Successfully reported this slideshow.
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...
1800 syntax lm
Upcoming SlideShare
Loading in …5
×

1800 syntax lm

945 views

Published on

  • Be the first to comment

  • Be the first to like this

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 />

×