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Showing papers by "Marco Valgimigli published in 2015"



Journal ArticleDOI
TL;DR: The comparison of prasugrel at the time of Percutaneous Coronary Intervention or as Pretreatment at the Time of Diagnosis in Patients with Non-ST Elevation Myocardial Infarction was conducted by as mentioned in this paper.
Abstract: ACC : American College of Cardiology ACCOAST : Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention or as Pretreatment at the Time of Diagnosis in Patients with Non-ST Elevation Myocardial Infarction ACE : angiotensin-converting enzyme ACS : acute coronary syndromes ACT

449 citations



Journal ArticleDOI
TL;DR: Compared with aspirin alone, DAPT beyond 1 year among stabilized high-risk patients with prior MI decreases ischaemic events, including significant reductions in the individual endpoints of cardiovascular death, recurrent MI, and stroke.
Abstract: Aims Recent trials have examined the effect of prolonged dual antiplatelet therapy (DAPT) in a variety of patient populations, with heterogeneous results regarding benefit and safety, specifically with regard to cardiovascular and non-cardiovascular mortality. We performed a meta-analysis of randomized trials comparing more than a year of DAPT with aspirin alone in high-risk patients with a history of prior myocardial infarction (MI). Methods and results A total of 33 435 patients were followed over a mean 31 months among one trial of patients with prior MI (63.3% of total) and five trials with a subgroup of patients that presented with, or had a history of, a prior MI (36.7% of total). Extended DAPT decreased the risk of major adverse cardiovascular events compared with aspirin alone (6.4 vs. 7.5%; risk ratio, RR 0.78, 95% confidence intervals, CI, 0.67–0.90; P = 0.001) and reduced cardiovascular death (2.3 vs. 2.6%; RR 0.85, 95% CI 0.74–0.98; P = 0.03), with no increase in non-cardiovascular death (RR 1.03, 95% CI 0.86–1.23; P = 0.76). The resultant effect on all-cause mortality was an RR of 0.92 (95% CI 0.83–1.03; P = 0.13). Extended DAPT also reduced MI (RR 0.70, 95% CI 0.55–0.88; P = 0.003), stroke (RR 0.81, 95% CI 0.68–0.97; P = 0.02), and stent thrombosis (RR 0.50, 95% CI 0.28–0.89; P = 0.02). There was an increased risk of major bleeding (1.85 vs. 1.09%; RR 1.73, 95% CI 1.19–2.50; P = 0.004) but not fatal bleeding (0.14 vs. 0.17%; RR 0.91, 95% CI 0.53–1.58; P = 0.75). Conclusion Compared with aspirin alone, DAPT beyond 1 year among stabilized high-risk patients with prior MI decreases ischaemic events, including significant reductions in the individual endpoints of cardiovascular death, recurrent MI, and stroke. Dual antiplatelet therapy beyond 1 year increases major bleeding, but not fatal bleeding or non-cardiovascular death.

331 citations


Journal ArticleDOI
TL;DR: In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin.
Abstract: BACKGROUND Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome METHODS We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event) The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events RESULTS The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (103% and 109%, respectively; relative risk, 094; 95% confidence interval [CI], 081 to 109; P = 044), nor was the rate of net adverse clinical events (112% and 124%, respectively; relative risk, 089; 95% CI, 078 to 103; P = 012) Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (110% and 119%, respectively; relative risk, 091; 95% CI, 074 to 111; P = 034) CONCLUSIONS In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrialsgov number, NCT01433627) abstr act

