Παύλος ΣτουγιάννοςΚαρδιολόγος

ΓΝΑ «Η ΕΛΠΙΣ»

Historical overview of the most prominent advances in stent technology

Bioabsorbable scaffolds : the fourth revolution in interventional cardiology

Concerns-problems with the use of stents

Vascular Health and Risk Management 2012:8 125–132

Sustained inflammation attributed to the presence of apermanent foreign body in the vessel wall

Risk of stent thrombosis at long-term follow-up

Prolonged double antiplatelet therapy

Future treatments in the vessel if needed (either PCI orCABG)

Access to side branches initially jailed by the stent

Follow-up with noninvasive techniques such as MSCT

Potential advantages of bioresorbable scaffolds (BRS) over BMS and DES

Vascular Health and Risk Management 2012:8 125–132

Leading compounds and degradation end-products according to type of polymer family

Onuma Y, Serruys P. Circulation 2011;123:779-797

Mechanical properties and degradation time for different polymers

Onuma Y, Serruys P. Circulation 2011;123:779-797

The reaction pathway for hydrolytic degradation of the PLA family of polymers

Igaki-Tamai PLLA stent

Coronary angiography performed 10 years after implantation

The Absorbable Metallic StentAMS-1 magnesium alloy

Onuma Y, Serruys P. Circulation 2011;123:779-797

High restenosis rate TLR at 1 year 45%

DREAMS G2

Improved design

Limus derivative drug

Clinical study

AMS

Magnesium alloy

No drug coating

Clinical study

DREAMS

Refined magnesium alloy

Paclitaxel drug + PLGA

Clinical study

Purpose

To evaluate the clinical feasibility of the AMS (Absorbable Metal Scaffold)

Conclusion

Concept safe and feasible

Need for prolonged scaffolding time and an anti-proliferative drug

Study design

Prospective, multi-center, non-randomized trial

Timing

2010 (patient enrollment)

Results

TLF 6.8% at 24-months

From AMS to DREAMS 2nd generationDevice evolution

The Lancet 381, Issue 9869, 9–15 March 2013, 836–844

BIOSOLVE-1: IVUS and OCT findings after implantation and at 6 and 12 mo follow-up

The Lancet 381, Issue 9869, 9–15 March 2013, 836–844

Tyrosine polycarbonate stent: the REVA stent

RESORB study (27 patients)high TLR rate (66.7%) between 4 and 6 mo

This has led to a new design, the ReZolve stent, which has improved robustness of the polymer and is able to elute sirolimus.

Patient enrollment was initiated in March 2013 and is currently ongoing

REVA announced initial clinical results in TCT in Oct. 28, 2013 first 65 pts 30-day follow-up,

• no reported MACE• no incidences of ischemic TLR, myocardial infarction or stent

thrombosis.

Everolimus-eluting bioresorbable scaffoldBVS 1.0 and 1.1

Bioresorbable Polymer

Polymer backbone

Drug/polymer matrix

Everolimus/PDLLA Matrix Coating

• Thin layer

• Amorphous (non-crystalline)

• 1:1 ratio of Everolimus/PDLLA matrix

• Conformal coating, 2-4 m thick

• Controlled drug release

PLLA Scaffold

• Semi-crystalline

• Provides device structure

• Processed for required radial strength

Everolimus-eluting bioresorbable scaffoldBVS 1.0 and 1.1

OCT and histology at 28 days, at 2, 3, and 4 years after stent implantation in a porcine model

Onuma Y, Serruys P, et al. Circulation 2010;122:2288 –2300

28 days

2 years

3 years

4 years

IVUS echogenicity, palpography and VH of BVS 1.0

Onuma Y, Serruys P. Circulation 2011;123:779-797

Echogenicity

Palpography

Virtual Histology

Serial changes in OCT images after implantation of BVS

Onuma Y, Serruys P. Circulation 2011;123:779-797

BVS 1.0

BVS 1.1

Changes from after the procedure to 6 months in the vessel area, scaffold area, lumen area, and NIH area and percent VO in Xience V, BVS 1.0 and BVS 1.1

Onuma Y, Serruys P. Circulation 2011;123:779-797

Late lumen loss of different fully bioabsorbablevascular scaffolds

How About Clinical Outcomes?

Cutlip DE,et al. Circulation. 2007;115: 2344–2351.

At 3 years, clinical follow-up was obtained from 29 of 30 enrolled patients.

