Showing papers by "Marco Valgimigli published in 2019"
Icahn School of Medicine at Mount Sinai1, Technische Universität München2, University of Florida3, University of Catania4, Aix-Marseille University5, Beth Israel Deaconess Medical Center6, McMaster University7, Food and Drug Administration8, Harvard University9, University of London10, Uppsala University11, Seoul National University Hospital12, Kyoto University13, Pharmaceuticals and Medical Devices Agency14, Columbia University Medical Center15, National University of Ireland, Galway16, Scripps Health17, Durham University18, Erasmus University Medical Center19, Core Laboratories20, University of Bern21, Paris Descartes University22, Duke University23
TL;DR: This research presents a novel probabilistic approach that allows us to assess the importance of knowing the carrier and removal status of canine coronavirus, as a source of infection for other animals.
Abstract: Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limi ...
450 citations
TL;DR: In patients with atrial fibrillation who had PCI, the edoxaban- based regimen was non-inferior for bleeding compared with the VKA-based regimen, without significant differences in ischaemic events.
427 citations
Semmelweis University1, National and Kapodistrian University of Athens2, Brigham and Women's Hospital3, Aix-Marseille University4, University of Paris5, University of Florida6, Gyeongsang National University7, Icahn School of Medicine at Mount Sinai8, University of Kentucky9, University of Freiburg10, Mayo Clinic11, Scripps Health12, University of Ottawa13, Columbia University Medical Center14, University of Sheffield15, University of Bern16, MedStar Washington Hospital Center17
TL;DR: An international expert consensus group of key leaders from North America, Asia, and Europe with expertise in the field of antiplatelet treatment was convened and summarizes the contemporary updated expert consensus recommendations for the selective use of PFT or genotyping in patients undergoing percutaneous coronary intervention.
Abstract: Dual-antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor is the standard treatment for patients undergoing percutaneous coronary intervention. The availability of different P2Y12 receptor inhibitors (clopidogrel, prasugrel, ticagrelor) with varying levels of potency has enabled physicians to contemplate individualized treatment regimens, which may include escalation or de-escalation of P2Y12-inhibiting therapy. Indeed, individualized and alternative DAPT strategies may be chosen according to the clinical setting (stable coronary artery disease vs. acute coronary syndrome), the stage of the disease (early- vs. long-term treatment), and patient risk for ischemic and bleeding complications. A tailored DAPT approach may be potentially guided by platelet function testing (PFT) or genetic testing. Although the routine use of PFT or genetic testing in percutaneous coronary intervention-treated patients is not recommended, recent data have led to an update in guideline recommendations that allow considering selective use of PFT for DAPT de-escalation. However, guidelines do not expand on when to implement the selective use of such assays into decision making for personalized treatment approaches. Therefore, an international expert consensus group of key leaders from North America, Asia, and Europe with expertise in the field of antiplatelet treatment was convened. This document updates 2 prior consensus papers on this topic and summarizes the contemporary updated expert consensus recommendations for the selective use of PFT or genotyping in patients undergoing percutaneous coronary intervention.
346 citations
Icahn School of Medicine at Mount Sinai1, Technische Universität München2, University of Florida3, University of Catania4, Aix-Marseille University5, Beth Israel Deaconess Medical Center6, McMaster University7, Food and Drug Administration8, Harvard University9, University of London10, Uppsala University11, Seoul National University Hospital12, Kyoto University13, Pharmaceuticals and Medical Devices Agency14, Columbia University Medical Center15, National University of Ireland, Galway16, Scripps Health17, Durham University18, Core Laboratories19, Erasmus University Medical Center20, University of Bern21, Paris Descartes University22, Duke University23
TL;DR: The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
Abstract: Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
245 citations
Anglia Ruskin University1, University of California, San Francisco2, University of Turin3, Paris Descartes University4, University of Bern5, Brighton and Sussex University Hospitals NHS Trust6, Sapienza University of Rome7, Medical University of Vienna8, Leeds General Infirmary9, Ludwig Maximilian University of Munich10, University of Catania11, Technische Universität München12, Okayama University13, University of Colorado Denver14, University of Pennsylvania15, University of Vienna16, Boston Children's Hospital17, University of Copenhagen18, University of Bergen19
TL;DR: This position paper provides the first largely shared, interdisciplinary approach for a rational PFO management based on the best available evidence.
