C OMPARATIVE E FFECTIVENESS E FFECTIVENESS AND AND S AFETY S AFETY OF - - PowerPoint PPT Presentation

▶

Feb 13, 2023 250 likes •371 views

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

SLIDE 1

COMPARATIVE COMPARATIVE EFFECTIVENESS EFFECTIVENESS AND

AND SAFETY

SAFETY OF

OF

NEW-VERSUS EARLY-GENERATION DRUG-ELUTING STENTS NEW-VERSUS EARLY-GENERATION DRUG-ELUTING STENTS

ACCORDING ACCORDING TO THE C TO THE COMPLEXITY OMPLEXITY OF OF CORONARY ARTERY

CORONARY ARTERY DISEASE DISEASE : : A PATIENT-LEVEL POOLED ANALYSIS A PATIENT-LEVEL POOLED ANALYSIS OF

OF 6,081 PATIENTS

6,081 PATIENTS

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

SLIDE 2

SLIDE 3

PROGRESS WITH METALLIC DRUG-ELUTING STENTS PROGRESS WITH METALLIC DRUG-ELUTING STENTS

Piccolo R et al. Lancet 2015;386:702-713

SLIDE 4

STUDY OBJECTIVE STUDY OBJECTIVE

Piccolo R et al. Lancet 2015;386:702-713

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 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

SLIDE 5

4 All-comers RCTs (n=6,081)

METHODS METHODS

2003-04 2006-07 2008-08 2012-13

11.8±9 14.7±9 13.6±9 11.7±7

New- vs. Early-DES Pooled trials SYNTAX Score Distribution

Early-DES: 12.5±8 New-DES: 13.3±9

SIRTAX LEADERS RESOLUTE BIOSCIENCE

Early-DES: SES and PES (SIRTAX and LEADERS)
New-DES: EES, Resolute ZES, BP-BES, and BP-SES (LEADERS, RESOLUTE, BIOSCIENCE)
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)

SLIDE 6

BASELINE CLINICAL CHARACTERISTICS BASELINE CLINICAL CHARACTERISTICS

New-DES (n =4,554) Early-DES (n =1,527) p-value Age — years 64.5±11.2 62.7±11.1 <0.001 Female gender 1,117 (24.5%) 380 (24.9%) 0.78 Diabetes 1,012 (22.2%) 298 (19.5%) 0.03 Insulin-requiring 330 (7.2%) 101 (6.6%) 0.42 Hypertension 3,160 (69.4%) 998 (65.4%) 0.003 Hypercholesterolemia 2,915 (64.0%) 934 (61.2%) 0.05 Renal Failure 625 (14.3%) 172 (13.3%) 0.39 Current smoker 1,317 (28.9%) 512 (34.3%) <0.001 Family history of CAD 1,347 (31.8%) 606 (39.7%) <0.001 Previous MI 1,043 (23.1%) 432 (28.3%) <0.001 Previous PCI 1,297 (28.5%) 387 (25.3%) 0.02 LVEF (%) 56.1±11.8 56.4±11.7 0.48 Clinical presentation 0.01 Stable CAD 1,752 (40.6%) 648 (42.4%) 0.22 NSTE-ACS 1,678 (38.9%) 528 (34.6%) 0.003 ST-elevation MI 887 (20.5%) 351 (23.0%) 0.05

SLIDE 7

ANGIOGRAPHIC AND PROCEDURAL CHARACTERISTICS ANGIOGRAPHIC AND PROCEDURAL CHARACTERISTICS

New-DES (n =4,554) Early-DES (n =1,527) p- value

No. of treated lesions per patient

1.48±0.75 1.41±0.66 0.043 Multivessel treatment per patient 1,076 (23.6%) 277 (18.1%) <0.001 Target-vessel location <0.001 Right coronary artery 2,169 (32.2%) 724 (33.6%) Left main artery 75 (1.1%) 12 (0.6%) Left anterior descending artery 2,885 (42.8%) 975 (45.3%) Left circumflex artery 1,610 (23.9%) 441 (20.5%) Bypass graft 4 (0.1%) 0 (0.0%) De novo lesion per lesion 6,289 (93.8%) 2,061 (95.9%) 0.001 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 — mm 25.29±15.66 21.20±12.58 <0.001 Mean stent diameter per lesion — mm 2.99±0.46 2.90±0.44 <0.001

