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Effect of tailored use of tirofiban in patients with Non-ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention: a randomized controlled trial.

ABSTRACT: BACKGROUND:We conducted a randomized controlled trial to investigate whether an additional platelet inhibition with tirofiban would reduce the extent of myocardial damage and prevent periprocedural myonecrosis in patients with Non-ST-elevation acute coronary syndrome (NSTE-ACS) with a high residual platelet activity (HPR). METHODS:Patients with an HPR, defined as P2Y12 reaction unit (PRU) >?230, were randomly assigned to group A (tirofiban treatment, n?=?30) or C1 (n?=?30) and patients without an HPR to C2 (n?=?78). Periprocedural myocardial damage was assessed using the area under the curve (AUC) of serial cardiac enzyme levels from the time of the procedure to post-36 h. Periprocedural myonecrosis incidence was evaluated. RESULTS:The troponin I AUC was not different between the groups (197.2 [41.5395.7], 37.9 [8.9313.9], 121.3 [43.7481.8] h?ng/mL; p?=?0.088). The results did not change when the baseline levels were adjusted (365.3 [279.5, 451.1], 293.0 [207.1, 379.0], and 298.0 [244.7, 351.3] h?ng/mL; p?=?0.487). The rate of periprocedural myonecrosis was also not different between the groups (53.0% vs. 50.0% vs. 33.3%, p?=?0.092). The CK-MB isoenzyme analysis showed similar results. No difference in complications was noted. CONCLUSION:Additional tirofiban administration was not beneficial to patients with NSTE-ACS even with an HPR. TRIAL REGISTRATION:Clinical trial no. NCT03114995 , registered 11 April, 2017, retrospectively.

SUBMITTER: Lee W

PROVIDER: S-EPMC6198526 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Effect of tailored use of tirofiban in patients with Non-ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention: a randomized controlled trial.

Lee Wonjae W Suh Jung-Won JW Park Jin Joo JJ Yoon Chang-Hwan CH Cho Young-Seok YS Youn Tae-Jin TJ Chae In-Ho IH

BMC cardiovascular disorders 20181022 1

<h4>Background</h4>We conducted a randomized controlled trial to investigate whether an additional platelet inhibition with tirofiban would reduce the extent of myocardial damage and prevent periprocedural myonecrosis in patients with Non-ST-elevation acute coronary syndrome (NSTE-ACS) with a high residual platelet activity (HPR).<h4>Methods</h4>Patients with an HPR, defined as P<sub>2</sub>Y<sub>12</sub> reaction unit (PRU) > 230, were randomly assigned to group A (tirofiban treatment, n = 30) ...[more]

PMID: 30348101

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Project description:Objective:We aim to evaluate the long-term prognosis of non-ST elevation acute coronary syndrome (NSTE-ACS) patients with high-risk coronary anatomy (HRCA). Background:Coronary disease severity is important for therapeutic decision-making and prognostication among patients presenting with NSTE-ACS. However, long-term outcome in patients undergoing percutaneous coronary intervention (PCI) with HRCA is still unknown. Method:NSTE-ACS patients undergoing PCI in Fuwai Hospital in 2013 were prospectively enrolled and subsequently divided into HRCA and low-risk coronary anatomy (LRCA) groups according to whether angiography complies with the HRCA definition. HRCA was defined as left main disease >50%, proximal LAD lesion >70%, or 2- to 3- vessel disease involving the LAD. Prognosis impact on 2-year and 5-year major adverse cardiovascular and cerebrovascular events (MACCE) is analyzed. Results:Out of 4,984 enrolled patients with NSTE-ACS, 3,752 patients belonged to the HRCA group, while 1,232 patients belonged to the LRCA group. Compared with the LRCA group, patients in the HRCA group had worse baseline characteristics including higher age, more comorbidities, and worse angiographic findings. Patients in the HRCA group had higher incidence of unplanned revascularization (2 years: 9.7% vs. 5.1%, p < 0.001; 5 years: 15.4% vs. 10.3%, p < 0.001), 2-year MACCE (13.1% vs. 8.8%, p < 0.001), and 5-year death/MI/revascularization/stroke (23.0% vs. 18.4%, p = 0.001). Kaplan-Meier survival analysis showed similar results. After adjusting for confounding factors, HRCA is independently associated with higher risk of revascularization (2 years: HR?=?1.636, 95% CI: 1.225-2.186; 5 years: HR?=?1.460, 95% CI: 1.186-1.798), 2-year MACCE (HR?=?1.275, 95% CI?=?1.019-1.596) and 5-year death/MI/revascularization/stroke (HR?=?1.183, 95% CI: 1.010-1.385). Conclusion:In our large cohort of Chinese patients, HRCA is an independent risk factor for long-term unplanned revascularization and MACCE.

Project description:ImportanceThe association of parenteral anticoagulation therapy with improved outcomes in patients with non-ST-segment elevation acute coronary syndrome was previously established. This benefit has not been evaluated in the era of dual antiplatelet therapy and percutaneous coronary intervention.ObjectiveTo evaluate the association between parenteral anticoagulation therapy and clinical outcomes in patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention.Design, setting, and participantsThis cohort study included 8197 adults who underwent percutaneous coronary intervention for non-ST-segment elevation acute coronary syndrome from January 1, 2010, to December 31, 2014, at 5 medical centers in China. Patients receiving parenteral anticoagulation therapy only after percutaneous coronary intervention were excluded.ExposuresParenteral anticoagulation therapy.Main outcomes and measuresThe primary outcome was in-hospital all-cause death and in-hospital major bleeding as defined by the Bleeding Academic Research Consortium definition (grades 3-5).ResultsOf 6804 patients who met the final criteria, 5104 (75.0%) were male, with a mean (SD) age of 64.2 (10.4) years. The incidence of in-hospital death was not significantly different between the patients who received and did not receive parenteral anticoagulation therapy (0.3% vs 0.1%; P = .13) (adjusted odds ratio, 1.27; 95% CI, 0.38-4.27; P = .70). A similar result was found for myocardial infarction (0.3% vs 0.3%; P = .82) (adjusted odds ratio, 0.77; 95% CI, 0.29-2.07; P = .61). In-hospital major bleeding was more frequent in the parenteral anticoagulation group (2.5% vs 1.0%; P < .001) (adjusted odds ratio, 1.94; 95% CI, 1.24-3.03; P = .004). At a median (interquartile range) follow-up of 2.96 years (1.93-4.46 years), all-cause death was not significantly different between the 2 groups (adjusted hazards ratio, 0.87; 95% CI, 0.71-1.07; P = .19), but the incidence of major bleeding was higher in the parenteral anticoagulation group (adjusted hazards ratio, 1.43; 95% CI, 1.01-2.02; P = .04). The propensity score analysis confirmed these primary analyses.Conclusions and relevanceIn the patients undergoing percutaneous coronary intervention for non-ST-segment elevation acute coronary syndrome, parenteral anticoagulation therapy was not associated with a lower risk of all-cause death or myocardial infarction but was significantly associated with a higher risk of major bleeding. These findings raise important safety questions about the current practice of routine parenteral anticoagulation therapy while we await randomized trials of this practice.

Dataset Information

Effect of tailored use of tirofiban in patients with Non-ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention: a randomized controlled trial.

Publications

Effect of tailored use of tirofiban in patients with Non-ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention: a randomized controlled trial.

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