322 citations


Journal ArticleDOI
16 Apr 2015-BMJ
TL;DR: Compared with a standard 12 month duration, short term DAPT after drug eluting stent implementation yields reduced bleeding with no apparent increase in ischaemic complications, and could be considered for most patients.
Abstract: ObjeCtive To assess the benefits and risks of short term ( 12 months) dual antiplatelet therapy (DAPT) versus standard 12 month therapy, following percutaneous coronary intervention with drug eluting stents. Design Meta-analysis of randomised controlled trials. Data sOurC es PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Scopus, Web of Science, Cochrane Library, and major congress proceedings, searched from 1 January 2002 to 16 February 2015. review methOD s Trials comparing short term ( 12 months) DAPT regimens with standard 12 month duration of therapy. Primary outcomes were cardiovascular mortality, myocardial infarction, stent thrombosis, major bleeding, and all cause mortality. results 10 randomised controlled trials (n=32 287) were included. Compared to 12 month DAPT, a short term course of therapy was associated with a significant reduction in major bleeding (odds ratio 0.58 (95% confidence interval 0.36 to 0.92); P=0.02) with no significant differences in ischaemic or thrombotic outcomes. Extended versus 12 month DAPT yielded a significant reduction in the odds of myocardial infarction (0.53 (0.42 to 0.66); P 12 months) could be considered. The increase in all cause but not cardiovascular death with extended DAPT requires further investigation.

286 citations


Journal ArticleDOI
TL;DR: Platelet reactivity assessment during thienopyridine-type P2Y12-inhibitors identifies PCI-treated patients at higher risk for mortality and ST (HPR) or at an elevated risk for bleeding (LPR).
Abstract: Aims Although platelet reactivity during P2Y12-inhibitors is associated with stent thrombosis (ST) and bleeding, standardized and clinically validated thresholds for accurate risk stratification after percutaneous coronary intervention (PCI) are lacking. We sought to determine the prognostic value of low platelet reactivity (LPR), optimal platelet reactivity (OPR), or high platelet reactivity (HPR) by applying uniform cut-off values for standardized devices. Methods and results Authors of studies published before January 2015, reporting associations between platelet reactivity, ST, and major bleeding were contacted for a collaborative analysis using consensus-defined, uniform cut-offs for standardized platelet function assays. Based on best available evidence for each device (exploratory studies), LPR–OPR–HPR categories were defined as 208 PRU for VerifyNow, 46 U for the Multiplate analyser and 50% for VASP assay. Seventeen studies including 20 839 patients were used for the analysis; 97% were treated with clopidogrel and 3% with prasugrel. Patients with HPR had significantly higher risk for ST [risk ratio (RR) and 95% CI: 2.73 (2.03–3.69), P < 0.00001], yet a slight reduction in bleeding [RR: 0.84 (0.71–0.99), P = 0.04] compared with those with OPR. In contrast, patients with LPR had a higher risk for bleeding [RR: 1.74 (1.47–2.06), P < 0.00001], without any further benefit in ST [RR: 1.06 (0.68–1.65), P = 0.78] in contrast to OPR. Mortality was significantly higher in patients with HPR compared with other categories ( P < 0.05). Validation cohorts ( n = 14) confirmed all results of exploratory studies ( n = 3). Conclusions Platelet reactivity assessment during thienopyridine-type P2Y12-inhibitors identifies PCI-treated patients at higher risk for mortality and ST (HPR) or at an elevated risk for bleeding (LPR).

279 citations


Journal ArticleDOI
TL;DR: In this paper, the Euroscore guidelines for acute coronary syndromes are presented. But they do not specify the risk stratification of stents, angina, and stable coronary artery disease.
Abstract: Acute coronary syndromes Bare-metal stents Coronary artery bypass grafting Coronary artery disease Drug-eluting stents EuroSCORE Guidelines Heart Team Myocardial infarction Myocardial ischaemia Myocardial revascularization Medical therapy Percutaneous coronary intervention Recommendation Revascularisation Risk stratification Stents Stable angina Stable coronary artery disease ST-segment elevation myocardial infarction SYNTAX score

249 citations


Journal ArticleDOI
TL;DR: Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantations.

247 citations


Journal ArticleDOI
TL;DR: The objective of the present document is to provide some points of consensus among highly experienced operators on the most controversial steps of RA in an attempt to build the basis of a standardised and universally accepted protocol.
Abstract: The interest in rotational atherectomy (RA) has increased over the past decade as a consequence of more complex and calcified coronary stenoses being attempted with percutaneous coronary interventions. Yet adoption of RA is hampered by several factors: amongst others, by the lack of a standardised protocol. This European expert consensus document stems from the awareness of the large heterogeneity in the protocols adopted to perform rotational atherectomy. The objective of the present document is to provide some points of consensus among highly experienced operators on the most controversial steps of RA in an attempt to build the basis of a standardised and universally accepted protocol.

