PTCA 1979: : I

Transcription

1 The SYNTAX Message is Clear: CABG is Preferred in Complex MVD Angioplasty Summit TCTAP 2012 Seoul, Korea April 2012 David R. Holmes, MD Mayo Clinic Rochester, MN

2 Presenter Disclosure Information David R. Holmes, Jr., M.D. The SYNTAX Message is Clear: CABG is Preferred in Complex MVD The following relationships exist related to this presentation: Immediate Past President ACC

3 Patient Centric Care Stroke Death Myocardial infarction Repeat procedures Sternotomy t

4 Patient GF 1979: Age 39 was the 16 th patient treated with PTCA at Mayo Clinic : I performed 15 different PCI procedures. 2007: Office visit with patient: It went something like this. 2011: Remains asymptomatic

5 What do we know about SYNTAX Constructed to be an all comer study with limitations Carried out in expert centers by expert surgeons and expert interventional cardiologists Extensive disease which pushed the limit of PCI Excellent surgical techniques although postop meds not as optimal Stent selected first generation, results may not be relevant to current technology

6 Patient in SYNTAX Randomized Controlled Trial Intent-to to-treat CABG n=897 RCT: Enrolled N=1800 PCI * n=903 CABG n=849 RCT: 1 Year Follow-up CABG 94.6% PCI 98.7% PCI * n=891 CABG n=836 RCT: 2 Year Follow-up CABG 93.2% PCI 98.0% PCI * n=885 CABG n=827 RCT: 3 Year Follow-up PCI * CABG 92.2% 2% PCI 98.0% n=885 CABG n=819 RCT: 4 Year Follow-up CABG 91.3% PCI 97.3% PCI * n=879 * TAXUS Express

7 Overall Randomized Cohort 4-year Outcomes (N=1800) CABG (n=897) TAXUS (n=903) 50 P=0.07 P=0.048 P<0.001 P=0.06 P< Patients (% %) Death/CVA/MI Death MI CVA Revasc. Cumulative KM Event Rate; log-rank P value ITT population

8 All-Cause Death to 4 Years CABG (N=897) TAXUS (N=903) (%) nt Rate 50 Before 1 year * 3.5% vs 4.4% P= years * 1.5% vs 1.9% P=0.53 P= years * 1.9% vs 2.6% P= years * 2.2% vs 3.2% P=0.22 ive Eve umulat C % Months Since Allocation 8.8% Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates ITT population

9 Myocardial Infarction to 4 Years CABG (N=897) TAXUS (N=903) (%) nt Rate ve Even umulativ Cu Before 1 year * 3.3% vs 4.8% P= years * 0.1% vs 1.2% P=0.008 P< years * 0.3% vs 1.2% P= years * 0.3% vs 1.5% P= Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates 8.3% 3.8% ITT population

10 CVA to 4 Years CABG (N=897) TAXUS (N=903) (%) nt Rate ve Even umulativ Cu Before 1 year * 2.2% vs 0.6% P= years * 0.6% vs 0.7% P=0.82 P= years * 0.5% vs 0.6% P= years * 0.4% vs 0.2% P= Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates 3.7% 2.3% ITT population

11 MACCE to 4 Years CABG (N=897) TAXUS (N=903) (%) nt Rate ve Even umulativ Cu Before 1 year * 12.4% vs 17.8% P= years * 5.7% vs 8.3% P=0.03 P< years * 4.8% vs 6.7% P= years * 4.2% vs 7.9% P= % 23.6% Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates ITT population

12 Repeat Revascularization to 4 Years CABG (N=897) TAXUS (N=903) (%) nt Rate ( ve Even umulativ Cu Before 1 year * 1-2 years * 2-3 years * 3-4 years * 5.9% vs 13.5% 3.7% vs 5.6% 2.5% vs 3.4% 1.6% vs 4.2% P<0.001 P=0.06 P=0.33 P=0.002 P< % 11.9% Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates ITT population

13 Drug-Eluting Stents vs CABG Repeat Revascularization Meta-Analysis EES vs PES HR=0.51, 95% CI TLR at 1 Year Trials EES PES RR (95% CI) SYNTAX HR=2.3, 95% CI EES vs CABG? SPIRIT II 4/223 5/ (0.08, 1.00) PES SPIRIT III 22/669 18/ (0.33, 1.12) EES 6.9 SPIRIT IV 61/ / (0.39, 0.79) COMPARE 15/897 40/ (0.21, 0.68) Overall (I-squared = 0.0%, p = 0.491) 0.51 (0.39, 0.66) NOTE: Weights are from random effects analysis Risk ratio Favors EES Favors PES Kalesan, Juni Updated 8/2011 Serruys PW et al: NEJM 2009

