Efficacy and safety of bivalirudin without post-procedure infusion in patients with coronary heart disease during elective percutaneous coronary intervention: a real-world study.
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SUBMITTER: Wang P
PROVIDER: S-EPMC8850814 | biostudies-literature | 2021 Oct
REPOSITORIES: biostudies-literature
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Efficacy and safety of bivalirudin without post-procedure infusion in patients with coronary heart disease during elective percutaneous coronary intervention: a real-world study.
Wang Ping P Zhao Xin X Yuan Qimin Q Yu Xiaoxue X Yang Lin L Wang Xiaozeng X
Chinese medical journal 20220101 1
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Project description:IntroductionIn clinical practice, the dose of bivalirudin may not be fully applicable to the Chinese population. Therefore, this study aimed to explore the efficacy and safety of a reduced dose (80% of the recommended dose) of bivalirudin without post-procedure infusion for 3-4 h in patients with acute coronary syndrome (ACS) undergoing elective percutaneous coronary intervention (PCI).MethodsThis was a single-center, retrospective study. Patients who met the inclusion criteria and no exclusion criteria were divided into reduced-dose and recommended-dose groups for analysis. Confounders were corrected using propensity score matching. The incidence of net adverse clinical events (NACE), major adverse cardiovascular events (MACE), and Bleeding Academic Research Consortium (BARC) type 2-5 bleeding events were observed 30 days postoperatively.ResultsIn total, 1,590 patients (795 per group) were obtained after propensity score matching. The results after propensity score matching were as follows: The activated clotting time (ACT) after 5 min in the reduced-dose group was 349.37 ± 47.59 s, which was statistically lower than that in the recommended-dose group, 353.12 ± 44.98 s (P = 0.024). There was no significant difference in the proportion of ACT values of ≥ 250 s after 5 min between the two groups (P > 0.05). There were no significant differences in NACE, MACE, and BARC type 2-5 bleeding events between the two groups (5.0% vs. 4.5%, P = 0.638; 0.0% vs. 0.1%, P = 1.000; 0.3% vs. 0.5%, P = 0.687). There were no statistically significant differences in cumulative NACE and cumulative bleeding events between the two groups at 30 days (P = 0.635 and P = 0.716, respectively).ConclusionIn patients with UA and NSTEMI undergoing elective PCI, 80% of the recommended dose of bivalirudin without post-procedure infusion can be used for anticoagulation without increasing the risk of thrombosis and bleeding.
| S-EPMC11657573 | biostudies-literature
Project description:Procedural myocardial injury (PMI), which is the most common complication of elective percutaneous coronary intervention (ePCI), is associated with future adverse cardiac events. In this randomized pilot trial, we assessed the effects of prolonged use of the anti-coagulant bivalirudin on PMI after ePCI. Patients undergoing ePCI were randomized into the following two groups: the bivalirudin use during operation group (BUDO, 0.75 mg/kg bolus plus 1.75 mg/kg/h) and the bivalirudin use during and after operation for 4 h (BUDAO, 0.75 mg/kg bolus plus 1.75 mg/kg/h). Blood samples were collected before and 24 h after ePCI (per 8 h). The primary outcome, PMI, was defined as an increase in post-ePCI cardiac troponin I (cTnI) levels of > 1 × 99th% upper reference limit (URL) when the pre-PCI cTnI was normal or a rise in cTnI of > 20% of the baseline value when it was above the 99th percentile URL, but it was stable or falling. Major PMI (MPMI) was defined as a post-ePCI cTnI increase of > 5 × 99th% URL. A total of 330 patients were included (n = 165 per group). The incidences of PMI and MPMI were not significantly higher in the BUDO group than in the BUDAO group (PMI: 115 [69.70%] vs. 102 [61.82%], P = 0.164; MPMI: 81 [49.09%] vs. 70 [42.42%], P = 0.269). However, the absolute change in cTnI levels (calculated as the peak value 24 h post-PCI minus the pre-PCI value) was notably larger in the BUDO group (0.13 [0.03, 1.95]) than in the BUDAO group (0.07 [0.01, 0.61]) (P = 0.045). Moreover, the incidence of bleeding events was similar between the two groups (BUDO: 0 [0.00%]; BUDAO: 2 [1.21%], P = 0.498). Prolonged infusion of bivalirudin for 4 h after ePCI reduces PMI severity without increasing the risk of bleeding.ClinicalTrials.gov.Number: NCT04120961, 09/10/2019.
| S-EPMC10126106 | biostudies-literature
Project description:Fontan procedure is known to increase the risk of thromboembolic events. However, coronary artery thrombotic occlusion is rarely reported in patients with Fontan procedure. We present a case of a 10-year-old boy with hypoplastic left heart syndrome palliated with a Fontan procedure who presented with myocardial infarction secondary to thrombotic occlusion of the left circumflex coronary artery. He underwent successful percutaneous coronary intervention with thrombus aspiration, balloon angioplasty, and stent placement, highlighting the necessity of collaboration between congenital and adult cardiologists to treat acute coronary syndrome among this challenging young population.
