10-­‐year  Outcome  of  LM  Sten4ng    &  

 Management  of  Restenosis  

I Sheiban

Director Interventional Cardiology Pederzoli Hospital

Peshiera del Garda ( Verona ) / Italy

E-mail: isheiban@gmail.com profsheiban@gmail.com

 

Background  •  Unprotected  Le1  Main  disease  is  burdened  by  relevant  risk  of  death  and  MI    

(  up  to  10-­‐15%  of  pts  presenBng  both  with    ACS  or  stable  presentaBon  

•  CABG  has  represented  the  standard  of  care  for  these  paBents  for  many  years,  offering  if  performed  with  LIMA  gra1s  rates  of  patency  up  to  90%  at  ten  years,  but    very  inferior  if  performed  with    SVG  vein  gra1s.    

•  In  the  last  12    years  PCI  for  LM  disease  has  become  widely  used  offering  a  feasible  alternaBve  

•  The  5-­‐year  follow  up  data  from  the  Syntax  trial  and  others  :  similar  rates  of  MACE  in  paBents  treated  with  PCI  vs.  CABG  for  ULM    leading    to    significant  change  in    ESC  guidelines  for  paBents  with  ULM    

•  EvaluaBon  of  long  term  outcome  of  PCI  vs.  CABG  is  mandatory,  but  no  data  have  been  reported  from  observaBonal  registries  on    10    year  outcome  of  PCI  on  ULM  .        

 •  DiparBmento  di  Scienze  Mediche,  Divisione  di  Cardiologia,  CiWà  

della  Salute  e  della  Scienza,  Turin,  Italy,    •  Pederzoli  Hospital  ,  Peschiera  del  Garda  ,  Italy    •  Division  of  Cardiology,  Brighton,  UK    •  ScienBfic  InsBtute  S.  Raffaele,  Milan,  Italy,    •  Department  of  Cardiology,  InsBtut  Cardiovasculaire  Paris  Stud,  •             Hôpital  Privé  Jacques  CarBer,  Générale  de  Santé,  Massy,  France,    •  Cardiovascular  InsBtute,  Hospital  Clínico  San  Carlos,  Madrid,  

Spain;    •  Servicio  de  Cardiología,  Hospital  Marqués  de  Valdecilla,  

Santander,  Cantabria,  Spain  (JDLT)    •  Divisione  di  Cardiologia,  Ospedale  Mauriziano,  Turin,    •  Divisione  di  Cardiologia  ,  Ospedale  Di  Rivoli  ,  Tutrin  ,  Italy    

326  consecuBve  paBents  were  enrolled  in    10  Centers    Index  Procedure      for  ULM  disease  performed  prior  to  2004    with  DES  

q  All  paBents  treated  with  PCI  on  ULM  in  our  Centers  with  at  least  10  years  follow  up  were  enrolled.  

Methods      

q For  each  paBent    the  following  data  were  recorded  :    •  burden  of  cardiovascular  risk  factors,  indicaBon  for  PCI,  

ejecBon  fracBon  •  site  of  the  lesion  (osBal,  mid,  distal),  of  kind  of  technique  

for  bifurcaBon  (provisional  vs.  two-­‐stents  strategies),  of  kind  of  stent  and  its  diameter    

•   angiographic  features  on  non-­‐ULM  stenosis,  site  of  vessel  and  of  lesion      

q  for  a  subgroup  of  paBents  Syntax  Score  was  evaluated  by  two  different  operators  at  each  center.  

