Late Breaking Clinical Trials: The Consistent CTO study
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1 Late Breaking Clinical Trials: The Consistent CTO study CONventional antegrade vs Sub-Intimal Synergy stenting in Chronic Total Occlusions Dr Simon Walsh on behalf of the Consistent CTO Investigators
2 Introduction
3 The Evidence Gap in CTO PCI Contemporary CTO PCI success rates of ~90% (with no anatomical exclusions to treatment) Complex lesions require dissection-based approaches Rigorous medium & long-term follow-up currently lacking
4 Aims: observational study to describe outcomes for a modern cohort of CTO patients revascularised using up-to-date technologies and techniques
5 Aims: observational study to describe outcomes for a modern cohort of CTO patients revascularised using up-to-date technologies and techniques
6 Aims: observational study to describe outcomes for a modern cohort of CTO patients revascularised using up-todate technologies and techniques
7 Antegrade Dissection Re-entry ADR Retrograde Dissection Re-entry RDR Antegrade Wire Escalation AWE Retrograde Wire Escalation RWE
8 Investigators, Enrolment & Organisation
9 Investigators Dr Simon Walsh Belfast Trust Chief Investigator Dr Colm Hanratty Belfast Trust Principal Investigator Dr James Spratt Royal Infirmary Edinburgh Principal Investigator Dr Margaret McEntegart Golden Jubilee Glasgow Principal Investigator Dr Julian Strange, Bristol Royal Infirmary Principal Investigator Dr Elliot Smith, St Bartholamew s London Principal Investigator Dr Jonathan Hill, Kings College London Principal Investigator Funding: Unrestricted Grant Boston Scientific NCT CRO Data oversight, CEC, DSMB, Angiographic/OCT Core Laboratory Project Lead: Jessica Heringer
10 Investigators, Enrolment & Organisation
11 Power Calculations
12 The primary endpoint for stent efficacy: 12-month target vessel failure (TVF) rate Cardiac Death MI (Q-wave and non Q-wave) related to the target vessel Any ischemia-driven revascularization of the target vessel Expected TVF rate at 1 year = 13% Performance goal (PG) estimate = 19.5% Test significance level (α) = 0.05 (1- sided) Power (1 β) = 80% Plan 215 subjects with 3% expected attrition Aim 207 evaluable subjects, PG met if TVF<15% Synergy stent for all study lesions
13 1) Patient has CTO and clinical indication for PCI (no anatomical exclusion) 3) Baseline assessment for symptoms and QoL 5) IVUS before stent implant to confirm dissection or not 7) Telephone follow-up 2, 3 & 5 years ) Informed consent provided 4) CTO PCI: Strategy as appropriate to lesion anatomy (hybrid approach) 6) 12-month hospital visit: Angiogram/OCT and repeat qualitative assessments
14 Study Flow
15 231 Patients 231 patients provided consent for study enrolment
16 231 patients provided consent for study enrolment 210 CTOs opened with Synergy stents implanted & enrolled in the study 90% CTOs Opened 90% CTOs OPENED 206 / 207 patients Clinical follow-up (99.5%) 188 / 207 patients Angiographic follow up (90.8%) 175 / 207 patients OCT obtained (84.5%)
17 231 patients provided consent for study enrolment 210 CTOs opened with Synergy stents implanted & enrolled in the study 90% CTOs Opened 210 Patients Enrolled 206 / 207 patients Clinical follow-up (99.5%) 188 / 207 patients Angiographic follow up (90.8%) 175 / 207 patients OCT obtained (84.5%)
