Percutaneous Revascularization in Surgically Ineligible Patients
This study explores the outcomes of percutaneous revascularization in surgically ineligible patients with multivessel or left main coronary artery disease. The OPTIMUM registry primary results are examined, shedding light on mortality rates, health status outcomes, and the complexities of decision-making in such cases.
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Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients with Multivessel or Left Main Coronary Artery Disease: Primary Results from the OPTIMUM Registry David E. Kandzari, Adam C. Salisbury, and J. Aaron Grantham on behalf of the OPTIMUM Investigators
Disclosure 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 Company Grant/Research Support (Institutional) Consulting Fees/Honoraria Major Stock Shareholder/Equity Abbott Vascular, Boston Scientific, Medtronic CardioVascular, Biotronik, Medinol, Orbus Neich, Teleflex Medtronic CardioVascular, CSI, Magenta BioStar Ventures (none related to ASI) Royalty Income None Ownership/Founder None Intellectual Property Rights None Other Financial Benefit None
Perspective Surgical Ineligibility and Complex Left Main/Multivessel Coronary Disease Increasing prevalence: 1 in 5 patients with left main and/or multivessel disease may be deemed surgically ineligible1 Increasing sensitivity to public reporting of outcomes and physician metrics Historical sense of PCI as default therapy Advancing CHIP momentum and expanding interventional therapeutic toolbox Many factors that influence decision for operative ineligibility not captured in risk models Societal guidelines offer limited, if any, decision making in complex coronary disease when surgery is not an option Surgical turndown patients are systematically excluded from clinical trials; no data regarding health status outcomes following PCI procedures in these patients When selected for PCI, no consensus regarding goals of interventional revascularization (e.g, complete revascularization versus targeted PCI) 1Waldo et al. Circulation 2014; 2Brennan et al. JACC Intv 2013
OPTIMUM Study Design Outcomes of Percutaneous Revascularization for Management of Surgically Ineligible Patients with Multivessel or Left Main Disease 750 surgically ineligible patients by Heart Team enrolled at 22 US centers Medical Therapy, N=24 PCI, N=726 1o Objective: 30-day/in-hospital mortality in PCI cohort compared with predicted STS surgical risk Key 2o Objectives 30-day/in-hospital mortality in PCI cohort compared with (1) EuroSCORE II and (2) Surgeon s predicted risk SAQ, KCCQ at 6 and 12 months 12 month SAQ PCI complete vs incomplete revascularization Additional Endpoints: Reasons for determination of CABG ineligibility Completeness of revascularization and predictors Predictors of survival and health status 30-day, 6 month and 1 year clinical, health status and economic outcomes Survival through 5 years Study support provided by an unrestricted grant from Boston Scientific Corporation; Study Sponsor Saint Luke s Hospital of Kansas City
