September 18th 2012 Case #3: KA, 70 yr M Presentation: Presented on 9/11/2012 with new onset CCS class II angina and a stress MPI moderate apical and mild inferior ischemia. Cath revealed 3 V+LM CAD and normal LV function Prior History: Hyperlipidemia, Hypertension- uncontrolled, Asthma, GI upset Medications: All once daily dosage Candesartan/HCTZ 32/12.5mg, ISMN 60mg, Atorvastatin 20mg, Clopidogrel 75mg, Amlodipine 10mg, Ezetimibe 10mg, Inhalers 1
Case# 3: cont… Syntax score 34 Cardiac Cath 09/11/2012: 3 Vessel + LM CAD with LVEF 65% Left Main: 80% LAD: 80% prox and 80% D1 bifurcation lesion (1,1,1) LCx: 50% prox and 90% multiple lesions in LPL1 RCA: 80% prox and 70% lesion in mid RCA Subsequent Course: - Pt was taken out of the cath lab for Heart Team consultation and CABG recommended for high Syntax score. Pt refused CABG due to personal belief and asthma. Pt was given 162mg enteric coated aspirin and underwent 2 CoCr EES & did well Plan Today: - PCI of LM/LAD-D1 bifurcation/LCx lesions (5 lesions) with FFR 2
Appropriateness Criteria for Coronary Revascularization
Issues Involving The Case Complex CAD: PCI vs. CABG; SYNTAX Trial- 5 Year F/U Non-Complex CAD: PCI vs. (O,R)MMT FAME II Trial
Issues Involving The Case Complex CAD: PCI vs. CABG; SYNTAX Trial- 5 Year F/U Non-Complex CAD: PCI vs. (O,R)MMT FAME II Trial
SYNTAX Trial: Study Design & Patient Disposition 62 EU Sites + 23 US Sites De novo 3VD and/or LM (isolated, +1,2,3 VD) Heart Team (Surgeon & Interventional Cardiologist) Review Randomized if suitable for either CABG or PCI or Enrolled in nested registry if not equally suitable CABG Reg. n=649* CABG RCT n=897 PCI RCT n=903 PCI Registry n=198 Enrolled CABG n=644** From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc Exhibit 5 SYNTAX 5-Year Report_Randomized_15JUN12.doc Exhibit 4 (evaluable for 5-year MACCE) SYNTAX 5-Year Report_Registry_22JUN12.doc Exhibits 4 and 8 CABG 849 (94.6%) PCI 891 (98.7%) PCI n=192** Primary Endpoint 1 Year Follow-up CABG 610 (94.7%) CABG 805 (89.7%) Completed Study 5 Year Follow-up PCI 871 (96.5%) PCI 188 (97.9%) *N=649 followed for 5 years, N=1077 enrolled, **CABG N=644, PCI N=192 treated per protocol. PCI performed with TAXUS Express
SYNTAX Trial: All-Cause Death to 5 Years PES (N=903) CABG (N=897) Before 1 year* 3.5% vs 4.4% P=0.37 1-2 years* 1.5% vs 1.9% P=0.53 2-3 years* 1.9% vs 2.6% P=0.32 3-4 years* 2.2% vs 3.2% P=0.22 4-5 years* 3.1% vs 2.3% P=0.34 25 50 P=0.10 P=0.10 Cumulative Event Rate (%) 1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 1 2-Year_Randomized_20090917.doc Exhibit 2 (binary interval rate) SYNTAX 3-Year Report_Randomized_12JUL10.doc Exhibit 2 (binary interval rate) SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 1 (KM rate on right sidea) and exhibit 2 (binary interval rate in white box) 13.9% 11.4% 12 60 24 36 48 Months Since Allocation ESC 2012 Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates ITT population 7
SYNTAX Trial: Myocardial Infarction to 5 Yrs PES (N=903) CABG (N=897) Before 1 year* 3.3% vs 4.8% P=0.11 1-2 years* 0.1% vs 1.2% P=0.008 2-3 years* 0.3% vs 1.2% P=0.03 3-4 years* 0.3% vs 1.5% P=0.01 4-5 years* 0% vs 1.2% P=0.004 25 50 P=0.001 P<0.001 Cumulative Event Rate (%) 1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 1 2-Year_Randomized_20090917.doc Exhibit 2 (binary interval rate) SYNTAX 3-Year Report_Randomized_12JUL10.doc Exhibit 2 (binary interval rate) SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 1 (KM rate on right sidea) and exhibit 2 (binary interval rate in white box) 9.7% 3.8% 12 60 24 36 48 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates ITT population 8
