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 Stable CAD at a time when it is being severely challenged!
Will the debate go on forever? • Balloon angioplasty vs CABG BARI – RITA – GABI – EAST - CABRI • Bare metal stent vs CABG – ERACI - II – ARTS – SOS • Drug eluting stents vs CABG - SYNTAX - FREEDOM
The Key Question … Can we extrapolate the findings from prior revascularization studies based upon CABG vs PCI to NEWER STENTS in 2016?
PCI with DES vs CABG • SYNTAX 2009 • FREEDOM 2012
SYNTAX Trial Design De novo disease (n=1800) Limited Exclusion Criteria Previous interventions Acute MI with CPK>2x Concomitant cardiac surgery Left Main Disease 3 Vessel Disease (isolated, +1, +2 or +3 vessels) (revasc all 3 vascular territories) N=705 N=1095 Primary endpoint = death/MI/stroke/repeat revasc at 1 year Serruys PW et al. NEJM 2009;360:961-72
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%)
MACCE at 5 yrs by SYNTAX Score Tercile Low Scores (0-22)
Limitations of SYNTAX Trial • 1 st generation DES (PES) • Suboptimal antithrombotics • Limited use of bivalirudin • No potent P2Y ₁₂ inhibition • Infrequent IVUS / FFR (<10% in SYNTAX) • Infrequent staging in PCI (14% in SYNTAX)
FREEDOM: 1900 pts with diabetes + MVD randomized to SES/PES vs CABG 1 Endpoint: Death, Stroke, or MI 30 PCI/DES 26.6% Death, Stroke, MI, % CABG 20 18.7% 13.0% 10 11.9% p = 0.005 0 0 1 2 3 4 5 6 Years PCI/DES 953 848 788 625 416 219 40 CABG 943 814 758 613 422 221 44 Farkouh ME et al: NEJM 2012
PCI is Better Now than it Was in SYNTAX and FREEDOM!
Differences In … • Clinical Experience. • Newer Stents ( newer generations and BVS ). • FFR. • Syntax Derived Scores. • Complete revascularization.
Differences In … • Clinical Experience. • Newer Stents ( newer generations and BVS ). • FFR. • Syntax Derived Scores. • Complete revascularization.
Stent Material Drug Polymer Strut Thickness
SCAAR Registry (94,384 pts) Adjusted Risks of Adverse Events at 2 yrs Restenosis Definite ST BMS BMS “ Old DES ” “ Old DES ” “ New DES ” “ New DES ” Sarno et al, Eur Heart J 2012
st G DES EES EES vs vs 1 st
Differences In … • Clinical Experience. • Newer Stents ( newer generations and BVS ). • FFR. • Syntax Derived Scores. • Complete revascularization.
FAME: Primary Endpoint 1005 pts with MVD undergoing PCI with DES were randomized to FFR-guided vs. angio-guided intervention FFR assessment → PCI deferred in 37% of lesions 1.00 Freedom from death, MI, revasc 0.95 FFR-guided (n=509) 0.90 30 days 0.85 2.9% 90 days 180 days 3.8% Angio-guided 4.9% 0.80 (n=496) 360 days 5.1% MACE 13.2% vs. 18.3% 0.75 P=0.02 0.70 0 60 120 180 240 300 360 Days Tonino PAL et al. NEJM 2009;360:213 – 24
Change in SYNTAX Score after FFR
Differences In … • Clinical Experience. • Newer Stents ( newer generations and BVS ). • FFR. • Syntax Derived Scores. • Complete revascularization.
Combining clinical and anatomic variables represents a major improvement for risk-stratifying patients in different clinical scenarios.
Differences In … • Clinical Experience. • Newer Stents ( newer generations and BVS ). • FFR. • Syntax Derived Scores. • Complete revascularization.
Completeness of Revascularization • Anatomic – All lesions > 50% • Functional – Lesions producing ischemia • Myocardial perfusion imaging • FFR
Hannan EL: JACC Intv 2009; 2: 17-25
Incomplete Revascularization in DES Era 11, 294 pts (39 Hosp) in NY State PCI Registry; 69% IR Survival CR IR p=0.02 Months Hannan EL: JACC Intv 2009; 2: 17-25
Incomplete Revascularization in DES Era 11, 294 pts in NY State PCI Registry; 69% IR Survival Free from MI CR IR p=0.02 Months Hannan EL: JACC Intv 2009; 2: 17-25
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.
So if Revascularization of Multivessel Disease is Necessary / Desired … Which Procedure Would YOU Have?
Two Very Different Procedures …
Conclusion
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. Circ Cardiovasc Interv 7(4):518-525, 2014
All cause Mortality Circ Cardiovasc Interv 7(4):518-525, 2014
Myocardial Infartion Circ Cardiovasc Interv 7(4):518-525, 2014
Repeat Revascularization Circ Cardiovasc Interv 7(4):518-525, 2014
Stroke Circ Cardiovasc Interv 7(4):518-525, 2014
• 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
PCI for Multivessel CAD Summary • 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
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.
Thank You For Attention
Global Risk Score
SYNTAX II • Additional scoring factors • Anatomical syntax score • Age • Creatinine clearance • LVEF • Presence of unprotected LMCA disease • PAD • Female sex • COPD
Potential SYNTAX MACCE with 2 nd Generation DES
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