REVASC ClinicalTrials.gov, Identifier: NCT01924962 Recovery of Left - - PowerPoint PPT Presentation

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REVASC ClinicalTrials.gov, Identifier: NCT01924962 Recovery of Left - - PowerPoint PPT Presentation

Feb 13, 2024 277 likes •495 views

REVASC ClinicalTrials.gov, Identifier: NCT01924962 Recovery of Left Ventricular Function in Coronary Chronic Total Occlusion K. Mashayekhi, T. Nhrenberg, A.Toma, M.Gick, M. Ferenc, W. Hochholzer, T. Comberg, J. Rothe, C.Valina, N.

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SLIDE 1

REVASC

ClinicalTrials.gov, Identifier: NCT01924962

Recovery of Left Ventricular Function in Coronary Chronic Total Occlusion

  • K. Mashayekhi, T. Nührenberg, A.Toma, M.Gick, M. Ferenc, W. Hochholzer, T. Comberg, J.

Rothe, C.Valina, N. Löffelhardt, M. Ayoub, M.Zhao, J.Bremicker, N. Jander, J.Minners, P. Ruile,

  • M. Behnes, I. Akin, T. Schäufele, F. -J. Neumann, H.-J. Büttner.

University Heart Center Freiburg · Bad Krozingen Bad Krozingen / Germany

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SLIDE 2

Disclosure Statement of Financial Interest

  • Grant/Research Support
  • Consulting Fees/Honoraria
  • REVASC was sponsored by Cordis
  • Ashai Intecc, Vascular Solutions,

Cordis, Abboth, Biotronik, Terumo, AstraZeneca, Daiichi Sankyo

Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.

Affiliation/Financial Relationship Company

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SLIDE 3

Randomized Trials

Trial N Study Type Population Primary Endpoints: EXPLORE

304 CTO PCI vs. no CTO PCI STEMI with CTO 4-month: LVEF, LVEDV per MRI comparable in both groups

DECISION- CTO

834 CTO PCI + OMT

  • vs. OMT

Stable Angina

  • r ACS

3-year death, MI, stroke, or repeat revascularization comparable in both groups

EURO-CTO

396 CTO PCI + OMT

  • vs. OMT

Stable angina PCI group experienced lower angina frequency per SAQ

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SLIDE 4

REVASC Trial

Recovery of Left Ventricular Function After Stent Implantation in Chronic Total Occlusion of Coronary Arteries :

  • Whether percutaneous coronary

intervention (PCI) in chronic

  • ccluded coronary arteries

(CTO) may improve outcomes compared to optimal medical therapy (OMT) is still controversial.

  • We evaluated whether PCI of

CTO (CTO-PCI) improves left ventricular function in addition to PCI of relevant coexisting non-CTO vessels (no-CTO-PCI).

Background

Objective

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SLIDE 5

Primary Endpoint:

Segmental wall thickening (SWT) measured by cMRI after 6 months

Modified from Kirschbaum SW et al, JACC Cardiovasc Imaging. 2010 Jun;3(6):614-22

Baseline 6 months

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SLIDE 6

Study endpoints

  • Primary endpoint:

 Change in segmental wall thickening (SWT) in the CTO territory

according to the 17-segment model between baseline and follow-up at 6 months

  • Secondary endpoints:

 Changes in LV end-diastolic and end-systolic volume indices and left

ventricular ejection fraction (LVEF)

  • Clinical outcomes:

 MACE at 12 months was defined as all-cause death, myocardial

infarction and any clinically driven repeat revascularization.

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SLIDE 7

Patient selection

  • CTO with an estimated

reference vessel diameter of 2.5- 4.0mm.

  • Clinical symptoms or positive

functional study for ischemia

  • Left ventricular ejection fraction

< 25%

  • Acute coronary syndrome < 72

hours preceding the index procedure

  • Contraindications to cMRI

Major inclusion criteria Exclusion criteria

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SLIDE 8

Estimation of sample size

  • Hypothesis:

15%-recovery of SWT with CTO-PCI versus a 2%-recovery with No-CTO- PCI at a common standard deviation of 30%.

