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Coronary Artery Disease: HELP
Articles by Marco Antonio Perin
Based on 13 articles published since 2010
(Why 13 articles?)
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Between 2010 and 2020, Marco Perin wrote the following 13 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
1 Clinical Trial Hypotheses, rationale, design, and methods for prognostic evaluation of cardiac biomarker elevation after percutaneous and surgical revascularization in the absence of manifest myocardial infarction. A comparative analysis of biomarkers and cardiac magnetic resonance. The MASS-V Trial. 2012

Hueb, Whady / Gersh, Bernard J / Rezende, Paulo Cury / Garzillo, Cibele Larrosa / Lima, Eduardo Gomes / Vieira, Ricardo D'Oliveira / Garcia, Rosa Maria Rahmi / Favarato, Desiderio / Segre, Carlos Alexandre W / Pereira, Alexandre Costa / Soares, Paulo Rogério / Ribeiro, Expedito / Lemos, Pedro / Perin, Marco A / Strunz, Célia Cassaro / Dallan, Luis A O / Jatene, Fabio B / Stolf, Noedir A G / Hueb, Alexandre Ciappina / Dias, Ricardo / Gaiotto, Fabio A / da Costa, Leandro Menezes Alves / Oikawa, Fernando Teiichi Costa / de Melo, Rodrigo Morel Vieira / Serrano, Carlos Vicente / de Ávila, Luiz Francisco Rodrigues / Villa, Alexandre Volney / Filho, José Rodrigues Parga / Nomura, César / Ramires, José A F / Kalil Filho, Roberto / Anonymous2610734. ·Heart Institute of the University of São Paulo, São Paulo, Brazil. whady.hueb@incor.usp.br ·BMC Cardiovasc Disord · Pubmed #22898311.

ABSTRACT: BACKGROUND: Although the release of cardiac biomarkers after percutaneous (PCI) or surgical revascularization (CABG) is common, its prognostic significance is not known. Questions remain about the mechanisms and degree of correlation between the release, the volume of myocardial tissue loss, and the long-term significance. Delayed-enhancement of cardiac magnetic resonance (CMR) consistently quantifies areas of irreversible myocardial injury. To investigate the quantitative relationship between irreversible injury and cardiac biomarkers, we will evaluate the extent of irreversible injury in patients undergoing PCI and CABG and relate it to postprocedural modifications in cardiac biomarkers and long-term prognosis. METHODS/DESIGN: The study will include 150 patients with multivessel coronary artery disease (CAD) with left ventricle ejection fraction (LVEF) and a formal indication for CABG; 50 patients will undergo CABG with cardiopulmonary bypass (CPB); 50 patients with the same arterial and ventricular condition indicated for myocardial revascularization will undergo CABG without CPB; and another 50 patients with CAD and preserved ventricular function will undergo PCI using stents. All patients will undergo CMR before and after surgery or PCI. We will also evaluate the release of cardiac markers of necrosis immediately before and after each procedure. Primary outcome considered is overall death in a 5-year follow-up. Secondary outcomes are levels of CK-MB isoenzyme and I-Troponin in association with presence of myocardial fibrosis and systolic left ventricle dysfunction assessed by CMR. DISCUSSION: The MASS-V Trial aims to establish reliable values for parameters of enzyme markers of myocardial necrosis in the absence of manifest myocardial infarction after mechanical interventions. The establishments of these indices have diagnostic value and clinical prognosis and therefore require relevant and different therapeutic measures. In daily practice, the inappropriate use of these necrosis markers has led to misdiagnosis and therefore wrong treatment. The appearance of a more sensitive tool such as CMR provides an unprecedented diagnostic accuracy of myocardial damage when correlated with necrosis enzyme markers. We aim to correlate laboratory data with imaging, thereby establishing more refined data on the presence or absence of irreversible myocardial injury after the procedure, either percutaneous or surgical, and this, with or without the use of cardiopulmonary bypass.

