P1187Pocket-Hematoma after cardiac implantable electronic devices surgery: a single centre study

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
L Spighi ◽  
F Notaristefano ◽  
R Annunziata ◽  
M D"ammando ◽  
G Zingarini ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Antithrombotic Therapy ◽  
Pulse Generator ◽  
Dual Antiplatelet Therapy ◽  
Vitamin K Antagonists ◽  
Multivariate Regression Analysis ◽  
New Device ◽  
Increased Risk ◽  
The Impact ◽  
Pocket Hematoma

Abstract Intro Pocket hematoma is a common complication after pacemaker (PMK) or implantable cardioverter defibrillator (ICD) surgery. In this clinical setting anticoagulant and antiplatelet therapy are associated with an increased risk of hemorrhagic complications, but data are sparse. Purpose We examined  the impact of antiplatelet therapy and anticoagulation with vitamin K antagonists (VKA) or heparin on the risk of pocket hematoma. Materials and method: between august 2017 and june 2019, a total of 639 devices were implanted or replaced at our centre. Predictors of hematoma occurrence were determined by multivariate regression analysis. We used a specific definition of pocket hematoma: a) any palpable swelling in the pocket area requiring an unscheduled visit or prolonged hospitalization > 24 h or re-hospitalization for hematoma, b) interruption of antithrombotics, c) reoperation, d) hemoglobin drop > 2 g/dl or blood transfusion. The above criteria were assessed during hospitalization and up to 10 days after discharge. Results: the incidence of pocket hematoma was 7.5%. Among 639 patients (pts) including in the study 33.5% (214 pts) didn’ t take any antithrombotic therapy, 40.2 % (257 pts) were on single antiplatelet therapy (SAPT), 8.8 % (56 pts) were on dual antiplatelet therapy, 11.1 % (71 pts) were on uninterrupted VKA (mean INR 2). Heparin bridging was administered in 6.4% (41 pts). Ejection fraction (43 ±13 %) and  hemoglobin value before implantation (12.3 ±2.6 g/dL) in patients who developed hematoma were significantly lower compared with whose without hematoma. Patients with hematoma had a higher prevalence of congestive heart failure, ischemic cardiomyopathy and intake antithrombotic therapy. After adjusting for confounding factors with multivariate logistic regression only the use of dual antiplatelet therapy (OR 5.9 95% CI 1.5-21 p = 0.008) and the bridging with enoxaparin (OR 5.6 95% CI 1.4-22 p = 0.013) increased the risk of pocket hematoma. Single antiplatelet therapy (OR 2.6 95% CI 0.8-8.4 p = ns) and uninterrupted VKA (OR 0.9 95% CI 0.7-11 p = ns) did not increased the risk of pocket hematoma compared to no antithrombotic therapy. Pulse generator change and new device implant/upgrading (OR 1.8 95% CI 0.6-5.2 p = ns) carried the same haemorrhagic risk. Conclusion the use of DAPT or bridging with enoxaparin are highly predictive for the occurrence of perioperative pocket hematoma in patients scheduled for pmk/icd surgery. In contrast, single antiplatelet therapy and uninterrupted VKA  did not increase the risk of hematoma.

scholarly journals Impact of bleeding during dual antiplatelet therapy in patients with coronary artery disease

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Ying-Chang Tung ◽  
Lai-Chu See ◽  
Shu-Hao Chang ◽  
Jia-Rou Liu ◽  
Chi-Tai Kuo ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
East Asian ◽  
Asian Population ◽  
Adverse Outcomes ◽  
Research Database ◽  
Coronary Syndrome ◽  
Asian Patients ◽  
Increased Risk ◽  
The Impact

