Felipe Hernández

Drug-Eluting Stent Thrombosis Results From the Multicenter Spanish Registry ESTROFA (Estudio ESpañol sobre TROmbosis de stents FArmacoactivos)

OBJECTIVES This study sought to assess the incidence, predictors, and outcome of drug-eluting stent(DES) thrombosis in real-world clinical practice. BACKGROUND The DES thromboses in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications. METHODS We designed a large-scale, nonindustry-linked multicentered registry, with 20 centers in Spain. The participant centers provided follow-up data for their patients treated with DES, reporting a detailed standardized form in the event of any angiography-documented DES-associated thrombosis occurring. RESULTS Of 23,500 patients treated with DES, definite stent thrombosis(ST) developed in 301: 24 acute, 125 subacute, and 152 late. Of the late, 62 occurred >1 year(very late ST). The cumulative incidence was 2% at 3 years. Antiplatelet treatment had been discontinued in 95 cases(31.6%). No differences in incidences were found among stent types. Independent predictors for subacute ST analyzed in a subgroup of 14,120 cases were diabetes, renal failure, acute coronary syndrome, ST-segment elevation myocardial infarction, stent length, and left anterior descending artery stenting, and for late ST were ST-segment elevation myocardial infarction, stenting in left anterior descending artery, and stent length. Mortality at 1-year follow-up was 16% and ST recurrence 4.6%. Older age, left ventricular ejection fraction <45%, nonrestoration of Thrombolysis In Myocardial Infarction flow grade 3, and additional stenting were independent predictors for mortality. CONCLUSIONS The cumulative incidence of ST after DES implantation was 2% at 3 years. No differences were found among stent types. Patient profiles differed between early and late ST. Short-term prognosis is poor, especially when restoration of normal flow fails.

Prospective application of pre-defined intravascular ultrasound criteria for assessment of intermediate left main coronary artery lesions results from the multicenter LITRO study.

OBJECTIVES This study is a prospective validation of 6 mm(2) as a minimum lumen area (MLA) cutoff value for revascularization of left main coronary artery (LMCA) lesions. BACKGROUND Lesions involving the LMCA are prognostically relevant. Angiography has important limitations in the evaluation of LMCA lesions with intermediate severity. An MLA of 6 mm(2) assessed by intravascular ultrasound has been proposed as a cutoff value to determine lesion severity, but there are no large studies evaluating the prospective application and safety of this approach. METHODS We have designed a multicenter, prospective study. Consecutive patients with intermediate lesions in unprotected LMCA were evaluated with intravascular ultrasound. An MLA <6 mm(2) was used as criterion for revascularization. RESULTS A total of 354 patients were included in 22 centers. LMCA revascularization was performed in 90.5% (152 of 168) of patients with an MLA <6 mm(2) and was deferred in 96% (179 of 186) of patients with an MLA of 6 mm(2) or more. A large scatter was observed between both groups regarding angiographic parameters. In a 2-year follow-up period, cardiac death-free survival was 97.7% in the deferred group versus 94.5% in the revascularized group (p = 0.5), and event-free survival was 87.3% versus 80.6%, respectively (p = 0.3). In the 2-year period, only 8 (4.4%) patients in the deferred group required subsequent LMCA revascularization, none with an infarction. CONCLUSIONS Angiographic measurements are not reliable in the assessment of intermediate LMCA lesions. An MLA of 6 mm(2) or more is a safe value for deferring revascularization of the LMCA, given the application of the clinical and angiographic inclusion criteria used in this study.

