PCI vs CABG for Multivessel and LMCA Disease: NOBLE vs. EXCEL Trial Alexander (Sandy) Dick, MD
Disclosures • Interventionist
NOBLE and EXCEL Clarity for PCI vs CABG Debate
WindeckerS, Piccolo R. JACC. 2016;68:1010-3
Capodanno D, et al, JACC, 2011; 58:1426-32
Cavalcante R, et al. JACC 2016;68:999-1009
Levine G, et al. JACC 2011;58:44-122 Windecker S, et al Eur Hrt J 2014;35:2541-619
Need for Updated LM Trial • SYNTAX, LM subgroup • 1 yr follow-up insufficient to capture true benefit accrual of CABG • 1 st generation DES • IVUS/FFR guidance uncommon • Discretional angiographic f/u overinflated number events in PCI arm • Best standards CABG underused
Capodanno D, et al. Int J Cardiol 2012;156;1-3
Randomized (n= 1201) Allocated to PCI (n=598) Allocated to CABG (n=603) • Received PCI (n=585) • Received CABG (n=570 ) • Did not receive PCI (n=13) • Did not receive CABG (n=33) • Died before PCI (n=1) • Died before CABG (n=1) • Patient declined PCI (n=4) • Patient declined CABG (n=15) • PCI operator declined (n=4) • Not eligible for CABG (n=15) • LMCA lesion not significant (n=4) • Cross over by mistake (n=2) Lost to follow-up (n=6) Lost to follow-up (n=11) • Emigration (n=1) • Emigration (n=0) • Contact lost (n=2) • Contact lost (n=0) • Withdrawal (n=3) • Withdrawal (n=11) Patients allocated to PCI in Patients allocated to CABG in analysis (n=592) analysis (n=592) 580 received PCI 567 received CABG 7 received CABG 23 received PCI
Enrollment 2905 patients enrolled at 126 sites in 17 countries Screening registry phase open Randomized enrollment Registry enrollment N=747 N=1000 Screening registry closed Followed through initial treatment (no outcomes data) N=1000 Randomized enrollment N=1158 additional N=1905 total randomized PCI with CoCr-EES CABG N=948 N=957
Stone GW, et al. NEJM 2016; Christiansen EH, et al. Lancet 2016
Results Non-procedural myocardial infarction HR 2·88 (1·40 – 5·90); p=0·004 6·9% 1·9%
Results Total repeat revascularization HR 1·50 (1·04 – 2·17); p=0·03 16·2% 10·4%
Results Stroke HR 2·25 (0·92 – 5·48); p=0·07 4·9% 1·7%
Conclusions • PCI did not meet non-inferiority for the primary endpoint of 5- year MACCE compared to CABG • CABG was superior to PCI • PCI resulted in higher rates of non-procedural myocardial infarctions • Repeat revascularization was higher after PCI, primarily due to de novo lesions and non LMCA target lesion revascularization • All-cause mortality was similar for PCI and CABG
Primary Endpoint Death, Stroke or MI at 3 Years 25% CABG (n=957) PCI (n=948) Death, stroke or MI (%) 20% 15.4% 15% 14.7% 10% HR [95%CI] = 5% 1.00 [95% CI: 0.79, 1.26] P = 0.98 0% 0 1 6 12 24 36 Months No. at Risk: PCI 948 896 875 850 784 445 CABG 957 868 836 817 763 458
Primary Endpoint Definitions • Death: Adjudicated due to CV, non-CV, or undetermined causes • Peri-procedural MI (<72 hrs): CK-MB >10x URL, or >5x URL plus either i) new pathological Q waves in ≥ 2 contiguous leads or new LBBB, or ii) angio documented graft or coronary artery occlusion or new severe stenosis with thrombosis, or iii ) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality • Spontaneous MI ( ≥72 hrs): CK-MB or troponin >1x URL plus new ST-segment elevation or depression or other findings as above • Stroke: Requires: 1) Rapid onset of a focal/global neurological deficit with no other readily identifiable non-stroke cause; 2) Duration ≥ 24 hrs, or <24 hrs if i) pharmacologic or non-pharmacologic Rx; or ii) positive brain imaging; or iii) death; 3) Confirmation by neurologist plus confirmatory brain imaging or LP; 4) ≥ 1 increase in modified Rankin Scale (mRS)
Stone GW, et al. NEJM 2016
Stone GW, et al. NEJM 2016
Christiansen EH, et al. Lancet 2016
Stone GW, et al. NEJM 2016; Christiansen EH, et al. Lancet 2016
Stone GW, et al. NEJM 2016; Christiansen EH, et al. Lancet 2016
Stone GW, et al. NEJM 2016; Christiansen EH, et al. Lancet 2016
Stone GW, et al. NEJM 2016; Christiansen EH, et al. Lancet 2016
Capodanno D, et al. JACC Card Interv 2016
SYNTAX Score Low (≤22) Site Reported Core Lab Intermediate (23-32) High (≥33) 42.8% 40.8% PCI 59.2% 32.2% 25.1% Mean 20.6 ± 6.2 Mean 26.9 ± 8.8 37.3% 38.2% CABG P=0.52 39.3% P=0.005 61.8% 23.4% Mean 20.5 ± 6.1 Mean 26.0 ± 9.8