AbstractThis nationwide retrospective cohort study used the National Health Insurance Research Database of Taiwan to compare the impact of bleeding on clinical outcomes in patients with acute myocardial infarction (AMI) versus chronic coronary syndrome (CCS). Between July 2007 and December 2010, patients with AMI (n = 15,391) and CCS (n = 19,724) who received dual antiplatelet therapy after coronary stenting were identified from the database. AMI was associated with increased risks of MI (AMI vs. CCS: 0.38 vs. 0.16 per 100 patient-months; p < 0.01), all-cause death (0.49 vs. 0.32 per 100 patient-months; p < 0.01), and BARC type 3 bleeding (0.22 vs. 0.13 per 100 patient-months; p < 0.01) at 1 year compared with CCS, while the risk of BARC type 2 bleeding was marginally higher in the CCS patients than in the AMI patients (1.32 vs. 1.4 per 100 person-months; p = 0.06). Bleeding was an independent predictor of MI, stroke, and all-cause death in this East Asian population, regardless of the initial presentation. Among the patients with bleeding, AMI was associated with a higher risk of ischemic events at 1 year after bleeding compared with CCS (MI: 0.34 vs. 0.25 per 100 patient-months; p = 0.06; ischemic stroke: 0.22 vs. 0.13 per 100 patient-months; p = 0.02). The 1-year mortality after bleeding was comparable between the two groups after propensity score weighting. In conclusion, bleeding conferred an increased risk of adverse outcomes in East Asian patients with AMI and CCS.

Dual antiplatelet therapy after carotid artery stenting: trends and outcomes in a large national database

2020 ◽  
Vol 13 (1) ◽  
pp. 8-13
Author(s):  
Eric S Sussman ◽  
Michael Jin ◽  
Arjun V Pendharkar ◽  
Benjamin Pulli ◽  
Austin Feng ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Carotid Artery ◽  
Antiplatelet Therapy ◽  
Carotid Artery Stenting ◽  
Dual Antiplatelet Therapy ◽  
National Database ◽  
Increased Risk ◽  
Hemorrhagic Complications ◽  
The Impact ◽  
Large National Database

BackgroundWhile dual antiplatelet therapy (dAPT) is standard of care following carotid artery stenting (CAS), the optimal dAPT regimen and duration has not been established.MethodsWe canvassed a large national database (IBM MarketScan) to identify patients receiving carotid endarterectomy (CEA) or CAS for treatment of ischemic stroke or carotid artery stenosis from 2007 to 2016. We performed univariable and multivariable regression methods to evaluate the impact of covariates on post-CAS stroke-free survival, including post-discharge antiplatelet therapy.ResultsA total of 79 084 patients diagnosed with ischemic stroke or carotid stenosis received CEA (71 178; 90.0%) or CAS (7906; 10.0%). After adjusting for covariates, <180 days prescribed post-CAS P2Y12-inhibition was associated with increased risk for stroke (<90 prescribed days HR=1.421, 95% CI 1.038 to 1.946; 90–179 prescribed days HR=1.484, 95% CI 1.045 to 2.106). The incidence of hemorrhagic complications was higher during the period of prescribed P2Y12-inhibition (1.16% per person-month vs 0.49% per person-month after discontinuation, P<0.001). The rate of extracranial hemorrhage was nearly six-fold higher while on dAPT (6.50% per patient-month vs 1.16% per patient-month, P<0.001), and there was a trend towards higher rate of intracranial hemorrhage that did not reach statistical significance (5.09% per patient-month vs 3.69% per patient-month, P=0.0556). Later hemorrhagic events beyond 30 days post-CAS were significantly more likely to be extracranial (P=0.028).ConclusionsIncreased duration of post-CAS dAPT is associated with lower rates of readmissions for stroke, and with increased risk of hemorrhagic complications, particularly extracranial hemorrhage. The potential benefit of prolonging dAPT with regard to ischemic complications must be balanced with the corresponding increased risk of predominantly extracranial hemorrhagic complications.