SLIDE 8

NEW-GENERATION NEW-GENERATION V

VS. EARLY-GENERATION DES:
S. EARLY-GENERATION DES:

2-YEAR FOLLOW- 2-YEAR FOLLOW- UP UP

Definite ST

Adjusted HR 0.40 (0.25-0.65), P<0.001 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

New-DES (n =4,554), Early-DES (n =1,527). Follow-up available in 97.2% of patients at 2-year

Cdeath, MI, TLR

Adjusted HR 0.75 (0.63-0.89), P=0.001

Target-Lesion Revasc

Adjusted HR 0.56 (0.44-0.70), P<0.001

5 10 15 20 60 120 180 240 300 360 420 480 540 600 660 730

Days

5 10 15 60 120 180 240 300 360 420 480 540 600 660 730 1 2 3 4 5 60 120 180 240 300 360 420 480 540 600 660 730

Days Days (%) (%) (%)

New-DES 10.4% Early-DES 13.2% New-DES 5.0% Early-DES 8.6% New-DES 0.9% Early-DES 2.5%

SLIDE 9

Cdeath, MI, TLR Target-Lesion Revasc Definite ST

Pint =0.16 Pint =0.25 Pint =0.11 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)

No significant interaction between the type of DES and the SYNTAX score

CLINICAL OUTCOMES ACCORDING TO THE SYNTAX SCORE CLINICAL OUTCOMES ACCORDING TO THE SYNTAX SCORE

1 2.5 5 10 20 5 10 15 20 25 30 35 40 45 50 55 60 1 2.5 5 10 20 5 10 15 20 25 30 35 40 45 50 55 60 1 2.5 5 10 20 40 80 5 1 1 5 2 2 5 3 3 5 4 4 5 5 5 5 6

SYNTAX score SYNTAX score SYNTAX score HR HR HR

Early-DES New-DES Benefit of New-DES vs. Early-DES

SLIDE 10

STRATIFIED ANALYSIS OF CLINICAL ENDPOINTS STRATIFIED ANALYSIS OF CLINICAL ENDPOINTS

New-DES Early-DES Adj HR (95% CI) p pinteraction

Primary Endpoint Cardiac death Any MI ID-TLR ID-TVR Definite ST

SYNTAX score ≤11 SYNTAX score >11 SYNTAX score ≤11 SYNTAX score >11 SYNTAX score ≤11 SYNTAX score >11 SYNTAX score ≤11 SYNTAX score >11 SYNTAX score ≤11 SYNTAX score >11 SYNTAX score ≤11 SYNTAX score >11

Favours New-DES Favours Early-DES

0.25 0.5 1 2 4

175 (8.0%) 287 (12.7%) 71 (8.9%) 129 (17.8%) 0.86 (0.64-1.16) 0.68 (0.54-0.85) 0.32 0.001 0.22 39 (1.8%) 67 (3.0%) 10 (1.3%) 40 (5.5%) 1.03 (0.51-2.09) 0.46 (0.31-0.70) 0.93 <0.001 0.042 87 (4.0%) 141 (6.2%) 28 (3.5%) 41 (5.7%) 1.16 (0.73-1.84) 1.18 (0.80-1.73) 0.54 0.41 0.87 88 (4.1%) 129 (5.9%) 45 (5.7%) 84 (11.9%) 0.74 (0.50-1.08) 0.46 (0.34-0.61) 0.12 <0.001 0.059 110 (5.1%) 167 (7.6%) 52 (6.6%) 100 (14.1%) 0.81 (0.57-1.15) 0.51 (0.39-0.66) 0.23 <0.001 0.039 20 (0.9%) 22 (1.0%) 10 (1.3%) 28 (3.9%) 0.94 (0.40-2.23) 0.24 (0.13-0.44) 0.89 <0.001 0.013

.125 .25 .5 1 2 4 Adjusted Hazard ratio (95% CI)

SLIDE 11

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
f 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