scholarly journals Ischemic Events Occur Early in Patients Undergoing Percutaneous Coronary Intervention and Are Reduced With Cangrelor: Findings From CHAMPION PHOENIX

2021 ◽  
Author(s):  
Matthew A. Cavender ◽  
Robert A. Harrington ◽  
Gregg W. Stone ◽  
Ph. Gabriel Steg ◽  
C. Michael Gibson ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Stent Thrombosis ◽  
Odds Ratio ◽  
Academic Research ◽  
Coronary Intervention ◽  
End Point ◽  
Percutaneous Coronary ◽  
Research Consortium ◽  
Ischemic Events

Background: Thrombotic events are reduced with cangrelor, an intravenous P2Y 12 inhibitor. We sought to characterize the timing, number, and type of early events (within 2 hours of randomization) in CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention). Methods: CHAMPION PHOENIX was a double-blind, placebo-controlled trial that randomized patients undergoing percutaneous coronary intervention to cangrelor or clopidogrel. For this analysis, we evaluated the efficacy of cangrelor in the first 2 hours postrandomization with regards to the primary end point (death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis). Sensitivity analyses were performed evaluating a secondary, post hoc end point (death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium definite stent thrombosis). Results: The majority of events (63%) that occurred in the trial occurred within 2 hours of randomization. The most common early event was myocardial infarction; next were stent thrombosis, ischemia driven revascularization, and death. In the first 2 hours after randomization, cangrelor significantly decreased the primary composite end point compared with clopidogrel (4.1% versus 5.4%; hazard ratio, 0.76 [95% CI, 0.64–0.90], P =0.002). Similar findings were seen for the composite end point of death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium stent thrombosis at 2 hours (0.9% versus 1.6%; hazard ratio, 0.57 [95% CI, 0.40–0.80], P =0.001). Between 2 and 48 hours, there was no difference in the primary composite end point (0.6% versus 0.5%; odds ratio, 1.17 [95% CI, 0.71–1.93]; P =0.53). Early (≤2 hours of randomization) GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) moderate or severe bleeding events were infrequent, and there was no significant difference with cangrelor compared with clopidogrel (0.2% [n=10] versus 0.1% [n=4]; adjusted odds ratio, 1.41 [95% CI, 0.37–5.40]; P =0.62). Conclusions: The reductions in ischemic events and overall efficacy seen with cangrelor in CHAMPION PHOENIX occurred early and during the period of time in which patients were being actively treated with cangrelor. These findings provide evidence that supports the importance of potent platelet inhibition during percutaneous coronary intervention. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01156571.

Early stent thrombosis with bivalirudin in patients undergoing percutaneous coronary intervention

2015 ◽  
Vol 113 (05) ◽  
pp. 1010-1020 ◽  
Author(s):  
Raffaele Piccolo ◽  
Chiara De Biase ◽  
Carolina D’Anna ◽  
Bruno Trimarco ◽  
Federico Piscione ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Stent Thrombosis ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Academic Research ◽  
Coronary Intervention ◽  
Bleeding Events ◽  
Percutaneous Coronary ◽  
Research Consortium

SummaryAlthough bivalirudin has been shown to reduce bleeding events in patients undergoing percutaneous coronary intervention, residual concerns remain about a possible higher risk of early (within 30 days) stent thrombosis (ST). Therefore, we performed a meta-analysis of randomised trials reporting ST events with bivalirudin compared to other antithrombotic therapies (heparins ± glycoprotein IIb/IIIa inhibitors). A systematic literature search of electronic resources was performed through May, 2014. The primary endpoint was definite early ST, according to Academic Research Consortium criteria. Secondary endpoints included: all-cause death, myocardial infarction and major bleeding. A total of 11 trials, including 16,415 patients, were accrued. Compared to other regimens, bivalirudin significantly increased the risk of early ST (odds ratio [OR]=1.80; 95 % confidence interval [CI], 1.28 2.52; p=0.0007) and reduced the risk of major bleeding (OR [95 %CI]=0.64 [0.51 0.82], p=0.0003), with a comparable risk of mortality or myocardial infarction. The higher risk of early ST was mainly attributable to acute (OR [95 % CI] =4.33 [2.33 8.05], p < 0.001) than subacute (OR [95 % CI] =0.89 [0.53 1.50], p =0.67) ST events (p for interaction < 0.001). Non-fatal myocardial infarction was the most common presentation (83 %) of early ST events, while death occurred infrequently (about 5 %). In conclusion, in patients undergoing PCI, bivalirudin compared to heparins is associated with a higher risk of early ST, which is mainly related to more frequent acute events. Further studies are required to evaluate alternative strategies to mitigate this risk, without hampering the benefits derived from the reduction in bleeding events with bivalirudin.

