scholarly journals Ticagrelor Monotherapy Versus Ticagrelor With Aspirin in Acute Coronary Syndrome Patients With a High Risk of Ischemic Events

Author(s):  
Seung-Jun Lee ◽  
Yong-Joon Lee ◽  
Byeong-Keuk Kim ◽  
Sung-Jin Hong ◽  
Chul-Min Ahn ◽  
...  

Background: In patients with acute coronary syndrome (ACS) with a high risk of ischemia, the impact of ticagrelor monotherapy after short-term dual antiplatelet therapy (DAPT) has not been clearly elucidated. Methods: This post hoc analysis of the TICO trial (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus-Eluting Stent for Acute Coronary Syndrome) compared the impact of ticagrelor monotherapy after 3-month DAPT versus ticagrelor-based 12-month DAPT in patients with high-ischemic risk ACS, defined as any of the following: number of stents implanted ≥3, total stent length >60 mm, complex procedures (chronic total occlusion, left main occlusion, or bifurcation plaques remedied using the 2-stent technique), or a history of diabetes or chronic kidney disease. Ischemic (composite of death, myocardial infarction, stent thrombosis, stroke, and target vessel revascularization) and bleeding outcomes (major bleeding) were evaluated at 12 months. Results: Of the total population (N=3056), 1473 (48.2%) patients were identified as having high-ischemic risk ACS. The rate of the ischemic outcome was significantly higher in high-ischemic risk ACS patients than in nonhigh-ischemic risk ACS patients (3.9% versus 1.9%, hazard ratio, 2.14 [95% CI, 1.37–3.35], P =0.001). Furthermore, the risk of major bleeding (3.2% versus 1.5%, hazard ratio, 2.23 [95% CI, 1.36–3.68], P =0.001) and the composite ischemic and bleeding outcome (6.6% versus 3.3%, hazard ratio, 2.02 [95% CI, 1.44–2.84], P <0.001) were also higher in the high-risk ACS population. In ACS patients with or without high-ischemic risk, the effect of ticagrelor monotherapy after 3-month DAPT, as compared to that of 12-month DAPT, was consistent with ischemic ( P int =0.718), bleeding ( P int =0.092), and composite outcomes ( P int =0.094) without significant interactions. Conclusions: There were no significant heterogeneities in the impact of ticagrelor monotherapy after 3-month DAPT compared with that of ticagrelor-based 12-month DAPT on clinical outcomes according to the presence of high-ischemic risk. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02494895.

2021 ◽  
Vol 8 ◽  
Author(s):  
Wen-Jiao Zhang ◽  
Xuan Qiao ◽  
Wen-Fen Guo ◽  
Xi-Ying Liang ◽  
Yan Li ◽  
...  

Background and Objective: The optimum duration of dual antiplatelet therapy (DAPT) remains uncertain in patients with acute coronary syndrome treated with new generation stents. This meta-analysis was performed to investigate ischemia and bleeding outcomes with different DAPT strategies.Methods: PubMed, Embase, Cochrane and Web of science from inception to May 27, 2020, were systematically searched. Randomized controlled trials were included to compare short-term (6 months or less) with standard (12 months) DAPT in patients with acute coronary syndrome treated with new generation stents. The primary endpoints were myocardial infarction, definite or probable stent thrombosis and major bleeding. The secondary endpoints included all-cause death, cardiovascular death, stroke, target vessel revascularization and net adverse clinical events. Random effect model and fixed effect model were used to calculate the odds ratio (OR) and 95% confidence interval (CI) of each endpoint.Results: Four randomized controlled trials and seven subgroup analyses of larger randomized controlled trials, including a total of 21,344 patients with acute coronary syndrome, met our inclusion criteria. The shorter DAPT was associated with significantly lower major bleeding compared with the standard DAPT (OR 0.71, 95% CI 0.56–0.90, P = 0.005, I2 = 25%), while without increasing the risk of myocardial infarction (OR 1.18, 0.88–1.58, P = 0.28, I2 = 20%), definite or probable stent thrombosis (OR 1.60, 0.98–2.59, P = 0.06, I2 = 0%). No significantly difference was observed in the risk of all-cause death (OR 0.96, 0.72–1.27, P = 0.76, I2 = 2%), cardiovascular death (OR 0.91, 0.62–1.33, P = 0.62, I2 = 0%), stroke (OR 0.84, 0.54–1.30, P = 0.43, I2 = 0%), target vessel revascularization (OR 1.14, 0.84–1.55, P = 0.41, I2 = 8%), and net adverse clinical events (OR 0.93, 0.80–1.07, P = 0.3, I2 = 18%) between the two groups.Conclusions: In patients with acute coronary syndrome treated with new generation stents, the shorter DAPT leads to a marked reduction in the risk of major bleeding compared with the standard DAPT. This benefit is achieved without increasing the risk of mortality or ischemic outcomes. The study protocol was registered in PROSPERO (CRD42020189871).


