The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX StudyThe 3-year Outcomes...
Disclosure Statement of Financial Interest<br />I, Patrick W. Serruys, DO NOT have a financial interest/arrangement or aff...
SYNTAX Study Objectives<br />The SYNTAX randomized trial is an attempt to provide an evidence base to determine the most a...
Amenable for both<br />treatment options<br />Amenable for only one treatment approach<br />Randomized Arms<br />N=1800<br...
Patients in SYNTAXLeft Main (LM) Subset<br />RCT: Enrolled<br />N=705<br />CABG<br />n=348<br />PCI<br />n=357<br />RCT: 1...
Heterogeneity in the Left Main Group<br />Left Main Isolated<br />n=91<br />(13%)<br />Left Main + 1VD<br />Left Main + 3V...
Patient CharacteristicsLM Subset<br />Core laboratory reported unless *Site-reported<br />
TAXUS(N=357)<br />CABG(N=348)<br />40<br />20<br />0<br />12<br />36<br />24<br />All-Cause Death to 3 YearsLM Subset<br /...
TAXUS(N=357)<br />CABG(N=348)<br />40<br />20<br />0<br />12<br />36<br />24<br />CVA to 3 YearsLM Subset<br />P=0.02<br /...
TAXUS(N=357)<br />CABG(N=348)<br />40<br />20<br />0<br />12<br />36<br />24<br />Myocardial Infarction to 3 YearsLM Subse...
TAXUS(N=357)<br />CABG(N=348)<br />40<br />20<br />0<br />12<br />36<br />24<br />All-Cause Death/CVA/MI to 3 YearsLM Subs...
TAXUS(N=357)<br />CABG(N=348)<br />40<br />20<br />0<br />12<br />36<br />24<br />Repeat Revascularization to 3 YearsLM Su...
TAXUS(N=357)<br />CABG(N=348)<br />40<br />20<br />0<br />12<br />36<br />24<br />MACCE to 3 YearsLM Subset<br />P=0.20<br...
CABG(n=348)<br />TAXUS(n=357)<br />Symptomatic Graft Occlusion & Stent Thrombosis to 3 Years LM Subset<br />P=0.80<br />Pa...
MACCE to 3 Years in LM Subgroups<br />TAXUS<br />CABG<br />P=0.20<br />P=0.52<br />P=0.33<br />P=0.09<br />P=0.20<br />Pat...
Distal<br />7%<br />4%<br />11%<br />35%<br />27%<br />Nondistal<br />29%<br />61%<br />66%<br />59%<br />Both<br />Vessel...
CTO<br />29.6%<br />Non-CTO<br />Vessel Distribution in LM Population According to Syntax Score Terciles<br />5.9%<br />16...
CABG(N=104)<br />TAXUS(N=118)<br />40<br />30<br />Cumulative Event Rate (%)<br />20<br />10<br />0<br />0<br />12<br />24...
CABG(N=92)<br />TAXUS(N=103)<br />40<br />30<br />Cumulative Event Rate (%)<br />20<br />10<br />0<br />0<br />12<br />24<...
CABG(N=149)<br />TAXUS(N=135)<br />40<br />30<br />Cumulative Event Rate (%)<br />20<br />10<br />0<br />0<br />12<br />24...
SummaryLeft Main Subset <br />At 3 years, overall MACCE in the PCI group was comparable with CABG (22.3% CABG vs 26.8% PCI...
Conclusions<br />For patients with left main disease<br />Revascularization with PCI has comparable safety and efficacy ou...
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  • SYNTAX_CSR_Randomized_Unblinded_2008Oct10.docex. 1 title; intent to treat.exhibit 52, 53 % calculated by handRegistry: SYNTAX_CSR_Registry_Unblinded_2008Oct10.doc exhibit 2, 21 QC Comments:Note: Per Kristine, this slide has been QC’ed before. No QC needed.Please check the percents in last 4 boxes at bottom left.