  • Goal:

80% power, level of significance 5%

  • Sample size:

85 patients per study arm

  • Recruitment:

200 patients (to account for losses to follow-up)

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SLIDE 9

Study flow of REVASC

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SLIDE 10

Baseline demographic and angiographic characteristics

no-CTO-PCI (n = 104) CTO-PCI (n = 101) p Value

Age (years) 68 [61 - 74] 65 [57 - 72] 0.02 Male gender 90 (86.5) 91 (90.1) 0.43 Diabetes 31 (29.8) 32 (31.6) 0.77 LVEF (%) 59.6 [45.8 - 64.3] 54.7 [42.9 - 65.1] 0.48 Previous PCI 33 (31.7) 28 (27.7) 0.53 Previous myocardial infarction 38 (36.5) 39 (38.6) 0.76 Previous bypass operation 14 (13.5) 12 (11.9) 0.73

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SLIDE 11

Angiographic characteristics

no-CTO-PCI (n = 104) CTO-PCI (n = 101) p Value

Coronary artery disease 1-vessel disease 2,3-vessel disease 10 (9.6) 94 (90.4) 14 (13.9) 87 (86.1) 0.55 SYNTAX-Score 16 [11 - 21] 14 [9 - 22] 0.33 Residual SYNTAX-Score 11 [8 - 16] 2 [0 - 7] <0.01 J-CTO Score 2 [1 - 2] 2 [1 – 3] 0.43 PROGRESS Score 0 [0 – 1] 1 [0 – 1] <0.01

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SLIDE 12

Procedural CTO data

CTO-PCI (n = 101)

CTO recanalization technique antegrade only retrograde 61 (60.4) 40 (39.6) Technical success on first attempt 87 (86.1) Technical success including 2nd attempts 100 (99.0) Procedure time (minutes) 96 [65 – 149] Fluoroscopy time (minutes) 37 [20 – 76] Radiation dose (µGy*cm²) 10322 [5725 – 17539] Contrast Volume (ml) 280 [200 – 400]

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SLIDE 13

Primary endpoint:

baseline 6M FU baseline 6M FU

  • 50

50 100 150 200

All CTO segments

Segmental Wall Thickening (%) p = 0.57

OMT  no-CTO PCI OMT + CTO PCI

  • 40
  • 20

20 40

Change in Segmental Wall Thickening (%)

p = 0.57 All CTO segments

OMT + CTO PCI OMT  no-CTO PCI

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SLIDE 14

Primary endpoint:

baseline 6M FU baseline 6M FU

  • 50

50 100 150 200

Dysfunctional CTO segments

Segmental Wall Thickening (%)

p = 0.51

OMT  no-CTO PCI OMT + CTO PCI

  • 40
  • 20

20 40

Change in Segmental Wall Thickening (%) p = 0.51 Dysfunctional CTO segments

OMT  no-CTO PCI OMT + CTO PCI

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SLIDE 15

Primary endpoint:

OMT  no-CTO PCI OMT + CTO PCI

  • 40
  • 20

20 40

Change in Segmental Wall Thickening (%)

Patients with SYNTAX score < 13

p = 0.12

baseline 6M FU baseline 6M FU

Segmental Wall Thickening (%)

  • 50

50 100 150 200

Patients with SYNTAX Score < 13

OMT  no-CTO PCI OMT + CTO PCI

p = 0.12

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SLIDE 16

LVEDV index

baseline 6M FU baseline 6M FU

OMT + CTO PCI OMT  non-CTO PCI

LVEF

p = 0.79

20 40 60 80 100

LVEF (%)

Secondary endpoint:

100 200 300

LVEDV index (ml/m²)

p = 0.54 baseline 6M FU baseline 6M FU

OMT  non-CTO PCI OMT + CTO PCI

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SLIDE 17

Major adverse cardiac events at 12 months

(death, infarction, any revascularization)

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SLIDE 18

Major adverse cardiac events at 12 months

no-CTO-PCI (n = 104) CTO-PCI (n = 101) MACE 17 (18.2) 6 (5.9) Death of any cause at 12 months 2 (2.0) 1 (1.0) Acute myocardial infarction 1 (1.0) 0 (0.0) Clinically driven repeat revascularization at 12 months: CTO vessel 16 (15.4) 14 (13.5) 5 (5.0) 3 (3.0)

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SLIDE 19

Conclusion

  • In the entire cohort, CTO-PCI did not improve regional or

global left ventricular function over no-CTO PCI.

  • In the subset of patients without major non-CTO lesions,

CTO-PCI was associated with a trend towards larger improvement in segmental wall thickening than no-CTO-PCI.

  • In the entire cohort, CTO-PCI resulted in clinical benefit over

no CTO-PCI as evidenced by reduced MACE rates at 12 months.

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SLIDE 20

OMT  non-CTO PCI OMT + CTO PCI

  • 40
  • 20

20 40

Change in Segmental Wall Thickening (%)

CTO areas

all dysfunctional patients with SYNTAX score < 13

p = 0.57 p = 0.51

Primary endpoint: Change of SWT in %

p = 0.12