Lino Patrício

Randomized Comparison of Sirolimus-Eluting and Everolimus-Eluting Coronary Stents in the Treatment of Total Coronary Occlusions Results From the Chronic Coronary Occlusion Treated by Everolimus-Eluting Stent Randomized Trial

Background—Patients with coronary total occlusions are at especially high risk for restenosis and new revascularizations. Sirolimus-eluting stents dramatically improved the clinical outcome of this subset of patients in randomized trials, but other drug-eluting stents, mainly the everolimus-eluting stent (currently the most frequently used stent), have not yet been evaluated in patients with coronary total occlusions. The objective was to compare the second-generation everolimus-eluting stent with the first-generation sirolimus-eluting stent in patients with coronary total occlusions. Methods and Results—A total of 207 patients with coronary total occlusions and estimated time since occlusion >2 weeks were randomized to everolimus- or sirolimus-eluting stent. The primary end point was in-stent late loss at 9-month angiographic follow-up (noninferiority trial). Clinical follow-up was performed at 1 and 12 months. In-stent late loss at 9 months was 0.29±0.60 versus 0.13±0.69 mm in patients allocated to sirolimus- and everolimus-eluting stent, respectively. The observed difference in in-stent late loss between both groups was –0.16 mm (95% confidence interval, 0.04 to –0.36 mm; P for noninferiority <0.01). The rate of binary angiographic restenosis was 10.8% and 9.1% in patients allocated to sirolimus- and everolimus-eluting stent, respectively (P=0.709), whereas the rate of vessel reocclusion was 3.2% and 1.1%, respectively (P=0.339). At 12 months, the rate of major adverse events was 15.9% versus 11.1% with sirolimus- and everolimus-eluting stent, respectively (P=0.335), and probable or definitive stent thrombosis occurred in 3.0% and 0.0% of patients, respectively (P=0.075). Conclusions—In patients with coronary total occlusions, everolimus-eluting stent is as effective as sirolimus-eluting stent. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00793221.

The Ibero-American transcatheter aortic valve implantation registry with the CoreValve prosthesis. Early and long-term results

BACKGROUND Transcatheter aortic valve implantation (TAVI) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The aim of this study was to describe early experience and long-term follow-up with the CoreValve self-expanding aortic prosthesis at 42 Ibero-American hospitals. METHODS Multiple centre observational study including 1220 consecutive patients with symptomatic severe aortic stenosis who are not suitable candidates for surgery and underwent transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System between December 2007 and May 2012. RESULTS The registry included 1220 consecutive patients with a mean age of 80.8 ± 6.3 years and a mean logistic euroSCORE of 17.8% ± 13%. The procedural success rate was 96.1%. Hospital mortality was 7.3% and combined end-point was 21.3%. Aortic regurgitation after TAVI was present in 24.5% (Sellers grade ≥ 2). The estimated 1-year and 2-year survival rates were 82.1% and 73.4% respectively. The following issues were significant independent risk factors for hospital mortality: acute kidney failure (odds ratio 3.55); stroke (odds ratio 5.72); major bleeding (odds ratio 2.64) and euroSCORE (odds ratio 1.02). Long-term predictors of mortality were diabetes mellitus (hazard ratio 1.59, 95% confidence interval 1.09-2.31), severe chronic obstructive pulmonary disease (hazard ratio 1.85, 95% confidence interval 1.85-2.88), and functional classes NYHA III-IV (hazard ratio 1.31, 95% confidence interval 1.01-1.70). CONCLUSIONS Transcatheter aortic valve implantation constitutes a safe and viable therapeutic option for high operative risk patients with severe aortic stenosis. Long-term prognosis is conditioned by associate comorbidities.

Posição sobre suportes vasculares restaurativos transitórios coronários em Portugal

BACKGROUND Bioresorbable vascular scaffolds (BVS) were recently approved for percutaneous coronary intervention in Europe. The aim of this position statement is to review the information and studies on available BVS, to stimulate discussion on their use and to propose guidelines for this treatment option in Portugal. METHODS AND RESULTS A working group was set up to reach a consensus based on current evidence, discussion of clinical case models and individual experience. The evidence suggests that currently available BVS can produce physiological and clinical improvements in selected patients. There are encouraging data on their durability and long-term safety. Initial indications were grouped into three categories: (a) consensual and appropriate - young patients, diabetic patients, left anterior descending artery, long lesions, diffuse disease, and hybrid strategy; (b) less consensual but possible - small collateral branches, stabilized acute coronary syndromes; and (c) inappropriate - left main disease, tortuosity, severe calcification. CONCLUSION BVS are a viable treatment option based on the encouraging evidence of their applicability and physiological and clinical results. They should be used in appropriate indications and will require technical adaptations. Outcome monitoring and evaluation is essential to avoid inappropriate use. It is recommended that medical societies produce clinical guidelines based on high-quality registries as soon as possible.