Comparative Efficacy and Safety of Duration of Dual Antiplatelet Therapy in Patients with CAD Undergoing Drug-eluting Stent Implantation: A Systematic Review and Network Meta-analysis

2020 ◽  
Vol 26 (44) ◽  
pp. 5739-5745
Author(s):  
Jieqiong Guan ◽  
Wenjing Song ◽  
Pan He ◽  
Siyu Fan ◽  
Hong Zhi ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Dual Antiplatelet Therapy ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Drug Eluting Stent ◽  
Efficacy And Safety ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Drug Eluting

Objective: The aim was to evaluate the efficacy and safety of duration of dual antiplatelet therapy (DAPT) for patients who received percutaneous coronary intervention (PCI) with a drug-eluting stent. Background: The optimal duration of DAPT to balance the risk of ischemia and bleeding in CAD patients undergoing drug-eluting stent (DES) implantation remains controversial. Methods: PubMed, Cochrane Library, Web of Science, Clinicaltrials.gov, CNKI and Wanfang Databases were searched for randomized controlled trials of comparing different durations of DAPT after DES implantation. Primary outcomes were major adverse cardiac and cerebrovascular events (MACCE), and major bleeding, and were pooled by Bayes network meta-analysis. Net adverse clinical and cerebral events were used to estimate the surface under the cumulative ranking (SUCRA) curves. The subgroup analysis based on clinical status, follow-up and area was conducted using traditional pairwise meta-analysis. Results: A total of nineteen trials (n=51,035) were included, involving six duration strategies. The network metaanalysis showed that T2 (<6-month DAPT followed by aspirin, HR:1.51, 95%CI:1.02-2.22), T3 (standard 6-month DAPT, HR:1.47, 95%CI:1.14-1.91), T4 (standard 12-month DAPT, HR:1.41, 95%CI:1.15-1.75) and T5 (18-24 months DAPT, HR:1.47, 95%CI:1.09-1.97) was associated with significantly increased risk of MACCE compared to T6 (>24-month DAPT). However, no significant difference was found in MACCE risk between T1 (<6-month DAPT followed by P2Y12 monotherapy) and T6. Moreover, T5 was associated with significantly increased risk of bleeding compared to T1(RR:3.94, 95%CI:1.66-10.60), T2(RR:3.65, 95%CI:1.32-9.97), T3(RR:1.93, 95%CI:1.21-3.50) and T4(RR:1.89, 95%CI:1.15-3.30). The cumulative probabilities showed that T6(85.0%), T1(78.3%) and T4(44.5%) were the most efficacious treatment compared to the other durations. In the ACS (<50%) subgroup, T1 was observed to significantly reduce the risk of major bleeding compared to T4, but not in the ACS (≥50%) subgroup. Conclusions: Compared with other durations, short DAPT followed by P2Y12 inhibitor monotherapy showed non-inferiority, with a lower risk of bleeding and not associated with an increased MACCE. In addition, the risk of major bleeding increased significantly, starting with DAPT for 18-month. Compared with the short-term treatment, patients with ACS with the standard 12-month treatment have a better prognosis, including lower bleeding rate and the decreased risk of MACCE. Due to study's limitations, the results should be verified in different risk populations.

Antithrombotic Therapy in Lower Extremity Artery Disease

2020 ◽  
Vol 18 (3) ◽  
pp. 215-222 ◽  
Author(s):  
Mislav Vrsalovic ◽  
Victor Aboyans
Keyword(s):  
Lower Extremity ◽  
Antiplatelet Therapy ◽  
Antithrombotic Therapy ◽  
Cardiovascular Events ◽  
Cardiovascular Outcomes ◽  
Lower Limbs ◽  
Stent Type ◽  
Increased Risk ◽  
Artery Disease ◽  
Lower Extremity Artery Disease

