Showing papers by "Manel Sabaté published in 2014"

Reperfusion therapy for ST elevation acute myocardial infarction 2010/2011: current status in 37 ESC countries.

Abstract: Aims Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion therapy in ST-elevation myocardial infarction (STEMI). We conducted this study to evaluate the contemporary status on the use and type of reperfusion therapy in patients admitted with STEMI in the European Society of Cardiology (ESC) member countries. Methods and results A cross-sectional descriptive study based on aggregated country-level data on the use of reperfusion therapy in patients admitted with STEMI during 2010 or 2011. Thirty-seven ESC countries were able to provide data from existing national or regional registries. In countries where no such registries exist, data were based on best expert estimates. Data were collected on the use of STEMI reperfusion treatment and mortality, the numbers of cardiologists, and the availability of PPCI facilities in each country. Our survey provides a brief data summary of the degree of variation in reperfusion therapy across Europe. The number of PPCI procedures varied between countries, ranging from 23 to 884 per million inhabitants. Primary percutaneous coronary intervention and thrombolysis were the dominant reperfusion strategy in 33 and 4 countries, respectively. The mean population served by a single PPCI centre with a 24-h service 7 days a week ranged from 31 300 inhabitants per centre to 6 533 000 inhabitants per centre. Twenty-seven of the total 37 countries participated in a former survey from 2007, and major increases in PPCI utilization were observed in 13 of these countries. Conclusion Large variations in reperfusion treatment are still present across Europe. Countries in Eastern and Southern Europe reported that a substantial number of STEMI patients are not receiving any reperfusion therapy. Implementation of the best reperfusion therapy as recommended in the guidelines should be encouraged.

Comparison of Newer-Generation Drug-Eluting With Bare-Metal Stents in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Pooled Analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) Trials

Abstract: Objectives This study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients with ST-segment elevation myocardial infarction (STEMI). Background Among patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES. Methods Individual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year. Results Newer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk [RR]: 0.58; 95% confidence interval [CI]: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p Conclusions Among patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up.

The EXAMINATION Trial (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction): 2-Year Results From a Multicenter Randomized Controlled Trial

Abstract: Objectives This study sought to assess the 2-year outcomes of the population included in the EXAMINATION (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction) trial beyond the 1-year prescription period of dual antiplatelet therapy. Background The EXAMINATION trial compared the performance of everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population. Methods This was a multicenter, multinational, prospective, randomized, single-blind, controlled trial in patients with STEMI. The primary endpoint, which was the combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularization, and the endpoints target lesion revascularization and stent thrombosis were assessed at 2 years. Results Between December 31, 2008, and May 15, 2010, 1,498 patients were randomized to receive EES (n = 751) or BMS (n = 747). Compliance with dual antiplatelet regimen was reduced at 2 years to a similar degree (17.3% vs. 17.2%, p = 0.91). At 2 years, the primary endpoint occurred in 108 (14.4%) patients of the EES group and in 129 (17.3%) patients of the BMS group (p = 0.11). Rate of target lesion revascularization was significantly lower in the EES group than in the BMS group (2.9% vs. 5.6%; p = 0.009). Rates of definite and definite or probable stent thrombosis were also significantly reduced in the EES group (0.8% vs. 2.1%; p = 0.03, and 1.3% vs. 2.8%; p = 0.04, respectively). Conclusions The 2-year follow-up of the EXAMINATION trial confirms the safety and efficacy of the EES compared with BMS in the setting of STEMI. Specifically, both rates of target lesion revascularization and stent thrombosis were reduced in recipients of EES without any signs of late attrition for either of these endpoints. (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction: EXAMINATION Study; NCT00828087 )

Corrigendum to: ‘2013 ESC guidelines on the management of stable coronary artery disease’

Abstract: [Eur Heart J (2013);34:2949–3003; doi:10.1093/eurheartj/eht296]. In the legends for Figures 6 and 7, the amount of fractional flow reserve should read ‘< 0.80’ instead of ‘=0.80.’ There was also …

Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis

Abstract: Objectives To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents. Design Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported. Data sources and study selection Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients. Primary outcomes The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death. Results The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; P<0.001), and target vessel revascularisation (0.29, 0.20 to 0.41; P<0.001) at a median follow-up of 720 days. There was no significant difference in all cause death between groups (0.83, 0.65 to 1.06; P=0.14). Findings remained unchanged at multivariable regression after adjustment for the acuity of clinical syndrome (for instance, acute coronary syndrome v stable coronary artery disease), diabetes mellitus, female sex, use of glycoprotein IIb/IIIa inhibitors, and up to one year v longer duration treatment with dual antiplatelets. Conclusions This meta-analysis offers evidence that compared with bare metal stents the use of cobalt-chromium everolimus eluting stents improves global cardiovascular outcomes including cardiac survival, myocardial infarction, and overall stent thrombosis.

Selected CD133+ Progenitor Cells to Promote Angiogenesis in Patients With Refractory Angina: Final Results of the PROGENITOR Randomized Trial

Abstract: Rationale:Refractory angina constitutes a clinical problem. Objective:The aim of this study was to assess the safety and the feasibility of transendocardial injection of CD133+ cells to foster angiogenesis in patients with refractory angina. Methods and Results:In this randomized, double-blinded, multicenter controlled trial, eligible patients were treated with granulocyte colony-stimulating factor, underwent an apheresis and electromechanical mapping, and were randomized to receive treatment with CD133+ cells or no treatment. The primary end point was the safety of transendocardial injection of CD133+ cells, as measured by the occurrence of major adverse cardiac and cerebrovascular event at 6 months. Secondary end points analyzed the efficacy. Twenty-eight patients were included (n=19 treatment; n=9 control). At 6 months, 1 patient in each group had ventricular fibrillation and 1 patient in each group died. One patient (treatment group) had a cardiac tamponade during mapping. There were no significant di...

Lung function abnormalities are highly frequent in patients with heart failure and preserved ejection fraction.

Abstract: Background Heart failure with preserved ejection fraction (HFPEF) is the most prevalent form of heart failure in outpatients. Yet, the pathophysiology of this syndrome is unclear and pharmacological treatment does not improve prognosis. Because breathlessness during activities of daily living is the most frequent complaint of patients with HFPEF, we hypothesised that lung function may be often abnormal in these patients due to either a direct effect of HFPEF and/or shared risk factors. In this study we explore the frequency, type and severity of lung function abnormalities in HFPEF. Methods We measured forced spirometry, static lung volumes, pulmonary diffusing capacity (DL CO ) and arterial blood gases in 69 outpatients with newly diagnosed symptomatic HFPEF. Results We found that 94% of the patients showed abnormalities in at least one of the lung function measurements obtained: spirometry was abnormal in 59%, DL CO in 83% and arterial hypoxaemia was present in 62%. Their severity varied between patients, they were more prevalent in patients with NYHA functional class III/IV, and most often they were undiagnosed and untreated. Conclusions Lung function abnormalities are very frequent in HFPEF patients. A greater awareness among clinicians may contribute to improve their management and health status.

Guía de Práctica Clínica de la ESC 2013 sobre diagnóstico y tratamiento de la cardiopatía isquémica estable

Abstract: Miembros del Grupo de Trabajo: Gilles Montalescot * (Coordinador) (Francia), Udo Sechtem * (Coordinador) (Alemania), Stephan Achenbach (Alemania), Felicita Andreotti (Italia), Chris Arden (Reino Unido), Andrzej Budaj (Polonia), Raffaele Bugiardini (Italia), Filippo Crea (Italia), Thomas Cuisset (Francia), Carlo Di Mario (Reino Unido), J. Rafael Ferreira (Portugal), Bernard J. Gersh (Estados Unidos), Anselm K. Gitt (Alemania), Jean-Sebastien Hulot (Francia), Nikolaus Marx (Alemania), Lionel H. Opie (Sudafrica), Matthias Pfisterer (Suiza), Eva Prescott (Dinamarca), Frank Ruschitzka (Suiza), Manel Sabate (Espana), Roxy Senior (Reino Unido), David Paul Taggart (Reino Unido), Ernst E. van der Wall (Paises Bajos) y Christiaan J.M. Vrints (Belgica)