2 Article Diagnostic accuracy of 320-row computed tomography for characterizing coronary atherosclerotic plaques: Comparison with intravascular optical coherence tomography. 2019

Ybarra, Luiz F / Szarf, Gilberto / Ishikawa, Walther / Chamié, Daniel / Caixeta, Adriano / Puri, Rishi / Perin, Marco A. ·London Health Science Centre, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada; Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, SP, Brazil. Electronic address: luiz.ybarra@lhsc.on.ca. · Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, SP, Brazil. · Department of Interventional Cardiology, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil; Cardiovascular Research Center, São Paulo, SP, Brazil. · Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA. ·Cardiovasc Revasc Med · Pubmed #31501019.

ABSTRACT: BACKGROUND/PURPOSE: This study sought to determine the diagnostic accuracy of 320-row computed tomography (320CT) for characterizing coronary atherosclerotic plaques in comparison with optical coherence tomography (OCT). METHODS/MATERIALS: From 32 patients, 42 coronary segments were evaluated and co-registered by both 320CT and OCT. 320CT vulnerable plaque characteristics included low attenuation plaque (LAP) (<30HU), napkin-ring sign (NRS), positive remodeling (PR) and spotty calcification (SC). The presence of macrophage, neovascularization and cholesterol crystals was also determined by OCT. RESULTS: Minimal lumen area was 2.78 ± 1.23 mm by OCT and 3.29 ± 1.49 mm by 320CT (p < 0.001). Noncalcified plaques were classified accordingly by both methods in 88.2% of the cases (p = 0.005). There was no association between any 320CT plaque type and OCT fibroatheroma (p = 0.62). The combination of 2 or more of the 320CT vulnerable plaque characteristics was associated with the presence of macrophage (74.2 vs. 25.8%; p = 0.034) and cholesterol crystals (85.7 vs. 14.3%; p = 0.04), but not with neovascularization (p = 0.65). The presence of all four characteristics demonstrated an accuracy of 75.1% for detecting OCT fibroatheroma. CONCLUSIONS: 320CT is useful for non-invasive evaluation of calcified and noncalcified tissue characteristics of coronary atheroma. The combination of all four 320CT vulnerable plaque characteristics provided the highest accuracy for detecting fibroatheromas. SUMMARY: 320CT is useful for non-invasive evaluation of calcified and noncalcified tissue characteristics of coronary atheroma. The combination of all 320CT vulnerable plaque characteristics (low attenuation plaque (<30HU), napkin-ring sign, positive remodeling and spotty calcification) provided the highest accuracy for detecting fibroatheromas compared to optical coherence tomography.

3 Article Assessment of long-term mortality in patients with complex coronary artery disease undergoing percutaneous intervention: comparison of multiple anatomical and clinical prognostic risk scores. 2017

Janella, Bruno L / Campos, Carlos M / Caixeta, Adriano / Almeida, Breno O / Brito, Fabio Sandoli / Abizaid, Alexandre / Perin, Marco A. ·Hospital Israelita Albert Einstein, São Paulo, Brazil. ·EuroIntervention · Pubmed #28506936.

ABSTRACT: AIMS: Three-vessel and left main coronary artery disease (CAD) have important prognostic implications. Consequently, numerous risk scores have been developed to stratify patients with complex CAD. The aim of the present study was to compare the predictive performance of six risk scores for occurrence of fouryear all-cause mortality. METHODS AND RESULTS: From March 2008 to December 2012, 348 consecutive patients with complex CAD undergoing percutaneous coronary intervention (PCI) in a tertiary centre in São Paulo, Brazil, were analysed. Four-year mortality was assessed. The scores compared were: baseline SYNTAX score (SS), residual SYNTAX score (rSS), ACEF score, clinical SYNTAX score (cSS), SYNTAX revascularisation index (SRI) and SYNTAX score II (SSII). SSII had the best predictive performance, AUC 0.82, Brier score 0.10, surpassing all the other scores for long-term mortality prediction. Moreover, SSII discriminated well PCI patients in risk groups with p<0.01 for four-year all-cause mortality. The ACEF score (AUC 0.77) and the cSS (AUC 0.78) were significantly better than the SS (AUC 0.65), SRI (AUC 0.60) or the rSS (AUC 0.55). CONCLUSIONS: For patients with complex CAD treated by PCI, the combination of baseline clinical and angiographic factors provided better risk assessment. The SSII demonstrated the most precise predictive performance for long-term mortality.

