Journal article: long-term clinical outcomes of coronary artery bypass graft surgery compared to those of percutaneous coronary intervention with second generation drug eluting stents in patients with stable angina and an isolated lesion in the proximal left anterior descending artery year: 2020 ref: doi: 10.1002/ccd.29247.Age or date of birth: average age.Sex: majority gender.Date of event: date of publication death was reported as a clinical outcome of this study, however there is no information to suggest the device has caused or contributed to a death.If information is provided in the future, a supplemental report will be issued.
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A journal article titled - long-term clinical outcomes of coronary artery bypass graft surgery compared to those of percutaneous coronary intervention with second generation drug eluting stents in patients with stable angina and an isolated lesion in the proximal left anterior descending artery - was submitted for review.This article compared the long-term outcomes of percutaneous coronary intervention with second-generation drug-eluting stents (pci-des) and coronary artery bypass graft surgery (cabg) with the left internal mammary artery in stable angina patients with isolated single-vessel proximal left anterior descending artery (plad) disease.The sample consisted of 1,010 patients with isolated plad with chronic stable angina.29.5% of patients in the study received the medtronic endeavor sprint des.Clinical outcomes included, cardiac death and non-cardiac death, myocardial infarction, target lesion revascularization, stable angina, unstable angina and arrhythmia.Two patients in the pci-des group had post-operative complications of intraprocedural vessel dissection during pci.Pci-des had a borderline significantly greater risk of repeat revascularization.Angina recurred more often after pci whereas more arrhythmias developed after cabg.Pci-des resulted in fewer in-hospital complications and shorter hospitalizations.
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Additional information: the vessel dissections were due to procedural reasons and not related to the stent type.A causal relation with the type of stent was not possible to be revealed in patients with arrhythmias.Myocardial infarction, not attributed to a non-target vessel, occurred in four patients in the pci-des group.One of these patients had a coronary angiography, which revealed definite thrombosis of the stent.Tlr was performed in nineteen patients in the pci-des group due to stent restenosis.The main indication for repeat coronary angiography to these patients was angina and/or ischemia induced on stress tests.One of these patients had a premature discontinuation of dual antiplatelet therapy.Of these patients,13 had angina recurrence.No causal relation with pci-des stent was revealed after a repeat angiography or/and non-invasive ischemia evaluation tests in the remaining patients with angina recurrence.A causal relationship with the type of stent, the stent material or the eluted drug could not be attributed to any of the reported deaths.Patient weight provided a4.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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