C OMPARATIVE E FFECTIVENESS E FFECTIVENESS AND AND S AFETY S AFETY OF OF C OMPARATIVE N EW - VERSUS E ARLY -G ENERATION D RUG -E LUTING S TENTS N EW - VERSUS E ARLY -G ENERATION D RUG -E LUTING S TENTS ACCORDING TO THE C TO THE C OMPLEXITY OMPLEXITY OF OF C ORONARY A RTERY C ORONARY A RTERY ACCORDING D ISEASE : : A P ATIENT -L EVEL P OOLED A NALYSIS A P ATIENT -L EVEL P OOLED A NALYSIS D ISEASE OF OF 6,081 P ATIENTS 6,081 P ATIENTS Raffaele Piccolo, Dik Heg, Julie Rat-Wirtzler, Anna Franzone, Sigmund Silber, Patrik W Serruys, Thomas Pilgrim, Peter Jüni, Stephan Windecker Department of Cardiology Bern University Hospital Bern – Switzerland
P ROGRESS WITH M ETALLIC D RUG -E LUTING S TENTS P ROGRESS WITH M ETALLIC D RUG -E LUTING S TENTS Piccolo R et al. Lancet 2015;386:702-713
S TUDY O BJECTIVE S TUDY O BJECTIVE Piccolo R et al. Lancet 2015;386:702-713 New-generation DES improved the safety and efficacy compared with Early-generation DES It is not well established whether the anatomic complexity of CAD influences the clinical benefits of New- generation DES AIM: To investigate the safety and effectiveness of New-DES vs Early-DES in relation to anatomic CAD Complexity as assessed by the SYNTAX score
M ETHODS M ETHODS 4 All-comers RCTs (n=6,081) SYNTAX Score Distribution 11.8±9 Pooled trials New- vs. Early-DES 2012-13 14.7±9 SIRTAX 2008-08 LEADERS 13.6±9 Early-DES: 12.5±8 RESOLUTE New-DES: 13.3±9 2006-07 BIOSCIENCE 11.7±7 2003-04 • Primary device-oriented endpoint: the composite of cardiac death, MI, or ischemia-driven TLR • Principal effectiveness and safety endpoints: TLR and definite stent thrombosis (ST) • Early-DES: SES and PES (SIRTAX and LEADERS) • New-DES: EES, Resolute ZES, BP-BES, and BP-SES (LEADERS, RESOLUTE, BIOSCIENCE)
B ASELINE C LINICAL C HARACTERISTICS B ASELINE C LINICAL C HARACTERISTICS New-DES Early-DES p-value (n =4,554) (n =1,527) Age — years 64.5±11.2 62.7±11.1 <0.001 1,117 Female gender 380 (24.9%) 0.78 (24.5%) 1,012 Diabetes 298 (19.5%) 0.03 (22.2%) Insulin-requiring 330 (7.2%) 101 (6.6%) 0.42 3,160 Hypertension 998 (65.4%) 0.003 (69.4%) 2,915 Hypercholesterolemia 934 (61.2%) 0.05 (64.0%) Renal Failure 625 (14.3%) 172 (13.3%) 0.39 1,317 Current smoker 512 (34.3%) <0.001 (28.9%) 1,347 Family history of CAD 606 (39.7%) <0.001 (31.8%) 1,043 Previous MI 432 (28.3%) <0.001 (23.1%) 1,297 Previous PCI 387 (25.3%) 0.02 (28.5%) LVEF (%) 56.1±11.8 56.4±11.7 0.48 Clinical presentation 0.01 1,752 Stable CAD 648 (42.4%) 0.22 (40.6%) 1,678 NSTE-ACS 528 (34.6%) 0.003 (38.9%) ST-elevation MI 887 (20.5%) 351 (23.0%) 0.05
A NGIOGRAPHIC AND P ROCEDURAL C HARACTERISTICS A NGIOGRAPHIC AND P ROCEDURAL C HARACTERISTICS New-DES Early-DES p- (n =4,554) (n =1,527) value No. of treated lesions per patient 1.48±0.75 1.41±0.66 0.043 1,076 Multivessel treatment per patient 277 (18.1%) <0.001 (23.6%) Target-vessel location <0.001 2,169 Right coronary artery 724 (33.6%) (32.2%) Left main artery 75 (1.1%) 12 (0.6%) 2,885 Left anterior descending artery 975 (45.3%) (42.8%) 1,610 Left circumflex artery 441 (20.5%) (23.9%) Bypass graft 4 (0.1%) 0 (0.0%) 6,289 2,061 De novo lesion per lesion 0.001 (93.8%) (95.9%) Occlusion per lesion 640 (9.6%) 148 (6.9%) <0.001 Number of stents per lesion 1.32±0.67 1.20±0.56 <0.001 Total stent length per lesion — 25.29±15.66 21.20±12.58 <0.001 mm Mean stent diameter per lesion — 2.99±0.46 2.90±0.44 <0.001 mm
