Randomized clinical trials

Scheerders ERY, van der Velden SK, Goossens LMA, Hamann SAS, de Maeseneer MGR, Malskat WSJ et al, for the members of the SAPTAP group.

Br J Surg 2023: 110: 333–342.

Some 464 patients had ambulatory phlebectomies first; 227 were randomized to subsequent saphenous trunk ablation. Only 57 (25 per cent) of patients who had phlebectomies alone required later truncal ablation on symptomatic grounds. Overall disease-specific quality of life was similar in both groups at one year.

Comment: This revolutionary study reverses the standard treatment of truncal ablation first. Longer term outcomes are needed to test the hypothesis fully.

Farber A, Menard MT, Conte MS, Kaufman JA, Powell RJ, Choudhry NK et al, for the BEST-CLI Investigators.

N Engl J Med 2022; 387: 2305-2316.

This international trial enrolled 1830 patients, and the endpoint was a composite of amputation, major reintervention or death. In the group with adequate saphenous vein, after a median of 2.7 years of follow-up, the endpoint was reached by 42.6 per cent of the surgery group compared to 57.4 per cent of the endovascular first group P<0.001). Outcomes were equivalent in those without an adequate vein.

Comment: Great study that confirms what many vascular surgeons have thought for a long time: endovascular treatment is great, but if you are fit enough and have vein for a bypass it will probably last you longer.

Dewulf M, Muysoms F, Vierendeels T, Huyghe M, Miserez M, Ruppert M et al.

Ann Surg 2022; 276: e217-e222.

After five years, 67 patients were available for analysis by clinical examination. The rate of incisional hernias was 49.2% in the no mesh group versus none in the mesh group. Some 5/23 in the no mesh group required reoperation.

Comment: Prophylactic mesh remains controversial, but the evidence of benefit is increasing, and incisional hernia can be very debilitating in this patient group who tend to be elderly.

Stubenrouch FE, Peters LJ, de Mik SML, Klemm PL, Peppelenbosch AG, Schreurs SC et al, on behalf of the OVIDIUS study group.

Eur J Vasc Endovasc Surg 2022; 64: 73-81.

The study included 342 patients with various vascular conditions. Those seen by clinicians trained in how to apply shared decision making (SDM) had improved OPTION-5 scores (an objective tool to assess the level of SDM): 28.7 to 37.8 per cent, P=0.025.

Comment: More support for shared decision making.

Eid MA, Barry MJ, Tang GL, Henke PK, Johanning JM, Tzeng E et al, for the Preferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) Study Team.

JAMA Surg 2022; 157: e222935.

The study included 235 patients with a large AAA suitable for both open and endovascular repair. Patients seen in clinics where a decision aid was used were more likely to receive their preferred type of repair: 95 versus 86 per cent, P=0.03.

Comment: More support for the use of a decision aid.

McDermott M, Bazzano L, Peterson CA, Sufit R, Ferrucci L, Domanchuk K et al.

JAMA 2022; 328: 1315-1325.

After six months, Telmisartan, an angiotensin receptor blocker, did not improve six-minute walking distance compared with placebo in this study that included 114 patients (P=0.08).

Comment: Still no good medicines for claudication.

Lindholt JS, Sogaard R, Rasmussen LM, Mejldal A, Lambrechtsen J, Steffensen FH et al.

N Engl J Med 2022; 387: 1385-1394.

Some 46,611 men were randomized. After five years, intention to treat analyses showed no difference in overall mortality rate compared to controls: hazard ratio 0.95, 95 per cent confidence interval 0.9 to 1.0, P=0.06. There was no significant reduction in the rates of stroke, myocardial infarction or aortic aneurysm rupture.

Comment; This is a very disappointing result after the same authors’ previous study showed a significant mortality reduction. It’s back to the drawing board for cardiovascular screening.

Goeteyn J, Pesser N, Houterman S, van Sambeek MR, van Nuenen BFL, Teijink JAW.

Eur J Vasc Endovasc Surg 2022; 64: 119-127.

This study included 50 patients. After three months mean Disability of the Arm, Shoulder and Hand (DASH) score was significantly better in the surgery group: 45.1 versus 64.9, P<0.001. All patients in the conservative group applied for surgery after three months.

Comment: Although small, this is the first study to justify TOS surgery in this group.

Pham T-T, Gariani K, Richard J-C, Kressmann B, Jornayvaz FR, Philippe J et al.

Ann Surg 2022; 276: 233-238.