Thrombosis of Second-Generation Drug-Eluting Stents in Real Practice: Results From the Multicenter Spanish Registry ESTROFA-2 (Estudio Español Sobre Trombosis de Stents Farmacoactivos de Segunda Generacion-2)

OBJECTIVES This study sought to evaluate second-generation drug-eluting stent (DES) thrombosis in clinical practice. BACKGROUND First-generation DES are associated with a significant incidence of late thrombosis. There is paucity of data regarding real practice late thrombosis incidence and predictors with second-generation DES, zotarolimus-eluting stent (ZES), and everolimus-eluting stents (EES). METHODS A prospective, large-scale, non-industry-linked multicenter registry was designed. Complete clinical-procedural data and systematic follow-up of all patients treated with these stents was reported in a dedicated registry supported by the Spanish Working Group on Interventional Cardiology. RESULTS From 2005 to 2008, 4,768 patients were included in 34 centers: 2,549 treated with ZES, and 2,219 with EES. The cumulative incidence of definite/probable thrombosis for ZES was 1.3% at 1 year and 1.7% at 2 years and for EES 1.4% at 1 year and 1.7% at 2 years (p = 0.8). The increment of definite thrombosis between the first and second year was 0.2% and 0.25%, respectively. In a propensity score analysis, the incidence remained very similar. Ejection fraction (adjusted hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.95 to -0.99; p = 0.008), stent diameter (adjusted HR: 0.37; 95% CI: 0.17to 0.81; p = 0.01) and bifurcations (adjusted HR: 2.1; 95% CI: 1.14 to 3.7; p = 0.02) emerged as independent predictors of thrombosis. In the subgroup of patients with bifurcations, the use of ZES was independently associated with a higher thrombosis rate (adjusted HR: 4; 95% CI: 1.1 to 13; p = 0.03). CONCLUSIONS In a real practice setting, the incidence of thrombosis at 2 years with ZES and EES was low and quite similar. The incidence of very late thrombosis resulted lower than was reported in registries of first-generation DES. In the subset of bifurcations, the use of ZES significantly increased the risk of thrombosis.

A Prospective Randomized Trial of Everolimus-Eluting Stents Versus Bare-Metal Stents in Octogenarians: The XIMA Trial (Xience or Vision Stents for the Management of Angina in the Elderly)

OBJECTIVES The aim of this study was to determine whether drug-eluting stents (DES) are superior to bare-metal stents (BMS) in octogenarian patients with angina. BACKGROUND Patients ≥80 years of age frequently have complex coronary disease warranting DES but have a higher risk of bleeding from prolonged dual antiplatelet therapy. METHODS This multicenter randomized trial was conducted in 22 centers in the United Kingdom and Spain. Patients ≥80 years of age underwent stent placement for angina. The primary endpoint was a 1-year composite of death, myocardial infarction, cerebrovascular accident, target vessel revascularization, or major hemorrhage. RESULTS In total, 800 patients (83.5 ± 3.2 years of age) were randomized to BMS (n = 401) or DES (n = 399) for treatment of stable angina (32%) or acute coronary syndrome (68%). Procedural success did not differ between groups (97.7% for BMS vs. 95.4% for DES; p = 0.07). Thirty-eight percent of patients had ≥2-vessel percutaneous coronary intervention, and 66% underwent complete revascularization. Patients who received BMS had shorter stent implants (24.0 ± 13.4 mm vs. 26.6 ± 14.3 mm; p = 0.01). Rates of dual antiplatelet therapy at 1 year were 32.2% for patients in the BMS group and 94.0% for patients in the DES group. The primary endpoint occurred in 18.7% of patients in the BMS group versus 14.3% of patients in the DES group (p = 0.09). There was no difference in death (7.2% vs. 8.5%; p = 0.50), major hemorrhage (1.7% vs. 2.3%; p = 0.61), or cerebrovascular accident (1.2% vs. 1.5%; p = 0.77). Myocardial infarction (8.7% vs. 4.3%; p = 0.01) and target vessel revascularization (7.0% vs. 2.0%; p = 0.001) occurred more often in patients in the BMS group. CONCLUSIONS BMS and DES offer good clinical outcomes in this age group. DES were associated with a lower incidence of myocardial infarction and target vessel revascularization without increased incidence of major hemorrhage. (Xience or Vision Stent-Management of Angina in the Elderly [XIMA]; ISRCTN92243650).