244 citations



01 Jan 2015
TL;DR: ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation were published by the European Society of Cardiology (ESC).
Abstract: ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation : The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC).


Journal ArticleDOI
TL;DR: Suboptimal implantation with incomplete lesion coverage, underexpansion, and malapposition comprises the main pathomechanism for both early and late BVS thrombosis, similar to metallic stent thromBosis.
Abstract: Background—As bioresorbable vascular scaffolds (BVSs) are being increasingly used in complex real-world lesions and populations, BVS thrombosis cases have been reported. We present angiographic and optical coherence tomography (OCT) findings in a series of patients treated in our center for definite bioresorbable scaffold thrombosis. Methods and Results—Up to June 2014, 14 patients presented with definite BVS thrombosis in our center. OCT was performed in 9 patients at the operator’s discretion. Angiographic and OCT findings were compared with a control group comprising 15 patients with definite metallic stent thrombosis. In the BVS group, time interval from index procedure to scaffold thrombosis ranged from 0 to 675 days. Incomplete lesion coverage by angiography was identified in 4 of 14 cases, malapposition by OCT in 5 of 9 cases, strut discontinuity in 2 of 9 cases, and underexpansion in 2 of 9 cases. Five patients had discontinued dual antiplatelet therapy, and in 3 of them discontinued dual antiplat...

Journal ArticleDOI
TL;DR: This analysis suggests that clinical presentation may be a treatment modifier with respect to DAPT duration after stenting consistent with the hypothesis that SCAD-but not ACS-patients are exposed to a significant increase in bleeding and net adverse clinical events when treated with 24-month compared with 6-month therapy.
Abstract: Aims We investigated if acute coronary syndrome (ACS) rather than stable coronary artery disease (SCAD) presentation is an outcome modifier with respect to the duration of dual-antiplatelet therapy (DAPT) in patients undergoing coronary stenting. Methods and results In the Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia (PRODIGY) trial, a total of 1465 (74.3%) patients presented ACS whereas 505 (25.7%) had SCAD and were randomized to 6- or 24-month DAPT. At 24 months, the composite of death, myocardial infarction (MI), or cerebrovascular accident (CVA) did not differ between the long- and short-term DAPT arms in both ACS (11.1 vs. 11.7%; P = 0.67) and SCAD (7.5 vs. 4.8%; P = 0.21) patients, respectively. Long-term DAPT was associated with a 75% increase of Bleeding Academic Research Consortium (BARC)-class 2, 3, or 5 bleeding in ACS [7.1 vs. 4.1%; hazard ratio (HR) 1.75, 95% confidence interval (CI) 1.11–2.74, P = 0.015; number needed to treat for harm (NNTH): 33.3] and a five-fold increase in SCAD (8.2 vs. 1.6%; HR 5.37, 95% CI 1.84–15.74, P = 0.002; NNTH: 15.1) patients, with a borderline quantitative interaction ( P INT = 0.056). As a result, net adverse cardiovascular events (death, MI, CVA, BARC class 2, 3, or 5 bleeding) were more than doubled in SCAD patients receiving 24-month DAPT, whereas they did not differ in ACS patients ( P INT = 0.024). Conclusions This analysis suggests that clinical presentation may be a treatment modifier with respect to DAPT duration after stenting consistent with the hypothesis that SCAD—but not ACS—patients are exposed to a significant increase in bleeding and net adverse clinical events when treated with 24-month compared with 6-month therapy. Trial registration clinicaltrials.gov Identifier: [NCT00611286][1]. [http://clinicaltrials.gov/ct2/show/[NCT00611286][1]?term=prodigy&rank=2][2]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00611286&atom=%2Fehj%2F36%2F20%2F1242.atom [2]: http://clinicaltrials.gov/ct2/show/NCT00611286?term=prodigy&rank=2