Clinical outcomes of nonagenarians with acute myocardial infarction who undergo percutaneous coronary intervention

2020 ◽  
Vol 9 (5) ◽  
pp. 488-495 ◽  
Author(s):  
Kensaku Nishihira ◽  
Nozomi Watanabe ◽  
Nehiro Kuriyama ◽  
Yoshisato Shibata
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Academic Research ◽  
Coronary Intervention ◽  
Percutaneous Coronary ◽  
Research Consortium ◽  
Therapeutic Decision Making

Background With increases in life expectancy, percutaneous coronary intervention is being performed more often, even in elderly patients with acute myocardial infarction. However, the optimal management of nonagenarians with acute myocardial infarction is uncertain. This study sought to investigate clinical outcomes of nonagenarians who undergo percutaneous coronary intervention. Methods Of 2640 consecutive patients with acute myocardial infarction hospitalised within 24 hours after symptom onset in 2009–2018, we prospectively analysed 96 nonagenarians (median age 92 years; interquartile range 91–94) who underwent percutaneous coronary intervention. Results The median follow-up period was 375 days. Inhospital major bleeding (Bleeding Academic Research Consortium type 3 or 5) and inhospital death occurred in 15.6% and 17.7% of patients, respectively. The proportion of patients with frailty increased during hospitalisation, from 43.8% (mild frailty 37.5%; moderate to severe frailty 6.3%) at admission to 60.7% (mild frailty 46.8%; moderate to severe frailty 13.9%) at discharge ( P < 0.01). The cumulative incidence of all-cause mortality was 22.2% at 180 days and 27.5% at 365 days. After adjusting for confounders, cardiogenic shock (hazard ratio (HR) 2.85; 95% confidence interval (CI) 1.07–7.64) and final thrombolysis in myocardial infarction flow grade less than 3 (HR 2.45; 95% CI 1.03–5.58) were associated with higher mid-term mortality and cardiac rehabilitation (HR 0.25; 95% CI, 0.13–0.50) was associated with lower mid-term mortality. Conclusions The mid-term mortality of selected nonagenarians with acute myocardial infarction who undergo percutaneous coronary intervention is reasonable, but older patients have high rates of inhospital major bleeding and progression of frailty. This study provides physicians, patients and families with important information for therapeutic decision-making.

scholarly journals Clinical Impact of Intraprocedural Stent Thrombosis During Percutaneous Coronary Intervention in Patients Treated With Potent P2Y12 inhibitors ‐ a VALIDATE‐SWEDEHEART Substudy

2021 ◽  
Author(s):  
Sofia Bergman ◽  
Moman A. Mohammad ◽  
Stefan K. James ◽  
Oskar Angerås ◽  
Henrik Wagner ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Stent Thrombosis ◽  
Coronary Intervention ◽  
Cardiovascular Death ◽  
St Segment Elevation ◽  
P2y12 Inhibitors ◽  
End Point ◽  
St Segment ◽  
Percutaneous Coronary

