1) The document discusses the history and evolution of biovascular scaffolds, from plain old balloon angioplasty to bare metal stents to drug-eluting stents.
2) It describes the potential advantages of bioabsorbable vascular scaffolds (BVS) compared to permanent stents, including restoration of vascular function and no need for long-term antiplatelet therapy.
3) Several types of BVS are presented, including those made of polylactic acid, magnesium alloys, and polyanhydrides, along with results from early clinical trials testing safety and performance.
A presentation regarding a analysis of the marketplace for stents and also how Abbott could enter the market with their new stent technology in order to acquire the most amount of customers.
A presentation regarding a analysis of the marketplace for stents and also how Abbott could enter the market with their new stent technology in order to acquire the most amount of customers.
MT5007: The coronary stent revolution (A group project for the Management of ...Stefan
This project tracks the development of coronary artery disease interventions, ranging from early method of cardiac bypass to balloon angioplasty to the development of biomedical stents. Analyses of the competitive climate in the biomedical stents industry is discussed. New market and technology strategies are proposed for a regional MNC to leverage domestic industry infrastructure within emerging economies accompanied by a projected 30% growth in CAD due to increased consumption trends and lifestyle factors, e.g. smoking.
Problem associated with drug eluting stentPRAVEEN GUPTA
This ppt will tell us about the problem which a cardiologist has to face after implantation of Drug eluting stent in a patient of coronary artery diseases. Although there are lots of problem but i am going to describe only three major problem.
A stent is a small, expandable tube. During a procedure called angioplasty, the stent is inserted into a coronary artery and expanded using a small balloon. A stent is used to open a narrowed or clotted artery.
MT5007: The coronary stent revolution (A group project for the Management of ...Stefan
This project tracks the development of coronary artery disease interventions, ranging from early method of cardiac bypass to balloon angioplasty to the development of biomedical stents. Analyses of the competitive climate in the biomedical stents industry is discussed. New market and technology strategies are proposed for a regional MNC to leverage domestic industry infrastructure within emerging economies accompanied by a projected 30% growth in CAD due to increased consumption trends and lifestyle factors, e.g. smoking.
Problem associated with drug eluting stentPRAVEEN GUPTA
This ppt will tell us about the problem which a cardiologist has to face after implantation of Drug eluting stent in a patient of coronary artery diseases. Although there are lots of problem but i am going to describe only three major problem.
A stent is a small, expandable tube. During a procedure called angioplasty, the stent is inserted into a coronary artery and expanded using a small balloon. A stent is used to open a narrowed or clotted artery.
Beta blockers have a variety of different uses in the management of ischemic heart disease. This presentation by Dr Vivek Baliga, Internal Medicine Physician talks about the role in ST elevation MI.
Innovations in Percutaneous Intervention, 1977-2007. Slides created by Simon H. Stertzer, MD, FACC, FAHA, Professor Emeritus, Stanford University School of Medicine.
The adaptability of the stent concept has mainly opened horizons beyond the vasculature, with stent technology now being developed for, amongst others, pulmonary, gastro-intestinal and structural heart applications. There were inter-woven themes that mainly illustrate the complexity and multi-disciplinary character of the modern medical stenting domain (Brown et al., 2009):
The importance of the real-world clinical data in assessing stent performance Mathematical modeling, both computational and analytical, covering solid mechanics, fluid mechanics, fluid–structure interaction (FSI) techniques, and diffusion and transport modeling Modelling informed and validated by the experimental information, including in vitro and in vivo data (pre-clinical and clinical) Drug eluting the stents (DES),
A new polymer-free drug-eluting stent with nanocarriers eluting sirolimus fro...Paul Schoenhagen
Background: Permanent polymers in first generation drug-eluting stent (DES) have been imputed to be a possible cause of persistent inflammation, remodeling, malapposition and late stent thrombosis. We aim to describe the in vivo experimental result of a new polymer-free DES eluting sirolimus from stent-plus-balloon (Focus np stent, Envision Scientific) compared with a bare-metal stent (BMS) (Amazonia CroCo, Minvasys) and with a biolimus A9 eluting stent (Biomatrix, Biosensors).
Assessment and management of anterior vaginal wall defects presents a unique surgical challenge and is the most common site of initial prolapse in women and the most common site of recurrence.