Lower extremity artery disease (LEAD) is a marker of a more advanced atherosclerotic process often affecting multiple vascular beds beyond the lower limbs, with a consequent increased risk for all-cause and cardiovascular mortality. Antithrombotic therapy is the cornerstone of management of these patients to prevent ischaemic cardiovascular and limb events and death. In patients with symptomatic LEAD, the efficacy of aspirin has been established long ago for the prevention of cardiovascular events. In the current guidelines, clopidogrel may be preferred over aspirin following its incremental ability to prevent cardiovascular events, while ticagrelor is not superior to clopidogrel in reducing cardiovascular outcomes. Dual antiplatelet therapy (DAPT, aspirin with clopidogrel) is currently recommended for at least 1 month after endovascular interventions irrespective of the stent type. Antiplatelet monotherapy is recommended after infra-inguinal bypass surgery, and DAPT may be considered in below-the-knee bypass with a prosthetic graft. In symptomatic LEAD, the addition of anticoagulant (vitamin K antagonists) to antiplatelet therapy increased the risk of major and life-threatening bleeding without benefit regarding cardiovascular outcomes. In a recent trial, low dose of direct oral anticoagulant rivaroxaban plus aspirin showed promising results, not only to reduce death and major cardiovascular events, but also major limb events including amputation. Yet, this option should be considered especially in very high risk patients, after considering also the bleeding risk. Despite all the evidence accumulated since >40 years, many patients with LEAD remain undertreated and deserve close attention and implementation of guidelines advocating the use of antithrombotic therapies, tailored according to their level of risk.

scholarly journals Ischemic and bleeding risk stratification in diabetic patients after acute coronary syndrome based on insulin requirement

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
I Cavallari ◽  
E Sagazio ◽  
E Antonucci ◽  
P Calabro' ◽  
F Gragnano ◽  
...  
Keyword(s):  
Insulin Therapy ◽  
Antiplatelet Therapy ◽  
Clinical Benefit ◽  
Dual Antiplatelet Therapy ◽  
Bleeding Risk ◽  
Diabetic Patients ◽  
Coronary Syndrome ◽  
Diabetes Status ◽  
Increased Risk ◽  
Net Clinical Benefit

Abstract Background Diabetes is a known risk factor for a first or recurrent cardiovascular event, however, its association with an increased risk of bleeding is controversial. To date, no study has explored the prognostic weight of insulin therapy in the setting of ACS. Purpose To investigate the differential role of insulin versus no insulin therapy on ischemic and bleeding risks in patients with diabetes and ACS. Methods START-ANTIPLATELET is a prospective, real-world multicenter registry including consecutive patients admitted for ACS. For the purpose of this analysis, patients were stratified according to diabetes status and insulin therapy. We compared 1-year rates of major adverse cardiovascular events, a composite of cardiovascular death, myocardial infarction and stroke, and of any bleeding, according to diabetes status (no diabetes, diabetes not on insulin therapy, diabetes on insulin therapy). In addition, we evaluated the net clinical benefit of dual antiplatelet therapy with the newer P2Y12 inhibitors (ticagrelor or prasugrel) vs dual antiplatelet therapy with clopidogrel according to diabetes status. Results In an overall population of 907 patients, 198 had diabetes, 10.6% of whom were on insulin. From non-diabetic patients to diabetic patients not on insulin and diabetic patients on insulin there was a stepwise decrease of MACE-free survival (log-rank p 0.039) with incidence of events at 1 year being 3.8%, 6.8% (adjusted p vs no diabetes 0.49) and 12.5% (adjusted p vs no diabetes 0.047), respectively (Figure, panel A). The rates of any bleeding were higher in patients on insulin (20.8% vs 8.8% in those without diabetes and 5.8% in diabetic patients not receiving insulin; log-rank p 0.028; Figure, panel B). Multivariable analysis demonstrated an almost 5-fold increase of any bleeding in diabetic patients with vs without insulin (OR 4.98, 95% CI 1.46–16.92; p=0.010). In the overall population, the incidence of the net composite endpoint including MACE or major bleeding with the use of ticagrelor/prasugrel on top of aspirin was significantly lower compared to use of clopidogrel (4.7% vs 8.4%; OR 0.54, 95% CI 0.30–0.94, p=0.031). This net clinical benefit in patients receiving a newer P2Y12 inhibitor was regardless of the diabetes status (p for interaction 0.48). Conclusions In this cohort of ACS patients, the presence of diabetes stratified by insulin therapy was associated with a graded increase in the 1-year rates of MACE. Conversely, insulin therapy significantly contributed to the overall increase of bleeding risk in diabetes. Funding Acknowledgement Type of funding source: None

