Insights in Thrombosis and In-Stent Restenosis

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1 Clinical Value of OCT Insights in Thrombosis and In-Stent Restenosis Fernando Alfonso MD, PhD, FESC Interventional Cardiology. Cardiovascular Institute. Clinico San Carlos University Hospital. Madrid. Spain. (Nothing to Disclose) ESC Munich Sunday 26 August Chairpersons: F Pratti & IRA Rashdan

2 OCT Stent Failure Stent Failure In-Stent Restenosis Stent Thrombosis (Frequent, Bening) (Rare, Major Complication) Curfman GD, Morrissey S, Jarcho JA, Drazen JM. Drug-eluting coronary stents--promise and uncertainty. N Egl J Med 2007;356(10):

3 DES ISR: Underlying Mechanisms Focal DES Fracture DES Gap Geographic Miss Uneven/Undelivered Drug Non-uniform Strut Distribution DES Damage DES Underexpansion () Hypersensitivity Drug Resistance Mechanical Factors IVUS / OCT Diffuse Biological Factors

4 Algorithm for DES ISR Treatment FFR (IVUS/OCT) (-) Medical Rx Asymptomatic Severity? DES ISR IVUS / OCT Underlying Mechanism Focal Diffuse Gap Fracture Edge Body DES DES DES Underexpansion? Avoid Geo Miss Pressure NC BA Optimization Prefered DES: Hetero DES & 2nd G Favor PEB: Multiple ST layers, major SB DES / PEB

5 Intravascular Ultrasound Assessment of In-ST Restenosis? RIBS: 214 BD: 5338

6 Intracoronary Imaging In-ST Restenosis IVUS OCT

$fracture & ISR Nakazawa G, et al.$

7 DES Fractures DES Fractures: Pathology of DES Fractures: DES fracture & ISR Nakazawa G, et al. J Am Coll Cardiol 2009;54:

8 DES Fractures DES Fractures: OCT for restenosis evaluation. Identification of the mechanism Clinico San Carlos University Hospital # IVUS #3412

9 ISR OCT vs IVUS Neointima As compared with histology, the diagnostic accuracy of OCT (AUC 0.967) was higher than that of IVUS (AUC 0.781) Suzuki Y Fearon WF. J Am Coll Cardiol Intv 2008;1:168 73)

10 Gonzalo N, et al. Am Heart J 2009;158: OCT-ISR

11 OCT-ISR 24 Patients ISR (4 BMS, 21 DES) Heterogeneous & low backsactter: Focal ISR Layered appearance: ISR >12 months Irregular lumen shape: Unstable angina Gonzalo N, et al. Am Heart J 2009;158:284-93

12 OCT-ISR Irregular Lumen Intraluminal Material (Irregular lumen shape 28%. Intraluminal material 20%) Gonzalo N, et al. Am Heart J 2009;158:284-93

13 OCT-ISR Focal ISR: Heterogeneous Tissue, Low Backscatter Gonzalo N, et al. Am Heart J 2009;158:284-93

14 OCT-ISR Diffuse ISR: Layered, High Backscatter (Layered in 52%, homogeneous in 28%, and heterogeneous in 20%) Gonzalo N, et al. Am Heart J 2009;158:284-93

15 OCT-ISR Layered ISR VCP DB # (9M FU RIBS 4)

16 OCT-ISR DES Follow-up: 192 non-isr lesions vs 33 ISR lesions Layered Low backscatter Heterogeneous Microvessels Lee SJ et al. Clin Cardiol 2011 Oct;34(10):633-9.

17 OCT-ISR (Microvessels) 78 ISR lesions (72 DES, 6 BMS) 21 (27%) had microvessels. (Microvessels: low backscattering structures <200 μm in diameter) Microvessels associated with: Neointimal hyperplasia (NIH) CSA (5.4 vs 4.2 mm²; p=0.024) % NIH CSA (79 vs 67%; p=0.001). Kim BK et al. J Invasive Cardiol 2012 Mar;24(3):

OCT-ISR PEB for ISR Neointimal Healing Patterns after Paclitaxel-Eluting Balloon Therapy Of Drug-Eluting Stent Restenosis - 80-year-old man, stable angina,

18 OCT-ISR PEB for ISR Neointimal Healing Patterns after Paclitaxel-Eluting Balloon Therapy Of Drug-Eluting Stent Restenosis - 80-year-old man, stable angina, EES (2.75x12 mm), proximal LAD - 3 years later severe edge ISR - RIBS IV (PEB) (3x15 mm) - 9 month FU Sandoval J, Alfonso F. J Invas Cardiol 2012 (In press)

19 OCT-ISR PEB for ISR (Acute) A B C D E F Sandoval J, Alfonso F. J Invas Cardiol 2012 (In press) 2/6/2011 RIBS IV (DB #52323, # )

20 OCT-ISR PEB for ISR (Follow-up) A B C D E F Sandoval J, Alfonso F. J Invas Cardiol 2012 (In press) 2/6/2011 RIBS IV (DB #52323, # )

21 Secco GG. EuroIntervention 2011;7: OCT-ISR

OCT-ISR Calcified ISR Challenging Treatment of Calcified ISR Dilation Failure Bail Out Rotational Atherectomy A 77-year-old man on hemodialysis was investigated for unstable angina.

