Three global registries reported fresh data at the 2017 Leipzig Interventional Course (LINC; 24–27 January, Leipzig, Germany), all of which showed encouraging outcomes for drug-coated balloon treatment, one at six months’ follow-up and two at one year.
The data presented were 12-month data from the IN.PACT Global Study investigating the IN.PACT Admiral drug-coated balloon (Medtronic), the ILLUMENATE Global Study investigating the Stellarex drug-coated balloon (Spectranetics), and the Lutonix DCB BTK Registry Study evaluating below-the-knee use of the Lutonix drug-coated balloon (Bard)—currently the only ongoing multicentre below-the-knee registry.
IN.PACT Global Clinical Cohort
Marianne Brodmann (Medical University of Graz, Graz, Austria) told LINC delegates that real-world 12-month results of the IN.PACT Global Clinical Cohort “demonstrate consistent efficacy of the IN.PACT Admiral drug-coated balloon in the clinical cohort and across pre-specified imaging subgroups.”
The all-comers femoropopliteal registry enrolled 1,535 patients at 64 sites in Europe, the Middle East, Latin America and Asia. The primary efficacy endpoint was freedom from clinically-driven target lesion revascularisation within 12 months, with the primary safety endpoint as freedom from device-and procedure-related death through 30 days and freedom from target limb major amputation and clinically-driven target vessel revascularisation within 12 months. The study included patients of Rutherford class 2–4 with lesions in the superficial femoral and/or popliteal arteries. Patients had single or multiple stenosis or occlusions of any length ≥2cm, de novo or restenotic lesions (including in-stent restenosis) with at least one infrapopliteal run-off vessel.
Mean patient age was 68.6±10.1 years, with males making up 67.8% of those treated. Diabetes was present in 39.9% of patients, and the majority (58%) were in Rutherford class 3 (31% in class 2, 8% in class 4 and 3% class 5).
Treated lesion length was 12.09±9.54cm with a mean calcification rate of 68.7%, 10.2% of which was classed as severe. Device success was 99.4% and procedural success 99.3%.
Brodmann reported 92.6% freedom from clinically-driven target lesion revascularisation at one year. She also announced additional effectiveness outcomes of clinically driven target lesions revascularisation of 7.4%, any target lesions revascularisation of 7.8% and primary sustained clinical improvement—defined as freedom from target limb amputation, freedom from target vessel revascularisation and improvement in Rutherford class at 12 months—of 80.6%.
The primary safety composite endpoint—freedom from device- and procedure-related to 30 days, freedom from target limb amputation within 12 months and freedom from clinically-driven target vessel revascularisation within 12 months—was met in 92.1% of cases. The 12-month rate of major adverse events was 12%. All-cause death was 3.5% at 12 months, with 0.2% (n=3) cases of device- or procedure-related death at 30 days.
“This real-world experience confirms the safety of the IN.PACT Admiral drug-coated balloon,” Brodmann told delegates. “The one-year IN.PACT Global results and durable long-term results from the IN.PACT SFA randomised trial provide reassurance to the vascular community that IN.PACT Admiral is a first-line therapy for superficial femoral and/or popliteal peripheral artery disease, and can be used in complex lesions and patient populations.”
ILLUMENATE Global Study
Thomas Zeller (University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany) presented data from the ILLUMENATE Global Study, suggesting that “low-dose next-generation drug-coated balloons can perform within a wide range of patient complexities.”
The prospective, multicentre, single-arm study is following patients out to five years after treatment with the Stellarex drug-coated balloon (Spectranetics) in the superficial femoral and/or popliteal arteries. Independent adjudication is being conducted through an angiographic core laboratory, duplex ultrasound core laboratory, clinical events committee and data safety monitoring board.
All patients are in Rutherford class 2–4 with at least one patent run-off below the knee, one or two target lesions with a cumulative length of ≤20cm and target vessel reference diameter of 4–6mm.
