Optimal Revascularization Strategy in Patients With. 3-Vessel and/or Left Main Disease

Transcription

1 Final Five-Year Follow-up of the SYNTAX Trial: Optimal Revascularization Strategy in Patients With 3-Vessel and/or Left Main Disease On behalf of the SYNTAX investigators SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 1

2 SYNTAX Trial Design 62 EU Sites + 23 US Sites Heart Team (surgeon & interventional cardiologist) Amenable for both treatment options Amenable for only one treatment approach Stratification: LM and Diabetes Randomized Arms N=18 Two Registry Arms N=1275 3VD n=549 (66.3%) n=897 vs LM n=348 (33.7%) 3VD n=546 (65.4%) TAXUS * n=93 SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 2 LM n=357 (34.6%) n=177 PCI n=198 * TAXUS Express

3 Patient Characteristics RCT N=897 SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 3 PCI RCT N=93 P value Registry N=644 PCI Registry N=192 Age * (y) 65.± ± ± ±1.4 Male, % Diabetes *, % Additive euroscore * 3.8± ± ± ±3.1 Total Parsonnet score * 8.4± ± ± ±9.5 Total SYNTAX Score 29.1± ± ± ±12.3 Mean # of lesions 4.4± ± ± ±1.8 3VD only, % Left main, any, % Total occlusion, % Complete revasc, % Values are mean±sd or %. Core laboratory reported unless * Site-reported Medically treated

4 The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX Study Final Five-year Follow-up of the SYNTAX Trial: Optimal Revascularization Strategy in Patients with Three-vessel Disease SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 4

5 Patient Disposition to 5 Years 3VD Subset Intent-to-Treat n=549 RCT: Enrolled N=195 PCI * n=546 n=513 n=55 n=52 RCT: 1 Year Follow-up 93.4% PCI 98.2% RCT: 2 Year Follow-up 92.% PCI 97.6% RCT: 3 Year Follow-up 91.4% PCI 98.2% PCI * n=536 PCI * n=533 PCI * n=536 n=495 RCT: 4 Year Follow-up 9.2% PCI 97.1% PCI * n=53 n=483 SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 5 RCT: 5 Year Final Follow-up 88.% PCI 96.2% PCI * n=525 * TAXUS Express

6 Summary of 1-Year Results 3VD Subset Event Rate ± 1.5 SE, * Fisher exact test Death/CVA/MI 7.9% 6.4% %.8% 6 12 Event Rate ± 1.5 SE, * Fisher exact test Stroke P=.29 * P=.9 * Event Rate ± 1.5 SE, * Fisher exact test Repeat Revasc. Death/Stroke/MI rates were similar between and PCI Stroke was not significantly increased in Repeat revascularization and MACCE increased in PCI vs SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide % 5.4% Event Rate ± 1.5 SE, * Fisher exact test MACCE P<.1 * P<.1 * (N=549) 19.1% 11.2% PCI (N=546)

7 All-Cause Death/CVA/MI to 5 Years 3VD Subset (N=549) TAXUS (N=546) 5 25 Before 1 year * 6.6% vs 8.% P=.39 SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide years * 1.8% vs 3.7% P= years * 2.5% vs 4.4% P=.1 P< years * 2.1% vs 4.4% P= % 14.% Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates 4-5 years * 2.4% vs 3.7% P=.29

8 Repeat Revascularization to 5 Years 3VD Subset (N=549) TAXUS (N=546) 5 25 Before 1 year * 5.5% vs 14.6% P<.1 SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide years * 2.8% vs 3.9% P= years * 2.5% vs 3.% P=.63 P< years *.6% vs 4.4% P< % 12.6% Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates 4-5 years * 2.% vs 4.5% P=.3

9 MACCE to 5 Years 3VD Subset (N=549) TAXUS (N=546) 5 25 Before 1 year * 11.5% vs 19.2% P<.1 SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide years * 4.4% vs 7.% P= years * 4.6% vs 7.4% P=.6 P< years * 2.8% vs 7.7% P< % 24.2% Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates 4-5 years * 4.5% vs 6.9% P=.11

10 MACCE to 5 Years by SYNTAX Score Tercile 3VD Subset Low Scores (N=171) TAXUS (N=181) 3-Vessel Disease P= % 26.8% PCI P value Death 9.3% 1.2%.81 CVA 3.9% 1.8%.24 MI 4.9% 8.8%.2 Death, CVA or MI 14.8% 17.5%.56 Revasc. 14.6% 23.1%.4 Cumulative KM Event Rate ± 1.5 SE; log-rank P value SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 1 Site-reported Data;

11 MACCE to 5 Years by SYNTAX Score Tercile 3VD Subset Intermediate Scores (N=28) TAXUS (N=27) 3-Vessel Disease P< % 22.6% PCI P value Death 9.6% 16.3%.47 CVA 3.6% 2.5%.53 MI 3.1% 13.8% <.1 Death, CVA or MI 14.7% 23.2%.4 Revasc. 11.% 25.1% <.1 Cumulative KM Event Rate ± 1.5 SE; log-rank P value SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 11 Site-reported Data;

12 MACCE to 5 Years by SYNTAX Score Tercile 3VD Subset High Scores (N=166) TAXUS (N=155) 3-Vessel Disease P< % 24.1% PCI P value Death 8.8% 17.8%.2 CVA 2.6% 5.1%.31 MI 1.9% 8.7%.8 Death, CVA or MI 12.5% 26.2%.2 Revasc. 12.6% 28.2% <.1 Cumulative KM Event Rate ± 1.5 SE; log-rank P value SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 12 Site-reported Data;