Safety and Effectiveness of the Genous™ Endothelial Progenitor Cell-Capture Stent in the First Year Following ST-Elevation Acute Myocardial Infarction: A Single Center Experience and Review of the Literature

PURPOSE The Genous™ stent (GS) is designed to accelerate endothelization, which is potentially useful in the pro-thrombotic environment of ST-elevation acute myocardial infarction (STEMI). We aimed to evaluate the safety and effectiveness of the GS in the first year following primary percutaneous coronary intervention (PCI) and to compare our results with the few previously published studies. METHODS AND MATERIALS All patients admitted to a single center due to STEMI that underwent primary PCI using exclusively GS, between May 2006 and January 2012, were enrolled. The primary study endpoints were major adverse cardiac events (MACEs), defined as the composite of cardiac death, acute myocardial infarction and target vessel revascularization, at one and 12 months. RESULTS In the cohort of 109 patients (73.4% male, 59 ± 12 years), 24.8% were diabetic. PCI was performed in 116 lesions with angiographic success in 99.1%, using 148 GS with median diameter of 3.00 mm (2.50-4.00) and median length of 15 mm (9-33). Cumulative MACEs were 2.8% at one month and 6.4% at 12 months. Three stent thromboses (2.8%), all subacute, and one stent restenosis (0.9%) occurred. These accounted for the four target vessel revascularizations (3.7%). At 12 months, 33.9% of patients were not on dual antiplatelet therapy. CONCLUSIONS GS was safe and effective in the first year following primary PCI in STEMI, with an apparently safer profile comparing with the previously published data. SUMMARY We report the safety and effectiveness of the Genous™ stent (GS) in the first year following primary percutaneous coronary intervention in ST-elevation acute myocardial infarction. A comprehensive review of the few studies that have been published on this subject was included and some suggest a less safe profile of the GS. Our results and the critical review included may add information and reinforce the safety and effectiveness of the GS in ST-elevation in acute myocardial infarction.

Coronary optical coherence tomography: A practical overview of current clinical applications

Coronary optical coherence tomography has emerged as the most powerful in-vivo imaging modality to evaluate vessel structure in detail. It is a useful research tool that provides insights into the pathogenesis of coronary artery disease. This technology has an important clinical role that is still being developed. We review the evidence on the wide spectrum of potential clinical applications for coronary optical coherence tomography, which encompass the successive stages in coronary artery disease management: accurate lesion characterization and quantification of stenosis, guidance for the decision to perform percutaneous coronary intervention and subsequent planning, and evaluation of immediate and long-term results following intervention.

Power of Contemporary Clinical Strategies to Detect Patients withObstructive Coronary Artery Disease

Background: Non-invasive Ischemia Testing (NIST) is recommended for most patients suspected to have stable coronary artery disease (CAD) before invasive cardiac angiography (ICA). We sought to assess the diagnostic predictive ability of NIST over clinical risk profiling in a contemporary sample of patients undergoing the currently recommended diagnostic triage strategy. Methods and results: From 2006 - 2011, 2600 consecutive patients without known CAD undergoing elective ICA in a single tertiary - care centre were retrospectively identified and the prevalence of obstructive CAD determined. To understand the incremental value of frequently used clinical parameters in predicting obstructive CAD, receiver - operating - characteristic curves were plotted for six sequential models starting with Framingham risk score and then progressively adding multiple clinical factors and finally NIST results. At ICA 1268 patients (48.8%) had obstructive. The vast majority (85%) were classified in an intermediate clinical pre - test probability of CAD and NIST prior to ICA was used in 86% of the cohort. The most powerful correlate of obstructive CAD was the presence of severe angina (OR = 9.1, 95% confidence interval (CI), 4.3 - 19.1). Accordingly, the incorporation of NIST in a sequential model had no significant effect on the predictive ability over that achieved by clinical and symptomatic status model (C - statistic 0.754; 95% CI, 0.732 - 0.776, p = 0.28). Conclusions: Less than half the patients with suspect stable obstructive CAD referred to a tertiary level centre for elective ICA had the diagnosis confirmed. In this clinical setting, the results of NIST may not have the power to change the discriminative ability over clinical judgment alone.

