Early and late outcome associated with bleeding events in the setting of dual antiplatelet therapy following stent placement

2012 ◽  
Vol 80 (3) ◽  
pp. 406-407
Author(s):  
Wael El Mallah ◽  
David J. Moliterno
2020 ◽  
Vol 14 ◽  
Author(s):  
Johny Nicolas ◽  
Usman Baber ◽  
Roxana Mehran

A P2Y12 inhibitor-based monotherapy after a short period of dual antiplatelet therapy is emerging as a plausible strategy to decrease bleeding events in high-risk patients receiving dual antiplatelet therapy after percutaneous coronary intervention. Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention (TWILIGHT), a randomized double-blind trial, tested this approach by dropping aspirin at 3 months and continuing with ticagrelor monotherapy for an additional 12 months. The study enrolled 9,006 patients, of whom 7,119 who tolerated 3 months of dual antiplatelet therapy were randomized after 3 months into two arms: ticagrelor plus placebo and ticagrelor plus aspirin. The primary endpoint of interest, Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, occurred less frequently in the experimental arm (HR 0.56; 95% CI [0.45–0.68]; p<0.001), whereas the secondary endpoint of ischemic events was similar between the two arms (HR 0.99; 95% CI [0.78–1.25]). Transition from dual antiplatelet therapy consisting of ticagrelor plus aspirin to ticagrelor-based monotherapy in high-risk patients at 3 months after percutaneous coronary intervention resulted in a lower risk of bleeding events without an increase in risk of death, MI, or stroke.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H.Y Wang ◽  
K.F Dou ◽  
B Xu ◽  
R.L Gao ◽  
A Kirtane

Abstract Background Dual-antiplatelet therapy (DAPT) exceeding 1 year may increase a bleeding risk despite reducing the risk of ischemic events. The benefits and harms of prolonging DAPT with aspirin and clopidogrel beyond 1 year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation for TWLIGHT-like patients with high-risk for bleeding or an ischemic event remain unknown. Method Between January 2013 and December 2013, all consecutive patients undergoing PCI were prospectively included in the China Fuwai PCI Registry. We evaluated 7521 patients who were at high risk for ischemic or hemorrhagic complications and were events free (no death, myocardial infarction [MI], stroke, stent thrombosis [ST], any revascularization, or major bleeding) at 1 year after the index procedure. Subjects were divided into 2 groups: DAPT&gt;1-year group (n=5252) and DAPT≤1-year group (n=2269). Patients at high-risk for ischemic or bleeding events were defined as having at least one additional clinical feature and one angiographic feature according to TWILIGHT trial criteria. The clinical criteria for high risk were age≥65 years, female sex, troponin-positive ACS, established vascular disease, diabetes mellitus that was being treated with medication, and CKD. Angiographic criteria included multivessel coronary artery disease, total stent lengthd≥30 mm, a thrombotic target lesion, a bifurcation lesion treated with two stents, an obstructive left main or proximal left anterior descending lesion, and a calcified target lesion treated with atherectomy. The primary outcome was major adverse cardiac and cerebrovascular events [MACCE] (a composite of all-cause death, MI, or stroke). Results During a median follow-up of 30 months after the index procedure, DAPT&gt;1-year was associated with a reduction in risk for MACCE compared with DAPT≤1-year (1.5% vs. 3.8%; adjusted hazard ratio [HR]: 0.36; 95% confidence interval [CI]: 0.27–0.50; P&lt;0.001) after multivariable adjustment. This difference was largely driven by a lower risk of all-cause mortality. In contrast, the risk of BARC type 2, 3 or 5 bleeding was statistically similar between the 2 groups (1.0% vs. 1.1%; adjusted HR: 0.81; 95% CI: 0.50–1.30; P=0.373). After propensity score matching, incidence of MACCE was still lower in the DAPT&gt;1-year group than the DAPT≤1-year group (1.6% versus 4.5%; HR, 0.34; 95% CI, 0.22–0.52; P&lt;0.001) and the rates of BARC type 2, 3 or 5 bleeding was not different between the 2 groups (1.1% versus 0.9%; adjusted HR, 1.12; 95% CI, 0.57–2.18; P=0.744). In subgroup analysis, the treatment effect of prolonged DAPT was consistent across subgroups regardless of ACS, DAPT score, or type of used DES. Conclusions DAPT continuation with aspirin and clopidogrel beyond 1-year after DES implantation resulted in a significantly lower rate of MACCE, with no higher risk of clinically relevant bleeding in TWLIGHT-like patients who were at high-risk for ischemic or bleeding events. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences; National Natural Science Foundation of China


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Sami J Natour ◽  
May Myint Thanda Kyaw ◽  
Ronald W Busuttil ◽  
Jonathan M Tobis ◽  
Henry M Honda

