Resolute in Bifurcation Lesions: Data from the RESOLUTE Clinical Program

Transcription

1 Resolute in Bifurcation Lesions: Data from the RESOLUTE Clinical Program Prof. Ran Kornowski, MD, FESC, FACC Director - Division of Interventional Cardiology Rabin Medical Center and Tel Aviv University, Israel

2 Background Bifurcation lesions remain a therapeutic challenge and a focus of great interest among interventional cardiologists. The impact of the Resolute DES platform, with its open-cell design and unique BioLinx polymer and Zotarolimus anti-proliferative drug, on the technical and clinical outcomes in bifurcation lesions has not been yet explored.

3 RESOLUTE Global Clinical Program Enrollment Complete - In Follow Up RESOLUTE 1 Non-RCT First-in-Human (R=139) 4 yr RESOLUTE AC 2,3 1:1 RCT vs. Xience V (R=1,140; X=1,152) 2 yr RESOLUTE Int Non-RCT Observational (R=2349) 1 yr mm Non-RCT vs. Hx Control (R=1,242) 1 yr RESOLUTE US mm Angio/IVUS Non-RCT vs. Hx Control (R=100) 1 yr RESOLUTE Japan 4.0mm Angio Non-RCT vs. Hx Control (R=60) mm Non-RCT (R=100) vs. Hx Control 1 yr 1 yr R Japan SVS 2.25 Non-RCT vs. PG (R=63) <1 yr RESOLUTE US Enrolling / Planning 38 mm sub-study Non-RCT vs. PG (R= ) < 30d RESOLUTE Asia Non-RCT (R 300) enroll R-China Registry Registry (R=1800 max) enroll R-China RCT 1:1 vs. Taxus (R=200; T=200) 1 Meredith IT, et al. EuroIntervention. 2010;5: Serruys PW, et al. N Engl J Med. 2010;363: Silber S, et al. Lancet. 2011;377: Yeung AC, et al. JACC. 2011;57: plan

4 Patient Flowchart RESOLUTE All Comers N = 1140 (R-ZES arm) RESOLUTE International N = 2349 Bifurcations N = 190 Bifurcations N = 512 Bifurcations N = Year Follow-up n = 690

5 Baseline Characteristics % N = 702 patients Age (yr) 63.9 ± 11.1 Male 79.3 Diabetes mellitus 27.1 IDDM 7.7 Hypertension 68.9 Hyperlipidemia 64.4 Current smoker 23.9 Family history 33.4 Prior MI 27.7 Prior PCI 28.9 Prior CABG 6.6 Cardiac status: Stable angina 37.0 Unstable angina 23.9 Myocardial infarction (STEMI + NSTEMI) 31.2

6 Lesion Characteristics % N = 702 patients, 1087 lesions LAD 64.8 LCX 33.5 RCA 21.9 Left Main 6.4 De Novo 97.3 B2/C 73.2 Thrombus (angiographically visible) 9.4 Total occlusions (TIMI 0) 10.9

7 Medina Classification (1,1,1) 29.4% (1,1,0) 8.4% (1,0,1) 3.7% (0,1,1) 7.1% (1,0,0) 4.1% (0,1,0) 9.1% (0,0,1) 3.0% R-All Comers only; n = 296 lesions

8 Procedure Characteristics - 1 % N = 702 patients, 1087 lesions Number of lesions treated per patient 1.55 ± 0.78 Number of stents per patient 2.0 ± 1.2 Total stent length per patient (mm) 37.4 ± 24.8 Lesion length* (mm) 17.1 ± 11.3 Reference Vessel Diameter* (mm) 2.86 ± 0.53 Minimum Lumen Diameter* (mm) 0.62 ± 0.50 Side Branch RVD* (R-INT only, mm) 2.2 ± 0.6 (n=587) * For RESOLUTE International (R-INT) angiographic measurements are site reported.

9 Procedure Characteristics - 2 % (n) N = 702 patients, 1087 lesions Double guidewires 63.9% Main vessel stented 98.0 % Side branch stenting* 19.1% Bifurcation technique Culotte 5.4% Mini-crush \ Crush 25.9% T 38.8% Simultaneous Kissing Stent 7.5% V 9.5% Other 12.9% Kissing balloon post-dilatation (R-INT only) 78.4% *Provisional in 40.2% of cases

10 Acute Success Rates % Lesion success (the attainment of <50% residual stenosis of the target lesion using any percutaneous method) Device success (the attainment of <50% residual stenosis of the target lesion using only the assigned device) N = 702 patients, 1087 lesions 99.6% 94.7% Procedure success (the attainment of <50% residual stenosis of the target lesion and no in-hospital MACE) 93.9%

11 In-hospital Clinical Outcomes % N = 702 patients Death (all) 0.7 Cardiac death 0.7 Target vessel MI 4.3 Q Wave 0.7 Non Q wave 3.6 Cardiac death + target vessel MI 4.8 TLR 0.7 TVR 0.7 TLF (cardiac death, target vessel MI, TLR) 5.3 TVF (cardiac death, target vessel MI, TVR) 5.3 MACE (death, MI, TLR, emergent CABG) 5.3

