Application of Appropriate Use Criteria in Clinical Care of CAD Peter K. Smith, MD Professor and Chief Thoracic Surgery Duke University 4/29/2012
Influence of Severity and Location of Stenosis on Cardiac Death Over a 7-Year Mean Follow-up in 29,082 Patients Catheterized for CAD at Duke Between 1986 2000 and Treated Without Revascularization Group Severity and Location of Stenosis Relative Chance of Cardiac Death Number of Patients A B C D E F G H I J K L M N None 50% One 50 74% Two or Three 50 74% One 75% Two 75%; None 95% One 95% Prox. LAD or 50 74% LM Two 75%; At least one 95% Two 75% with 95% LAD or 25 49% LM or three 75% and < 95% Two 75% with either Prox. LAD or LM 50 74% Three 75% and two or three 95% Three 75% and either 75% Prox. LAD or 25 49% LM Three 75% and either 95% Prox. LAD or 50 74% LM 75% LM 95% LM 59 71 76 81 94 98 100 0 23 34 37 42 48 50 0 20 40 60 80 100 0 4000 8000
Revascularization vs Medical Therapy 1986-2000 1 Revascularization Medical Therapy 0.9 0.8 Low Severity CAD Survival Probability 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Years
Revascularization vs Medical Therapy 1986-2000 1 Revascularization Medical Therapy Survival Probability 0.9 0.8 0.7 0.6 0.5 0.4 Low Severity CAD Intermediate Severity CAD P<0.05 0.3 0.2 0.1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Years
Revascularization vs Medical Therapy 1986-2000 1 Revascularization Medical Therapy 0.9 Low Severity CAD 0.8 Intermediate Severity CAD Survival Probability 0.7 0.6 0.5 0.4 High Severity CAD P<0.05 0.3 0.2 P<0.05 0.1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Years
J Am Coll Cardiol Intv 2009;2:614-21
SYNTAX 4-year cumulative results Outcome CABG surgery, n=819 (%) PCI, n=879 (%) p MACCE 23.6 33.5 <0.001 Death/stroke/MI 14.6 18 0.07 All-cause mortality 8.8 11.7 0.048 Cardiac death 4.3 7.6 0.004 Stroke 3.7 2.3 0.06 MI 3.8 8.3 <0.001 Repeat revascularization 11.9 23 <0.001 "CABG remains the standard of care for patients with complex disease and an intermediate or high SYNTAX score. However, PCI may be an acceptable alternative revascularization method to CABG when treating patients with less complex diseases (SYNTAX score <22), including left main." To put it another way, 75% of patients with left main or threevessel disease are still best treated with CABG, but for the remaining 25%, "PCI is an alternative to surgery, at least out to four years," Serruys commented.
MACCE to 3 Years by SYNTAX Score Tercile Low Scores (0-22) 40 CABG (N=104) TAXUS (N=118) Left Main CABG PCI P value > Death 6.0% 2.6% 0.21 Cumulative Event Ra ate (%) 30 20 10 P=0.33 23.0% 18.0% > CVA 4.1% 0.9% 0.12 MI 2.0% 4.3% 0.36 Death, CVA or MI < > 11.0% 6.9% 0.26 0 0 12 24 Months Since Allocation 36 < Revasc. 13.4% 15.4% 0.69 Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population
MACCE to 3 Years by SYNTAX Score Tercile Intermediate Scores (23-32) 40 CABG (N=92) TAXUS (N=103) Left Main CABG PCI P value > Death 12.4% 4.9% 0.06 Cumulative Event Ra ate (%) 30 20 10 P=0.90 23.4% 23.4% > CVA 2.3% 1.0% 0.46 MI 3.3% 5.0% 0.63 Death, CVA or MI < > 15.6% 10.8% 0.29 0 0 12 24 Months Since Allocation 36 < Revasc. 14.0% 15.9% 0.75 Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population
MACCE to 3 Years by SYNTAX Score Tercile High Scores (>32) Cumulative Event Ra ate (%) 40 30 20 10 0 CABG (N=149) TAXUS (N=135) P=0.003 0 12 24 Months Since Allocation Left Main 36 37.3% 21.2% CABG PCI P value < Death 7.6% 13.4% 0.10 CVA 4.9% > 1.6% 0.13 MI 6.1% 10.9% 0.18 Death, CVA or MI < < 15.7% 20.1% 0.34 < Revasc. 9.2% 27.7% <0.001 Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population
SYNTAX Randomized Patients 3 Vessel Disease Syntax Score CABG PCI Total% of Total 0-22 171 181 352 32% 23-32 208 207 415 38% >=33 166 155 321 30% Total 1088 CABG Better 68% Left Main CAD Syntax Score CABG PCI Total % of Total Randomized 0-22 103 118 221 32% Randomized 23-32 92 103 195 28% Randomized >=33 150 135 285 41% Total 701 41%
SYNTAX All Patients 3 Vessel Disease Syntax Score CABG PCI Total% of Total 0-22 171 181 352 19% 23-32 208 207 415 22% >=33 166 155 321 17% Registry (Mean 38) 646 133 779 42% Total 1867 Left Main CAD Syntax Score CABG PCI Total % of Total Randomized 0-22 103 118 221 19% Randomized 23-32 92 103 195 16% Randomized >=33 150 135 285 24% Registry (Mean 38) 431 55 486 41% Total 1187 CABG Better 81% 65%
The Usual Talking Points Increased stroke with CABG Revascularization drives the difference, and is not a major complication Neurocognitive Dysfunction with CABG The patient made me do it
Heart Team Approach to Revascularization Decisions I IIa IIb III A Heart Team approach to revascularization is recommended in patients with unprotected left main or complex CAD. I IIa IIb III Calculation of the STS and SYNTAX scores is reasonable in patients with unprotected left main and complex CAD.
