BASIL Trials. Professor Andrew Bradbury. Chief Investigator University of Birmingham, UK
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1 BASIL Trials Professor Andrew Bradbury Chief Investigator University of Birmingham, UK
2 BASIL-1 Trial 2005 Still the only RCT! NIHR HTA funding 1998 Between 1999 and SLI patients randomised : Bypass first (25% prosthetic) PBA first (6 stents) 75% femoro-popliteal After 2 years (vein) bypass better than PBA in terms of: Amputation free survival Overall survival Quality of revascularisation 2010
3 BASIL 1: Results diverge at two years Adam DJ et al. Lancet 2005; 366:
4 BASIL- 1: usual interpretation Patient with SLI due to (femoro-popliteal FP) disease Anticipated life expectancy? < 2 years? > 2 years? Vein? Angioplasty No Yes Bypass
5 BASIL-1: Femoro-popliteal disease (75%)
6 BASIL-1: Major Adverse Limb Events Femoro-popliteal bypass versus plain balloon angioplasty (PBA) +/- bare metal stent (BMS) (n = 311) FP Bypass 25% 30-day failure rate (c. 5% bypass) FP PBA +/- BMS HR 1.51, P = 0.04 Freedom from any re-intervention p = 0.04
7 Are BASIL-1 endovascular outcomes still relevant? (BASIL interventions )
8 Amputation free survival after FP PBA in BASIL-1 and in out contemporary endo series BASIL-1 ( ) % Current outcomes highly significantly worse than BASIL-1 (p = ) HEFT ( ) Years of follow-up
9 Overall survival after FP PBA in BASIL-1 and in a contemporary series at HEFT BASIL-1 ( ) % Current outcomes highly significantly worse than BASIL-1 (p = ) HEFT ( ) Years of follow-up
10
11 BASIL 2 infra popliteal (IP) CLTI Vein Bypass first (n = 300) Best Endovascular Treatment first (n = 300) BASIL 3 femoro popliteal (FP) CLTI PBA +/ BMS (n = 282) DCB +/ BMS (n = 282) DES (n = 282) Follow up months Amputation free survival Overall Survival Clinical end points Quality of revascularisation Quality of life Functional status Health economic
12 Why BASIL-2? There is no level 1 evidence to support endovascular intervention as the preferred treatment for CLTI due to IP disease in patients who can have a vein bypass Indeed, what data we have suggests that endovascular is unlikely to be better and should usually be reserved for those who cannot have distal vein bypass
13
14 What about infra-popliteal (IP) intervention? BASIL-1: IP sub-group analysis (EJVES 2017)
15 BASIL-1 IP vein bypass versus PBA P = 0.06 VB Overall survival N = 104 PBA -40% P = 0.1 VB Amputation free survival PBA
16 BASIL-1 IP: relief of rest pain HR=2.19, 95% CI: , p=0.005 Vein bypass PBA 28%
17 BASIL-1 IP: time to wound healing HR=1.69, 95% CI: , p=0.1 Vein bypass % PBA
18 BASIL-1 IP: Statistical Interpretation While the BASIL-1 IP sub-group results do not all meet standard criteria for statistical significance, the direction of the effect consistently favours bypass and the confidence intervals rule out the possibility of clinically important effects in favour of plain balloon angioplasty
19 Endovascular first is not a free shot Editor s Choice EJVES May 2018
20 Outcomes after primary bypass and secondary bypass after failed PBA in BASIL-1 Amputation free survival Overall survival Secondary bypass P = 0.04 P = 0.06 Primary bypass Primary bypass D20% D17% Secondary bypass AFS and OS worse after secondary bypass for failed PBA
21 Jones DG et al. J Am Heart Assoc 2013
22 B-2 Delphi Consensus Study 67 UK vascular surgeons and interventional radiologists Shown 15 DSA s from patients randomised in BASIL-2 Assumptions: fit for surgery, good vein, tissue loss Asked to choose between 4 options Best endovascular Vein bypass Primary amputation No equipoise Equipoise would randomise 8 14 DSA same trial patient (same images shown < 15 minutes apart) Only 63% respondents chose same option!!! (Pearson s = 0.38 = weak) CLTI IP revascularisation decisions appear arbitrary