4 Article Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial. 2015

Lemos, Pedro A / Abizaid, Alexandre A C / Meireles, George C / Sarmento-Leite, Rogério / Prudente, Mauricio / Cantarelli, Marcelo / Dourado, Adriano D / Mariani, Jose / Perin, Marco A / Costantini, Costantino / Costa, Ricardo A / Costa, José Ribamar / Chamie, Daniel / Campos, Carlos A / Ribeiro, Expedito. ·Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, SP, Brazil. · Instituto Dante Pazzanese de Cardiologia, Sao Paulo, SP, Brazil. · Hospital do Servidor Público Estadual - IAMSPE, São Paulo, SP, Brazil. · Institute of Cardiology/Fundação Universitária de Cardiologia de Porto Alegre, Porto Alegre, RS, Brazil. · Hospital Encore, Aparecida de Goiania, GO, Brazil. · Hospital Bandeirantes, São Paulo, SP, Brazil. · Hospital Santa Izabel, Salvador, BA, Brazil. · Faculdade de Ciências Médicas da Santa Casa de São Paulo, São Paulo, SP, Brazil. · Hospital Santa Marcelina, Sao Paulo, SP, Brazil. · Hospital Cardiológico Costantini, Curitiba, PR, Brazil. ·Cardiovasc Ther · Pubmed #26352896.

ABSTRACT: AIMS: To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. METHODS: This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. RESULTS: After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. CONCLUSIONS: The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent.

5 Article Impact of post-dilation on the acute and one-year clinical outcomes of a large cohort of patients treated solely with the Absorb Bioresorbable Vascular Scaffold. 2015

De Ribamar Costa, José / Abizaid, Alexandre / Bartorelli, Antonio L / Whitbourn, Robert / van Geuns, Robert Jan / Chevalier, Bernard / Perin, Marcos / Seth, Ashok / Botelho, Roberto / Serruys, Patrick W / Anonymous3380830. ·Instituto de Cardiologia Dante Pazzanese, São Paulo, Brazil. ·EuroIntervention · Pubmed #25982921.

ABSTRACT: AIMS: We sought to determine the impact of post-dilation (PD) on clinical outcomes in a large cohort of patients treated only with the Absorb Bioresorbable Vascular Scaffold (BVS). METHODS AND RESULTS: We evaluated all consecutive patients enrolled in the multicentre, single-arm ABSORB EXTEND study up to June 2013. The study allowed treatment of up to two coronaries (diameter 2.0 to 3.8 mm) and the use of overlapping (lesion length ≤28 mm). Patients with severe lesion calcification/tortuosity were excluded. Aggressive lesion predilation (balloon to artery ratio of 0.9-1.0) was mandatory, and PD was left to the operator's discretion. Patients were grouped according to whether PD was performed or not, and the one-year incidences of MACE and scaffold thrombosis were compared. A total of 768 patients were enrolled in the study; PD was performed in 526 (68.4%). There were no significant differences between the PD group and non-PD group in the majority of baseline characteristics, including the presence of moderate calcification and of B2/C lesions. Lesion length was similar (12.3±5.1 mm vs. 12.1±5.3 mm, p=0.6), as was RVD (2.6 mm for both groups, p=0.2). Residual in-scaffold stenosis (15.5±6.4% with PD, 15.0±6% without PD, p=0.3) and the need for bail-out scaffold/stent (4.2% with PD, 4.6% without PD, p=0.8) were comparable. Acute gain was higher in the non-PD group (1.14±0.3 mm vs. 1.21±0.4 mm, p=0.02). Clinical device success was 98.9% in both groups. At one year, there was no difference in MACE (5.4% in the PD group vs. 2.5% in the non-PD group, p=0.1). All individual components of TLR, death, and MI were similar as well as definite/probable scaffold thrombosis between the two groups. CONCLUSIONS: These results reflect very similar final angiographic and clinical results achieved with or without post-dilation in the treatment of low to moderately complex coronary lesions. Therefore, post-dilation should be performed whenever needed to optimise acute results.

