Newer stents challenges vs surgery in triple vessel diabetic patients - - PowerPoint PPT Presentation

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Newer stents challenges vs surgery in triple vessel diabetic patients - - PowerPoint PPT Presentation

Apr 20, 2023 478 likes •966 views

Newer stents challenges vs surgery in triple vessel diabetic patients Is it suitable for all patients Sameh Emil, MD., FSCAI FACT Studies of CABG (for MVD) offer some of the most compelling evidence in favor of revascularization for

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Newer stents challenges vs surgery in triple vessel diabetic patients – Is it suitable for all patients

Sameh Emil, MD., FSCAI

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FACT…

Studies of CABG (for MVD) offer some of the most compelling evidence in favor of revascularization for Stable CAD at a time when it is being severely challenged!

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Will the debate go on forever?

  • Bare metal stent vs CABG

– ERACI - II – ARTS – SOS

  • Drug eluting stents vs CABG
  • SYNTAX
  • FREEDOM
  • Balloon angioplasty vs CABG

BARI – RITA – GABI – EAST - CABRI

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The Key Question…

Can we extrapolate the findings from prior revascularization studies based upon CABG vs PCI to NEWER STENTS in 2016?

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PCI with DES vs CABG

  • SYNTAX 2009
  • FREEDOM 2012
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SYNTAX Trial Design

Left Main Disease (isolated, +1, +2 or +3 vessels)

N=705

3 Vessel Disease (revasc all 3 vascular territories)

N=1095 De novo disease (n=1800)

Limited Exclusion Criteria Previous interventions Acute MI with CPK>2x Concomitant cardiac surgery

Serruys PW et al. NEJM 2009;360:961-72

Primary endpoint = death/MI/stroke/repeat revasc at 1 year

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SYNTAX Trial

  • Outcomes were broken down by disease

complexity according to Syntax Score

  • SS < 23 - no difference in composite endpoint
  • SS 23-32 - endpoint was higher with PCI (37.9% vs 22.6%)
  • SS > 33 - endpoint was higher with PCI (41.9% vs 24.1%)
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MACCE at 5 yrs by SYNTAX Score Tercile

Low Scores (0-22)

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Limitations of SYNTAX Trial

  • 1st generation DES (PES)
  • Suboptimal antithrombotics
  • Limited use of bivalirudin
  • No potent P2Y₁₂ inhibition
  • Infrequent IVUS / FFR (<10% in SYNTAX)
  • Infrequent staging in PCI (14% in SYNTAX)
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1 Endpoint: Death, Stroke, or MI

Years 1 2 3 4 6 10 20 30

Death, Stroke, MI, %

953 848 788 416 219 40 PCI/DES 943 814 758 422 221 44 CABG

p = 0.005

PCI/DES CABG

5

625 613

26.6% 18.7% 13.0% 11.9%

Farkouh ME et al: NEJM 2012

FREEDOM: 1900 pts with diabetes + MVD

randomized to SES/PES vs CABG

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PCI is Better Now than it Was in SYNTAX and FREEDOM!

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Differences In …

  • Clinical Experience.
  • Newer Stents ( newer generations and BVS ).
  • FFR.
  • Syntax Derived Scores.
  • Complete revascularization.
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Differences In …

  • Clinical Experience.
  • Newer Stents ( newer generations and BVS ).
  • FFR.
  • Syntax Derived Scores.
  • Complete revascularization.
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Stent Material Strut Thickness Polymer

Drug

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Sarno et al, Eur Heart J 2012

SCAAR Registry (94,384 pts) Adjusted Risks of Adverse Events at 2 yrs

BMS BMS “Old DES” “Old DES” “New DES” “New DES”

Restenosis Definite ST

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EES EES vs vs 1st

st G DES

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Differences In …

  • Clinical Experience.
  • Newer Stents ( newer generations and BVS ).
  • FFR.
  • Syntax Derived Scores.
  • Complete revascularization.
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FAME: Primary Endpoint

Tonino PAL et al. NEJM 2009;360:213–24

FFR-guided (n=509) 30 days 2.9% 90 days 3.8% 180 days 4.9% 360 days 5.1% Angio-guided (n=496)