23 B 2 Monthly Recruitment (at 25/09/18) Target end of September 2018 = Sep 18 Jul 14 Sep 14 Nov 14 Jan 15 Mar 15 May 15 Jul 15 Sep 15 Nov 15 Jan 16 Mar 16 May 16 Jul 16 Sep 16 Nov 16 Jan 17 Mar 17 May 17 Jul 17 Sep 17 Nov 17 Jan 18 Mar 18 May 18 Jul 18 Cumulative no. of patients Recruitment Cumulative 290 Month
24 BASIL 2: Recruitment against projection 293 No. of patients Aug 14 Oct 14 Dec 14 Feb 15 Apr 15 Jun 15 Aug 15 Oct 15 Dec 15 Feb 16 Apr 16 Jun 16 Aug 16 Oct 16 Dec 16 Feb 17 Apr 17 Jun 17 Aug 17 Oct 17 Dec 17 Feb 18 Apr 18 Jun 18 Aug 18 Oct 18 Month Actual Recruitment 6 pcm 310
25 Sites BASIL 2: Recruitment by centre York Health Services Trust Worcestershire Royal Southampton General Queen Alexandra Northwick Park Barts & The London Outreach Clinics Royal Cornwall (Treliske) John Radcliffe (Oxford) Royal Sussex County Doncaster Royal Infirmary Royal Oldham Ninewells (Dundee) Cumberland Infirmary Colchester General Addenbrooke's City Birmingham Queen Elizabeth Birmingham Northern General University Hospital Coventry (Walsgrave) Royal Bournemouth Pilgrim Frimley Park St George's Freeman St Mary's (Imperial) QEUH (Western Infirmary) Southmead Kent & Canterbury Leicester Royal Infirmary Kolding Royal Free Royal Gwent Russells Hall Manchester Royal Infirmary Leeds General Infirmary Heartlands Sodersjukhuset Guys & St Thomas' Hull Royal Infirmary No. of patients
26 B2 AMPUTATION FREE SURVIVAL High event rate only 48% AFS at 3 years Higher than expected? No longer need 600 patients? Sample Size Current 1 year years years
27 B-2 Future: HTA accepts Option 4 No. of patients HTA agreed Option 4 end February 2018 : 1) Long run average recruitment continues at 6/month 2) Higher than expected event rate continues 3) Maintain 90% power at 5% 4) Maintain original effect size (HR = 0.66) on AFS 5) Maintain minimum 2 year follow-up 6) Requires 247 events (deaths, major amputations) 7) Revised sample size around 400? 8) Around 120 patients to go? 9) About another 24 months of recruitment? New target 400+? Just over 70% of the way there! 0 Aug 14 Oct 14 Dec 14 Feb 15 Apr 15 Jun 15 Aug 15 Oct 15 Dec 15 Feb 16 Apr 16 Jun 16 Aug 16 Oct 16 Dec 16 Feb 17 Apr 17 Jun 17 Aug 17 Oct 17 Dec 17 Feb 18 Apr 18 Month Actual Recruitment 6 pcm
28 BASIL 2: quo vadis? Recruitment difficult: lack of equipoise (despite Delphi!!!) Target = 6 / month = another 18 months (Q2 2020) Minimum 2 year follow up (Q2 2022) Report results Q3/ IPD Meta analysis with BEST CLI in the US
29 BASIL 3 Trial Update
30 The academic case for Why do we need BASIL 3 when it is obvious that DCB and DEB are the new standard of care for the endovascular treatment of CLTI due to femoro popliteal disease
31 Drug coated balloon (DCB) Trial Device End Points Patients PACIFIER (2016) LEVANT 2 (2015) BIOLUX P 1 (2015) IN.PACT pacific (Medtronic) Lutonix (Bard) Passeo 18 LUX (Biotronik) Radiological DCB Clinical No difference Radiological DCB Clinical No difference Radiological DCB Clinical No difference N= 91 (1:1) IC = 87 N=476 (2:1) IC = 438 N = 52 (1:1) IC = 50 IN.PACT SFA (2015) IN.PACT admiral (Medtronic) Radiological DCB Clinical No difference N=331 (2:1) IC = 313 THUNDER (2014) Standard Balloon coated with Paclitaxel Radiological DCB Clinical No difference N = 102 (1:1) IC = 82 LEVANT 1 (2014) Lutonix (Bard) Radiological DCB Clinical No difference N = 92 (1:1) IC = 84 DEBELLUM (2012) IN.PACT admiral (Medtronic) Radiological DCB Clinical No difference N = 50 (1:1) IC = 45 FemPac (2008) Coated PTA Balloon (Bavaria MT GmbH) Radiological DCB Clinical No difference N = 87 (1:1) IC = 82