Two-year clinical outcome from the Iberian registry patients after left atrial appendage closure

Aims The aim of this study was to observe the percentage of thromboembolic and haemorrhagic events over a 2-year follow-up in patients with non-valvular atrial fibrillation (NVAF) undergoing closure of the left atrial appendage (LAA) with an occlusion device. Observed events and CHADS2 (congestive heart failure, hypertension, age, diabetes, stroke history), CHA2DS2-VASc (also adding: vascular disease and sex) and HAS-BLED (hypertension, abnormal liver/renal function, stroke history, bleeding predisposition, labile international normalised ratios, elderly, drugs/alcohol use)-predicted events were compared. Methods LAA closure with an occlusion device was performed in 167 NVAF patients contraindicated for oral anticoagulants and recruited from 12 hospitals between 2009 and 2013. At least two transoesophageal echocardiograms were performed in the first 6 months postimplantation. Antithrombotics included clopidogrel and aspirin. Patients were monitored for death, stroke, major and relevant bleeding and hospitalisation for concomitant conditions. Mean age was 74.68±8.58, median follow-up was 24 months, 5.38% had intraoperative complications and implantation was successful in 94.6% of subjects. Mortality during follow-up was 10.8%, mostly (9.5%) non-cardiac related. Bleeding occurred in 10.1% of subjects, 5.7% major and 4.4% minor though relevant, and 4.4% suffered stroke. Major bleeding and stroke/transient ischaemic attack events within 2 years (annual event rates, 290 patients/year) were less frequent than expected from CHADS2 (2.4% vs 9.6%), CHA2DS2-VASc (2.4% vs 8.3%) and HAS-BLED (3.1% vs 6.6%) risk scores (p<0.001, p=0.003, p=0.047, respectively). Conclusions LAA closure with an occlusion device in patients contraindicated for oral anticoagulants is a therapeutic option associated with fewer thromboembolic and haemorrhagic events than expected from risk scores, particularly in the second year postimplantation.

Spanish Cardiac Catheterization and Coronary Intervention Registry. 23rd Official Report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2013)

INTRODUCTION AND OBJECTIVES The Working Group on Cardiac Catheterization and Interventional Cardiology presents its yearly report on the data from the registry of the activity in Spain corresponding to 2013. METHODS The centers introduce their data online voluntarily and the information is analyzed by the Steering Committee of the Working Group on Cardiac Catheterization. RESULTS In 2013, 104 hospitals sent their data (72 public centers and 32 private). In all, 136 715 diagnostic studies were performed (120 358 coronary angiograms), with a slight decrease with respect to 2012, a reduction that was also observed in the rate, which was 2944 diagnostic studies per million population. A total of 65 912 interventional procedures were carried out during a phase of stability, for a rate of 1419 interventions per million population. Other techniques included the implantation of 99 417 stents and 1384 biodegradable intracoronary devices (64% of them drug-eluting devices). There were 18 337 procedures in acute myocardial infarction, for an increase of 7% with respect to 2012 and representing 27.8% of all the percutaneous coronary interventions. Radial access was the approach used in 71% of the diagnostic procedures and in 65% of the interventional procedures. The performance of renal denervation has nearly doubled with respect to 2012. For the first time, more than 1000 transcatheter aortic valve implantation procedures were carried out in 1 year, although the frequency increased only slightly (23%). CONCLUSIONS There continued to be a slight increase in the activity in cardiac catheterization in association with ST-segment elevation myocardial infarction, whereas, with the exception of recently introduced, highly specific procedures, the use of the remainder of the procedures, among them transcatheter aortic valve implantation, leveled off.

