72 research outputs found
Performance of an automated real-time ST-segment analysis program to detect coronary occlusion and reperfusion
Embedding clinical interventions into observational studies
Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed
Direct Stenting versus Conventional Stenting in Patients with ST-Segment Elevation Myocardial Infarction—A COMPARE CRUSH Sub-Study
Background: Direct stenting (DS) compared with conventional stenting (CS) after balloon predilatation may reduce distal embolization during percutaneous coronary intervention (PCI), thereby improving tissue reperfusion. In contrast, DS may increase the risk of stent underexpansion and target lesion failure. Methods:In this sub-study of the randomized COMPARE CRUSH trial (NCT03296540), we reviewed the efficacy of DS versus CS in a cohort of contemporary, pretreated ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI. We compared DS versus CS, assessing (1) stent diameter in the culprit lesion, (2) thrombolysis in myocardial infarction (TIMI) flow in the infarct-related artery post-PCI and complete ST-segment resolution (STR) one-hour post-PCI, and (3) target lesion failure at one year. For proportional variables, propensity score weighting was applied to account for potential treatment selection bias. Results: This prespecified sub-study included 446 patients, of whom 189 (42%) were treated with DS. Stent diameters were comparable between groups (3.2 ± 0.5 vs. 3.2 ± 0.5 mm, p = 0.17). Post-PCI TIMI 3 flow and complete STR post-PCI rates were similar between groups (DS 93% vs. CS 90%, adjusted OR 1.16 [95% CI, 0.56–2.39], p = 0.69, and DS 72% vs. CS 58%, adjusted OR 1.29 [95% CI 0.77–2.16], p = 0.34, respectively). Moreover, target lesion failure rates at one year were comparable (DS 2% vs. 1%, adjusted OR 2.93 [95% CI 0.52–16.49], p = 0.22). Conclusion:In this contemporary pretreated STEMI cohort, we found no difference in early myocardial reperfusion outcomes between DS and CS. Moreover, DS seemed comparable to CS in terms of stent diameter and one-year vessel patency.</p
Meeting Report: ESC Forum on Drug Eluting Stents European Heart House, Nice, 27-28 September 2007
Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk
Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance,
but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic
Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities,
and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention–related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of
the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the
pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on
review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic
approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention
Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention A Consensus Document From the Academic Research Consortium for High Bleeding Risk
Identification and management of patients at high bleeding
risk undergoing percutaneous coronary intervention are of major
importance, but a lack of standardization in defining this population
limits trial design, data interpretation, and clinical decision-making.
The Academic Research Consortium for High Bleeding Risk (ARC-HBR)
is a collaboration among leading research organizations, regulatory
authorities, and physician-scientists from the United States, Asia, and
Europe focusing on percutaneous coronary intervention–related bleeding.
Two meetings of the 31-member consortium were held in Washington,
DC, in April 2018 and in Paris, France, in October 2018. These meetings
were organized by the Cardiovascular European Research Center on
behalf of the ARC-HBR group and included representatives of the US
Food and Drug Administration and the Japanese Pharmaceuticals and
Medical Devices Agency, as well as observers from the pharmaceutical
and medical device industries. A consensus definition of patients at high
bleeding risk was developed that was based on review of the available
evidence. The definition is intended to provide consistency in defining this
population for clinical trials and to complement clinical decision-making
and regulatory review. The proposed ARC-HBR consensus document
represents the first pragmatic approach to a consistent definition of
high bleeding risk in clinical trials evaluating the safety and effectiveness
of devices and drug regimens for patients undergoing percutaneous
coronary intervention
Noninvasive assessment of speed and stability of infarct-related artery reperfusion: Results of the GUSTO ST segment monitoring study
Recurrence of ST elevation after early reperfusion as a marker of prognosis in ST elevation infarction
RR-interval irregularity precedes ventricular fibrillation in ST elevation acute myocardial infarction
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