scholarly journals Safety and efficacy of bivalirudin in diabetic acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI)

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
A Golam Mostofa ◽  
T Parvin ◽  
R Masum Mandal ◽  
S Ali Ahsan ◽  
R Afrin
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Major Bleeding ◽  
Guide Wire ◽  
Coronary Intervention ◽  
Diabetic Patients ◽  
Safety And Efficacy ◽  
Coronary Syndrome ◽  
Percutaneous Coronary ◽  
Hemorrhagic Complications

Abstract Background Prevention of hemorrhagic complications has emerged as a priority in patients undergoing Percutaneous Coronary Intervention (PCI) in addition to suppressing thrombotic complications. This goal is challenging to achieve in diabetic Acute Coronary Syndrome (ACS) patients as Diabetes Mellitus (DM) itself is a prothrombotic state with more pronounced vascular injury response and have a worse outcome after PCI compared with non-diabetic patients. In patients with ACS, Bivalirudin has been shown to result in similar rates of composite ischemia as Heparin plus GPI (GP IIb /IIIa inhibitor), while significantly reducing major bleeding and has received class I recommendation for PCI by American College of Cardiology (ACC 2013). Whether Bivalirudin is safe and effective specially in diabetic ACS patients undergoing PCI, as compared with Heparin (UFH) monotherapy, is unknown. Purpose To determine and compare the incidence of in-hospital and 30-day hemorrhagic complications and major adverse cardiac events (MACEs) as evidence of safety and efficacy using Bivalirudin versus Heparin in diabetic ACS patients undergoing PCI. Methods 218 diabetic ACS patients (age>18 years and ≤75 years) who underwent PCI from May 2018 to April 2019 at University Cardiac Centre, BSM Medical University, Dhaka, Bangladesh were randomly assigned to have UFH or Bivalirudin. Before the guide wire crossed the lesion, 111 patients in the UFH group received a bolus of 70–100 U/kg (targeted activated clotting time, ACT: 200–250 s). 107 patients in the Bivalirudin group received a loading dose of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h for up to 4 hours. Dual antiplatelet (DAPT) loading as Aspirin 300 mg plus P2Y12 inhibitors (Clopidogrel 600 mg or Prasugrel 60 mg or Ticagrelor 180 mg) was given in all patients before the procedure. The maintenance dose of DAPT was continued for at least one month and patients were followed telephonically up to 30 days. The outcome measures were in-hospital and 30-day hemorrhagic complications and MACEs [death, MI, target vessel revascularization (TVR) and stroke]. Results Patients treated with Bivalirudin compared with Heparin had a significantly lower in-hospital incidence of QMI (0% vs. 6%; p=0.03) and major bleeding (0% vs. 7%; p=0.02). However, the incidence of cardiac death, stent thrombosis, TVR were no differences between two groups (p>0.05). There was only one NQMI in the Bivalirudin group as opposed to 8% in the Heparin group in 30 days following stenting (p=0.04). Conclusion In diabetic ACS patients undergoing PCI, Bivalirudin is safe and effective as it reduces immediate and short-term hemorrhagic complications as well as MACEs as compared with Heparin. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals Safety and Efficacy of Bivalirudin in Diabetic Acute Coronary Syndrome (ACS) Patients Undergoing Percutaneous Coronary Intervention (PCI)

2021 ◽  
Vol 3 (2) ◽  
pp. 93-97
Author(s):  
A.B.M. Golam Mostofa ◽  
Tanjima Parvin ◽  
Mohammad Rayhan Masum Mandal ◽  
Rawnak Afrin ◽  
Syed Ali Ahsan
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Major Bleeding ◽  
Coronary Intervention ◽  
Controlled Study ◽  
Small Scale ◽  
Safety And Efficacy ◽  
Coronary Syndrome ◽  
Percutaneous Coronary ◽  
Hemorrhagic Complications