Journal ArticleDOI
TL;DR: Overall, bivalirudin in ACS patients is associated with a significant reduction of major bleeding compared with heparin plus routinely administered GPI, but with a marked increase in ST rates compared withHeparin with or without routine GPI.
Abstract: Objectives The aim of this meta-analysis was to compare the 30-day safety and efficacy of bivalirudin with those of heparin with or without routine administration of a glycoprotein IIb/IIIa inhibitor (GPI) in patients with acute coronary syndrome (ACS). Background Bivalirudin has been a mainstay of anticoagulation in patients with ACS compared with heparin. The extent to which trial results have been affected by the coadministration of heparin with a GPI, however, remains unclear. Methods A total of 13 randomized, controlled trials involving 24,605 patients were included. Results There was no significant difference in 30-day mortality or myocardial infarction rate with bivalirudin compared with heparin with or without routine GPI administration. A reduction of 30-day major bleeding was observed with bivalirudin compared with heparin that was significant when GPI was routinely administered (odds ratio [OR]: 0.52, 95% confidence interval [CI]: 0.45 to 0.60), p Conclusions Overall, bivalirudin in ACS patients is associated with a significant reduction of major bleeding compared with heparin plus routinely administered GPI, but with a marked increase in ST rates compared with heparin with or without GPI.

Journal ArticleDOI
TL;DR: The analysis suggests that the CRUSADE score predicts major bleeding similarly to ACUITY and better than HAS BLED in an all‐comer population with percutaneous coronary intervention and potentially identifies patients at higher risk of hemorrhagic complications when treated with a long‐term dual antiplatelet therapy regimen.
Abstract: Background Multiple scores have been proposed to stratify bleeding risk, but their value to guide dual antiplatelet therapy duration has never been appraised. We compared the performance of the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines), ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy), and HAS‐BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) scores in 1946 patients recruited in the Prolonging Dual Antiplatelet Treatment After Grading Stent‐Induced Intimal Hyperplasia Study (PRODIGY) and assessed hemorrhagic and ischemic events in the 24‐ and 6‐month dual antiplatelet therapy groups. Methods and Results Bleeding score performance was assessed with a Cox regression model and C statistics. Discriminative and reclassification power was assessed with net reclassification improvement and integrated discrimination improvement. The C statistic was similar between the CRUSADE score (area under the curve 0.71) and ACUITY (area under the curve 0.68), and higher than HAS−BLED (area under the curve 0.63). CRUSADE, but not ACUITY, improved reclassification (net reclassification index 0.39, P =0.005) and discrimination (integrated discrimination improvement index 0.0083, P =0.021) of major bleeding compared with HAS‐BLED. Major bleeding and transfusions were higher in the 24‐ versus 6‐month dual antiplatelet therapy groups in patients with a CRUSADE score >40 (hazard ratio for bleeding 2.69, P =0.035; hazard ratio for transfusions 4.65, P =0.009) but not in those with CRUSADE score ≤40 (hazard ratio for bleeding 1.50, P =0.25; hazard ratio for transfusions 1.37, P =0.44), with positive interaction ( P int=0.05 and P int=0.01, respectively). The number of patients with high CRUSADE scores needed to treat for harm for major bleeding and transfusion were 17 and 15, respectively, with 24‐month rather than 6‐month dual antiplatelet therapy; corresponding figures in the overall population were 67 and 71, respectively. Conclusions Our analysis suggests that the CRUSADE score predicts major bleeding similarly to ACUITY and better than HAS BLED in an all‐comer population with percutaneous coronary intervention and potentially identifies patients at higher risk of hemorrhagic complications when treated with a long‐term dual antiplatelet therapy regimen. Clinical Trial Registration URL: . Unique identifier: [NCT00611286][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00611286&atom=%2Fahaoa%2F4%2F12%2Fe002524.atom

Journal ArticleDOI
TL;DR: The comparison of prasugrel at the time of Percutaneous Coronary Intervention or as Pretreatment at the Time of Diagnosis in Patients with Non-ST Elevation Myocardial Infarction was conducted by.
Abstract: ACC : American College of Cardiology ACCOAST : Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention or as Pretreatment at the Time of Diagnosis in Patients with Non-ST Elevation Myocardial Infarction ACE : angiotensin-converting enzyme ACS : acute coronary syndromes ACT

