Why Go Beyond DES?
Adverse events remain high with current DES
MACE and Mortality 10 Years — ISAR-Test 414
MACE and DoCE – RESOLUTE All Comers3
*Combination of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel and clinically indicated target lesion revascularization
Adverse Events Continue to Accrue at a Rate of 2-3% Per Year with No Plateau
Traditional DES can longitudinally stretch or straighten the arteries.4
- Longitudinal stretch may contribute to MACE and stent restenosis severity
Adverse events, which occur after the first year at a rate of approximately 2 to 3% per year, may be attributed to strut fractures, loss of vessel compliance, vasomotion and the capability for vascular adaptive remodeling, coverage of side branches and the development of late neoatherosclerosis.
Stone et al. JAMA Cardiology 2019
DynamX Clinical Evidence
The DynamX Mechanistic Clinical Study
Design
- Multi-center, single-arm, mechanistic clinical study
- 50 patients
- 7 international sites
- 2 Principal investigators: Stefan Verheye, MD – ZNA Middelheim; Antonio Columbo, MD, San Raffaele Hospital, Milan
- Treatment of single, de novo lesions
- Followed out to 30 days, 9 and 12 months, 2 and 3 years
Principal endpoints:
- The primary safety endpoint is Target Lesion Failure at six months. TLF is a composite endpoint defined as cardiac death, target vessel MI and clinically-indicated target lesion revascularization
- The primary imaging/efficacy endpoints for those patients undergoing imaging follow-up are the change in mean in-device area and mean lumen area at nine or 12 months. These endpoints are compared to post-procedure as measured by IVUS
- Co-primary imaging/efficacy endpoints for those patients undergoing imaging follow-up are late lumen loss. The endpoints are measured by QCA and IVUS at nine or 12 months
Outstanding Efficacy and Safety Outcomes
Outstanding imaging results show acute gain similar to best-in-class DES and vessel lumen maintained at 1 year
Angiographic Results15
| Post-Procedure, Paired (n=45) | 9 & 12 Month Follow-Up, Paired (n=45) |
|
| In-Segment | ||
| RVD (mm) | 2.95 ± 0.38 | 2.89 ± 0.39 |
| MLD (mm) | 2.51 ± 0.37 | 2.39 ± 0.39 |
| %DS | 14.7 ± 7.8 | 17.0 ± 9.5 |
| Acute Gain (mm) | 1.39 ± 0.38 | — |
| Balloon-Artery Ratio | 1.15 ± 0.12 | — |
| Late Lumen Loss (mm) | — | 0.11 ± 0.14 |
| In-Bioadaptor | ||
| RVD (mm) | 3.08 ± 0.27 | 2.98 ± 0.30 |
| MLD (mm) | 2.75 ± 0.30 | 2.63 ± 0.37 |
| %DS | 5.4 ± 8.1 | 7.7 ± 10.8 |
| Acute Gain (mm) (Mean ± SD) | 1.63 ± 0.34 | — |
| Late Lumen Loss (mm) (Mean ± SD) | — | 0.12 ± 0.18 |
| Late Lumen Loss (mm) (Median, IQR)7 | — | 0.05 (0.02, 0.17) |
Excellent safety and efficacy through 36 months.15,22,24 No device thrombosis and only 1 TLR at 36 months.
Clinical Follow-up
| 9 Months (n = 49)5 | 12 Months (n = 48)6 | 24 Months (n = 48) | 36 Months (n = 46)25 |
|
|---|---|---|---|---|
| TLF | 2 | 2 | 2 | 4 |
| Death (CV)* | 2 | 2 | 2 | 3 |
| Target Vessel MI | 0 | 0 | 0 | 0 |
| CD-TLR | 0 | 0 | 0 | 1 |
| Device Thrombosis (Def/Prob) | 0 | 0 | 0 | 0 |
*Investigational sites report deaths as not related to device or procedure. Unwitnessed death (Day 255), History of Korsakoff’s Syndrome, no autopsy performed; Adjudicated per ARC-2 as Cardiac Death due to unwitnessed death. Multi-organ failure following Heart Failure (HF) Hospitalization (Day 267); Adjudicated per ARC-2 as Cardiac Death due to HF hospitalization. Death at Day 927 due to end stage Cardiovascular (CV) disease (88 y/o patient). At 9-months patient hospitalized for cardiogenic shock with aortic stenosis and LV dysfunction. At 1-year hospitalized for HF, at 2-year hospitalized for HF & dyspnea.
Thin uniform strut coverage demonstrates healing – DynamX clinical data shows struts are 99% covered at 12 months7 with neointimal thickness similar to best-in-class DES
Clinical Roadmap
Robust global clinical program
Resources
