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

Background Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation includeprolonged 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 durationDAPT (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 secondgeneration E-ZES in real-world patients undergoing percutaneous coronary intervention.

Complicaçöes atuais do cateterismo cardíaco: análise de 1000 pacientes / Current complications of heart catheterization: analysis of 1000 cases

Avaliar o imnpacto das novas técnicas de cateterismo cardíaco sobre a incidência de complicaçöes. Mil pacientes consecutivos submetidos a cateterismo cardíaco no período de agosto a dezembro de 1989 (739 cateterismos diagnósticos e 261 terapêuticos) acompanhados até a alta hospitalar. As complicaçöes foram classificadas segundo o tipo e a gravidade e correlacionadas à técnica do procedimento e à fraçäo de ejeçäo do ventrículo esquerdo (FEVE). Em 77,7% dos pacientes näo houve complicaçöes. Nos restantes (22,3%) as complicaçöes foramÑ leves (11,2%), moderadas (7,3%) e severas (3,8%). Entre as últimas, ocorreram ,5% de intercorrências vasculares graves, 0,1% de perfuraçäo cardíaca necessitando de cirurgia de emergência, 1,4% de arritmias severas, 0,4% de infarto agudo do miocárdio, 0,3% de edema agudo de pulmäo e 0,5% de mortalidade. Os estudos hemodinâmicos permanecem com índice relativamente baixo de complicaçöes, apesar do crescente número de procedimentos intervencionistas e da maior gravidade dos pacientes estudados

Oclusäo de ramos secundários após angioplastia da artéria coronária descendente anterior / Occlusion of secondary branches after angioplasthy of the left descending coronary artery

Avaliar a incidência de oclusäo de ramos secundários em pacientes com lesäo única da artéria descendente anterior, em que a angioplastia coronária foi aplicada pela primeira vez e com sucesso. Duzentos e treze casos com ramos secundários em pacientes com lesäo única da ar considerados " em risco" por estarem envolvidos na lesäo (grupo I - GI; 85 casos - 39,9%); ou por terem sido atingidos pela insuflaçäo do baläo (grupo II - GII, 128 casos - 61,5%). Corresponderam a: GI - 54 ramos septais (S) e 31 ramos diaggonais (Dg), sendo que 36% tinham evidência angiográfica de doença ostial; GII - 77 S e 51 Dg, com 7,8% de doença ostial. Oclusäo de 7 (3,3%) ramos secundários " em "em risco", 4 (4,7%) do GI e 3 (2,3%) do GII. Na evoluçäo clínica destes 7 casos observaram-se angina de peito em 57% e alteraçöes isquêmicas discretas ao eletrocardiograma em 28.6%. Näo houve qualquer alteraçäo enzímica. A oclusäo foi clinicamente silenciosa em 43% dos casos. A oclusäo de ramos secundários é de baixa incidência, ocorre com maior freqüência nos septais, que nascem da lesäo e nos que têm doença ostial, sendo silenciosa em quase metade dos pacientes ou acompanhada de alteraçeos isquêmicas.

Purpose: To evaluate the incidence and clinical presentation of the occlusion of such secondary branches in patients with single vessel coronary artery disease in the left anterior descending artery, who underwent a first elective and successful PTCA. Material and Methods: Two hundred and thirteen side branches of 121 patients considered to be at risk. They were divided into group I (GI85 side branches, 39.9%), if they originated from the atherosclerotic site; and group II (GII120 side branches, 61.5%), if their origin would be involved during the balloon inflation. In the GI there were 54 septal branches and 3.1 diagonal branches, and 36& had angiographic evidence of ostium disease. GII was constituted by 77 septal and 51 diagonal branches, and 7.8% of them had evidence of ostium disease. Results: Seven side branches (3.3%) at risk occluded, 4 from GI (4.7%) and 3 (2.3%) from GII. As for the clinical presentation, 57% of them had angina, where as 28.6% showed minor abnormalities in the ECG. No patient elevated its serum CK-MB, and silent occlusion cccurred in 43% if them. Conclusion: Occlusion of side branches is a low incidence phenomenon, which happens more often in septal branches with ostium disease that originates from the atherosclerotic site; that about half of the patient had silent occlusion (43%) or mild ischemic manifestations