SYNTAX Trial: CVA to 5 Years PES (N=903) CABG (N=897) Before 1 year* 2.2% vs 0.6% P=0.003 1-2 years* 0.6% vs 0.7% P=0.82 2-3 years* 0.5% vs 0.6% P=1.00 3-4 years* 0.4% vs 0.2% P=0.68 3-4 years* 0% vs 0.1% P=1.00 25 50 P=0.09 P=0.09 Cumulative Event Rate (%) 1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 1 2-Year_Randomized_20090917.doc Exhibit 2 (binary interval rate) SYNTAX 3-Year Report_Randomized_12JUL10.doc Exhibit 2 (binary interval rate) SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 1 (KM rate on right sidea) and exhibit 2 (binary interval rate in white box) 3.7% 2.4% 12 60 24 36 48 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates 9
SYNTAX Trial: All Death/CVA/MI to 5 Yrs PES (N=903) CABG (N=897) Before 1 year* 7.7% vs 7.6% P=0.98 1-2 years* 2.2% vs 3.5% P=0.11 2-3 years* 2.5% vs 3.8% P=0.14 3-4 years* 2.7% vs 4.6% P=0.05 4-5 years* 3.1% vs 3.1% P=0.98 25 50 P=0.03 P=0.03 Cumulative Event Rate (%) 20.8% 1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 1 2-Year_Randomized_20090917.doc Exhibit 2 (binary interval rate) SYNTAX 3-Year Report_Randomized_12JUL10.doc Exhibit 2 (binary interval rate) SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 1 (KM rate on right sidea) and exhibit 2 (binary interval rate in white box) 16.7% 12 60 24 36 48 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates 10
SYNTAX Trial: Repeat Revasc to 5 Years PES (N=903) CABG (N=897) Before 1 year* 5.9% vs 13.5% P<0.001 1-2 years* 3.7% vs 5.6% P=0.06 2-3 years* 2.5% vs 3.4% P=0.33 3-4 years* 1.6% vs 4.2% P=0.002 4-5 years* 1.9% vs 4.3% P=0.008 25 50 P<0.001 P<0.001 25.9% Cumulative Event Rate (%) 1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 1 2-Year_Randomized_20090917.doc Exhibit 2 (binary interval rate) SYNTAX 3-Year Report_Randomized_12JUL10.doc Exhibit 2 (binary interval rate) SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 1 (KM rate on right sidea) and exhibit 2 (binary interval rate in white box) 13.7% 12 60 24 36 48 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates 11
SYNTAX Trial: MACCE to 5 Years PES (N=903) CABG (N=897) Before 1 year* 12.4% vs 17.8% P=0.002 1-2 years* 5.7% vs 8.3% P=0.03 2-3 years* 4.8% vs 6.7% P=0.10 3-4 years* 4.2% vs 7.9% P=0.002 4-5 years* 5.0% vs 6.3% P=0.27 25 50 P<0.001 P<0.001 37.3% Cumulative Event Rate (%) 26.9% 1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 1 2-Year_Randomized_20090917.doc Exhibit 2 (binary interval rate) SYNTAX 3-Year Report_Randomized_12JUL10.doc Exhibit 2 (binary interval rate) SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 1 (KM rate on right sidea) and exhibit 2 (binary interval rate in white box) 12 60 24 36 48 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates ITT population 12
SYNTAX Trial: PP Graft Occlusion or Stent Thrombosis to 5 Years (Per Patient Binary Rates) 7 CABG PCI Patients (%) 7 SYNTAX 5-Year Report_Randomized_22JUN12.doc Exhibit 9 Acute ≤1d Subacute 2-30d Late 31-365d Very Late 731- 1095d 1096- 1460d 1461- 1825d Total 5 year 366- 730d Days Postprocedure 13
SYNTAX score is purely High >32 an anatomic score of the extent of CAD (>50%) in a pt Each lesion is assigned a numerical number and then sum of all lesions score for a patient is calculated to come up with the final numerical Syntax score Pt are divided in 3 groups: Low <22 Intermediate 23-32 High >32 Serruys P et al. NEJM 2009;360:961.
