Prof. Dr. med. Sigmund Silber Cardiology Practice and Hospital FACC, FESC Cardiology Practice and Hospital Munich, Germany Outpatient Practice Heart Center at the Isar

New Guidelines for Myocardial Revascularization ESC Stockholm 29th of August 2010

The 2010 ESC Guidelines replaced the previously published ESC Guidelines The following ESC Guidelines are very relevant for Myocardial Revascularisation and served as background and foundation for our Task Force: Silber S, Albertsson P, Aviles FF, et al. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J 2005;26:804-847. Fox K, Garcia MA, Ardissino D, et al. Guidelines on the management of stable angina pectoris: executive summary: The Task Force on the Management of Stable Angina Pectoris of the European Society of Cardiology. Eur Heart J 2006;27:1341-1381. Bassand JP, Hamm CW, Ardissino D, et al. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J 2007;28:1598-1660. Van De Werf F, Bax J, Betriu A, et al. Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J 2008;29:2909-2945.

only 46 pages !

EHJ, 31: 2501-2555, (2010)

Clinical cardiologist (non interventional) Interventional cardiologist NEW: The Heart Team Clinical cardiologist (non interventional) The patient with CAD Interventional cardiologist Cardiac surgeon Task Force composition = 8 clinical cardiologists (non interventional) + 9 interventional cardiologists + 8 cardiac surgeons

Do we need the Heart Team for Patients with ACS ? EHJ, 31: 2501-2555, (2010)

The Heart Team for Patients with stable CAD: ˮOculostenotic  Reflexˮ ist o.k. if… Ad hoc PCI is convenient for the patient, associated with fewer access site complications, and often cost-effective. Ad hoc PCI is reasonable for many patients, but not desirable for all, and should not be automatically applied as a default approach.

The Heart Team for Patients with stable CAD: Avoid the ˮOculostenotic  Reflexˮ if… Hospital teams without a cardiac surgical unit or with interventional cardiologists working in an ambulatory setting should refer to standard evidence-based protocols designed in collaboration with an expert interventional cardiologist and a cardiac surgeon, or seek their opinion for complex cases.

Anatomical representation Stenting Aorto-Coronary Bypass Wijns W & Kolh Ph. Eur Heart J. 2009;30(18):2182-5.

Strength of Recommendation:

Strength of Recommendation:

Bypass Surgery (CABG) versus PCI (with predominantly DES) in Patients with stable CAD In the most severe patterns of CAD, CABG appears to offer a survival advantage as well as a marked reduction in the need for repeat revascularisation.

SYNTAX Score is only anatomy, it does not reflect the clinical status Limitation:

SYNTAX-Score > 33: prefer bypass surgery !

EHJ, 31: 2501-2555, (2010) Do the ESC guidelines from 2010 have to be updated after the presentation of SYNTAX 4-years results at the TCT ?

DES in complex multivessel disease: The Syntax Trial at 4 years: Overall results and breakdown of the 3VD cohort Patrick W. Serruys, MD PhD Erasmus Medical Center, Rotterdam, The Netherlands On behalf of the SYNTAX investigators The Moscone Centre 135 9:58-10:10, 7 Nov, 2011 Conflicts of Interest: None 20

All-Cause Death to 4 Years TAXUS (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 25 50 P=0.048 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) 11.7% 8.8% 12 48 24 36 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates ITT population 21

Repeat Revascularization to 4 Years TAXUS (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 25 50 P<0.001 Cumulative Event Rate (%) 23.0% 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) 11.9% 12 48 24 36 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates ITT population 22

MACCE to 4 Years by SYNTAX Score Tercile High Scores (33) TAXUS (N=290) CABG (N=315) CABG PCI P value Death 8.4% 16.1% 0.004 CVA 3.7% 3.5% 0.80 MI 3.9% 9.3% 0.01 Death, CVA or MI 14.6% 22.7% Revasc. 11.4% 28.8% <0.001 Overall < Months Since Allocation Cumulative Event Rate (%) 12 24 50 25 48 36 P<0.001 40.1% < 23.6% SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibit 56 < < Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

MACCE to 4 Years by SYNTAX Score Tercile Intermediate Scores (23-32) TAXUS (N=207) CABG (N=208) CABG PCI P value Death 12.4% 18.6% 0.048 CVA 3.6% 2.5% 0.53 MI 3.1% 10.5% 0.004 Death, CVA or MI 0.09 Revasc. 8.3% 21.0% 0.0005 3-vessel Disease < Months Since Allocation Cumulative Event Rate (%) 12 24 50 25 48 36 > 33.3% P=0.0006 < 4-Year_Randomized_SX23-32(Core)-3VD(Site)_18JUL11.doc exhibit 1 < 17.9% < Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

Bypass Surgery (CABG) versus PCI (with predominantly DES) in Patients with stable CAD In the most severe patterns of CAD, CABG appears to offer a survival advantage as well as a marked reduction in the need for repeat revascularisation.

MACCE to 4 Years by SYNTAX Score Tercile Low to Intermediate Scores (0-32) TAXUS (N=221) CABG (N=196) CABG PCI P value Death 11.8% 7.5% 0.12 CVA 3.9% 1.4% 0.11 MI 3.8% 5.1% 0.55 Death, CVA or MI 17.1% 13.5% 0.25 Revasc. 16.9% 19.1% 0.57 Left Main > 40 29.0% > 30 P=0.65 < Cumulative Event Rate (%) Cumulative Event Rate (%) 20 27.6% 10 > < 12 24 36 48 Months Since Allocation Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

Bypass Surgery (CABG) versus PCI (with predominantly DES) in Patients with stable CAD In the most severe patterns of CAD, CABG appears to offer a survival advantage as well as a marked reduction in the need for repeat revascularisation.

EHJ, 31: 2501-2555, (2010) Do the ESC guidelines from 2010 have to be updated after the presentation of the SYNTAX 4-years results at the TCT ? No ! These data even confirm the ESC recommendations