Journal ArticleDOI
TL;DR: This EAPCI survey highlights considerable uncertainty within the medical community with regard to the optimal duration of DAPT after coronary stenting in the light of recent reported trial results.
Abstract: AIMS Our aim was to report on a survey initiated by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) concerning opinion on the evidence relating to dual antiplatelet therapy (DAPT) duration after coronary stenting. METHODS AND RESULTS Results from three randomised clinical trials were scheduled to be presented at the American Heart Association Scientific Sessions 2014 (AHA 2014). A web-based survey was distributed to all individuals registered in the EuroIntervention mailing list (n=15,200) both before and after AHA 2014. A total of 1,134 physicians responded to the first (i.e., before AHA 2014) and 542 to the second (i.e., after AHA 2014) survey. The majority of respondents interpreted trial results consistent with a substantial equipoise regarding the benefits and risks of an extended versus a standard DAPT strategy. Two respondents out of ten believed extended DAPT should be implemented in selected patients. After AHA 2014, 46.1% of participants expressed uncertainty about the available evidence on DAPT duration, and 40.0% the need for clinical guidance. CONCLUSIONS This EAPCI survey highlights considerable uncertainty within the medical community with regard to the optimal duration of DAPT after coronary stenting in the light of recent reported trial results. Updated recommendations for practising physicians to guide treatment decisions in routine clinical practice should be provided by international societies.

Journal ArticleDOI
TL;DR: Autores/Miembros del Grupo de Trabajo: Stephan Windecker*, Philippe Kolh* (coordinador de la EACTS) (Bélgica), Fernando Alfonso (España), Jean-Philippe Collet (Francia), Jochen Cremer (Alemania), Volkmar Falk (Suiza), Gerasimos Filippatos (Grecia)
Abstract: Autores/Miembros del Grupo de Trabajo: Stephan Windecker* (coordinador de la ESC) (Suiza), Philippe Kolh* (coordinador de la EACTS) (Bélgica), Fernando Alfonso (España), Jean-Philippe Collet (Francia), Jochen Cremer (Alemania), Volkmar Falk (Suiza), Gerasimos Filippatos (Grecia), Christian Hamm (Alemania), Stuart J. Head (Países Bajos), Peter Jüni (Suiza), A. Pieter Kappetein (Países Bajos), Adnan Kastrati (Alemania), Juhani Knuuti (Finlandia), Ulf Landmesser (Suiza), Günther Laufer (Austria), Franz-Josef Neumann (Alemania), Dimitrios J. Richter (Grecia), Patrick Schauerte (Alemania), Miguel Sousa Uva (Portugal), Giulio G. Stefanini (Suiza), David Paul Taggart (Reino Unido), Lucia Torracca (Italia), Marco Valgimigli (Italia), William Wijns (Bélgica) y Adam Witkowski (Polonia)

Journal ArticleDOI
TL;DR: Contrast‐induced acute kidney injury (CI‐AKI) is associated with poor outcome and whether this association differs in stable coronary artery disease (CAD) as compared to acute coronary syndrome (ACS) patients is unknown.
Abstract: Background: Contrast-induced acute kidney injury (CI-AKI) is associated with poor outcome. Whether this association differs in stable coronary artery disease (CAD) as compared to acute coronary syndrome (ACS) patients is unknown. Definitions and Methods: PRODIGY trial patients were defined as stable CAD or ACS according to the initial presentation. CI-AKI was defined as an increase (D) of serum creatinine (SCr) � 25% above baseline. Two endpoints were considered: all-cause death and the composite of death, stroke, or myocardial infarction (MI). The interaction between CI-AKI, clinical setting, and the impact of increasing DSCr% cut-offs were also explored. Results: Two thousand three patients were enrolled in the PRODIGY trial, 85 patients were excluded for missing SCr data, leading to a population of 1,918 patients. CI-AKI incidence was 6.7% in stable CAD and 12.2% in ACS patients. CI-AKI was associated with all-cause mortality [adjusted hazard ratio (aHR) of 2.05, 95% confidence interval (CI) 1.38–3.05, P 0.001]. Conclusions: In a large, contemporary, all-comers percutaneous coronary intervention population, CI-AKI was associated with an increased risk of all-cause death and the composite of death, stroke, or MI. While CI-AKI is more common in ACS than in stable CAD patients, its adjusted prognostic impact on the composite endpoint appears to be more pronounced in patients with stable CAD. V C 2015 Wiley Periodicals, Inc.

