The PARTICIPATE trial Prove ART (Abluminal Reservoir Technology) clinical benefit in all comers PATiEnts

Transcription

1 The PARTICIPATE trial Prove ART (Abluminal Reservoir Technology) clinical benefit in all comers PATiEnts A multicentre, multinational trial in a large cohort of patients comparable to the everyday clinical practice, with a specific focus on diabetics subjects Antonio Colombo San Raffaele Scientific Institute Milano, Italy

2 Potential conflicts of interest Speaker's name: Antonio Colombo I have no potential conflicts of interest to report

3 The PARTICIPATE study Background It is known that the presence of diabetes mellitus has been a consistent, independent predictor of restenosis in most stent trials and registries. Thus, this is an unmet need in coronary interventions. Results of the diabetic subgroup analysis of the Next study suggested that the particular features of the Cre8 stent may be advantageous in these patients. A multicentre, multinational trial was designed to evaluate the safety and efficacy of the Cre8 Drug Eluting Stent in a large cohort of patients comparable to the everyday clinical practice, with a specific focus on diabetic subjects.

4 The PARTICIPATE study Cre8 Drug Eluting Stent: a polymer free platform with abluminal reservoirs to release the amphilimus formulation (Sirolimus formulated with organic fatty acid)

5 The PARTICIPATE study Inclusion criteria Stable angina or documented silent ischemia Syntax score ranging between 0 and 22 ACS, including unstable angina, NSTEMI and STEMI Patients eligible for PCI and acceptable candidate for surgical revascularization LVEF>30% Written informed consent Target de-novo lesions with diameter stenosis > 50% (including total occlusion) Target lesion located in a target vessel with a diameter ranging from 2.5 to 4.0 mm Main exclusion criteria Target vessel revascularization with a DES within 3 months prior to the index procedure Target lesion is located or supplied by an arterial or venous bypass graft

6 Endpoints The PARTICIPATE study Primary Endpoint Incidence of the device oriented composite endpoint at 6 months: Cardiac death / Target vessel MI / Clinically indicated TLR Secondary Endpoints Incidence of clinical composite endpoints at 30 day, 1 year and yearly up to 5 years from the index procedure: Cardiac death / Target vessel MI / Clinically indicated TLR* All death / All MI / All Repeat Revascularization ** *Device oriented composite endpoint **Patient oriented composite endpoint Incidence of stent thrombosis throughout the study, classified according to ARC definition; Angiographic measurements in-stent and in-segment (reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss) pre and post intervention and at 6-month follow-up, in the patients included in the pre-specified diabetic subgroup.

7 The PARTICIPATE study Real world" patients with ischemic myocardial symptoms related to de novo coronary artery lesions, treated with CRE patients 30 European Sites Pre-specified diabetic subgroup Diabetic subgroup angio FU Enrolment completed: December 2013 Last patient last visit: December 2018 Clinical FU 1 month 6month 1, 2, 3, 4, 5 years

8 Study organization Sponsor: CID - Alvimedica CRO: Mediolanum Cardio Research e-crf Corelab QCA Data management & statistics Since mid-2014: project management and monitoring Independent Event Adjudication Committee

9 30 Involved sites A. Colombo- Milano A. Bartorelli- Milano G. Sardella Roma P. Bellone Savona P. Presbitero Rozzano (MI) P. Rubino Mercogliano R. Garbo Torino M. Bianchi Milano G. Isabella Padova L. Bolognese Arezzo R. Fattori Pesaro B. Doronzo Savigliano (TO) A. Stabile - Palermo O. Pachinger - Innsbruck The PARTICIPATE study J. Shofer - Hamburg W. Dewilde Tilburg T. Slagboom Amsterdam J. J. Koolen Eindoven J Van der Heyden Nieuwegein K. Endresen - Oslo J. Zueco - Santander E. Teiger Creteil D. Carrè Toulouse M. Amor Essey-les-Nancy J. Berland Rouen J. Brunet Avignon A. Tirouvanziam Nantes B. Karsenty Pessac L. Maillard Aix-en-Provence M. Vrolix - Genk

10 The PARTICIPATE study 1186 patients First patient in: 27/02/2012 Last patient in: 23/12/ I-Milano HSR I-Milano Monzino I-Roma I-Savona I-Rozzano I-Arezzo I-Savigliano I-Milano ICCS I-Palermo I-Torino I-Padova I-Pesaro I-Mercogliano A-Innsbruck N-Oslo NL- Eindhoven NL-Nieuwegein NL -Amsterdam NL-Tilburg B-Genk D-Hamburg E-Santander F-Creteil F-Toulose F-Nancy F-Rouen F-Avignon F-AIX F-Pessac F-Nantes

11 The PARTICIPATE study: first 12 months clinical follow-up At least one DES: 1186 Deceased before discharge (n= 1) 1 M FU 1185 Did not perform visit (n= 30) Lost to FU (n=22 ) Deceased (n= 3) Withdrawal of consent (n=4) 6 M FU 1156 Did not perform visit (n= 51) Deceased (n= 5) Withdrawal of consent (n=4) 12 M FU 1147 Did not perform visit (n= 36) Deceased (n= 7) Withdrawal of consent (n=1)

12 PATIENTS CHARACTERISTICS CHARACTERISTIC N= 1186 Mean Age (yrs) (± 10.52) Male sex 929 (78.7%) Diabetes 308 (25.8%) Hypertension 817 (68.9%) Previous myocardial infarction STEMI NSTEMI 231 (19.5%) 118 (9.9%) 87 (7.3%) Previous revascularization 373 (31.5%) Clinical presentation Asymptomatic/ silent ischemia Stable angina Unstable angina STEMI NSTEMI 305 (25.7%) 496 (41.8%) 92 (7.8%) 93 (7.8%) 200 (16.9%) Diabetes subgroup QCA analysis : 54 patients, 73 lesions

13 Lesson learned Angiographic follow-up planned in 100 patients but performed in 54 only; recently an updated FU rate is getting closer to 80% or higher Long follow-up and patient retention: the importance of stable and dedicated staff