Background The clinical importance of intraprocedural stent thrombosis (IPST) during percutaneous coronary intervention in the contemporary era of potent oral P2Y12 inhibitors is not established. The aim of this study was to assess IPST and its association with clinical outcome in patients with myocardial infarction undergoing percutaneous coronary intervention with contemporary antithromboticmedications. Methods and Results The VALIDATE‐SWEDEHEART study (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) included 6006 patients with myocardial infarction, treated with potent P2Y12 inhibitors during percutaneous coronary intervention. IPST, defined as a new or worsening thrombus related to a stent deployed during the procedure, was reported by the interventional cardiologist in 55 patients (0.9%) and was significantly associated with ST‐segment elevation myocardial infarction presentation, longer stents, bailout glycoprotein IIb/IIIa inhibitors, and final Thrombolysis in Myocardial Infarction flow <3. The primary composite end point included cardiovascular death, myocardial infarction, out‐of‐laboratory definite stent thrombosis and target vessel revascularization within 30 days. Secondary end points were major bleeding and the individual components of the primary composite end point. Patients with versus without IPST had significantly higher rates of the primary composite end point (20.0% versus 4.4%), including higher rates of cardiovascular death, target vessel revascularization, and definite stent thrombosis, but not myocardial infarction or major bleeding. By multivariable analysis, IPST was independently associated with the primary composite end point (hazard ratio, 3.82; 95% CI, 2.05–7.12; P <0.001). Conclusions IPST is a rare but dangerous complication during percutaneous coronary intervention, independently associated with poor prognosis, even in the current era of potent antiplatelet agents. Future treatment studies are needed to reduce the rate of IPST and to improve the poor outcome among these patients. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02311231.

scholarly journals Sex-related response to bivalirudin and unfractionated heparin in patients with acute myocardial infarction undergoing percutaneous coronary intervention: A subgroup analysis of the VALIDATE-SWEDEHEART trial

2018 ◽  
Vol 8 (6) ◽  
pp. 502-509 ◽  
Author(s):  
D Venetsanos ◽  
S Sederholm Lawesson ◽  
O Fröbert ◽  
E Omerovic ◽  
L Henareh ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Unfractionated Heparin ◽  
Lower Risk ◽  
Academic Research ◽  
Coronary Intervention ◽  
Hazard Ratio ◽  
Percutaneous Coronary ◽  
Significant Difference ◽  
Research Consortium

Aims: Our aim was to study the impact of sex on anticoagulant treatment outcomes during percutaneous coronary intervention in acute myocardial infarction patients. Methods: This study was a prespecified analysis of 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) trial, in which patients with myocardial infarction were randomised to bivalirudin or unfractionated heparin during percutaneous coronary intervention. The primary outcome was the composite of death, myocardial infarction or major bleeding at 180 days. Results: There was a lower risk of the primary outcome in women assigned to bivalirudin than to unfractionated heparin (13.6% vs 17.1%, hazard ratio 0.78, 95% confidence interval (0.60–1.00)) with no significant difference in men (11.8% vs 11.2%, hazard ratio 1.06 (0.89–1.26), p for interaction 0.05). The observed difference was primarily due to lower risk of major bleeding (Bleeding Academic Research Consortium definition 2, 3 or 5) associated with bivalirudin in women (8.9% vs 11.8%, hazard ratio 0.74 (0.54–1.01)) but not in men (8.5% vs 7.3%, hazard ratio 1.16 (0.94–1.43) in men, p for interaction 0.02). Conversely, no significant difference in the risk of Bleeding Academic Research Consortium 3 or 5 bleeding, associated with bivalirudin, was found in women 4.5% vs 5.4% (hazard ratio 0.84 (0.54–1.31)) or men 2.9% vs 2.1% (hazard ratio 1.36 (0.93–1.99)). Bleeding Academic Research Consortium 2 bleeding occurred significantly less often in women assigned to bivalirudin than to unfractionated heparin. The risk of death or myocardial infarction did not significantly differ between randomised treatments in men or women. Conclusion: In women, bivalirudin was associated with a lower risk of adverse outcomes, compared to unfractionated heparin, primarily due to a significant reduction in Bleeding Academic Research Consortium 2 bleeds.