In this pilot trial, clinical remission at two months occurred after 27/35 patients who had 10 days of antibiotics versus 22/31 who had them for 20 days, P=0.32.

Comment: Is the full trial justified?

Haile ST, Joelsson-Alm E, Johansson B, Loof H, Palmer-Kazen U, Gillgren P et al.

Br J Surg 2022; 109: 846-856.

Nurse led follow-up did not increase compliance with best medical therapy after one year in this study that included 214 patients: 79 versus 82 per cent.

Comment: Disappointing, but useful for planning ongoing care. The focus must be on comprehensive patient information at the point of treatment.

Mohamed AH, Thadani S, Mohamed SH, Sidapra M, Smith G, Chetter I, et al.

Br J Surg 2022; 109: 679-685.

There were 18 studies including 2584 legs. Use of compression for 1 to 2 weeks after intervention was associated with improved comfort and quality of life. Use of compression after 1-2 weeks was not beneficial.

Comment: This is helpful, but not novel. Focus should turn to which is the best form of compression.

Koelemay M, van Reijen NS, van Dieren S, Frans FA, Vermeulen EJG, Buscher HCJL, et al for the SUPER Study Collaborators.

Eur J Vasc Endovasc Surg 2022; 63: 421-429.

The trial was terminated after 240 patients were included and analysed. Compliance with supervised exercise was 50 per cent at six months. After one year, mean maximum walking distance improved similarly in both groups (P=0.69).

Comment: The authors conclude that supervised exercise should be the initial treatment, followed by revascularisation if that is not successful.

Ashrafi M, Ahmad SA, Antoniou SA, Khan T, Antoniou GA.

Eur J Vasc Endovasc Surg 2022; 63: 323-334.

Seven RCTs were examined. Active clot removal strategies resulted in higher patency than anticoagulation alone for proximal (iliofemoral) DVTs. Complication rates were similar. Active treatments have not been shown to reduce post thrombotic syndrome.

Comment: Lots more work to be done here before active clot removal can be recommended routinely.

Belramman A, Bootun R, Tang TY, Lane TRA, Davies AH.

JAMA Surg 2022; 157: 395-404.

Pain scores were similar after both of these non tumescent venous ablation methods in this study that included 167 procedures. Both methods improved disease-specific quality of life.

Comment: Late clinical outcomes will be important.

Hu H, Wang J, Wu Z, Liu Y, Ma Y, Zhao J et al.

Eur J Vasc Endovasc Surg 2022; 63: 103-111.

There were seven RCTs including 1146 procedures. Wearing a compression stocking reduced early postoperative pain (P<0.001), but had no effect on complications, quality of life, vein occlusion rates, or time to return to work.

Comment: Post intervention compression is not necessary.

Katsanos K, Spiliopoulos S, Teichgraber U, Kitrou P, Del Giudice C, Bjorkman P et al.

Eur J Vasc Endovasc Surg 2022; 63: 60-71.

This analysis included 21 RCTs with 3760 treated legs. Amputation was increased in the paclitaxel group: 4 versus 2.7%, hazard ratio 1.66, 95 per cent confidence interval 1.14 to 2.42, P=0.008.

Comment: a previous review suggested an increased death rate; this study suggests amputations are increased too with paclitaxel balloons.

Bearne M, Volkmer B, Sekhon M, Fisher G, Galea Homes MN, Douiri A, et al for the MOSAIC Trial Collaboration.

JAMA 2022; 327: 1344-1355.

The study included 190 participants randomly allocated to a walking exercise behaviour change intervention by physiotherapists. After three months, those who had received the intervention had an improved 6-minute walking test by around 30m (P=0.009).

Comment: The questions remain whether this improvement is meaningful and durable.

Souroullas P, Barnes R, Carradice D, Smith G, Huang C, Chetter I.

Br J Surg 2022; 109: 426-432.

In this study that included 152 procedures, the five day course reduced the rate of surgical site infection (11.8 versus 39.5 per cent, P<0.001) and revisional surgery (6.6 versus 21 per cent, P=0.01).

Comment: Is this now the standard of care?

Goldenberg NA, Kittelson JM, Abshire TC, Bonaca M, Casella JF, Dale RA et al, for the Kids-DOTT Trial investigators and the ATLAS Group.
JAMA 2022; 327: 129-137.

Some 417 patients under 21 years of age were included. Rates of recurrent venous thromboembolism were similarly low after both treatments: 0.66 per cent after six weeks of versus 0.7 per cent after three months of anticoagulation.

Comment: Very low recurrence rates, but six weeks of anticoagulation seems reasonable.