Mean patient age was 68.2±9.3 years, 73% of patients were male and 33.7% of patients had diabetes. Most (57.7%) patients were Rutherford class 3, while 0.3% were class 1, 33.4% class 2, 6.2% class 4 and 2.4% class 5.
At baseline, 31.3% of lesions were total occlusions and 40.7% exhibited severe calcification. Most lesions were in either the mid (42%) or distal (33%) superficial femoral arteries.
Pre-dilatation was performed in 98.1% of cases and provisional stenting in 17.3%. Lesion success—reduction of ≤50% in final residual diameter stenosis—was achieved in 97.6% of cases.
The primary safety endpoint— 30-day freedom from device and procedure-related death and freedom from target limb major amputation and clinically-driven target lesion revascularisation through 12 months—was met in 94.8% of patients. There was one major target limb amputation following a clinically-driven target revascularisation (in a patient who was Rutherford class 5 at baseline) and 19 cases of clinically driven target lesion revascularisation. At 12 months, the clinically-driven target lesion revascularisation rate was 6.2%. This figure, Zeller said, was similar or superior to outcomes for selected trials with similar lesion characteristics—5.9% for the ILLUMENATE EU randomised controlled trial, 4.6% for the IN.PACT SFA trial, and 12.3% for the LEVANT 2 trial.
Zeller reported 12-month primary patency of 81.4%, noting that this was also comparable or superior to other previously-published data from other trials treating similar lesion characteristics (89% for ILLUMENATE EU, 87.5% for IN.PACT SFA, and 73.5% for the LEVANT 2).
Notable secondary outcomes included that 90.3% of subjects experienced an improvement in Rutherford class at 12 months compared with baseline (with 60% down to class 0 at 12 months), and that 83.6% of subjects saw an improvement in walking distance (composite score of 60.7 at 12 months compared to 32.1 at baseline as per the Walking Impairment Questionnaire).
“These data support and reinforce previous findings from the ILLUEMNATE pivotal trial in a similarly high (>40%) severe calcium patient cohort,” Zeller said. “This builds on the robust ILLUMENATE programme with over 1,000 patients,” he concluded.
Six-month below-the-knee drug-coated balloon results “promising”
Six-month results of the only ongoing multicentre below-the-knee drug-coated balloon trial showed encouraging data, with high rates of freedom from target lesion revascularisation and a low amputation rate, according to Michael Lichtenberg (Vascular Centre Clinic Arnsberg, Arnsberg, Germany), who presented the findings at LINC.
The trial is studying the performance of the Lutonix drug-coated balloon (Bard) for treatment of stenosis or occlusion of native below-the-knee arteries, and will enrol up to 500 patients at 35 international sites. All patients are Rutherford class 3–5 with 70% stenosis lesions and target vessels reconstituted at or above the ankle with in-line flow to at least one patent vessel.
At LINC, Lichtenberg presented data from 85 patients. The mean age of this group was 73.9±10.2 years and most (70.6%) were male. Of these, 57.6% had diabetes and a high proportion (64.3%) were of Rutherford class 5 (19% class 3 and 16.7% class 4).
Mean total target lesion length was 102±79.5mm and severe calcification was observed in 10.5% of cases (with 63.8% exhibiting some calcification). The treated lesions were located in the popliteal artery (9.4%), tibioperoneal trunk (27.1%), anterior tibial artery (34.1%), posterior tibial artery (24.7%) and peroneal artery (25.9%).
Freedom from a composite of all-cause death and above-ankle amputation or major reintervention was 100% at 30 days, Lichtenberg reported. At six months, this fell to 94%. Six-month freedom from all-cause death was 89.2%, from major amputation 95.2% and from reintervention for thrombosis or thrombolysis 96.1%. There were no reinterventions for distal embolisation. Freedom from target lesion revascularisation was reported for 98.8% of patients at 30 days, falling to 89.3% at six months.
“These safety outcomes are consistent with the strong safety profile of the Lutonix drug-coated balloon in peripheral artery disease,” Lichtenberg concluded. Further follow-up will be conducted at 12 and 24 months.