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Successful management of patients with a drug-eluting coronary stent presenting for elective surgery
- Stephen N Bolsin, Liam Broad, Myles Conroy, Neil Orford, Garth Birdsey, Alexander Black (15 March 2007)
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Re: Response
- Stephen N Bolsin, Liam Broad, Myles Conroy, Neil Orford, Garth Birdsey, Alexander Black (15 March 2007)
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Anti Platelet Agents To Stop or Not Stop Pre-operatively.
- sheshagiri Bengeri, 1H247 Department of Anaesthesiology, University of Michigan Hospital,1500 East medical Center Drive, Ann Arbor 48105 MI, USA (5 February 2007)
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Response
- Kuruvanka G Srinivas (19 January 2007)
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Stephen N Bolsin, Associate Professor Melbourne University, Liam Broad, Myles Conroy, Neil Orford, Garth Birdsey, Alexander Black
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Dear Sir, Thank you for the opportunity to comment on the wide-ranging letter from sheshagiri Bengeri, which raises some important issues. We agree with Dr Bengeri that there is increased interest in the issue of antiplatelet treatment after DES insertion and we would support the January 4th 2007 update from the US Food & Drug Administration (FDA) that includes the following bullet points (Available at http://www.fda.gov/cdrh/news/010407.html). · Data from several studies suggests that a longer duration of antiplatelet therapy than is currently included in the CYPHER and TAXUS labeling may be beneficial. · The optimal duration of antiplatelet therapy, specifically clopidogrel is unknown and DES thrombosis may still occur despite continued therapy. · The labeling for both approved DES should include reference to the ACC/AHA/SCAI PCI Practice Guidelines, which recommend that patients receive aspirin indefinitely plus a minimum of 3 months (for Cypher patients) or 6 months (for TAXUS patients) of clopidogrel, with therapy extended to 12 months in patients at a low risk of bleeding. We also confirm that the DES inserted in the 3 cases we reported were in compliance with the Victorian DHS Guidelines for DES, which fall within the FDA guidelines, and therefore do not constitute “off-label” use. With respect to the protocol developed in the Geelong Hospital we assumed that the DES was a “high-risk lesion” in the coronary circulation and devised a treatment regimen to reduce the risk of coronary occlusion while at the same time minimising the risk of bleeding at the time of surgery 1. We are not sure what the view of “most surgeons” with respect to anti -platelet agents is but would add some data from our unpublished survey of 24 patients with DES presenting for a total of 43 non-cardiac surgery procedures at this institution. On 15 occasions clopidogrel was stopped, although aspirin was continued. Three patients suffered myocardial infarction due to in-stent thrombosis and 2 of the myocardial infarcts occurred prior to surgery. Of the 18 patients undergoing surgery while still on Clopidogrel the only patient to suffer excessive bleeding was transferred from a rural hospital and required 2 emergency laparotomies, following an episode of severe rectal bleeding. Our institutional guidelines now advise that patients undergoing superficial, ophthalmic or minor surgery (including endoscopy without biopsy) should continue clopidogrel throughout the perioperative period. More complex surgery should be planned in consultation with a perioperative physician or cardiologist experienced in the management of these patients at the time of surgery. Stephen Bolsin, Associate Professor Liam Broad, Myles Conroy Specialist Anaesthetists Department of Perioperative Medicine, Anaesthesia & Pain Management Sandy Black, Associate Professor, Department of Cardiology Neil Orford, Intensive Care Specialist Garth Birdsey, Pharmacy, The Geelong Hospital, Ryrie Street, Geelong, Victoria 3220 References 1. Broad L, et al. Successful management of patients with a drug-eluting coronary stent presenting for elective, non-cardiac surgery. Br. J. Anaesth. 2007; 98:19-22. Conflict of Interest:We are all authors of the Case reports in the BJA |
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Stephen N Bolsin, Associate Professor Melbourne University, Liam Broad, Myles Conroy, Neil Orford, Garth Birdsey, Alexander Black