Cleveland Clinic UPMC Geisinger Wyoming Valley MC R. Carter, J. Blankenship Wilkes-Barre, PA Geisinger MC R. Carter, J. Blankenship Danville, PA J. Khatri, F. Bakaeen, S. Ellis, S. Kapadia Univ Hospitals Cleveland MC H. Bezerra, J. Sabik, S. Filby Cleveland, Ohio C. Toma, C. Cook Pittsburg, PA University of Washington MC W. Lombardi, J. Pal Seattle, WA Mayo Clinic R. Gulati Rochester, MN Mass General Hospital F. Jaffer, D. Doshi Beth Israel Deaconess R. Yeh, K. Khabbaz Boston, MA Henry Ford Hospital K. Alaswad, W. O Neill, J. Borgi Detroit, MI UC-San Diego MC M. Patel San Diego, CA Northwell Health System K. Poumpouridis, C. Grines Manhasset, NY Columbia/NY Presbyterian A. Kirtane, M. Karmpaliotis D, Moses J, Argenziano NY, NY Univ of AZ-Banner Health A. Pershad Phoenix, AZ MedStar Washington Hospital Ctr R. Waksman, P. Corso Washington, DC Univ of KS MC M Wiley, G. Zorn III Kansas City, KS Piedmont Heart Institute D. Kandzari, W. Ballard, W.M. Brown III Emory Univ Hospital H. Liberman, W. Jaber Atlanta, GA Univ of Virginia MC M. Ragosta, G. Ailawadi Charlottesville, VA Charleston Area MC A. Nanjundappa Charleston, WV Saint Luke s MAHI A. Salisbury, J.A. Grantham, K. Allen Kansas City, MO Washington University MC J. Lasala, P. Kachroo St. Louis, MO
OPTIMUM Key Enrollment Criteria and Trial Conduct Inclusion Criteria Age 18 years Unprotected left main stenosis of 50%, 3 vessel disease (stenoses 70%) or 2 vessel coronary disease ( 70%) with one lesion involving the proximal left anterior descending artery Patients with prior bypass surgery: 2 epicardial coronary distributions subtended by a severe native coronary stenosis with either no bypass graft supplying the vessel, a severely diseased ( 70% angiographic stenosis) bypass graft supplying the affected vessel Heart Team determination for coronary bypass surgery ineligibility Exclusion Criteria Presentation with STEMI, ventricular arrhythmia or hemodynamic instability Expected survival of <1 year or any condition that would preclude ability for 1-year follow-up Clinical events site reported with source document verification and adjudication of 30-day events Patient-reported health status outcomes at 6 months and 1 year Independent Angiographic Core Laboratory: Cardiovascular Research Foundation, NY, NY Independent Clinical Events Adjudication: Mid America Heart Institute, Kansas City, MO
OPTIMUM Baseline Clinical Characteristics N= 726 Age, years 70.0 10.9 31.5% Female Diabetes mellitus 56.6% Prior MI 48.2% Prior PCI 32.8% Prior CABG 16.4% Current smoking 18.2% History of stroke 13.8% Chronic kidney disease 37.2% Atrial fibrillation 23.1% Class III/IV heart failure 23.4% LVEF, % 42.6 16.3 Clinical presentation No angina 26.8% Stable angina 35.5% Unstable angina/ACS 37.7% Data expressed as percent or mean SD
OPTIMUM Risk Characteristics and Reasons for Surgical Ineligibility N= 726 18.9% Poor distal target/conduit 16.8% Severe LV dysfunction/non-viable myocardium Severe lung disease 10.1% 9.7% Frailty/immobility 8.7% Prior sternotomy 6.1% Advanced age 3.9% Prior stroke/severe cerebrovascular disease 3.4% Severe aortic calcification 3.2% Renal impairment 2.2% End-stage liver disease 1.9% Morbid obesity 1.5% Malignancy 1.4% Systemic infection 12.4% Other Data expressed as percent
OPTIMUM Angiographic and Procedural Characteristics Angiographic Characteristics Procedural Characteristics N= 726 N= 726 Stents/patient 3.2 1.9 Calcification, severe 82.5% Left main PCI 38.2% Bifurcation 80.2% CTO 56.9% CTO PCI 20.3% Any lesion 20 mm 78.5% Atherectomy 32.0% Total lesion length (mm) 74.2 46.4 Hemodynamic support 27.0% SYNTAX Score (baseline) 32.4 12.2 Intravascular imaging* 63.9% Low (0-22) 21.8% Intermediate (23-32) 32.8% Procedural complications (MI, CIN, perforation, emergency surgery, bleed)* 9.8% High ( 33) 45.3% Data expressed as percent or mean SD. *Non-hierarchical