Increased Rates of Hemorrhages after Endovascular Stroke Treatment with Emergency Carotid Artery Stenting and Dual Antiplatelet Therapy

2021 ◽  
pp. 1-9
Author(s):  
Felix Hadler ◽  
Raveena Singh ◽  
Martin Wiesmann ◽  
Arno Reich ◽  
Omid Nikoubashman
Keyword(s):  
Risk Factors ◽  
Carotid Artery ◽  
Antiplatelet Therapy ◽  
Carotid Artery Stenting ◽  
Dual Antiplatelet Therapy ◽  
Stroke Treatment ◽  
Systemic Thrombolysis ◽  
Stroke Registry ◽  
Increased Risk ◽  
Arterial Thrombolysis

<b><i>Background:</i></b> While endovascular stroke treatment (EST) of large vessel occlusions in acute ischemic stroke (AIS) is proven to be safe and effective, there are subgroups of patients with increased rates of hemorrhages. Our goal was to identify risk factors for intracerebral hemorrhage and to assess whether acute carotid artery stenting (CAS) was associated with increased bleeding rates. <b><i>Methods:</i></b> We performed a retrospective analysis of our monocentric prospective stroke registry in the period from May 2010 to May 2018 and compared AIS patients receiving EST with (<i>n</i> = 73) versus without acute CAS (<i>n</i> = 548). Patients with intracranial stents, intra-arterial thrombolysis, or dissection of the carotid artery were excluded. <b><i>Results:</i></b> Parenchymal hemorrhage rates (PH2 according to the ECASS classification) and symptomatic hemorrhage (sICH) rates were increased in EST patients receiving CAS with odds being 6.3 (PH2) and 6.5 (sICH) times higher (PH2 17.8 vs. 3.3%, <i>p</i> &#x3c; 0.001 and sICH: 16.4 vs. 2.9%, <i>p</i> &#x3c; 0.001). Additional systemic thrombolysis with rtPA (IVRTPA) was no risk factor for cerebral hemorrhage (<i>p</i> = 0.213). <b><i>Conclusion:</i></b> AIS patients receiving EST with acute CAS and consecutive tirofiban or dual antiplatelet therapy suffered from an increased risk of relevant secondary intracranial bleeding. After adjusting for confounders, tirofiban and dual antiplatelet therapy were associated with higher bleeding rates.

Management of Oral Anti-Coagulation in Patients with Heart Failure—Insights from the ThrombEVAL Study

2018 ◽  
Vol 118 (11) ◽  
pp. 1930-1939
Author(s):  
Sebastian Göbel ◽  
Jürgen Prochaska ◽  
Lisa Eggebrecht ◽  
Ronja Schmitz ◽  
Claus Jünger ◽  
...  
Keyword(s):  
Heart Failure ◽  
Adverse Events ◽  
Vitamin K Antagonists ◽  
Plasma Concentrations ◽  
Regular Care ◽  
Increased Risk ◽  
Patients With Heart Failure ◽  
Specialized Care ◽  
The Impact