Journal ArticleDOI
TL;DR: The Minimizing Adverse hemorrhagic events by TRansradial access site and systemic Implementation of AngioX (MATRIX) trial has been designed to test whether to minimize bleeding events by using radial access and bivalirudin will result in improved outcomes with respect to both ischemic and bleeding complications.
Abstract: Acute kidney injury (AKI) is an important complication of both diagnostic cardiac catheterization and percutaneous coronary intervention (PCI). A large body of evidence supports that AKI is related to volume of contrast used. Despite several measures are available to reduce the impact of contrast media on AKI, its incidence remains significant as other mechanisms of renal damage are involved. A new paradigm is established according to which bleeding prevention is at least as important as preventing recurrent ischemic events in the management of patients with acute coronary syndromes (ACS) undergoing an invasive approach. Periprocedural bleeding, which is consistently reduced by radial approach, is emerging as a risk factor for the development of AKI. Therefore, the role of vascular access as a measure to prevent AKI needs to be systematically assessed in randomized studies. To date, no prospective comparison on renal outcomes has been carried out in randomized trials between radial and femoral approach. The Minimizing Adverse hemorrhagic events by TRansradial access site and systemic Implementation of AngioX (MATRIX) trial (ClinicalTrials.gov identifier: NCT01433627) has been designed to test whether to minimize bleeding events by using radial access and bivalirudin, across the whole spectrum of patients with ACS undergoing PCI, will result in improved outcomes with respect to both ischemic and bleeding complications. The AKI-MATRIX sub-study will provide a unique opportunity to assess whether the advantages of radial approach may even contribute to the reduction of the risk of AKI in patients with ACS.

Journal ArticleDOI
TL;DR: In women across the clinical spectrum of CAD, STEMI was associated with a greater risk of long-term mortality, whereas the adjusted risk of mortality between UAP or NSTEMI and SAP was similar, and new-generation DESs provide improved long- term clinical outcomes irrespective of the clinical presentation in women.
Abstract: The long-term risk associated with different coronary artery disease (CAD) presentations in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is poorly characterized. We pooled patient-level data for women enrolled in 26 randomized clinical trials. Of 11,577 women included in the pooled database, 10,133 with known clinical presentation received a DES. Of them, 5,760 (57%) had stable angina pectoris (SAP), 3,594 (35%) had unstable angina pectoris (UAP) or non-ST-segment-elevation myocardial infarction (NSTEMI), and 779 (8%) had ST-segment-elevation myocardial infarction (STEMI) as clinical presentation. A stepwise increase in 3-year crude cumulative mortality was observed in the transition from SAP to STEMI (4.9% vs 6.1% vs 9.4%; p <0.01). Conversely, no differences in crude mortality rates were observed between 1 and 3 years across clinical presentations. After multivariable adjustment, STEMI was independently associated with greater risk of 3-year mortality (hazard ratio [HR] 3.45; 95% confidence interval [CI] 1.99 to 5.98; p <0.01), whereas no differences were observed between UAP or NSTEMI and SAP (HR 0.99; 95% CI 0.73 to 1.34; p = 0.94). In women with ACS, use of new-generation DES was associated with reduced risk of major adverse cardiac events (HR 0.58; 95% CI 0.34 to 0.98). The magnitude and direction of the effect with new-generation DES was uniform between women with or without ACS (pinteraction = 0.66). In conclusion, in women across the clinical spectrum of CAD, STEMI was associated with a greater risk of long-term mortality. Conversely, the adjusted risk of mortality between UAP or NSTEMI and SAP was similar. New-generation DESs provide improved long-term clinical outcomes irrespective of the clinical presentation in women.

