Long-term Zilver PTX Data from Japan: 5-year Results in the Real World

Transcription

1 Long-term Data from Japan: 5-year Results in the Real World Hiroyoshi Yokoi, MD Department of Cardiovascular Medicine Fukuoka Sanno Hospital Fukuoka, Japan On behalf of the Investigators

2 Disclosure Speaker name:...hiroyoshi Yokoi... I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) Cook, I do not have any potential conflict of interest

3 2-year follow-up COMPLETE 1-year follow-up COMPLETE 5-year follow-up COMPLETE 5-year follow-up ongoing 1-year follow-up COMPLETE Global Clinical Program for Pre-Market Studies Post-Market Studies RCT Moderate lesions SAS More complex lesions China Similar lesions to RCT Japan PMS All-comers US PAS Similar lesions to RCT EU Longer Lesions PTA n=242 Optimal n=118 Suboptimal 5-year follow-up COMPLETE Zilver Flex n=56 n=63 n=787 n=178 n=904 n=200 n=45 More than 2400 patients to be included in current clinical program

4 Japan PMS Compared to RCT and SAS Key Study Criteria RCT SAS Japan PMS No significant untreated inflow tract stenosis At least one patent runoff vessel Maximum 2 stents Maximum 4 per lesion stents per patient Lesion length 14 cm One lesion per limb No exclusions No prior stent in SFA ISR included ALL patients treated with enrolled (up to enrollment limit), NO exclusion criteria Excluded if serum creatinine > 2.0, renal failure, or dialysis No exclusions Antiplatelets Clopidogrel or ticlopidine recommended for 60 days, aspirin indefinitely Follow-up 5 years 2 years 5 years Patency DUS core laboratory analysis DUS site analysis Stent Integrity X-ray core laboratory analysis Increasingly complex patients and lesions

5 Japan PMS (n=904) Japan PMS Subgroups Analyzed Complex Lesions (>14cm, no runoff, ISR) Diabetic patients CLI patients ISR lesions Chronic renal failure patients No runoff Long (>14cm) total occlusions

6 Subgroup Analyses Patients with chronic renal failure (CRF) Patients with no continuous patent runoff vessels Lesions with in-stent restenosis (ISR)

7 Chronic Renal Failure egfr< 60mL/min/1.73m 2 and/or dialysis Higher incidence of diabetes (69% vs. 53%) in the CRF group CRF n = 321 (35%) Japan PMS n = 905 No CRF n = 584 Lower rate of total occlusions (34% vs. 45%) in the CRF group No other significant demographic or lesion differences

8 Chronic Renal Failure 91.5% 90.8% 84.9% 81.4% p = 0.24 Freedom from TLR rates are similar through 2 years

9 No Patent Runoff Vessels Patients who did not have any continuous patent runoff vessels to the foot Japan PMS n = 905 Higher incidence of CLI (45% vs. 20%) in the no runoff group No other significant demographic or lesion differences No runoff vessels n = 54 (7%) 1 runoff vessel n = 846

10 No Patent Runoff Vessels Amputation 3 no runoff group patients, 7 runoff group patients All 3 amputations in the no runoff group occurred within 2 months of the initial procedure DES remained patent Likely reflects pre-procedure expectation of amputation From 2 months through 2 years there was no difference in the amputation rate (0% vs. 0.7%), supporting the safety of DES treatment for patients with no patent runoff vessels

11 No Patent Runoff Vessels 91.0% 89.5% 83.8% 81.3% p = 0.87 Freedom from TLR rates are similar through 2 years

12 In-Stent Restenosis In-stent restenosis is outside of the approved indication for use in the US ISR n = 175 (19%) Japan PMS n = 905 Non ISR n = 730 Higher incidence of hypercholesterolemia (70% vs. 59%) and lower ABI (0.59 vs. 0.64) in the ISR group Longer lesion length (17.8 vs cm) in the ISR group No other significant demographic or lesion differences

13 In-Stent Restenosis 92.4% 84.2% 85.3% 76.6% p = 0.05 Nearly similar outcomes for ISR and non-isr patients

14 Subgroup Conclusions Results indicate that the DES appears safe and effective for: Patients with chronic renal failure Patients with no patent runoff vessels Patients with in-stent restenosis (outside of approved indication in US)

15 5-year Follow-up for Japan PMS 904 patients with 1080 lesions treated with 1877 stents 411 patients completed 5-year follow-up 493 patients exited study through 5 years (~10% per year) 226 lost to follow-up through 5 years (25%) 82 withdrawals through 5 years (9%) 185 deaths through 5 years (20%) None adjudicated as device or procedure related Follow-up and exit rates very similar to those observed in RCT

16 Patient Demographics and Comorbidities RCT SAS Japan PMS Patients Age (years) 68 ± 10 * 67 ± 10 * 74 ± 9 Male 66% 73% 70% Diabetes 50% * 36% * 59% High cholesterol 76% * 58% 61% Hypertension 89% 80% * 85% Pulmonary disease 19% * 9% 8% Renal disease 10% * 11% * 44% Renal failure (egfr < 60 and/or on dialysis ) 0% * Not assessed 36% * p < 0.05 compared to Japan PMS Japan PMS patients were older, and had diabetes and renal failure more often

17 Baseline Lesion Characteristics RCT SAS Japan PMS Lesions Lesion length (cm) 6.6 ± 3.9 * 10.0 ± 8.2 * 14.6 ± 9.6 Diameter stenosis (%) 81 ± 16 * 85 ± 16 * 92 ± 11 Total occlusions 30% * 38% 42% In-stent restenosis 0% * 15%* 19% Patent runoff vessels 0 0% 0% 7% 1 22% 19% 32% * * 2 35% 35% 33% 3 42% 46% 29% * p < 0.05 compared to Japan PMS Japan PMS lesions were more complex (e.g., longer, more ISR, fewer patent runoff vessels)

18 Baseline Clinical Assessment Pre-procedure Clinical Assessment Rutherford 1 0% RCT SAS 0.5% Japan PMS 8% 2 53% 32% 27% 3 38% 56% 44% * * 4 6% 5% 10% 5 3% 6% 10% 6 0% 0.2% 1% ABI 0.67 ± 0.20 * 0.64 ± ± 0.18 * p < 0.01 compared to Japan PMS Japan PMS had significantly more CLI patients

19 Freedom from TLR Freedom from TLR Years (n=patients) RCT SAS Japan PMS (n=305) (n=787) (n=904) % 89.8% 90.8% % 83.3% 83.4% % 78.9% % n/a 77.5% % 74.3% Consistently good results in challenging patient population including diabetics, renal failure, long lesions, ISR, no runoff, CLI

20 5-year Overall Conclusions Large amount of clinical data ranging from carefully controlled Level I evidence to large, global, real-world experience As expected, patient population and lesion characteristics become more challenging in realworld, all-comer studies like Japan PMS 5-year Japan PMS results are consistently good, and remarkable given the high incidence of diabetics, renal failure, long lesions, ISR, no runoff, CLI Patients traditionally excluded from other clinical studies

21 Long-term Data from Japan: 5-year Results in the Real World Hiroyoshi Yokoi, MD Department of Cardiovascular Medicine Fukuoka Sanno Hospital Fukuoka, Japan On behalf of the Investigators