Intravascular lithotripsy (ivl) for peripheral arterial diseaseRamachandra Barik
There are a number of observations that suggest IVL produces
compliance changes in the vessel wall:Effacement of calcified stenoses with lithotripsy at low pressure with no change in angioplasty balloon pressure •Changes in echotexture on Duplex Ultrasound•Changes in appearances on Optical Coherence Tomography
Similar to Biovascular scaffolds - current status 2015 (20)
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
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ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
LGBTQ+ Adults: Unique Opportunities and Inclusive Approaches to CareVITASAuthor
This webinar helps clinicians understand the unique healthcare needs of the LGBTQ+ community, primarily in relation to end-of-life care. Topics include social and cultural background and challenges, healthcare disparities, advanced care planning, and strategies for reaching the community and improving quality of care.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
Trauma Outpatient Center is a comprehensive facility dedicated to addressing mental health challenges and providing medication-assisted treatment. We offer a diverse range of services aimed at assisting individuals in overcoming addiction, mental health disorders, and related obstacles. Our team consists of seasoned professionals who are both experienced and compassionate, committed to delivering the highest standard of care to our clients. By utilizing evidence-based treatment methods, we strive to help our clients achieve their goals and lead healthier, more fulfilling lives.
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2. OVERVIEW
History & evolution of BVS
Physiology of BVS
Advantages
Types of BVS
Clinical trials
Future perspectives
3.
4. • First revolution- balloon
angioplasty
• Invention of balloon
angioplasty as a
percutaneous treatment
for obstructive coronary
disease by Andreas
Gruntzig in 1977.
5. Plain Old Balloon Angioplasty
(POBA)
Dissections – Focal to threatened dissection
Acute recoil
Chronic constrictive remodeling
6. • Second revolution – BMS
• The advent of BMS and the landmark Belgian-Netherlands Stent
Study (BENESTENT) and Stent Restenosis Study (STRESS) trials
have established BMS as the second revolution in interventional
cardiology.
• A solution to acute vessel occlusion by
– sealing the dissection flaps
– preventing recoil
– making emergency bypass surgery a rare occurrence.
– Serruys et al.A comparison of balloon-expandable-stent implantation with
balloon angioplasty in patients with coronary artery disease: Benestent Study
Group. N Engl J Med. 1994;331:489–495.
8. • Third revolution - DES
• The first 45 patients implanted with the sirolimus
eluting Bx velocity stent (Cordis, Johnson &
Johnson) were found to have negligible neointimal
hyperplasia at follow-up.
• This was confirmed in the randomized comparison of
sirolimus-eluting stent with a standard stent for
coronary revascularization (RAVEL) study.
– Morice MC, et al. A randomized comparison of a sirolimus-eluting
stent with a standard stent for coronary revascularization. N Engl J
Med. 2002.
9. • Disadvantages
• Increased risk of late and very late ST.
• late ST rates of 0.53%/y, with a continued increase to 3% over 4
years.
– Late thrombosis in DES after discontinuation of antiplatelet therapy.
Lancet. 2004
• In the (ARTS II) trial, the rate of combined definite, probable, and
possible ST was as high as 9.4% at 5 years, accounting for 32% of
MACE.
– J Am Coll Cardiol. 2009
–
• Postmortem specimens of DES revealed significant numbers of
uncovered struts with persistent inflammation around the stent
struts.
• Vasomotion testing demonstrated vasoconstriction to Ach.
– Vascular responses to drug eluting stents: importance of delayed
11. Why Bioabsorbable stents??
Potentially: no late stent thrombosis and no need for prolonged antiplatelet
therapy
MRI / CT compatibility (allows non-invasive follow ups)
No “Full metal jacket” makes later treatments of the same segment easier (e.g.,
surgical bypass)
Leaves no stent behind long-term (no chronic inflammation, no long-term impact
on local vasomotion)
Provides stent scaffolding and radial strength properties as long as needed to
ensure an open lumen – same as permanent stent
13. • On Premise that scaffolding & drug are only required on a
temporary basis following coronary interventions.
• Several studies support this concept and indicate that there is no
incremental clinical benefit of a permanent implant over time.
• Use of Absorbable scaffold eliminates the presence of a mechanical
restraint and offers potential of restoring natural vessel reactivity.
– Incidence of restenosis after successful coronary angioplasty: a time-related
phenomenon. A quantitative angiographic study in 342 consecutive patients at 1,
2, 3, and 4 months. Circulation, 1988.