32 Drug eluting stent (DES) Trial Device End Points Patients ZILVER PTX (2011) ZILVER PTX (COOK) 1 Patency (12m) 83.1% vs 32.8% FF TLR 90.5% vs 82.5% Amputation 0% vs 0% Overall survival 100% vs 100% Improvement in walking distance? DES=241 PBA=238 R2/3 91% (IC) R4 6 9% Some other stent trials comparing DES vs BMS in femoro popliteal segment: Duda et al Duda et al SIROCCO trial Majority of DES trials in the infra popliteal segment: Rastan et al Scheinert et al Tepe et al 2010 BELOW study Falkowski et al Siablis et al IDEAS trial
33 Why BASIL 3? Most published DCB/DES studies are industry sponsored Almost all (90%+) patients are claudicants Almost all CLTI (90%+) have rest pain only (no tissue loss) Highly selected (centres, patients, lesions) Exclusions and short (incomplete) follow-up Anatomic >> clinical end-points No credible evidence of clinical effectiveness in real world (Some evidence of possible harm?) No credible evidence of cost-effectiveness (WTPT) UK NICE unconvinced (2012, 2017) await BASIL-3
34 B 3 monthly recruitment ( ) As of 25 September /861 randomised (c. 45% of original target) Number of Patients Jan 16 Feb 16 Mar 16 Apr 16 May 16 Jun 16 Jul 16 Aug 16 Sep 16 Oct 16 Nov 16 Dec 16 Jan 17 Feb 17 Mar 17 Apr 17 May 17 Jun 17 Jul 17 Aug 17 Sep 17 Oct 17 Nov 17 Dec 17 Jan 18 Feb 18 Mar 18 Apr 18 May 18 Jun 18 Jul 18 Aug 18 Sep 18 Month
35 BASIL-3 Recruitment to 11 July 2018 Berkshire Royal Bournemouth Dumfries and Galloway Colchester General Edinburgh Newcastle UHNM North Cumbria St. George's NHS Forth Valley Imperial Basildon North Durham Royal Cornwall (Truro) Nottingham Royal Oldham Cardiff United Lincolnshire Frimley Park East Kent Leeds Manchester Royal Brighton South Manchester Southmead (Bristol) Royal Gwent Hull Black Country Dorset County Sheffield Leicester Guy's and St. Thomas' Heartlands 33 UK centres now open + another 5 UK? + Europe?
36 BASIL 3: Recruitment against projection Number of Patients Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Nov-17 Dec-17 Jan-18 Feb-18 Mar-18 Apr-18 May-18 Jun-18 Jul-18 Aug-18 Sep-18 Oct-18 Nov-18 Dec-18 Jan-19 Month Projected Recruitment Target Recruitment Target Pilot Recruitment Actual recruitment
37 B3 amputation free survival Whole cohort (n = 357) at 31 May 2018 High event rate only 72% AFS at 12 months Higher than expected? May not need 861 patients?
38 BASIL Recruitment Projections (August 2018) Jan 2019 July 2019 June 2020 July Original projection Actual recruitment 10pcm 20pcm Original monthly target (36pcm) Do we still need 861 patients? 100 Jan- Apr- Jul-16 Oct-16 Jan- Apr- Jul-17 Oct-17 Jan- Apr- Jul-18 Oct-18 Jan- Apr- Jul-19 Oct-19 Jan- Apr- Jul-20 Oct-20 Jan- Apr- Jul-21 Oct-21 Jan- Apr- Jul-22 0
39 BASIL 3: quo vadis? Currently % of 861 Recruitment Follow up Event rate Overpowered? 600? Projection Actual 15pcm 20pcm 25pcm 30pcm 36pcm Jan 19 Sep 19 Nov 19 Feb 20 Jul 20 Mar 21 3 month average 6 month average 12 month average /month = Q year FU = Q Report Q But if 600, not 861 Q4 2021? Jan 16 Mar 16 May 16 Jul 16 Sep 16 Nov 16 Jan 17 Mar 17 May 17 Jul 17 Sep 17 Nov 17 Jan 18 Mar 18 May 18 Jul 18 Sep 18 Nov 18 Jan 19 Mar 19 May 19 Jul 19 Sep 19 Nov 19 Jan 20 Mar 20 May 20 Jul 20 Sep 20 Nov 20 Jan 21 Mar 21 50
40 Thank you Questions?
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