AbstractPatients with heart failure (HF) are frequently anti-coagulated with vitamin K-antagonists (VKAs). The use of long-acting VKA may be preferable for HF patients due to higher stability of plasma concentrations. However, evidence on phenprocoumon-based oral anti-coagulation (OAC) therapy in HF is scarce. The aim of this study was to assess the impact of the presence of HF on quality of phenprocoumon-based OAC and the subsequent clinical outcome. Quality of OAC therapy and the incidence of adverse events were analysed in a cohort of regular care (n = 2,011) from the multi-centre thrombEVAL study program (NCT01809015) stratified by the presence of HF. To assess the modifiability of outcome, results were compared with data from individuals receiving specialized care for anti-coagulation (n = 760). Overall, the sample comprised of 813 individuals with HF and 1,160 subjects without HF in the regular care cohort. Quality of OAC assessed by time in therapeutic range (TTR) was 66.1% (47.8%/82.8%) for patients with HF and 70.6% (52.1%/85.9%) for those without HF (p = 0.0046). Stratification for New York Heart Classification (NYHA)-class demonstrated a lower TTR with higher NYHA classes: TTRNYHA-I 69.6% (49.4%/85.6%), TTRNYHA-II 66.5% (50.1%/82.9%) and TTRNYHA-≥III 61.8% (43.1%/79.9%). This translated into a worse net clinical benefit outcome for HF (hazard ratio [HR] 1.63 [1.31/2.02]; p < 0.0001) and an increased risk of bleeding (HR 1.40 [1.04/1.89]; p = 0.028). Management in a specialized coagulation service resulted in an improvement of all, TTR (∆+12.5% points), anti-coagulation-specific and non-specific outcome of HF individuals. In conclusion, HF is an independent risk factor for low quality of OAC therapy translating into an increased risk for adverse events, which can be mitigated by specialized care.

scholarly journals Impact of Diabetes Mellitus on Antithrombotic Management Patterns and Long‐Term Clinical Outcomes in Patients With Acute Coronary Syndrome: Insights From the EPICOR Asia Study

2020 ◽  
Vol 9 (22) ◽  
Author(s):  
Shaoyi Guan ◽  
Xiaoming Xu ◽  
Yi Li ◽  
Jing Li ◽  
Mingzi Guan ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Acute Coronary Syndrome ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
Antiplatelet Agents ◽  
Coronary Syndrome ◽  
Increased Risk ◽  
Antithrombotic Management

Background Long‐term use of antiplatelet agents after acute coronary syndrome in diabetic patients is not well known. Here, we describe antiplatelet use and outcomes in such patients enrolled in the EPICOR Asia (Long‐Term Follow‐up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Asia) registry. Methods and Results EPICOR Asia is a prospective, observational study of 12 922 patients with acute coronary syndrome surviving to discharge, from 8 countries/regions in Asia. The present analysis included 3162 patients with diabetes mellitus (DM) and 9602 patients without DM. The impact of DM on use of antiplatelet agents and events (composite of death, myocardial infarction, and stroke, with or without any revascularization; individual components, and bleeding) was evaluated. Significant baseline differences were seen between patients with DM and patients without DM for age, sex, body mass index, cardiovascular history, angiographic findings, and use of percutaneous coronary intervention. At discharge, ≈90% of patients in each group received dual antiplatelet therapy. At 2‐year follow‐up, more patients with DM tended to still receive dual antiplatelet therapy (60% versus 56%). DM was associated with increased risk from ischemic but not major bleeding events. Independent predictors of the composite end point of death, myocardial infarction, and stroke in patients with DM were age ≥65 years and use of diuretics at discharge. Conclusions Antiplatelet agent use is broadly comparable in patients with DM and patients without DM, although patients with DM are more likely to be on dual antiplatelet therapy at 2 years. Patients with DM are at increased risk of ischemic events, suggesting an unmet need for improved antithrombotic treatment. Registration URL: https://www.clini​caltr​ials.gov ; Unique identifier: NCT01361386.

Optimal Medical Therapy on Top of Dual-Antiplatelet Therapy: 1-Year Clinical Outcome in Patients With Acute Coronary Syndrome: The START Antiplatelet Registry

Angiology ◽  
2019 ◽  
Vol 71 (3) ◽  
pp. 235-241 ◽  
Author(s):  
Plinio Cirillo ◽  
Luigi Di Serafino ◽  
Vittorio Taglialatela ◽  
Paolo Calabrò ◽  
Emilia Antonucci ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Clinical Outcome ◽  
Antiplatelet Therapy ◽  
Medical Therapy ◽  
Real World ◽  
Dual Antiplatelet Therapy ◽  
Optimal Medical Therapy ◽  
Cerebrovascular Event ◽  
Coronary Syndrome ◽  
The Impact