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Dear Sir, We agree wholeheartedly with the comments made by Dr Srinivas that all patients with drug-eluting coronary artery stents should be referred to an anaesthetist for preoperative assessment. The issue of regional anaesthesia for these patients is more complex and requires a balanced consideration of the benefits provided by a regional technique compared to the risks associated with regional blockade in a patient on a thienopyridine or glycoprotein IIb/IIIa inhibitor. While we are aware of the need for efficient management of beds within any modern health service, the primary consideration must be the optimal management of individual patients, with their informed consent, about the likely outcomes of treatment decisions 1, 2. Furthermore, we would suggest that the bed occupancy and cost of patients with a 20% risk of suffering a perioperative myocardial infarct or severe bleeding would be greater than the bed occupancy in the proposed guideline. Even if bed occupancy is higher in the guideline treated group, the morbidity and mortality is likely to be lower in this group and consequently the patient should be asked for their informed consent prior to following or abandoning the guidelines 3. Yours sincerely Stephen Bolsin Associate Professor Myles Conroy Liam Broad Tao Chern Lee Specialist Anaesthetists, Department of Perioperative Medicine, Anaesthesia & Pain Management Sandy Black Associate Professor Department of Cardiology Neil Orford Intensive Care Specialist Garth Birdsey Pharmacy The Geelong Hospital, Ryrie Street, Geelong, Victoria, Australia 3220 References 1 American College of Physicians. Ethics Manual: Fourth Edition. Ann Intern Med 1998; 128:576-94 2 Bolsin SN. Whistle blowing. Medical Education 2003; 37:294-6 3 Broad L, et al. Successful management of patients with a drug- eluting coronary stent presenting for elective, non-cardiac surgery. Br. J. Anaesth. 2007; 98:19-22 Conflict of Interest:Authors of the Case Reports in the BJA |
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sheshagiri Bengeri , 1H247 Department of Anaesthesiology, University of Michigan Hospital,1500 East medical Center Drive, Ann Arbor 48105 MI, USA
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L. Broad, T. Lee, M. Conroy, S. Bolsin, N. Orford, A. Black, and G. Birdsey Successful management of patients with a drug-eluting coronary stent presenting for elective, non-cardiac surgery BJA Advance Access published on November 22, 2006 Br. J. Anaesth. 2007 98: 19-22; doi:10.1093/bja/ael318 I read with interest your management of three cases. I think the case report was accepted for publication at a time when a firestorm was developing by the presentation of results of a meta- analysis at World congress of Cardiologists at Barcelona in September 2006. In response to the presentation of meta-analysis from 9 randomized trials at the World Cardiology Congress “Comparison of sirolimus- and paclitaxel-eluting coronary stents regarding the risk of stent thrombosis. A meta-analysis from 9 randomized trials”, the Food and Drug Administration (FDA) held an open meeting of its Circulatory System Devices Panel on December 7 and 8, 2006. They also heard the story of a man who had a stent thrombosis 8 days after he stopped taking clopidogrel in preparation for oral surgery (3). The authors themselves report a similar case in which one of their patients had stent occlusion after 7 days of stopping clopidogrel prior to subacromial decompression. Both patients had DES for 18 months. At present most of surgeons stop all the anti-platelet agents for 7 days prior to surgery. The Current Practice Guidelines for continuation of dual anti- platelet drugs are as follows released. (1) ACC/AHA/SCAI PCI Practice Guidelines * – Clopidogrel therapy for at least 3 months after CYPHER stent implantation, at least 6 months after TAXUS stent implantation • Reflects recommendations in the present label for the CYPHER and TAXUS stents, respectively – Ideally up to 12 months in patients who are not at high risk of bleeding (Class IB recommendation ) The European Society of Cardiology have issued the following guidelines – Clopidogrel administration for 6 to 12 months after DES implantation (Class IC recommendation) The Second ASRA Consensus Conference on Neuraxial Anesthesia and Anticoagulation wrote the following (5) “Antiplatelet medications, including NSAIDs, thienopyridine derivatives (ticlopidine and clopidogrel), and platelet GP IIb/IIIa antagonists (abciximab, eptifibatide, tirofiban) exert diverse effects on platelet function. The pharmacologic differences make it impossible to extrapolate between the groups of drugs regarding the practice of neuraxial techniques. There is no wholly accepted test, including the bleeding time, which will guide antiplatelet therapy. Careful preoperative assessment of the patient to identify alterations of health