SKEJBY Early healing after treatment of coronary lesions by everolimus, or biolimus eluting bioresorbable polymer stents One-month results of the SORT-OUT VIII OCT study Ida Riise Balleby 1 , Trine Krejberg Ørhøj 1 , Christian Juhl Terkelsen 1 , Lisette Okkels Jensen 2 , Michael Maeng 1 , Lars Romer Krusell 1 , Jouke Dijkstra 3 , Lisbeth Antonsen 2 , Anne Kaltoft 1 , Steen Dalby Kristensen 1 , Mikkel Hougaard 2 , Hans Erik Bøtker 1 , Jens Flensted Lassen 1 , Evald Høj Christiansen 1 , Niels Ramsing Holm 1 1 Department of Cardiology, Aarhus University Hospital, Skejby, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark 2 Department of Cardiology, Odense University Hospital, Sdr. Boulevard 29, 5000 Odense C, Denmark 3 Division of Image Processing, Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands
Potential conflicts of interest Speaker's name: Ida Riise Balleby I have the following potential conflicts of interest to report: Travelgrants: ABBOTT VASCULAR, MEDTRONIC, ST. JUDE MEDICAL SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
Background • Improved early healing may reduce the risk of stent thrombosis in patients treated by DES • Biomatrix DES (Biosensors) has shown excellent long term clinical outcome 1 • Synergy DES (Boston Scientific) is designed to facilitate early healing and has shown promising clinical outcome 2 1 Serruys PW, et al . ” Improved safety and reduction in stent thrombosis associated with biodegradable polymer -based biolimus- eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial .” JACC Cardiovasc Interv. 2013 Aug;6(8):777-89. 2 Kereiakes DJ ” Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial” Circ Cardiovasc Interv. 2015 Apr;8(4) SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
Objective: One-month healing Synergy Biomatrix Biodegradable polymer Biodegradable polymer ~ Absorption time: 6-9 months Absorption time: 4 months Biolimus A9 eluting vs. Everolimus eluting 120 µm 74 µm Boston Scientific, USA Biosensors, Schwitzerland SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
Patient population Inclusion criteria • 18 years of age or older • Indications: SAP, UAP, NSTEMI, STEMI Exclusion criteria • Life expectancy less than one year • Unacceptable risk by 12-month dual antiplatelet treatment • Creatinine >120 mmol/L • Severe vessel tortuosity • Allergy to aspirin, clopidogrel, ticagrelor, sirolimus, or biolimus • Unable to provide written informed consent SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
Methods • Dual-center study • Randomization 1:1 - stratification for STEMI and diabetes • OCT at baseline and at 1-month follow-up • Clinicaltrials identifier: NCT02253108 • Matched OCT analysis: QCU-CMS, LUMC, Leiden, NL PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
Primary endpoint at one month Coronary Stent Healing Index Healing index component Score 1) Uncovered struts (% of all strut counts pr lesion) >2%=1, >5%=2, >10%=3, >15%=4, >20%=5, >25%=6, >30%=7, >35%=8 >40%=9 2) Uncovered jailing struts and uncovered acquired or >10%=1, >20%=2, >30%=3, >40%=4, >50%=5 ect. persisting malapposed struts (% of all strut counts pr lesion) 3) Persisting malapposition (score for cummulated strut >1mm=1, ≥2mm=2 ≥3mm=3 length pr lesion) 4) Acquired malapposition (score for cummulated strut >1mm=1, ≥2mm=4, ≥3mm=6 length pr lesion) 5) Maximum neointimal thickness (score pr neointimal >200µm=1, >300µm=2, >400µm=3 or diameter thickness interval) stenosis>50%=4, >75%=5 6) Cumulated extra stent lumen enlargement (score pr area 0.2mm 2 =1, ≥0.4 mm 2 =2, ≥0.6mm 2 =3, ≥0.8 mm 2 =4, interval) ≥1.0 mm 2 =5, ≥1.2 mm 2 =6 SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
