Compare Absorb
ABSORB bioresorbable scaffold vs. Xience metallic stent for prevention of restenosis following percutaneous coronary intervention in patients at high risk of restenosis. ;Annex study of in-stent restenosis
COMPARE ABSORB ISR study: A single-arm, annex study of patients with in-DES restenotic lesions requiring PCI and treated with Absorb BVS

In patients with a simple lesion, the ABSORB first-in-man trials showed a
clinical safety up to 5 years with potential late benefits such as lumen
enlargement, plaque reduction and restoration of vasomotion. These phenomena
start to appear >=1-2 years after implantation of bioresorbable scaffold in due
course of bio-resorption. Based on the clinical safety demonstrated in the
ABSORB A and B studies, the fully bio-resorbable everolimus-eluting scaffold
had acquired a CE-mark in Europe and became commercially available.

Until now extensive dissemination of revascularization with a bioresorbable
scaffold has occurred without randomized comparison with a metallic
drug-eluting stent. The ABSORB II randomized trial comparing a metallic
everolimus-eluting stents with drug-eluting bioresorbable scaffolds was
initiated in Europe in 2011. Currently the 3 randomized trials are ongoing to
acquire regulatory approval in China, Japan and USA. In these randomized
trials, however, the patients with complex lesion(s) are excluded.

The performance and long-term safety/efficacy of bio-resorbable scaffolds in
complex lesions still remain unclear. Unlike a metallic stent, the polymeric
device is inherently limited in an expansion range and therefore pre-procedural
sizing is mandatory to avoid overexpansion of the device, which might result in
acute mechanical dis-integrity. Similarly, implantation of the device in
lesions with a large side-branch is currently not recommended to prevent
mechanical disintegrity caused by complex bifurcation scaffolding such as
crush, T-scaffolding, or culottes techniques.

The purpose of the current investigation is therefore to prove the short-term
equivalence and long-term benefit of the ABSORB scaffold over a Xience in
patients at high risk of restenosis or with complex lesion(s).


Diabetic substudy
The ABSORB bioresorbable vascular scaffold system (ABSORB BVS), combining the
drug elution with the reabsorption of the scaffold, may preserve the natural
function of the coronary artery (motility and positive remodeling) as well as
the chance of bypass grafting in case of failure of percutaneous treatment.


Smart Follow-up
In the ABSORB II trial, it was observed that the patients receiving the BVS had
significantly less angina episodes during the first year than the patients
implanted with Xience stents (16.4% versus 25.6%), however the there was no
difference in the SAQ scores between the 2 groups. The hypothesis is that, as
the Seattle questionnaire only reflects on the preceding 4 weeks and is
performed only 2 or 3 times during the follow up, a more longitudinal
(frequent) follow up performed via a connected platform will detect more
episodes of angina, increase the adherence of the pts than traditional FU
(questionnaire at FU visits and Seattle questionnaire) between normal FU pts
and the SMART FU pts.


Compare Aborb ISR: Annex study of in-stent restonsis
Restenosis after implantation of a drug eluting stent (DES) is a rare event and
its mechanisms are specific and multi-factorial thereby hindering direct
extrapolation of the results obtained in bare-metal stent restenosis. Its
optimal treatment remains to be determined. Small studies and registries have
suggested that the use of limus eluting stent for DES restenosis may be
associated with better angiographic results and a lower rate of recurrent
target lesion revascularization (TLR) compared to plain balloon angioplasty
and, even more recently, to drug-eluting balloon. The absence of additional
layer of metallic struts, when using bioresorbable scaffold, could have a
positive impact in terms of clinical outcome in combination with a non-inferior
angiographic result.

The purpose of the current investigation is therefore to prove the short-term
equivalence and long-term benefit of the ABSORB scaffold over a Xience in
patients at high risk of restenosis or with complex lesion(s).


Diabetic substudy
To assess the performance of Absorb BVS family scaffold compared to Xience
everolimus eluting stents family in diabetic patients with complex coronary
artery disease, in terms of regression of the total plaque (percentage change
in total atheroma volume) at 62 months.