6 Article Intravascular ultrasound guidance to minimize the use of iodine contrast in percutaneous coronary intervention: the MOZART (Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy) randomized controlled trial. 2014

Mariani, José / Guedes, Cristiano / Soares, Paulo / Zalc, Silvio / Campos, Carlos M / Lopes, Augusto C / Spadaro, André G / Perin, Marco A / Filho, Antonio Esteves / Takimura, Celso K / Ribeiro, Expedito / Kalil-Filho, Roberto / Edelman, Elazer R / Serruys, Patrick W / Lemos, Pedro A. ·Department of Interventional Cardiology, Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, Brazil. · Department of Interventional Cardiology, Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, Brazil; Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. · Institute of Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts. · Institute of Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. · Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Imperial College London, London, United Kingdom. · Department of Interventional Cardiology, Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, Brazil. Electronic address: pedro.lemos@incor.usp.br. ·JACC Cardiovasc Interv · Pubmed #25326742.

ABSTRACT: OBJECTIVES: The aim of this study was to evaluate the impact of intravascular ultrasound (IVUS) guidance on the final volume of contrast agent used in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: To date, few approaches have been described to reduce the final dose of contrast agent in PCIs. We hypothesized that IVUS might serve as an alternative imaging tool to angiography in many steps during PCI, thereby reducing the use of iodine contrast. METHODS: A total of 83 patients were randomized to angiography-guided PCI or IVUS-guided PCI; both groups were treated according to a pre-defined meticulous procedural strategy. The primary endpoint was the total volume contrast agent used during PCI. Patients were followed clinically for an average of 4 months. RESULTS: The median total volume of contrast was 64.5 ml (interquartile range [IQR]: 42.8 to 97.0 ml; minimum, 19 ml; maximum, 170 ml) in the angiography-guided group versus 20.0 ml (IQR: 12.5 to 30.0 ml; minimum, 3 ml; maximum, 54 ml) in the IVUS-guided group (p < 0.001). Similarly, the median volume of contrast/creatinine clearance ratio was significantly lower among patients treated with IVUS-guided PCI (1.0 [IQR: 0.6 to 1.9] vs. 0.4 [IQR: 0.2 to 0.6, respectively; p < 0.001). In-hospital and 4-month outcomes were not different between patients randomized to angiography-guided and IVUS-guided PCI. CONCLUSIONS: Thoughtful and extensive use of IVUS as the primary imaging tool to guide PCI is safe and markedly reduces the volume of iodine contrast compared with angiography-alone guidance. The use of IVUS should be considered for patients at high risk of contrast-induced acute kidney injury or volume overload undergoing coronary angioplasty. (Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy [MOZART]; NCT01947335).

7 Article First-in-man randomised comparison of a novel sirolimus-eluting stent with abluminal biodegradable polymer and thin-strut cobalt-chromium alloy: INSPIRON-I trial. 2014

Ribeiro, Expedito E / Campos, Carlos M / Ribeiro, Henrique B / Lopes, Augusto C / Esper, Rodrigo B / Meirelles, George X / Perin, Marco A / Abizaid, Alexandre / Lemos, Pedro A. ·Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, São Paulo, Brazil. ·EuroIntervention · Pubmed #24755382.

ABSTRACT: AIMS: The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-eluting stent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy. METHODS AND RESULTS: This is a randomised, multicentre comparison between Inspiron and a stent with the same metallic structure but without polymer coating or drug elution (Cronus). The primary objective was to evaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound (IVUS) at six months and major adverse cardiac events (MACE). Fifty-eight patients were enrolled (60 lesions), 39 for Inspiron and 19 for Cronus. Baseline clinical and angiographic characteristics of both groups were similar. At six months, the in-segment LLL was reduced in the Inspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p<0.001), as well as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p<0.001). At two-year follow-up, incidence of MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesion revascularisation for Inspiron (0 vs. 21.1%, respectively; p=0.01) and no stent thrombosis. CONCLUSIONS: Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months.

