Publications by authors named "Imanol Otaegui"

23 Publications

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Predictors of cardiovascular outcomes after surgery in severe tricuspid regurgitation: clinical, imaging and hemodynamic prospective study.

Rev Esp Cardiol (Engl Ed) 2020 Oct 21. Epub 2020 Oct 21.

Departamento de Cardiología, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.

Introduction And Objectives: Severe tricuspid regurgitation (TR) is a prevalent valve disease with a high mortality rate. Current guidelines do not define specific thresholds at which patients should be considered for surgery or percutaneous procedures. Thus, patients are usually referred for intervention at a late stage of the disease. This study aimed to assess predictors of cardiovascular outcomes in a prospective cohort of patients with severe TR referred for surgery.

Methods: This was an observational, prospective, nonrandomized study. All patients underwent surgery for severe TR based on current clinical guidelines. Complete anamnesis, blood test, echocardiogram, cardiovascular magnetic resonance and right and left catheterization were performed. Patients were followed up in the outpatient department and a combined endpoint (hospitalization for heart failure and cardiovascular mortality) was registered.

Results: Forty-three consecutive patients were included (age: 66.9 ± 9.6 years, 67.4% female). Tricuspid annuloplasty was performed in all patients. After a median follow-up of 38 months, 12 patients (27.9%) showed the combined endpoint and 7 (16.3%) died. Above all clinical, blood and imaging data, the indexed right ventricular end-diastolic volume constituted the best predictor of the combined endpoint (HR, 1.1; P = .02) and cardiovascular mortality (HR, 1.1; P = .05). Furthermore, indexed right ventricular end-diastolic volume was associated with TR recurrence after surgery, with no impact on clinical outcomes.

Conclusions: In patients with severe TR referred for surgery, right ventricular remodeling assessed by cardiovascular magnetic resonance constituted the best independent predictor of cardiovascular outcomes at follow-up.
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http://dx.doi.org/10.1016/j.rec.2020.09.008DOI Listing
October 2020

Effect of COMBinAtion therapy with remote ischemic conditioning and exenatide on the Myocardial Infarct size: a two-by-two factorial randomized trial (COMBAT-MI).

Basic Res Cardiol 2021 Jan 25;116(1). Epub 2021 Jan 25.

Cardiology Department, Vall D'Hebron Institut de Recerca (VHIR), Vall D'Hebron Hospital Universitari, Vall D'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Passeig Vall d'Hebron 119-129, 08035, Barcelona, Spain.

Remote ischemic conditioning (RIC) and the GLP-1 analog exenatide activate different cardioprotective pathways and may have additive effects on infarct size (IS). Here, we aimed to assess the efficacy of RIC as compared with sham procedure, and of exenatide, as compared with placebo, and the interaction between both, to reduce IS in humans. We designed a two-by-two factorial, randomized controlled, blinded, multicenter, clinical trial. Patients with ST-segment elevation myocardial infarction receiving primary percutaneous coronary intervention (PPCI) within 6 h of symptoms were randomized to RIC or sham procedure and exenatide or matching placebo. The primary outcome was IS measured by late gadolinium enhancement in cardiac magnetic resonance performed 3-7 days after PPCI. The secondary outcomes were myocardial salvage index, transmurality index, left ventricular ejection fraction and relative microvascular obstruction volume. A total of 378 patients were randomly allocated, and after applying exclusion criteria, 222 patients were available for analysis. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. IS was similar between groups for the RIC (24 ± 11.8% in the RIC group vs 23.7 ± 10.9% in the sham group, P = 0.827) and the exenatide hypotheses (25.1 ± 11.5% in the exenatide group vs 22.5 ± 10.9% in the placebo group, P = 0.092). There were no effects with either RIC or exenatide on the secondary outcomes. Unexpected adverse events or side effects of RIC and exenatide were not observed. In conclusion, neither RIC nor exenatide, or its combination, were able to reduce IS in STEMI patients when administered as an adjunct to PPCI.
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http://dx.doi.org/10.1007/s00395-021-00842-2DOI Listing
January 2021

First in man evaluation of a sirolimus-eluting stent with abluminal fluoropolymeric/triflusal coating with ultrathin struts by OCT at 9 months follow up. The PROMETHEUS study.

Cardiovasc Revasc Med 2020 Dec 29. Epub 2020 Dec 29.

Hospital Marques de Valdecilla, IDIVAL, Santander, Spain.

Objectives: We sought to investigate stent healing and neointimal hyperplasia with ihtDEStiny drug-eluting stent (DES) by optical coherence tomography (OCT) examination conducted 9 months after implantation.

Background: The currently used DES present certain features that have been linked separately to their better performance in terms of efficacy and safety.