Smart Follow-up
To evaluate the efficacy, performance and cost effectiveness of a web bassed,
connected self-evaluation of angina using companion dedicated tablet (SMART
FUP®) during the first year of follow-up (Smart follow-up group) in the COMPARE
ABSORB trial.


Compare Aborb ISR: Annex study of in-stent restonsis
To evaluate the safety, efficacy and performance of Absorb scaffold in the
treatment of subjects with ischemic heart disease caused by in-DES restenotic
coronary artery lesions

The Compare ABSORB trial is a randomized (1:1; ABSORB family scaffold versus
XIENCE family stent), active control, single-blind, non-inferiority, European
multi-center clinical trial. Two thousand and one hundred subjects will be
enrolled at up to 42 European sites.

Clinical follow-up at 30 days, 180 days, 1, 2, 3, 4, 5, 6 and 7 years days
post-procedure. Hospital visits are planned at 1 month (* 7 days), 6 months (*
14 days) and 1 year (* 30 days). An assessment of the anginal status,
cardiovascular drug use and any Serious Adverse Events is recorded during
clinical follow-up visits. Phone contacts are scheduled at 2 year (* 30 days),
3 year (* 30 days) and 4 years (* 30 days), 5, 6 and 7 years.
Quality of Life questionnaire (EQ5D) and Seattle Angina Questionnaire (SAQ) at
30, 180 and 360 days post-procedure and at the time of any recurrent event
Questionnaire on perception of patients about the type of device implanted is
performed at 30, 180 and 360 days post-procedure.
Chest symptoms potentially related to angina is assessed using a dedicated
structured questionnaire (Appendix III) at 1, 6 and 12 months and at
intermittent events.
Cost effectiveness of two treatment arms related to chest pain or angina is
assessed at one year using unit costs in 5 countries.


Diabetic substudy
Prospective, randomized, active control, single blinded, multi-center clinical
investigation using ABSORB BVS compared to XIENCE.*The two groups of randomized
patients will undergo angiographic and IVUS follow up at 62 months after the
index procedure. Main analyses by intention to treat.


Smart Follow-up
Prospective, multi-center study as an ancillary of the Compare Absorb
randomized controlled trial.


Compare Absorb ISR: Annex study of in-stent restenosis
Prospective, multi-centre, open label, single arm study as an annex registry of
the Compare Absorb randomized controlled trial

All patients will undergo coronary angiography and PCI on clinical indication.
Based on their randomization outcome they will get a Absorb bioresorbable
Scaffold or a Xience stent implanted.


Diabetic substudy
Baseline:
IVUS: to be performed pre-procedure and post-procedure

Invasive follow-up:
Angiography: All subjects at 62 months follow-up
IVUS: to be performed after angiography. All subjects at 62 months follow-up


Compare Absorb ISR: Annex study of in-stent restenosis
Repeat angiography will be performed one year after index procedure

All patients will undergo coronary angiography and PCI on clinical indication.
Based on their randomization outcome they will get a Absorb bioresorbable
Scaffold or a Xience stent implanted.
In addition patients will be asked to come to the clinic for follow up visits
at 1, 6 and 12 months. Often these visits can be combined with their out-clinic
visit planned for their normal clinical follow-up.
At 2, 3, 4, 5, 6, 7 year patients will be contacted by phone with some
questions about their current health status.


Diabetic substudy
Patients will get an IVUS during the index PCI and in addition they will have
to be hospitalized for 1 day after 5 years for an controle angio and IVUS.

Smart Follow-up
The patients included in the substudy will receive a box including a companion
dedicated tablet, with a connected activity tracker bracelet, a connected
wireless blood pressure cuff and a connected wireless scale, they will be asked
to report every week on their angina status and answer to dedicated questions
via the "Smart Follow-Up" online Platform.

Compare Absorb ISR: Annex study of in-stent restenosis
Repeat angiography will be performed one year after index procedure