Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: An intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy
Andrew W Bradbury, Donald J Adam, Jocelyn Bell, John F Forbes, F Gerry R Fowkes, Ian Gillespie, Charles Vaughan Ruckley, Gillian M Raab, BASIL trial Participants, P Bachoo, J Brittenden, G Cooper, S Cross, J Engeset, J Hussey, E Macauley, P Thorpe, G Stewart, K Osbourne, J Moss, P Nicholl, S Silverman, J Wingate, D Adam, B Balasubramanian, A Bradbury, P Crowe, J Ferrando, M Gannon, M Henderson, K Makhdoomi, D Mosquera, T Wilmink, T Buckenham, R Chalmers, R Dawson, S Fraser, I Gillespie, S Ingram, A Jenkins, J Murie, Z Raza, N Jones, D Lambert, T Lees, R Owen, J Rose, G Stansby, M Wyatt, D Byrne, R Edwards, A MacKay, J Moss, R Quin, P Rogers, D Gilmour, D Leiberman, D McCarter, A Reid, S Dodds, M Cleesby, A Jewkes, B Jones, C Nelson, A Parnell, P Bell, A Bolia, N Chalmers, I Mohan, V Smyth, M Walker, M Collins, A Garnham, G Mackie, P Stonebridge, J Houston, M Armon, J Clarke, J Cockburn, J Colin, S Girling, S Scott-Barrett, P Wilson, Y Wilson, J Beard, J Cleveland, P Chan, P Gaines, R Lonsdale, J Michaels, A Nassif, R Niar, J Rochester, S Thomas, R Wood, A Ashour, V Bhattacharya, A Nudawi, G Timmons, A Howd, M Fleet, H Ireland, K McBride, A Milne, A Turner, G Ferguson, M Onwudike, R Razzaq, J Tuck, D Baker, G Hamilton, F Hyint, A Platts, J Tibballs, A Watkinson, K Choji, R Grimley, A Jayatunga, R Patel, J Renny, S Shiralkar, A Wilinski, M Alner, M Duddy, A Edwards, M Simms, S Smith, R Vohra, G MacBain, R Johnstone, G Urquhart, G Welch, D Durrans, B Gwynn, C Willard, M Thompson, R Morgan, J Patel, J Scott, I Spark, K Allen, A Khan, J Holland, R Ashleigh, S Butterfield, R England, C McCollum, A Nasim, M Welch, Andrew W Bradbury, Donald J Adam, Jocelyn Bell, John F Forbes, F Gerry R Fowkes, Ian Gillespie, Charles Vaughan Ruckley, Gillian M Raab, BASIL trial Participants, P Bachoo, J Brittenden, G Cooper, S Cross, J Engeset, J Hussey, E Macauley, P Thorpe, G Stewart, K Osbourne, J Moss, P Nicholl, S Silverman, J Wingate, D Adam, B Balasubramanian, A Bradbury, P Crowe, J Ferrando, M Gannon, M Henderson, K Makhdoomi, D Mosquera, T Wilmink, T Buckenham, R Chalmers, R Dawson, S Fraser, I Gillespie, S Ingram, A Jenkins, J Murie, Z Raza, N Jones, D Lambert, T Lees, R Owen, J Rose, G Stansby, M Wyatt, D Byrne, R Edwards, A MacKay, J Moss, R Quin, P Rogers, D Gilmour, D Leiberman, D McCarter, A Reid, S Dodds, M Cleesby, A Jewkes, B Jones, C Nelson, A Parnell, P Bell, A Bolia, N Chalmers, I Mohan, V Smyth, M Walker, M Collins, A Garnham, G Mackie, P Stonebridge, J Houston, M Armon, J Clarke, J Cockburn, J Colin, S Girling, S Scott-Barrett, P Wilson, Y Wilson, J Beard, J Cleveland, P Chan, P Gaines, R Lonsdale, J Michaels, A Nassif, R Niar, J Rochester, S Thomas, R Wood, A Ashour, V Bhattacharya, A Nudawi, G Timmons, A Howd, M Fleet, H Ireland, K McBride, A Milne, A Turner, G Ferguson, M Onwudike, R Razzaq, J Tuck, D Baker, G Hamilton, F Hyint, A Platts, J Tibballs, A Watkinson, K Choji, R Grimley, A Jayatunga, R Patel, J Renny, S Shiralkar, A Wilinski, M Alner, M Duddy, A Edwards, M Simms, S Smith, R Vohra, G MacBain, R Johnstone, G Urquhart, G Welch, D Durrans, B Gwynn, C Willard, M Thompson, R Morgan, J Patel, J Scott, I Spark, K Allen, A Khan, J Holland, R Ashleigh, S Butterfield, R England, C McCollum, A Nasim, M Welch
Abstract
Background: A 2005 interim analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI; rest pain, ulceration, gangrene) due to infrainguinal disease, bypass surgery (BSX)-first and balloon angioplasty (BAP)-first revascularization strategies led to similar short-term clinical outcomes, although BSX was about one-third more expensive and morbidity was higher. We have monitored patients for a further 2.5 years and now report a final intention-to-treat (ITT) analysis of amputation-free survival (AFS) and overall survival (OS).
Methods: Of 452 enrolled patients in 27 United Kingdom hospitals, 228 were randomized to a BSX-first and 224 to a BAP-first revascularization strategy. All patients were monitored for 3 years and more than half for >5 years.
Results: At the end of follow-up, 250 patients were dead (56%), 168 (38%) were alive without amputation, and 30 (7%) were alive with amputation. Four were lost to follow-up. AFS and OS did not differ between randomized treatments during the follow-up. For those patients surviving 2 years from randomization, however, BSX-first revascularization was associated with a reduced hazard ratio (HR) for subsequent AFS of 0.85 (95% confidence interval [CI], 0.5-1.07; P = .108) and for subsequent OS of 0.61 (95% CI, 0.50-0.75; P = .009) in an adjusted, time-dependent Cox proportional hazards model. For those patients who survived for 2 years after randomization, initial randomization to a BSX-first revascularization strategy was associated with an increase in subsequent restricted mean overall survival of 7.3 months (95% CI, 1.2-13.4 months, P = .02) and an increase in restricted mean AFS of 5.9 months (95% CI, 0.2-12.0 months, P = .06) during the subsequent mean follow-up of 3.1 years (range, 1-5.7 years).
Conclusions: Overall, there was no significant difference in AFS or OS between the two strategies. However, for those patients who survived for at least 2 years after randomization, a BSX-first revascularization strategy was associated with a significant increase in subsequent OS and a trend towards improved AFS.
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Source: PubMed