Methods: First-in-man, prospective and multicenter study including patients treated with ihtDEStiny stent undergoing OCT examination at 9 months follow up. The ihtDEStiny stent is a sirolimus eluting stent with an oval shape ultrathin struts (68 μm) and an abluminal coating of a fluoropolymer containing the antiplatelet agent triflusal. Primary endpoint was the percentage of obstruction of the in-stent volume by the neointima.

Results: In 58 patients (63 lesions) in-stent late lumen loss was 0.11 ± 0.23 mm (95% CI 0.05-0.16) with only in 6% of stents being > 0.5 mm and in-segment binary stenosis was 1.6%. In OCT mean neointima volume obstruction was 10.5 ± 6.9% with a mean neointima thickness of 110.9 ± 89.8 μm. The proportion of uncovered struts was 2.5%, malapposed struts 1.1% and malapposed/uncovered struts 0.7% and no subclinical thrombi detected. Mean incomplete stent apposition area was 0.1 ± 0.1 mm. At 12 months target lesion revascularization rate was 3% and no stent thrombosis was reported.

Conclusions: In this study the ihtDEStiny stent has shown a very low degree of neointimal proliferation associated with a low rate of uncovered/malapposed struts and total absence of subclinical thrombi at 9 months follow up.
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http://dx.doi.org/10.1016/j.carrev.2020.12.025DOI Listing
December 2020

Comparison of one year outcomes between the ihtDEStiny BD stent and the durable polymer everolimus and zotarolimus eluting stents. A propensity score matched analysis.

Cardiovasc Revasc Med 2020 Oct 3. Epub 2020 Oct 3.

Clinica Universitaria de Navarra, Madrid, Spain.

Objectives: We sought to evaluate clinical outcomes in patients treated with the drug-eluting stent ihtDEStiny BD.

Background: The ihtDEStiny BD stent is a metallic sirolimus eluting stent with a biodegradable polymer with both drug and polymer coating the abluminal surface of the stent and balloon.

Methods: In this study, the clinical outcomes of a multicenter prospective registry of patients treated with this stent (DEStiny group) were analyzed and compared with those of a control group of patients treated with durable polymer everolimus or zotarolimus eluting stents (CONTROL group) paired by propensity score matching. Primary outcome was the target vessel failure (TVF) at 12 months defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target vessel revascularization (TVR).

Results: A total of 350 patients were included in the DESTtiny group. The control group consisted initially of 1368 patients, but after matching (1:1) 350 patients were selected as CONTROL group. The baseline clinical, angiographic and procedural characteristics were quite comparable in both groups. At 12 months follow up the TVF was 6.6% in DEStiny group and 6.3% in CONTROL group (p = 0.8). No differences were observed for any of the individual components of the primary endpoint: cardiac death 1.1% vs. 1.4%, TV-MI 3.4% vs. 3.7% and TVR 2.6% vs. 2.3% respectively.

Conclusions: The use of ihtDEStiny stent in real practice is associated with a clinical performance at 12 months follow up that appears to be non-inferior to the most widely used and largely evidence supported durable polymer drug eluting stents. A longer follow up is warranted.
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http://dx.doi.org/10.1016/j.carrev.2020.09.046DOI Listing
October 2020

Longitudinal strain in remote non-infarcted myocardium by tissue tracking CMR: characterization, dynamics, structural and prognostic implications.

Int J Cardiovasc Imaging 2021 Jan 2;37(1):241-253. Epub 2020 Jun 2.

Hospital Clínico Universitario de Valencia, Department of Cardiology, Instituto de Investigación Sanitaria del Hospital Clínico Universitario de Valencia (INCLIVA), University of Valencia, Blasco Ibanez 17, 46010, Valencia, Spain.

Purpose: In ST-segment elevation myocardial infarction (STEMI) patients, longitudinal strain (LS) in remote non-infarcted myocardium (RNM) has not yet been characterized by tissue tracking (TT) cardiovascular magnetic resonance (CMR). In STEMI patients, we aimed to characterize RNM-LS by TT-CMR and to assess both its dynamics and its structural and prognostic implications.

Methods: We recruited 271 patients with a first STEMI studied with TT-CMR 1 week after infarction. Of these patients, 145 underwent 1-week and 6-month TT-CMR and were used to characterize both the dynamics and the short-term and long-term structural implications of RNM-LS. Based on previously validated data, RNM areas were defined depending on the culprit coronary artery.

Results: Reduced RNM-LS at 1 week (n = 70, 48%) was associated with larger infarct size and more depressed left ventricular ejection fraction (LVEF) at both the 1-week and 6-month TT-CMR (p value < 0.001). Late normalization of RNM-LS was frequent (28/70, 40%) and independently related to late recovery of LVEF (p value = 0.002). Patients with reduced RNM-LS at 1-week TT-CMR had more major adverse cardiac events (death, heart failure or re-infarction) in both the 271 patients included in the study group (26% vs. 11%, p value = 0.002) and in an external validation cohort made up of 177 STEMI patients (57% vs. 13%, p value < 0.001).