| S-EPMC7152654 | biostudies-literature
Project description:Background and aimsUnfractionated heparin (UFH) and bivalirudin are widely used as anticoagulants in cardiovascular medicine, including for thrombosis prevention during coronary angiography (CAG) and percutaneous coronary intervention (PCI). Little is known of the effects of UFH and bivalirudin on liver and kidney function in patients subjected to these procedures. This study compared the effects of bivalirudin and UFH on liver/renal function in patients with coronary artery disease who underwent CAG, with or without PCI.MethodsThe study comprised 134 consecutive patients (40-89 years-old), who underwent CAG (or CAG and PCI); among them, 66 and 68 patients were subject to, respectively, bivalirudin or UFH. The following indicators of liver/renal function were measured before and after the procedures: plasma alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen, estimated glomerular filtration rate (eGFR), creatinine clearance, and serum creatinine. Patients were further stratified by severity of chronic kidney disease (CKD), based on original eGFR.ResultsRelative to baseline, in the bivalirudin group, ALT and AST were higher after CAG (p=0.005, 0.025), while blood urea nitrogen and serum creatinine were lower (p=0.049, <0.001). In the UFH group, ALT, AST, eGFR, and creatinine clearance were lower after CAG (p≤0.001, all). Patients given bivalirudin with moderate or severe CKD, but not those with mild CKD, gained significant improvement in kidney function.ConclusionsRelative to UFH, bivalirudin may better safeguard the renal function of patients with coronary artery disease who undergo CAG, especially patients with moderate-to-severe renal insufficiency. UFH may cause less liver damage than bivalirudin.
| S-EPMC8369018 | biostudies-literature
Project description:Iatrogenic coronary artery dissection is a potentially life-threatening complication of cardiovascular interventions. The optimal management of iatrogenic coronary artery dissection is not clear; however, both conservative management and percutaneous or surgical revascularization have been performed depending on the patient's clinical status and the extent of dissection. We present the first reported case of right coronary artery dissection after Bentall procedure performed for ascending aortic aneurysm. Urgent percutaneous intervention using adjunctive coronary imaging was performed with excellent clinical recovery. In this article, we highlight coronary artery dissection after Bentall procedure as a possible complication, provide an insight into various options in its management, and review published data on iatrogenic coronary artery dissection. We also discuss the challenges in percutaneous treatment of coronary artery dissection with special focus on intracoronary imaging for accurate diagnosis and guidance in the management of this complex lesion.
| S-EPMC6231389 | biostudies-literature
Project description:Even cardiac surgery has been accepted as the standard therapy for Lutembacher syndrome, a combination of congenital ostium secundum atrial septal defect (ASD) and acquired mitral valve stenosis (MVS), it also owns many limitations and disadvantages. Therefore, seeking for a less invasive therapy with the same efficacy may be worthwhile. Thanks to the development in technology and experience gaining in cardiovascular intervention, the combination of the two proved effective procedures, including percutaneous MVS treatment using balloon valvuloplasty and percutaneous ASD closure using atrial septal occluders, can be utilized as an attractive alternative therapy for these conditions. Here, we present a successful percutaneous intervention in Lutembacher syndrome using the combination of mitral balloon valvuloplasty and ASD device closure and thoroughly review the experience of using this combined procedure existing in the literature.
| S-EPMC6306122 | biostudies-other
Project description: Not available
| S-EPMC11017352 | biostudies-literature
Project description:BackgroundSalvia Miltiorrhiza Depside Salt for Infusion (SMDS) is made of a group of highly purified listed drugs. However, its safety data is still reported limitedly. Compared with the clinical trials, its safety in the real world setting is barely assessed.ObjectiveTo investigate the safety issues, including adverse events (AEs), adverse events related to SMDS (ADEs), and adverse drug reactions (ADRs) of the SMDS in the real world clinical practice.MethodsThis is a prospective, multicenter, pharmacist-led, cohort study in the real world setting. Consecutive patients prescribed with SMDS were all included in 36 sites. Pharmacists were well trained to standardized collect the patients information, including demographics, medical history, prescribing patterns of SMDS, combined medications, adverse events, laboratory investigations, outcomes of the treatment when discharge, and interventions by pharmacists. Adverse events and adverse drug reactions were collected in details. Multivariate possion regression analysis was applied to identify risk factors associated with ADEs using the significance level (α) 0.05. ClinicalTrials.gov Identifier: NCT01872520.ResultsThirty six hospitals were participated in the study and 30180 consecutive inpatients were included. The median age was 62 (interquartile range [IQR], 50-73) years, and male was 17384 (57.60%) among the 30180 patients. The incidences of the AEs, ADEs and ADRs were 6.40%, 1.57% and 0.79%, respectively. There were 9 kinds of new ADEs which were not on the approved label found in the present study. According to the multivariate analysis, male (RR = 1.381, P = 0.009, 95%CI [1.085~1.759]), more concomitant medications (RR = 1.049, P<0.001, 95%CI [1.041~1.057]), longer duration of SMDS therapy (RR = 1.027, P<0.001, 95%CI [1.013~1.041]), higher drug concentration (RR = 1.003, P = 0.014, 95%CI [1.001~1.006]), and resolvent unapproved (RR = 1.900, P = 0.002, 95%CI [1.260~2.866]) were the independent risk factors of the ADEs. Moreover, following the approved indication (RR = 0.655, P<0.001, 95%CI [0.532~0.807]) was associated with lower incidence of ADEs.ConclusionsSMDS was well tolerated in the general population. The incidences of the AEs, ADEs and ADRs were 6.40%, 1.57% and 0.79%, respectively. Several risk factors of its ADEs have been identified. It is recommended to follow the instructions when prescribing and administrating SMDS in the real world clinical practice.
