Impact of Access Site on Bleeding and Ischemic Events in Patients With Non-ST-Segment Elevation Myocardial Infarction Treated With Prasugrel: The ACCOAST Access Substudy (original) (raw)
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Jacc-cardiovascular Interventions, 2016
This study assessed whether the choice of vascular access site influenced outcomes among non-STsegment elevation myocardial infarction (NSTEMI) patients enrolled in the ACCOAST (A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-STsegment elevation myocardial infarction NCT01015287). BACKGROUND Transfemoral access (TFA) has been associated with the risk of bleeding and increased mortality that is elevated compared to transradial access (TRA) in acute coronary syndromes, although less consistently in NSTE acute coronary syndrome (NSTE-ACS) than in STE-ACS. METHODS The ACCOAST study evaluated a prasugrel loading dose of 60 mg given at the start of percutaneous coronary intervention (PCI) versus a split loading dose of 30 mg given at the time of diagnosis of NSTE-ACS (prior to coronary angiography), followed by 30 mg given at the start of PCI. In the study, choice of access site was at the investigator's discretion. We compared ischemic and bleeding outcomes with TFA versus those with TRA, using propensity score correction. RESULTS Of 4,033 patients, 1,711 (42%) underwent TRA. Use of TRA varied widely by country. TFA was not associated with significant increases in noncoronary bypass graft (CABG)-related thrombolysis in myocardial infarction (TIMI) (hazard ratio [HR] for TFA ¼ 1.46; 95% confidence interval [CI]: 0.59 to 3.62; p ¼ 0.42), nor in GUSTO (Global Utilization Of Streptokinase and Tpa for Occluded arteries) or STEEPLE (Safety and Efficacy of Enoxaparin in PCI) major bleeding after propensity score correction. TFA, however, increased combined non-CABG TIMI major or minor bleeding (HR for TFA ¼ 2.34; 95% CI: 1.17 to 4.69; p ¼ 0.017). Primary ischemic outcomes did not differ by access site, albeit individual endpoint analysis suggested an association between TFA with an increase in urgent revascularizations and reduced risk of procedure-related stroke. CONCLUSIONS In the ACCOAST trial, TFA did not significantly increase TIMI major bleeding, although TRA was associated with a reduction in TIMI major or minor bleeding. Further study is needed to determine whether wider application of radial approach to NSTE-ACS patients at high risk for bleeding improves overall outcomes.
Circulation: Cardiovascular Interventions, 2014
Background— Compared with transfemoral access, transradial access (TRA) for percutaneous coronary intervention is associated with reduced risk of bleeding and vascular complications. Studies suggest that TRA may reduce mortality in patients with ST-segment–elevation myocardial infarction. However, there are few data on the effect of TRA on mortality, specifically, in patients with non–ST-segment–elevation myocardial infarction. Methods and Results— We analyzed 10 095 consecutive patients with non–ST-segment–elevation myocardial infarction treated with percutaneous coronary intervention between 2005 and 2011 in all 8 tertiary cardiac centers in London, United Kingdom. TRA was a predictor for reduced bleeding (odds ratio=0.21; 95% confidence interval [CI]: 0.08–0.57; P =0.002), access-site complications (odds ratio=0.47; 95% CI: 0.23–0.95; P =0.034), and 1-year mortality (hazard ratio [HR]=0.72; 95% CI: 0.54–0.94; P =0.017). Between 2005 and 2007, TRA did not appear to reduce mortalit...
Journal of the American College of Cardiology, 2019
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American Heart Journal, 2011
Background The precise risk/benefit of thienopyridine pretreatment and the optimal dosage and timing of a thienopyridine loading dose (LO) for patients presenting with non-ST-segment elevation (NSTE) acute coronary syndromes are still being debated. Prasugrel, a novel thienopyridine, is an appropriate drug to address this issue as it provides predictably high and rapid inhibition of platelet aggregation. Study Design ACCOAST is a phase 3, multicenter, parallel-group, double-blind, and event-driven study designed to compare 2 prasugrellD schedules in patients with NSTE myocard'iol infarction who ore scheduled for coronary angiography/ percutaneous coronary intervention (PCI). Approximately 4, 1 00 patients will be randomly assigned to an initial LD of 30 mg of prasugrel after the diagnosis followed by coronary angiography with an additional dose of 30 mg of prasugrel given atthe time of PCI (pretreatment) or an LD of 60 mg of prasugrel given to patients undergOing PCI at the time of the procedure (non-pretreatment). All patients undergoing PCI will receive 5 or 10 mg of prasugrel daily. The primary objective is to test the hypothesis that prasugrel pretreatment is superior to prasugrel non-pretreatment as measured by a reduction in the composite end point of cardiovascular death, myocardial infarction, stroke, urgent revascularization, or glycoprotein lib/Ilia inhibitor bailout through 7 days from randomization. Key safety end points include TIMI (Thrombolysis In Myocardial Infarction) major and minor bleeding risks. Conclusions The ACCOAST study will provide important evidence with regard to the benefits and risks of prasugrel pretreatment compared with administration of prasugrel at the time of PCI in patients with NSTE myocardial infarction.
