Abdominal Injuries ; Antithrombins/adverse effects* ; Atrial Fibrillation ; Dabigatran/adverse effects* ; Humans ; Thoracic Injuries

OBJECTIVEThe study was designed to compare the antithrombotic property and safety between nadroparin and unfractionated heparin during percutaneous coronary intervention (PCI).

METHODSA prospective, single blind, randomized study was performed. A total of 98 patients (aged 65.1 +/- 8.6 years, female, 28.6%, diabetes, 7.1%) undergoing selective PCI were randomized to be administered intravenously either nadroparin (0.075 ml/10 kg) or unfractionated heparin (100U/kg) for procedural anticoagulation, in whom stable angina was 42.9%, unstable angina, 27.6%, myocardial infarction, 29.6%, two or three-vessel disease, 23.5%, stent, 100%. Blood samples for anti-Xa level were assayed in the first 22 patients of the nadroparin group before and after administration at the following intervals: 8 min, 1 h, 2 h and 4 h. Bleeding complications were classified according to Thrombolysis In Myocardial Infarction (TIMI) criteria. The bleeding index (change in hemoglobin) was calculated. All patients were monitored for adverse clinical events (i.e. death, myocardial infarction, need for revascularization) during the period of 30 days after PCI.

RESULTS(1) There were no significant differences in baseline characteristics between the two randomized groups. (2) Plasma anti-Xa activities were 0.10 +/- 0.00 IU/ml at the time just before the administration of nadroparin, 1.89 +/- 0.24 IU/ml, 0.96 +/- 0.24 IU/ml, 0.47 +/- 0.13 IU/ml, and 0.30 +/- 0.12 IU/ml at the time of 8 min, 1 h, 2 h and 4 h after the use of nadroparin (and the rate of > 0.5 IU/ml were 100%, 100%, 45% and 9% patients), respectively. (3) There were no significant differences in the mean bleeding index, post-PCI hemoglobin and hematocrit between nadroparin and unfractionated heparin group [(1.16 +/- 5.80) g/L vs (0.90 +/- 6.50) g/L, P = 0.858; (129.5 +/- 13.6) g/L vs (125.5 +/- 14.9) g/L, P = 0.175; (39.0 +/- 3.9)% vs (37.9 +/- 4.6)%, P = 0.205]. (4) None of the patients in two randomized groups were observed hemorrhagic events, which including TIMI major or minor bleeding complications, gross or microscopic hematuria, melena, positive stool occult blood. There were no blood transfusions and no hematoma at the vascular access site in either of the group. (5) No death, no recurrent angina pectoris, and no urgent revascularization occurred within 30 days in both groups. One patient in nadroparin group was observed "no reflow" phenomenon that was accompanied with an elevated ST segment and a risen serum level of cTnI. This patient was diagnosed as non-Q-wave myocardial infarction. Though no myocardial infarction was found in unfractionated heparin group, there was no significant difference in the rate of myocardial infarction between the two groups of the study (P = 0.970).

CONCLUSIONSThe administration of nadroparin before PCI seems effective and safe. Compared with unfractionated heparin, nadroparin was associated with neither an excess of bleeding nor an increase of clinical complications in this study.

Adult ; Aged ; Aged, 80 and over ; Angioplasty, Balloon, Coronary ; methods ; Antithrombins ; adverse effects ; therapeutic use ; Female ; Heparin ; adverse effects ; therapeutic use ; Humans ; Male ; Middle Aged ; Myocardial Infarction ; therapy ; Nadroparin ; adverse effects ; therapeutic use ; Prospective Studies ; Single-Blind Method ; Treatment Outcome

BACKGROUNDBivalirudin was widely used as an anticoagulant during coronary interventional procedure in western countries. However, it was not available in China before this clinical trial was designed. This randomized, single-blind and multicenter clinical trial aimed to evaluate the efficacy and the safety of domestic bivalirudin during percutaneous coronary intervention (PCI).

METHODSA randomized, single-blind, multicenter trial was designed. Elective PCI candidates in five centers were randomized into a bivalirudin group and a heparin group, which were treated with domestic bivalirudin and non-fractional heparin during the PCI procedure. The efficacy was evaluated by comparing the activated coagulation time (ACT), the procedural success rate (residual stenosis < 20% in target lesions without any coronary artery related adverse events within 24 hours after PCI), and the survival rate without major adverse cardiac events at 30 days after PCI between the two groups. Safety was evaluated by the major/minor bleeding rate.

RESULTSA total of 218 elective PCI patients were randomized into a bivalirudin group (n = 110) and heparin group (n = 108). Except for two patients needing additional dosing in the heparin group, the ACT values of all other patients in both groups were longer than 225 seconds at 5 minutes after the first intravenous bolus. Procedural success rates were respectively 100.0% and 98.2% in the bivalirudin group and heparin group (P > 0.05). Survival rates without major adverse cardiac events at 30 days after PCI were 100.0% in the bivalirudin group and 98.2% in the heparin group (P > 0.05). Mild bleeding rates were 0.9% and 6.9% (P < 0.05) at 24 hours, and 1.9% and 8.8% (P < 0.05) at 30 days after PCI in the bivalirudin group and heparin group respectively. There was one severe gastrointestinal bleeding case in the heparin group.

CONCLUSIONSDomestic bivalirudin is an effective and safe anticoagulant during elective PCI procedures. The efficacy is not inferior to heparin, but the safety is superior to heparin.

Aged ; Antithrombins ; adverse effects ; therapeutic use ; Female ; Heparin ; therapeutic use ; Hirudins ; adverse effects ; Humans ; Male ; Middle Aged ; Peptide Fragments ; adverse effects ; therapeutic use ; Percutaneous Coronary Intervention ; Recombinant Proteins ; adverse effects ; therapeutic use ; Single-Blind Method ; Survival Rate ; Whole Blood Coagulation Time

Endoscopic hemostasis is the first-line treatment for upper gastrointestinal bleeding (UGIB). Although several factors are known to be risk factors for rebleeding, little is known about the use of antithrombotics. We tried to verify whether the use of antithrombotics affects rebleeding rate after a successful endoscopic hemostasis for peptic ulcer disease (PUD). UGIB patients who underwent successful endoscopic hemostasis were included. Rebleeding was diagnosed when the previously treated lesion bled again within 30 days of the initial episode. Of 522 UGIB patients with PUD, rebleeding occurred in 93 patients (17.8%). The rate of rebleeding was higher with aspirin medication (P=0.006) and after a long endoscopic hemostasis (P<0.001). Of all significant variables, procedure time longer than 13.5 min was related to the rate of rebleeding (OR, 2.899; 95% CI, 1.768-4.754; P<0.001) on the logistic regression analysis. The rate of rebleeding after endoscopic hemostasis for PUD is higher in the patients after a long endoscopic hemostasis. Endoscopic hemostasis longer than 13.5 min is related to rebleeding after a successful endoscopic hemostasis for PUD.
Antithrombins/*therapeutic use ; Aspirin/adverse effects ; Female ; Gastrointestinal Hemorrhage/drug therapy/*surgery ; Hemorrhage/*drug therapy ; Hemostasis, Endoscopic/methods ; Humans ; Male ; Middle Aged ; Peptic Ulcer/*surgery ; Recurrence ; Upper Gastrointestinal Tract/pathology