Abstract: The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions; however, the subject remains controversial and no official statements have been published This interdisciplinary paper, prepared with involvement of eight European scientific societies, aims to review the available trial evidence and to define the principles needed to guide decision making in patients with PFO In order to guarantee a strict process, position statements were developed with the use of a modified grading of recommendations assessment, development, and evaluation (GRADE) methodology A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio The level of evidence and the strength of the position statements of particular management options were weighed and graded according to predefined scales Despite being based often on limited and non-randomised data, while waiting for more conclusive evidence, it was possible to conclude on a number of position statements regarding a rational general approach to PFO management and to specific considerations regarding left circulation thromboembolism For some therapeutic aspects, it was possible to express stricter position statements based on randomised trials This position paper provides the first largely shared, interdisciplinary approach for a rational PFO management based on the best available evidence
213 citations
TL;DR: Patients who underwent complex PCI had a higher risk of ischemic events, but benefitted from long-term DAPT only if HBR features were not present, and these data suggested that when concordant, bleeding, more than ischemic risk, should inform decision-making on the duration of D APT.
201 citations
TL;DR: Double antithrombotic therapy, particularly if consisting of a NOAC instead of VKA and a P2Y12 inhibitor, is associated with a reduction of bleeding, including major and intracranial haemorrhages, but is counterbalanced by a higher risk of cardiac-mainly stent-related-but not cerebrovascular ischaemic occurrences.
Abstract: AIMS: To investigate the safety and efficacy of double vs. triple antithrombotic therapy (DAT vs. TAT) in patients with atrial fibrillation (AF) and acute coronary syndrome or who underwent percutaneous coronary intervention (PCI). METHODS AND RESULTS: A systematic review and meta-analysis was performed using PubMed to search for non-vitamin K antagonist oral anticoagulant (NOAC)-based randomized clinical trials comparing DAT vs. TAT in AF patients undergoing PCI. Four trials encompassing 10 234 patients (DAT = 5496 vs. TAT = 4738) were included. The primary safety endpoint (ISTH major or clinically relevant non-major bleeding) was significantly lower with DAT compared with TAT [risk ratio (RR) 0.66, 95% confidence interval (CI) 0.56-0.78; P < 0.0001; I2 = 69%], which was consistent across all available bleeding definitions. This benefit was counterbalanced by a significant increase of stent thrombosis (RR 1.59, 95% CI 1.01-2.50; P = 0.04; I2 = 0%) and a trend towards higher risk of myocardial infarction with DAT. There were no significant differences in all-cause and cardiovascular death, stroke and major adverse cardiovascular events. The comparison of NOAC-based DAT vs. vitamin K antagonist (VKA)-TAT yielded consistent results and a significant reduction of intracranial haemorrhage (RR 0.33, 95% CI 0.17-0.65; P = 0.001; I2 = 0%). CONCLUSION: Double antithrombotic therapy, particularly if consisting of a NOAC instead of VKA and a P2Y12 inhibitor, is associated with a reduction of bleeding, including major and intracranial haemorrhages. This benefit is however counterbalanced by a higher risk of cardiac-mainly stent-related-but not cerebrovascular ischaemic occurrences.
193 citations
University of Naples Federico II1, University of Tromsø2, University of Bern3, Paris Descartes University4, University Hospital of Basel5, University of Sussex6, Maastricht University7, University of Belgrade8, University of São Paulo9, National Institutes of Health10, University of Barcelona11, Technische Universität München12, National University of Ireland, Galway13, University of Toronto14
TL;DR: The performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety and further development of DES technology should target improvements in clinical outcomes beyond 1 year.
146 citations
TL;DR: A randomised clinical trial to investigate the safety and efficacy of ultrathin strut biodegradable polymer sirolimus-eluting stents versus thin strut durable polymer everolimus-eluted stents in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (PCI).
125 citations
Journal Article•
102 citations
TL;DR: The authors provide easily applicable and effective recommendations to prevent periprocedural RAO and maximize the chances of access in case of repeat catheterization or coronary artery bypass grafting surgery.