There was only 1 non–Q-wave myocardial infarction (peak troponin, 2.21ng/mL) related to the treatment of a non–flow-limiting stenosis (QCAdiameter stenosis, 42%) in a patient implanted with the BVS 46 days earlier.Furthermore, this patient experienced a single episode of angina at restwithout any ECG evidence of ischemia.

Otherwise, there were no new MACEs between 6 months and 3 years andno instances of ST as defined by the protocol or Academic ResearchConsortium definitions.

In total, the MACE rate at 3 years was 3.4%

PW Serruys, et al. J Am Coll Cardiol 2011;58:1578–88

PW Serruys, et al. J Am Coll Cardiol 2011;58:1578–88

OCT, IVUS Gray-Scale, and IVUS-VH at Baseline and 12 Months

Two patients experienced peri-procedural and iatrogenic MI, respectively,whereas 2 underwent repeat intervention, resulting in the MACE rate of 7.1%

Serial Cineangiograms Before, After Procedure, and at 12-Month Follow-Up

PW Serruys, et al. J Am Coll Cardiol 2011;58:1578–88

Vasomotion Test Results at 12 Months

PW Serruys, et al. J Am Coll Cardiol 2011;58:1578–88

Information contained herein for use with physicians outside the US and Japan only.

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States. Please check the

regulatory status of the device in your geographical location before distribution. Not to be reproduced, distributed or excerpted.

©2013 Abbott. All rights reserved. AP2937781 Rev. D 07/13 32

ABSORB Clinical Trial Program

Note: Sample sizes reflect Absorb patients only.

2011 2012 2013 2014 2015 2016

Total Pts Studied n=~599 n~800 n~5,474 n~13,253 n~13,253 n~13,253

ABSORB IIIn = ~1,500

Enrollment & Follow-Up

ABSORB Japann = ~267

Enrollment & Follow-Up 2 Y1 Y

ABSORB Chinan = ~220

Enrollment & Follow-Up 2 Y1 Y

ABSORB IIn = ~335

2 Y 3 Y1 YEnrollment & Follow-Up

ABSORB FIRST* n = 10,000

Enrollment & Follow-Up

ABSORB Extendn= ~800

2 Y 3 Y1 YEnrollment & Follow-Up

ABSORB Cohort Bn = 101; FIM

1 Y 2 Y 3 Y 4 Y 5 Y

ABSORB Cohort An = 30; FIM

5 Y

2 Y1 Y

2 Y1 Y

* n= 10.000 f/u at 1 year. 1.000 patients f/u at 3 years, 1.000 patients at 2-4 years

3 Y

Takashi Kajiya, et al. EuroIntervention 2013;9:501-504 published online ahead of print May 2013

Takashi Kajiya, et al. EuroIntervention 2013;9:501-504 published online ahead of print May 2013

These are the first real-world data using BVS in patients with STEMI. The ABSORB™ BVS may be safely used in patients with STEMI undergoing primary PCI with favourable short-term outcome.

Tommaso Gori, et al. EuroIntervention 2013; 9online publish-ahead-of-print September 2013

Clinical outcomes at 30 days

BVS implantation for patients with ACS is safe, with outcomes comparable with those of drug-eluting metal stents.

Tommaso Gori, et al. EuroIntervention 2013; 9online publish-ahead-of-print September 2013

Absorb Study cohort B at 6, 12, 24 and 36 months

PW Serruys, et al. EuroIntervention 2013; 9-online publish-ahead-of-print December 2013

Between one and three years, LLL remained unchanged (6 mo: 0.19

mm, 1 yr: 0.27 mm, 2 yrs: 0.27 mm, 3 yrs: 0.29 mm)

The in-segment angiographic restenosis rate for the entire cohort B

(n=101) at 3 years was 6%.

In the entire cohort B (n=101), the three-year MACE rate was 10.0%

without any scaffold thrombosis.

Comparison of Absorb B cohort with SPIRIT

PW Serruys, et al. EuroIntervention 2013; 9-online publish-ahead-of-print December 2013

Conclusions

Bioabsorbable stents appear as one of the most promising fields in

interventional cardiology, with several potential advantages over

permanent metallic stents.

Professor Serruys, one of the pioneers in PCIs, has named them “the fourth

revolution” after balloon angioplasty, bare-metal stents, and drug-eluting

stents

Trials have shown the safety and efficacy of the BRS in simple lesions in

stable patients

Larger studies are required to evaluate the performance of the device in

other clinical and angiographic scenarios.