22 OCT-ISR Calcified ISR Challenging Treatment of Calcified ISR Dilation Failure Bail Out Rotational Atherectomy A 77-year-old man on hemodialysis was investigated for unstable angina. - Coronary angiography revealed ISR of a bare metal stent that had been implanted in the right coronary artery 10 years before Alfonso F. Calcified In-Stent Restenosis : A Rare Cause of Dilation Failure Requiring Rotational Atherectomy. Circ Cardiovasc Interv 2012;5;e1-e2.

23 OCT-ISR Calcified ISR B A E C D Alfonso F. Calcified In-Stent Restenosis : A Rare Cause of Dilation Failure Requiring Rotational Atherectomy. Circ Cardiovasc Interv 2012;5;e1-e2.

24 OCT-ISR A Calcified ISR B C Alfonso F. Calcified In-Stent Restenosis : A Rare Cause of Dilation Failure Requiring Rotational Atherectomy. Circ Cardiovasc Interv 2012;5;e1-e2.

25 OCT-ISR Neoatherosclerosis: Elusive Link From ISR to ST?

26 OCT-ISR Contribution of organized thrombus to SES ISR (12 Mo FU) Fujii K Eur Heart J 2008 Jun;29(11):1385

27 OCT-ISR Detection of atherosclerotic progression with rupture of degenerated instent intima 5 years after BMS implantation by OCT Habara M, et al. J Invasive Cardiol 2009 Oct;21(10):552-3

28 OCT-ISR 39 Pts (60 BMS) average time to OCT 6.5 years. Features of lipid-rich plaque was found in 20 stents (33.3%) in 16 patients (41%). Average fibrous cap thickness was 56.7 um Lipid arc was 173º. 6 patients had plaque disruption 6 patients had mural thrombus. Hypertension and smoking were more common Hou J et al. Heart 2010 Aug;96(15):

Neoatherosclerosis & ISR Newly Formed Atherosclerotic Changes Within Neointima After Stent Implantation SES implanted for 13 months Foamy macrophage clusters in the peristrut region Fibroatheroma

29 Neoatherosclerosis & ISR Newly Formed Atherosclerotic Changes Within Neointima After Stent Implantation SES implanted for 13 months Foamy macrophage clusters in the peristrut region Fibroatheroma with foamy macrophage-rich lesion and early necrotic core Fibroatheroma, peristrut early necrotic core, cholesterol clefts, surface foamy macrophages, and early calcification (arrows) Nakazawa G, Virmani R. J Am Coll Cardiol 2011;57:

30 OCT: Early vs Very Late BMS ISR 9-Mo FU after BMS 8Y FU after BMS Habara M, et al. Circ Cardiovasc Interv 2011 Jun;4(3):232-8

31 OCT DES ISR: Pathophysiology OCT in 50 Pts with DES ISR 58% Rupture, 52% TCFA, 58% Thrombus Rupture TCFA Microvessels Thrombus TCFA Rupture Kang SJ, Mintz GS. Circulation. 2011;123:

32 OCT-ISR Limitations OCT to Detect Neoatherosclerosis (The pathologist s perspective) 1.- OCT cannot discern the newly formed atherosclerosis within stent from the metal strut penetration into the preexisting necrotic core. DES strut penetration into necrotic core leads to delayed arterial healing or subtle neointimal coverage, which might be recognized as a new lesion of TCFA with or without intimal disruption by OCT. 2.- Fibrin accumulation is frequently observed around the struts of paclitaxeleluting stents. Massive fibrin accumulation is seen on OCT as a dark area without a clear border, which resembles necrotic core. 3.- Limitations of OCT to identify foamy macrophages on the luminal surface of neointima, with a typical appearance of a thin bright line with trailing shadows. This feature mimics the so-called OCT-derived TCFA and prevents assessment of deeper tissues. 4.- Accumulated macrophages are fragile, easily cracked (wire or catheter), and will end up with discontinuation or disruption in neointimal surface. (Letter) Nakano M Virmani R. Circulation Dec 20;124(25):e954

33 OCT-ST BMS ST Thrombus Rupture TCFA Macrophage Thrombus Aspirration Low Intensity Ca Karanasos A, Ligthardt J, Regar E. JACC CV Interv 2012; 5:

34 OCT-ISR A ISR Presenting as ST B C D T T Alfonso F, New Insights on Stent Thrombosis. JACC Cardiovasc Interv Feb;5(2): RIBS (14/10/2011)

