After listening to the latest data for the Zilver PTX drug-eluting peripheral stent, 81% of delegates at yesterday’s stent data session voted against the motion that “plain old balloon and bare metal stents reign supreme in the superficial femoral artery”.

At the session, Frank Criado, Baltimore, USA, reviewed whether plain old balloons and bare metal stents were still the first-line treatment devices for the superficial femoral artery. He said that currently, vascular physicians were “addicted to stents” because they are predictable, easy to use, and widely available. According to Criado, there are disadvantages with this approach and these include monetary costs, the risk of in-stent restenosis, fractures and the possible need for re-intervention. However, with current positive data from the RESILIENT trial and the one-year data from the Zilver PTX trial, Criado predicted that the use of plain old balloons and bare metal stents—in the next five years—will be replaced by drug-eluting stents, drug-eluting balloons, mechanical and laser atherectomy, and endoluminal bypass.

In a following presentation, Marc Bosiers (Dendermonde, Belgium) discussed the use of the Zilver PTX in long lesions in the superficial femoral artery (>15cm). He said that stent integrity decreases as lesion length increases, but added that the Zilver PTX “provides better results in long lesions than bare metal stents”. Concluding his presentation, Bosiers announced the launch of the Zilverpass (The Cook Zilver PTX drug-eluting stent versus bypass surgery for the treatment of femoropopliteal TASC C and D lesions) study, which has a primary endpoint of patency at 12 months.

Michael Dake (Stanford, USA) then presented the three-year data from the Zilver PTX (Cook Medical) drug-eluting stent clinical trial. The Zilver PTX, according to Dake, is designed for the superficial femoral artery and is approved in Europe, Japan, and the USA. He reported that the Zilver PTX trial had a primary and secondary randomisation process. According to the results, event-free survival was 83.5% in the 185 patients who received the Zilver PTX stent compared with 72.7% in 189 patients who were treated with percutaneous transluminal angioplasty alone (p<0.01). The rate of freedom from target lesion revascularisation was 84% in the 185 patients and 70.2% in the 189 patients. Dake added that, at three years, the Zilver PTX demonstrated a low fracture rate of 2.1%.

Additionally, the primary patency of the Zilver PTX was 68.7% in 184 lesions vs. 22.8% in 207 lesions with percutaneous transluminal angiography. In a comparison between the Zilver PTX stent and a bare metal stent, the primary patency was 79.6% in 44 lesions and 56.3% in 53 lesions respectively. “Three-year results support sustained safety and effectiveness,” He concluded.

Yesterday, at the Abbott Vascular Satellite Symposium, Johannes Lammer (Vienna, Austria) presented the 30-day data for a drug-eluting bioresorbable scaffold (Espirit; Abbott Vascular) for the management of de novo lesions in the superficial femoral or iliac arteries—the data showed that the scaffold was associated with a 100% procedural success rate and a substantial improvement in functional status.

Lammer reported that the scaffold was made from poly L-lactide, was naturally resorbed and fully metabolised, and was a hybrid between a balloon-expandable and a self-expanding stent. He added that ESPRIT I study is a single-arm, multicentre and its aim is evaluate the use of the bioresorbable scaffold in patients with a single de novo lesion in the superficial femoral or iliac arteries and who had symptomatic claudication. The trial objectives, Lammer reported, were to evaluate the safety and performance of the scaffold and the endpoints included the procedural, clinical and functional outcomes at one, six, 12 months and at two and three years.

At 30 days, in 35 patients (recruited across seven centres), there were no deaths, no scaffold thrombosis, and no target lesion revascularisations. Also, there was a 100% acute procedural success rate. Furthermore, there was a substantial improvement in functional status—Lammer commented that the percentage of severe claudicants (Rutherford category 3) dropped from 57% at baseline to 0% at 30 days. Concluding his presentation, Lammer said: “So, you can see the initial results are remarkable.”

Delegates at the Satellite Symposium also listened to Frank Vermassen, Ghent, Belgium, speaking about femoral anatomy, characteristics and challenges, and Richard Rapoza, San Francisco, USA, on evolution in superficial femoral artery technology.