P2812Ischemic efficacy and bleeding safety of ticagrelor monotherapy in patients with multivessel percutaneous coronary intervention: insights from the Global Leaders trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K Takahashi ◽  
P Chichareon ◽  
C C Chang ◽  
M Tomaniak ◽  
R Modolo ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Primary Endpoint ◽  
Academic Research ◽  
Composite Endpoint ◽  
Coronary Intervention ◽  
Clinical Events ◽  
Percutaneous Coronary ◽  
Research Consortium ◽  
Type 3

Abstract Background/Introduction The optimal duration of DAPT after coronary stent implantation remains a matter of debate and a novel antiplatelet regimen without an increased risk of bleeding while maintaining an anti-ischemic efficacy is of paramount importance in patients at higher risk of ischemia. Purpose The aim of the present sub-study of the Global Leaders trial is to evaluate the efficacy and safety of the experimental antiplatelet strategy (1-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) vs. the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in patients with multivessel percutaneous coronary intervention (PCI). Methods The Global Leaders trial enrolled 15,991 patients treated by default with a biolimus A-9 eluting stent. The present sub-study of the trial sought to evaluate the impact of the long-term ticagrelor monotherapy on the primary endpoint (composite of all-cause death and new Q-wave myocardial infarction [MI] centrally adjudicated with the Minnesota code) at two years. In addition, the patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, and any revascularization) and the net adverse clinical events (NACE) (composite of POCE and Bleeding Academic Research Consortium [BARC] type 3 or 5 bleeding) were also evaluated at two years. Results A total of 15,845 patients was included in this analysis, of whom 3,576 patients received multivessel PCI. At two years, the experimental strategy significantly reduced a risk of the primary endpoint (the composite of all-cause death and new Q-wave myocardial infarction [MI]) (3.05% vs. 4.85%, HR: 0.62, 95% CI: 0.44–0.88, p=0.006, Pinteraction=0.031) in patients with multivessel PCI. Similarly, the experimental treatment had a significant risk reduction in the patient-oriented composite endpoint (POCE), defined as the composite of all-cause death, any stroke, any MI, and any revascularization (13.37% vs. 16.74%, HR: 0.78, 95% CI: 0.66–0.93, p=0.005, Pinteraction=0.020) and the net adverse clinical events (NACE), defined as the composite of POCE and Bleeding Academic Research Consortium [BARC] defined bleeding type 3 or 5 (14.65% vs. 18.38%, HR: 0.78, 95% CI: 0.66–0.92, p=0.003, Pinteraction=0.014) at two years. There was no significant difference in BARC type 3 or 5 bleeding (2.44% vs. 2.65%, HR: 0.92, 95% CI: 0.61–1.39, p=0.685, Pinteraction=0.754) at two years between the two regimens. KM in patients with multivessel PCI Conclusion The present study has demonstrated the experimental antiplatelet strategy, when compared with the reference regimen, could potentially have a favourable balance between ischemic efficacy and bleeding safety in patients who underwent multivessel PCI. Acknowledgement/Funding The Global Leaders trial was supported by unrestricted grants from AstraZeneca, Biosensors, and The Medicines Company. ECRI (European Cardiovascular R

P960Association of peri-procedural intravenous morphine use on clinical outcomes in ST-elevation myocardial infarction treated by percutaneous coronary intervention: systematic review and meta-analysis

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Batchelor ◽  
D Liu ◽  
J Bloom ◽  
S Noaman ◽  
W Chan
Keyword(s):  
Myocardial Infarction ◽  
Systematic Review ◽  
Percutaneous Coronary Intervention ◽  
Clinical Outcomes ◽  
Odds Ratio ◽  
Meta Analysis ◽  
Coronary Intervention ◽  
Increased Risk ◽  
Percutaneous Coronary ◽  
St Elevation