Revascularization to Improve Survival: Left Main CAD Revascularization I IIa IIb III CABG to improve survival is recommended for patients with significant ( 50% diameter stenosis) left main coronary artery stenosis. I IIa IIb III PCI to improve survival is reasonable as an alternative to CABG in selected stable patients with significant ( 50% diameter stenosis) unprotected left main CAD with: 1) anatomic conditions associated with a low risk of PCI procedural complications and a high likelihood of a good long-term outcome (e.g., a low SYNTAX score [ 22], ostial or trunk left main CAD); and 2) clinical characteristics that predict a significantly increased risk of adverse surgical outcomes (e.g., STSpredicted risk of operative mortality 5%).
Revascularization to Improve Survival: Left Main CAD Revascularization (cont.) I IIa IIb III PCI to improve survival may be reasonable as an alternative to CABG in selected stable patients with significant ( 50% diameter stenosis) unprotected left main CAD with: 1) anatomic conditions associated with a low to intermediate risk of PCI procedural complications and an intermediate to high likelihood of good long-term outcome (e.g., low- intermediate SYNTAX score of <33, bifurcation left main CAD); and 2) clinical characteristics that predict an increased risk of adverse surgical outcomes (e.g., moderate-severe chronic obstructive pulmonary disease, disability from previous stroke, or previous cardiac surgery; STS-predicted risk of operative mortality >2%).
Revascularization to Improve Survival: Left Main CAD Revascularization (cont.) I IIa IIb III Harm PCI to improve survival should not be performed in stable patients with significant ( 50% diameter stenosis) unprotected left main CAD who have unfavorable anatomy for PCI and who are good candidates for CABG.
Revascularization to Improve Survival: Non- Left Main CAD Revascularization (cont.) I IIa IIb III I IIa IIb III CABG with a left internal mammary artery graft to improve survival is reasonable in patients with a significant ( 70% diameter) stenosis in the proximal LAD artery and evidence of extensive ischemia. It is reasonable to choose CABG over PCI to improve survival in patients with complex 3-vessel CAD (e.g., SYNTAX score >22) with or without involvement of the proximal LAD artery who are good candidates for CABG.
Revascularization to Improve Survival: Non- Left Main CAD Revascularization (cont.) I IIa IIb III CABG is probably recommended in preference to PCI to improve survival in patients with multivessel CAD and diabetes mellitus, particularly if a LIMA graft can be anastomosed to the LAD artery.
2012 Update Appropriateness Criteria
All the usual talking points, plus Unmeasured Confounders such as diffuse vs focal CAD, frailty, medical compliance and patient preference Industry conflict not explicitly declared
Crossroads Appropriate Use Criteria to be utilized to deny payment when criteria are not designated as appropriate unless: Specific documentation of exception for uncertain Second opinion from surgeon for inappropriate Dramatic shift in leadership in Cardiology away from Industry support.
ACCF-STS Database Collaboration on the Comparative Effectiveness of Revascularization Strategies (ASCERT) 86,244 CABG and 103,549 PCI with two- or threevessel disease, age >= 65 STS and NCDR clinical data matched CMS outcome and resource data Longitudinal 3-Year follow-up for mortality
Unnecessary stenting case in Tennessee grabs government attention June 10, 2011 Reed Miller Jackson, TN - The US Department of Justice is looking into charges of fraudulent billing leveled by a Tennessee cardiologist against another cardiologist and two hospitals. Dr Wood Deming (Regional Cardiology Consultants, Jackson, TN) is accusing Dr Elie Hage Korban (Heart and Vascular Center of West Tennessee, Jackson) of "blatant overutilization of cardiac medical services, including, but not limited to, cardiac sonography, scintigraphic stress imaging, angiography, angioplasty, and stenting" in order to defraud government insurance programs, according to documents filed with the US District Court for Western Tennessee. Deming also alleges that the executives of Jackson-Madison County General Hospital and the Regional Hospital of Jackson and radiologist Dr Joel Perchik (Advanced Radiology, Jackson, TN) condoned or assisted in Korban's fraud in addition to engaging in a bilateral kickback and self-referral scheme [1].
