Late Results from the PAINT trial PercutAneous INTervention with biodegradable-polymer based paclitaxel-eluting, sirolimus-eluting, or bare stents for.

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Late Results from the PAINT trial PercutAneous INTervention with biodegradable-polymer based paclitaxel-eluting, sirolimus-eluting, or bare stents for the treatment of de novo coronary lesions Pedro A. Lemos MD PhD, on behalf of the PAINT trial investigators Heart Institute – InCor University of Sao Paulo, Brazil

Potential conflicts of interests Advisory Board:Advisory Board: Speakers Board:Speakers Board: Institutional Research Grants:Institutional Research Grants: Cordis, Boston Scientific, Scitech Boston Scientific, Lilly, Scitech, Abbott SMT, Boston Scientific, Scitech

To evaluate the late safety and efficacy of 2 novel formulations of DES with paclitaxel or sirolimus, eluted in biodegradable polymers, in comparison to bare stents LATE-PAINT trial Main Objective

274 patients treated with coronary stenting for: - De novo coronary lesion in a native vessel - Vessel size mm - Single stent per lesion up to 29-mm stent length 274 patients treated with coronary stenting for: - De novo coronary lesion in a native vessel - Vessel size mm - Single stent per lesion up to 29-mm stent length Randomization (1:2:2) Infinnium PES (n=111 pts) Infinnium PES (n=111 pts) Supralimus SES (n=106 pts) Supralimus SES (n=106 pts) Matrix BMS (n=57 pts) Matrix BMS (n=57 pts) 36-month clinical follow-up Clopidogrel for 1 year Study Design 9-month angiographic follow-up (96%)

Infinnium Paclitaxel-Eluting Stent & Supralimus Sirolimus-Eluting Stent Slow drug release profile 50% release within 9 days 100% within 48 days Drug released from the porous surface by diffusion Polymers breaks into CO 2 & H 2 O. No residual polymer after 7 m. Total drug content (µg) Infinnium 19-mm23-mm29-mm Supralimus Drug dose (µg) Infinnium x 19 mm 122 Taxus x 20 mm 135 Supralimus x 19 mm 125 Cypher x 18 mm 153

Steering Committee - Pedro A. Lemos, Princ. Investigator - Expedito E. Ribeiro - Bruno M. Machado - Maurício de Rezende Barbosa - César R. Medeiros - Itamar Ribeiro Oliveira - Eulógio E. Martinez - Valter C. Lima - J. Airton Arruda - Fábio S. de Brito Jr. - Paulo R. A. Caramori Data Safety and Adjudication Committee - Antonio Carlos Carvalho, President - Luciano Drager - Carlos Augusto Campos Steering Committee - Pedro A. Lemos, Princ. Investigator - Expedito E. Ribeiro - Bruno M. Machado - Maurício de Rezende Barbosa - César R. Medeiros - Itamar Ribeiro Oliveira - Eulógio E. Martinez - Valter C. Lima - J. Airton Arruda - Fábio S. de Brito Jr. - Paulo R. A. Caramori Data Safety and Adjudication Committee - Antonio Carlos Carvalho, President - Luciano Drager - Carlos Augusto Campos Contract Research Organization Fundação Zerbini, São Paulo, Brazil Database management Coreware, São Paulo, Brazil Angiographic core lab Cardialysis BV, Rotterdam, The Netherlands Partial Corporate Sponsoring Sahajanand MT, Surat, India CMS Medical, Goiânia, Brazil Contract Research Organization Fundação Zerbini, São Paulo, Brazil Database management Coreware, São Paulo, Brazil Angiographic core lab Cardialysis BV, Rotterdam, The Netherlands Partial Corporate Sponsoring Sahajanand MT, Surat, India CMS Medical, Goiânia, Brazil Study Coordination

Multicenter in Brazil Enrollment by Center Pedro A. Lemos InCor Bruno Moulin HUCAM Marco Perin Hosp. Sta Marcelina Ludmilla de Oliveira Natal Hospital Center Valter C. Lima UNIFESP J. Airton de Arruda Intercath Meridional Antonio A. G. Lima HU Walter Cantidio Paulo R. A. Caramori PUCRS Cesar R. Medeiros Rede DOr de Hospitais Mauricio R. Barbosa Biocor Fabio S. Brito Jr. Hospital São Camilo 103 pts 39 pts 32 pts 21 pts 18 pts 15 pts 14 pts 8 pts 4 pts 2 pts

BMS (n=57 pts) P Male Diabetes SES (n=106 pts) ACS Baseline Characteristics PES (n=111 pts) 32 Age, y 60±1059± ±11 LAD treated MVD St. diam., mm St. length, mm 3.1±0.43.1±0.33.1± ± ± ±

Cardiac Death Any event 8.6 <0.05 P Myocardial infarction Target lesion revasc <0.01 Target vessel revasc < Month Clinical Outcomes BMS (n=57 pts) SES (n=106 pts) PES (n=111 pts) Lemos et al. CCI 2009

BMS SES PES 7.1% 8.3% 9.7% P=0.7 3-Year Death or Non-Fatal MI Years Incidence (%)

BMS SES PES 28.2% 11.3% 8.7% P<0.01 Years Incidence (%) 3-Year Target Vessel Revascularization

P Stent Thrombosis* *Academic Research Consortium Criteria BMS (n=57 pts) SES (n=106 pts) PES (n=111 pts) 1.90 Definite Definite/probable year 0 Definite Definite/probable - 1 – 2 years 0 Definite - 0 Definite/probable - 2 – 3 years

Definite or Probable Thrombosis in PAINT trial Pooled DES data

Compared to bare stents, implantation of biodegradable-polymer Infinnium paclitaxel- and Supralimus sirolimus- eluting stents resulted in: No late increase in hard events, with zero stent thrombosis after 24 months No loss in efficacy up to 36 months of follow-up Persistance of significantly better 36-m MACE rates Conclusions