Primary endpoint at one month Coronary Stent Healing Index Healing index component Score 1) Uncovered struts (% of all strut counts pr lesion) >2%=1, >5%=2, >10%=3, >15%=4, >20%=5, >25%=6, >30%=7, >35%=8 >40%=9 2) Uncovered jailing struts and uncovered acquired or >10%=1, >20%=2, >30%=3, >40%=4, >50%=5 ect. persisting malapposed struts (% of all strut counts pr lesion) 3) Persisting malapposition (score for cummulated strut >1mm=1, ≥2mm=2 ≥3mm=3 length pr lesion) 4) Acquired malapposition (score for cummulated strut >1mm=1, ≥2mm=4, ≥3mm=6 length pr lesion) 5) Maximum neointimal thickness (score pr neointimal >200µm=1, >300µm=2, >400µm=3 or diameter thickness interval) stenosis>50%=4, >75%=5 6) Cumulated extra stent lumen enlargement (score pr area 0.2mm 2 =1, ≥0.4 mm 2 =2, ≥0.6mm 2 =3, ≥0.8 mm 2 =4, interval) ≥1.0 mm 2 =5, ≥1.2 mm 2 =6 SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
Power calculation Estimates for the individual components of the Coronary Stent Healing Index Coronary Stent Healing Index Synergy Biomatrix Uncovered stent struts 4 8 Uncovered jailing and malapposed struts 7 7 Persisting malapposition 1 2 Acquired malapposition 4 4 Neointimal thickness 2 2 Cummulated extra stent lumen enlargement 0 0 Total (lower value indicates improved healing) 18 23 Estimates derived by historical data. Assumptions were α =0.05, power=0.90. Normal distribution assumed with estimated population SD=5 and SD=7 for Synergy and Biomatrix respectively. Sample size estimate: n=32 in both groups Planned inclusion of 40 patients in each group SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
Patient flow chart Patients in SORT-OUT VIII OCT n=80 Synergy Biomatrix n=38 n=42 Excluded n=7 Excluded n=6 Withdrawal=5 Withdrawal n=4 Poor image quality=1 Failed to appear n=2 No baseline OCT=1 Events n=3 Events n=0 Cardiac death n=2 Stent thrombosis n =1 Synergy in analysis Biomatrix in analysis 1-month FU n=31 n=33 SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
Patient characteristics Synergy n=31 Biomatrix n=33 P-value Age (years) 63.4±8.2 64.7±8.8 0.53 Male gender 24 (77.4%) 26 (78.8%) 0.90 BMI (kg/m 2 ) 27.4±4.7 27.2±3.9 0.84 Diabetes 4 (12.9%) 4 (12.2%) 0.61 Creatinine (mmol/L) 78.7±18.1 81.9±19.3 0.50 Antihypertensive treatment 17 (56.7%) 16 (50.0%) 0.60 Statin treatment 11(36.7%) 15(53.1%) 0.42 Systolic blood pressure (mmHg) 138.3±22.3 140.7±21.5 0.68 Diastolic blood pressure (mmHg) 79.6±13.5 76.7±16.0 0.45 Previous PCI 2 (6.6%) 3 (9.1%) 0.53 Previous CABG 0 0 - LVEF, % 55.3±10.0 55.3±9.2 0.99 Indications for PCI: SAP 13 (41.9%) 14 (42.4%) UAP 1 (3.2%) 0 (0%) Non-STEMI 7 (22.6%) 10 (30.3%) STEMI 10 (32.5%) 9 (27.3%) 0.58 SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
Procedural characteristics Synergy n=31 Biomatrix n=33 P-value Reference diameter (mm) 3.5±0.6 3.6±0.6 0.50 Number of stents (n) 1.2±0.4 1.1±0.4 0.30 Stent length (mm) 23.6±10.6 20.9±12.4 0.36 Max. balloon diameter (mm) 3.6±0.8 3.6±0.6 0.74 Max. balloon pressure (mmHg) 17.2±5.6 18.2±4.7 0.45 SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
One-month clinical endpoints Synergy n=38 Biomatrix n=42 Cardiac death 0 2* Stent thrombosis 0 1 TLR 0 1 Same patient Myocardial infarction 0 1 MACE 0 3** (7.1%) * Both cardiac deaths were STEMI patients with out-of-hospital sudden death **No follow-up OCT performed SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
Primary endpoint at one month Coronary Stent Healing Index 25 Worse healing Cumulated healing index score 20 15 10 5 Better healing 0 Synergy Biomatrix median [IQR] 10[6;12] 16[5.5;18] p=0.16 SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
Secondary endpoint Strut coverage at one month Lesion level Full strut coverage 100 90 80 Coverage % 70 60 50 40 Worse 30 Synergy Biomatrix p=0.09 72.2% [56.9;96.5] 64.3% [55.5;77.2] Coverage %, median [IQR] SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
Secondary endpoint Strut coverage at one month Lesion level Full strut coverage 100 26% 6% >95% coverage 90 80 Coverage % <75% coverage 58% 67% 70 60 50 <50% coverage 13% 18% 40 Worse 30 Synergy Biomatrix p=0.09 72.2% [56.9;96.5] 64.3% [55.5;77.2] Coverage %, median [IQR] SORT-OUT VIII OCT SORT-OUT VIII OCT PCI Research Ida.balleby@post.au.dk Aarhus University Hospital, Skejby ● Denmark SKEJBY
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