Optimization in Stent Implantation by Manual Thrombus Aspiration in ST-Segment–Elevation Myocardial Infarction Findings From the EXAMINATION Trial

Abstract: Background—Manual thrombus aspiration (TA) is effective to reduce the thrombus burden during primary percutaneous coronary intervention for ST-elevation myocardial infarction. The objective of this study is to assess the impact of manual TA on stent implantation during primary percutaneous coronary intervention. Methods and Results—Population of the EXAMINATION trial (n=1498) was divided into 2 groups according to the use of TA. Immediate angiographic results, primary patient-oriented end point (combination of all-cause death, myocardial infarction, and any revascularization) and secondary device-oriented end point (combination of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization), definite/probable stent thrombosis, and major/minor bleeding were evaluated at 2 years. A total of 976 (65.2%) patients were classified into TA group and 522 (34.8%) patients into nonthrombus aspiration group. Manual TA was most frequently used in patients with worse initi...

Qualitative and quantitative accuracy of ultrasound-based virtual histology for detection of necrotic core in human coronary arteries

Abstract: The aim was to test the accuracy of virtual histology (VH) for detecting necrotic core (NC) in an ex vivo human model of coronary arteries as compared to real histology (RH). A total of nine consecutive explanted hearts were included in the study. Coronary segments, clearly identified by anatomical landmarks, were analyzed by intravascular ultrasound (IVUS-VH) immediately after heart collection and thereafter by RH. NC was expressed as absolute (total amount) and relative (corrected for plaque area) values. Correlation analysis was performed using linear regression models at cross-section level, with correction for repeated measurements per patient, and at segment level. Receiver operator curves (ROC) were developed for testing accuracy of VH in detecting RH-NC. Overall, 321 mm were analyzed corresponding to 642 IVUS-VH frames and corresponding histological slices. VH and RH-NC areas were 0.24 ± 0.43 and 0.16 ± 0.43 mm2, respectively (p < 0.001). At cross-section level, the correlation between VH and RH-NC was moderate in absolute (r = 0.50, p < 0.001) and poor in relative values (r = 0.43, p = 0.120). At the segment level, this correlation improves in terms of absolute values (r = 0.80, p = 0.01), but was not significant in terms of relative values (r = 0.43, p = 0.25). The ROC curve showed a C-statistics of 0.904 (p < 0.001) with high sensitivity (94 %), but low specificity (53 %) and low positive predictive value (48 %). Although VH has a high sensitivity in identifying RH-NC, it has a low specificity and low positive predictive value. In addition, it is not able to accurately quantify its size within the corresponding histological specimen.

Assessment of plaque composition by intravascular ultrasound and near-infrared spectroscopy: from PROSPECT I to PROSPECT II.

Abstract: Atherosclerosis is the main cause of coronary artery disease (CAD), which is today the leading cause of death worldwide and will continue to be the first in the world in 2030. Vulnerable coronary plaques are usually characterized by a high content of necrotic core, a thin inflamed fibrous cap (intense accumulation of macrophages) and scarce presence of smooth muscle cells. None of these characteristics can be estimated by coronary angiography, which on the contrary underestimates the magnitude of atherosclerotic burden, particularly in earlier stage disease when positive vascular remodeling may allow "normal" lumen caliber despite substantial vascular wall plaque. The recognition of the ubiquity of substantial but non-flow limiting lesions that may be at high risk for subsequent plaque rupture has resulted in a paradigm shift in thinking about the pathophysiology of CAD, with the focus no longer solely on the degree of arterial luminal narrowing. This growing need for more information about coronary atherosclerosis in order to identify patients and lesions at risk for complications during PCI and for future adverse cardiac events has been the primary impetus for the development of novel intracoronary imaging methods able to detect plaque composition, in particular presence of a necrotic core/lipid pool, such as intravascular ultrasound virtual histology and near-infrared spectroscopy. These imaging technologies and their clinical and clinical/research applications are discussed in detail.

