Objective To compare the effectiveness and safety of three types of stents (sirolimus eluting, paclitaxel eluting, and bare metal) in people with and without diabetes mellitus. Design Collaborative network meta-analysis. Data sources Electronic databases (Medline, Embase, the Cochrane Central Register of Controlled Trials), relevant websites, reference lists, conference abstracts, reviews, book chapters, and proceedings of advisory panels for the US Food and Drug Administration. Manufacturers and trialists provided additional data. Review methods Network meta-analysis with a mixed treatment comparison method to combine direct within trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Overall mortality was the primary safety end point, target lesion revascularisation the effectiveness end point. Results 35 trials in 3852 people with diabetes and 10 947 people without diabetes contributed to the analyses. Inconsistency of the network was substantial for overall mortality in people with diabetes and seemed to be related to the duration of dual antiplatelet therapy (P value for interaction 0.02). Restricting the analysis to trials with a duration of dual antiplatelet therapy of six months or more, inconsistency was reduced considerably and hazard ratios for overall mortality were near one for all comparisons in people with diabetes: sirolimus eluting stents compared with bare metal stents 0.88 (95% credibility interval 0.55 to 1.30), paclitaxel eluting stents compared with bare metal stents 0.91 (0.60 to 1.38), and sirolimus eluting stents compared with paclitaxel eluting stents 0.95 (0.63 to 1.43). In people without diabetes, hazard ratios were unaffected by the restriction. Both drug eluting stents were associated with a decrease in revascularisation rates compared with bare metal stents in people both with and without diabetes. Conclusion In trials that specified a duration of dual antiplatelet therapy of six months or more after stent implantation, drug eluting stents seemed safe and effective in people both with and without diabetes.
INTRODUCTIONPeople with diabetes experience a more generalised form of atherosclerosis than people without diabetes. They are at an increased risk for coronary heart disease and have more restenoses after the implantation of coronary stents. On average sirolimus eluting stents and paclitaxel eluting stents are associated with a noticeable reduction in target lesion revascularisation compared with bare metal stents, whereas the rates of overall mortality and cardiac mortality associated with the three stents are similar.1 Differences in the process and dynamics of restenosis along with variations in metabolic profiles may, however, alter safety or effectiveness profiles of the different stent types, particularly in people with diabetes.Randomised trials have reported a reduced revascularisation rate with both sirolimus eluting stents and paclitaxel eluting stents compared with bare metal stents in people with diabetes, 2...
Prasugrel and ticagrelor are similarly effective during the first year after MI. Economically motivated early post-discharge switches to clopidogrel were not associated with an increased risk of ischemic events. (Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction [PRAGUE-18]; NCT02808767).
In our randomized trial we failed to demonstrate the superiority of the IVUS guidance during DES implantation over standard high-pressure postdilatation. However we confirmed worrisome results concerning DES thrombosis after discontinuation of dual antiplatelet-treatment with documented stent thrombosis related events in almost 5% of patients with 50% of mortality in this high-risk clinical scenario.
BACKGROUND:No randomized head-to-head comparison of the efficacy and safety of ticagrelor and prasugrel has been published in the 7 years since the higher efficacy of these newer P2Y 12 inhibitors were first demonstrated relative to clopidogrel.
METHODS:This academic study was designed to compare the efficacy and safety of prasugrel and ticagrelor in acute myocardial infarction treated with primary or immediate percutaneous coronary intervention. A total of 1230 patients were randomly assigned across 14 sites to either prasugrel or ticagrelor, which was initiated before percutaneous coronary intervention. Nearly 4% were in cardiogenic shock, and 5.2% were on mechanical ventilation. The primary end point was defined as death, reinfarction, urgent target vessel revascularization, stroke, or serious bleeding requiring transfusion or prolonging hospitalization at 7 days (to reflect primarily the in-hospital phase). This analysis presents data from the first 30 days (key secondary end point). The total followup will be 1 year for all patients and will be completed in 2017.
RESULTS:The study was prematurely terminated for futility. The occurrence of the primary end point did not differ between groups receiving prasugrel and ticagrelor (4.0% and 4.1%, respectively; odds ratio, 0.98; 95% confidence interval, 0. 55-1.73; P=0.939). No significant difference was found in any of the components of the primary end point. The occurrence of key secondary end point within 30 days, composed of cardiovascular death, nonfatal myocardial infarction, or stroke, did not show any significant difference between prasugrel and ticagrelor (2.7% and 2.5%, respectively; odds ratio, 1.06; 95% confidence interval, 0.53-2.15; P=0.864).
CONCLUSIONS:This head-to-head comparison of prasugrel and ticagrelor does not support the hypothesis that one is more effective or safer than the other in preventing ischemic and bleeding events in the acute phase of myocardial infarction treated with a primary percutaneous coronary intervention strategy. The observed rates of major outcomes were similar but with broad confidence intervals around the estimates. These interesting observations need to be confirmed in a larger trial. 1604 F low restoration through an infarct-related artery via implantation of intracoronary stents during primary percutaneous coronary intervention (PCI) is, if possible, the preferred reperfusion therapy in patients with acute myocardial infarction (AMI) with ST-segment elevation (STEMI).
CLINICAL TRIAL REGISTRATION:1 The highest thrombotic risk associated with this condition requires intensive antithrombotic treatment.2 In addition to aspirin, guidelines recommend the use of ticagrelor or prasugrel over clopidogrel. 1,3 Except for patients after an ischemic stroke, in whom prasugrel is contraindicated, class and level of guideline recommendations are identical for both agents. Physicians are increasingly being confronted with the need to select a P2Y 12 antagonist as part of the daily care of patients with AMI. For all practical pu...
AimsSurgical ablation procedure can restore sinus rhythm (SR) in patients with atrial
fibrillation (AF) undergoing cardiac surgery. However, it is not known whether it has
any impact on long-term clinical outcomes.Methods and resultsThis multicentre study randomized 224 patients with AF scheduled for valve and/or
coronary surgery: group A (left atrial surgical ablation, n =
117) vs. group B (no ablation, n = 107). The primary efficacy
outcome was the SR presence (without any AF episode) during a 24 h electrocardiogram
(ECG) after 1 year. The primary safety outcome was the combined endpoint of
death/myocardial infarction/stroke/renal failure at 30 days. A Holter-ECG after 1 year
revealed SR in 60.2% of group A patients vs. 35.5% in group B
(P = 0.002). The combined safety endpoint at 30 days occurred
in 10.3% (group A) vs. 14.7% (group B, P = 0.411).
All-cause 1-year mortality was 16.2% (A) vs. 17.4% (B, P
= 0.800). Stroke occurred in 2.7% (A) vs. 4.3% (B) patients
(P = 0.319). No difference (A vs. B) in SR was found among
patients with paroxysmal (61.9 vs. 58.3%) or persistent (72 vs. 50%) AF,
but ablation significantly increased SR prevalence in patients with longstanding
persistent AF (53.2 vs. 13.9%, P < 0.001).ConclusionSurgical ablation improves the likelihood of SR presence post-operatively without
increasing peri-operative complications. However, the higher prevalence of SR did not
translate to improved clinical outcomes at 1 year. Further follow-ups (e.g. 5-year) are
warranted to show any potential clinical benefit which might occur later.
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