Research presented at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online)—including new VOYAGER PAD data, five-year STABLE II results, and the first ever analysis of transcarotid artery revascularisation (TCAR) in standard surgical risk patients—caught readers’ attention in August.
1. FDA approves expanded PAD indication for Xarelto plus aspirin to include patients after LER due to symptomatic PAD
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the US Food and Drug Administration (FDA) has approved an expanded peripheral arterial disease (PAD) indication for the Xarelto (rivaroxaban) vascular dose (2.5mg twice daily plus aspirin 100mg once daily) to include patients following recent lower-extremity revascularisation (LER) due to symptomatic PAD.
2. Terumo Aortic announces US FDA approval for RelayPro endovascular device
Terumo Aortic has announced that the US Food and Drug Administration (FDA) has granted approval of its RelayPro thoracic stent-graft system for sale in the USA for the treatment of patients with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAUs).
3. Five-year STABLE II results show Zenith system makes the cut for acute complicated TBAD treatment
Joseph V Lombardi (Cooper University Hospital, Camden, USA) reported long-term outcomes favouring the continued safety and effectiveness of a composite device (proximal covered stent graft plus distal bare stent) deployed for the endovascular repair of acute, type B aortic dissection (TBAD) complicated by aortic rupture and/or malperfusion.
4. Boston Scientific initiates randomised controlled trial for the EkoSonic endovascular system
Boston Scientific has commenced enrolment in the HI-PEITHO clinical trial, a collaborative research study with the Pulmonary Embolism Response Team (PERT) Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz (Mainz, Germany) comparing use of the EkoSonic endovascular system (EKOS) in combination with anticoagulation to anticoagulation alone for the treatment of acute, intermediate-high-risk pulmonary embolism (PE).
5. First patient enrolled in Shape Memory Medical’s AAA-SHAPE Netherlands study
Shape Memory Medical has announced the initiation of AAA-SHAPE Netherlands, the company’s prospective, multicentre early feasibility study of the Impede-FX RapidFill device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR). The Dutch study’s first procedure was performed by Michel Reijnen, vascular surgeon at Rijnstate Hospital in Arnhem, The Netherlands.
6. VOYAGER PAD: Rivaroxaban plus aspirin should be considered after lower extremity bypass regardless of conduit type
“A strategy of adding rivaroxaban 2.5mg twice daily to aspirin should be considered after lower extremity bypass regardless of conduit type,” concluded Nicholas Govsyeyev (University of Colorado, Aurora, USA) during the William J von Liebig Forum at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online). Govsyeyev was giving an update on the VOYAGER PAD trial, addressing the efficacy of rivaroxaban and aspirin in peripheral arterial disease (PAD) patients with venous and prosthetic surgical bypass conduits.
7. DCBs favoured over PTA for treatment of dysfunctional haemodialysis venous access
A patient-level meta-analysis of randomised controlled trials (RCTs) has shown that drug-coated balloons (DCBs) were “consistently favoured” over percutaneous transluminal angioplasty (PTA) to prolong target lesion primary patency and access circuit primary patency in the treatment of dysfunctional haemodialysis venous access. The research, authored by Khi Yung Fong, Joseph J Zhao (both National University of Singapore, Singapore), Chow Wei Too (SingHealth-Duke-NUS Academic Medical Centre, Singapore), and colleagues, was recently published online in the European Journal of Vascular and Endovascular Surgery (EJVES).
8. AHA scientific statement provides update on epidemiology, diagnosis, and management of PAD
The American Heart Association (AHA) has released a new scientific statement on lower extremity peripheral arterial disease (PAD), focusing on contemporary epidemiology, management gaps, and future directions.
9. First ever analysis of TCAR in standard surgical risk patients demonstrates clinical benefits in large comparative dataset
Silk Road Medical has announced positive results from an independent analysis of standard surgical risk patients undergoing carotid endarterectomy (CEA) and transcarotid artery revascularisation (TCAR) for atherosclerotic carotid disease. The analysis was presented at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online) and, according to Silk Road Medical, is the first ever presentation of outcomes for TCAR in standard surgical risk patients.
10. Favourable cost-effectiveness results for endovascular SFA treatment in claudicants
From a cost-effectiveness standpoint, primary stenting of the superficial femoral artery (SFA) for the treatment of intermittent claudication can, in many countries, be used as an adjunct to exercise training advice. This is the main conclusion of Henrik Djerf (Sahlgrenska University Hospital, Gothenburg, Sweden) and colleagues, reporting two-year results of a randomised, multicentre trial online in the European Journal of Vascular and Endovascular Surgery (EJVES).