Frequently Asked Questions

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Frequently asked questions

The ABSORB III trial (n=2,008) has demonstrated: the safety and effectiveness of Absorb at 1 year in patients with stable coronary artery disease and stabilized acute coronary syndrome.1 The findings listed below were similar to those in three smaller randomized trials.2-4

There was no significant difference in the rate of adverse events between the Absorb scaffold and the XIENCE stent at 1 year, as noted below. (XIENCE, the control device, has been associated with the lowest rates of stent thrombosis and other events.5)

  • Cardiac death (0.6% and 0.1%, respectively; p=0.29)
  • Target-vessel myocardial infarction (6.0% and 4.6%, respectively; p=0.18)
  • Ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; p = 0.50)
  • Device thrombosis (1.5% and 0.7%, respectively; p=0.13)

Specifically, when restricting data analysis to appropriate vessel sizes (omitting reference vessel diameter < 2.25 mm), the rates of device thrombosis were 0.9% and 0.6% with Absorb and XIENCE, respectively. Additionally, other studies have revealed that when physicians followed an implant protocol specifically for the bioresorbable vascular scaffold (BVS), there was a significant (~70%) reduction in the incidence of scaffold thrombosis (p=0.035).6

The ABSORB II RCT and ABSORB EXTEND study show an annual accumulation of Absorb event rates that is comparable to what is seen with XIENCE out to 2 and 3 years, respectively.7,8
Yes, there are hypothesis-generating signals in the small ABSORB Cohort B study, showing that late lumen gain and plaque regression are maintained out to 5 years.9
XIENCE is a drug-eluting stent (DES) which remains in the vessel; the Absorb scaffold fully resorbs over time. However, key design elements of Absorb are built on proven XIENCE technology:
  • The drug used—everolimus
  • The stent/scaffold design—MULTI‑LINK
  • The delivery system—based on XIENCE Alpine catheter technology
Bioresorbable scaffold therapy (BRS) is a term used by the clinical community to refer to a fully bioresorbable percutaneous coronary intervention (PCI) solution. Absorb itself is not a stent; it is referred to as a bioresorbable vascular scaffold (BVS).
Absorb is technically a bioresorbable vascular scaffold (BVS), but you might hear it referred to as a:
  • Dissolving stent
  • Biodegradable stent
  • Bioresorbable stent
  • Bioabsorbable stent
No. There are drug-eluting stents (DES) such as SynergyTM with a polymer coating that degrades over time, but the metal stent remains embedded in place. Absorb is a new type of therapy with a completely bioresorbable vascular scaffold (BVS). With Absorb, vascular function is restored,* and vessel remodeling continues through year 5.9
The polymer struts themselves cannot be seen on angiography, so each Absorb scaffold is equipped with small radiopaque marker beads to allow for visualization of scaffold location and for aligning scaffolds for overlap.
Use the current ACC/AHA DAPT guidelines. As you would with any drug-eluting stent (DES) procedure, select patients who are able to comply with DAPT protocol.
  • In ABSORB III all patients were maintained on DAPT for a minimum of 12 months.
  • Risks versus benefits should be considered for each patient, including judgment regarding risk of antiplatelet therapy.
  • Antiplatelet therapy should be used per ACC/AHA guidelines, information from the ABSORB family of clinical trials, current literature on DES and scaffolds, and the specific needs of individual patients.
The Absorb scaffold design is based on the concept of vascular restorative therapy (VRT)—that scaffolding and drug delivery are required only temporarily. Radial support is needed for at least 3 months, given that major vascular changes stabilize at approximately 90 days.10 The Absorb scaffold retains radial support for about 6 months.

During Absorb's restoration phase, which begins at about 6 months, the scaffold begins to alter its structure as a supportive scaffold while not yet losing its mass. Each scaffold strut becomes more porous during a hydrolysis-driven degradation process. As water and blood penetrate the matrix, this action dissolves the bonds in the polymer chains, creating shorter chains and ultimately minute polymer elements. The scaffold eventually breaks down to water and CO2 which are naturally metabolized.

Absorb was intentionally designed to degrade only after a period of months, to avoid triggering late inflammation. At 36 months, no measurable polymer remains in the vessel, and the vessel has gradually reclaimed arterial load and function.

*Absorb improves coronary luminal diameter, restores blood flow and enables movement of the treated vessel. Source: Absorb GT1 IFU.

References

  • 1. Ellis SG et al. N Engl J Med. 2015;373:1905–1915. doi: 10.1056/NEJMoa1509038.
  • 2. Serruys PW et al. Lancet. 2015;385:43–54.
  • 3. Gao RL. ABSORB China 1 Year. TCT. 2015.
  • 4. Kimura T et al. Eur Heart J. 2015;36:3332–3342. doi:10.1093/eurheartj/ehv435.
  • 5. Palmerini T et al. Lancet. 2012;379:1393–1402.
  • 6. Puricel S et al. J Am Coll Cardiol. 2016;67:921–931. doi: 10.1016/j.jacc.2015.12.019.
  • 7. Wu CJ. ABSORB EXTEND. TCTAP. 2015.
  • 8. Chevalier B. ABSORB II 2 Year. TCT. 2015.
  • 9. Serruys PW et al. Absorb Cohort B 5 Year. TCT. 2015.
  • 10. Serruys PW et al. Circulation. 1988;77:361–371.

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Important Safety Information

Absorb GT1TM

Bioresorbable Vascular Scaffold System

INDICATIONS

The Absorb GT1 Bioresorbable Vascular Scaffold (BVS) is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

CONTRAINDICATIONS

The Absorb GT1 BVS System is contraindicated for use in:

  • Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or the post-procedural antiplatelet regimen.
  • Patients with hypersensitivity or contraindication to everolimus or structurally‑related compounds, or known hypersensitivity to scaffold components (poly(L‑lactide), poly(D,L‑lactide), platinum) or with contrast sensitivity.