•  Primary  End-­‐point                  Re-­‐PCI  on  ULM  at  10  years      •  Secondary  End-­‐point                  MACE  (Major  Adverse  Cardiac  Events)  and  its            

single  components  (cardiac  and  not  cardiac  death,  myocardial  infarcBon,  re-­‐PCI  not  on  ULM  and  Stent  Thrombosis)    

 

Registry  Endpoint  

338  consecuBve  paBents  treated      with  PCI  for  LM  disease      with  DES      before    2004      10    paBents    lost    to      FU        6    paBents  alive  ,  excluded  for  incomplete  clinical    data      326  paBents  with  completed    follow  Up    (96%),  included  in  the  Registry        256  paBents      without    re-­‐PTCA  on  LM    (  79%)    70    paBents      with  re-­‐PTCA  on  LM                      (  21%)      

Study  PopulaBon    

Overall population

(326)

Patients with rePTCA on LM at 10 years (70, 21%)

Patients without rePTCA on LM at 10 years (256, 79%)

P

Age (years) 65±9 66±10 65±9 0.45 Female gender (%) 37 (28) 18 (25) 19 (51) 0.67 Hypertension (%) 231(71) 53 (77) 178 (71) 0.69 Hyperlipidemia (%) 231 (71) 49 (71) 182 (73) 0.83 Diabetes mellitus

-  Non insulin dependent

-  Insulin dependent

96 (32)

29 (12)

24 (35)

8 (13)

72 (28)

21 (11)

0.44

Smoker habit, both previous and current (%)

128 (39) 26 (37) 102 (43) 0.88

Previous Percutaneous Coronary Intervention (PCI)

103 (31) 22 (32)

81 (33) 0.53

Previous surgical revascularization

102 (38) 28 (41) 74 (29) 0.05

Creatinine at admission (md/dl)

1.11±0.54 1.21±0.82 0.91±0.45 0.07

PaBents  CharacterisBcs    

Overall population (326) Patients with rePTCA on LMat 10 years (70, 21%)

Patients without rePTCA on LM at 10 years (256, 79%)

P

Admission diagnosis

-  NSTEMI

-  Unstable angina

-  Stable angina

-  Silent ischemia

27 (8)

119 (37)

136 (41)

44 (12)

4 (6)

27 (38)

29 (41)

10 (12)

23 (9)

92 (36)

107 (42)

34 (13)

0.84

Site of LM disease

-  Ostial

-  Mid

-  Distal

205 (64)

44 (12)

79 (23)

46 (67)

7(10)

16 (23)

159 (62)

37 (14)

63 (24)

0.54

PCI:

-  LM/DA

-  LM/CX

-  LM/ramus

195

99

13

56 (39)

28 (40)

3 (4)

139 (54)

71 (27)

10 (4)

0.83

Bifurcation:

-  Provisional

-  Crush

-  Culotte

-  T stenting

-  V stenting

178

27

12

36

12

35 (61)

8 (12)

4 (6)

9 (13)

1 (2)

143 (69)

19 (7)

8 (3)

27(11)

11 (4)

0.48

PaBents  CharacterisBcs    

Temporal trend for rePTCA on LM.  

Outcome according to rePTCA on ULM or not.

Sensitivity analysis for outcomes according to temporal trends of rePTCA on ULM (p<0.01 for MACE and rePTCA not on ULM).

Freedom from MACE according to isolated (green) vs. not isolated (blu) ULM disease (p for rank <0.01)

Freedom from rePTCA not on left main according to isolated (green) vs. not isolated (blu) ULM disease (p for rank <0.001)

Independent predictors for MACE at 10 years follow up.

Sensitivity analysis for outcomes according to Syntax score (p<0.01 for MACE and rePTCA not on ULM).

What about 2 stents vs. provisional for patients with true bifurcation? Before and after propensity score for type C lesions, lesion of ostial Cx and DA.

Two stents strategy: incidence of acute myocardial infarction and TLR (p not significant)

Provisional vs. two stents tecnhique after ten years follow up. (*p<0.05)

Provisional vs. two stents tecnhique after ten years follow up after propensity score with matching.

Long term freedom from MACE betwenn provisional (green) vs. two stents strategy after propensity matching (p for log-rank 0.67)

Long term freedom from TLR between provisional (green) vs. two stents strategy after propensity matching (p for log-rank 0.67)

Management  of  In-­‐Stent  Restenosis    

 In-­‐Stent-­‐Restenosis  :  Predictors  &  Mechanisms    

Kim  MS.  et  al,  Cardiovasc  Ther  2011;29:190-­‐8    

Similar  in  BMS  &  DES..  