35 OCT-ISR Ruptured Neoatherosclerosis The elusive link between very late ISR and ST 55 year-old man presenting with NSTEMI ( ST V1-V4). (8 years ago: BMS LCX. 6 Mo excellent BMS result)?? Alfonso F, (PRESTIGE Study) PRESTIGE (13/08/2012)

36 OCT-ISR Ruptured Neoatherosclerosis A The elusive link between very late ISR and ST B C T E D C B D E Alfonso F, (PRESTIGE Study) PRESTIGE (13/08/2012)

37 OCT- ST Stent Thrombosis

38 OCT-ST DETECTIVE STEMI (MVD) Early (3-7d) Healing % ST Coverage (88%) % Uncoverage DES / CCS; Non-culprit/Culprit Covered Malapposition Thrombus Prati F, et al. Heart 2011;97; Uncoverage

39 IVUS & OCT Malapposition Alfonso F, RIBS IV, Clinico San Carlos University Hospital

in higher rates of uncovered and malapposed stent at

40 OCT-ST In STEMI patients PES as compared with BMS significantly reduces neointimal hyperplasia but results in higher rates of uncovered and malapposed stent at 13-month follow-up. Guagliumi G, et al. Circulation. 2011;123:

41 OCT-ST Evolving Stent Thrombosis? Zakehn B, Ortiz A, Alfonso F. J Invasive Cardiol 2011;23:E222 E225

42 OCT-ST Evolving Stent Thrombosis Spider Web like Spider Web like Swiss Cheese like Swiss Cheese like Zakehn B, Ortiz A, Alfonso F. J Invasive Cardiol 2011;23:E222 E225

43 Cho JM, Jang JK. J Am Coll Cardiol 2010;55:1274. OCT-ISR

001) IVUS: Patients with LST had positive remodeling - Vessel area 19.4 mm2 vs. 15.1 mm2 (p< 0.003).

44 OCT-ST 18 Pts Late DES ST vs 36 Controls OCT: Patients with LST had a higher % of: - uncovered struts (12.3 vs. 4.1, p< 0.001) - malapposed struts (4.6 vs. 1.8, p< 0.001) IVUS: Patients with LST had positive remodeling - Vessel area 19.4 mm2 vs mm2 (p< 0.003). Independent predictors of LST: - length of segment with uncovered stent by OCT - remodeling index by IVUS Guagliumi G, et al. J Am Coll Cardiol Intv 2012;5:12 20

45 Guagliumi G, et al. J Am Coll Cardiol Intv 2012;5:12 20 OCT-ST

46 OCT-ST 15 Patients ST with OCT & IVUS (before and after PCI) 7 DES / 8 BMS (Median time 347 days) All Patients AMI (11STEMI, 4 NSTEMI) Peak CPK: 2,4352,606 IU Alfonso F, et al. Heart 2012;98:1213e1220

47 OCT-ST A 1 T A2 T B1 B2 T T T T Alfonso F, et al. Heart 2012;98:1213e1220

48 A1 OCT-ST A2 T T B1 B2 Alfonso F, et al. Heart 2012;98:1213e1220

49 OCT-ST A B T C T D E F T T T T D T SB Alfonso F, et al. Heart 2012;98:1213e1220

50 OCT-ST Intra-Stent: Edge-related Dissections MNA Alfonso F, et al. Heart 2012;98:1213e1220

51 OCT-ST OCT Findings at Rescue Interventions Stent Before After Minimal area (mm 2 ) Minimal expansion (%) Severe underexpansion 13 (87%) 6 (40%) Asymmetry Thrombus 15 (100%) 15 (100%) Red/White/Both 7/1/7 7/1/7 Shadowing Length (mm) Maximal TH area (mm 2 ) Residual lumen (mm 2 ) Maximal obstruction (%) Alfonso F, et al. Heart 2012;98:1213e1220

52 OCT-ST A B Alfonso F, et al. Circ Cardiovasc Interv. 2011;4:

53 A OCT-ST B C D Alfonso F. Circ Cardiovasc Interv 2011;4; ;

54 OCT-ST A B C Alfonso F, et al. Circ Cardiovasc Interv. 2011;4:

55 OCT Stent Failure Stent Failure In-Stent Restenosis Stent Thrombosis T (Frequent, Bening) (Rare, PRESTIGE Major (13/08/2012) Complication) Curfman GD, Morrissey S, Jarcho JA, Drazen JM. Drug-eluting coronary stents--promise and uncertainty. N Egl J Med 2007;356(10):

2yrs 2-6yrs >6yrs BMS 0% 22% 42% DES 29% 41% Nakazawa et al. J Am Coll Cardiol 2011;57:

2yrs 2-6yrs >6yrs BMS 0% 22% 42% DES 29% 41% Nakazawa et al. J Am Coll Cardiol 2011;57: Pathology of In-stent Neoatherosclerosis in BMS and DES 197 BMS, 103 SES, and 106 PES with implant duration >30 days The incidence of neoatherosclerosis was significantly greater in DES (31%) than BMS