MH - Male MH - Aged MH - Aged, 80 and over MH - Femoral Artery MH - Popliteal Artery MH - *Drug-Eluting Stents MH - Incidence MH - Retrospective Studies MH - Treatment Outcome MH - Ischemia/therapy MH - *Peripheral Arterial Disease/therapy MH - Risk Factors MH - *Angioplasty, Balloon/adverse effects MH - Chronic Limb-Threatening Ischemia MH - *Thrombosis MH - Vascular Patency OTO - NOTNLM OT - acute thrombotic occlusion OT - contemporary device OT - endovascular therapy OT - femoropopliteal segment OT - peripheral arterial disease COIS- Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. EDAT- 2022/09/03 06:00 MHDA- 2024/03/14 06:46 CRDT- 2022/09/02 02:53 PHST- 2024/03/14 06:46 [medline] PHST- 2022/09/03 06:00 [pubmed] PHST- 2022/09/02 02:53 [entrez] AID - 10.1177/15266028221120519 [doi] PST - ppublish SO - J Endovasc Ther. 2024 Apr;31(2):263-273. doi: 10.1177/15266028221120519. Epub 2022 Sep 1.