Abstract: Highlights •RAO remains the most frequent post-procedural complication of transradial access, restricting the use of the same radial artery for future procedures, as a conduit for coronary artery bypass grafting or for arteriovenous fistula creation in patients requiring hemodialysis. •The real-world reported incidence of RAO remains high, with wide variability in the uptake of RAO prevention strategies. •The paper reviews the main recent advances in the field of RAO prevention and provides a series of expert recommendations to prevent RAO. •This consensus document is meant to provide guidance to increase the adoption of simple and effective methods to achieve an institutional rate of RAO
TL;DR: In East Asians, prolonged DAPT may have no effect in reducing the ischaemic risk, while significantly increases the bleeding risk, according to a Cox proportional hazards model.
Abstract: Background Prolonged dual anti-platelet therapy (DAPT) is intended to reduce ischaemic events, at the cost of an increased bleeding risk in patients undergoing percutaneous coronary intervention (PCI). In this study, we evaluated whether race influences the ischaemia/bleeding risk trade-off. Methods We searched for randomized clinical trials (RCTs) comparing DAPT duration after PCI. To compare the benefit or harm between DAPT duration by race, individual patient-level landmark meta-analysis was performed after discontinuation of the shorter duration DAPT group in each RCT. The primary ischaemic endpoint was major adverse cardiac events (MACEs), and the primary bleeding endpoint was major bleeding events (clinicaltrials.gov NCT03338335). Results Seven RCTs including 16,518 patients (8,605 East Asians, 7,913 non-East Asians) were pooled. MACE occurred more frequently in non-East Asians (0.8% vs. 1.8%, p Conclusion We suggest that the ischaemia/bleeding trade-off may be different between East Asians and non-East Asians. In East Asians, prolonged DAPT may have no effect in reducing the ischaemic risk, while significantly increases the bleeding risk.
University of Naples Federico II1, Cork University Hospital2, University of Pavia3, Imperial College London4, Erasmus University Rotterdam5, Medical University of Silesia6, Jagiellonian University Medical College7, East Lancashire Hospitals NHS Trust8, Paris Diderot University9, University of Bern10, University of Toronto11
TL;DR: Ticagrelor monotherapy after 1-month DAPT was noninferior, but not superior, to conventional treatment in the prevention of ischemic events, and it did not decrease major bleeding risk as compared with conventional treatment.
Medical University of Warsaw1, Erasmus University Rotterdam2, Prince of Songkla University3, University of Amsterdam4, Core Laboratories5, State University of Campinas6, University of Sheffield7, Icahn School of Medicine at Mount Sinai8, Brigham and Women's Hospital9, University of Florida10, University of Giessen11, University of Bern12, Paris Diderot University13, National Institutes of Health14
TL;DR: Between 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events.
Abstract: Importance: The role of aspirin as part of antiplatelet regimens in acute coronary syndromes (ACS) needs to be clarified in the context of newer potent P2Y12 antagonists. Objective: To evaluate the benefit and risks of aspirin in addition to ticagrelor among patients with ACS beyond 1 month after percutaneous coronary intervention (PCI). Design, Setting, and Participants: This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI. The trial included 130 secondary/tertiary care hospitals in different countries, with 15991 unselected patients with stable coronary artery disease or ACS undergoing PCI. Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure. Interventions: The experimental group received aspirin plus ticagrelor for 1 month followed by 23-month ticagrelor monotherapy; the reference group received aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS) for 12 months, followed by 12-month aspirin monotherapy. In this analysis, we examined the clinical outcomes occurring between 31 days and 365 days after randomization, specifically in patients with ACS who, within this time frame, were assigned to receive either ticagrelor alone or ticagrelor and aspirin. Main Outcomes and Measures: The primary outcome was the composite of all-cause death or new Q-wave myocardial infarction. Results: Of 15968 participants, there were 7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group. Between 31 and 365 days after randomization, the primary outcome occurred in 55 patients (1.5%) in the experimental group and in 75 patients (2.0%) in the reference group (hazard ratio [HR], 0.73; 95% CI, 0.51-1.03; P =.07); investigator-reported Bleeding Academic Research Consortium-defined bleeding type 3 or 5 occurred in 28 patients (0.8%) in the experimental group and in 54 patients (1.5%) in the reference arm (HR, 0.52; 95% CI, 0.33-0.81; P =.004). Conclusions and Relevance: Between 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. These findings should be interpreted as exploratory and hypothesis generating; however, they pave the way for further trials evaluating aspirin-free antiplatelet strategies after PCI.