Randomized Comparison Between Polymer-Free Versus Polymer-Based Paclitaxel-Eluting Stent Two-Year Final Clinical Results

Abstract: Background—Most drug-eluting stents currently in use are coated with a polymer carrying the drug that is released for several weeks. However, a durable polymer may provoke hypersensitive reaction, delayed artery healing, and eventually stent thrombosis. The aim of this study was to investigate the safety and efficacy of a polymer-free paclitaxel-eluting stent (PF-PES) versus a polymer-based PES (PB-PES). Methods and Results—Eligible patients undergoing percutaneous coronary intervention were randomized 1:1 to receive either PF-PES or PB-PES. The primary end point was late loss at 9 months. Intravascular ultrasound analysis at 9 months and final 2-year clinical follow-up were also performed. From October 2007 to April 2009, 164 patients were enrolled and randomized into 2 groups (PF-PES: n=84; PB-PES: n=80). Mean in-stent lumen loss was 0.90±0.59 mm for PF-PES and 0.49±0.52 mm for PB-PES (P<0.001). Mean neointimal area by intravascular ultrasound was higher in PF-PES than in PB-PES (1.42±1.09 versus 0.51±0...

Recanalized thrombus treated with bioresorbable vascular scaffold: insights from optical coherence tomography.

Abstract: A 29-year-old man underwent coronary angiography after non–ST-segment elevation myocardial infarction. He was a current smoker and did not have any other relevant medical history. Coronary angiography revealed a lesion with contrast filling defect and irregular lumen border at the mid-segment of

Does manual thrombus aspiration help optimize stent implantation in ST-segment elevation myocardial infarction?

Abstract: AIM: To evaluate the impact of thrombus aspiration (TA) on procedural outcomes in a real-world ST-segment elevation myocardial infarction (STEMI) registry. METHODS: From May 2006 to August 2008, 542 consecutive STEMI patients referred for primary or rescue percutaneous coronary intervention were enrolled and the angiographic results and stent implantation characteristics were compared according to the performance of manual TA. RESULTS: A total of 456 patients were analyzable and categorized in TA group (156 patients; 34.2%) and non-TA (NTA) group (300 patients; 65.8%). Patients treated with TA had less prevalence of multivessel disease (39.7% vs 54.7%, P = 0.003) and higher prevalence of initial thrombolysis in myocardial infarction flow < 3 (P < 0.001) than NTA group. There was a higher rate of direct stenting (58.7% vs 45.5%, P = 0.009), with shorter (24.1 ± 11.8 mm vs 26.9 ± 15.7 mm, P = 0.038) and larger stents (3.17 ± 0.43 mm vs 2.93 ± 0.44 mm, P < 0.001) in the TA group as compared to NTA group. The number of implanted stents (1.3 ± 0.67 vs 1.5 ± 0.84, P = 0.009) was also lower in TA group. CONCLUSION: In an “all-comers” STEMI population, the use of TA resulted in more efficient procedure leading to the implantation of less number of stents per lesion of shorter lengths and larger sizes.

Corrigendum to: Reperfusion therapy for ST elevation acute myocardial infarction 2010/2011: current status in 37 ESC countries

Abstract: [Eur Heart J 2014;35:1957-1970, doi:10.1093/eurheartj/eht529] Figure 1 of this article contained …

Drug-eluting stents and acute myocardial infarction: A lethal combination or friends?

Abstract: Primary percutaneous coronary intervention is the preferred reperfusion strategy for patients presenting with ST-segment elevation myocardial infarction (STEMI). First generation drug-eluting stents (DES), (sirolimus drug-eluting stents and paclitaxel drug-eluting stents), reduce the risk of restenosis and target vessel revascularization compared to bare metal stents. However, stent thrombosis emerged as a major safety concern with first generation DES. In response to these safety issues, second generation DES were developed with different drugs, improved stent platforms and more biocompatible durable or bioabsorbable polymeric coating. This article presents an overview of safety and efficacy of the first and second generation DES in STEMI.