Conclusion: After STEMI, reduced RNM-LS by TT-CMR is common and is associated with more severe short- and long-term structural damage. There is a beneficial tendency towards recovery of RNM-LS that parallels late recovery of LVEF. More events occur in patients with reduced RNM-LS.
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http://dx.doi.org/10.1007/s10554-020-01890-wDOI Listing
January 2021

Unrestricted use of polymer-free sirolimus eluting stents in routine clinical practice.

Medicine (Baltimore) 2020 Feb;99(8):e19119

Städtische Kliniken Esslingen, Esslingen, Germany.

Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population.Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible.In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%).PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.
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http://dx.doi.org/10.1097/MD.0000000000019119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034709PMC
February 2020

Device specificity of vascular healing following implantation of bioresorbable vascular scaffolds and bioabsorbable polymer metallic drug-eluting stents in human coronary arteries: the ESTROFA OCT BVS vs. BP-DES study.

EuroIntervention 2018 Dec 20;14(12):e1295-e1303. Epub 2018 Dec 20.

Department of Interventional Cardiology, Hospital Marques de Valdecilla, IDIVAL, Santander, Spain.

Aims: We sought to compare vascular healing with bioresorbable everolimus-eluting vascular scaffolds (BVS) and drug-eluting stents with bioabsorbable polymers (BP-DES) at six and 12 months both implanted in the same patients.

Methods And Results: This was a multicentre and prospective study including patients with at least two comparable lesions to treat. In every patient both BVS and BP-DES (SYNERGY, Orsiro or BioMatrix Flex) were implanted by lesion randomisation. Patients included were evaluated with optical coherence tomography at six or 12 months (2:1). Finally, 68 patients had an examination at six months and 27 patients at 12 months. The rates of uncovered struts at six months were 1.7±3.2% for BVS and 5.3±5.6% for BP-DES (p=0.0001), and at 12 months 0.48±0.72% and 4.8±5%, respectively (p=0.001). Rates of strut malapposition were significantly lower with BVS. There was no significant intra-patient correlation with BP-DES/BVS for endpoints. Evaginations were more frequent and larger with BVS. Discontinuities in BVS were observed in 19.4% at six months and 14.3% at 12 months.

Conclusions: Vascular healing with BVS and BP-DES could be more device-specific than patient-specific. At follow-up, BVS presented fewer uncovered or non-apposed struts than BP-DES but more frequent and larger evaginations. Discontinuities in BVS were relatively frequent at both time points.
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http://dx.doi.org/10.4244/EIJ-D-17-00952DOI Listing
December 2018

Area at risk and collateral circulation in a first acute myocardial infarction with occluded culprit artery. STEMI vs non-STEMI patients.

Int J Cardiol 2018 05 31;259:14-19. Epub 2018 Jan 31.

Unitat Coronària, Servei de Cardiologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.

Background: It is unclear why among patients with first acute myocardial infarction and an occluded culprit artery only some present ST segment elevation. In fact, there is no study that compares the angiographic area at risk and the collateral circulation in first NSTEMI vs STEMI patients.

Methods And Results: 205 patients admitted for myocardial infarction with occluded culprit artery were included, 132 STEMI and 73 NSTEMI. Demographic data, the area at risk determined by the BARI score and collateral supply by the Rentrop score from the 2 groups were compared. NSTEMI patients showed lower peak Tn I than STEMI in the overall group but also in the 3 subsets with different culprit arteries (p < .001). They also presented a higher rate of left circumflex coronary artery (CFX) as culprit artery (52% vs 14%, p < .001), smaller BARI score area of the culprit artery (5.4 vs 7.6, p < .001), and higher frequency of well-developed collaterals (Rentrop score ≥ 2, 1.82 vs 0.41, p < .001). The latter was also higher in each of the 3 different culprit arteries (p = .002-<0.001) Among 38 NSTEMI patients with CFX occlusion, 20 with ≥1 mm ST depression in V2 to V4 (possible posterior infarction) showed a similar Rentrop score than the 18 with other ECG changes but lower Tn I peak (p = .012).

Conclusions: In first acute myocardial infarction with an occluded culprit artery NSTEMI patients - including those with possible posterior infarction - present smaller infarct size and higher collateral blood supply than STEMI patients in each of the 3 main culprit arteries.
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http://dx.doi.org/10.1016/j.ijcard.2018.01.047DOI Listing
May 2018

Three- and 6-month optical coherence tomographic surveillance following percutaneous coronary intervention with the Angiolite® drug-eluting stent: The ANCHOR study.

Catheter Cardiovasc Interv 2018 02 14;91(3):435-443. Epub 2017 Jul 14.

Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada.

Background: Pre-clinical results of a novel open-cell, thin strut, durable polymer, laser cut cobalt chromium sirolimus-eluting stent (Angiolite) were promising. Using quantitative optical coherence tomographic (OCT) analyses, we explored the healing characteristics of the Angiolite DES system at 3- and 6-months post implantation.