SYNTAX Trial: MACCE vs. SYNTAX Score *P= 0.03 vs PCI with SYNTAX score ≤22 †P= 0.002 vs PCI with SYNTAX score 23-32 Trend for PCI: P=0.006 P < 0.001 CABG (n= 897) PES DES (n= 903) 23.4*† 16.7 14.7 13.6 12.0 MACCE at 12 Months (%) 10.9 In patients with a SYNTAX score of 22 or less (meaning less complicated disease), there was no significant difference between CABG and PCI in rates of major adverse cardiac and cerebrovascular events. In patients with moderately complicated disease (represented by a SYNTAX score of 23 to 32) a trend toward better outcomes with CABG was seen, although the difference did not reach statistical significance. In patients with very complicated disease (represented by a SYNTAX score of 33 or more), CABG had significantly better outcomes than PCI (P<.001). The rate of MACCE in the high-score PCI group was statistically significantly higher than in the other PCI groups; the trend for all 3 PCI groups was statistically significant as well. These results provide evidence for current practices in which patients with complex, multivessel disease receive CABG while patients with less complex disease are treated with PCI. ≤22 23-32 ≥33 SYNTAX Score Serruys P et al. NEJM 2009;360:961. Serruys PW, Mohr FW. Presented at: Transcatheter Cardiovascular Therapeutics 2008; October 12-17, 2008; Washington, DC.
MACCE to 5 Years by SYNTAX Score Tercile Low Scores (0-22) PES (N=299) CABG (N=275) CABG PCI P value Death 10.1% 8.9% 0.64 CVA 4.0% 1.8% 0.11 MI 4.2% 7.8% Death, CVA or MI 14.9% 16.1% 0.81 Revasc. 16.9% 23.0% 0.06 Overall 50 32.1% P=0.43 Cumulative Event Rate (%) 25 28.6% SYNTAX 5-Year Report_Randomized_15JUN12.doc exhibit 53 12 24 36 48 60 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value
MACCE to 5 Years by SYNTAX Score Tercile Intermediate Scores (23-32) PES (N=310) CABG (N=300) CABG PCI P value Death 12.7% 13.8% 0.68 CVA 3.6% 2.0% 0.25 MI 11.2% <0.001 Death, CVA or MI 18.0% 20.7% 0.42 Revasc. 24.1% Overall 50 36.0% P=0.008 Cumulative Event Rate (%) 25 SYNTAX 5-Year Report_Randomized_15JUN12.doc exhibit 55 25.8% 12 24 36 48 60 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value
MACCE to 5 Years by SYNTAX Score Tercile High Scores (33) PES (N=290) CABG (N=315) CABG PCI P value Death 11.4% 19.2% 0.005 CVA 3.7% 3.5% 0.80 MI 3.9% 10.1% 0.004 Death, CVA or MI 17.1% 26.1% 0.007 Revasc. 12.1% 30.9% <0.001 Overall 50 P<0.001 44.0% Cumulative Event Rate (%) 25 26.8% SYNTAX 5-Year Report_Randomized_15JUN12.doc exhibit 57 12 24 36 48 60 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value
MACCE to 5-Years Based on Syntax Score Tercile: 3 V CAD CABG PES DES Death, MI or CVA 0-22 11.6 p=0.06 23-32 >33 18.8 8.4 18.2 21.1 10.5 p=0.004 p=0.006 171 155 166 181 208 207 Revascularization p=0.007 26.1 p=0.81 p=0.42 20.7 18.0 17.1 16.1 14.9 % % 171 181 208 207 166 155 0-22 23-32 >33 Serruys et al, ESC 2012
ACC/AHA/SCAI Guidelines: Revascularization to Improve Survival in Complex CAD Revasc Method COR LOE CABG I B PCI IIaFor 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., STS-predicted risk of operative mortality ≥5%) IIbFor 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: HarmFor SIHD in patients (versus performing CABG) with unfavorable anatomy for PCI and who are good candidates for CABG IIaFor UA/NSTEMI if not a CABG candidate IIaFor STEMI when distal coronary flow is <TIMI grade 3 and PCI can be performed more rapidly and safely than CABG C GNL 2011
Appropriate Use Criteria 2012 Method of Revascularization of Multi-vessel CAD CABG PCI Two-vessel CAD with proximal LAD stenosis A Three Vessel CAD with low CAD burden (i.e., three focal stenosis, low SYNTAX score) Three-vessel CAD with intermediate to high CAD burden (i.e., multiple diffuse lesions, presence of CTO, or high SYNTAX score). U Isolated left main stenosis Left main stenosis and additional CAD with low CAD burden (i.e., one to two vessel additional involvement, low SYNTAX score) Left main stenosis and additional CAD with intermediate to high CAD burden (i.e., three vessel involvement, presence of CTO, or high SYNTAX score) I Patel et al., JACC 2012; 59:0000 21
Heart Team Approach to UPLM or Complex CAD Anatomic Setting COR LOE UPLM or Complex CAD I – Heart Team Approach C IIa – Calculation of the STS and SYNTAX scores B GNL 2011
