Background: Drug-eluting stents have reduced the need of target vessel revascularization (TVR), when compared to bare metal stents. However, some studies have shown increased risk of stent thrombosis with the use of these devices. As a consequence, new drug-eluting stents with biodegradable polymers have been developed to improve results. Methods: The first 100 patients treated with the Biomatrix TM stent from November 2008 to September 2010, were included. Only those with contraindication to dual antiplatelet therapy were excluded. Primary endpoint was the occurrence of major adverse cardiac events in the late follow-up. Results: Mean age was 64 ± 11.7 years, 73% were men, 43% were diabetic and 40% had stable angina. One hundred and sixty-four lesions were treated, 71% of them were complex lesions (B2/C). The vessel reference diameter and the length of lesions were, respectively, 2.79 ± 0.49 mm and 18.3 ± 9.2 mm. Procedure success was 96%. Clinical follow-up data was obtained in 99% of the eligible patients in a mean period of 243 ± 160 days. The primary endpoint rate was 9% (cardiac death 4%, nonfatal myocardial infarction 2%, TVR 3%). Stent thrombosis was observed in 1% of the patients. There was no late or very late thrombosis. Conclusions: In this real world experience, the use of the Biomatrix TM stent showed good results. These findings, together with those available in the literature, provide additional evidences for the use of this stent in the daily clinical practice, including off-label indications.
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 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. 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 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.
Background: The SYNTAX score stratifies the angiographic complexity of coronary artery disease and establishes the prognosis of patients with triple vessel and/or left main coronary artery disease, being an important tool to decide the best revascularization strategy. We assessed the impact of the SYNTAX score in the prognosis of a daily practice population with multivessel coronary artery disease treated by percutaneous coronary intervention with drug-eluting stents. Methods: We identified in the SAFIRA Registry elective patients with multivessel coronary artery disease treated with drug-eluting stents. Patients were grouped in SYNTAX score ≤ 8; SYNTAX score > 8 and ≤ 16, and SYNTAX score > 16, and clinical outcomes in terms of major adverse cardiac events were stratified according to the SYNTAX score groups. Results: Between 2009 and 2014, we identified 244 patients that met the study inclusion criteria. Patients were distributed in those with SYNTAX score ≤ 8 (n = 61; 25%), > 8 and ≤ 16 (n = 116; 47.5%), and > 16 (n = 67; 27.5%). Mean age was 64.6 ± 11.5 years and 73% were male. The SYNTAX score ranged between 1 and 39, with an average of 13.4 ± 6.8. In the follow-up period of 3.6 ± 2.1 years, there were higher rates of major adverse cardiac events in group > 16 (4.9% vs. 6.9% vs. 11.9%; p < 0.01) due to a higher incidence of target vessel revascularization (1.6% vs. 2.6% vs. 7.5%; p = 0.08). Four cases of definitive or probable stent thrombosis were detected (zero vs. 1.7% vs. 3.0%; p = 0.41). Conclusions: The SYNTAX score is able to stratify the risk of a daily practice population with coronary multivessel disease treated by percutaneous coronary intervention with drug-eluting stents.
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