Circulation. Cardiovascular interventions, 2015
In European Ambulance Acute Coronary Syndrome Angiography (EUROMAX), bivalirudin improved 30-day clinical outcomes with reduced major bleeding compared with heparins plus optional glycoprotein IIb/IIIa inhibitors. We assessed whether choice of access site (radial or femoral) had an impact on 30-day outcomes and whether it interacted with the benefit of bivalirudin. In EUROMAX, choice of arterial access was left to operator discretion. Overall, 47% of patients underwent radial and 53% femoral access. Baseline risk was higher in the femoral access group. Unadjusted proportions for the primary outcome (death or noncoronary artery bypass graft protocol major bleeding at 30 days) were lower with radial access, however, without differences in major or major plus minor bleeding proportions. After multivariable adjustment, ischemic outcomes were no longer different between access site groups, except for a lower risk of stroke in radial patients. Bivalirudin was associated with lower proport...
Interventional Cardiology Review, 2013
Despite advances in antithrombotic and antiplatelet therapy, bleeding complications remain an important cause of morbidity and mortality in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). A significant proportion of such bleedings are related to the access site, and adoption of transradial access (TRA) may reduce these complications. In patients with ST-segment elevation myocardial infarction (STEMI), TRA reduced cardiac mortality in comparison with the femoral approach (TFA). High-risk patients such as women, obese patients and elderly subjects who are at increased risk for vascular complications and bleeding, might particularly benefit from the TRA. However, specific radial expertise providing procedural time and a success rate comparable to those with the TFA are strongly recommended before using this technique in the emergency setting.
Archives of Medical Science, 2014
Introduction: Superior outcomes with transradial (TRPCI) versus transfemoral coronary intervention (TFPCI) in the setting of acute ST-segment elevation myocardial infarction (STEMI) have been suggested by earlier studies. However, this effect was not evident in randomized controlled trials (RCTs), suggesting a possible allocation bias in observational studies. Since important studies with heterogeneous results regarding mortality have been published recently, we aimed to perform an updated review and meta-analysis on the safety and efficacy of TRPCI compared to TFPCI in the setting of STEMI. Material and methods: Electronic databases were searched for relevant studies from January 1993 to November 2012. Outcome parameters of RCTs were pooled with the DerSimonian-Laird random-effects model. Results: Twelve RCTs involving 5,124 patients were identified. According to the pooled analysis, TRPCI was associated with a significant reduction in major bleeding (odds ratio (OR): 0.52 (95% confidence interval (CI) 0.38-0.71, p < 0.0001)). The risk of mortality and major adverse events was significantly lower after TRPCI (OR = 0.58 (95% CI: 0.43-0.79), p = 0.0005 and OR = 0.67 (95% CI: 0.52-0.86), p = 0.002 respectively). Conclusions: Robust data from randomized clinical studies indicate that TRPCI reduces both ischemic and bleeding complications in STEMI. These findings support the preferential use of radial access for primary PCI.
Journal of the American College of Cardiology, 2014
Transradial access (TRA) has been associated with reduced access site-related bleeding complications and mortality after percutaneous coronary intervention (PCI). It is unclear, however, whether these observed benefits are influenced by baseline bleeding risk. This study investigated the relationship between baseline bleeding risk, TRA utilization, and procedure-related outcomes in patients undergoing PCI enrolled in the British Cardiovascular Intervention Society database. Baseline bleeding risk was calculated by using modified Mehran bleeding risk scores in 348,689 PCI procedures performed between 2006 and 2011. Four categories for bleeding risk were defined for the modified Mehran risk score (MMRS): low (<10), moderate (10 to 14), high (15 to 19), and very high (≥20). The impact of baseline bleeding risk on 30-day mortality and its relationship with access site were studied. TRA was independently associated with a 35% reduction in 30-day mortality risk (odds ratio [OR]: 0.65 [...