| S-EPMC5268476 | biostudies-literature
Project description:ObjectiveThe optimal antithrombotic regimen for patients on oral anticoagulation (OAC) after acute coronary syndrome (ACS) and percutaneous coronary intervention (PCI) remains debated. This study sought to evaluate the efficacy and safety of OAC plus clopidogrel with or without aspirin in a real-world setting.MethodsWe retrospectively analyzed data from an international, multi-center registry between 2003 and 2014 (n = 15,401). Patients with ACS and receiving OAC after PCI were screened. The composite primary endpoint was 1-year all-cause death, re-infarction, or severe bleeding.ResultsThe final analysis enrolled 642 patients including 62 patients (9.7%) with OAC and clopidogrel (dual therapy), and 580 patients (90.3%) with the combination of aspirin, OAC and clopidogrel (triple therapy). Patients on triple therapy were more often female and were more likely to have comorbidities. There was no significant difference regarding the primary end point between dual therapy with triple therapy patients [17.74% vs. 17.24%; unadjusted hazard ratio (HR): 1.035; 95% confidence interval (CI): 0.556-1.929; adjusted HR: 1.026; 95% CI: 0.544-1.937]. However, the re-infarction rate was significantly higher in dual therapy than triple therapy patients (14.52% vs. 5.34%; unadjusted HR: 2.807; 95% CI: 1.329-5.928; adjusted HR: 2.333; 95% CI: 1.078-5.047). In addition, there was no difference between two regimes in all-cause death and severe bleeding.ConclusionsIn real-life patients with ACS following PCI and with an indication of OAC, triple therapy was not associated with an increased rate of adverse outcomes compared to dual therapy. Moreover, it decreased risk of re-infarction and did not increase risk of severe bleeding.
| S-EPMC5756741 | biostudies-literature
Project description:Percutaneous coronary intervention with bivalirudin plus bail-out glycoprotein IIb/IIIa inhibitors has been shown to be as effective as unfractionated heparin plus routine glycoprotein IIb/IIIa inhibitors in preventing cardiac ischemic events, but with a lower bleeding risk. It is unknown whether bivalirudin would have the same beneficial effects if compared with heparin when the use of glycoprotein IIb/IIIa inhibitors was similar between treatment arms. We searched the MEDLINE, Web of Science, and Cochrane databases from inception until March 2015 for randomized trials that compared bivalirudin to heparin in patients undergoing percutaneous coronary intervention. We required that the intended use of glycoprotein IIb/IIIa inhibitors was similar between the study groups. Summary estimates were principally constructed by the Peto method. Fifteen trials met our inclusion criteria, which yielded 25,824 patients. Bivalirudin versus heparin was associated with an increased hazard of stent thrombosis (odds ratio [OR] 1.49, 95% confidence interval [CI] 1.15-1.92, P = .002, I2 = 16.9%), with a similar hazard of myocardial infarction (OR 1.09, 95% CI 0.98-1.22, P = .11, I2 = 35.8%), all-cause mortality (OR 0.88, 95% CI 0.72-1.08, P = .21, I2 = 31.5%) and major adverse cardiac events (OR 1.04, 95% CI 0.94-1.14, P = .46, I2 = 53.9%). Bivalirudin was associated with a reduced hazard of major bleeding (OR 0.80, 95% CI 0.70-0.92, P = .001, I2 = 63.5%). The dose of heparin in the control arm modified this association; when the dose of unfractionated heparin in the control arm was ≥ 100 units/kg, bivalirudin was associated with a reduction in major bleeding (OR 0.55, 95% CI 0.45-0.68, P < .0001), but when the dose of unfractionated heparin was ≤ 75 units/kg, bivalirudin was not associated with reduction in bleeding (OR 1.09, 95% CI 0.91-1.31, P = .36). Among patients undergoing PCI, bivalirudin was associated with an increased hazard of stent thrombosis. Bivalirudin may be associated with a reduced hazard of major bleeding; however, this benefit was no longer apparent when compared with a dose of unfractionated heparin ≤ 75 units/kg.
| S-EPMC4444249 | biostudies-literature