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Previous studies have suggested a benefit of cilostazol in addition to standard dual-antiplatelet therapy (DAPT), reducing in-stent late luminal loss and restenosis after percutaneous coronary intervention (PCI) with bare-metal and drug-eluting stent (DES) implantation. However, there is a paucity of intravascular ultrasound (IVUS) assessment of neointimal tissue hyperplasia (NIH) after triple-antiplatelet therapy (TAPT), especially in diabetic patients treated with DES.This prospective, placebo-controlled trial was conducted in diabetic patients randomized (1:1) to receive either standard DAPT (aspirin and clopidogrel) vs TAPT with cilostazol for a minimum of 12 months after PCI with Endeavor zotarolimus-eluting stent (E-ZES). The primary endpoint was the 9-month comparison of percentage of NIH in both groups. Additionally, we compared in-stent late lumen loss, binary restenosis, major adverse cardiac event (MACE; cardiac death, non-fatal myocardial infarction, and restenosis) rates, and the incidence of vascular/bleeding complications.In total, 133 diabetic patients were enrolled (cilostazol cohort = 65 patients) with 56.4% male and mean age of 60.8 years. Overall, the two cohorts were comparable in terms of baseline clinical and angiographic characteristics, except for the reference vessel diameter, which was smaller among patients randomized to cilostazol (2.48 ± 0.46 mm vs 2.69 ± 0.48 mm; P=.01). At 9 months, there was a non-significant trend toward less percentage of NIH obstruction in the TAPT cohort (33.2 ± 8.29% vs 35.1 ± 8.45%; P=.07). However, this finding did not impact angiographic late-lumen loss (0.60 ± 0.46 mm cilostazol group vs 0.64 ± 0.48 mm control group; P=.30) and binary restenosis (9.8% vs 6.8%; P=.99). MACE rate also did not significantly differ between the cohorts (13.8% cilostazol group vs 8.8% control group; P=.81). Of note, the addition of a third antiplatelet agent did not increase vascular and bleeding complications.In diabetic patients treated with E-ZES, TAPT with cilostazol did not add any significant benefit in terms of NIH suppression or MACE reduction.

BACKGROUND: The percutaneous treatment of coronary artery disease has been revolutionized by the use of drug-eluting stents (DES). However, its use in the daily practice involves patients with more complex clinical and angiographic characteristics than those found in randomized trials. This registry was designed to characterize diabetic patients and their outcomes following DES implantation in our country. METHODS: Prospective single-center registry enrolling consecutive patients after DES implantation. Clinical, angiographic and procedure-related data, as well as early and long-term outcomes were recorded. The primary endpoint, including cardiac death, myocardial infarction or target lesion revascularization, was compared between diabetics and non-diabetics. RESULTS: We evaluated 1,670 patients treated with DES from 2002 to 2012 with a follow-up of 3.2 ± 2.5 years. One third of the patients were diabetic and had lower event-free survival when compared to non-diabetic patients (79.4% vs. 82.6%; P = 0.015). The adjusted odds ratio, however, was 1.22 (95% CI, 0.89-1.69) and was not significant. A significantly lower event-free survival was observed in the subgroup of patients receiving insulin, whereas it was similar for diabetic and non-diabetic patients in the subgroup not receiving insulin (68.7% vs. 83.9% vs. 82.8%, respectively; P < 0.01). The adjusted odds ratio was 1.72 (95% CI, 1.13-2.63) higher for diabetic patients receiving insulin when compared to the remaining patients. CONCLUSIONS: The use of DES is beneficial for all diabetic patients, especially those who do not receive insulin.

BackgroundThe percutaneous treatment of coronary artery disease has been revolutionized by the use of drug-eluting stents (DES). However, its use in the daily practice involves patients with more complex clinical and angiographic characteristics than those found in randomized trials. This registry was designed to characterize diabetic patients and their outcomes following DES implantation in our country.MethodsProspective single-center registry enrolling consecutive patients after DES implantation. Clinical, angiographic and procedurerelated data, as well as early and long-term outcomes were recorded. The primary endpoint, including cardiac death, myocardial infarction or target lesion revascularization, was compared between diabetics and non-diabetics.ResultsWe evaluated 1,670 patients treated with DES from 2002 to 2012 with a follow-up of 3.2±2.5years. One third of the patients were diabetic and had lower event-free survival when compared to non-diabetic patients (79.4% vs. 82.6%; P=0.015). The adjusted odds ratio, however, was 1.22 (95% CI, 0.89-1.69) and was not significant. A significantly lower event-free survival was observed in the subgroup of patients receiving insulin, whereas it was similar for diabetic and nondiabetic patients in the subgroup not receiving insulin (68.7% vs. 83.9% vs. 82.8%, respectively; P < 0.01). The adjusted odds ratio was 1.72 (95% CI, 1.13-2.63) higher for diabetic patients receiving insulin when compared to the remaining patients.ConclusionsThe use of DES is beneficial for all diabetic patients, especially those who do not receive insulin.

Introdução: O escore SYNTAX estratifica a complexidade angiográfica e estabelece o prognóstico de portadores de doença triarterial e/ou com lesão de tronco, sendo uma importante ferramenta para decidir a melhor estratégia de revascularização. Avaliamos o impacto do escore SYNTAX no prognóstico de pacientes com doença arterial coronariana multiarterial da prática clínica tratados por intervenção coronária percutânea. Métodos: Identificamos no Registro SAFIRA pacientes com acometimento multiarterial tratados eletivamente com stents farmacológicos. Os pacientes foram agrupados em escore SYNTAX ≤ 8; escore SYNTAX > 8 e ≤ 16; e escore SYNTAX > 16, e comparados quanto aos eventos cardíacos adversos maiores. Resultados: No período de 2009 a 2014, identificamos 244 pacientes, que preencheram os critérios de inclusão para o estudo. Foram distribuídos em escore SYNTAX ≤ 8 (n = 61; 25%), > 8 e ≤ 16 (n = 116; 47,5%), e > 16 (n = 67; 27,5%). A média de idade foi de 64,6 ± 11,5 anos e 73% eram do sexo masculino. O escore SYNTAX variou de 1 a 39, com média de 13,4 ± 6,8. No período de 3,6 ± 2,1 anos, observaram-se maiores taxas de eventos cardíacos adversos maiores no grupo > 16 (4,9% vs. 6,9% vs. 11,9%; p < 0,01), às custas de maior revascularização do vaso-alvo (1,6% vs. 2,6% vs. 7,5%; p = 0,08). Quatro casos de trombose do stent definitiva ou provável foram detectados (zero vs. 1,7% vs. 3,0%; p = 0,41). Conclusões: O escore SYNTAX é capaz de estratificar o risco em uma população com doença coronária multiarterial da prática clínica submetida à revascularização percutânea com implante de stents farmacológicos.