Journal ArticleDOI
TL;DR: Aguilar et al. as discussed by the authors present a Guia de Practica Clinica de the Sociedad Europea de Cardiologia (ESC) that recoge the opinion of the ESC and se ha elaborado tras el estudio minucioso de los datos and la evidencia disponibles hasta la fecha.
Abstract: Los miembros del Comite de la ESC para la Elaboracion de GPC y los revisores del documento representantes de las sociedades nacionales de cardiologia aparecen listados en el apendice. Entidades de la ESC que han participado en el desarrollo de este documento: Asociaciones: Asociacion de Cuidados Cardiovasculares Agudos (ACCA), Asociacion Europea para la Prevencion y Rehabilitacion Cardiovascular (EACPR), Asociacion Europea de Imagen Cardiovascular (EACVI), Asociacion Europea de Intervencionismo Coronario Percutaneo (EAPCI), Asociacion de Insuficiencia Cardiaca (HFA). Consejos: Consejo de Enfermeria Cardiovascular y Profesiones Afines (CCNAP), Consejo de Practica Cardiologica (CCP), Consejo de Cuidados Cardiovasculares Primarios (CCPC). Grupos de Trabajo: Farmacoterapia Cardiovascular, Cirugia Cardiovascular, Fisiopatologia y Microcirculacion Coronaria, Trombosis. El contenido de esta Guia de Practica Clinica de la Sociedad Europea de Cardiologia (ESC) se publica exclusivamente para uso personal y educativo. No se autoriza su uso comercial. No se autoriza la traduccion o reproduccion de ningun fragmento de esta guia sin la autorizacion escrita de la ESC. La autorizacion se solicitara por escrito a Oxford University Press, editorial de European Heart Journal y representante autorizado de la ESC para gestionar tales permisos. Descargo de responsabilidad. Esta guia recoge la opinion de la ESC y se ha elaborado tras el estudio minucioso de los datos y la evidencia disponibles hasta la fecha. La ESC no es responsable en caso de que haya alguna contradiccion, discrepancia o ambiguedad entre la guia de practica clinica (GPC) de la ESC y cualquier otra recomendacion oficial o GPC publicada por autoridades relevantes de la sanidad publica, particularmente en lo que se refiere al buen uso de la atencion sanitaria y las estrategias terapeuticas. Se espera que los profesionales de la salud tengan en consideracion esta GPC a la hora de tomar decisiones clinicas, asi como al implementar estrategias medicas preventivas, diagnosticas o terapeuticas. No obstante, esta guia no anula la responsabilidad individual de cada profesional al tomar las decisiones oportunas relativas a cada paciente, de acuerdo con dicho paciente y, cuando fuera necesario, con su tutor o representante legal. Ademas, las GPC de la ESC no eximen al profesional medico de su obligacion etica y profesional de consultar y considerar atentamente las recomendaciones y las GPC actualizadas emitidas por autoridades sanitarias competentes. Es tambien responsabilidad del profesional verificar la normativa y la legislacion sobre farmacos y dispositivos medicos a la hora de prescribirlos. Se puede consultar las declaraciones de conflicto de intereses de los expertos participantes en el desarrollo de esta guia en la pagina web de la ESC: www.escardio.org/guidelines El texto completo solo esta disponible en PDF

Journal ArticleDOI
TL;DR: This editorial refers to ‘ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting’, by S. Schulz-Schupke et al, on page doi:10.1093/eurheartj/ehu523.
Abstract: This editorial refers to ‘ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting’, by S. Schulz-Schupke et al. , on page doi:10.1093/eurheartj/ehu523. ‘Well? Shall we go?’—‘Yes, let's go’. ‘They do not move.’Waiting for Godot, by Samuel Beckett, Combined treatment with aspirin and a P2Y12 inhibitor, the so-called dual antiplatelet therapy (DAPT) regimen, exerts protection against ischaemic myocardial recurrences via a double mechanism of action. First, it prevents sudden thrombotic occlusion of previously implanted stent(s) in the coronary arteries, thereby reducing the risk of stent thrombosis that occurs as a result of inflammation during healing.1,2 Since the vast majority of stent thrombosis cases are known to occur within the first weeks after stent implantation, an arbitrary 30 day to 6 weeks duration of DAPT has been investigated and a 30 day duration of therapy has become the standard of care approach after uncoated stent implantation. Secondly, DAPT has also been shown to mitigate the risk of subsequent myocardial infarction in patients not previously treated with coronary stents or arising from non-previously stented coronary segments.3,4 While the capability of DAPT to limit the progression of atherosclerosis per se has never been demonstrated, it remains likely—even if not proven—that DAPT protects the patient from the consequences of spontaneous coronary plaque rupture. The reasons why long-term prolongation of DAPT is debated, despite its unquestionable value, are two-fold. Long-term DAPT carries a time-dependent risk of major and clinically relevant bleeding complications, which affects morbidity and mortality at least as much as ischaemic recurrences.4–7 Moreover, the advent of drug-eluting stents (DES) has prompted attention …