National Institutes of Health1, University of Amsterdam2, Prince of Songkla University3, Medical University of Warsaw4, State University of Campinas5, Medical University of Silesia6, University of Hasselt7, University of Giessen8, Paris Diderot University9, University of Toronto10, University of Bern11
TL;DR: Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI, and these findings of a post hoc analysis should be considered as hypothesis generating.
Abstract: AIMS : To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI). METHODS AND RESULTS: In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48-0.85] and POCE (HR: 0.80, 95% CI: 0.69-0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011). CONCLUSION : Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.
University of Bern1, MedStar Washington Hospital Center2, University of Liège3, University of Hasselt4, Cork University Hospital5, University of Messina6, Duke University7, University of Minnesota8, University of Michigan9, Icahn School of Medicine at Mount Sinai10, University of Florida11, Imperial College London12, Center for Drug Evaluation and Research13, Technische Universität München14, Columbia University Medical Center15, Brigham and Women's Hospital16, University of Amsterdam17
TL;DR: A document describing consensus recommendations for reporting, collecting, and analysing adherence endpoints across clinical trials is described, guaranteeing robustness and consistency in the comparative safety and effectiveness evaluation of investigational drugs from early development to post-marketing approval studies.
Abstract: Non-adherence has been well recognized for years to be a common issue that significantly impacts clinical outcomes and health care costs Medication adherence is remarkably low even in the controlled environment of clinical trials where it has potentially complex major implications Collection of non-adherence data diverge markedly among cardiovascular randomized trials and, even where collected, is rarely incorporated in the statistical analysis to test the consistency of the primary endpoint(s) The imprecision introduced by the inconsistent assessment of non-adherence in clinical trials might confound the estimate of the calculated efficacy of the study drug Hence, clinical trials may not accurately answer the scientific question posed by regulators, who seek an accurate estimate of the true efficacy and safety of treatment, or the question posed by payers, who want a reliable estimate of the effectiveness of treatment in the marketplace after approval The Non-adherence Academic Research Consortium is a collaboration among leading academic research organizations, representatives from the US Food and Drug Administration and physician-scientists from the USA and Europe One in-person meeting was held in Madrid, Spain, culminating in a document describing consensus recommendations for reporting, collecting, and analysing adherence endpoints across clinical trials The adoption of these recommendations will afford robustness and consistency in the comparative safety and effectiveness evaluation of investigational drugs from early development to post-marketing approval studies These principles may be useful for regulatory assessment, as well as for monitoring local and regional outcomes to guide quality improvement initiatives
TL;DR: SEV were associated with a lower frequency of PPM compared with BEV irrespective of annulus area, and there was no impact of P PM on cardiovascular mortality or New York Heart Association functional class at 1 year.
Abstract: Objectives This study sought to compare the frequency of prosthesis-patient mismatch (PPM) with self-expandable valves (SEV) to balloon-expandable valves (BEV). Background PPM has been associated with increased mortality after transcatheter aortic valve replacement. Data on the frequency of PPM as a function of supra-annular or intra-annular position of transcatheter heart valves are insufficient. Methods A total of 757 patients treated with SEV (CoreValve, Evolut R) and BEV (SAPIEN THV/XT/3) were enrolled in the present analysis between August 2007 and June 2017. PPM was classified based on discharge prosthetic effective orifice area indexed to body surface area (BSA) as severe ( Results Propensity score matching resulted in 224 matched pairs. At discharge, SEV were associated with a lower incidence of PPM compared with BEV (PPM, 33.5% vs. 46.9%; p = 0.004; severe PPM, 6.7% vs. 15.6%; p = 0.003). The lower frequency of severe PPM in SEV was observed even in patients with larger annulus. Although patients with BSA >1.83 m2 had a significantly lower incidence of PPM with SEV compared with BEV, there was no significant difference in patients with BSA ≤1.83 m2. We found no impact of PPM on cardiovascular mortality or New York Heart Association functional class at 1 year. Conclusions SEV were associated with a lower frequency of PPM compared with BEV irrespective of annulus area. The difference was mainly driven by larger patients with BSA >1.83 m2.