Management  of  Restenosis  :  

Mechanisms  of  DES  Restenosis      

•  Biological  factors    Drug  resistance      HypersensiBvity    Neoatherosclerosis      •Mechanical  factors    Non  uniform  stent  strut  distribuBon      Stent  fractures      Polymer  peeling      Non  uniform  drug  deposiBon    

   •Technical  factors    Incomplete  stent  expansion      Stent  gaps  or  “misses”  (uncovered  lesion  segments)      Barotrauma  to  unstented  segments      

Management  of  Restenosis  :  

Management  of  Restenosis  :  

Restenosis  :  Stent  underexpansion    

Management  of  Restenosis  :  

 

In-­‐Stent-­‐Restenosis  Treatment  Op4ons      Ø  POBA    Ø  Cuong  Balloon    Ø  Scoring  Balloon    Ø  Laser,  RotablaBon    Ø  DEB    Ø  DES  (same  vs.  different)    Ø  VBT    Ø  CABG    

Management  of  Restenosis  :  

 DES  vs.  POBA  :  RIBS  II:  150  paBents  with  BMS-­‐restenosis:  SES  vs.  POBA    

 Alfonso  F.  et  al,  JACC  2006;56:2152-­‐60    

Management  of  Restenosis  :  

 Repeat  DES  vs.  POBA  :345  paBents  with  DES-­‐restenosis:  Repeat  DES  vs.  POBA    

 Cheng  SY.  et  al,  Euro-­‐PCR  2012    

Management  of  Restenosis  :  

   Comparison  Among  Drug-­‐eluBng  Balloon,  Drug-­‐eluBng  Stent,  and  Plain  Balloon  Angioplasty  for  Treatment  of  In-­‐Stent  Restenosis:  A  Network  Meta-­‐analysis  of  11  Randomized  Controlled  Trials  

Management  of  Restenosis  :  

JM  Lee,  TCT  2014  

   11  Trials    including  2059  pts  

DES      =  808    pts  POBA  =  557  pts  DEB        =  694  pts      

Target  Lesions  RevascularizaBon    

Management  of  Restenosis  :  

JM  Lee,  TCT  2014  

MACE    

JM  Lee,  TCT  2014  

Management  of  Restenosis  :  

In-­‐  BVS  Restenosis  

•  Total  paBents  recieving  BVS    =  101    

•  In-­‐BVS    Restenosis  =  6  (6%)    

•  Managment  :    •  CABG  =    1  •  DES          =  5    

     

Management  of  Restenosis  :  

Diffuse  ISR  :      CABG    could  be  the  best  opBon  …    

Post  LM  Trifurca8on    Sten8ng     A;er  5-­‐month  :  diffuse  ISR      

Management  of  Restenosis  :  

Procedural aspects of PCI : Specific  PCI  devices  

Management  of  Restenosis  :  

Ø Despite  use  of  first  generaBon  stents,  PCI  on  ULM  is  safe  and  efficacy  is  long  lasBng  over  Bme  (10  yrs)  with  low  rates  of  recurrent  events  due  to  index-­‐revascularizaBon.    

Ø Progression  of  atheroscleroBc  lesions  on  other  coronary  vessels  (  and  not  LM  itself)  represents  the  only  independent  predicBve  factor  for  prognosis  following  index  procedure  .    

Ø Despite    many  limitaBons    (observaBonal  with  mainly  a  descripBve  aim,  use  of  first  generaBon  stents),  the  concept  of  the  PCI  on  ULM  and  of  its  feasibility    is  the  most  useful  finding.  

Ø In-­‐stent  Restenosis    ,  when  occurs  ,  can  be  safely      and  effecBvely  managed  with    DES  and  DCB  

Final  Remarks