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The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX Study Primary Endpoint Results at One Year in the Randomized.

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Presentation on theme: "The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX Study Primary Endpoint Results at One Year in the Randomized."— Presentation transcript:

1 The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX Study Primary Endpoint Results at One Year in the Randomized Cohort Patrick W. Serruys MD PhD Friedrich W. Mohr MD PhD On behalf of the SYNTAX investigators Conflicts of Interest: None

2 During the present decade, major developments in CABG (e.g. off-pump technique, less invasive approach, increased arterial revascularization and optimal perioperative care). In PCI (e.g. improved technique, stent design, guide wires, anti-platelet therapy, and drug- eluting stents) have made it important to reassess the respective values of the two revascularization techniques in an all-comers population as seen by the surgeon and the interventional cardiologist in their daily practice. Background: I

3 At the time of the trial design (in ), a retrospective website survey of 104 medical centers over a period of 3 months showed that 12,072 patients (1/3 LM, 2/3 3VD) were revascularized by surgery (2/3) or by PCI (1/3). The SYNTAX randomized trial is an attempt to provide an evidence-base to determine whether this approach, which is already currently practiced, is valid. Background: II Kappetein et al, Eur J Cardiothorac Surg. 2006;29:

4 Intended all-comers study design instead of a highly selected patient population Consensus physician agreement (surgeon & cardiologist) instead of inclusion & exclusion criteria And, nested registries for CABG only and PCI only to define patient characteristics and outcomes of these two unique treatment options SYNTAX: Intended All-Comers Design with Nested Registries

5 Left Main Disease (isolated, +1, +2 or +3 vessels) 3 Vessel Disease (revasc all 3 vascular territories) SYNTAX Eligible Patients De novo disease Limited Exclusion Criteria Previous interventions Acute MI with CPK>2x Concomitant cardiac surgery

6 Patient Profiling Local Heart team (surgeon & interventional cardiologist) assessed each patient in regards to : Patients operative risk (EuroSCORE & Parsonnet score) Coronary lesion complexity (Newly developed SYNTAX score) Goal: SYNTAX score to provide guidance on optimal revascularization strategies for patients with high risk lesions Sianos et al, EuroIntervention 2005;1: Valgimigli et al, Am J Cardiol 2007;99: Serruys et al, EuroIntervention 2007;3: BARI classification of coronary segments Leaman score, Circ 1981;63: Lesions classification ACC/AHA, Circ 2001;103: Bifurcation classification, CCI 2000;49: CTO classification, J Am Coll Cardiol 1997;30: No. & Location of lesion LeftMain Tortuosity 3 Vessel Thrombus Bifurcation CTO Calcification SYNTAXSCORE Dominance

7 Patient 1 Patient 2 SYNTAX SCORE 21 SYNTAX SCORE 52 LCx 70-90% LAD 70-90% RCA % RCA % LM 99% LCx 100% LAD 99% RCA 100% There is 3-vessel disease and 3-vessel disease

8 71% enrolled (N=3,075) All Pts with de novo 3VD and/or LM disease (N=4,337) Treatment preference (9.4%) Referring MD or pts. refused informed consent (7.0%) Inclusion/exclusion (4.7%) Withdrew before consent (4.3%) Other (1.8%) Medical treatment (1.2%) TAXUS n=903 PCI n=198 CABG n=1077 CABG n=897 no f/u n=428 5yr f/u n=649 PCI all captured w/ follow up CABG w/ f/u vs Total enrollment N=3075 Stratification: LM and Diabetes Two Registry Arms Randomized Arms n=1800 Two Registry Arms N=1275 Randomized Arms N=1800 Heart Team (surgeon & interventionalist) PCI N=198 CABG N=1077 Amenable for only one treatment approach TAXUS * N=903 CABG N=897 vs Amenable for both treatment options Stratification: LM and Diabetes LM 33.7% 3VD 66.3% LM 34.6% 3VD 65.4% DM 28.5% Non DM 71.5% NonDM 71.8% DM 28.2% 23 US Sites62 EU Sites + SYNTAX Trial Design * TAXUS Express

9 SYNTAX Primary Endpoint Randomized trial The primary clinical endpoint is the 12 Month major Cardiovascular or Cerebrovascular event rate (MACCE * ) MACCE is defined as: All cause Death Cerebrovascular Accident (CVA/Stroke) Documented Myocardial Infarction (ARC definition) Any Repeat Revascularization (PCI and/or CABG) All events CEC Adjudicated * ARC MACCE definition Circ 2007; 115:

10 Piaggio et al, JAMA 2006; 295: Primary Endpoint (12 Month MACCE) Non-inferiority to CABG Difference in MACCE rates (CABG-PCI with TAXUS Express) Zone of Non-inferiority Pre-specified Margin = 6.6% 02%4%6%8%10% -2%-4% Non-inferior Non-inferior Inferior Inferior Difference in MACCE rates Upper 1-sided 95% confidence intervals

11 100% randomized 20% registries Monitoring Data Monitoring Committee S. Pocock (Chair) J-P. Bassand T. Clayton D.P. Faxon B.J. Gersh J.L. Monro M.I. Turina Clinical Events Committee P.G. Steg (Chair) D. Birnbaum T.P. Carrel M. Gorman C. Hanet O.M. Hess E.W.L. Jansen L.J. Kappelle SYNTAX Methodology Steering Committee P.W. Serruys (PI) F.W. Mohr (PI) M-C. Morice (Co - PI) A.P. Kappetein (Co - PI) A. Colombo K.D. Dawkins T.E. Feldman D.R. Holmes M.J. Mack J.L. Pomar E. Stahle M. vd Brand Blood & Biochemistry: Covance ECG: Cardialysis QCA: Cardialysis Core Laboratory

12 Top 30 Enrolling Centers: I CABG InvestigatorPCI Investigator Paul SimonDietmar Glogar Jan TosovskyMichael Aschermann Per Nielsen HostrupLeif Thuesen Gerard FournialDidier Carrie Arnaud FargeMarie-Claude Morice Jean-Paul BessouJacques Berland Patrick SoulaJean Marco Friedrich MohrGerhard Schuler Bruno ReichartPeter Boekstegers Hermann ReichenspurnerThomas Meinertz Lajos PappIvan G. Horvath Ferenc TarrIstvan Preda Paolo FerrazziGiulio Guagliumi Andrea dArminiEzio Bramucci Lucia TorraccaAntonio Colombo Austria Czech Rep Norway France Germany Hungary Italy

13 CABG InvestigatorPCI Investigator Mattia GlauberSergio Berti Romans LacisAndrejs Erglis Pieter KappeteinPatrick Serruys Jacques SchonbergerJacques Koolen Andrejs BochenekJanus Drzewiecki Elisabeth StahleStefan James Stephen WestabyAdrian Banning Geoff BergKeith G. Oldroyd Steven LiveseyKeith D. Dawkins Jatin DesaiMartyn Thomas Tomasz SpytAnthony H. Gershlick Andrew ForsythAdam De Belder Graham VennSimon Redwood William KillingerTift Mann Michael MackDavid L. Brown Top 30 Enrolling Centers: II Italy Latvia Netherlands Poland Sweden UK US

14 Patient Characteristics (l) Randomized Cohort CABG N=897 TAXUS N=903 P value Age, mean ± SD (y)65.0 ± ± Male, % BMI, mean ± SD27.9 ± ± Diabetes, % Hypertension, % Hyperlipidemia, % Current smoker, % Prior MI, % Unstable angina, % Additive EuroSCORE, mean ± SD3.8 ± ± Total Parsonnet score, mean ± SD8.4 ± ±

15 Patient Characteristics (II) Randomized Cohort Patient-based CABG N=897 TAXUS N=903 P value Total SYNTAX Score29.1 ± ± Diffuse disease or small vessels, % No. lesions, mean ± SD4.4 ± ± VD only, % Left main, any, % Left Main only Left Main + 1 vessel Left Main + 2 vessel Left Main + 3 vessel Total occlusion, % Bifurcation, % Trifurcation, %

16 Staged procedure, %14.1 Lesions treated/pt, mean ± SD3.6 ± 1.6 No. stents implanted, mean ± SD Total length implanted, mm ± SD Range, mm8 – 324 Long stenting (>100 mm), %33.2 Procedural Characteristics PCI Randomized Cohort TAXUS N=903 Patient-based

17 CABG N=897 Off-pump surgery, %15.0 Graft revascularization, % At least one arterial graft97.3 Arterial graft to LAD95.6 LIMA+venous78.1 Double LIMA/RIMA27.6 Complete arterial revascularization18.9 Radial artery14.1 Venous graft only2.6 Grafts per patient, mean ± SD Distal anastomosis/pt, mean ± SD Procedural Characteristics CABG Randomized Cohort