Introduction: Randomized trials have demonstrated the safety and efficacy of one month of dual antiplatelet therapy (DAPT) after placement of drug-eluting stents in patients with high bleeding risk. Patients with end-stage liver disease (ESLD) are underrepresented in these trials. Patients who undergo percutaneous coronary intervention (PCI) in preparation for orthotopic liver transplantation (OLT) exhibit a high incidence of bleeding complications on DAPT. The rates of bleeding versus thrombotic complications in ESLD patients placed on DAPT following PCI are poorly described. Methods: We retrospectively collected data from 61 patients who were evaluated for OLT between 2016 and 2019 and underwent PCI prior to listing. Bleeding events were classified using the Bleeding Academic Research Consortium (BARC) definitions and included if the following criteria were met: events occurred in the setting of DAPT, were non-procedural in etiology, and occurred during the time following PCI and prior to OLT. Ischemic complications were evaluated by the incidence of myocardial infarction (MI), stent thrombosis, in-stent restenosis (>50%) and all-cause mortality at 1 year follow-up. Results: A total of 55/61 patients (90%) were placed on DAPT following PCI. Among them, 21/55 patients (38%) bled while taking DAPT, including 15 patients (27%) with BARC types 3-5 first-time bleeding events and 10 patients (18%) requiring early discontinuation of therapy. The median time to first bleeding event was 8 days (range 1 to 477 days, 85 th percentile 17 days). Among ischemic complications, MI occurred in 11/55 patients (20%) however only one patient had a type 1 MI with the remaining being type 2 in etiology. There were no episodes of stent thrombosis and 2 episodes of in-stent restenosis during the 1 year follow-up. A total of 12/55 patients (22%) went on to receive OLT and 18/55 (33%) passed away by 1 year post-PCI. Conclusions: Patients with ESLD exhibit a high rate of clinically significant bleeding on DAPT when compared to overall thrombotic events. The majority of bleeds occurred within the first month after PCI. These findings illustrate the need for larger studies to assess the safety of single instead of dual antiplatelet therapy in patients with ESLD who receive PCI.


2009 ◽  
Vol 1 ◽  
pp. CMT.S1170
Author(s):  
Roberta Rossini ◽  
Giuseppe Musumeci ◽  
Tamar Nijaradze ◽  
Antonello Gavazzi

Antiplatelet therapy is the cornerstone in the modern therapy of patients with acute coronary syndromes (ACS), because of the unique role of platelets in coronary thrombosis. Clopidogrel in combination with aspirin is the current “gold standard” for reducing cardiovascular events in such patients, providing a synergistic platelet inhibition through different platelet activation pathways. Clopidogrel is a thienopyridine which inhibits ADP-induced platelet aggregation, with no direct effects on the metabolism of arachidonic acid. Due to a better safety profile with a similar antiplatelet effectiveness, it is preferred to ticlopidine. In patients with ACS without ST segment elevation (NSTEMI), clopidogrel plus aspirin is able to reduce the relative risk of adverse cardiovascular events by 20%, compared with aspirin alone. Clopidogrel plays a key role also in patients undergoing coronary stenting, in order to prevent stent thrombosis. Pretreatment and long-term treatment with clopidogrel reduces by about one-third the risk of cardiovascular death or myocardial infarction in NSTEMI ACS patients undergoing percutaneous coronary angioplasty (PCI). However, a long-term dual antiplatelet therapy is associated with a higher rate of bleeding events. Clinical practice guidelines currently recommend long-term dual antiplatelet therapy with aspirin and clopidogrel in patients with ACS and a pre-treatment with clopidogrel in every patient scheduled for PCI. The concept of clopidogrel resistance and the need for a pretreatment in patients undergoing coronary stent implantation led to the concept that an improved antiplatelet regimen with novel drugs is desirable.


2020 ◽  
Vol 13 (5) ◽  
pp. 749-752
Author(s):  
Alexandru Burlacu ◽  
Adrian Covic

Abstract In this issue of Clinical Kidney Journal, Park et al. presents the results of a nationwide population-based trial that included &gt;5000 dialysis patients receiving a drug-eluting stent (DES). The main objective was to evaluate the effectiveness and the safety of prolonged dual antiplatelet therapy (DAPT). The primary outcome was a composite of mortality, non-fatal myocardial infarction, coronary revascularization and stroke, significantly lowered by a longer DAPT regimen at 12, 15 and 18 months, respectively. Longer DAPT tended to be correlated with higher bleeding events at all landmarks, with no statistical significance. An important element was that almost 75% of the index events were acute coronary syndromes. This study presents the first solid evidence for a significant benefit of prolonged DAPT in dialysis patients receiving a DES. We believe that end-stage renal disease is still in the middle of a rope game, being pulled to one side or another by other features, inclining towards a higher bleeding risk or towards higher ischaemic risk. The acute versus elective presentation seems to weigh in choosing the antiplatelet regimen. The ‘one-size-fits-all strategy’ is not suitable for this particular group. Probably in the future, practitioners will be provided with decision pathways generated by artificial intelligence algorithms yielding ‘truly individualized’ DAPT protocols for every single patient.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1249-1249
Author(s):  
Chenyu Lin ◽  
Karlyn A. Martin ◽  
Mei Wang ◽  
Brady L. Stein ◽  
Kush R. Desai