Special Thanks To Slide Set Editors L. David Hillis, MD, FACC, Chair and Peter K. Smith, MD, FACC, Vice-Chair CABG Guideline Writing Committee Members L. David Hillis, MD, FACC, Chair Peter K. Smith, MD, FACC, Vice-Chair Jeffrey L. Anderson, MD, FACC John A. Bittl, MD, FACC Charles R. Bridges, MD, ScD, FACC, FAHA John G. Byrne, MD, FACC Joaquin E. Cigarroa, MD, FACC Verdi J. DiSesa, MD, FACC Loren F. Hiratzka, MD, FACC Adolph M. Hutter, Jr., MD, MACC, FAHA Michael E. Jessen, MD, FACC Ellen C. Keeley, MD, MS Stephen J. Lahey, MD Richard A. Lange, MD, FACC Martin J. London, MD Michael J. Mack, MD, FACC Manesh R. Patel, MD, FACC John D. Puskas, MD, FACC Joseph F. Sabik, MD, FACC Ola Selnes, PhD David M. Shahian, MD, FACC, FAHA Jeffrey C. Trost, MD, FACC Michael D. Winniford, MD, FACC Developed in Collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society for Thoracic Surgeons
UPLM PCI to Improve Survival (SIHD) Risk of PCI Complication Likelihood of Good Long-term Outcome CABG Mortality Risk Low Hi Hi Hi Low Low COR IIa For SIHD when low risk of PCI complications and high likelihood of good long-term outcome (e.g., SYNTAX score of 22, ostial or trunk left main CAD), and a signficantly increased CABG risk (e.g., STSpredicted risk of operative mortality 5%) IIb For SIHD when low to intermediate risk of PCI complications and intermediate to high likelihood of good long-term outcome (e.g., SYNTAX score of <33, bifurcation left main CAD) and increased CABG risk (e.g., moderate-severe COPD, disability from prior stroke, prior cardiac surgery, STS-predicted operative mortality >2%) III: Harm For SIHD in patients (versus performing CABG) with unfavorable anatomy for PCI and who are good candidates for CABG LOE B B B
Comprehensive Update 1264 References New Sections Cardiac Anesthesiology/TEE Hybrid Coronary Revascularization Anti-Platelet Therapy Cardiac Rehabilitation Revascularization harmonized with PCI Guidelines
Anesthetic Considerations I IIa IIb III Efforts are recommended to improve interdisciplinary communication and patient safety in the perioperative environment (e.g., formalized checklist-guided multidisciplinary communication). I IIa IIb III A fellowship-trained cardiac anesthesiologist (or experienced board-certified practitioner) credentialed in the use of perioperative TEE is recommended to provide or supervise anesthetic care of patients who are considered to be at high risk.
Intraoperative TEE I IIa IIb III Intraoperative TEE should be performed for evaluation of acute, persistent, and life-threatening hemodynamic disturbances that have not responded to treatment. I IIa IIb III I IIa IIb III Intraoperative TEE should be performed in patients undergoing concomitant valvular surgery. Intraoperative TEE is reasonable for monitoring of hemodynamic status, ventricular function, regional wall motion, and valvular function in patients undergoing CABG.
Bypass Graft Conduit I IIa IIb III When anatomically and clinically suitable, use of a second IMA to graft the left circumflex or right coronary artery (when critically stenosed and perfusing LV myocardium) is reasonable to improve the likelihood of survival and to decrease reintervention. I IIa IIb III Complete arterial revascularization may be reasonable in patients less than or equal to 60 years of age with few or no comorbidities.
Preoperative Antiplatelet Therapy I IIa IIb III In patients referred for elective CABG, clopidogrel and ticagrelor should be discontinued for at least 5 days before surgery and prasugrel for at least 7 days to limit blood transfusions. I IIa IIb III In patients referred for elective CABG, prasugrel should be discontinued for at least 7 days to limit blood transfusions.
Preoperative Antiplatelet Therapy (cont.) I IIa IIb III In patients referred for urgent CABG, clopidogrel and ticagrelor should be discontinued for at least 24 hours to reduce major bleeding complications. I IIa IIb III In patients referred for CABG, short-acting intravenous glycoprotein IIb/IIIa inhibitors (eptifibatide or tirofiban) should be discontinued for at least 2 to 4 hours before surgery and abciximab for at least 12 hours beforehand to limit blood loss and transfusions.
Preoperative Antiplatelet Therapy (cont.) I IIa IIb III In patients referred for urgent CABG, it may be reasonable to perform surgery less than 5 days after clopidogrel or ticagrelor has been discontinued and less than 7 days after prasugrel has been discontinued.