Abstract Background Morphine analgesia may affect absorption of co-prescribed P2Y12 antagonists attenuating platelet inhibition. The impact of peri-procedural intravenous (IV) morphine administration on clinical outcomes in patients undergoing primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI) is not well defined. Purpose To conduct a systematic review and meta-analysis exploring clinical outcomes with peri-procedural IV morphine in patients undergoing PPCI for STEMI. Methods Analysis of the electronic databases MEDLINE, EMBASE, CENTRAL, Scopus, Web of Science and ClinicalTrials.gov for association of peri-PCI IV morphine use with myocardial infarction (MI) and mortality. Primary and secondary outcomes were in-hospital or 30-day MI and all-cause mortality respectively. Results Eleven studies (1 randomised controlled trial; 10 cohort studies) were included for systematic review. Five studies, including 3,748 patients were included in meta-analysis of the primary outcome. Of 3,748 patients, 2,239 were treated concurrently with ticagrelor, 1,256 treated with clopidogrel and 253 with prasugrel. As shown in the Figure, there was a trend towards increased risk of myocardial infarction with IV morphine (odds ratio 1.88; 95% CI 0.87–4.09, I2 0%). Across seven studies and 6585 patients, no increased risk of mortality at the same composite time endpoint was evident (odds ratio 0.70, 95% CI 0.40–1.23, I2 19%). Figure 1. MI in hospital or at 30 days Conclusion Based on current literature, evidence of an association between IV morphine and myocardial infarction in patients undergoing PPCI for STEMI is limited by observational methodology and conflicting results. There is no evidence of an association between intravenous peri-procedural morphine and mortality. Clinical trial evidence with strong documentation of adverse events data is required to demonstrate association or causality. Acknowledgement/Funding None

scholarly journals Efficacy and safety of thrombus aspiration in ST-segment elevation myocardial infarction: an updated systematic review and meta-analysis of randomised clinical trials

2018 ◽  
Vol 8 (1) ◽  
pp. 24-38 ◽  
Author(s):  
Nevio Taglieri ◽  
Maria Letizia Bacchi Reggiani ◽  
Gabriele Ghetti ◽  
Francesco Saia ◽  
Miriam Compagnone ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Stent Thrombosis ◽  
Primary Percutaneous Coronary Intervention ◽  
Coronary Intervention ◽  
Thrombus Aspiration ◽  
St Segment Elevation ◽  
Segment Elevation Myocardial Infarction ◽  
St Segment ◽  
Percutaneous Coronary

Background: The role of thrombus aspiration plus primary percutaneous coronary intervention in ST-segment elevation myocardial infarction remains controversial. Methods: We performed a meta-analysis of 25 randomised controlled trials in which 21,740 ST-segment elevation myocardial infarction patients were randomly assigned to thrombus aspiration plus primary percutaneous coronary intervention or primary percutaneous coronary intervention. Study endpoints were: death, myocardial infarction, stent thrombosis and stroke. Results: On pooled analysis, the risk of death (4.3% vs. 4.8%, odds ratio (OR) 0.90, 95% confidence interval (CI) 0.79–1.03; P=0.123), myocardial infarction (2.4% vs. 2.5%, OR 0.95, 95% CI 0.80–1.13; P=0.57) and stent thrombosis (1.3% vs. 1.6%, OR 0.80, 95% CI 0.63–1.01; P=0.066) was similar between thrombus aspiration plus primary percutaneous coronary intervention and primary percutaneous coronary intervention. The risk of stroke was higher in the thrombus aspiration plus primary percutaneous coronary intervention than the primary percutaneous coronary intervention group (0.84% vs. 0.59%, OR 1.401, 95% CI 1.004–1.954; P=0.047). However, on sensitivity analysis after removing the TOTAL trial, thrombus aspiration plus primary percutaneous coronary intervention was not associated with an increased risk of stroke (OR 1.01, 95% CI 0.58–1.78). The weak association between thrombus aspiration and stroke was also confirmed by the fact that the lower bound of the 95% CI was slightly below unity after removing either the study by Kaltoft or the ITTI trial. There was no interaction between the main study results and follow-up, evidence of coronary thrombus, or study sample size. Conclusions: In patients with ST-segment elevation myocardial infarction, thrombus aspiration plus primary percutaneous coronary intervention does not reduce the risk of death, myocardial infarction or stent thrombosis. Thrombus aspiration plus primary percutaneous coronary intervention is associated with an increased risk of stroke; however, this latter finding appears weak.

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