  • 1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 522-Year_Randomized_20090820.doc Exhibits 21SYNTAX 3-Year Report_Randomized_12JUL10.doc exhibits 21 (KM overall rate), 22 (year 2-3)
  • 1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 522-Year_Randomized_20090820.doc Exhibits 21SYNTAX 3-Year Report_Randomized_12JUL10.doc exhibits 21 (KM overall rate), 22 (year 2-3)
  • SYNTAX 3-Year Report_Randomized_12JUL10.docex.1
  • 8 anatomic patterns of disease (1 or 2 vd with/without proximal LAD, 3vd being ‘simple or complex,4 categories of left main)CABG is stilll considered IA for all except ½ vd not involving prox LAD (comparable to Appropriateness recommendations by six US organizations)½ vd +prox LAD CABG is IA because of proven durability of IMA graft over decades of follow upFor 3vd PCI had different recommendations depending on complexityFor LM easing of previous ESC recommendations and more than appropriateness recommendations and may change again with further trials
  • Transcript of "1800 syntax lm"

    1. 1. The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX StudyThe 3-year Outcomes of the SYNTAX Trial in the Subset of Patients With Left Main Disease<br />Patrick W. Serruys, MD PhD<br />Erasmus Medical Center<br />On behalf of the SYNTAX investigators<br />6:00-6:10PM, Sept 21, 2010<br />Featured Clinical Research I<br />Conflicts of Interest: None<br />
    2. 2. Disclosure Statement of Financial Interest<br />I, Patrick W. Serruys, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.<br />
    3. 3. SYNTAX Study Objectives<br />The SYNTAX randomized trial is an attempt to provide an evidence base to determine the most appropriate treatment option for patients in a ‘real-world’ population seen by the surgeon and the interventional cardiologist in their daily practice<br />In 2009, the ACC-AHA PCI Guidelines were updated and raised LM stenting from Class III to Class IIb (level B)1<br />In 2010, ESC-EACTS Guidelines revised and upgraded LM (isolated or in conjuction with 1 vessel disease) stenting from Class IIb (level C) to IIa (level B)2<br />1Kushner et al. Circulation 2009; 120:2271-2306<br />2Wijns et al. EHJ 2010<br />
    4. 4. Amenable for both<br />treatment options<br />Amenable for only one treatment approach<br />Randomized Arms<br />N=1800<br />Two Registry ArmsN=1275<br />SYNTAX Trial Design<br />+<br />23 US Sites<br />62 EU Sites<br />Heart Team (surgeon & interventional cardiologist)<br />Stratification: LM and Diabetes<br />PCI<br />n=198<br />CABG<br />n=1077<br />TAXUS*<br />n=903<br />CABG<br />n=897<br />vs<br />LM<br />n=348(33.7%)<br />3VDn=549<br />(66.3%)<br />3VD<br />n=546 (65.4%)<br />LMn=357(34.6%)<br />*TAXUS Express<br />
    5. 5. Patients in SYNTAXLeft Main (LM) Subset<br />RCT: Enrolled<br />N=705<br />CABG<br />n=348<br />PCI<br />n=357<br />RCT: 1 Year Follow-up<br />N=691 (98.0%)<br />CABG<br />n=336<br />PCI<br />n=355<br />RCT: 2 Year Follow-up<br />N=683 (96.9%)<br />CABG<br />n=331<br />PCI<br />n=352<br />RCT: 3 Year Follow-up<br />N=674 (95.6%)<br />CABG<br />n=325<br />PCI<br />n=349<br />