WARNINGS

  • For single use only. Do not resterilize or reuse. Note the product "Use by" date on the package.
  • Careful assessment of the target lesion reference vessel diameter and selection of the appropriate scaffold diameter relative to the target lesion reference vessel diameter are required to minimize potential damage to the scaffold during post-dilatation and to ensure adequate scaffold apposition and an appropriate post-implantation minimum lumen diameter.
  • In small vessels (visually assessed reference vessel diameter ≤ 2.75 mm), on-line QCA or intravascular imaging with intravascular ultrasound or optical coherence tomography is strongly recommended to accurately measure and confirm appropriate vessel sizing (reference vessel diameter ≥ 2.5 mm). (See Section 8.1.6 – Implantation of Absorb in Small Coronary Arteries (Post Hoc Analysis).)
  • If quantitative imaging determines a vessel size < 2.5 mm, do not implant the Absorb GT1 BVS. Implantation of the device in vessels < 2.5 mm may lead to an increased risk of adverse events such as myocardial infarction and scaffold thrombosis.
  • Adequate lesion preparation prior to scaffold implantation is required to ensure safe delivery of the scaffold across the target lesion. It is not recommended to treat patients having a lesion that prevents complete inflation of an angioplasty balloon. It is strongly recommended to achieve a residual stenosis between 20% and 40% after pre-dilatation to enable successful delivery and full expansion of the scaffold.
  • Ensure the scaffold is not post-dilated beyond the allowable expansion limits (see Absorb GT1 IFU Section 12.7 ‑ Clinician Use Information, Further Expansion of the Deployed Scaffold).
  • Antiplatelet therapy should be administered post-procedure (see Absorb GT1 IFU Section 9.1 ‑ Patient Selection and Treatment, Individualization of Treatment).
  • This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.
  • Judicious selection of patients is necessary, since the use of this device carries the associated risk of scaffold thrombosis, vascular complications, and / or bleeding events.

PRECAUTIONS

  • Implantation of the scaffold should be performed only by physicians who have received appropriate training.
  • Do not exceed the Rated Burst Pressure (RBP) as indicated on the product label.
  • Post‑dilatation is strongly recommended for optimal scaffold apposition. When performed, post‑dilatation should be at high pressure (> 16 atm) with a noncompliant balloon.
  • Care must be taken to properly size the scaffold to ensure that the scaffold is in full contact with the arterial wall upon deflation of the balloon. All efforts should be made to ensure that the scaffold is not under dilated. Refer to Absorb GT1 IFU Section 12.7 - Clinical Use Information, Further Expansion of the Deployed Scaffold.
  • Balloon dilatation of any cells of a deployed Absorb GT1 BVS may cause scaffold damage. Avoid scaffolding across any side branches ≥ 2.0 mm in diameter. Placement of a scaffold has the potential to compromise side branch patency.
  • It is not recommended to treat patients having a lesion with excessive tortuosity proximal to or within the lesion.
  • Non‑clinical testing has demonstrated the Absorb GT1 BVS is MR Conditional. A patient with this device can be safely scanned in all MR environments 3T or less.
  • The safety and effectiveness of the Absorb GT1 BVS have not been established for subject populations with the following characteristics:
    • Coronary artery reference vessel diameters < 2.5 mm or > 3.75 mm
    • Lesion lengths > 24 mm
    • Lesions located in arterial or saphenous vein grafts
    • Lesions located in unprotected left main artery
    • Ostial lesions
    • Lesions located at a bifurcation
    • Previously stented lesions
    • Moderate to severe calcification
    • Chronic total occlusion or poor flow (< TIMI 1) distal to the identified lesions
    • Three‑vessel disease
    • Unresolved thrombus at the lesion site or anywhere in the vessel to be treated
    • Excessive tortuosity proximal to or within the lesion
    • Recent acute myocardial infarction (AMI)

POTENTIAL ADVERSE EVENTS

Adverse events that may be associated with PCI, treatment procedures and the use of a coronary scaffold in native coronary arteries include the following, but are not limited to:

  • Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, device materials (platinum, or polymer [poly(L‑lactide) (PLLA), polymer poly(D,L‑lactide) (PDLLA)]), and drug reactions to everolimus, anticoagulation, or antiplatelet drugs, Vascular access complications which may require transfusion or vessel repair, including: Catheter site reactions, Bleeding (ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage), Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, Embolism (air, tissue, plaque, thrombotic material or device), Peripheral nerve injury, Peripheral ischemia, Coronary artery complications which may require additional intervention, including: Total occlusion or abrupt closure, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, Tissue prolapse / plaque shift, Embolism (air, tissue, plaque, thrombotic material or device), Coronary or scaffold thrombosis (acute, subacute, late, very late), Stenosis or restenosis, Pericardial complications which may require additional intervention, including: Cardiac tamponade, Pericardial effusion, Pericarditis, Cardiac arrhythmias (including conduction disorders, atrial and ventricular arrhythmias), Cardiac ischemic conditions (including myocardial ischemia, myocardial infarction [including acute], coronary artery spasm and unstable or stable angina pectoris), Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA), System organ failures: Cardio‑respiratory arrest, Cardiac failure, Cardiopulmonary failure (including pulmonary edema), Renal insufficiency / failure, Shock, Blood cell disorders (including Heparin Induced Thrombocytopenia [HIT]), Hypotension / hypertension, Infection, Nausea and vomiting, Palpitations, dizziness, and syncope, Chest pain, Fever, Pain, Death.