Results SYNTAX score subgroups K-M estimates 4.9% 1.9% HR 1·88 (1·23 – 2·89); p=0·0031 HR 1·16 (0·76 – 1·78); p=0·48 HR 1·41 (0·62 – 3·20); p=0·41 SYNTAX score assessed by independent corelab (CERC)
Stone GW, et al. NEJM 2016; Christiansen EH, et al. Lancet 2016
Core Lab Data PCI (N=942) CABG (N=936) Qualifying LM lesion* - LM coronary segment 97.6% 97.0% - LM equivalent disease** 1.2% 1.5% - Neither 1.3% 1.5% Distal LM bifurcation or trifurcation ds. 81.8% 79.2% # Diseased non-LM coronary arteries* - 0 17.3% 17.8% - 1 31.0% 31.2% - 2 34.5% 31.5% - 3 17.2% 19.4% *DS ≥ 50% by QCA **DS of both the ostial left LAD and ostial LCX ≥ 50% by QCA
PCI Procedure 935 patients, 1021 planned procedures, 2287 stents # Vessels treated per pt* † 1.7 ± 0.8 Planned staged procedures 9.1% - LM 100.0%** Arterial access site* - LAD 28.3% - Femoral 72.9% - LCX 16.6% - Radial 26.9% - RCA 26.7% - Brachial 0.2% # Lesions treated per pt* 1.9 ± 1.1 # Stents implanted per pt* 2.4 ± 1.5 IVUS guidance 77.2% - Total stent length (mm)* 49.1 ± 35.6 FFR assessment 9.0% Type of stents implanted* Hemodynamic support device* 5.2% - DES 99.8% Contrast use* (cc) 256 ± 127 - EES 99.2% Fluoroscopy time* (min) 24 ± 16 - XIENCE 98.4% *All procedures (index + planned staged); **Excludes pts with LM equivalent ds; † Max 4 vessels, including LM as a separate vessel
Registry (n=1000) Major reasons for exclusion Treatment from randomization of registry patients 50-<70% LM stenosis which did not meet 29.9% criteria for hemodynamic significance Site-assessed SYNTAX 38.1% score ≥33 33.1% 64.8% Heart team consensus of 36.0% ineligibility for PCI 2.1% Heart team consensus of 17.1% ineligibility for CABG CABG PCI No revasc 0% 10% 20% 30% 40% 50% Of the 1747 pts enrolled during the registry period, 62% were eligible for PCI (1078; 331 reg + 747 rand), and 80% were eligible for CABG (1395; 648 reg + 747 rand)
OHI Unprotected LM PCI • 68 unprotected LM in 10 months • Only 8 EXCEL or NOBLE like patients – Too high risk for CABG – SYNTAX >32 – Refused CABG • Uniform excellent angiographic results
Bottom Line EXCEL • Contemporary PCI (best DES, IVUS) vs suboptimal standards CABG (minor off- pump and full arterial revascularization) • Applicable selected patients amenable to both procedures • Noninferiority of PCI met for meaningful range of endpoints; superiority not met
Bottom Line EXCEL • Results largely explained by less periprocedural MIs (large) in PCI group but important catch in MIs up to 3yrs (may continue with ongoing collection)
Bottom Line NOBLE • Very long enrollment period • Reported 5-yr KM estimates while having a median 3 yr follow up. Portion patients received first-generation DES at beginning of trial • Differences with EXCEL partly explained by different MI definition, inclusion repeat revascularization and focus on longer follow up
Bottom Line NOBLE • More thrombosis in NOBLE with SES/BES than in EXCEL with EES: need stratified analysis with stent type • SYNTAX score results at odds with current guidelines
Bottom bottom line • New left main recommendations to be patient-centered based on the early-and long-term trade-offs of each procedure
Circulation, Feb 28, 2017
“….additional evidence that may influence current guidelines by broadening the patient pool that might undergo PCI.” “….considering each patient’s individual circumstances, including life expectancy, comorbidities, extent of disease, angiographic anatomy, likelihood and perceived need for complete revascularization, and patient preference.”
Revascularization Heart Team • Most often none on committee has seen patient • No responsibility for decision • If you don’t routinely – Make evidence based decision (DM, SYNTAX) in conjunction with referring physician with special attention paid to comorbid conditions and patient wishes
Heart Team Revasc vs TAVI • Physician presenting has seen patient • No complex imaging with Revasc – CT, TEE, Mitral valve assessment, Dobutamine Echo – contractile reserve • Allied team members such as geriatric assessment much more relevant TAVI
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