Methods: A total of 103 patients with de novo coronary lesions underwent percutaneous coronary intervention with the Angiolite DES and were randomized 1:3 into two cohorts for angiographic and OCT follow-up, with 28 and 70 patients returning for 3- or 6-month post-PCI surveillance, respectively. The primary endpoints were the 6-month rates of OCT-derived neointimal proliferation, strut coverage and incomplete strut apposition (ISA), whilst the secondary endpoints were 3-month OCT-derived measures of strut coverage and ISA, as well as 6-month quantitative coronary angiographic-derived measures [late lumen loss (LLL), binary restenosis].

Results: The Angiolite stent was successfully implanted in all patients, without periprocedural complications. At 3- and 6-months follow-up, OCT strut coverage was evident in 86.3% and 83.3% of struts, mean neointimal thickness was 73.7 ± 46.5 μm and 73.9 ± 54.3 μm, mean neo-intimal area obstruction of 5.8% ±10.3% and 4.4% ± 11.3%, and ISA rates were 1.3% ± 7.3% and 1.1% ± 6.2%, respectively. In-stent LLL at 6 months was 0.07 ± 0.37 mm, with a binary in-stent angiographic restenosis rate of 0% without any stent thrombosis, myocardial infarction or cardiovascular death, with 1 patient undergoing ischemia-driven target-lesion revascularization.

Conclusions: At 6 months, the Angiolite DES was safe with high rates of strut coverage, modest degrees of neointimal hyperplasia and very low rates of strut malapposition. These data coupled with the absence of in-stent binary restenosis and a very low 6-month in-stent LLL point towards an efficacious DES. Future studies are required to evaluate its efficacy in broader lesion subsets with longer follow-up.
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http://dx.doi.org/10.1002/ccd.27189DOI Listing
February 2018

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis: Results From a Patient-Level Pooled Analysis of the RIBS IV and V Trials.

Circ Cardiovasc Interv 2016 07;9(7)

From the Hospital Universitario de La Princesa, Madrid, Spain (F.A., T.B.); Hospital Universitario Clínico San Carlos, Madrid, Spain (M.J.P.-V., N.G., P.J.-Q., A. Cárdenas, C.F.); Fundación Interhospitalaria Investigación Cardiovascular, Madrid, Spain (M.J.P.-V.); Hospital Universitario Vall d'Hebron, Barcelona, Spain (B.G.d.B., I.O.); Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain (A.G.-T.); Hospital Universitario Infanta Cristina, Badajoz, Spain (J.-R.L.-M.); Hospital Universitario Clinic de Barcelona, Spain (M.M.); Hospital Universitario Marqués de Valdecilla, Santander, Spain (J.Z.); Hospital Universitario Virgen de las Nieves, Granada, Spain (R. Melgares); Hospital Universitario de Alicante, Spain (V. Mainar); Hospital Universitario La Paz, Madrid, Spain (R. Moreno); Hospital Universitario Virgen de la Victoria, Málaga, Spain (A.D.); Hospital Universitario Clínico de Valencia, Spain (J.S.); Hospital Universitario Son Espases, Palma de Mallorca, Spain (A.B.); Hospital Universitario Virgen de la Salud Toledo, Spain (J.M.); Hospital Universitario de Bellvitge, Barcelona, Spain (A. Cequier); and Hospital Universitario de San Pau, Barcelona, Spain (V. Martí).

Background: Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled.

Methods And Results: A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P<0.001) and diameter stenosis (23±22 versus 13±17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group.

Conclusions: This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EES provide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003479DOI Listing
July 2016

Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

JACC Cardiovasc Interv 2016 06 20;9(12):1246-1255. Epub 2016 Jun 20.

Hospital Universitario Clínico San Carlos, Madrid, Spain.

Objectives: The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR).

Background: The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown.

Methods: The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire.

Results: A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p < 0.001). At 3 years, the rates of cardiac death (2% vs. 1%), myocardial infarction (4% vs. 5%) and target vessel revascularization (9% vs. 5%) were similar in the DEB and EES arms. Importantly, however, at 3 years, the rate of target lesion revascularization was significantly lower in the EES arm (2% vs. 8%; p = 0.04; hazard ratio: 0.23; 95% confidence interval: 0.06 to 0.93). The need for "late" (>1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms.

Conclusions: The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953).
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http://dx.doi.org/10.1016/j.jcin.2016.03.037DOI Listing
June 2016

Increased von Willebrand factor, P-selectin and fibrin content in occlusive thrombus resistant to lytic therapy.

Thromb Haemost 2016 06 10;115(6):1129-37. Epub 2016 Mar 10.