University of Bern1, University of Hasselt2, Fujita Health University3, University of Amsterdam4, St. Michael's Hospital5, Erasmus University Rotterdam6, University of Paris7, Brighton and Sussex University Hospitals NHS Trust8, Geneva College9, Rabin Medical Center10, University of Western Australia11, Poznan University of Medical Sciences12, Madras Medical Mission13, Uppsala University14, University of Belgrade15, Tan Tock Seng Hospital16, Saarland University17
TL;DR: The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus‐eluting bioresorbable polymer‐coated stent implantation.
TL;DR: The European Society of Cardiology guideline-endorsed high-risk features were associated with increased ischemic and bleeding risks following percutaneous coronary intervention in routine clinical practice and high-PRECISE-DAPT score was associated with an increased risk of DOCE and BARC 3-5 bleeding.
Abstract: Objectives This study sought to validate European Society of Cardiology guideline-endorsed high-risk features of stent-related recurrent ischemic events for the prediction of ischemic and bleeding outcomes including a stratification according to the PRECISE-DAPT score estimated bleeding risk. Background The 2017 European Society of Cardiology–focused update on dual-antiplatelet therapy endorsed high-risk features of stent-related recurrent ischemic events. Because patients with high ischemic risk also have an increased bleeding risk, appropriate risk stratification for ischemic and bleeding events is crucial. Methods Between January 2009 and December 2015, a total of 10,236 consecutive patients undergoing clinically indicated percutaneous coronary intervention were prospectively included in the Bern PCI Registry. Guideline-endorsed high-risk features were retrospectively assessed. The primary ischemic endpoint was device-oriented composite endpoint (DOCE) (cardiac death, target-vessel myocardial infarction, and target lesion revascularization) at 1 year, and the primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) 3–5 at 1 year. Results A total of 5,323 (52.0%) patients had at least 1 high-risk feature. Among patients with high-risk features, DOCE (12.3% vs. 5.5%; p Conclusions The European Society of Cardiology guideline-endorsed high-risk features were associated with increased ischemic and bleeding risks following percutaneous coronary intervention in routine clinical practice. (CARDIOBASE Bern PCI Registry; NCT02241291)
TL;DR: In patients with ST-segment–elevation myocardial infarction, ticagrelor maintenance therapy was not superior to prasugrel in preventing coronary microvascular injury in the infarct-related territory as assessed by the index of microcirculatory resistance.
Abstract: Background: Despite successful restoration of epicardial vessel patency with primary percutaneous coronary intervention, coronary microvascular injury occurs in a large proportion of patients with ...
TL;DR: The prevention of AKI appeared predominantly responsible for the mortality benefit of radial as compared with femoral access in the MATRIX trial, and there was little evidence for an equally important, independent role of bleeding.
Abstract: Aims
In the Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) trial, adults with acute coronary syndrome undergoing coronary intervention who were allocated to radial access had a lower risk of bleeding, acute kidney injury (AKI), and all-cause mortality, as compared with those allocated to femoral access. The mechanism of the mortality benefit of radial access remained unclear.
Methods and results
We used multistate and competing risk models to determine the effects of radial and femoral access on bleeding, AKI and all-cause mortality in the MATRIX trial and to disentangle the relationship between these different types of events. There were large relative risk reductions in mortality for radial compared with femoral access for the transition from AKI to death [hazard ratio (HR) 0.55, 95% confidence interval (CI) 0.31-0.97] and for the pathway from coronary intervention to AKI to death (HR 0.49, 95% CI 0.26-0.92). Conversely, there was little evidence for a difference between radial and femoral groups for the transition from bleeding to death (HR 1.05, 95% CI 0.42-2.64) and the pathway from coronary intervention to bleeding to death (HR 0.84, 95% CI 0.28-2.49).