Objective: To determine and compare the incidence of in-hospital and 30-day hemorrhagic complications and major adverse cardiac events (MACEs) as evidence of safety and efficacy using Bivalirudin versus Heparin in diabetic acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) in a tertiary care cardiac hospital. Background: Prevention of hemorrhagic complications has emerged as a priority in patients undergoing PCI in addition to suppressing thrombotic complications. This goal is challenging to achieve in diabetic ACS patients as DM itself is a prothrombotic state with more pronounced vascular injury response and have a worse outcome after PCI compared with non-diabetic patients. In patients with ACS, Bivalirudin has been shown to result in similar rates of composite ischemia as Heparin plus GPI (GP IIb /IIIa inhibitor), while significantly reducing major bleeding and has received class I recommendation for PCI. Whether Bivalirudin is safe and effective in diabetic ACS patients undergoing PCI, as compared with Heparin (UFH) monotherapy, is unknown. Methods: 218 diabetic ACS patients (age>18 years and ≤ 75 years) who underwent PCI from May 2018 to April 2019 at UCC, BSMMU, Dhaka, Bangladesh were randomly assigned to have UFH or Bivalirudin. Before the guide wire crossed the lesion, 111 patients in the UFH group received a bolus of 70-100 U/kg (targeted activated clotting time, ACT: 200-250 s). 107 patients in the Bivalirudin group received a loading dose of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h for up to 4 hours. Dual antiplatelet (DAPT) loading as Aspirin 300 mg plus P2Y12 inhibitors (Clopidogrel 600 mg or Prasugrel 60 mg or Ticagrelor 180 mg) was given in all patients before the procedure. The maintenance dose of DAPT was continued for at least one month and patients were followed telephonically up to 30 days. The outcome measures were in-hospital and 30-day hemorrhagic complications and MACEs [death, MI, target vessel revascularization (TVR) and stroke]. Results: Patients treated with Bivalirudin compared with Heparin had a significantly lower in-hospital incidence of QMI (0% vs. 6%; p=0.03) and major bleeding (0% vs. 7%; p=0.02). However, the incidence of cardiac death, stent thrombosis, TVR were no differences between the groups (p>0.05). There was only one NQMI in the Bivalirudin group as opposed to 8% in the Heparin group in 30 days following stenting (p=0.04). No other adverse effects were found significantly different between groups in 30 days of PCI. Conclusion: In this small scale, prospective, randomized controlled study of diabetic ACS patients undergoing PCI in a single center showed that Bivalirudin is safe and effective as it reduces immediate and short-term hemorrhagic complications as well as MACEs as compared with Heparin.

scholarly journals Early aspirin discontinuation following acute coronary syndrome or percutaneous coronary intervention: a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Guedeney ◽  
J Mesnier ◽  
S Sorrentino ◽  
F Abcha ◽  
M Zeitouni ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Randomized Controlled Trials ◽  
Major Bleeding ◽  
Coronary Intervention ◽  
Controlled Trials ◽  
Coronary Syndrome ◽  
Randomized Controlled ◽  
Percutaneous Coronary ◽  
Significant Difference

Abstract Background The respective ischemic and bleeding risks of early aspirin discontinuation following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) remains uncertain. Objectives To evaluate the safety and efficacy of early aspirin discontinuation in ACS or PCI patients treated with P2Y12 inhibitors with or without anticoagulants. Methods We performed a review of randomized controlled trials (RCTs) comparing a P2Y12 inhibitor-based single antiplatelet strategy following early aspirin discontinuation to a strategy of sustained dual antiplatelet therapy (DAPT) in ACS or PCI patients requiring or not anticoagulation for another indication. The primary safety endpoint was major bleeding while non-major bleeding and all bleeding were secondary safety endpoints. The primary efficacy endpoint was all-cause mortality while secondary efficacy endpoints included major adverse cardiovascular and cerebrovascular events (MACCE), myocardial infarction (MI), definite stent thrombosis (ST) or any stroke. We estimated risk ratios (RR) and 95% confidence intervals (CI) using random effect models. The study is registered in PROSPERO (CRD42019139576). Results We included 9 RCTs comprising 40,621 patients.Compared to prolonged DAPT, major bleeding (2.2% vs. 2.8%; RR 0.68; 95% CI: 0.54 to 0.87; p=0.002; I2: 63%), non-major bleeding (5.0% vs. 6.1%; RR: 0.66; 95% CI: 0.47 to 0.94; p=0.02; I2:87%) and all bleeding (7.4% vs. 9.9%; RR: 0.65; 95% CI: 0.53 to 0.79; p<0.0001; I2: 88%) were significantly reduced with early aspirin discontinuation (Figure 1), without significant difference for all-cause death (p=0.60), MACCE (p=0.60), MI (p=0.77), definite ST (p=0.63), and any stroke (p=0.59). Results were consistent in patients with or without anticoagulation, without significant interaction for any outcomes but MI (p=0.04). Conclusions In patients on DAPT after an ACS or a PCI, early aspirin discontinuation prevents bleeding events with no effect on the ischemic risk or mortality. Figure 1. Central illustration Funding Acknowledgement Type of funding source: None

scholarly journals P2Y12 Inhibitor Monotherapy with Clopidogrel versus Ticagrelor in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

2020 ◽  
Vol 9 (6) ◽  
pp. 1657
Author(s):  
Po-Wei Chen ◽  
Wen-Han Feng ◽  
Ming-Yun Ho ◽  
Chun-Hung Su ◽  
Sheng-Wei Huang ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Primary Endpoint ◽  
Major Bleeding ◽  
Lower Risk ◽  
Coronary Intervention ◽  
P2y12 Inhibitor ◽  
Coronary Syndrome ◽  
Percutaneous Coronary ◽  
All Cause Mortality