Vascular Reparative therapy
14. While stent performance is characterized by a single
phase (Revascularization), the performance of Absorb is
governed by three distinct phases:
Revascularization
Restoration
Resorption.
Together, these phases of Absorb performance deliver
VRT
15.
16. What is Required of a Fully Bioresorbable
Scaffold to Fulfill the Desire for ‘Vascular
Restoration Therapy’?
Revascularization Restoration Resorption
0 to 3 months 3 to ~6-9 months + ~9 months +
Performance should mimic
that of a standard DES
Transition from scaffolding
to discontinuous structure
Implant is discontinuous
and inert
• Good deliverability
• Minimum of acute recoil
• High acute radial strength
• Controlled delivery of drug
to abluminal tissue
• Excellent conformability
• Gradually lose radial strength
• Struts must be incorporated
into the vessel wall (strut
coverage)
• Become structurally
discontinuous
• Allow the vessel to respond
naturally to physiological
stimuli
• Resorb in a benign fashion
17. What is Required of a Fully Bioresorbable Scaffold to Fulfill the
Desire for ‘Vascular Restoration Therapy’?
1 3 6 2 Yrs
Full Mass Loss &
Bioresorption
Mos
Platelet Deposition
Leukocyte Recruitment
SMC Proliferation and Migration
Matrix Deposition
Re-endothelialization
Vascular Function
Forrester JS, et al., J. Am. Coll. Cardiol. 1991; 17: 758.
Revascularization Restoration Resorption
Everolimus Elution
Mass Loss
Support
Oberhauser JP, et al., EuroIntervention Suppl. 2009; 5: F15-F22.
18. • Vessel Remodeling
• Through the use of the imaging modality
intravascular ultrasound (IVUS), data from the
ABSORB Cohort B trial, reveals an increase in
lumen area between 6 months and 2 years.
• As Absorb resorbs, the vessel segment becomes
unconstrained and there is the potential for lumen
gain.
19. • Vasomotion
• As Absorb resorbs, the treated vessel segment is able to react
to changes in blood flow and physiological stimuli that may
occur with exercise or certain drugs.
• By no longer supporting or caging the vessel, there is the
potential for allowing the vessel to respond naturally to
physiological stimuli, which could provide unique benefits.
20. MECHANICAL CONDITIONING IN PRE-CLINICAL
MODEL (PORCINE)
Tests were performed by and data are on file at Abbott Vascular.
Transmission Electron Microscopy (TEM) Smooth Muscle -Actin
Dense
bodies
At 36 months, SMCs are well organized and have undergone
transformation to a functional, contractile phenotype
Mechanical
conditioning
23. First absorbable stent implanted in
humans
Constructed from PLLA.
Hydrolysis of bonds between
repeating lactide units produces
lactic acid that enters the Krebs
cycle
first-in-man prospective,
nonrandomized trial that enrolled
50 pts
4yr follow-up of all pts revealed a
low complication rate.
loss index (late loss/acute gain)
was 0.48 mm, which was
comparable to BMS
Tamai H, Igaki K, et al. Circulation
2000
IGAKI – TAMAI Bioabsorbable STENT
24. • Despite impressive initial results, failure of the stent to
progress was related primarily to the use of heat to
induce self-expansion.
• Concerns - could cause necrosis of the arterial wall,
leading to excessive intimal hyperplasia or increased
platelet adhesion, leading to ST.
• Biodegradable peripheral Igaki-Tamai stents PERSEUS
study, the stent became available in Europe for
peripheral use.
– Biamino G, Schmidt A, Scheinert D. Treatment of SFA lesions with
PLLA biodegradable stents: results of the PERSEUS Study. J Endovasc
Ther. 2005;12:5.
25. Igaki Tamai – 10 yr follow up (n=50)
Kaplan-Meier curves showing:-
(A)survival rates free of cardiac death
(B) Death
(C) major cardiac adverse events.
Cumulative rates of :-
target lesion revascularization (TLR)
target vessel revascularization (TVR)
Circulation 2012.
27. • Prolonged mechanical stability, different Mg alloy
with a higher collapse pressure and slower
degradation time.
• Modified stent surface - strut thickness reduced
• Shape of the strut changed from rectangular to
square (improving radial strength).
• Prolonged scaffolding and stent integrity, improved
radial strength, and reduced neointimal proliferation
in animal models.