13 The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX Study Final Five-year Follow-up of the SYNTAX Trial Left Main Disease SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 13 Conflicts of Interest: None

14 Patient Disposition to 5 Years LM Subset Intent-to-Treat n=348 RCT: Enrolled N=75 PCI * n=357 n=336 n=331 n=52 RCT: 1 Year Follow-up 96.6% PCI 99.4% RCT: 2 Year Follow-up 92.% PCI 97.1% RCT: 3 Year Follow-up 95.1% PCI 98.6% PCI * n=355 PCI * n=533 PCI * n=352 n=325 RCT: 4 Year Follow-up 93.4% PCI 97.8% PCI * n=349 n=322 SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 14 RCT: 5 Year Final Follow-up 92.5% PCI 96.9% PCI * n=346 * TAXUS Express

15 Summary of 1-Year Results LM Subset 4 2 Death/CVA/MI P=.29 * 6 12 Event rate ± 1.5 SE, * Fisher exact test 9.1% 7.% 4 2 Stroke 6 12 Event rate ± 1.5 SE, * Fisher exact test P=.9 * 2.7%.3% 4 2 Repeat Revasc Event rate ± 1.5 SE, * Fisher exact test P=.2 * Death/Stroke/MI and MACCE rates were similar between groups Stroke was significantly increased in and revacularization in PCI SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide % 6.7% * Any revascularization (PCI or ); 4 2 MACCE P=.44 * 6 12 Event rate ± 1.5 SE, * Fisher exact test (N=348) 15.8% 13.6% PCI (N=357)

16 CVA to 5 Years Left Main Subset (N=348) TAXUS (N=357) 5 25 Before 1 year * 2.7% vs.3% P=.9 SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide years *.9% vs.6% P=.68 P= years *.3% vs.3% P= years *.3% vs.3% P= Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates 4-5 years * % vs % P=Undefined 4.3% 1.5%

17 All-Cause Death/CVA/MI to 5 Years Left Main Subset (N=348) TAXUS (N=357) 5 25 Before 1 year * 9.2% vs 7.% P=.29 SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide years * 2.8% vs 3.2% P=.76 P= years * 2.6% vs 3.% P= years * 3.7% vs 4.9% P= % 19.% Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates 4-5 years * 4.2% vs 2.3% P=.18

18 Repeat Revascularization to 5 Years Left Main Subset (N=348) TAXUS (N=357) 5 25 Before 1 year * 6.5% vs 11.8% P=.2 SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide years * 5.% vs 8.2% P=.1 P< years * 2.6% vs 3.9% P= years * 3.% vs 4.% P= % 15.5% Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates 4-5 years * 1.7% vs 3.9% P=.12

19 MACCE to 5 Years Left Main Subset (N=348) TAXUS (N=357) 5 25 Before 1 year * 13.7% vs 15.8% P=.44 SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide years * 7.5% vs 1.3% P=.22 P= years * 5.2% vs 5.7% P= years * 6.4% vs 8.3% P= % 31.% Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates 4-5 years * 5.9% vs 5.5% P=.82

20 MACCE to 5 Years by SYNTAX Score Tercile LM Subset Low Scores (N=14) TAXUS (N=118) LM Disease P= % 3.4% PCI P value Death 11.3% 7.%.28 CVA 4.1% 1.8%.28 MI 3.1% 6.2%.32 Death, CVA or MI 15.2% 13.9% Revasc. 2.3% 23.%.65 Cumulative KM Event Rate ± 1.5 SE; log-rank P value SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 2 Site-reported Data;

21 MACCE to 5 Years by SYNTAX Score Tercile LM Subset Intermediate Scores (N=92) TAXUS (N=13) P=.88 LM Disease % 32.3% PCI P value Death 19.3% 8.9%.4 CVA 3.6% 1.%.23 MI 4.6% 6.%.71 Death, CVA or MI 24.9% 15.7%.11 Revasc. 16.6% 22.2%.4 Cumulative KM Event Rate ± 1.5 SE; log-rank P value SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 21 Site-reported Data;

22 MACCE to 5 Years by SYNTAX Score Tercile LM Subset High Scores (N=149) TAXUS (N=135) P=.3 LM Disease % 29.7% PCI P value Death 14.1% 2.9%.11 CVA 4.9% 1.6%.13 MI 6.1% 11.7%.13 Death, CVA or MI 22.1% 26.1%.4 Revasc. 11.6% 34.1% <.1 Cumulative KM Event Rate ± 1.5 SE; log-rank P value SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 22 Site-reported Data;

23 Heterogeneity in the Left Main Group Left Main Isolated n=91 (13%) Left Main + 3VD n=258 (37%) n=138 (2%) Left Main + 1VD n=218 (31%) Left Main + 2VD Site-reported data SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 23

24 MACCE to 5 Years Interpreting Results Based on SYNTAX Score only 71% PCI only 7% PCI or 22% Five-year results of the SYNTAX trial suggest that 71% of all patients are still best treated with ; however, for the remaining patients PCI is an alternative to surgery SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 24

25 One-Year MACCE Rates per Site vs TAXUS Express Stent 5 TAXUS stent MACCE (%) MACCE (%) SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 25

26 Coronary tree segments AHA classification and modified for the ARTS study, Circulation 1975; 51:5-4 & Semin Interv Cardiol 1999; 4:29-19 Modified Leaman score, Circ 1981;63: Lesions classification ACC/AHA, Circ 21;13: Bifurcation classification, CCI 2;49: CTO classification, J Am Coll Cardiol 1997;3: SYNTAX 5-year Outcomes ESC 212 Mohr August 212 Slide 26