    6. 6. Heterogeneity in the Left Main Group<br />Left Main Isolated<br />n=91<br />(13%)<br />Left Main + 1VD<br />Left Main + 3VD<br />n=258<br />(37%)<br />n=138<br />(20%)<br />n=218<br />(31%)<br />Left Main + 2VD<br />Site-reported data<br />
    7. 7. Patient CharacteristicsLM Subset<br />Core laboratory reported unless *Site-reported<br />
    8. 8. TAXUS(N=357)<br />CABG(N=348)<br />40<br />20<br />0<br />12<br />36<br />24<br />All-Cause Death to 3 YearsLM Subset<br />P=0.64<br />Before 1 year*<br />4.5% vs 4.2%<br />P=0.88<br />1-2 years*<br />1.9% vs 1.5%<br />P=0.68<br />2-3 years*<br />2.3% vs 1.8%<br />P=0.67<br />Cumulative Event Rate (%)<br />8.4%<br />7.3%<br />0<br />Months Since Allocation<br />ITT population<br />Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates<br />
    9. 9. TAXUS(N=357)<br />CABG(N=348)<br />40<br />20<br />0<br />12<br />36<br />24<br />CVA to 3 YearsLM Subset<br />P=0.02<br />Before 1 year*<br />2.7% vs 0.3%<br />P=0.009<br />1-2 years*<br />0.9% vs 0.6%<br />P=0.68<br />2-3 years*<br />0.3% vs 0.3%<br />P=1.00<br />Cumulative Event Rate (%)<br />4.0%<br />1.2%<br />0<br />Months Since Allocation<br />ITT population<br />Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates<br />
    10. 10. TAXUS(N=357)<br />CABG(N=348)<br />40<br />20<br />0<br />12<br />36<br />24<br />Myocardial Infarction to 3 YearsLM Subset<br />P=0.14<br />Before 1 year*<br />4.2% vs 4.2%<br />P=0.97<br />1-2 years*<br />0.0% vs 1.2%<br />P=0.12<br />2-3 years*<br />0.0% vs 1.5%<br />P=0.06<br />Cumulative Event Rate (%)<br />6.9%<br />4.1%<br />0<br />Months Since Allocation<br />ITT population<br />Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates<br />
    11. 11. TAXUS(N=357)<br />CABG(N=348)<br />40<br />20<br />0<br />12<br />36<br />24<br />All-Cause Death/CVA/MI to 3 YearsLM Subset<br />P=0.60<br />Before 1 year*<br />9.2% vs 7.0%<br />P=0.29<br />1-2 years*<br />2.8% vs 3.2%<br />P=0.76<br />2-3 years*<br />2.6% vs 3.0%<br />P=0.76<br />Cumulative Event Rate (%)<br />14.3%<br />13.0%<br />0<br />Months Since Allocation<br />ITT population<br />Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates<br />
    12. 12. TAXUS(N=357)<br />CABG(N=348)<br />40<br />20<br />0<br />12<br />36<br />24<br />Repeat Revascularization to 3 YearsLM Subset<br />P=0.004<br />Before 1 year*<br />6.5% vs 11.8%<br />P=0.02<br />1-2 years*<br />5.0% vs 8.2%<br />P=0.10<br />2-3 years*<br />2.6% vs 3.9%<br />P=0.36<br />20.0%<br />Cumulative Event Rate (%)<br />11.7%<br />Repeat CABG: 1.7% vs 5.6%, P=0.01<br />Repeat PCI: 10.0% vs 16.2%, P=0.01<br />0<br />Months Since Allocation<br />ITT population<br />Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates<br />
    13. 13. TAXUS(N=357)<br />CABG(N=348)<br />40<br />20<br />0<br />12<br />36<br />24<br />MACCE to 3 YearsLM Subset<br />P=0.20<br />Before 1 year*<br />13.7% vs 15.8%<br />P=0.44<br />1-2 years*<br />7.5% vs 10.3%<br />P=0.22<br />2-3 years*<br />5.2% vs 5.7%<br />P=0.78<br />26.8%<br />Cumulative Event Rate (%)<br />22.3%<br />0<br />Months Since Allocation<br />ITT population<br />Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates<br />