18 231 patients provided consent for study enrolment 210 CTOs opened with Synergy stents implanted & enrolled in the study 90% CTOs Opened 190/210 IVUS 190 / 210 Pre-PCI IVUS (90.5%) 188 / 207 patients Angiographic follow up (90.8%) 175 / 207 patients OCT obtained (84.5%)
19 231 patients provided consent for study enrolment 210 CTOs opened with Synergy stents implanted & enrolled in the study 90% CTOs Opened 190/210 IVUS 190 / 210 Pre-PCI IVUS (90.5%) Three withdrew consent 188 / 207 patients Angiographic follow up (90.8%) 175 / 207 patients OCT obtained (84.5%)
20 231 patients provided consent for study enrolment 210 CTOs opened with Synergy stents implanted & enrolled in the study 90% CTOs Opened 206/207 Clinical Follow Up 190 / 210 Pre-PCI IVUS (90.5%) Three withdrew consent 206 / 207 patients Clinical follow-up (99.5%) 188 / 207 patients Angiographic follow up (90.8%) 175 / 207 patients OCT obtained (84.5%)
21 231 patients provided consent for study enrolment 210 CTOs opened with Synergy stents implanted & enrolled in the study 90% CTOs Opened 188/207 Angiography 190 / 210 Pre-PCI IVUS (90.5%) Three withdrew consent 206 / 207 patients Clinical follow-up (99.5%) 188 / 207 patients Angiography (90.8%) 175 / 207 patients OCT obtained (84.5%)
22 231 patients provided consent for study enrolment 210 CTOs opened with Synergy stents implanted & enrolled in the study 90% CTOs Opened 175/207 OCT obtained 190 / 210 Pre-PCI IVUS (90.5%) Three withdrew consent 206 / 207 patients Clinical follow-up (99.5%) 188 / 207 patients Angiography (90.8%) 175 / 207 patients OCT obtained (84.5%)
23
24 Lesion & Procedure Details Target Vessel
25 Target Vessel LMS 2 (1%) RCA 130 (62%) LCx 31 (15%) LAD 47 (22%)
26 Lesion & Procedure Details Lesion Length (Core Lab) JCTO score Stents Dual Catheter Access Procedure Time (min) Fluoroscopy Time (min) Skin Dose (Gy) 29.1 ± 20.4mm 2.4 ± 1.3 n= 2.8 ± 1.1, 85.6 ± 33.2mm 78.7% (10.4% radial only) ± 54.2mins 44.6 ± 24.6mins 1.7 ± 1.3, DAP (cgy.cm 2 ) (±9033.9)Target
27 CTO Approaches (60%) (34%) (30%) (14%) (18%) (12%) (18%) (14%)
28 CTO Approaches 2 strategies: 87 (41.4%) 3 strategies: 19 (9.1%)
29 18% ADR AWE 34% RWE 18% 30% RDR Final Successful Strategy
30 ADR RDR 101 (48%) Anticipated ~50%/50%
31 ADR RDR 101 (48%) AWE RWE 109 (52%) Anticipated ~50%/50%
32 IVUS Adjudicated Sub-Intimal Wire Passage Operator Presumed (n) IVUS Proven (n) % Incorrect ADR 38/38 30/ Operator Presumed (n) IVUS Proven (n) % Incorrect AWE 0/68 8/ Operator Presumed (n) IVUS Proven (n) % Incorrect RWE 0/34 9/ Operator Presumed (n) IVUS Proven (n) % Incorrect RDR 63/63 45/ Discordance 16%
33 Procedure Results
34 Complete revascularisation of target territory 207/210 (98.6%) Actual number of patients Perforation Any (operator) 5/210 (5.38%) Ellis 1 (Core Lab) 1/210 (0.5%) Ellis 3 (Core Lab) 2/210 (1.0%) Pericardiocentesis 2/210 (1.0%) CIN 1/210 (0.5%) Any bleeding requiring transfusion 4/210 (1.9%)
35 Complete revascularisation of target territory 207/210 (98.6%) Actual number of patients Vascular Access Any complication: 13/210 (6.2%) Haematoma: 10/210 (4.8%) RP bleed: 1 conservative Mx RP bleed: 1 transfused Delayed discharge: 1