Optimal medical therapy (OMT) at discharge is recommended after acute coronary syndrome (ACS). Few studies report the impact of OMT on long-term clinical outcome in a real-world scenario. We evaluated the impact of discharge OMT on top of dual-antiplatelet therapy (DAPT) on clinical outcome in the real-world ACS population of the Survey on anTicoagulated pAtients RegisTer ANTIPLATELET registry. The primary end point was major adverse cardiac and cerebrovascular event (MACCE), a composite of death, myocardial infarction, stroke, or target vessel revascularization. The co-primary end point was net adverse cardiac and cerebrovascular event (NACE), based on MACCE plus major bleeding. Consecutive patients with ACS with 1-year follow-up were enrolled. They were evaluated at discharge for the use of a β-blocker, angiotensin-converting enzyme inhibitor/angiotensin II receptor blockers and statins. Optimal medical therapy was defined as the use of ≥2 of 3 medications. At multivariate analysis, both MACCE and NACE were significantly higher in non-OMT patients than in OMT patients (MACCE 18 [19] vs 59 [9], hazard ratio [HR] = 0.44 [0.26-0.75], P = .002, NACE 19 [20] vs 67 [10], HR = 0.47 [0.28-0.79], P = .004). In this real-world scenario, OMT at discharge on top of DAPT seems associated with a better clinical outcome compared with patients discharged on non-OMT.

scholarly journals Antithrombotic therapy according to baseline bleeding risk in patients with atrial fibrillation undergoing percutaneous coronary intervention: applying the PRECISE-DAPT score in RE-DUAL PCI

2020 ◽  
Author(s):  
Francesco Costa ◽  
Marco Valgimigli ◽  
Philippe Gabriel Steg ◽  
Deepak L Bhatt ◽  
Stefan H Hohnloser ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Antithrombotic Therapy ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Bleeding Complications ◽  
Event Analysis ◽  
Increased Risk ◽  
Safety Endpoint ◽  
High Bleeding Risk ◽  
The Impact

Abstract Aims Patients with atrial fibrillation undergoing coronary intervention are at higher bleeding risk due to the concomitant need for oral anticoagulation and antiplatelet therapy. The RE-DUAL PCI trial demonstrated better safety with dual antithrombotic therapy (DAT: dabigatran 110 or 150 mg b.i.d., clopidogrel or ticagrelor) compared to triple antithrombotic therapy (TAT: warfarin, clopidogrel or ticagrelor, and aspirin). We explored the impact of baseline bleeding risk based on the PRECISE-DAPT score for decision-making regarding DAT vs. TAT. Methods and results A score ≥25 points qualified high bleeding risk (HBR). Comparisons were made for the primary safety endpoint International Society of Thrombosis and Haemostasis major or clinically relevant non-major bleeding, and the composite efficacy endpoint of death, thrombo-embolic events, or unplanned revascularization, analysed by time-to-event analysis. PRECISE-DAPT was available in 2336/2725 patients, and 37.9% were HBR. Compared to TAT, DAT with dabigatran 110 mg reduced bleeding risk both in non-HBR [hazard ratio (HR) 0.42, 95% confidence interval (CI) 0.31–0.57] and HBR (HR 0.70, 95% CI 0.52–0.94), with a greater magnitude of benefit among non-HBR (Pint = 0.02). Dual antithrombotic therapy with dabigatran 150 mg vs. TAT reduced bleeding in non-HBR (HR 0.60, 95% CI 0.45–0.80), with a trend toward less benefit in HBR patients (HR 0.92, 95% CI 0.63–1.34; Pint = 0.08). The risk of ischaemic events was similar on DAT with dabigatran (both 110 and 150 mg) vs. TAT in non-HBR and HBR patients (Pint = 0.45 and Pint = 0.56, respectively). Conclusions PRECISE-DAPT score appeared useful to identify AF patients undergoing PCI at further increased risk of bleeding complications and may help clinicians identifying the antithrombotic regimen intensity with the best benefit–risk ratio in an individual patient.

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