Real-world outcomes of endovascular treatment in a non-selected population with peripheral artery disease – prospective study with 2-year follow-up

Abstract

Summary. Background: The study aimed to evaluate the outcomes of percutaneous transluminal angioplasty (PTA) in lower-extremity peripheral artery disease (PAD) patients. Patients and methods: A multi-centre, observational study was performed with 32 German and Austrian centres contributing data to the PTA registry. Data of 1,781 patients with lower-leg and pelvic PAD who were suitable for endovascular PTA treatment were contributed from participating centres. Data from 1,533 patients are reported here (1,055 male and 478 female). This study did not have exclusion criteria. Quality of life (QOL) questionnaire (EQ-5D) scores, Rutherford classification, mortality, patency rate and details of major adverse cardiovascular events were collected at 6-, 12-, 18-, and 24-month follow ups. Results: PTA with/without stenting achieved 90.3 %, 86.5 %, 82.7 %, and 71.9 % technical success (recanalisation achieving ≥ 70 % patency, no evidence of embolisation, recoiling or dissection) in iliac, femoral, popliteal, and below-the-knee arteries, respectively. Procedural/postprocedural complications occurred in 142 (9.3 %, 1 death) and 74 (4.8 %) patients. QOL, mobility, self-care, activity, and pain/discomfort scores improved (p < 0.01), anxiety/depression was insignificantly improved. During follow-up, 409 (26.7 %) patients were hospitalised for PAD, 281 (18.3 %) required reintervention, and 145 (9.5 %) died or needed amputation (n = 49; 3.2 %). Multivariate analysis demonstrated poorer outcomes in patients with comorbidities. Conclusions: PTA with/without stenting is effective, safe, and widely applicable, with few complications. It improves QOL, but not anxiety/depression.

Demographic and procedural characteristics in the RECording COurses of vasculaR Diseases (RECCORD) registry – the first 1000 patients

“…In a real-world setting in Germany as depicted by the RECCORD registry, 25.0% of EVR are performed in CLTI, while 75.0% in non-CLTI patients. This finding is consistent with previous observations in real-world registries and in claims data analyses in Germany [4,8]. In a multicenter real-world registry conducted in 1,533 patients in Germany approximately 15 years ago [4] the fraction of CLTI population among all EVR was 22.7%, comparable to 25.0% in the RECCORD registry.…”

“…While there is strong evidence for revascularization regarding hard clinical endpoints such as limb salvage and wound healing in patients with CLTI, the beneficial impact of revascularization in claudicants is unclear. Despite the gap in evidence, the majority of peripheral revascularizations, particularly of endovascular revascularizations (EVR), is performed in patients with intermittent claudication (IC) [4].…”

Endovascular interventions for peripheral arterial disease have to be integrated in a concept of total cardiovascular care by angiologists to improve patients and limbs prognosis

“…Roughly a quarter of all peripheral EVR documented in RECCORD were performed in patients with chronic-limb-treating ischemia, roughly three quarters in patients with intermittent claudication and a minority in asymptomatic patients that required interventions to improve bypass patency by correction of bypass stenosis, by treatment of peripheral aneurysms, and by treatment of complications due to plaque shift. This distribution of indications for EVR has also been shown in a previous German registry [11] and claim data analyses in Germany [12]. In the recently published Voyager PAD trial, which included patients after an either endovascular or surgical peripheral arterial revascularization for PAD and examined the effect of an antithrombotic strategy with either aspirin alone or in combination low-dose rivaroxaban on cardiovascular and limb-related endpoints, the indications for revascularizations were also around in three quarters intermittent claudication and in one quarter critical limb ischemia [13].…”

Delayed severe median nerve palsy due to undiagnosed brachial pseudoaneurysm

“…Even if pseudoaneurysm remains a typical complication, endovascular procedures with brachial and/or radial access are still the most frequent etiology despite their low incidence, ranging from 0.4 to 0.7 % [1,2]. Regarding femoral access, a recent real-world study on 1781 patients showed a complication rate of 1.8 % for PA [3]. Non-iatrogenic causes can be infections, inflammatory vascular disease and elastic tissue disorders.…”