36 Early Optimisation Angiography/procedure optimisation allowed within 3/12 When significant positive remodelling anticipated or distal disease present beyond CTO segment of borderline severity Not considered MACE event if scheduled at time of index CTO PCI Early angiography in 40/210 (19%) Nothing further required in 19 (9.1%) Further stent optimisation by POBA in 9 (4.3%) patients Further stents (distal vessel) in 12 patients (5.7%)
37 12-month outcomes
38 Primary endpoint: TVF 5.24%
39 Performance goal Primary endpoint: TVF 5.24% for Synergy achieved (target <15%)
40 Primary endpoint: TVF 5.24% Performance goal for Synergy achieved (target <15%) Cardiac Death: 0
41 Primary endpoint: TVF 5.24% Stent Thrombosis: 3/210 Performance goal for Synergy achieved (target <15%) Cardiac Death: 0 (1.4%)
42 Primary endpoint: TVF 5.24% MACE (all death, MI or TVR): 21/210 Performance goal for Synergy achieved (target <15%) Cardiac Death: 0 Stent Thrombosis: 3/210 (1.4%) (10%)
43 Diabetes predictor of MACE (p = 0.004) mainly driven by Primary endpoint: TVF 5.24% Performance goal for Synergy achieved (target <15%) Cardiac death: 0 Stent Thrombosis: 3/210 (1.4%) MACE (all death, MI or TVR): 21/210 (10%) TVR
44 Dissection vs Not
45 Dissection vs Not Variable Statistic Dissection N=101 No Dissection N = 109 No Diabetes N = 166 Diabetes N = 44 P-value Lesion Length (mm) N (SD) 36.3 (22.0) 22.6 (16.6) < Prior CABG Target Vessel N (%) 22 (21.8) 11 (10.1) JCTO Score Mean (SD) 2.9 (1.2) 2.0 (1.1) < Stent Length (mm) Mean (SD) 96.6 (31.6) 75.4 (31.4) < TVF at 12 months N (%) 8 (5.9) 3 (3.7) MACE at 12 months N (%) 14 (13.9) 7 (6.4) TVR at 12 months N (%) 11 (10.9) 4 (3.7) TVF at 12 months N (%) 8 (4.8) 3 (6.8) MACE at 12 months N (%) 11 (6.6) 10 (22.7) TVR at 12 months N (%) 8 (4.8) 7 (15.9) 0.02
46 Dissection vs Not Variable Statistic Dissection N=101 No Dissection N = 109 No Diabetes N = 166 Diabetes N = 44 P-value Lesion Length (mm) N (SD) 36.3 (22.0) 22.6 (16.6) < Prior CABG Target Vessel N (%) 22 (21.8) 11 (10.1) JCTO Score Mean (SD) 2.9 (1.2) 2.0 (1.1) < Stent Length (mm) Mean (SD) 96.6 (31.6) 75.4 (31.4) < TVF at 12 months N (%) 8 (5.9) 3 (3.7) MACE at 12 months N (%) 14 (13.9) 7 (6.4) TVR at 12 months N (%) 11 (10.9) 4 (3.7) TVF at 12 months N (%) 8 (4.8) 3 (6.8) MACE at 12 months N (%) 11 (6.6) 10 (22.7) TVR at 12 months N (%) 8 (4.8) 7 (15.9) 0.02
47 Dissection vs Not Variable Statistic Dissection N=101 No Dissection N = 109 No Diabetes N = 166 Diabetes N = 44 P-value Lesion Length (mm) N (SD) 36.3 (22.0) 22.6 (16.6) < Prior CABG Target Vessel N (%) 22 (21.8) 11 (10.1) JCTO Score Mean (SD) 2.9 (1.2) 2.0 (1.1) < Stent Length (mm) Mean (SD) 96.6 (31.6) 75.4 (31.4) < TVF at 12 months N (%) 8 (5.9) 3 (3.7) MACE at 12 months N (%) 14 (13.9) 7 (6.4) TVR at 12 months N (%) 11 (10.9) 4 (3.7) TVF at 12 months N (%) 8 (4.8) 3 (6.8) MACE at 12 months N (%) 11 (6.6) 10 (22.7) TVR at 12 months N (%) 8 (4.8) 7 (15.9) 0.02
48 Dissection vs Not Variable Statistic Dissection N=101 No Dissection N = 109 No Diabetes N = 166 Diabetes N = 44 P-value Lesion Length (mm) N (SD) 36.3 (22.0) 22.6 (16.6) < Prior CABG Target Vessel N (%) 22 (21.8) 11 (10.1) JCTO Score Mean (SD) 2.9 (1.2) 2.0 (1.1) < Stent Length (mm) Mean (SD) 96.6 (31.6) 75.4 (31.4) < TVF at 12 months N (%) 8 (5.9) 3 (3.7) MACE at 12 months N (%) 14 (13.9) 7 (6.4) TVR at 12 months N (%) 11 (10.9) 4 (3.7) TVF at 12 months N (%) 8 (4.8) 3 (6.8) MACE at 12 months N (%) 11 (6.6) 10 (22.7) TVR at 12 months N (%) 8 (4.8) 7 (15.9) 0.02