Incorporation of intermediate-high SYNTAX Score (23-32, 33+) for revascularization choice in pts with 3V CAD: 4-Yr Data of SYNTAX Trial As you all know, since Jan 2010, we have incorporated Syntax score in stratifying patients for revascularization choices (PCI or CABG) for advanced CAD and pts with Syntax score 33 who are not high-surgical risk, being preferentially referred for CABG. Recent presentation of 4-year data of Syntax Trial at TCT 2011, revealed CABG arm having significantly lower individual endpoint of death or MI or revascularization compared to Taxus DES PCI, even in the intermediate Syntax score (23-32) patients with 3V CAD. This observation was noted in both diabetic and non-diabetic pts. Outcomes of pts with low Syntax score (<23) was comparable in both groups. Hence as per evidence-based guidelines, optimal coronary revascularization for intermediate Syntax scores (23-32) pts as well as high scores (>33) pts, should be CABG. Therefore, patients with SYNTAX Score 23 and not having absolute contraindications to CABG (included below), should be taken out of the cath room for discussion with Heart Team regarding choices of revascularization. As a rule, these 3V CAD patients (SYNTAX Score 23) should be categorically recommended for CABG because of survival & MI advantage over PCI. Consultation with of a cardiac surgeon will be required if PCI is contemplated in these pts. Only exception to this rule (taking the pt out of the cath room for discussion) could be, if the referring MD (who has to be different then the Interventionalist) is physically present in the cath lab and expresses strong desire against CABG (because of his/her own belief or known wishes of the patient). Patients with 3V CAD and SYNTAX Score 23 but following situations and co-morbidities could be excluded from routine CT surgery consultations: 1) Acute MI (STEMI or Non-STEMI) 2) Age >85 years old 4) Prior CVA/recent TIA 5) Severe COPD (FEV1 <50% predicted) and on chronic bronchodilator therapy 6) BMI >50 7) Participation in IRB approved trial of PCI Also patient’s firm refusal for CABG should be entertained only after the CT surgery consultation outside the cath room in the holding area or the telemetry unit. We will monitor and report the data of this system process going forward by analyzing the triage of all 3V CAD pts with Syntax score of (23).
Various Risk Classifications for Revascularization in CAD 24
Garg et al., Circ. Cardiovasc. Interv 2010;3; 317 25
Kaplan Meier Curves for MACCE Garg et al., Circ. Cardiovasc. Interv 2010;3; 317
Global Risk Classification (GRC) for CAD Capodanno et al, Am Heart J 2010; 159:103
Features considered score calculation Score name Ref. Score Range Features considered score calculation Comments SRS (SYNTAX risk score) Serruys and co workers 0 to ~ 75 Exclusively based on coronary anatomy. Can be complex to calculate; usually requires online assistance or dedicated software. CSS (Clinical SYNTAX score) Garg et al 0 to ~ 500 Based on both coronary and clinical features. Calculated by multiplying the SRS with the ACEFmod scores. NYSRS (New York State Risk Score) Wu et al 0 to 40 Age, gender, hemodynamic state, LVEF, pre-procedure MI, PAD, CHF, renal failure, LM CAD. 8 of 9 elements are clinical co-morbidities, with only 1 coronary anatomical feature (LM disease). ACEF (Age, Creatinine, Ejection Fraction score) Ranucci et al 1 to ~10 Considers only age, creatinine and ejection fraction. = [Age (yrs)/LVEF (%)] + 1 if creatinine ≥ 2.0 mg/dL. Originally derived in cardiac surgery patients. ACEFmod (Modified ACEF score) 1 to ~14 Considers only age, creatinine clearance and ejection fraction. = [Age (yrs)/LVEF (%)] + 1 point for every 10 mL/min reduction in CrCl below 60 mL/min per 1.73 m2 (up to a maximum of 6 points). NCDR (National Cardiovascular Data Registry score) Peterson et al 0 to 100 Age, prior CHF, shock, PAD, lung disease, GFR, NYHA class IV, PCI urgency. Does not consider coronary anatomy. Other risk scores: EuroSCORE, Society of Thoracic Surgeons (STS), Global Risk Classification (GRC) score (= EuroSCORE + SRS), FFR-based SYNTAX, NYSRS for patients >65 years of age, Northern New England, Michigan Consortium, William Beaumont Hospital, Mayo Clinic.