N EW -G ENERATION V S . E ARLY -G ENERATION DES: N EW -G ENERATION VS . E ARLY -G ENERATION DES: 2-Y EAR F OLLOW - U P 2-Y EAR F OLLOW - U P Cdeath, MI, TLR Target-Lesion Revasc Definite ST Adjusted HR 0.75 (0.63-0.89), P=0.001 Adjusted HR 0.56 (0.44-0.70), P<0.001 Adjusted HR 0.40 (0.25-0.65), P<0.001 (%) (%) (%) 5 20 15 4 Early-DES 13.2% 15 Early-DES 8.6% 10 Early-DES 2.5% 3 10 2 New-DES 10.4% 5 5 1 New-DES 5.0% New-DES 0.9% 0 0 0 0 60 120 180 240 300 360 420 480 540 600 660 730 0 60 120 180 240 300 360 420 480 540 600 660 730 0 60 120 180 240 300 360 420 480 540 600 660 730 Days Days Days New-DES (n =4,554), Early-DES (n =1,527). Follow-up available in 97.2% of patients at 2-year HR (95% CI) and p-values are from Cox Regressions. Adjusted HR (95% CI) and p-values are from Multiple Imputation estimated Cox Regressions (20 data-sets using Rubin's rule to combine estimates), adjusting for baseline variables associated with the primary outcome: age, diabetes, renal failure, previous myocardial infarction
C LINICAL O UTCOMES A CCORDING TO T HE SYNTAX S CORE C LINICAL O UTCOMES A CCORDING TO T HE SYNTAX S CORE Cdeath, MI, TLR Target-Lesion Revasc Definite ST Pint =0.25 Pint =0.11 Pint =0.16 HR HR HR 10 20 40 80 20 20 10 10 5 5 5 2.5 2.5 2.5 1 1 1 0 5 10 15 20 25 30 35 40 45 50 55 60 0 5 1 0 1 5 2 0 2 5 3 0 3 5 4 0 4 5 5 0 5 5 6 0 0 5 10 15 20 25 30 35 40 45 50 55 60 SYNTAX score SYNTAX score SYNTAX score Early-DES New-DES Benefit of New-DES vs. Early-DES No significant interaction between the type of DES and the SYNTAX score The interaction between the type of DES (new-generation vs. early-generation DES) and the SYNTAX score (after logarithm transformation) was tested in the Cox-regression analyses and graphically represented the results with spline curves by using a flexible STATA model (xblc command)
Adjusted Hazard ratio (95% CI) .125 .25 .5 1 2 4 S TRATIFIED A NALYSIS OF C LINICAL E NDPOINTS S TRATIFIED A NALYSIS OF C LINICAL E NDPOINTS New-DES Early-DES Adj HR (95% CI) p p interaction Primary Endpoint 0.22 SYNTAX score ≤11 175 (8.0%) 71 (8.9%) 0.86 (0.64-1.16) 0.32 SYNTAX score >11 287 (12.7%) 129 (17.8%) 0.68 (0.54-0.85) 0.001 Cardiac death 0.042 SYNTAX score ≤11 39 (1.8%) 10 (1.3%) 1.03 (0.51-2.09) 0.93 SYNTAX score >11 67 (3.0%) 40 (5.5%) 0.46 (0.31-0.70) <0.001 Any MI 0.87 SYNTAX score ≤11 87 (4.0%) 28 (3.5%) 1.16 (0.73-1.84) 0.54 SYNTAX score >11 141 (6.2%) 41 (5.7%) 1.18 (0.80-1.73) 0.41 ID-TLR 0.059 88 (4.1%) 45 (5.7%) 0.12 SYNTAX score ≤11 0.74 (0.50-1.08) 129 (5.9%) 84 (11.9%) <0.001 SYNTAX score >11 0.46 (0.34-0.61) ID-TVR 0.039 SYNTAX score ≤11 110 (5.1%) 52 (6.6%) 0.81 (0.57-1.15) 0.23 SYNTAX score >11 167 (7.6%) 100 (14.1%) 0.51 (0.39-0.66) <0.001 Definite ST 0.013 20 (0.9%) 10 (1.3%) 0.94 (0.40-2.23) 0.89 SYNTAX score ≤11 22 (1.0%) 28 (3.9%) 0.24 (0.13-0.44) <0.001 SYNTAX score >11 0.25 0.5 1 2 4 Favours New-DES Favours Early-DES
C ONCLUSIONS C ONCLUSIONS • New-generation DES provide greater safety and effectiveness compared with early-generation DES in the overall population by reducing the risk of the primary device-oriented endpoint, ischemia-driven TLR, and definite ST • The anatomic complexity of CAD does not impact on the benefits of new-generation DES • The safety and the effectiveness of new-generation DES is greater in patients with SYNTAX score >11 • Additional benefits conferred by new-generation DES can be expected in patients with high SYNTAX scores, which may have important implications in the comparative effectiveness of PCI versus coronary artery bypass grafting
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