8 Article Clinical, angiographic, and intravascular ultrasound results of the VestSaync II trial. 2014

Costa, J Ribamar / Oliveira, Breno A / Abizaid, Alexandre / Costa, Ricardo / Perin, Marco / Abizaid, Andréa / Chamié, Daniel / Fernando Tanajura, Luiz / Sousa, Amanda / Sousa, J Eduardo M R. ·Department of Invasive Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brasil. ·Catheter Cardiovasc Interv · Pubmed #23460415.

ABSTRACT: AIM: We sought to assess the long term efficacy of the novel VESTAsync™ Eluting Stent (VES) combining a Cro-Co platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of Sirolimus (55 μg). METHODS: The Vestasync II trial was a randomized (2:1), double-blinded, multicenter comparison of the VES to its platform, the Gen X stent, with microporous hydroxyapatite surface coating without sirolimus. Patients were eligible if they presented de novo lesions in native coronary arteries with 3.0-3.5 mm diameter and ≤ 14 mm in length. Primary endpoint was 8-month in-stent late loss and % of stent obstruction. Lifelong aspirin and 6-month clopidogrel were prescribed to all patients. RESULTS: Seventy-five patients were enrolled (VES = 50 pts). Baseline characteristics included mean age of 58 years and 29% of diabetics. Reference vessel diameter and lesion length were 2.8 ± 0.4 mm and 13.0 ± 2.0 mm, respectively. In-stent late loss (0.39 ± 0.20 vs. 0.74 ± 0.52, P = 0.03) and % of neointima hyperplasia (9.3 ± 6.6% vs. 17.6 ± 9.4%, P = 0.0016) were significantly reduced in the VES cohort. Up to 1 year, there was a single case of myocardial infarction and one target lesion revascularization (TLR) (2%) in the VES group while in the control cohort there were one TLR (4%) and one cardiac death (4%). CONCLUSION: The VestSync II trial is a proof-of-concept study and demonstrates the sustained efficacy of this novel polymer-free sirolimus drug-eluting stents. A larger trial, with more complex lesions, clinical endpoints and longer FU period is warranted. © 2013 Wiley Periodicals, Inc.

9 Article Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial. 2013

Feres, Fausto / Costa, Ricardo A / Abizaid, Alexandre / Leon, Martin B / Marin-Neto, J Antônio / Botelho, Roberto V / King, Spencer B / Negoita, Manuela / Liu, Minglei / de Paula, J Eduardo T / Mangione, José A / Meireles, George X / Castello, Hélio J / Nicolela, Eduardo L / Perin, Marco A / Devito, Fernando S / Labrunie, André / Salvadori, Décio / Gusmão, Marcos / Staico, Rodolfo / Costa, J Ribamar / de Castro, Juliana P / Abizaid, Andrea S / Bhatt, Deepak L / Anonymous390774. ·Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil. · New York Presbyterian Medical Center, Columbia University Medical Center, and the Cardiovascular Research Foundation, New York, New York. · University of São Paulo, Ribeirão Preto, São Paulo, Brazil. · Instituto do Coração do Triângulo Mineiro, Uberlândia, Minas Gerais, Brazil. · Saint Joseph's Medical Group, Atlanta, Georgia. · Medtronic CardioVascular, Santa Rosa, California. · Unicor de Linhares, Linhares, Espírito Santo, Brazil. · Hospital Beneficência Portuguesa de São Paulo, São Paulo, São Paulo, Brazil. · Hospital Público Estadual de São Paulo, São Paulo, São Paulo, Brazil. · Hospital Bandeirantes, São Paulo, São Paulo, Brazil. · Emcor Emergências do Coração, Piracicaba, São Paulo, Brazil. · Hospital Santa Marcelina, São Paulo, Brazil. · Hospital Padre Albino-FIPA, Catanduva, São Paulo, Brazil. · Santa Casa de Misericórdia de Marilia, Marilia, São Paulo, Brazil. · Hospital Agamenon Magalhães, Recife, Pernambuco, Brazil. · Cardiovascular Research Center, São Paulo, São Paulo, Brazil. · VA Boston Healthcare System, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts. ·JAMA · Pubmed #24177257.

