N/A
Completed N=2,008
ABSORB III Randomized Controlled Trial (RCT)
Coronary Artery Disease · Coronary Artery Stenosis · Coronary Disease · Coronary Stenosis
Source: ClinicalTrials.gov NCT01751906 ↗
Enrolled (actual)
2,008
Serious AEs
59.7%
Results posted
Feb 2018
Primary outcomePrimary: Number of Cardiac Death/TV-MI/ID-TLR (TLF) — 102; 41 Participants
Summary
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).
The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
220; 98 | — |
| SECONDARY Number of Participants With Powered Secondary Endpoint: Angina |
238; 125 | 0.9256 |
| SECONDARY Number of Participants With Powered Secondary Endpoint: All Revascularization |
120; 55 | 0.5040 |
| SECONDARY Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR) |
66; 25 | 0.2126 |
| SECONDARY Acute Success- Device Success (Lesion Level Analysis) |
94.3; 99.3 | — |
| SECONDARY Acute Success: Procedural Success (Subject Level Analysis) |
1240; 652 | — |
| SECONDARY Number of Death (Cardiac, Vascular, Non-cardiovascular) |
85; 44 | — |
| SECONDARY Number of Participants With All Myocardial Infarction (MI) |
159; 69 | — |
| SECONDARY Number of Participants With All Target Lesion Revascularization (TLR) |
118; 51 | — |
| SECONDARY Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR) |
108; 40 | — |
| SECONDARY Number of Participants With All Revascularization |
255; 114 | — |
| SECONDARY Number of Death/All MI |
230; 101 | — |
| SECONDARY Number of Cardiac Death/All MI |
185; 81 | — |
| SECONDARY Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
220; 98 | — |
| SECONDARY Number of Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) |
245; 113 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) |
290; 128 | — |
| SECONDARY Number of Death/All MI/All Revascularization (DMR) |
378; 168 | — |
| SECONDARY Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition) |
3; 4; 3; 4; 0; 0 | — |
| SECONDARY Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition) |
14; 5; 12; 5; 2; 0 | — |
| SECONDARY Number of Participants With Subacute Stent/Scaffold Thrombosis |
12; 1; 10; 1; 2; 0 | — |
| SECONDARY Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition) |
6; 0; 6; 0; 0; 0 | — |
| SECONDARY Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Cumulative Stent/Scaffold Thrombosis |
32; 7; 30; 7; 2; 0 | — |
| SECONDARY Pre-Procedure Minimum Lumen Diameter (MLD) |
0.92; 0.90 | — |
| SECONDARY Pre-Procedure Percent Diameter Stenosis (%DS) |
65.25; 65.90 | — |
| SECONDARY Post-Procedure In-Segment Minimum Lumen Diameter (MLD) |
2.15; 2.14 | — |
| SECONDARY Post-Procedure In-Segment Percent Diameter Stenosis (%DS) |
20.04; 19.82 | — |
| SECONDARY Post-Procedure In-Device Minimum Lumen Diameter (MLD) |
2.37; 2.49 | — |
| SECONDARY Post-Procedure In-Device Percent Diameter Stenosis (%DS) |
11.62; 6.41 | — |
| SECONDARY Post-Procedure In-Device Acute Gain |
1.45; 1.59 | — |
| SECONDARY Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS) |
-0.30; -0.60 | 0.0665 |
| SECONDARY Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA) |
1.12; 1.19 | — |
| SECONDARY Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal |
6.89; 7.25; 7.70; 7.24 | — |
| SECONDARY Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area |
7.99; 7.50; 6.67; 6.06 | — |
| SECONDARY Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area |
6.47; 6.07; 4.95; 4.54 | — |
| SECONDARY Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts |
7.42; 7.64; 0.32; 0.07 | — |
Eligibility Criteria
General Inclusion Criteria:
- Subject must be at least 18 years of age.
- Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
- Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and 30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
- Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions 700,000 cells/mm3.
- Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
- Subject has renal insufficiency as defined as an estimated GFR 5 minutes.
- No ST depression or elevation lasting > 5 minutes.
- Lesion is located in left main.
- Aorto-ostial RCA lesion (within 3 mm of the ostium).
- Lesion located within 3 mm of the origin of the LAD or LCX.
- Lesion involving a bifurcation with a:
- side branch ≥ 2 mm in diameter, or
- side branch with either an ostial or non-ostial lesion with diameter stenosis > 50%, or
- side branch requiring dilatation
- Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:
- Extreme angulation (≥ 90°) proximal to or within the target lesion.
- Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
- Moderate or heavy calcification proximal to or within the target lesion. If IVUS used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
- Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
- Lesion or vessel involves a myocardial bridge.
- Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach the target lesion.
- Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
- Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.
Data sourced from ClinicalTrials.gov (NCT01751906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.