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Nov 07, 2023 182 likes •393 views

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 rhj 1 , Christian Juhl Terkelsen 1 ,

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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

SKEJBY

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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

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk SORT-OUT VIII OCT

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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 outcome1

  • Synergy DES (Boston Scientific) is designed to facilitate early

healing and has shown promising clinical outcome2

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk

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

  • f 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

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Objective: One-month healing

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk SORT-OUT VIII OCT

vs. Synergy

Biodegradable polymer Absorption time: 4 months Everolimus eluting Boston Scientific, USA

Biomatrix

Biodegradable polymer Absorption time: 6-9 months Biolimus A9 eluting Biosensors, Schwitzerland

120 µm 74 µm

~

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SLIDE 5

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

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk SORT-OUT VIII OCT

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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:

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk

QCU-CMS, LUMC, Leiden, NL

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SLIDE 7

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 persisting malapposed struts (% of all strut counts pr lesion) >10%=1, >20%=2, >30%=3, >40%=4, >50%=5 ect. 3) Persisting malapposition (score for cummulated strut length pr lesion) >1mm=1, ≥2mm=2 ≥3mm=3 4) Acquired malapposition (score for cummulated strut length pr lesion) >1mm=1, ≥2mm=4, ≥3mm=6 5) Maximum neointimal thickness (score pr neointimal thickness interval) >200µm=1, >300µm=2, >400µm=3 or diameter stenosis>50%=4, >75%=5 6) Cumulated extra stent lumen enlargement (score pr area interval) 0.2mm2=1, ≥0.4 mm2=2, ≥0.6mm2=3, ≥0.8 mm2=4, ≥1.0 mm2=5, ≥1.2 mm2=6

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk SORT-OUT VIII OCT

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SLIDE 8

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 persisting malapposed struts (% of all strut counts pr lesion) >10%=1, >20%=2, >30%=3, >40%=4, >50%=5 ect. 3) Persisting malapposition (score for cummulated strut length pr lesion) >1mm=1, ≥2mm=2 ≥3mm=3 4) Acquired malapposition (score for cummulated strut length pr lesion) >1mm=1, ≥2mm=4, ≥3mm=6 5) Maximum neointimal thickness (score pr neointimal thickness interval) >200µm=1, >300µm=2, >400µm=3 or diameter stenosis>50%=4, >75%=5 6) Cumulated extra stent lumen enlargement (score pr area interval) 0.2mm2=1, ≥0.4 mm2=2, ≥0.6mm2=3, ≥0.8 mm2=4, ≥1.0 mm2=5, ≥1.2 mm2=6

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk SORT-OUT VIII OCT

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Estimates for the individual components of the Coronary Stent Healing Index

Power calculation

SORT-OUT VIII OCT

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk

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 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

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Patient flow chart

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk

Synergy n=38

Excluded n=7

Withdrawal=5 Poor image quality=1 No baseline OCT=1

Excluded n=6

Withdrawal n=4 Failed to appear n=2

Biomatrix n=42

Events n=0 Events n=3

Cardiac death n=2 Stent thrombosis n =1

1-month FU

Patients in SORT-OUT VIII OCT n=80 Biomatrix in analysis n=33 Synergy in analysis n=31

SORT-OUT VIII OCT

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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/m2) 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

  • LVEF, %

55.3±10.0 55.3±9.2 0.99 Indications for PCI: SAP UAP Non-STEMI STEMI 13 (41.9%) 1 (3.2%) 7 (22.6%) 10 (32.5%) 14 (42.4%) 0 (0%) 10 (30.3%) 9 (27.3%) 0.58

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk SORT-OUT VIII OCT

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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

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk SORT-OUT VIII OCT

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One-month clinical endpoints

Synergy n=38 Biomatrix n=42 Cardiac death 2* Stent thrombosis 1 TLR 1 Myocardial infarction 1 MACE 3** (7.1%)

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk

* Both cardiac deaths were STEMI patients with out-of-hospital sudden death **No follow-up OCT performed

SORT-OUT VIII OCT

Same patient

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SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk

Primary endpoint at one month Coronary Stent Healing Index

5 10 15 20 25

Cumulated healing index score

Better healing Worse healing

SORT-OUT VIII OCT

Synergy Biomatrix

median [IQR] 10[6;12] 16[5.5;18] p=0.16

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30 40 50 60 70 80 90 100

Coverage %

Lesion level

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk

Strut coverage at one month

SORT-OUT VIII OCT

Full strut coverage

Biomatrix Synergy

Worse Coverage %, median [IQR]

72.2% [56.9;96.5] 64.3% [55.5;77.2] p=0.09 Secondary endpoint

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30 40 50 60 70 80 90 100

Coverage %

Lesion level

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk

26% 6% 58% 67%

>95% coverage <75% coverage

SORT-OUT VIII OCT

Full strut coverage

Biomatrix Synergy

13% 18%

<50% coverage

SORT-OUT VIII OCT

Worse

Strut coverage at one month

Secondary endpoint

Coverage %, median [IQR]

72.2% [56.9;96.5] 64.3% [55.5;77.2] p=0.09

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Clustered malapposition*

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk

Synergy Biomatrix Malapposed at baseline 12 8

Abolished 8(66.7%) 4(50.0%) Persisting 4(33.3%) 4(50.0%)

*minimum 10 malapposed strut counts within 5 adjacent frames (0.65mm)

Baseline 1-month FU

Acquired 1(8.3%)

SORT-OUT VIII OCT

Secondary endpoint

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Minimal lumen area

6.3 mm2 6.6mm2

5,3 5,5 5,7 5,9 6,1 6,3 6,5 6,7 6,9 7,1 7,3 7,5

mm2

Synergy Biomatrix

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk

P-value 0.45

Synergy Biomatrix

SORT-OUT VIII OCT

Secondary endpoint

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60.0 µm 56.7 µm

45 50 55 60 65 70 75

µm

Lesion level

p = 0.59

Average neointimal thickness*

*Neointimal thickness measured as the shortest distance from strut surface to lumen boarder

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk SORT-OUT VIII OCT

Biomatrix Synergy

Secondary endpoint

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Conclusion

  • No statistical difference was detected in one-month Coronary

Stent Healing Index between Synergy and Biomatrix DES

  • Synergy DES showed a trend towards better early strut

coverage compared to Biomatrix DES

  • Wide inter-patient variation in early healing was prominent in

both stent groups

SKEJBY

PCI Research Aarhus University Hospital, Skejby ● Denmark Ida.balleby@post.au.dk

The SORT-OUT VIII OCT study

SORT-OUT VIII OCT