OPTIMUM Procedural Outcomes Baseline and Post-PCI Total SYNTAX Scores Baseline and Post-PCI SYNTAX Scores p <0.0001* 50 100 9.3 15 40 80 45.3 Percent of Patients (%) Syntax Score 30 32.4 60 20 40 32.8 75.7 15 10 20 21.8 0 0 Pre Post Pre Post Low ( 22) Intermediate (23-32) High ( 33) Post SYNTAX Score 8 Post SYNTAX Score 0 34.3% 11.4% *p-value represents McNemar-Bowker Test
OPTIMUM Surgical Risk Prediction, 30-day/In-hospital Mortality N= 726 STS Predicted Mortality 5.3 5.7 EuroSCORE II Predicted Mortality 5.7 5.4 10.4 12.3 Surgeon s Predicted Mortality Data expressed as percent
OPTIMUM Surgical Risk Prediction, 30-day/In-hospital Mortality N= 726 STS Predicted Mortality 5.3 5.7 EuroSCORE II Predicted Mortality 5.7 5.4 10.4 12.3 Surgeon s Predicted Mortality Observed 30-day/In-hospital Mortality 5.6 Data expressed as percent
OPTIMUM 30-day/In-hospital Mortality and Observed/Expected Estimates N= 726 5.6% Death, 30 Days In-hospital 3.0% Post-discharge 2.6% Death, 6 Months 12.3% 100% 30-day follow-up regarding survival status; confidence intervals calculated using bootstrap samples
OPTIMUM Patient-reported Health Status Baseline and 6-Month Health Status Baseline and 6-Month SAQ Angina Frequency p<0.0001 p<0.0001 p<0.0001 p<0.0001 100 6 100 94.5 90 11.6 27.7 86.6 90 82.6 80 78.8 p<0.0001 77.1 80 70 67.4 70 60 57.9 31.9 60 54.1 Score 50 50 82.4 40 40 30 30 40.5 20 20 10 10 0 0 Baseline 6 months SAQ Summary SAQ Quality of SAQ Angina Frequency 6 months KCCQ Overall Summary Life None Monthly Weekly/Daily Baseline
OPTIMUM 30 Day Mortality and 6 Month Change in Health Status According to Completeness of Revascularization 30-day/In-hospital Mortality 6-Month Health Status Change 7 35 6.3 p=0.40 28.8 6 30 p=0.19 p=0.11 p=0.07 26.6 5 25 22.7 p=0.94 21.5 3.9 4 20 17.9 17.2 15.3 15.1 15 3 10 2 5 1 0 0 8 SAQ Summary SAQ Quality of Life SAQ Angina Frequency KCCQ Overall Summary SYNTAX Score <8 SYNTAX Score >8 SYNTAX score 8 SYNTAX score 8
OPTIMUM Outcomes of Percutaneous Revascularization for Management of Surgically Ineligible Patients with Multivessel or Left Main Disease Patients deemed prohibitive risk for CABG who undergo PCI have complex clinical profiles and high disease burden that are incompletely represented by surgical prediction models Following complex PCI, short-term mortality rates are similar to predicted mortality using surgical risk models, but considerably lower than the evaluating surgeon s estimates PCI is associated with significant, meaningful improvements in patients symptom burden, physical function and quality of life Findings underscore the potential of revascularization to improve patients health status if it can be performed safely, even if surgery is not an option These findings inform decision making and outcomes for a high-risk and largely unstudied patient population relative to risk/benefit, procedural strategies and completeness of revascularization with complex PCI
OPTIMUM Risk Characteristics and 30-day/In-hospital Death/Survival Death N= 41 Alive N= 685 P value 0.03 Age 73.5 8.5 69.8 11.0 STS Mortality <0.001 9.0 8.7 5.1 5.3 <0.001 EuroScore II 9.2 8.4 5.5 5.1 0.055 14.1 17.0 10.2 11.9 Surgeon s Mortality Estimate 61.0% 24.7% <0.001 Hemodynamic Support 70.7% 46.9% 0.002 Prior MI 94.1% 65.3% 0.014 NYHA Class III/IV Heart Failure 0.03 LVEF 36.4 15.9 43.0 16.3 0.04 NSTEMI 84.0% 64.2% 19.5% 9.2% 0.050 Procedural Complications 51.2% 36.4% 0.055 Chronic Kidney Disease 9.8% 16.8% 0.24 Prior CABG 31.6% 22.9% 0.22 Mod/severe Mitral Regurgitation 7.3% 14.2% 0.22 History of Stroke Chronic Lung Disease 36.6% 32.0% 0.54 24.3% 34.9% 0.19 Residual SYNTAX Score <8 Data expressed as percent or mean SD