Risk Score Distributions in 500 MV CAD at MSH SRS CSS NYSRS ACEF ACEFmod NCDR 29
Mortality SRS CSS NYSRS ACEF ACEFmod NCDR p = 0.006 p < 0.0001 proportion proportion proportion ACEF ACEFmod NCDR p < 0.0001 p < 0.0001 p = 0.002 proportion proportion proportion
Myocardial Infarction SRS CSS NYSRS p = 0.024 p = 0.041 p = 0.27 proportion proportion proportion ACEF ACEFmod NCDR p = 0.27 p = 0.26 proportion proportion proportion p = 0.28
Target Lesion Revascularization SRS CSS NYSRS p = 0.075 proportion proportion proportion p = 0.37 p = 0.89 ACEF ACEFmod NCDR p = 0.24 p = 0.14 p = 0.045 proportion proportion proportion 32
Major Adverse Cardiac Events SRS CSS NYSRS p < 0.0001 p = 0.027 p < 0.0001 proportion proportion proportion ACEF ACEFmod NCDR p = 0.001 proportion proportion proportion p = 0.37 p = 0.67
Mortality SRS NYSRS ACEFmod Reference CSS ACEF NCDR Risk Score AUC p value vs. SRS ACEF 0.7586 0.082 CSS 0.7550 0.019 NYSRS 0.7408 0.17 Risk Score AUC p value vs. SRS ACEFmod 0.7400 0.18 NCDR 0.6789 0.78 SRS 0.6616 - 34
Major Adverse Cardiac Events SRS NYSRS ACEFmod Reference CSS ACEF NCDR Risk Score AUC p value vs. SRS SRS 0.6282 - CSS 0.6059 0.39 NYSRS 0.5942 0.38 Risk Score AUC p value vs. SRS ACEF 0.5865 0.26 ACEFmod 0.5589 0.076 NCDR 0.5333 0.021
Issues Involving The Case Complex CAD: PCI vs. CABG; SYNTAX Trial- 5 Year F/U Non-Complex CAD: PCI vs. (O,R)MMT FAME II Trial
Page 991 Conclusions In patients with stable coronary artery disease and functionally significant stenosis, FFR-guided PCI plus the best available medical therapy,, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to favorable with the best available medical therapy alone. (Funded by St. Jude Medical; Clinic al trials. Gov. number. NCT 01132495) 37
FAME II Trial: Flow Chart Stable patients scheduled for 1,2 or 3 vessel DES stenting FFR in all targets lesions Randomized Trial Registry At least 1 stenosis with FFR < 0.80 When all FFR >0.80 Randomization 1:1 OMT PCI + OMT OMT 50 % randomly assigned to FU Follow-up after 1,6 months, 1,2,3,4 and 5 years 38
FAME II Trial: Cumulative Incidence of Primary End Points and Its Components Bruyne et al., NEJM 2012:367:991
FAME II Trial: Revascularization Status P<0.001 5.2% MT alone and 0.9% PCI patients had MI or UA with ECG changes requiring TVR (HR 0.13; P=<0.001) P<0.001 (%) P<0.001 Bruyne et al., NEJM 2012:367:991 40
FAME II Trial: Landmark Analysis of the Primary End Point and Its Components Bruyne et al., NEJM 2012:367:991
FAME II Trial: Patients with Angina Class II to IV and Corresponding Relative Risk Bruyne et al., NEJM 2012:367:991 42
Japanese Stable Angina Pectoris (JSAP Trial) 469 met eligibility criteria 85 declined to give permission 384 consented to participate (82% of patients with protocol eligibility) 192 were assigned to PCI plus medical group, and underwent initial elective PCI 41 (21.4%) underwent additional elective PCI 192 were assigned to initial medical therapy only group 70 (36.5%) underwent additional elective PCI 192 were included in the primary analysis 192 were included in the primary analysis Nishigaki et al., JACC Intv 2008;1:469 43
JSAP Trial: PCI + MT for Low Risk CAD Nishigaki et al., JACC Intv 2008;1:469
JSAP Trial: PCI + MT for Low Risk CAD MT (n= 182) PCI (n= 183) % Nishigaki et al., JACC Intv 2008;1:469 45
