PVI Trials book 2023

OVER long-term: Long-term outcomes of the OVER trial – EVAR vs OR

Objectives: To analyse long-term outcomes after EVAR and open repair of infrarenal AAA.
Study: US, multicentre, randomised.
Population: Patients with infrarenal abdominal aortic aneurysms suitable for open or endovascular repair.
Endpoints: Long-term mortality.

Conclusion: Procedural death and stroke trended higher with TF-CAS but serious complications are uncommon after TF-CAS and CEA, and the long-term effects of the procedures on fatal or disabling stroke are comparable.

Lederle FA, et al. N Engl J Med. 2019;380:2126-35. doi: 10.1056/NEJMoa1715955

Surgery or endovascular therapy for chronic limb-threatening ischaemia

Objectives: To evaluate if an initial strategy of endovascular therapy or surgicalvrevascularisation for CLTI is superior for improving limb outcomes.
Study: International, randomised trial (1:1).
Population: 1,830 patients with CLTI and infrainguinal peripheral artery disease were enrolled in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2.
Endpoints: The primary outcome was a composite of a major adverse limb event — which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) — or death from any cause.

Conclusion: Among patients with CLTI who had an adequate great saphenousvein for surgical revascularisation (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar.

Farber A, et al. N Engl J Med. 2022;387:2305-16. doi: 10.1056/NEJMoa2207899

CaVenT - Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis

Objectives: Evaluate presence of PTS 5 years after CDT + standard versus standard treatment for DVT.
Study: Open-label, multicentre, randomised controlled trial.
Population: Patients with DVT located higher than the proximal half of the femoral vein or iliac vein or both and symptom onset less than 21 days.
Endpoints: Post-thrombotic syndrome development, patency and reflux, and quality of life 5 years after the index DVT.

 
Conclusion: The results after 5 years of follow-up showed a continued and increased reduction in development of post-thrombotic syndrome in catheter-directed thrombolysis group compared with those assigned to standard treatment group.

ACST-2 trial - Second asymptomatic carotid surgery trial: a randomised comparison of carotid artery stenting versus carotid endarterectomy

Objectives: Compare short and long-term protective effects of CEA and TF-CAS against stroke in asymptomatic carotid stenosis.
Study: Randomised controlled trial.
Population: Severe asymptomatic carotid stenosis (97% of patients had ≥70% stenosis, 62% had ≥80% stenosis).
Endpoints: Procedural death, any stroke, disabling stroke.

Conclusion: Procedural death and stroke trended higher with TF-CAS but serious complications are uncommon after TF-CAS and CEA, and the long-term effects of the procedures on fatal or disabling stroke are comparable.

^{Halliday A, et al. Lancet. 2021;398:1065-73. doi: 10.1016/S0140-6736(21)01910-3}

ATTRACT trial - Pharmacomechanical catheter-directed thrombolysis for DVT

Objectives: Examine if PMT can resolve thrombus rapidly and reduces the risk of PTS.
Study: Phase 3, multicentre randomised, open-label, assessor-blinded, controlled clinical trial.
Population: Symptomatic proximal DVT involving the femoral, common femoral, or iliac vein (with or without other involved ipsilateral veins) were enrolled at 56 clinical centres in the United States of America.
Endpoints: Development of PTS (Villalta score ≥5 or an ulcer), at any time between 6-month FU visit and 24-month FU visit; severity of PTS; bleeding rate.

Severity of PTS was lower in PMT than in control (p<0.01)
QOL improvement between baseline and 24 months did not significantly differ between groups

Conclusion: Among patients with acute proximal DVT, the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of PTS but did result in a higher risk of major bleeding.

^{Vedantham S, et al. N Engl J Med. 2017;377:2240-52. doi: 10.1056/NEJMoa1615066}