14 MACCE to 4 Years by SYNTAX Score Tercile Low Scores (0-22) 50 CABG (N=275) TAXUS (N=299) Overall CABG PCI P Death 8.9% 8.3% 0.77 Rate (%) Cumulati ive Event 25 P= % 26.1% CVA 4.0% 1.4% MI 4.2% 6.6% 0.25 Death, CVA or MI 14.6% 14.4% 0.87 Revasc 13.6% 20.0% Months Since Allocation Cumulative KM Event Rate ± 15SE 1.5 SE; log-rank P value Site-reported Data; ITT population

15 MACCE to 4 Years by SYNTAX Score Tercile Intermediate Scores (23-32) 32) ate (%) e Event Ra Cumulative CABG (N=300) TAXUS (N=310) P= Overall 32.0% 21.5% CABG PCI P Death 9.3% 11.1% 0.49 CVA 3.6% 2.0% 0.25 MI 36% 3.6% 90% 9.0% Death, CVA or MI 14.9% 17.3% 0.44 Revasc 10.9% 20.7% Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

16 MACCE to 4 Years by SYNTAX Score Tercile High Scores ( 33) Cumulative Event Ra ate (%) CABG (N=315) TAXUS (N=290) P<0.001 Overall 40.1% 23.6% CABG PCI P Death 8.4% 16.1% CVA 3.7% 3.5% 0.80 MI 3.9% 9.3% 0.01 Death, CVA or MI 14.6% 22.7% 0.01 Revasc 11.4% 28.8% < Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

17 ARC ST Definite ARC ST (Per Patient) Probable ARC ST (Per Patient) Patie ents, % Acute 1d 2.6 Subacute 2-30d 1.7 Late d365d Very Late d d 1095d d1460d Total 4 year Days Postprocedure Definite plus probable per ARC definitions (Cutlip, et al. Circulation 2007;115:2344). 1PCI patient had an ST 1d and 6d post-procedure; procedure; therefore, counted in the 1d and 2-30d intervals but only once in the total.

18 Everolimus-Eluting Eluting vs Paclitaxel-Eluting StentsDES Safety - Risk of Stent Thrombosis Definite ST Definite or Probable ST EES PES RR (95% CI) EES PES RR (95% CI) SPIRIT II 1/223 2/ (0.02, 1.88) SPIRIT II 2/223 2/ (0.05, 2.41) SPIRIT III 6/669 2/ (0.30, 7.36) SPIRIT III 8/669 5/ (0.26, 2.42) SPIRIT IV 8/ / (0.14, 0.81) SPIRIT IV 10/ / (0.15, 0.74) COMPARE 5/897 5/897 24/ (0.08, 0.55) COMPARE 8/897 8/897 35/ (0.11, 0.49) Overall (I 2 = 34.6%, p = 0.205) 0.35 (0.16, 0.77) Overall (I 2 = 9.0%, p = 0.348) 0.34 (0.21, 0.57) Risk ratio Favors EES Favors PES Risk ratio Favors EES Favors PES N = 6,789 Kalesan, Windecker

19 Summary and Conclusions Four-year MACCE rates in the overall randomized cohort were significantly higher for PCI than CABG Significant increase of cardiac death, MI and repeat revascularization in PCI vs CABG-treated patients Composite safety (death/stroke/mi) remains not significantly different between arms at 4 years (P=0.07) MACCE rates at 4 years were not significantly different for patients with a low baseline SYNTAX Score; for patients with intermediate or high SYNTAX Scores, MACCE was increased at 4 years in patients treated with PCI The 4-year SYNTAX results suggest that PCI may be an acceptable alternative revascularization method to CABG when treating gp patients with less complex (lower SYNTAX Score) disease including LM disease

20 SYNTAX and MVD The game is not over We need to know more about causes of death and MI We need to know what a current DES would behave like What about Hybrid procedures with LIMA to LAD and DES to the rest? Still, currently with very severe and extensive disease, CABG appears to be the better option