ABSTRACT: IMPORTANCE: The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown. OBJECTIVE: To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents. DESIGN, SETTING, AND PATIENTS: The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents. INTERVENTIONS: After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point. MAIN OUTCOMES AND MEASURES: The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis. RESULTS: NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, -1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]). CONCLUSIONS AND RELEVANCE: In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01113372.

10 Article Safety and efficacy of biolimus-eluting stent with biodegradable polymer: insights from EINSTEIN (Evaluation of Next-generation drug-eluting STEnt IN patients with coronary artery disease) Registry. 2013

Souza, Cristiano Freitas de / El Mouallem, Anwar Mohamed / de Brito Júnior, Fábio Sândoli / Abizaid, Alexandre Antônio Cunha / Almeida, Breno Oliveira / Almeida, Amanda Gonçalves / Nascimento, Teresa Cristina Dias Cunha / Perin, Marco Antonio / Caixeta, Adriano. · ·Einstein (Sao Paulo) · Pubmed #24136763.

ABSTRACT: OBJECTIVE: To evaluate the incidence of major adverse cardiac events (cardiac death, or acute myocardial infarct, or target vessel revascularization) at one year in "real world" patients. METHODS: The EINSTEIN registry is an observational, prospective, single center study that consecutively included 103 patients (152 lesions) treated with the BiomatrixTM stent, a biolimus A9-eluting stent with biodegradable polymer. RESULTS: The mean age was 65.0±12.4 years; male gender represented 83.5% of the patients; and 37.9% of them were diabetic. At one-year, major adverse cardiac events occurred in 11.7% of the patients, including 2.9% of cardiac death, 4.9% of with non ST- segment elevation acute myocardial infarction, and 3.9% of target vessel revascularization. Stent thrombosis occurred in only 1% (1 patient) at one-yearfollow-up. CONCLUSION: The present Registry suggests that new generation biolimus A9 drug-eluting stents are safe and effective in a "real world", all-comers patients, showing low rates of major cardiac adverse events on long-term follow-up.

11 Article Optimized duration of clopidogrel therapy following treatment with the Endeavor zotarolimus-eluting stent in real-world clinical practice (OPTIMIZE) trial: rationale and design of a large-scale, randomized, multicenter study. 2012

Feres, Fausto / Costa, Ricardo A / Bhatt, Deepak L / Leon, Martin B / Botelho, Roberto V / King, Spencer B / de Paula, J Eduardo T / Mangione, José A / Salvadori, Décio / Gusmão, Marcos O / Castello, Hélio / Nicolela, Eduardo / Perin, Marco A / Devito, Fernando S / Marin-Neto, J Antônio / Abizaid, Alexandre. ·Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. ·Am Heart J · Pubmed #23194480.

ABSTRACT: BACKGROUND: Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation include prolonged dual antiplatelet therapy (DAPT) with aspirin and clopidogrel ≥12 months. However, the impact of such a regimen for all patients receiving any DES system remains unclear based on scientific evidence available to date. Also, several other shortcomings have been identified with prolonged DAPT, including bleeding complications, compliance, and cost. The second-generation Endeavor zotarolimus-eluting stent (E-ZES) has demonstrated efficacy and safety, despite short duration DAPT (3 months) in the majority of studies. Still, the safety and clinical impact of short-term DAPT with E-ZES in the real world is yet to be determined. METHODS: The OPTIMIZE trial is a large, prospective, multicenter, randomized (1:1) non-inferiority clinical evaluation of short-term (3 months) vs long-term (12-months) DAPT in patients undergoing E-ZES implantation in daily clinical practice. Overall, 3,120 patients were enrolled at 33 clinical sites in Brazil. The primary composite endpoint is death (any cause), myocardial infarction, cerebral vascular accident, and major bleeding at 12-month clinical follow-up post-index procedure. CONCLUSIONS: The OPTIMIZE clinical trial will determine the clinical implications of DAPT duration with the second generation E-ZES in real-world patients undergoing percutaneous coronary intervention.