49 Dissection vs Not Variable Statistic Dissection N=101 No Dissection N = 109 No Diabetes N = 166 Diabetes N = 44 P-value Lesion Length (mm) N (SD) 36.3 (22.0) 22.6 (16.6) < Prior CABG Target Vessel N (%) 22 (21.8) 11 (10.1) JCTO Score Mean (SD) 2.9 (1.2) 2.0 (1.1) < Stent Length (mm) Mean (SD) 96.6 (31.6) 75.4 (31.4) < TVF at 12 months N (%) 8 (5.9) 3 (3.7) MACE at 12 months N (%) 14 (13.9) 7 (6.4) TVR at 12 months N (%) 11 (10.9) 4 (3.7) TVF at 12 months N (%) 8 (4.8) 3 (6.8) MACE at 12 months N (%) 11 (6.6) 10 (22.7) TVR at 12 months N (%) 8 (4.8) 7 (15.9) 0.02
50
51 AWE Baseline 12 months
52 RDR Baseline 12 months
53 QoL - SAQ p<0.001 p<0.001 p<0.001 p<0.001 p<0.001
54 QoL EQ5D
55 QoL EQ5D
56 QoL EQ5D
57 QoL EQ5D
58 Conclusions: Consistent CTO
59 Examined complex lesions in very symptomatic patients Dissection techniques used in longer and more difficult disease More complex lesions have higher TVR Synergy stent highly effective CTO PCI in Substantial QoL gains at 12 months after successful CTO PCI
60 Examined complex lesions in very symptomatic patients Dissection techniques used in longer and more difficult disease More complex lesions have higher TVR Synergy stent highly effective CTO PCI in Substantial QoL gains at 12 months after successful CTO PCI
61 Examined complex lesions in very symptomatic patients Dissection techniques used in longer and more difficult disease More complex lesions have higher TVR Synergy stent highly effective CTO PCI in Substantial QoL gains at 12 months after successful CTO PCI
62 Examined complex lesions in very symptomatic patients Dissection techniques used in longer and more difficult disease More complex lesions have higher TVR Synergy stent highly effective CTO PCI in Substantial QoL gains at 12 months after successful CTO PCI
63 Examined complex lesions in very symptomatic patients Dissection techniques used in longer and more difficult disease More complex lesions have higher TVR Synergy stent highly effective CTO PCI in Substantial QoL gains at 12 months after successful CTO PCI
64 Examined complex lesions in very symptomatic patients Dissection techniques used in longer and more difficult disease More complex lesions have higher TVR Synergy stent highly effective CTO PCI in Substantial QoL gains at 12 months after successful CTO PCI
65
66 Back-up Slides
67 12-Month MACE in Context Consistent: 10% (All cause death, MI or TVR) 100% CTO *Syntax 2: 11.6% (All cause death, MI or any revascularisation) 28% CTO *Matched Syntax 1 PCI: 21.4% 28% CTO *Matched Syntax 1 CABG: 11% Undefined SENIOR (DES pts): 12% (All cause death, MI or ischaemia driven TLR) 7% CTO ± Noble: 9% (all cause death, non-procedure MI and any revascularisation) CTO excluded *Escaned. Eur Heart J 2017;38:3124 ± Evald Christiansen TCT 2016 Varenne. Lancet 2018;391:41
68 Not Reported *Decision CTO unpublished, estimates from presented data 12-month re-assessment: Consistent, Decision & Euro- CTO 6-week re-assessment: Orbita 30-day re-assessment: Open Baseline in PCI arms Follow-up in PCI arms
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