Yesterday’s Peripheral Arterial Challenges session saw a host of new developments being presented and a lift for drug-coated balloons (DCBs), swirling flow stents and drug-eluting stents.
The day began by trying to avoid any intervention by exercise, best medical treatment and smoking cessation. Presenters showed that supervised exercise is effective, but costly and that patients do not submit to it.rug-coated balloons are in the ascendancy for moderate length lesions, as is the support for pretreatment for calcified or severe disease by predilation or atherectomy/debulking followed by DCB to discourage restenosis. Yet, the treatment of long lesions remains a challenge for interventionists. Various endovascular approaches such as the use of DCBs, atherectomy followed by drug-coated balloon, sequential stents and the use of a single long stent are being used in the treatment of long lesions, but surgical bypass still has a place for these patients, the voting results showed. Swirling flow in stents is here to stay, as are drug-eluting stents, but costs remain a factor and members of the CX audience also expressed an interest in and are awaiting three- to five-year data for DCB.
Vessel preparation before use of DCBs gains further support
A vast majority, 87% of the Charing Cross audience, believes in the idea of pretreating superficial artery lesions before the use of drug-coated balloons. In 2013, just 32% supported the idea of pretreatment, and this number has steadily grown to 43% in 2014 and 77%, last year. Pretreatment of calcified lesions or severe disease can be approached in various ways including by predilatation, atherectomy or debulking.
Speaking on the rationale, evidence and indication for plaque modification before DCB, Erwin Blessing, Heidelberg, Germany, said that it is observed that DCBs work less well in heavily calcified lesions, meaning that there could be improved penetration of drug after lesion preparation or removal.
Then, Stephan Duda, Berlin, Germany, explained that pre-dilatation was important to protect DCB performance, to best assess lesion type and to potentially reduce need for post-dilatation and stenting. It is highly recomended in presence of calcium and in total occlusions, he said.
Subsequently, new data were presented on the use of DCB for increasingly complex patients and lesions. The data included the one-year results from the chronic total occlusion imaging cohort from the IN.PACT Global Study and the two-year gender and diabetic subgroup analyses from the pivotal IN.PACT SFA Trial that used the IN.PACT Admiral DCB (Medtronic) and the 12-month interim ILLUMENATE Global Study that used the Stellarex DCB (Spectranetics).
New data from the chronic total occlusion imaging cohort of the real-world, IN.PACT Global Study were presented by Gunnar Tepe, Rosenheim, Germany. Chronic total occlusions are typically characterised by calcified plaque, which often result in complete (or nearly complete) obstruction of blood flow through the artery.
As part of the 1,535 patients enrolled across 27 countries in IN.PACT Global Study, 126 patients with an average lesion length of 22.9cm were included in the chronic total occlusion imaging cohort analysis. The primary patency rate was 84.4% and the clinically-driven target lesion revascularisation rate (CD-TLR) was 12.2% at one year. Additional safety and efficacy outcomes included low rates of all-cause mortality (4.3%), thrombosis (4.3%) and no occurrences of major target limb amputation (0%). Previous reports from the IN.PACT Global Study demonstrated effectiveness in complex in-stent restenosis lesions and long lesions in the superficial femoral artery through one year.
“Despite the complexity of these challenging and complex long chronic total occlusion lesions, the outcomes were excellent and remarkably consistent to that of the overall cohort. These results show the effectiveness of the IN.PACT Admiral drug-coated balloon as a primary treatment in this complex lesion subset,” concluded Tepe.
IN.PACT SFA Trial investigators sought to better understand the treatment effect of the IN.PACT Admiral DCB compared to balloon angioplasty in females and patients with diabetes, patient populations whose outcomes have historically not fared as well as males and non-diabetic patients, respectively. Peter Schneider, Honolulu, USA, presented outcomes from the IN.PACT SFA Trial gender and diabetes subgroups, which showed superior and durable outcomes for the IN.PACT Admiral DCB compared to balloon angioplasty across both subgroups at two years.
The IN.PACT SFA Trial enrolled 331 patients, 113 of which were women, at 57 sites across Europe and the United States. At two years, females who were treated with the IN.PACT Admiral DCB demonstrated a higher primary patency rate compared to balloon angioplasty arm (76.7% vs. 42.3%, p<0.001). Similarly, women in the IN.PACT Admiral DCB arm had a lower clinically-driven target lesion revascularisation rate compared to the balloon angioplasty arm (13.2% vs. 38.2%, p=0.005). The beneficial treatment effect seen in female patients who were treated with the IN.PACT Admiral DCB was consistent with the male population, who had a primary patency rate of 80.2% in the IN.PACT Admiral DCB arm, compared to 53.7% in the balloon angioplasty arm (p<0.001), and a 6.9% CD-TLR rate vs. 23.6% (p=0.002), respectively.
Among patients with diabetes, those treated with an IN.PACT Admiral DCB had significantly higher rates of primary patency (73.3% vs.45.8%, p<0.001) and CD-TLR (10.7% vs. 29.4%, p=0.010) compared to balloon angioplasty. Similarly, in the non-diabetes subgroup, the IN.PACT Admiral DCB arm showed consistent and significant improvements in primary patency (82.5% vs. 54.5%, p<0.001) and CD-TLR (8.1% vs. 27.3%, p=0.002).
Twelve-month interim ILLUMENATE Global Study data show 84.7% primary patency rate
Thomas Zeller, Bad Krozingen, Germany, presented 12-month interim data from the ILLUMENATE Global Study. The ILLUMENATE Global Study is a prospective, multicentre, single-arm study designed to assess the clinical performance of the Stellarex drug-coated balloon (Spectranetics) in the superficial femoral and popliteal arteries.
According to Zeller, interim results from the first 153 of 371 patients enrolled demonstrate a primary patency rate at 12 months of 84.7%. These results are consistent with the results of the ILLUMENATE First-In-Human Study, validating the early results of the Stellarex DCB.
The ILLUMENATE Global Study is being conducted with angiographic and duplex ultrasound core lab assessments, as well as an independent clinical events committee (CEC) to adjudicate adverse events. Key interim results, fully core lab and CEC adjudicated from the first 153 patients (174 lesions) at 365 days include an 84.7% primary patency rate and a 91% freedom from clinically driven target lesion revascularisation rate (CD-TLR). Further, 84% of patients experienced an improvement in their walking distance score.
“The 12-month interim results of the ILLUMENATE Global Study demonstrate consistency with the promising results observed in the previously published ILLUMENATE First-In-Human Study,” said Zeller, global principal investigator of the ILLUMENATE Global Study. “Overall, these interim results compare well with the highest DCB patency rates reported in comparable studies with similar patient populations, but with a lower level of drug concentration,” he added.
New pre-clinical data presented by Renu Virmani, Gaithersburg, USA, demonstrated that IN.PACT Admiral DCB’s coating demonstrates sustained paclitaxel in tissue over time, facilitating an extended retention of drug in tissue available for a sustained antirestenotic effect (read more on page 20).
Peter Gaines, Sheffield, UK, made the case for why inducing swirling flow improves the outcomes from endovascular procedures. “Blood flow is naturally not laminar, but swirling. Veryan’s biomimetic stent, Biomimimcs 3D, is capable of inducing swirling flow.