AMS – 2 STENT
28. • The AMS-3 stent (drug-eluting AMS) is
designed to reduce neointimal hyperplasia
by incorporating a bioresorbable matrix for
controlled release of an antiproliferative drug
onto the AMS-2 stent.
• Research is currently focused on
establishing the ideal drug kinetics; initial
animal trials have demonstrated a sustained
antiproliferative effect at 1 month.
AMS - 3 STENT
29. The degradation of Mg produces an
electronegative charge that results in
the stent being hypothrombogenic.
PROGRESS AMS trial: Lancet. 2007;369:1869 –1875.
PROGRESS AMS was a non randomized, prospective study in 63 pts.
Stent was completely absorbed within 2 mths, radial support was lost much
earlier there was an insufficient radial strength to counter the early negative
remodeling forces after PCI.
In addition, it did not release an antiproliferative drug to counter the intimal
hyperplastic response to stenting.
High restenosis rate at 4 months of almost 50% and target vessel
revascularization at 1 year was 45%. MACE rate 26.7% at one yr.
Magnesium
Bioabsorbable STENTs
30.
31. Stent:
Bioabsorbable
Magnesium Alloy
Discrete Drug
Delivery Reservoirs
Drug:
Pimecrolimus
Carrier:
Bioresorbable
Matrix
Modifications
Biotronik DREAMS
(Pimecrolimus – Eluting stent system)
BIOSOLVE II TRIAL is ongoing with DREAMS 2nd gen drug eluting AMS.
34. RESORB Study
(REVA Endovascular Study of a Bioresorbable Coronary
Stent) trial enrolled 30 pts at multiple sites in Germany and
Brazil
Non-randomized study
Endpoints
• Primary – 30 days MACE
• Secondary – 6 mths QCA & IVUS derived parameters for
restenosis.
Clinical follow up
• At discharge, 2 wks, 1, 6, 12, 24, 36, 48, 60 months.
• Subset of pts will be returning for long term angiographic
follow up.
35. 6 mths follow up showed absence of any significant vessel
recoil.
Unfortunately higher-than-anticipated rate of TLR (66.7%)
were seen between 4 and 6 months.
The degree of neointimal hyperplasia was similar to that of
a BMS
Redesigning of the stent ensued, resulting in the
second-generation ReZolve stent.
36. • More robust polymer, a spiral slide-and-lock mechanism to improve
clinical performance, and a coating of sirolimus (80% is eluted by 30
days and 95% by 90 days.)
• The RESTORE Trial evaluating the safety and performance of the
1st-generation ReZolve scaffold in 26 pts.
• One yr follow up showed late lumen loss comparable to that of DES.
• The ReZolve2 scaffold, a lower profile and sheathless version of
the original ReZolve scaffold evaluated clinically in the RESTORE II
TriaL (started in 2013)
ReZolve stent
38. • IDEAL stent is radio-opaque and salicylate acts as anti-
inflammatory agent.
• Whisper trial, a stent with strut thickness of 200 µm and
a crossing profile of 2.0 mm with a stent-to-artery
coverage of 65% was implanted in 8 patients.
• Because of higher-than-expected intimal hyperplasia, a
subsequent design iteration will have thinner struts, a
higher dose of sirolimus, and a lower percent wall
coverage.
39. Crossing profile of 1.4 mm with circumferential hoops of PLLA.
The struts are 150 µm thick and are either directly joined or linked by
straight bridges.
Both ends of the stent have 2 adjacent radiopaque platinum markers.
radial strength = BMS.
The backbone of the BVS device is made of semicrystalline polymer
called PLLA.
Coating of poly D,L-lactide acid (PDLLA).
Coating contains and controls the release of everolimus.
Everolimus-Eluting PLLA Stent: BVS Scaffold
45. Prospective, open-labeled, non-randomized, multi-center trial.
First in Man ABSORB stent
First clinical evaluation of the safety and performance of the BVS
Cohort A device. (n=30)
Among 29 patients, the 5-year MACE rate was low at 3.4%, due to
only one ischemic MACE event (non-Q wave MI.) that was reported
within the first 6 months of the trial.
There were no incidences of (ID-TLR)
No incidences of scaffold thrombosis or cardiac death out to 5 years
ABSORB cohort A study
46. • N = 30; 6 sites (Europe, New Zealand)
• Clinical follow-up schedule:
– 30 days, 6 months, 12 months, annually to 5 years
• Imaging schedule:
QCA, IVUS, OCT, IVUS VH Baseline
6 18 24
MonthsMonthsMonths
MSCT
(optional)
ABSORB cohort A study
47.