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K K Lee ◽  
A V Ferry ◽  
A Anand ◽  
F E Strachan ◽  
A R Chapman ◽  
...  

Abstract Background/Introduction Major disparities between women and men in the diagnosis, management and outcome of acute coronary syndrome are well recognised. Whether sex-specific diagnostic thresholds for myocardial infarction will address these differences is uncertain. Purpose To evaluate the impact of implementing a high-sensitivity cardiac troponin I (hs-cTnI) assay with sex-specific diagnostic thresholds for myocardial infarction in women and men with suspected acute coronary syndrome. Methods In a stepped-wedge, cluster-randomized controlled trial across ten hospitals we evaluated the implementation of a hs-cTnI assay in 48,282 (47% women) consecutive patients with suspected acute coronary syndrome. During a validation phase the hs-cTnI assay results were suppressed and a contemporary cTnI assay with a single threshold was used to guide care. Myocardial injury was defined as any hs-cTnI concentration >99th centile of 16 ng/L in women and 34 ng/L in men. The primary outcome was myocardial infarction after the initial presentation or cardiovascular death at 1 year. In this prespecified analysis, we evaluated outcomes in men and women before and after implementation of the hs-cTnI assay. Results Use of the hs-cTnI assay with sex-specific thresholds increased myocardial injury in women by 42% (from 3,521 (16%) to 4,991 (22%)) and by 6% in men (from 5,068 (20%) to 5,369 (21%)). Whilst treatment increased in both sexes, women with myocardial injury remained less likely than men to undergo coronary revascularisation (15% versus34%), or to receive dual anti-platelet (26% versus43%), statin (16% versus26%) or other preventative therapies (P<0.001 for all). The primary outcome occurred in 18% (369/2,072) and 17% (488/2,919) of women with myocardial injury during the validation and implementation phase respectively (adjusted hazard ratio 1.11, 95% confidence interval 0.92 to 1.33), compared to 18% (370/2,044) and 15% (513/3,325) of men (adjusted hazard ratio 0.85, 95% confidence interval 0.71 to 1.01). Patient management Conclusion Use of sex-specific thresholds identified five-times more additional women than men with myocardial injury, such that the proportion of women and men with myocardial injury is now similar. Despite this increase, women received approximately half the number of treatments for coronary artery disease as men and their outcomes were not improved. Acknowledgement/Funding The British Heart Foundation


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
Y Minematsu ◽  
M Natsuaki ◽  
G Yoshioka ◽  
K Shinzato ◽  
Y Nishimura ◽  
...  

Abstract Background/Introduction CREDO-Kyoto bleeding risk score was developed to predict the post-discharge bleeding events in patients with percutaneous coronary intervention. However, there were limited reports of the effectiveness of this score to predict the in-hospital bleeding events in patients with acute coronary syndrome (ACS). Methods We evaluated 562 consecutive ACS patients in Saga university hospital between 2014 and 2019. Primary outcome was major bleeding during hospitalization. Major bleeding was defined as the GUSTO moderate/severe bleeding. Patients were classified into three groups according to the CREDO-Kyoto bleeding risk score (low, intermediate and high). Results Major bleeding events occurred in 12.1% of all patients during hospitalization. Patients in the high risk group (n=22) had significantly higher incidence of major bleeding than those in the intermediate (n=113) and the low risk groups (n=427) (22.7%, 18.6%, versus 9.8%, respectively, p=0.018, see figure). Multivariate analysis showed that intermediate and high risk groups were independent predictors for the in-hospital major bleeding. Conclusions CREDO-Kyoto risk score successfully identified high risk ACS patients for the major bleeding during hospitalization. FUNDunding Acknowledgement Type of funding sources: None. Results


Author(s):  
Bradley H. Strauss ◽  
Merril L. Knudtson ◽  
Asim N. Cheema ◽  
P. Diane Galbraith ◽  
Gabby Elbaz-Greener ◽  
...  