    14. 14. CABG(n=348)<br />TAXUS(n=357)<br />Symptomatic Graft Occlusion & Stent Thrombosis to 3 Years LM Subset<br />P=0.80<br />Patients (%)<br />n=12<br />n=14<br />CABG<br />TAXUS<br />Post-procedure; ITT population<br />
    15. 15. MACCE to 3 Years in LM Subgroups<br />TAXUS<br />CABG<br />P=0.20<br />P=0.52<br />P=0.33<br />P=0.09<br />P=0.20<br />Patients, %<br />n= 348<br />357<br />49<br />42<br />122<br />136<br />106<br />112<br />71<br />67<br />All LM<br />LM<br />+ 1VD<br />LM<br />Isolated<br />LM<br />+ 2VD<br />LM<br />+ 3VD<br />Cumulative KM Event Rate; log-rank P value; *Binary rates<br />
    16. 16. Distal<br />7%<br />4%<br />11%<br />35%<br />27%<br />Nondistal<br />29%<br />61%<br />66%<br />59%<br />Both<br />Vessel Distribution in LM Population According to Syntax Score Terciles<br />33+<br />0-22<br />23-32<br />
    17. 17. CTO<br />29.6%<br />Non-CTO<br />Vessel Distribution in LM Population According to Syntax Score Terciles<br />5.9%<br />16.5%<br />33+<br />0-22<br />23-32<br />
    18. 18. CABG(N=104)<br />TAXUS(N=118)<br />40<br />30<br />Cumulative Event Rate (%)<br />20<br />10<br />0<br />0<br />12<br />24<br />36<br />Months Since Allocation<br />MACCE to 3 Years by SYNTAX Score Tercile Low Scores (0-22)<br />Left Main<br />><br />><br />P=0.33<br />23.0%<br /><<br />Cumulative Event Rate (%)<br />18.0%<br />><br /><<br />Months Since Allocation<br />Site-reported Data; ITT population<br />Cumulative KM Event Rate ± 1.5 SE; log-rank P value<br />
    19. 19. CABG(N=92)<br />TAXUS(N=103)<br />40<br />30<br />Cumulative Event Rate (%)<br />20<br />10<br />0<br />0<br />12<br />24<br />36<br />Months Since Allocation<br />MACCE to 3 Years by SYNTAX Score Tercile Intermediate Scores (23-32)<br />Left Main<br />><br />><br />P=0.90<br />23.4%<br /><<br />23.4%<br />><br /><<br />Site-reported Data; ITT population<br />Cumulative KM Event Rate ± 1.5 SE; log-rank P value<br />
    20. 20. CABG(N=149)<br />TAXUS(N=135)<br />40<br />30<br />Cumulative Event Rate (%)<br />20<br />10<br />0<br />0<br />12<br />24<br />36<br />Months Since Allocation<br />MACCE to 3 Years by SYNTAX Score Tercile Left Main SYNTAX Score 33<br />Left Main<br />Left Main<br /><<br />P=0.003<br />37.3%<br />><br /><<br />21.2%<br /><<br /><<br />Site-reported Data; ITT population<br />Cumulative KM Event Rate ± 1.5 SE; log-rank P value<br />
    21. 21. SummaryLeft Main Subset <br />At 3 years, overall MACCE in the PCI group was comparable with CABG (22.3% CABG vs 26.8% PCI)<br />Similar overall safety outcomes (Death/CVA/MI) between CABG and PCI at 3 years (14.3% CABG vs 13.0% PCI)<br />There was a higher rate of revascularization in the PCI group (11.7% CABG vs 20.0% PCI), and a higher rate of CVA in the CABG group (4.0% CABG vs 1.2% PCI)<br />PCI outcomes are excellent relative to CABG in LM isolated and LM+1VD<br />
    22. 22. Conclusions<br />For patients with left main disease<br />Revascularization with PCI has comparable safety and efficacy outcomes to CABG <br />PCI is therefore a reasonable treatment alternative in this patient population, in particular, when the SYNTAX Score is low (≤22) or intermediate (23-32)<br />
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