12 Article Late clinical outcomes after implantation of drug-eluting stents coated with biodegradable polymers: 3-year follow-up of the PAINT randomised trial. 2012

Lemos, Pedro A / Moulin, Bruno / Perin, Marco A / Oliveira, Ludmilla A R R / Arruda, J Airton / Lima, Valter C / Lima, Antonio A G / Caramori, Paulo R A / Medeiros, Cesar R / Barbosa, Mauricio R / Brito, Fabio S / Ribeiro, Expedito E. ·Heart Institute (InCor), University of São Paulo Medical School (USP), São Paulo, Brazil. pedro.lemos@incor.usp.br ·EuroIntervention · Pubmed #22580255.

ABSTRACT: AIMS: The long-term clinical performance of drug-eluting stents (DES) coated with biodegradable polymers is poorly known. METHODS AND RESULTS: A total of 274 coronary patients were randomly allocated to paclitaxel-eluting stents, sirolimus-eluting stents, or bare metal stents (2:2:1 ratio). The two DES used the same biodegradable polymers and were identical except for the drug. At three years, the pooled DES population had similar rates of cardiac death or myocardial infarction (9.0% vs. 7.1; p=0.6), but lower risk of repeat interventions (10.0% vs. 29.9%; p<0.01) than controls with bare stents. The cumulative 3-year incidence of definite or probable stent thrombosis in the pooled DES group was 2.3% (first year: 1.8%; second year: 0.4%; third year: zero). There were no significant differences in outcomes between paclitaxel- and sirolimus-eluting stents. CONCLUSIONS: The biodegradable-polymer coated DES releasing either paclitaxel or sirolimus were effective in reducing the 3-year rate of re-interventions.

13 Article Evaluation of plaque composition by intravascular ultrasound "virtual histology": the impact of dense calcium on the measurement of necrotic tissue. 2010

Sales, Fernando J R / Falcão, Breno A / Falcão, João L A / Ribeiro, Expedito E / Perin, Marco A / Horta, Pedro E / Spadaro, André G / Ambrose, John A / Martinez, Eulógio E / Furuie, Sergio S / Lemos, Pedro A. ·Heart Institute, University of São Paulo Medical School, Brazil. ·EuroIntervention · Pubmed #20884420.

ABSTRACT: AIMS: We aimed to evaluate if the co-localisation of calcium and necrosis in intravascular ultrasound virtual histology (IVUS-VH) is due to artefact, and whether this effect can be mathematically estimated. METHODS AND RESULTS: We hypothesised that, in case calcium induces an artefactual coding of necrosis, any addition in calcium content would generate an artificial increment in the necrotic tissue. Stent struts were used to simulate the "added calcium". The change in the amount and in the spatial localisation of necrotic tissue was evaluated before and after stenting (n=17 coronary lesions) by means of a especially developed imaging software. The area of "calcium" increased from a median of 0.04 mm2 at baseline to 0.76 mm2 after stenting (p<0.01). In parallel the median necrotic content increased from 0.19 mm2 to 0.59 mm2 (p<0.01). The "added" calcium strongly predicted a proportional increase in necrosis-coded tissue in the areas surrounding the calcium-like spots (model R2=0.70; p<0.001). CONCLUSIONS: Artificial addition of calcium-like elements to the atherosclerotic plaque led to an increase in necrotic tissue in virtual histology that is probably artefactual. The overestimation of necrotic tissue by calcium strictly followed a linear pattern, indicating that it may be amenable to mathematical correction.