Comparison of Paclitaxel-Eluting Stents (Taxus) and Everolimus-Eluting Stents (Xience) in Left Main Coronary Artery Disease With 3 Years Follow-Up (from the ESTROFA-LM Registry)

Evidence regarding therapy with drug-eluting stents in the left main coronary artery (LM) is based mostly on trials performed with first-generation drug-eluting stents. The aim of this study was to evaluate long-term clinical outcomes after treatment for unprotected LM disease with paclitaxel-eluting stents (PES) and everolimus-eluting stents (EES). The ESTROFA-LM is a multicenter retrospective registry including consecutive patients with unprotected LM disease treated with PES or EES. A total of 770 patients have been included at 21 centers, 415 with treated PES and 355 with EES. Treatment with 2 stents was more frequent with PES (17% vs 10.4%, p = 0.007), whereas intravascular ultrasound was more frequently used with EES (35.2% vs 26%, p = 0.006). The 3-year death and infarction survival rates were 86.1% for PES and 87.3% for EES (p = 0.50) and for death, infarction, and target lesion revascularization were 83.6% versus 82% (p = 0.60), respectively. Definite or probable thrombosis was 1.6% for PES and 1.4% for EES (p = 0.80). The use of 2 stents, age, diabetes, and acute coronary syndromes were independent predictors of mortality. In the subgroup of distal lesions, the use of intravascular ultrasound was an independent predictor of better outcome. Comparison of propensity score-matched groups did not yield differences between the 2 stents. In conclusion, the results of this multicenter registry show comparable safety and efficacy at 3 years for PES and EES in the treatment of LM disease. The use of bifurcation stenting techniques in distal lesions was a relevant independent predictor for events. The use of intravascular ultrasound appears to have a positive impact on patients treated for LM distal disease.

Acute coronary embolism: angiographic diagnosis and treatment with primary angioplasty.

Acute coronary embolism is rarely diagnosed and it may explain why normal coronary arteries are found after or even before an acute coronary event in patients with thromboembolic risk factors. Emergency coronary angiography was performed in three patients with prior normal coronary arteries and an acute myocardial infarction, followed by primary angioplasty with low‐pressure balloon inflations plus stenting and combined antiaggregation with aspirin, clopidogrel, and abciximab to disrupt the thrombi and protect distal circulation from microemboli. Angiographic success was achieved in 100%, and 6‐month follow‐up has been uneventful on oral anticoagulation and antiaggregation. Cathet Cardiovasc Intervent 2002;55:491–494.

Spanish Cardiac Catheterization and Coronary Intervention Registry. 22nd Official Report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2012)

INTRODUCTION AND OBJECTIVES The Working Group on Cardiac Catheterization and Interventional Cardiology presents the yearly report on the data collected for the Spanish registry. METHODS Institutions provided their data voluntarily (online) and the information was analyzed by the Working Groups Steering Committee. RESULTS Data were provided by 109 hospitals (71 public and 38 private) that mainly treat adults. There were 136,912 diagnostic procedures, 120, 441 of which were coronary angiograms, slightly fewer than the year before, with a rate of 2979 diagnostic studies per million population. Percutaneous coronary interventions increased slightly to 65,909 procedures, for a rate of 1434 interventions per million population. Of the 99,110 stents implanted, 62% were drug-eluting stents. In all, 17,125 coronary interventions were carried out during the acute phase of myocardial infarction, 10.5% more than in 2011, representing 25.9% of the total number of coronary interventions. The most frequently performed intervention for adult congenital heart disease was atrial septal defect closure (292 procedures). The use of percutaneous mitral valvuloplasty continued to decline (258 procedures) and percutaneous aortic valve implantations increased by only 10% in 2012. CONCLUSIONS In 2012, the only increase in hemodynamic activity occurred in the field of ST-elevation myocardial infarction, and the increasing trend had slowed for percutaneous aortic valve implantation and other procedures affecting structure.

Complicaciones del acceso femoral en el cateterismo cardíaco: impacto de la angiografía femoral sistemática previa y la hemostasia con tapón de colágeno VasoSeal-ES®

Introduccion y objetivos.Dado el uso generalizado del acceso femoral y del material hemostatico, se plantea realizar la angiografia femoral sistematica y la hemostasia con VasoSeal-ES