Abstract Introduction Chronic deep venous insufficiency (CVI) is a common disorder of the venous valves which can cause many debilitating symptoms including edema, pain, and skin changes. CVI may result from a primary non-thrombotic cause, such as May-Thurner syndrome (MTS) or extrinsic compression from a pelvic mass, or as the sequelae of an acute deep vein thrombosis (DVT). Endovascular interventions, including percutaneous transluminal angioplasty and venous stent placement, have been increasingly utilized as a minimally-invasive treatment option for CVI. In patients treated via endovascular therapy, stent restenosis is a significant area of clinical concern. However, there is a paucity of data on the optimal preventative long-term antithrombotic strategy. Current practice is highly variable and employs a combination of anticoagulation and antiplatelet agents, which borrows heavily from experience with venous thromboembolism and arterial stent management, respectively. This study examines the prescribing patterns and outcomes of various antithrombotic regimens after venous stent placement at a large academic medical center. Methods Patients who received venous stents at our institution between January 1st, 2010 and December 31st, 2015 were eligible for the study. A retrospective review was performed to determine the antithrombotic regimens and the rates of stent restenosis and major bleeding within two years of stent placement. The relationship between these outcomes and antithrombotic regimens was analyzed via logistic regression. Additional logistic regression and linear regression models were used to evaluate the impact of indications and hypercoagulable risk factors on the selection of antithrombotic agents. Results A total of 151 patients were included in the study (Table 1). Antithrombotic regimens were variable: 58 patients (38%) received triple therapy (i.e., anticoagulation plus dual antiplatelet therapy), 25 (17%) received anticoagulation only, 21 (14%) received anticoagulation plus a single antiplatelet agent, 15 (10%) received dual antiplatelet therapy only, 10 (7%) received a single antiplatelet, and 22 (15%) received no antithrombotic therapy (Figure 1). Patients with acute DVTs with or without MTS were more frequently given multiple antithrombotic agents compared to those with extrinsic compression. The duration of antithrombotic therapy was also variable. When anticoagulation was prescribed (n = 104), 31% received indefinite therapy, followed by 22% for 6 months and 12% for 3 months. Patients with a history of prior DVTs or thrombophilia were more likely to be prescribed indefinite anticoagulation. Aspirin was most commonly prescribed for an indefinite duration (62 of 88 patients) while clopidogrel was most commonly prescribed for just 3 months (60 of 89 patients). Twenty-three patients (15%) developed stent restenosis. Triple antithrombotic therapy had significantly lower rates of stent restenosis compared to no antithrombotic therapy (OR = 0.05, p < 0.01), and was associated with lower rates of restenosis compared to anticoagulation alone (OR = 0.19, p = 0.07) and dual antiplatelet therapy (OR = 0.25, p = 0.09). Anticoagulation with a single antiplatelet agent also led to lower rates of stent restenosis when compared to no antithrombotic therapy (OR = 0.08, p = 0.04). Medication non-compliance and antiphospholipid antibody syndrome were identified as independent predictors of stent restenosis (OR = 8.84, p = 0.01 and OR = 7.11, p = 0.03, respectively). Major bleeding was observed in 11 patients (7%). Of note, there were no major bleeding events observed in the dual antiplatelet or single antiplatelet groups, which were thus excluded from the regression model. Among the remaining treatment groups, there was no significant difference in major bleeding rates. Conclusions This study emphasizes the considerable variability in the prescribing patterns of long-term antithrombotic therapy after venous stent placement. There appears to be benefit to antithrombotic therapy in preventing stent restenosis, particularly when anticoagulation is combined with antiplatelet agents. However, this may be counterbalanced by an increased risk of bleeding. Larger prospective trials are needed to evaluate the relative risks and benefits of each antithrombotic regimen, and ultimately determine the optimal management strategy, following venous stent placement. Disclosures Desai: Philips/Spectranetics: Other: consulting; Cook Medical: Other: consulting, Speakers Bureau; Boston Scientific: Other: consulting, Speakers Bureau; AngioDynamics: Other: consulting, Speakers Bureau; OptiMed: Other: consulting.


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