48. Procedural success was 100% (30/30 pts)
Device success 94% (29/31 attempts)
At 1 year, MACE rate 3·3% (one pt having a non-Q wave MI and
no TLR.
No late stent thromboses.
At 6mths, angiographic in-stent late loss was 0·44 (0·35) mm and
was mainly due to a mild reduction of the stent area (–11·8%) as
measured by IVUS.
ABSORB cohort A study – 1yr Results
52. At 2 years:-
Stent was bioabsorbed
Vasomotion restored
Restenosis prevented
Clinically safe, freedom from late thrombosis
Late luminal enlargement due to plaque reduction without vessel
remodelling.
ABSORB cohort A study – 2 years results
54. J Am Coll Cardiol Intv 2013;6:999–1009
ABSORB cohort A study – 5 years results
55. ABSORB cohort A – 5 year clinical results
J Am Coll Cardiol Intv 2013;6:999–1009
56. Cohort A
Cohort B
• More uniform strut distribution
• More even support of arterial wall
• Lower late scaffold area loss
― Maintain radial strength for at least 3 months
• Storage at room temperature
• Improved device retention
• Unchanged:
– Material, coating and backbone
– Strut thickness
– Drug release profile
– Total degradation Time
• More uniform strut distribution
• More even support of arterial wall
• Lower late scaffold area loss
―Maintain radial strength for at
least 3 months
• Storage at room temperature
• Unchanged:
– Material, coating and backbone
– Strut thickness
– Drug release profile
– Total degradation Time
BVS Device optimization
57.
58. J Am Coll Cardiol 2011;58:1578–88)
ABSORB Cohort B study
59. • ABSORB Cohort B trial had two subgroups (B1 and B2) for follow-up
purposes as determined by protocol.
• 3-year follow-up data for Group B1 (n=45) was reported at the TCT
2012 meeting in Miami, Florida, USA
• Among 100 patients, there has been no reported scaffold
thrombosis or cardiac death.
• 2-year ischemic driven MACE rate was 9.0%, due to 3 non-Q wave
MIs and 6 ischemia driven TLR.
62. ABSORB Cohort B1 study results
No new MACE between 6 mths to 3 yrs.
63. Clinical Procedure Success 98%
ABSORB B Group 1 –MACE rate of 6.8% at 2 and 3 years (1 peri-
procedural MI & 2 TLR)
No additional MACE between 1 yr and 3 yrs
No scaffold thrombosis event.
Clinical data very comparable to Xience-V data from SPIRIT I+II+III.
Conclusion Absorb B study
64. MACE rates in ABSORB cohort B vs
XIENCE V (SPIRIT I+II+III Study)
65. The ABSORB EXTEND trial is a continuation in the assessment of
the safety and performance of Absorb in a larger study.
The lesions are longer than in the ABSORB Cohort A and Cohort B
trials.
Planned overlap of Absorb scaffolds during the procedure
ABSORB EXTEND is a prospective, single-arm, open-label clinical
study in 1,000 subjects at 100 global sites.
Clinical follow-up for up to 3 years.
ABSORB EXTEND Study
71. Conclusions from 6 mths data
6 months follow up data showed:-
Low event rates including MACE (3.0%) and Stent thrombosis
(0.6%)
MACE rate shown at 6 months were sustained with the first 250
pts enrolled through 12 mths follow up
Data from ABSORB EXTEND demonstrated the consistency in
clinical outcomes between ABSORB EXTEND, ABSORB Cohort
B and the SPIRIT pooled population.
78. Follow up of 250 pts at 12 months showed:-
Results comparing ABSORB EXTEND and Cohort B patient
demographics and lesion characteristics:
Over twice the percent of UA (35.2% in EXTEND vs 14.9% in
Cohort B)
Higher percentage of diabetics (24.8% in EXTEND vs 16.8% in
Cohort B)
Longer mean lesion length than in ABSORB Cohort B
Planned overlapping treatment permitted (6.4% of pts)
Findings on the 12 mths outcomes in 250 pts:-
Comparable MACE rates to ABSORD Cohort B and SPIRIT Pooled
population
Lower rate of ID-TLR (2.0%) in EXTEND compared to Cohort B
and SPIRIT Pooled population.