Drug-eluting stent thrombosis in the treatment of chronic total coronary occlusions: Incidence, presentation and related factors. Data from the CIBELES trial

INTRODUCTION AND OBJECTIVES The aim of this study was to analyze the incidence of drug-eluting stent thrombosis (sirolimus or everolimus) in patients with chronic total coronary occlusions (CTO) and to determine its clinical implications and related factors. METHODS Data from the 12-month follow-up of the 207 patients included in the CIBELES trial with CTO were analyzed. RESULTS Stent thrombosis occurred in three patients, two definite and one probable (overall thrombosis rate: 1.4%). However, there were no cases of death or Q-wave myocardial infarction. In univariate analysis, patients with a higher incidence of stent thrombosis were those in whom the target vessel was the left anterior descending, who had single-vessel disease, were assigned to treatment with sirolimus-eluting stents, and those with smaller minimum luminal diameter immediately after the procedure. In multivariate analysis, the only independent predictor of stent thrombosis was minimal luminal diameter immediately after the procedure. CONCLUSIONS The rate of drug-eluting stent thrombosis in patients with CTO is relatively low (1.4%). The only independent predictor of stent thrombosis in this context was minimal luminal diameter after the procedure and the clinical presentation was in all cases relatively benign.

Yield of contemporary clinical strategies to detect patients with obstructive coronary artery disease

Purpose Noninvasive ischemia testing (NIST) is recommended for most patients suspected to have stable coronary artery disease (CAD) before invasive coronary angiography (ICA). We sought to assess the diagnostic predictive ability of NIST over clinical risk profiling in a contemporary sample of patients undergoing the currently recommended diagnostic triage strategy. Methods From 2006 to 2011, 2,600 consecutive patients without known CAD undergoing elective ICA in a single tertiary-care center were retrospectively identified and the prevalence of obstructive CAD determined. To understand the incremental value of frequently used clinical parameters in predicting obstructive CAD, receiver operating characteristic curves were plotted for six sequential models starting with Framingham risk score and then progressively adding multiple clinical factors and finally NIST results. Results At ICA 1,268 patients (48.8%) had obstructive CAD. The vast majority (85%) were classified in an intermediate clinical pretest probability of CAD and NIST prior to ICA was used in 86% of the cohort. The most powerful correlate of obstructive CAD was the presence of severe angina (odds ratio (OR) = 9.1; 95% confidence interval (CI) 4.3-19.1). Accordingly, the incorporation of NIST in a sequential model had no significant effect on the predictive ability over that achieved by clinical and symptomatic status model (C-statistic 0.754; 95% CI 0.732-0.776, p = 0.28). Conclusions Less than half the patients with suspect stable obstructive CAD referred to a tertiary-level center for elective ICA had the diagnosis confirmed. In this clinical setting, the results of NIST may not have the power to change the discriminative ability over clinical judgment alone.

Techniques and material used in the percutaneous treatment of chronic coronary occlusions. Data from the CIBELES study

INTRODUCTION In recent years, various specific techniques and materials have been developed for the treatment of coronary chronic total occlusions (CTO). OBJECTIVE To evaluate the current situation in the treatment of CTO (techniques and material) in our setting. METHODS We evaluated data on techniques and material used in the CIBELES (ChronIc coronary occlusion treated By EveroLimus Eluting Stent) trial, a randomized comparison of sirolimus- and everolimus-eluting stents in 207 patients with CTO in 13 centers in Spain and Portugal. RESULTS A radial approach was used in 23% of patients, and retrograde techniques were used in only 5%. A high number of balloons were used (2.2±0.9 per patient). Microcatheters were used in 33% of patients, and post-dilatation balloons in only 25%. The mean number of stents implanted per patient was 2.1±1.0, with a mean total stent length of 49±24 mm. Other devices and techniques used were: Tornus penetration catheter in 4% of patients, rotational atherectomy in 2%, and cutting balloon in 1%. Intracoronary ultrasound was used in only 6% of patients. In 34% of cases, operators used guidewires that were not specifically for CTO. Considerable variability between centers was detected in the use of different techniques, the highest and lowest variability being observed in the use of intracoronary ultrasound and the use of CTO guidewires, respectively. CONCLUSIONS In the CIBELES trial, techniques and devices specifically designed for the treatment of CTO were used in a relatively low proportion of patients. Considerable variability between centers was detected.

EVALUATION OF PREGNANCY OUTCOMES IN WOMEN WITH VALVULAR HEART DISEASE: 10 YEARS OF A SPECIALIZED CENTRE EXPERIENCE

The population of pregnant women with valvular heart disease (VHD), in particular with valvular heart prostheses (VHP), represents a unique patient group, where data is scarce, with increased risk for adverse maternal and obstetric events. The aim of this study was to assess the experience of a