Antonia Sambola, Department of Cardiology, Hospital Universitari Vall d'Hebron, P. Vall d'Hebron, 119-129, 08035 Barcelona, Spain, Tel.: +34 932746002, Fax: +34 932746063, E-mail:

Therapeutic fibrinolysis is ineffective in 40 % of ST-segment elevation acute myocardial infarction (STEMI) patients, but understanding of the mechanisms is incomplete. It was our aim to compare the composition of coronary thrombus in lysis-resistant STEMI patients with that of lysis-sensitive patients. Intracoronary thrombi (n=64) were obtained by aspiration in consecutive STEMI patients. Of them, 20 had received fibrinolysis and underwent rescue percutaneous coronary intervention (r-PCI, lysis-resistant patients) and 44 underwent primary PCI (p-PCI). Lysis-sensitivity was determined in vitro by clot permeability measurements and turbidimetric lysis in plasma of 44 patients undergoing p-PCI and 20 healthy donors. Clot-lysis sensitivity was defined as a clot-lysis time not greater than 1 SD over the mean of healthy donors. Coronary thrombus composition in 20 lysis-resistant and in 20 lysis-sensitive patients was analysed by immunofluorescence with confocal microscopy. Plasma biomarkers (P-selectin, VWF, PAI-1, t-PA, D-dimer, TF pathway markers, plasmin and CD34+) were measured simultaneously on peripheral blood. Lysis-resistant clots had higher levels of fibrin (p=0.02), P-selectin (p=0.03) and VWF (p=0.01) than lysis-sensitive clots. Among thrombi obtained ≤ 6 hours after onset of symptoms, those from lysis-resistant patients showed a higher content in fibrin than those from p-PCI patients (p=0.01). Plasma PAI-1 (p=0.02) and D-dimer levels were significantly higher (p=0.003) in lysis-resistant patients, whereas plasmin levels were lower (p=0.03). Multivariate analysis showed the content of fibrin and VWF within thrombus as predictors of thrombolysis resistance. In conclusion, coronary thrombi in STEMI patients resistant to fibrinolysis are characterised by higher fibrin, P-selectin and VWF content than lysis-sensitive thrombi.
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http://dx.doi.org/10.1160/TH15-12-0985DOI Listing
June 2016

Plasma bilirubin values on admission and ventricular remodeling after a first anterior ST-segment elevation acute myocardial infarction.

Ann Med 2016 2;48(1-2):1-9. Epub 2015 Dec 2.

a Servicio de Cardiología, Hospital Universitari Vall d'Hebron, VHIR, Universitat Autònoma de Barcelona , Barcelona , Spain ;

Introduction: Bilirubin may elicit cardiovascular protection and heme oxygenase-1 overexpression attenuated post-infarction ventricular remodeling in experimental animals, but the association between bilirubin levels and post-infarction remodeling is unknown.

Materials And Methods: In 145 patients with a first anterior ST-segment elevation acute myocardial infarction (STEMI), we assessed whether plasma bilirubin on admission predicted adverse remodeling (left ventricular end-diastolic volume [LVEDV] increase ≥20% between discharge and 6 months, estimated by magnetic resonance imaging).

Results: Patients' baseline characteristics and management were comparable among bilirubin tertiles. LVEDV increased at 6 months (P < 0.001) with respect to the initial exam, but the magnitude of this increase was similar across increasing bilirubin tertiles (10.8 [30.2], 10.1 [22.9], and 12.7 [24.3]%, P = 0.500). Median (25-75 percentile) bilirubin values in patients with and without adverse remodeling were 0.75 (0.60-0.93) and 0.73 (0.60-0.92) mg/dL (P = 0.693). Absence of final TIMI flow grade 3 (odds ratio 3.92, 95% CI 1.12-13.66) and a history of hypertension (2.04, 0.93-4.50), but not admission bilirubin, were independently associated with adverse remodeling. Bilirubin also did not predict the increase in ejection fraction at 6 months.

Conclusions: Admission bilirubin values are not related to LVEDV or ejection fraction progression after a first anterior STEMI and do not predict adverse ventricular remodeling. Key messages Bilirubin levels are inversely related to cardiovascular disease, and overexpression of heme oxygenase-1 (the enzyme that determines bilirubin production) has prevented post-infarction ventricular remodeling in experimental animals, but the association between bilirubin levels and the progression of ventricular volumes and function in patients with acute myocardial infarction remained unexplored. In this cohort of patients with a first acute anterior ST-segment elevation myocardial infarction receiving contemporary management, bilirubin levels on admission were not predictive of the changes in left ventricular volumes or ejection fraction at 6 months measured by serial cardiac magnetic resonance imaging. The data are contrary to a significant protective effect of bilirubin against post-infarction ventricular remodeling.
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http://dx.doi.org/10.3109/07853890.2015.1112027DOI Listing
December 2016

Genetic association study of coronary collateral circulation in patients with coronary artery disease using 22 single nucleotide polymorphisms corresponding to 10 genes involved in postischemic neovascularization.