Conclusion
The prevention of AKI appeared predominantly responsible for the mortality benefit of radial as compared with femoral access in the MATRIX trial. There was little evidence for an equally important, independent role of bleeding.
TL;DR: Older age, female sex, and a prolonged latency period between symptom onset and angiography are associated with the occurrence of mechanical complications in this contemporary cohort of patients admitted with STEMI.
Abstract: BACKGROUND
The study aims to assess characteristics and outcomes of patients suffering a mechanical complication (MC) after ST-segment elevation myocardial infarction (STEMI) in a contemporary cohort of patients in the percutaneous coronary intervention era.
METHODS AND RESULTS
This retrospective single-center cohort study encompasses 2508 patients admitted with STEMI between March 9, 2009 and June 30, 2014. A total of 26 patients (1.1%) suffered a mechanical complication: ventricular septal rupture (VSR) in 17, ventricular free wall rupture (VFWR) in 2, a combination of VSD and VFWR in 2, and papillary muscle rupture (PMR) in 5 patients. Older age (74.5 ± 10.4 years versus 63.9 ± 13.1 years, p 24h: 42.3% versus 16.2%, p = 0.002) were more frequent among patients with MC as compared to patients without MC. The majority of MC patients had multivessel disease (77%) and presented in cardiogenic shock (Killip class IV: 73.1%). Nine patients (7 VSR, 2 VFWR & VSR) were treated conservatively and died. Out of the remaining 10 VSR patients, four underwent surgery, three underwent implantation of an occluder device, and another three patients had surgical repair following occluder device implantation. All patients with isolated VFWR and PMR underwent emergency surgery. At 30 days, mortality for VSR, VFWR, VFWR & VSR and PMR amounted to 71%, 50%, 100% and 0%, respectively.
CONCLUSIONS
Despite advances in the management of STEMI patients, mortality of mechanical complications stays considerable in this contemporary cohort. Older age, female sex, and a prolonged latency period between symptom onset and angiography are associated with the occurrence of these complications.
TL;DR: In this paper, the authors evaluated efficacy and safety of a full or low post-PCI bivalirudin regimen in acute coronary syndrome (ACS) patients with or without ST-segment elevation.
TL;DR: No difference in the device-oriented composite endpoint between BP-E ES and DP-EES was observed throughout 12 months, and there was a higher rate of acute stent thrombosis with the BP- EES, a difference that disappeared at 1 year.
Abstract: Objectives The aim of this study was to compare the efficacy and safety of a thin-strut, biodegradable-polymer everolimus-eluting stent (BP-EES) (Synergy, Boston Scientific, Marlborough, Massachusetts) and a thin-strut, durable-polymer everolimus-eluting stent (DP-EES) (XIENCE, Abbott Vascular, Abbott Park, Illinois) in an all-comers population. Background BP-EES have been shown to be noninferior to DP-EES in randomized trials in patients at low to moderate risk. Methods Among 7,042 consecutive patients who underwent percutaneous coronary intervention between December 2012 and December 2016, 3,870 patients were exclusively treated with BP-EES (n = 1,343) or with DP-EES (n = 2,527). After propensity score matching, the final study population consisted of 1,041 matched patients. The primary endpoint was the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction, and target lesion revascularization) at 12 months. Results The device-oriented composite endpoint did not differ between the 2 groups (7.8% with BP-EES vs. 7.1% with DP-EES; hazard ratio: 1.12; 95% confidence interval: 0.81 to 1.53; p = 0.49). There were no differences in rates of cardiac death (3.0% vs. 3.0%; p = 1.00), target vessel myocardial infarction (3.6% vs. 3.1%; p = 0.53), and target lesion revascularization (3.0% vs. 2.5%; p = 0.41). The rate of acute stent thrombosis was significantly higher in the BP-EES group compared with the DP-EES group (1.2% vs. 0.3%; hazard ratio: 4.00; 95% confidence interval: 1.13 to 14.19; p = 0.032). At 12 months, the frequency of definite stent thrombosis did not differ (1.5% vs. 0.9%; hazard ratio: 1.67; 95% confidence interval: 0.73 to 3.82; p = 0.22). Conclusions In this consecutively enrolled percutaneous coronary intervention population reflecting routine clinical practice, no difference in the device-oriented composite endpoint between BP-EES and DP-EES was observed throughout 12 months. There was a higher rate of acute stent thrombosis with the BP-EES, a difference that disappeared at 1 year. (CARDIOBASE Bern PCI Registry; NCT02241291)
TL;DR: Long-term ticagrelor monotherapy following 1-month DAPT can favorably balance ischemic and bleeding risks in patients with multivessel PCI, and need to be replicated in future dedicated randomized trials.