Background: P2Y12 inhibitor monotherapy is an alternative antiplatelet strategy in patients undergoing percutaneous coronary intervention (PCI). However, the ideal P2Y12 inhibitor for monotherapy is unclear. Methods and Results: We performed a multicenter, retrospective, observational study to compare the efficacy and safety of monotherapy with clopidogrel versus ticagrelor in patients with acute coronary syndrome (ACS) undergoing PCI. From 1 January 2014 to 31 December 2018, 610 patients with ACS who received P2Y12 monotherapy with either clopidogrel (n = 369) or ticagrelor (n = 241) after aspirin was discontinued prematurely were included. Inverse probability of treatment weighting was used to balance covariates between the groups. The primary endpoint was the composite of all-cause mortality, recurrent ACS or unplanned revascularization, and stroke within 12 months after discharge. Overall, 84 patients reached the primary endpoint, with 57 (15.5%) in the clopidogrel group and 27 (11.2%) in the ticagrelor group. Multivariate adjustment in Cox proportional-hazards models revealed a lower risk of the primary endpoint with ticagrelor than with clopidogrel (adjusted hazard ratio (aHR): 0.67, 95% confidence interval (CI): 0.49–0.93). Ticagrelor significantly reduced the risk of recurrent ACS or unplanned revascularization (aHR: 0.46, 95% CI: 0.28–0.75). No significant difference in all-cause mortality and major bleeding events was observed between the 2 groups. Conclusions: Among patients with ACS undergoing PCI who cannot complete course of dual antiplatelet therapy, a significantly lower risk of cardiovascular events was associated with ticagrelor monotherapy than with clopidogrel monotherapy. The major bleeding risk was similar in both the groups.

Abstract 14068: One-year Outcomes of Dpp-4 Inhibitor Treatment in Diabetic Patients After Contemporary Percutaneous Coronary Intervention - Ps Matching From Data of Multicenter Registry -

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Takehiro Hata ◽  
Kentaro Jujo
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Coronary Intervention ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Diabetic Patients ◽  
Ventricular Ejection Fraction ◽  
Coronary Syndrome ◽  
Percutaneous Coronary ◽  
Dipeptidyl Peptidase 4 Inhibitors

Introduction: Clinical prognosis in diabetic patients comorbid with coronary artery disease (CAD) remained poor, even in the current drug-eluting stent (DES) era. However, there has been a limited evidence about the prognosis in diabetic patients with CAD who were treated with dipeptidyl peptidase-4 inhibitors (DPP4i). Methods: This study is a subanalysis from the TWINCRE registry that is a multicentral prospective cohort including patients who underwent percutaneous coronary intervention (PCI) at 12 hospitals in Japan between 2017 and 2019. Among 1,905 registered patients who were followed up, we ultimately evaluated 615 diabetic patients. They were divided into two groups depending on the prescription of DPP4i at the hospital discharge after the index PCI; DPP4i group (n=287) and Non-DPP4i group (n=328). For the two groups, we performed propensity-score (PS) matching using variables as follows: age, sex, acute coronary syndrome, left ventricular ejection fraction, serum creatinine, insulin use, prescriptions of statin, beta blocker, aspirin, and ACE inhibitor/ARB. The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE) including death, acute coronary syndrome, stent thrombosis, hospitalization due to heart failure and ischemic stroke. Results: Overall MACCE was observed in 70 patients (11.4%) during 364 days of median observation period. In unmatched patients, Kaplan-Meier analysis showed that patients in the DPP4i group showed a significantly lower MACCE rate than those in the Non-DPP4i group (Log-rank test, p=0.009, Figure A). In 284 PS-matched patients, patients in the DPP4i group still had lower MACCE rate than those in the non-DPP4i group (hazard ratio 0.39, 95% confidence interval 0.16-0.96, p=0.034, Figure B). Conclusion: Propensity-matching analysis showed that hyperglycemia control by DPP4i was associated with better 1-year clinical outcomes in diabetic patients after PCI in the contemporary DES era.

Antiplatelet treatment in diabetic patients with acute coronary syndrome undergoing percutaneous coronary intervention

2018 ◽  
Vol 29 (1) ◽  
pp. 53-59 ◽  
Author(s):  
Michalis Hamilos ◽  
Stylianos Petousis ◽  
Ioanna Xanthopoulou ◽  
John Goudevenos ◽  
John Kanakakis ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Coronary Intervention ◽  
Diabetic Patients ◽  
Antiplatelet Treatment ◽  
Coronary Syndrome ◽  
Percutaneous Coronary
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