IMPORTANCE The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy ...with specific types of drug-eluting stents remains unknown. OBJECTIVE To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents. DESIGN, SETTING, AND PATIENTS The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents. INTERVENTIONS After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point. MAIN OUTCOMES AND MEASURES The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction MI, stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis. RESULTS NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 95% CI, −1.52 to 1.86; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 95% CI, 0.87-1.45). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 2.6% vs 38 2.6% for the short- and long-term groups, respectively; HR, 1.03 95% CI, 0.66-1.60), MACE (78 5.3% vs 64 4.3%; HR, 1.22 95% CI, 0.88-1.70), or stent thrombosis (4 0.3% vs 1 0.1%; HR, 3.97 95% CI, 0.44-35.49). CONCLUSIONS AND RELEVANCE In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01113372
Background Unsuccessful radial artery puncture, inability to advance the guide catheter to the ascending aorta, and inadequate guide catheter support represent mechanisms of transradial approach ...failure. With the rationale of sharing the same efficacy and safety promoted by radial access, the transulnar approach represents an alternative access site for percutaneous coronary procedures. Methods Between May 2007 and May 2012, 11,059 coronary invasive procedures were performed in a single institution: 10,108 by transradial approach (91.4%), 541 by transfemoral approach (4.9%), and 410 by transulnar approach (3.7%). Patients who underwent coronary procedures through transulnar access were included in a prospective registry of effectiveness and safety. Results Diagnostic procedures accounted for 71.8% of cases, and the right ulnar access was the most common route (88.9%). Procedure success was high (98.5%), with a crossover rate of 1.5% (6 cases), of which 5 were achieved through the contralateral radial access and 1 through femoral approach. Complications related to access site were low (3.9%), consisting mostly of minor bleeding due to subcutaneous hematomas. There were no cases of major bleeding, nerve injury, pseudoaneurysm, arteriovenous fistula, or necessity of vascular surgical repair. Conclusions The transulnar approach represents an alternative to the transradial approach in selected cases when performed by radial-trained operators, sharing a high success rate and extremely low incidence of access-site complications.
To compare severe complications related to radial access and those related to femoral access using vascular closure devices for patients undergoing primary percutaneous coronary intervention (PCI).
...Femoral artery access is still used for acute myocardial infarction management; studies comparing state-of-the-art radial and femoral techniques are required to minimize bias regarding the outcomes associated with operator preferences.
We performed a randomized study comparing radial access with a compression device and anatomic landmark-guided femoral access with a hemostatic vascular closure device. The severe complication rates related to the access site were assessed until hospital discharge. A meta- analysis including studies with comparable populations reporting severe bleeding and major adverse cardiovascular event rates was performed.
A total of 250 patients were included who underwent PCI between January 2016 and February 2019. Mean age was 61.5 ± 12.2 years, 73.2% were men, and 28.4% had diabetes. There were no differences between groups or in vascular access-related severe complication rates (8.0% for femoral group vs 5.6% for radial group; P=.45). Although radial access was associated with decreased vascular complications related to the access site when compared with the femoral approach (relative risk RR, 0.64; 95% confidence interval CI, 0.43-0.95), the meta-analysis did not show an impact on severe bleeding (RR, 0.74; 95% CI, 0.37-1.46) or severe cardiovascular adverse events (RR, 0.69; 95% CI, 0.30-1.58).
Compliance with femoral artery puncture techniques and routine use of a vascular closure device promoted low severe complication rates.
Occurrence of ischemic complications after transulnar coronary procedures is virtually absent. The presence of a complete deep palmar arch in approximately 95% of the population as well as the great ...capacity of the collateral circulation of the hand might justify these findings. We report the occurrence of complications in 62 patients submitted to coronary procedures through the transulnar approach, without assessment of the integrity of the deep palmar arch by the inverse Allen's test. The rate of asymptomatic occlusion of the ulnar artery was 3%, without any ischemic complication. We believe the performance of Allen's test is not necessary when using transulnar access.
The radial access provides a lower risk of bleeding and vascular complications related to the puncture site in comparison to the femoral access. Recent studies have suggested a reduction in mortality ...associated with the radial access in patients with acute myocardial infarction undergoing percutaneous coronary intervention.
To compare the occurrence of adverse cardiovascular ischemic and hemorrhagic events in patients undergoing primary angioplasty according to the type of arterial access route.
From August 2010 to December 2011, 588 patients undergoing primary percutaneous coronary intervention during acute ST-segment elevation myocardial infarction were assessed; they were recruited from 47 centers participating in the ACCEPT registry. Patients were grouped and compared according to the arterial access used for the procedure.
The mean age was 61.8 years; 75% were males and 24% had diabetes mellitus. There was no difference between groups as regards the procedure success rate, as well as regards the occurrence of death, reinfarction, or stroke at six months of follow-up. Severe bleeding was reported in 1.1% of the sample analyzed, with no statistical difference related to the access used.
The femoral and radial accesses are equally safe and effective for the performance of primary percutaneous coronary intervention. The low rate of cardiovascular events and of hemorrhagic complications reflects the quality of the participating centers and the operators expertise with the use of both techniques.
Arterial access is a major site of bleeding complications after invasive coronary procedures. Among strategies to decrease vascular complications, the radial approach is an established one. Vascular ...closure devices provide more comfort to patients and decrease hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications, requiring evidence through adequately designed randomized trials. The aim of this study is to compare the radial versus femoral approach using a vascular closure device for the incidence of arterial puncture site vascular complications among non-ST-segment elevation acute coronary syndrome patients submitted to an early invasive strategy.
ARISE is a national, multicenter, non-inferiority randomized clinical trial. Two hundred patients with non-ST-segment elevation acute coronary syndrome will be randomized to either radial or femoral access using a vascular closure device. The primary outcome is the occurrence of vascular complications at an arterial puncture site 30 days after the procedure, including major bleeding, retroperitoneal hematoma, compartment syndrome, hematoma ≥ 5 cm, pseudoaneurysm, arterio-venous fistula, infection, limb ischemia, arterial occlusion, adjacent nerve injury or the need for vascular surgical repair.
Enrollment was initiated in September 2012, and until October 2013 91 patients were included. The inclusion phase is expected to last until the second half of 2014.
The ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with NSTEACS.
ClinicalTrials.gov identifier: NCT01653587.
Major bleeding in acute coronary syndromes de Andrade, Pedro Beraldo; Tebet, Marden André; Maia da Silva, Felipe Souza ...
The Journal of invasive cardiology
23, Številka:
11
Journal Article
Recenzirano
Treatment of acute coronary syndrome has been based on the prevention of ischemic complications by means of antithrombotic therapy and invasive strategies. The desired reduction reached in the ...recurrence of ischemic events reveals its price, an increase in the occurrence of major bleeding. Initially tolerated as a benign complication, it is now shown to be an important predictor of mortality. Greater attention dedicated to the prognostic impact of bleeding is recent, motivated by the development of new antithrombotic agents. Detailed analysis of the risk factors for myocardial infarction or bleeding is an important issue and allows institution of individualized approach.
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