Edge Vascular Response After Polymer-Free vs. Polymer-Based Paclitaxel-Eluting Stent Implantation

Abstract: BACKGROUND It is unknown if lack of polymer can provoke a different edge response in drug-eluting stents. The aim of this study was to compare edge vascular response between polymer-free paclitaxel-eluting stent (PF-PES) and polymer-based paclitaxel-eluting stents (PB-PES). METHODS AND RESULTS: A total of 165 eligible patients undergoing percutaneous coronary intervention were prospectively randomized 1:1 to receive either PF-PES or PB-PES. Those patients with paired intravascular ultrasound (IVUS) after procedure and at 9-month follow-up were included in this analysis.Seventy-six patients with 84 lesions, divided into PB-PES (38 patients, 41 lesions) and PF-PES groups (38 patients, 43 lesions) had paired post-procedure and 9-month follow-up IVUS and were therefore included in this substudy. There was a significant lumen decrease at the proximal edge of PF-PES (from 9.02±3.06 mm(2)to 8.47±3.05 mm(2); P=0.040), and a significant plaque increase at the distal edges of PF-PES (from 4.39±2.73 mm(2)to 4.78±2.63 mm(2); P=0.004). At the distal edge there was a significant plaque increase in the PF-PES compared to PB-PES (+8.0% vs. -0.6%, respectively; P=0.015) with subsequent lumen reduction (-5.2% vs. +6.0%, respectively; P=0.024). CONCLUSIONS PF-PES had significant plaque increase and lumen reduction at the distal edge as compared to PB-PES, probably due to difference in polymer-based drug-release kinetics between the 2 platforms.

Can the vicious cycle of obscure or intractable gastrointestinal bleeding be broken in patients with atrial fibrillation subject to anticoagulant therapy?: the role of percutaneous left atrial appendage closure

Abstract: Gastrointestinal bleeding of obscure origin or with an intractable cause is particularly common in patients with atrial fibrillation subject to oral anticoagulant therapy. This condition is highly recurrent and therefore gives rise to high morbidity and mortality rates, thus entailing a vicious cycle that is difficult to solve.Percutaneous left atrial appendage closure has become a therapeutic alternative for patients with atrial fibrillation and a contraindication for oral anticoagulation. This technique would allow the discontinuation of oral anticoagulants, thus helping to reduce the risk for gastrointestinal bleeding, and would also be protective against embolic events in this group of patients, thereby eventually breaking this vicious cycle.We report our experience with percutaneous left atrial appendage closure in the management of patients with atrial fibrillation who are subject to oral anticoagulation therapy and suffer from obscure or intractable gastrointestinal bleeding.

Nitric-oxide coated bioactive titanium stents: safer and more effective than second-generation drug-eluting stents?

Abstract: interest has been renewed in alternative strategies and technologies to promote repair mechanisms after stent implantation. In general, a DES consists of a platform (made from different alloys) that acts as a scaffold for the vessel, a polymer coating (hardwearing and bioabsorbable) that includes certain copolymers to confer the desired degree of thromboresistance and hemocompatibility on the stent, and the drug which is released to provide the antiproliferative properties of the device. Guided by the above general considerations, a nitric-oxide coated bioactive stent (NO-BAS, Titan-2, Hexacath; Paris, France) was developed. Although not a DES, NO-BASs have been presented as a safe and feasible alternative to bare-metal stents. 3

Acute myocardial infarction, primary percutaneous coronary intervention and stent thrombosis in heart transplanted patient: Potential role of elevated coagulation factor VIII

Abstract: Elevated factor VIII levels have been established as thrombotic risk factor. In this case report, we describe a 51 years old patient with a history of heart transplantation and acute myocardial infarction, treated by stent implantation who presented with sub-acute stent thrombosis. Elevated factor VIII levels were detected as most plausible cause of this thrombotic event. A review of the literature is also performed.