12 Clinical Outcomes to 12 Months % n = 690 patients Death (all) 2.3 Cardiac death 1.6 Target vessel MI 5.9 Q Wave 1.3 Non Q wave 4.6 Cardiac death + target vessel MI 7.1 ARC Def/Prob ST (all) 2.0 Early ( 30 days) 2.0 Late ( days) 0.1 TLR 4.8 TVR 6.1 TLF (cardiac death, target vessel MI, TLR) 10.3 TVF (cardiac death, target vessel MI, TVR) 11.4 MACE (death, MI, TLR, emergent CABG) 11.3

13 Safety Outcomes to 12 Months n = 690 Percentage [%] Death Cardiac Death TV MI Cardiac death/mi ARC Def/Prob ST

14 Efficacy Outcomes to 12 Months n = 690 Percentage [%] TLR TVR TLF MACE

15 Target Lesion Failure to 12 Months (cardiac death, TV MI and clinically driven TLR) RESOLUTE Pooled Bifurcation Subset 25% Patients with Bifurcation Cumulative Incidence of TLF 20% 15% 10% 5% 10.3% 0% Patients at risk Time after Initial Procedure (months) N %CI 2.6% 6.7% 7.7% 9.0% 10.3% Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula.

16 Target Lesion Failure to 12 Months (cardiac death, TV MI and clinically driven TLR) RESOLUTE Pooled Bifurcation Subset Cumulative Incidence of TLF 25% 20% 15% 10% 5% Patients with Bifurcation Patients without Bifurcation 10.3% 6.6% 0% Patients at risk Time after Initial Procedure (months) Bifur %CI 2.6% 6.7% 7.7% 9.0% 10.3% No bifur %CI 1.0% 3.6% 4.8% 5.8% 6.6% Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula.

17 Mortality to 12 Months RESOLUTE Pooled Bifurcation Subset Cumulative Incidence of Death 10% 8% 6% 4% 2% Cardiac Death All Death 2.3% 1.6% Patients at risk Cardiac Death 0% Time after Initial Procedure (months) %CI 0% 0.9% 1.0% 1.4% 1.6% All Death %CI 0% 1.0% 1.6% % Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula.

18 Target Vessel MI to 12 Months RESOLUTE Pooled Bifurcation Subset 20% Cumulative Incidence of TVMI 15% 10% 5% 5.9% 0% Time after Initial Procedure (months) Patients at risk N %CI 2.6% 5.3% 5.6% 5.9% 5.9% Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula.

19 Revascularization to 12 Months RESOLUTE Pooled Bifurcation Subset 20% TLR TVR Cumulative Incidence of Revascularization 15% 10% 5% 6.2% 4.9% 0% Patients at risk Time after Initial Procedure (months) TLR %CI 0% 2.0% 3.0% 3.8% 4.9% TVR %CI 0% 2.7% 4.3% 5.1% 6.2% Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula.

20 Def/Prob Stent Thrombosis to 12 Months RESOLUTE Pooled Bifurcation Subset Cumulative Incidence of ARC Definite/Probable Stent Thrombosis 10% 5% 0% 0% Patients at risk Time after Initial Procedure (months) R-Pooled %CI 0.3% 2.0% 2.0% 2.0% 2.0% 2.0% Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula.

21 Clinical Outcomes to 12 Months By Number of Stents % 1 stent implanted n = 532 >1 stent implanted n = 158 P-value Death (all) Cardiac death MI (target vessel) Q Wave Non Q wave Cardiac death + target vessel MI ST Def/Prob (all) Early ( 30 days) Late ( days) TLR TVR TLF (cardiac death, TV-MI, TLR) TVF (cardiac death, TV-MI, TVR) MACE (death, MI, TLR, emergent CABG)

22 TLR to 12 Months by Number of Stents RESOLUTE Pooled Bifurcation Subset Cumulative Incidence of TLR 20% 15% 10% 5% Patients with 1 Stent Implanted Patients with >1 Stent Implanted 6.4% 4.4% Patients at risk 0% Time after Initial Procedure (months) 1 Stent %CI 0% 1.9% 3.0% 3.4% 4.4% >1 Stent %CI 0% 2.5% 3.1% 5.0% 6.4% Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula.

23 TLF to 12 Months Comparison Resolute ZES (R-Pooled) to Xience V EES (R-AC) Cumulative Incidence of TLF 25% 20% 15% 10% 5% R-ZES in Bifurcation Patients (RESOLUTE Pooled, N = 702) EES in Bifurcation Patients (RESOLUTE All Comers, N = 202) 11.4% 10.3% 0% Patients at risk Time after Initial Procedure (months) R-ZES %CI 2.6% 6.7% 7.7% 9.0% 10.3% EES %CI 4.5% 8.4% 9.9% 10.4% 11.4% Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula.

24 Conclusion In the pooled dataset with Resolute bifurcation lesions we observed: Excellent technical/angiographic success rate with 19.1% need for SB stenting in the treated cohort. Sustainable clinical efficacy out to one year (e.g. very low rates of TLR 4.8% and TVR 6.1%). Favorable TLF (10.3%) event rate with low stent thrombosis (2.0%, mostly early) up to one year. Thus, the Resolute DES platform is a viable treatment option for bifurcation lesion management.