Background: Chronic total occlusions (CTO) occur in nearly 20% of coronary angiograms. CTO revascularization, either by percutaneous coronary intervention (PCI) or coronary artery bypass grafting surgery (CABG), is infrequently performed, approximately one-third of cases. Long-term outcomes are unknown. The objective of the study was to determine whether early CTO revascularization of patients, either by CABG or PCI, was associated with improved clinical outcomes. Methods: One thousand six hundred twenty-four patients from the Canadian CTO registry were followed for at least 9.75 years. Revascularization was performed according to routine clinical practice. Patients were grouped according to CTO revascularization status (PCI or CABG of CTO vessel, CTO revasc) or no CTO revasc (medical therapy only, or PCI/CABG of non-CTO vessels only), within 3 months of initial angiogram. Patients were followed for mortality, revascularization procedures (PCI and CABG), and hospitalizations for acute coronary syndromes and heart failure. Results: Early CTO revasc was performed in 28.2% of patients (17.5% CABG, 10.7% PCI). The CTO revasc group was younger, with more males and generally fewer comorbidities. There was a significantly lower mortality probability at 10 years in the CTO revascularization group (22.7% [95% CI, 19.0%–26.9%]) compared with the no CTO revasc group (36.6% [95% CI, 33.8%–39.5%]). At 10 years, revascularization rates (14.0% versus 22.8%) and acute coronary syndrome hospitalization rates (10.0% versus 16.6%) were significantly lower in the CTO revasc group. Baseline-adjusted analysis showed CTO revasc was associated with significantly lower all-cause mortality (hazard ratio, 0.67 [95% CI, 0.54–0.84]). In both landmark and time varying analyses, association with lower mortality was particularly robust for CTO revascularization by CABG (hazard ratio 0.56 and 0.60, respectively), with a marginally significant result for PCI in the time varying analysis (hazard ratio 0.711 [95% CI, 0.51–0.998]). Conclusions: Early CTO revascularization was associated with significantly lower all-cause mortality, revascularization rates, and hospitalization for acute coronary syndrome at 10 years, and mainly driven by outcomes in patients with CABG.


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Roxana Mehran ◽  
Ajay J Kirtane ◽  
George D Dangas ◽  
E. M Ohman ◽  
Stuart Pocock ◽  
...  

Background: In the ACUITY Trial, patients (pts) with chronic renal insufficiency (CRI) had significantly higher rates of ischemic events and major bleeding compared to pts without CRI at 30 days. Bivalirudin (Biv) monotherapy provided similar protection from ischemic events but with significantly less bleeding compared to heparin + a GPIIb/IIIa inhibitor (Hep+GPI). The impact of a Biv alone strategy on one year mortality is unknown. Methods: Pts with moderate and high risk acute coronary syndromes (ACS) were randomized to Hep + GPI, Biv + GPI, or Biv monotherapy. CRI was defined as baseline creatinine clearance (CrCl) <60 mL/min. We evaluated the impact of CRI and antithrombotic strategy on composite ischemia (death, MI, or revascularization) and mortality at one year. Results: Of the pts enrolled, 12,933 had baseline CrCl data: 2468 (19.1%) pts had CrCl ≥60 mL/min and 10,465 (80.9%) pts had CrCl <60 mL/min. Rates of major bleeding at 30 days in pts with CRI were significantly lower with Biv alone vs Hep+GPI (6.2% vs 9.8%, p<0.01). Pts with CRI had higher mortality at one year compared to those without CRI (8.7% vs 3.0%, p<0.001). There was no difference in composite ischemia for pts who received Biv monotherapy vs Hep + GPI (23.0% vs 21.4%, p=0.10). One year mortality by antithrombin strategy is shown in the Figure . Conclusions: CRI in pts with ACS is associated with higher rates of one year mortality. In these high risk pts, Biv monotherapy improved early clinical outcomes compared to Hep + GPI by reducing major bleeding, and resulted in similar rates of one year mortality. Cumulative Mortality at One Year, Patients with CRI


2019 ◽  
Vol 8 (6) ◽  
pp. 510-519 ◽  
Author(s):  
Sebastian Völz ◽  
Oskar Angerås ◽  
Sasha Koul ◽  
Inger Haraldsson ◽  
Giovanna Sarno ◽  
...  

Aims: In the Bivalirudin versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated according to Recommended Therapies Registry Trial (VALIDATE-SWEDEHEART), bivalirudin was not superior to unfractionated heparin in patients with acute coronary syndrome undergoing invasive management. We assessed whether the access site had an impact on the primary endpoint of death, myocardial infarction or major bleeding at 180 days and whether it interacted with bivalirudin/unfractionated heparin. Methods and results: A total of 6006 patients with acute coronary syndrome planned for percutaneous coronary intervention were randomised to either bivalirudin or unfractionated heparin. Arterial access was left to the operator discretion. Overall, 90.5% of patients underwent transradial access and 9.5% transfemoral access. Baseline risk was higher in transfemoral access. The unadjusted hazard ratio for the primary outcome was lower with transradial access (hazard ratio 0.53, 95% confidence interval 0.43–0.67, p<0.001) and remained lower after multivariable adjustment (hazard ratio 0.56, 95% confidence interval 0.52–0.84, p<0.001). Transradial access was associated with lower risk of death (hazard ratio 0.41, 95% confidence interval 0.28–0.60, p<0.001) and major bleeding (hazard ratio 0.57, 95% confidence interval 0.44–0.75, p<0.001). There was no interaction between treatment with bivalirudin and access site for the primary endpoint ( p=0.976) or major bleeding ( p=0.801). Conclusions: Transradial access was associated with lower risk of death, myocardial infarction or major bleeding at 180 days. Bivalirudin was not associated with less bleeding, irrespective of access site.


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