BMC Cardiovasc Disord 2015 May 12;15:37. Epub 2015 May 12.

Unitat d'Anatomia i Embriologia Humanes, Departament de Patologia i Terapèutica Experimental, Facultat de Medicina, Campus de Ciències de la Salut de Bellvitge, Universitat de Barcelona, L'Hospitalet de Llobregat, Barcelona, 08907, Spain.

Background: Collateral growth in patients with coronary artery disease (CAD) is highly heterogeneous. Although multiple factors are thought to play a role in collateral development, the contribution of genetic factors to coronary collateral circulation (CCC) is largely unknown. The goal of this study was to assess whether functional single nucleotide polymorphisms (SNPs) in genes involved in vascular growth are associated with CCC.

Methods: 677 consecutive CAD patients were enrolled in the study and their CCC was assessed by the Rentrop method. 22 SNPs corresponding to 10 genes involved in postischemic neovascularization were genotyped and multivariate logistic regression models were adjusted using clinically relevant variables to estimate odds ratios and used to examine associations of allelic variants, genotypes and haplotypes with CCC.

Results: Statistical analysis showed that the HIF1A rs11549465 and rs2057482; VEGFA rs2010963, rs1570360, rs699947, rs3025039 and rs833061; KDR rs1870377, rs2305948 and rs2071559; CCL2 rs1024611, rs1024610, rs2857657 and rs2857654; NOS3 rs1799983; ICAM1 rs5498 and rs3093030; TGFB1 rs1800469; CD53 rs6679497; POSTN rs3829365 and rs1028728; and LGALS2 rs7291467 polymorphisms, as well as their haplotype combinations, were not associated with CCC (p < 0.05).

Conclusions: We could not validate in our cohort the association of the NOS3 rs1799983, HIF1A rs11549465, VEGFA rs2010963 and rs699947, and LGALS2 rs7291467 variants with CCC reported by other authors. A validated SNP-based genome-wide association study is required to identify polymorphisms influencing CCC.
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http://dx.doi.org/10.1186/s12872-015-0027-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4493944PMC
May 2015

Intracoronary injection of adenosine before reperfusion in patients with ST-segment elevation myocardial infarction: a randomized controlled clinical trial.

Int J Cardiol 2014 Dec 7;177(3):935-41. Epub 2014 Oct 7.

Cardiology Department, Vall d'Hebron Hospital, Universitat Autónoma de Barcelona, Barcelona, Spain; Research Center for Epidemiology and Public Health of the Carlos III Health Institute (CIBERESP), Spain.

Background: The effect of intracoronary adenosine (ADO) on ST-segment elevation myocardial infarction (STEMI) size and adverse remodeling is not well established.

Methods: In a double-blind trial, 201 patients with STEMI were randomized to receive percutaneous coronary intervention (PCI) within 6 hours of symptom onset, 4.5mg ADO or saline immediately prior to reperfusion. Primary end-point: percentage of total myocardial necrotic mass by cardiac magnetic resonance (CMR) 2-7 days post-reperfusion. Secondary end-points: changes in left ventricular volumes and ejection fraction (LVEF) at baseline and at 6 months.

Results: Baseline CMR could not be performed in 20 patients. Overall, no significant differences were observed between ADO and placebo regarding infarct size (20.8% vs. 22.5%; p=0.40). However, infarct size was significantly reduced (19.4% vs. 25.7%; p for interaction=0.031) in those with ischemia duration below the median (200 min). CMR at 6 months, performed in 138 patients, did not show statistically significant differences between groups in the rate of LVEF increase (3.3 units (SD 9.6) in ADO group vs. 1.5 units (SD 9) in placebo group; p=0.25). In the subgroup analysis, among patients with ischemia time below 200 min, the increase in LVEF was slightly higher with ADO (3.59% vs. 0.43%; p for interaction=0.06).

Conclusions: Although our study failed to demonstrate that intracoronary administration of ADO prior to PCI limits infarct size, in patients receiving early PCI ADO might enhance myocardial salvage and has a favorable effect on LVEF evolution, which may help to reconcile apparently contradictory results of previous studies.

Clinical Trial Registration: http://clinicaltrials.gov (NCT00781404).
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http://dx.doi.org/10.1016/j.ijcard.2014.09.203DOI Listing
December 2014

Relation of ST-segment elevation before and after percutaneous transluminal coronary angioplasty to left ventricular area at risk, myocardial infarct size, and systolic function.

Am J Cardiol 2014 Feb 23;113(4):593-600. Epub 2013 Nov 23.

Department of Cardiology, Hospital Universitari Vall d'Hebron, Vall Hebrón Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain.

