Assessing Myocardium at Risk: Applying SYNTAX

Transcription

1 Assessing Myocardium at Risk: Applying SYNTAX Farouc Jaffer MD PhD FSCAI FACC FAHA Associate Professor of Medicine, Harvard Medical School Director, CAD Program and Chronic Total Occlusion PCI Program Cardiology Division, Massachusetts General Hospital Session: PCI: Left Main and Multi-Vessel SCAI 2015 Fall Fellows Course, Las Vegas 2015 Dec 7 8:54AM

2 Disclosure Slide 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 Research Grant Consultant Intellectual Property (held by MGH) Company Kowa, Siemens, Canon Boston Scientific, Abbott Vascular Canon June 2015

3 CABG or PCI for Complex CAD?

4 Clinical case of Unprotected Left Main CAD 64F HTN, asthma, COPD presents with UAP. EW briefly hypotensive to 70s. ECG with ST depressions during angina. TnT negative Cath: RCA ok. 80% ostial left main with catheter damping. Mild LAD and CFX CAD. L SCL occluded. Nondiabetic. EF normal 67%. FEV1 reduced 0.85L CABG or PCI?

5 Overall results of the SYNTAX trial for PCI vs. CABG for Three Vessel CAD (3VD) or Left Main (LM) Landmark RCT 1 that demonstrated the value of (1) anatomical Syntax Score and (2) A CAD Heart Team approach to guide decision making between PCI and CABG Real-world 1800 pt trial; 41% of screened patients enrolled Primary endpoint: Non-inferiority of PES PCI and CABG at 1 year was not met, due to increased revascularization in PCI. Five year outcomes 2 based on Syntax Score (SS): CABG showed significantly reduced MACCE in: 3VD: Intermediate (23-32) and High (33+) SS groups Left main (LM): High (33+) Syntax score group 1 Serruys et al. New England Journal of Medicine 2009; 360: Mohr et al. Lancet 2013;381: (SYNTAX Five year follow-up)

6 Analyzing the Benefit of CABG vs. PCI in Syntax * 5 year MACCE for combined 3VD and LM * Low SS (0-22): MACCE n.s.: Subgroup TVR p= Intermediate SS (23-32): MACCE: MI, revasc * High SS (33+): MACCE: All-cause death, Cardiac death, MI and revasc Stroke neutral at 5 years Mohr et al. Lancet 2013;381:

7 Limitations of the SYNTAX Trial ( ) PCI Approach: We are so much better in 2015! New generation DES: MI, Revasc Better DAPT: ticagrelor and prasugrel to stent thrombosis / MI / revasc / death. Less incomplete revasc (linked to MACCE): CTO PCI CABG Approach: Applicable to the US? 28% Bilateral IMAs, 19% all arterial revascularization SYNTAX Score: Does not incorporate clinical characteristics Moderate interobserver variability New scores may improve the predictive accuracy the SS: SYNTAX II (Farooq et al. Lancet 2013) Functional SS (FFR-guided; invasive and noninvasive CT)

8 1st generation DES 2nd/3rd generation DES 1st generation DES Sirolimus eluting stent (SES) Paclitaxel eluting stent (PES; used in SYNTAX) 2nd/3rd generation DES CoCr Everolimus eluting stent (EES), PtCR EES Phosphylcholine Zotarolimus ES, Resolute ZES; PtCR PES

9 SPIRIT IV EES vs. PES: EES: Revascularization, Stent thrombosis at 1 year -GW Stone, et et al. SPIRIT IV 1 year NEJM EES CV Death /MI 30% CV death/mi TLF PES EES PES EES Ischemia-TVR ST PES PES EES EES EES TVR 50% EES ST 70%

10 EES: stent thrombosis by 2/3 rds compared to PES Palmerini et al. Methods: Network meta-analysis of RCTs of DES and BMS Findings: 49 trials, N= patients from RCTs. CoCr-EES vs. PES: CoCr-EES vs. PES: 1-year definite ST (OR 0.28, p<0.05) 2-year definite ST (OR 0.34, p<0.05) Interpretation: CoCr-EES substantially lowers ST compared to PES

11 Benefits of EES may not be extendable to patients with diabetes, however 2011;124: Methods: Pooled SPIRIT II, III, IV, COMPARE trials: CoCr-EES v. PES Findings: N=6780 patients. N=1869 (28%) with diabetes. No Diabetes: Significant reductions in 2 year death ( 39%), MI ( 50%), ST ( 88%), and ischemia-tvr ( 50%) Diabetes: No significant differences in 2 year outcomes Interpretation: CoCr-EES performs similarly to PES in diabetics

12 New off the press: EES is superior to PES in diabetics Taxus Element vs. Xience Prime, NEJM October 15, 2015

13 Modeling SYNTAX 5 year outcomes in Nondiabetics Using EES instead of PES EES vs. 1st gen PES, No Diabetes: TLR 50%, MI 50% Intermediate SS (23-32) High SS (33+) PES EES predicted PES EES predicted * p=ns? * p=ns? PES EES predicted PES EES predicted * p=ns? * p=ns?

14 The latest randomized trials suggests CABG still superior to EES for MVD..but some limits 1776 pts planned. 27 centers. Asia. RCT EES vs CABG -- SJ Park et al. NEJM 2015 March. BEST trial D+MI+TVR 2 yrs Stopped for slow enrollment N = % of those screened w ere enrolled. Mean SS 24. Limitations: (1) 40% diabetic! Subgroup of non diabetics was similar for primary endpoint; (2) CR PCI rate ½ that of CABG. Favors CABG

15 ESC 2014 Guidelines: More Support for Appropriate PCI in Complex CAD, including Left Main Left main and low SYNTAX score: PCI and CABG are BOTH Class I

16 Rationale for a CAD Heart Team Decision making for patients with multivessel or left main CAD is improved by collaboration between cardiac surgeons, interventional cardiologists, referring cardiologists, and other specialists A CAD Heart Team is a Class I recommendation (AHA, ESC) Initiated at MGH Fall CAD Heart Form filled out ahead of time including STS and Syntax scores (see next slide). Weekly meeting available for outpatient discussion, ad hoc meetings within 24 hours for inpatients.

17 CAD Heart Team Form Part 1

18 CAD Heart Team Form Part 2

19 Conclusions Major advances in PCI (new DES, better DAPT, CTO PCI) have occurred since publication of SYNTAX: Stent thrombosis, MI, Revascularization, rss leading to improved PCI outcomes compared to SYNTAX era Currently, it may be reasonable to practice as follows: In non-diabetic individuals who are EES candidates: Low SYNTAX Score: Intermediate SYNTAX Score: High SYNTAX Score: PCI or CABG reasonable CABG or PCI reasonable CABG preferred In all cases, CABG-PCI decisions should be individualized based on a CAD Heart Team evaluation and patient-centered decision making

20 Clinical Case Follow-Up CAD Heart Team Meeting: STS 1.6% mortality, low-risk. Surgeon however concerned about lung disease and prolonged ventilation Syntax Score 16. Syntax II favored PCI (43 vs. 47 points for CABG). AHA 2011 Guidelines: PCI: Class IIa (B) CABG: Class I (B) ESC 2014 Guidelines: PCI: Class I (B) CABG: Class I (B) Heart Team recommended UPLM PCI. Patient underwent successful LM PCI with a two DES in Culotte orientation, IVUS guided, no support (performed by our own Doug Drachman!)

21 Thank you for your attention!