MeRes-1 Extend Study Study Highlights

Principal Investigator: Dr. Alexandre Abizaid

The MeRes-1 Extend was a prospective, multicenter, single-arm, trial of MeRes100 sirolimus-eluting bioresorbable vascular scaffold system in patients with de novo native coronary artery lesions

Three-year clinical follow-up including QCA analysis at 6 and 36 months OCT analysis at 6 and 36 months

MeRes-1 Extend study demonstrated the favourable safety and efficacy of MeRes100 BRS at 24 months follow-up

Clinical outomes at 24 months

1.61 % MACE

0% ST, MI and

Cardiac death

0.18 mm in-scaffold

LLL at 6 months

97.95% covered

strut at 6 months

Study Design A multicentre, single-arm, prospective study

A total of 64 patients were enrolled in Spain, FYR of Macedonia, Brazil, South Africa, Malaysia and Indonesia

Clinical follow-up at 1 month, 6 months, 12 months, 24 months and 36 months post-procedure

Angiographic follow-up at 6 and 36 monthsAnalysed by Cardiovascular Research Centre, Sao Paulo, Brazil

OCT follow-up at 6 and 36 monthsAnalysed by Cardialysis BV, Rotterdam, the Netherlands

Clinical Presentation

Figure 1: Cardiac Status

Stable angina68.75 %

Unstable angina9.38 %

Silent ischemia21.88 %

Figure 2: Lesion Characteristics (ACC/AHA Classification)

Type A11.59 %

Type B117.39 %

Type B256.52 %

Type C14.49 %

Study Results

Figure 3: Late lumen loss at 6-month follow-up

0.15

0.155

0.16

0.165

0.17

0.175

0.18

In-segment LLL In-scaffold LLL

0.16

0.18

Late

lum

en lo

ss (m

m)

Late lumen loss at 6-month follow-up

References 1. ClinicalTrial.gov no: NCT02663323

https://clinicaltrials.gov/ct2/show/NCT02663323 2. Presented by Alexandre Abizaid. Evidences from the meriT-V randomized trial on BioMime SES and from

MeRes-1 Extend, MeRes100 BRS 1st in man evaluation. At EUROPCR 2017. https://www.pcronline.com/Cases-resources-images/Resources/Educational-interviews/Evidences-from-the-meriT-V-randomized-trial-on-BioMime-SES-and-from-MeRes-1-Extend-MeRes100-BRS-1st-in-man-evaluation

3. Presented by Alexandre Abizaid. MeRes-1 Extend: One-Year Clinical Results with a Thin-Strut PLLA Based Sirolimus-Eluting BRS in Patients with Coronary Artery Disease. At EUROPCR 2018. http://www.crtonline.org/presentation-detail/meres-1-extend-one-year-clinical-results-with-thin

4. Presented by Praveen Chandra. Next generation BRS-MeRes100 science & clinical update. TCT-2018. 5. Presented by Alexandre Abizaid. Implantation of Thin Strut Sirolimus-Eluting Bioresorbable Vascular

Scaffold in Patients With de novo Coronary Artery Lesions: Two-year Clinical and Six-month Imaging Outcomes of the MeRes-1 Extend Trial. Accepted in abstract book of Euro Intervention 2019.

6. Presented by Alexandre Abizaid. Clinical and imaging outcomes of thin-strut sirolimus-eluting BRS in patients with de novo coronary artery lesions: the MeRes-1 Extend trial. Accepted in abstract book of Euro Intervention 2020.