COURAGE Trial: 5-year death/MI Subgroup Analysis based on the Regional Practices OMT Group (n=1138) PCI Group (n=1149) P ≈ 0.02 22 22 21 17 15 Death/MI (%) at 4.6 years 14 27%↑ 29%↓ Canada 932 pts US VA 968 pts US non-VA 387 pts Boden et al. N Engl J Med 2007;356:1503 46 46
PCI vs. RMT in Stable CAD: NY State Database 4-Year Adverse Outcomes for Propensity-Matched PCI vs. Medical Therapy Overall survival Freedom from MI No at Risk 0.0 1.0 2.0 3.0 4.0 5.0 RMT 933 870 675 458 310 145 PCI 865 648 429 291 140 No at Risk 0.0 1.0 2.0 3.0 4.0 5.0 RMT 933 873 700 445 298 169 PCI 890 726 480 332 182 Hannan et al, Circulation 2012;125:1870 47
PCI vs. RMT in Stable CAD: NY State Database 4-Year Adverse Outcomes for Propensity-Matched PCI vs. Medical Therapy P = 0.005 P = 0.02 P = 0.007 % Hannan et al, Circulation 2012;125:1870 48
PCI vs. RMT in Stable CAD: NY State Database Hannan et al, Circulation 2012;125:1870
COURAGE Trial type Cases (N=265,184) Pattern and Intensity of Optimal Medical Therapy (OMT) during PCI: Impact of COURAGE Trial: Data from ACC-NCDR CathPCI Registry PRE- COURAGE (n=173,416) Post- COURAGE (n=293,795) 66.0 63.5 64.3 61.8 % 43.5 44.7 40.0 41.1 OMT Pre-PCI OMT Post-PCI OMT Pre-PCI OMT Post-PCI All Cases (N=467,211) COURAGE Trial type Cases (N=265,184) W Borden et al. JAMA 2011;305:1882
Pattern and Intensity of Optimal Medical Therapy (OMT) during PCI: Impact of COURAGE Trial: Data fro ACC-NCDR CathPCI Registry PRE- COURAGE (n=173,416) Post- COURAGE (n=293,795) 66.0 63.5 64.3 61.8 % 43.5 44.7 40.0 41.1 Implications: There is a large practice gap in medical care of PCI pts. Important opportunity to develop innovative and aggressive strategies to increase OMT in PCI pts, both before PCI (by referring MDs) and after PCI (by the Interventional team) OMT Pre-PCI OMT Post-PCI OMT Pre-PCI OMT Post-PCI All Cases (N=467,211) COURAGE Trial type Cases (N=265,184) W Borden et al. JAMA 2011;305:1882
Take Home Message: Incorporation of SYTAX and FAME II Trials in Coronary Revascularization Long-term data of coronary revascularization for complex extensive CAD (Syntax score >23), clearly favors CABG over 1st generation DES PCI and should become the default therapy by guidelines. FREEDOM Trial will be presented as the LBT in AHA 2012 Appropriate revascularization of obstructive lesions guided by physiological FFR (<0.8) during PCI, has shown to achieve excellent long-term results and is superior to MMT alone
Question # 1 5-Year f/u of SYNTAX Trial has shown CABG to be superior to DES PCI on following components except: All cause mortality Repeat revascularization CVA Myocardial infarction C
Question # 2 Appropriate dose of IV adenosine for hyperemic FFR evaluation is: 140 mcg/kg/min 160 mcg/kg/min 120 mcg/kg/min 10 mcg IC bolus A
Question # 3 FAME II Trial showed the following outcome in the FFR guided PCI vs. medical therapy; Higher readmission More angina class Reduced Mortality Lower TLR D
Question # 4 In the SYNTAX trial of DES vs CABG which drug eluting stent was used? Sirolimus eluting stent Paclitaxel eluting stent Everolimus eluting stent Zotarolimus eluting stent B
Question # 5 Following are the risk score for assessment of revascularization status except; Grace score Syntax score Global risk score EuroScore NY State risk score A