For the first time, as part of the new session “CX Meets Latin America”, Latin American physicians shared their experiences of treating abdominal aortic and thoraco-aortic aneurysm with CX delegates.

At the session entitled “Pushing the boundaries of EVAR and TEVAR”, CX delegates received information on case reports from Argentina, Brazil and Puerto Rico. Frank Criado, Baltimore, USA, chaired the session with Frans Moll, Utretcht, The Netherlands, and Tulio Navarro, Belo Horizonte, Brazil, as moderators. 

Mariano Ferreira, Buenos Aires, Argentina, presented a case of a 74-year-old man with a 7cm thoraco-abdominal aneurysm with distal dilatation of the aortic arch that was treated in a three-staged thoracic endovascular aortic repair (TEVAR) procedure. Ferreira said: “Due to elevated spinal cord ischaemic risk, a three-staged TEVAR procedure was planned with prophylactic left subclavian artery revascularisation.”

He explained that the patient underwent TEVAR under general anaesthetic with adjunctive spinal fluid drainage. “Through a direct right femoral access, three Gore Tag thoracic endoprostheses (40 x 140mm, 37 x 200mm and 34 x 200mm) were implanted in an overlapping proximal-to-distal fashion covering the entire length of the thoraco-aortic aneurysm (from the left common carotid artery origin to the celiac axis trunk).”

Ferreira commented that the patient did not present any complications after the procedure and was discharged home on the fourth postoperative day. He added: “Twelve days later, the patient underwent successful percutaneous proximal left subclavian plug embolization to guarantee complete sealing of the thoraco-abdominal aneurysm.” After one-year follow-up, Ferreira concluded, a CT scan revealed complete exclusion of the thoraco-abdominal aneurysm. 

A case of a “Hybrid treatment of ascending aorta and arch without opening the chest wall” was presented by Tulio Navarro, Belo Horizonte, Brazil. He said: “The treatment of the aortic arch is one of the greatest challenges to the surgeon. The conventional open repair requires sternotomy and cardiopulmonary bypass. In order to reduce complications, the use of endovascular techniques has been shown to be feasible.”

For this case, Navarro described an alternative approach to ascending aorta, arch and descending aorta with off-the-shelf devices without opening the chest wall. He said: “A 71-year-old male underwent a right-to-left carotid-carotid bypass graft. Using this access, a 16x16x95mm Medtronic limb extension was placed at the ascending aorta, and then a 44x44x200mm TEVAR Valiant-Captivia endograft was also placed at the ascending aorta distal to the limb extension, via right femoral artery.” According to Navarro, the patient tolerated the procedure well and was discharged after three days, asymptomatic and with no stroke. He told the audience that after 17 months of follow-up, the patient was still alive and remained asymptomatic, with no sequels, no strokes and that all grafts were patent.

Navarro also presented a second case, which was of a 58-year-old female with prior type A dissection and who was operated on five years ago. He explained that she presented with hoarseness and chest discomfort. According to Navarro, the CT scan showed an 8cm aortic arch aneurysm affecting all supraortic vessels and chronic dissection going down below visceral aorta. She was treated the same way as the previous case. After four months of follow-up, Navarro commented, there was still remaining hoarseness but no chest discomfort and CT scan did not show any leaks. This technique, Navarro concluded: “allows the treatment of aortic arch diseases without opening the chest wall with off-the-shelf devices with good results.”

However, this alternative approach should only be performed only in high-risk patients and needs to be evaluated with long-term results and larger series.

Also, at the session, several challenging cases from Brazil were presented—endovascular treatment of complex type IV aneurysm by Pierre Galvagni Silveira, Florianopolis, Brazil; a not suitable neck abdominal aortic aneurysm treated by physician fenestrated endograft by Gustavo Puludetto, Brasilia, Brazil; an endovascular treatment of aortic pseudoaneurysm by Alvaro Razuk, Sao Paulo, Brazil; and a case of ascending aorta treated by a heart and vascular team (Eduardo Saadi, Porto Alegre , Brazil).

Criado closed the session saying: “This is a good beginning of CX Meets Latin America; we hope that this will become a feature of CX making it better and bigger with more room for participants and more speakers from other Latin American countries.”