Journal ArticleDOI
TL;DR: In the early stage of acute coronary syndrome (ACSACS) reaching a medical facility where the management of ischaemia and infarction must include continuous electrocardiographic (ECG) and hemodynamic monitoring, and a prompt therapeutic response to incident sustained arrhythmias as mentioned in this paper.
Abstract: It is known that myocardial ischaemia and infarction leads to severe metabolic and electrophysiological changes that induce silent or symptomatic life-threatening arrhythmias. Sudden cardiac death is most often attributed to this pathophysiology, but many patients survive the early stage of an acute coronary syndrome (ACS) reaching a medical facility where the management of ischaemia and infarction must include continuous electrocardiographic (ECG) and hemodynamic monitoring, and a prompt therapeutic response to incident sustained arrhythmias. During the last decade, the hospital locations in which arrhythmias are most relevant have changed to include the cardiac catheterization laboratory, since the preferred management of early acute ACS is generally interventional in nature. However, a large proportion of patients are still managed medically.Both atrial and ventricular arrhythmias may occur in the setting of ACS and sustained ventricular tachyarrhythmias (VAs) may be associated with circulatory collapse and require immediate treatment. Atrial fibrillation (AF) may also warrant urgent treatment when a fast ventricular rate is associated with hemodynamic deterioration. The management of other arrhythmias is also based largely on symptoms rather than to avert progression to more serious arrhythmias. Prophylactic antiarrhythmic management strategies have largely been discouraged.Although the mainstay of antiarrhythmic therapy used to rely on antiarrhythmic drugs (AADs), particularly sodium channel blockers and amiodarone, their use has now declined, since clinical evidence to support such treatment has never been convincing. Therapy for acute coronary syndrome and arrhythmia management are now based increasingly on invasive approaches. The changes in the clinical approach to arrhythmia management in ACS have been so substantial that the European Heart Rhythm Association, the Acute Cardiovascular Care Association and the European Association of Percutaneous Cardiovascular Interventions established a task force to define the current position.


Journal ArticleDOI
TL;DR: The RXi microcatheter FFR system represents a novel technology that could allow easier lesion negotiation, maintaining guidewire position, facilitating pullbacks for assessment of serial lesions and simplifying the obtainment of post-intervention FFR measurements.
Abstract: Aims The present report describes a novel coronary fractional flow reserve (FFR) system which allows FFR assessment using a rapid exchange microcatheter (RXi). Methods and results The RXi microcatheter is compatible with standard 0.014" coronary guidewires facilitating lesion negotiation and FFR assessment in a wide range of coronary anatomies. In case of serial lesions, a microcatheter would have the important advantage of allowing multiple pullbacks while maintaining wire access to the vessel. The RXi is a fibre-optic sensor technology-based device. This technology might allow reduction in signal drift. The RXi microcatheter's fibre-optic sensor is located 5 mm from the distal tip. The microcatheter profile at the sensor site is 0.027"0.036". The segment of the catheter which is intended to reside within the target lesion is proximal to the sensor and has dimensions decreased to 0.020"0.025"; these dimensions are comparable to a 0.022" circular-shaped wire. Conclusions The RXi microcatheter FFR system represents a novel technology that could allow easier lesion negotiation, maintaining guidewire position, facilitating pullbacks for assessment of serial lesions and simplifying the obtainment of post-intervention FFR measurements. The optical sensing technology could additionally result in less signal drift. Further investigations are required to evaluate the clinical value of this technology fully.