Electrocardiography is an excellent tool for decision making in patients with ST elevation myocardial infarction (STEMI). However, little is known on the correlation between its dynamic changes during primary percutaneous coronary intervention (PCI) and the anatomic information provided by cardiovascular magnetic resonance. The study aimed to assess the predictive value of dynamic ST-segment changes before and after PCI on myocardial area at risk (AAR), infarct size, and left ventricular function in patients with STEMI. Eighty-five consecutive patients with a first STEMI were included. An electrocardiogram was recorded before and after PCI at 1, 24, 48, 72, and 120 hours. Sum of ST elevation (sumSTE), the number of STE, and STE resolution (resSTE) were determined. Complete resSTE was defined as ≥70% resolution, and patients were classified into 3 groups: group 1 (resSTE 1 hour after PCI) n = 39; group 2 (resSTE 120 hour after PCI) n = 27; and group 3, without resSTE (n = 19). Cardiovascular magnetic resonance was performed during hospitalization and at 6 months. Left ventricular volumes, ejection fraction, AAR, infarct size, myocardial salvage index, and microvascular obstruction were determined. Before PCI, the number of STE and sumSTE were best associated with AAR (p <0.001). After PCI, lack of resSTE (group 3) was associated with larger infarct size, MVO, and lower myocardial salvage index. However, sumSTE at 120 hours after PCI best discriminated patients with larger infarct size, ventricular volumes, and lower ejection fraction during hospitalization and at follow-up. In conclusion, admission sumSTE best correlates with AAR, whereas sumSTE at 120 hours rather than early resSTE best correlates with infarct size and left ventricular volumes during hospitalization and at 6 months.
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http://dx.doi.org/10.1016/j.amjcard.2013.11.007DOI Listing
February 2014

The rs1333049 polymorphism on locus 9p21.3 and extreme longevity in Spanish and Japanese cohorts.

Age (Dordr) 2014 Apr 28;36(2):933-43. Epub 2013 Oct 28.

Departament de Patología Mitocondrial i Neuromuscular, Institut de Recerca Hospital Universitari Vall d'Hebron, Barcelona, Spain.

The rs1333049 (G/C) polymorphism located on chromosome 9p21.3 is a candidate to influence extreme longevity owing to its association with age-related diseases, notably coronary artery disease (CAD). We compared allele/genotype distributions of rs1333049 in cases (centenarians) and controls (younger adults, without (healthy) or with CAD) in two independent cohorts: Spanish (centenarians: n = 152, 128 women, 100-111 years; healthy controls: n = 343, 212 women, age <50 years; CAD controls: n = 98, 32 women, age ≤65 years) and Japanese (centenarians: n = 742, 623 women, 100-115 years; healthy controls: n = 920, 511 women, < 60 years; CAD controls: n = 395, 45 women, age ≤65 years). The frequency of the "risk" C-allele tended to be lower in Spanish centenarians (47.0 %) than in their healthy (52.9 %, P = 0.088) or CAD controls (55.1 %, P = 0.078), and significant differences were found in genotype distributions (P = 0.034 and P = 0.045), with a higher frequency of the GG genotype in cases than in both healthy and CAD controls as well as a lower proportion of the CG genotype compared with healthy controls. In the Japanese cohort, the main finding was that the frequency of the C-allele did not differ between centenarians (46.4 %) and healthy controls (47.3 %, P = 0.602), but it was significantly lower in the former than in CAD controls (57.2 %, P < 0.001). Although more research is needed, the present and recent pioneer findings (Rejuvenation Res 13:23-26, 2010) suggest that the rs1333049 polymorphism could be among the genetic contributors to exceptional longevity in Southern European populations, albeit this association does not exist in the healthy (CAD-free) Japanese population.
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http://dx.doi.org/10.1007/s11357-013-9593-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4039251PMC
April 2014

Prognostic impact of tissue factor pathway on long-term ischemic events of ST-elevated myocardial infarction treated with a primary percutaneous coronary intervention.

Int J Cardiol 2013 Oct 1;168(3):2916-8. Epub 2013 May 1.

Cardiology Department, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain. Electronic address:

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http://dx.doi.org/10.1016/j.ijcard.2013.03.188DOI Listing
October 2013

Quantification of myocardial area at risk: validation of coronary angiographic scores with cardiovascular magnetic resonance methods.

Rev Esp Cardiol (Engl Ed) 2012 Nov 27;65(11):1010-7. Epub 2012 Jul 27.

Servicio de Cardiología, Hospital Universitario Vall d'Hebron, Universidad Autónoma de Barcelona, Barcelona, Spain.

Introduction And Objectives: Quantification of myocardial area-at-risk after acute myocardial infarction has major clinical implications and can be determined by cardiovascular magnetic resonance. The Bypass Angioplasty Revascularization Investigation Myocardial Jeopardy Index (BARI) and Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) angiographic scores have been widely used for rapid myocardial area-at-risk estimation but have not been directly validated. Our objective was to compare the myocardial area-at-risk estimated by BARI and APPROACH angiographic scores with those determined by cardiovascular magnetic resonance.

