Prognostic Factors in Patients Treated with Drug-Coated Balloon Angioplasty for Symptomatic Peripheral Artery Disease

Abstract

PurposeAim of this study is to report real-life experience on the treatment of peripheral artery disease (PAD) with a specific drug-coated balloon (DCB), and to evaluate potential prognostic factors for outcomes.Materials and MethodsThis is a retrospective study reporting outcomes in patients with PAD who were treated with the Lutonix DCB during a four-year period. Major outcomes included: all-cause mortality, amputation, clinical improvement, wound healing and target lesion revascularization (TLR). Mean follow-up was 24.2±2.3 months.ResultsOverall, 149 patients (mean age: 68.6±8.3 years; 113 males) were treated, either for intermittent claudication (IC) (n=86) or critical limb ischemia (CLI) (n=63). More than half the target lesions (n=206 in total) were located in the superficial femoral artery and 18.0% were below-the-knee lesions. CLI patients presented more frequently with infrapopliteal (P=0.002) or multilevel disease (P=0.0004). Overall, all-cause mortality during follow-up was 10.7%, amputation-free survival was 81.2% and TLR-free survival was 96.6%. CLI patients showed higher all-cause mortality (P=0.007) and total amputation (P=0.0001) rates as well as lower clinical improvement (P=0.0002), compared to IC patients. Coronary artery disease (CAD), gangrene and infrapopliteal disease were found to be predictors for death whereas CLI and gangrene were found to be predictors for amputation, during follow-up.ConclusionPAD treatment with Lutonix DCBs seems to be an efficient and safe endovascular strategy yielding promising results. However, CAD, gangrene, CLI and infrapopliteal lesions were found to be independent predictors for adverse outcomes. Larger series are needed to identify additional prognostic factors.

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

“…DCB use has been investigated for lesions below and above the knee in patients with CLTI. 9,10,35,36,[38][39][40][41][42][43][44][45][46][47][48][49] Overall, DCBs demonstrated favorable immediate and late outcomes, with 9% 12-month all-cause mortality, complete wound healing in 74% of all cases, and major amputation necessary in only 5% of all patients.…”

“…In 11 studies with data about inflow/outflow disease, these nontarget lesions were treated at the discretion of the operator using standard techniques. 9,35,[37][38][39]41,[43][44][45]48,49 Adjunctive devices were sometimes used for vessel preparation prior to DCB angioplasty. 9,37,39,40,43,44 Among lesions located in the femoropopliteal segment, the mean lesion length was 120.6±43.7 mm, with 48% (402/846) and 33% (249/763) of the lesions being occlusions and severely calcified, respectively.…”

“…The overall procedural success of DCB angioplasty was 98% (95% CI 95% to 100%; I 2 =87.7%) based on data from 16 studies. 9,10,35,38,39,[47][48][49][50][51][52][53][55][56][57][58] In 13 studies (918 patients) reporting adverse event data, 9,10,35,41,42,45,47,49,[51][52][53]56,58 DCB angioplasty was complicated by thrombosis/distal embolization in 1.2% (n=11), local hematoma in 5.9% (n=54), and residual dissection in 24% (n=220) of the cases. An iatrogenic perforation (n=3) and pseudoaneurysms at the access site with extravasation of contrast (n=3) were also observed.…”

“…Provisional stenting was necessary in 9% (95% CI 5% to 15%; I 2 =91.1%) in the 16 studies reporting this variable. 9,10,35,37,38,41,44,45,47,49,[51][52][53][56][57][58]…”

“…9,10,35,[40][41][42]50,52,53,55,56,58 The pooled incidences of all-cause mortality in 12 studies 9,10,36,41,42,47,49,50,52,53,56,58 and major amputation in 13 studies 9,10,37,[40][41][42]47,49,50,52,53,56,58 at the end of follow-up were 8% (95% CI 5% to 13%; I 2 =75.9%) and 7% (95% CI 3% to 14%; I 2 =89.6%), respectively. Three studies 40,41,49 reported complete wound healing and ulcer regression over 12 months in 58% (95% CI 40% to 75%; I 2 nonestimable) of the cases. The only study to compare DCB with BA ± stenting for femoropopliteal lesions demonstrated better 12-month primary patency rates in the DCB group (80%) vs BA group (58%; p=0.015; Figure 2A) in 126 patients (83 DCB and 43 BA) with Rutherford categories ranging from 2 to 4 (claudicants representing <30% of the population).…”