Prince of Songkla University1, University of Amsterdam2, State University of Campinas3, Leiden University Medical Center4, Erasmus University Rotterdam5, Medical University of Warsaw6, Core Laboratories7, Medical University of Silesia8, Manchester Royal Infirmary9, Cardiff and Vale University Health Board10, Golden Jubilee National Hospital11, Semmelweis University12, East Lancashire Hospitals NHS Trust13, University of Toronto14, University of Giessen15, Imperial College London16, Paris Diderot University17, University of Bern18
TL;DR: The ACEF II model did not improve the predictive ability of the ACEF score and recalibrated ACEF model can be used to estimated all-cause mortality rate at 30 days after PCI.
01 Dec 2019
TL;DR: Cancer patients carry an increased risk of cardiac mortality that was not associated with stent-related ischemic events among patients undergoing PCI in routine clinical practice and higher risk of bleeding in cancer patients undergoingPCI deserves particular attention.
Abstract: Objectives The purpose of this study was to evaluate ischemic and bleeding outcomes of unselected cancer patients undergoing percutaneous coronary intervention (PCI). Background The number...
TL;DR: Compared with ⩽1-year DAPT, >1- year D APT reduces the risk of myocardial infarction but increases the risk for major bleeding and noncardiac mortality.
Abstract: Background: We sought to determine whether the risks and benefits of prolonging dual-antiplatelet therapy (DAPT) beyond 1 year after drug-eluting stent implantation depend on clinical presentation ...
TL;DR: Short D APT does not appear to be inferior to longer DAPT in patients with CKD and drug-eluting stents and no definite conclusions can be drawn with respect to stent thrombosis.
Abstract: Background and objectives Whether prolonged dual antiplatelet therapy (DAPT) is more protective in patients with CKD and drug-eluting stents compared with shorter DAPT is uncertain. The purpose of this meta-analysis was to examine whether shorter DAPT in patients with drug-eluting stents and CKD is associated with lower mortality or major adverse cardiovascular event rates compared with longer DAPT. Design, setting, participants, & measurements A Medline literature research was conducted to identify randomized trials in patients with drug-eluting stents comparing different DAPT duration strategies. Inclusion of patients with CKD was also required. The primary outcome was a composite of all-cause mortality, myocardial infarction, stroke, or stent thrombosis (definite or probable). Major bleeding was the secondary outcome. The risk ratio (RR) was estimated using a random-effects model. Results Five randomized trials were included (1902 patients with CKD). Short DAPT (≤6 months) was associated with a similar incidence of the primary outcome, compared with 12-month DAPT among patients with CKD (48 versus 50 events; RR, 0.93; 95% confidence interval [95% CI], 0.64 to 1.36; P=0.72). Twelve-month DAPT was also associated with a similar incidence of the primary outcome compared with extended DAPT (≥30 months) in the CKD subgroup (35 versus 35 events; RR, 1.04; 95% CI, 0.67 to 1.62; P=0.87). Numerically lower major bleeding event rates were detected with shorter versus 12-month DAPT (9 versus 13 events; RR, 0.69; 95% CI, 0.30 to 1.60; P=0.39) and 12-month versus extended DAPT (9 versus 12 events; RR, 0.83; 95% CI, 0.35 to 1.93; P=0.66) in patients with CKD. Conclusions Short DAPT does not appear to be inferior to longer DAPT in patients with CKD and drug-eluting stents. Because of imprecision in estimates (few events and wide confidence intervals), no definite conclusions can be drawn with respect to stent thrombosis.