FFR assessment → PCI deferred in 37% of lesions

Days Freedom from death, MI, revasc

60 120 180 240 300 360 0.70 0.75 0.80 0.85 0.90 0.95 1.00

MACE 13.2% vs. 18.3% P=0.02

1005 pts with MVD undergoing PCI with DES were randomized to FFR-guided vs. angio-guided intervention

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Change in SYNTAX Score after FFR

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Differences In …

  • Clinical Experience.
  • Newer Stents ( newer generations and BVS ).
  • FFR.
  • Syntax Derived Scores.
  • Complete revascularization.
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Combining clinical and anatomic variables represents a major improvement for risk-stratifying patients in different clinical scenarios.

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Differences In …

  • Clinical Experience.
  • Newer Stents ( newer generations and BVS ).
  • FFR.
  • Syntax Derived Scores.
  • Complete revascularization.
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Completeness of Revascularization

  • Anatomic

– All lesions > 50%

  • Functional

– Lesions producing ischemia

  • Myocardial perfusion imaging
  • FFR
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Hannan EL: JACC Intv 2009; 2: 17-25

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Incomplete Revascularization in DES Era

Hannan EL: JACC Intv 2009; 2: 17-25

Months

p=0.02

CR IR

Survival

11, 294 pts (39 Hosp) in NY State PCI Registry; 69% IR

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Incomplete Revascularization in DES Era

Months

Survival Free from MI

p=0.02

CR IR

11, 294 pts in NY State PCI Registry; 69% IR

Hannan EL: JACC Intv 2009; 2: 17-25

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PCI or CABG

  • If patients are equally suited
  • Decision should be made by joint team.
  • Patients willingness to undergo repeat procedures

should be assessed.

  • Patients should be aware of slightly higher stroke risk

with CABG vs PCI.

  • Should not be attempted by low volume operators.
  • Assess ability to take DAPT for a long period of time.
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So if Revascularization of Multivessel Disease is Necessary / Desired… Which Procedure Would YOU Have?

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Two Very Different Procedures…

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Conclusion

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Circ Cardiovasc Interv 7(4):518-525, 2014

68 randomized trials that enrolled 24015 diabetic patients Comparing mode of revascularization in patients with DM. Primary outcome was all-cause mortality. Secondary outcomes were myocardial infarction, repeat revascularization, and stroke.

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All cause Mortality

Circ Cardiovasc Interv 7(4):518-525, 2014

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Myocardial Infartion

Circ Cardiovasc Interv 7(4):518-525, 2014

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Repeat Revascularization

Circ Cardiovasc Interv 7(4):518-525, 2014

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Stroke

Circ Cardiovasc Interv 7(4):518-525, 2014

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  • Conclusions—In patients with diabetes

mellitus, evidence shows similar mortality between CABG and PCI using cobalt– chromium everolimus-eluting stent. CABG was associated with numerically excess stroke and PCI with cobalt–chromium everolimus-eluting stent with numerically increased repeat revascularization.

Circ Cardiovasc Interv 7(4):518-525, 2014

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PCI for Multivessel CAD

  • PCI is appropriate for many diabetic pts with MV CAD

(including poor CABG candidates) .

  • CABG is superior for extensive, very complex CAD.
  • Complete revascularization is associated with better

longer-term outcomes.

  • Functional assessment of indeterminate lesions improves

clinical results with MV PCI.

  • Ischemia is key factor for PCI for stable IHD

Summary

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CONCLUSION

  • No one can claim that PCI can treat all diabetic

patients with MVD.

  • We will find some subsets of patients who will

do absolutely fine or even better with PCI using newer DES and some subsets of patients who will do better with CABG.

  • Honest patient selection.
  • Patient’s preference.
  • Heart team co-operation.
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Thank You For Attention

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Global Risk Score

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SYNTAX II

  • Additional scoring factors
  • Anatomical syntax score
  • Age
  • Creatinine clearance
  • LVEF
  • Presence of unprotected LMCA disease
  • PAD
  • Female sex
  • COPD
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Potential SYNTAX MACCE with 2nd Generation DES