ABSORB EXTEND – conclusion from 12mths
data
79. ABSORB II is a randomized, active-controlled, single-blinded,
multicenter clinical trial and will enroll approximately 501 subjects in
40 sites in Europe.
Aim: primary endpoints of vasomotion and change in lumen
diameter.
Subjects were clinically followed at 30 days, 180 days, 1, 2, and 3
years post-procedure
Imaging studies included angiography, IVUS/IVUS-virtual histology,
MSCT, all at 2 yrs and 3 yrs.
ABSORB II: European RCT
80. ABSORB II one year analysis was presented in TCT 2014
and published in Lancet September 2014 issue.
ABSORB II
89. Summary
Device success rates were comparable (100% vs 99%)
Acute gain by angiography and IVUS was significantly
lower in Absorb arm than Xience arm.
Difference in acute gain was not related to acute recoil
measured immediately after device implantation (0.19
mm for both) but could be attributed to the difference in
pressure and nominal size of the balloon used during
post-dilation performed in similar proportions (~60%) in
each arm.
90. Two definite scaffold thromboses were documented – one
acutely within 24 hrs and second subacutely on day 2.
The rate of definite stent thrombosis was 0.6% in the
Absorb arm and 0% in Xience arm (p=1.0)
At one year Device related composite end points DoCE
(cardiac death, TV-MI, and TLR, Absorb: 4.8% vs Xience:
3.0%, p = 0.35) and patient related composite end points
PoCE (all deaths, all MI and all revascularization, Absorb:
7.3% vs Xience: 9.1% p= 0.47) and their components were
similar between the two arms.
91. The ABSORB (RCT) is designed to evaluate the clinical safety and
efficacy of Absorb for US approval in comparison with the
XIENCE family.
The ABSORB III is a prospective, randomized, active-control, single-
blind, multi-center clinical trial that will register approximately 2,250
subjects in up to 220 sites in the US and outside the US.
Cohort of approx 2,000 pts will be used for approval of Absorb by
the US - FDA.
ABSORB III: US RCT for US approval
92. The ABSORB IV trial is similar in design to ABSORB III, and
designed to enroll approximately 2,500 to 3,000 patients with clinical
follow-up out to 5 years.
Clinical data from both ABSORB III and IV will be pooled to enable a
landmark analysis for 4,500 to 5,000 subjects to show superior
safety and benefits of Absorb compared to XIENCE.
ABSORB IV: RCT for Landmark analysis
93. ABSORB Japan is a prospective, single-blind, multi-center
randomized 2:1 trial of Absorb: XIENCE V involving up to 400
subjects in up to 35 Japanese sites to seek Japanese approval.
The patient eligibility criteria are similar to the ABSORB III study.
The primary endpoint is 1 year target lesion failure (TLF) showing
non-inferiority to XIENCE, with each subject returning for at least
one imaging follow-up involving one of the following modalities:
angiography, IVUS, and/or OCT.
ABSORB Japan: RCT
94. ABSORB China is a prospective, single-blind, multi-center
randomized 1:1 trial of Absorb: XIENCE V involving approximately
400 subjects in up to 25 Chinese sites.
The patient eligibility criteria are similar to ABSORB III.
The primary endpoint is 9 months angiographic endpoint of in-
segment late loss, showing non-inferiority to XIENCE, for Chinese
approval.
Patients will subsequently return only for clinical follow-up out to 5
years.
ABSORB China: RCT
95. • The ABSORB FIRST Registry is designed to evaluate the safety
and clinical outcomes of Absorb in daily use in patients with de
novo lesions in previously untreated vessels.
• Single arm, prospective, international post-market registry of
patients with de novo lesions in previously untreated vessels treated
with Absorb per IFU (on-label use).
• Enrolling min of 10,000 pts in approx 300 sites throughout multiple
countries worldwide where Absorb has regulatory approval and is
commercially available.
• One yr follow-up will be conducted on all pts. Annual follow-up visits
will be conducted in subgroups of 1,000 patients each from 2 to 4
years.
ABSORB FIRST: International Post-
Market Registry
96.
97. N=100
Cohort 1 – 46 pts with UA
Cohort 2 – 38 pts with NSTEMI
Cohort 3 – 16 pts with STEMI
101. • First, the optimal duration of scaffolding with drug-
elution should be further elucidated.
• In both AMS-1 magnesium stent and BVS 1.0 scaffolds, late scaffold
shrinkage was one of major contributors to luminal loss.