Methods: In a prospective study, cardiovascular magnetic resonance was performed in 70 patients with a first successfully-reperfused ST-segment elevation acute myocardial infarction in the first week after percutaneous coronary intervention. Myocardial area-at-risk was obtained both by analysis of T2-short tau inversion recovery sequences and calculation of infarct endocardial surface area with late enhancement sequences. These results were compared with those of BARI and APPROACH scores.

Results: BARI and APPROACH showed a statistically significant correlation with T2-short tau inversion recovery for myocardial area-at-risk estimation (BARI, intraclass correlation coefficient=0.72; P<.001; APPROACH, intraclass correlation coefficient=0.69; P<.001). Better correlations were observed for anterior acute myocardial infarction than for other locations (BARI, intraclass correlation coefficient=0.73 vs 0.63; APPROACH, intraclass correlation coefficient=0.68 vs 0.50). Infarct endocardial surface area showed a good correlation with both angiographic scores (BARI, intraclass correlation coefficient=0.72; P<.001; with APPROACH, intraclass correlation coefficient=0.70; P<.001).

Conclusions: BARI and APPROACH angiographic scores allow reliable estimation of myocardial area-at-risk in current clinical practice, particularly in anterior infarctions. Full English text available from:www.revespcardiol.org.
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http://dx.doi.org/10.1016/j.recesp.2012.04.020DOI Listing
November 2012

One-year outcomes with angiographic follow-up of paclitaxel-eluting balloon for the treatment of in-stent restenosis: insights from Spanish multicenter registry.

J Interv Cardiol 2011 Dec 15;24(6):518-28. Epub 2011 Sep 15.

Interventional Cardiology Unit, Hospital del Mar, Barcelone, Spain.

Introduction: Even in the drug-eluting stent (DES) era treatment of in-stent restenosis (ISR) is still a relatively common problem for which a satisfactory solution is yet to be found. We wished to assess the efficacy of a new paclitaxel-coated drug-eluting balloon (DEB) in the treatment of these lesions.

Methods: In this prospective multicenter registry 126 patients with ISR, treated with a new paclitaxel-eluting balloon (3.0 μg/m(2) balloon surface area), were included. All lesions were predilated using conventional balloon angioplasty. The DEB was inflated for a minimum of 60 seconds. Dual antiplatelet therapy was recommended for at least 1 month. The only exclusion criteria were acute STEMI and cardiogenic shock.

Results: Thirty-three percent of patients were diabetic and 51% presented acutely. Interestingly, 48% had ISR of DES, 54% had ISR in a small vessel, and 29% involved bifurcation lesions. The pattern of ISR was focal in 59% and the most treated artery was the left anterior descending artery (LAD). Angiographic success was 96%. In 2 centers, repeat angiography was performed in 79% and restenosis observed in 6 patients (17.6%). MACE rate at a median of 12 (6-13) months was 16.7% (4.0% cardiac death, 4.0% MI, and 12.0% TLR). There was only 1 probable thombotic event (ARC). As compared with BMS-ISR, patients with DES-ISR were more often diabetic (40 vs. 28%) and had more re-restenosis (TLR 14.8 vs. 9.2%).

Conclusion: In a real-world population, treatment of ISR (including 48% DES-ISR) with this DEB provides good mid-term results with 12% TLR at 1 year, especially in ISR pattern IC (9% MACE).
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http://dx.doi.org/10.1111/j.1540-8183.2011.00667.xDOI Listing
December 2011

Clinical and procedural evaluation of the Nile Croco® dedicated stent for bifurcations: a single centre experience with the first 151 consecutive non-selected patients.

EuroIntervention 2011 Jun;7(2):216-24

Hospital Vall Hebrón, Hospital Vall Hebrón, Barcelona, Spain.

Aims: To evaluate the feasibility and safety of the Nile Croco® coronary bifurcation stent system (Minvasys, Gennevilliers, France).

Methods And Results: The primary endpoint was to assess the acute device success and angiographic success with the use of the Nile Croco® stent system. Secondary endpoints included in-hospital and six month major cardiac events (MACE).There were 151 consecutive patients enrolled in the Nile Croco Study at Vall Hebrón Hospital. The Nile Croco® stent was successfully implanted in 144 patients (95.4%) and final angiographic success was obtained in 100% of the patients. 138 out of the 151 (91%) patients included have accomplished the six month follow-up. There was one in-hospital MACE in the 151 recruited patients. The MACE rate at six months in the 138 patients with follow-up was 14% and the ischaemia-driven TLR rate was 7.2 %.

Conclusions: The results of our Nile Croco® Study are the first to demonstrate the safety and high performance of this dedicated stent system for the treatment of bifurcation lesions. The device can be successfully implanted in more than 95% of all cases, with a high procedural success rate and low in-hospital and six month MACE rates.
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http://dx.doi.org/10.4244/EIJV7I2A36DOI Listing
June 2011