18 Event Rate ± 1.5 SE. * Fishers Exact Test ITT population P=0.37 * All-Cause Death to 12 Months 4.3% 3.5% Months Since Allocation Cumulative Event Rate (%) TAXUS (N=903) CABG (N=897)

19 CVA to 12 Months 0.6% 2.2% Months Since Allocation Cumulative Event Rate (%) ITT population P=0.003 * Event Rate ± 1.5 SE. * Fishers Exact Test TAXUS (N=903) CABG (N=897)

20 Myocardial Infarction to 12 Months 3.2% 4.8% Months Since Allocation Cumulative Event Rate (%) ITT population P=0.11 * Event Rate ± 1.5 SE. * Fishers Exact Test TAXUS (N=903) CABG (N=897)

21 All-Cause Death/CVA/MI to 12 Months P=0.98 * Months Since Allocation Cumulative Event Rate (%) ITT population 7.7% 7.6% Event Rate ± 1.5 SE. * Fishers Exact Test TAXUS (N=903) CABG (N=897)

22 Symptomatic Graft Occlusion & Stent Thrombosis to 12 Months CABGTAXUS P=0.89 Patients (%) n=27n=28 ITT population TAXUS (N=903) CABG (N=897)

23 Repeat Revascularization to 12 Months 5.9% 13.7% Months Since Allocation Cumulative Event Rate (%) ITT population P< * Event Rate ± 1.5 SE. * Fishers Exact Test Repeat Revasc CABG Group PCI Group PCI4.7%11.4% CABG1.3%2.8% TAXUS (N=903) CABG (N=897)

24 MACCE to 12 Months P= * Months Since Allocation Cumulative Event Rate (%) ITT population 12.1% 17.8% Event Rate ± 1.5 SE. * Fishers Exact Test TAXUS (N=903) CABG (N=897)

25 Primary Endpoint: 12 Month MACCE Non-inferiority analysis 05%10%15% Pre-specified Margin = 6.6% Difference in MACCE 20% +95% CI = 8.3% The criteria for non-inferiority comparison was not met for the primary endpoint, further comparisons for the LM and 3VD subgroups are observational only and hypothesis generating 5.5%

26 12 Month LM Subgroup MACCE Rates CABGTAXUS Left Main Isolated Left Main + 3VD Left Main + 2VD Left Main + 1VD N=258 (37%) N=218 (31%) N=138 (20%) N=91 (13%) All LM N=705 Patients (%)

27 12 Month LM Subgroup MACCE Rates CABGTAXUS All LM N=705 LM isolated N=91 Patients (%)

28 12 Month LM Subgroup MACCE Rates CABGTAXUS All LM N=705 LM+1VD N=138 LM isolated N=91 Patients (%)

29 12 Month LM Subgroup MACCE Rates CABGTAXUS All LM N=705 LM+1VD N=138 LM isolated N=91 LM+2VD N=218 Patients (%)

30 12 Month LM Subgroup MACCE Rates CABGTAXUS All LM N=705 LM+1VD N=138 LM isolated N=91 LM+2VD N=218 LM+3VD N=258 Patients (%)

31 12 Month Subgroup MACCE Rates All LM N=705 LM+1VD N=138 LM isolated N=91 LM+2VD N=218 LM+3VD N=258 Patients (%) 3VD (All) N=1095 CABGTAXUS

32 Outcome according to Diabetic Status Diabetes (Medical Treatment) N=452 Non-Diabetic N=1348 TAXUS CABG Death/CVA/MI MACCE Death/CVA/MI MACCE P=0.96 P= P=0.08 P=0.97

33 Conclusions: In the randomized SYNTAX cohort, there were comparable overall safety outcomes (Death, CVA, MI,) in CABG and PCI patients at 12 months (7.7 vs. 7.6 %). There was a significantly higher rate of revascularization in the PCI group (13.7 vs. 5.9 %), and a significantly higher rate of CVA in the CABG group (2.2 vs. 0.6 %). Overall MACCE in the PCI group was higher (17.8 vs.12.1 %) due to an excess of redo revascularization compared with CABG. Per protocol rates of symptomatic graft occlusion and stent thrombosis were similar. The SYNTAX score will help stratify patients for the appropriate revascularization option.


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