• In a previous study with serial IVUS imaging after angioplasty or
directional coronary atherectomy, some positive remodeling
occurred early after the procedure up to 1 month, whereas the
negative remodeling occurred at 1 to 6 months
Future Perspectives
102. This suggests that the need to prevent negative remodeling is
necessary at least until 6 months.
This could be achieved by tuning the biodegradation speed in
changing the molecular weight of the polymer and increasing its
crystallinity, thereby prolonging the mechanical integrity of the
scaffold.
103. 2. BRS technologies without drug elution such as REVA
and AMS-1 were associated with high TLR rates.
In AMS-1 trial, 45% of late luminal reduction was attributed to
neointimal hyperplasia at 6 mths.
These results suggest that the elution of antiproliferative agents might
be indispensable to make the BRS clinically applicable and efficient at
medium term.
104. 3. The clinical advantage of BRS technology over the
currently available DES needs to be further
investigated.
BVS and Mg stents showed the recovery of responsiveness of the
treated vessel to vasoactive agents such as nitroglycerin.
Restoration of vasomotion can indirectly stand for the completeness
of vessel healing; however, it is still unclear what the real clinical
advantage of this phenomenon is.
105. 4. A potential drawback of this new technology is strut
fracture.
Unlike metallic stents, the polymeric devices have inherent limit of
expansion and can break as a result of overdilatation.
In an anecdotal case from the ABSORB cohort A, a 3.0-mm scaffold
was overexpanded with 3.5-mm balloon, which resulted in strut
fracture as documented with OCT.
The clinical significance of such a case, evidenced only by OCT,
needs to be further elucidated, but undoubtedly fracture should be
avoided by respecting the nominal size of the scaffold.
106. 5. Data transferability might be another issue from the regulatory
perspective.
In conventional metallic stents, the essential component was
platform, coating, and drug.
In BRS polymeric stents, even with the same PLLA and design, the
speed of bioresorption can be different according to the
manufacturing process of PLLA.
Molecular weight of the polymer can influence the degree of
inflammation.
107. Absence of large RCTs
Experience in complex cases (bifurcation, ostial, CTO) is limited
and in such cases IVUS should support BVS implantation.
High strut thickness may lead to vessel injury, nonlaminar flow,
platelet deposition, and poor deliverability.
Calcification or tortuosity are technically challenging.
Regardless of lesion anatomy, pre-dilation is mandatory, direct
stenting is not possible.
Predilatation makes the system prone for dissection and
ischemia
Current limitations and challenges
108. Only limited scaffold sizes are currently available, and special
facilities are needed for storage of some.
Due to these technical particularities, the total cost and duration of
PCI with a BRS may be higher than with a conventional DES.
Duration of DAPT with BRS is unclear.
Current limitations of BVS contd…
109. Current BRS limitations will likely be resolved in the
future.
Although their advantages already outnumber their
disadvantages, large, randomized, controlled trials are
still needed.
Although promising in certain conditions but more
randomised trials and technology advance is required to
implement them in a wider perspective.
Future perspectives
110. Conclusions
Bioabsorbable scaffold technology is still in infancy but
developing at fast pace.
Preliminary trials have shown quite hopeful results
Larger randomized trials are ongoing and their results
will dictate the future of this novel technology.
Although promising in certain conditions at present but
more randomised trials and technology advance is
required to implement them in a wider perspective.
111. 117
THANK YOU …
“In 10 years, we may look back and laugh
at the time when we used to leave behind
little pieces of metal in
patients’ vessels,”
Dr. Ron Waksman MD, FACC
Associate director at Washington Hospital
Center, Washington, D.C.
112.
113. Characteristics of an ideal Bioabsorbable stent
Predictable degradation rate over a finite period of time
Should leave no residue
Degradation products should be biocompatible, non-toxic and non-
inflammatory
Stent material should have high tensile strength to allow creation of
low profile, balloon expandable stent
Material should have adequate radial strength and mechanical
properties for vessel support
Non-thrombogenic should not shed emboli
Material should be easily processed and sterilizable
Acceptable shelf life
114. Ideal characteristics of bioabsorbable polymer
Linear degradation profile
Fast degradation rate (< 6months)
Compatibility with hydrophilic and hydrophobic drugs
Stable under different pH
Good film forming properties
Solubility in common solvents
No toxic metabolic end products