that might contribute to bleeding is crucial. These conditions include a history of easy bruisability/excessive bleeding, female gender, and increased age. NSAIDs appear to represent no added significant risk for the development of spinal haematoma in patients having epidural or spinal anesthesia. The use of NSAIDs alone does not create a level of risk that will interfere with the performance of neuraxial blocks. The concurrent use of other medications affecting clotting mechanisms, such as oral anticoagulants, unfractionated heparin, and LMWH, may increase the risk of bleeding complications. COX-2 inhibitors have minimal effect on platelet function and should be considered in patients who require anti-inflammatory therapy in the presence of anticoagulation.” In view of the present recommendation from ACC/AHA/SCAI PCI Practice Guidelines and European society of Cardiologists guidelines, cessation of the dual anti-platelet, even 1 week prior to surgery, increases the likelihood stent restenosis and of peri-operative MI. Patients in whom the dual antiplatelet treatment is continued are at higher risk of peri- operative bleeding and will make these patients unfit for central neuraxial block. Broad et al have suggested use of shorter acting IV agents like tirofiban and heparin to prevent coronary artery stent restenosis and excessive bleeding. This is to be done with caution in view difficulty in extrapolating between the different groups of drugs (5). It may be prudent to have cardiology counseling preoperatively and careful management to prevent stent restenosis. Admitting patients for 7 days may put huge burden on the hospital. Non-cessation of clopidogrel and addition of other antiplatelet drugs might increase the perioperative blood loss and increase in the blood transfusions. In the present situation caution is paramount importance. The risk benefit assessment of stopping the antiplatelet treatment resulting in increased chances of perioperative MI vs. bleeding in the patient concerned is required. Consent after thorough discussion with the patient is essential as he / she is the one who needs the stent to keep their heart ticking. * The American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions (ACC/AHA/SCAI) References 1) http://www.fda.gov 2) Comparison of sirolimus- and paclitaxel-eluting coronary stents regarding the risk of stent thrombosis. A meta-analysis from 9 randomized trials Authors: R. Moreno (Madrid/Spain), C. Fernandez (Madrid/Spain), R. Hernandez (Madrid/Spain), F. Alfonso (Madrid/Spain), C. Banuelos (Madrid/Spain), J. Escaned (Madrid/Spain), A. Fernandez-Ortiz (Madrid/Spain), C. Macaya (Madrid/Spain) 3) Debating the Risks of Drug-Eluting Stents Miriam Shuchman, M.D. Volume 356:325-328January 25, 2007Number 4 4) T. Kövesi and D. Royston Editorial I: Is there a bleeding problem with platelet-active drugs? Br. J. Anaesth., Feb 2002; 88: 159 - 163. 5) Regional Anesthesia in the Anti-coagulated Patient: Defining the Risks (The Second ASRA Consensus Conference on Neuraxial Anesthesia and Anticoagulation) Terese T. Horlocker, M.D., Denise J. Wedel, M.D., Honorio Benzon, M.D., David L. Brown, M.D., F. Kayser Enneking, M.D., John A. Heit, M.D., Michael F. Mulroy, M.D., Richard W. Rosenquist, M.D., John Rowlingson, M.D., Michael Tryba, M.D., and Chun-Su Yuan, M.D., Ph.D. 6) Epidural haematoma after a combined spinal–epidural anaesthetic in a patient treated with clopidogrel and dalteparin Br. J. Anaesth., February 2006; 96: 262 – 265 N. L. K. Tam C. Pac-Soo and P. M. Pretorius Conflict of Interest:None declared |
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Kuruvanka G Srinivas, SHO Anaesthetics Watford General Hospital
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I read with interest the case report by L.Broad et al regarding the management of patients with drug-eluting coronary stents.I think it is highly relevant to have a perioperative drug guideline in the management of these patients in view of the high incidence of such patients presenting for non-cardiac surgeries.Considering that many pre-op anaesthetic assesments are done by nurse practioners it is my opinion that all such patients be referred to the concerned anaesthetist however minor the proposed surgery.Is there a role for regional anaesthesia in these patients? For example if a patient with severe chronic obstructive pulmonary disease and a drug eluting coronary stent presented for upper abdominal/thoracic surgery a working thoracic epidural would benefit his post-operative recovery.Lastly in this day of acute crises of beds,I wonder how many hospitals could afford patients coming in three days before surgery. Conflict of Interest:None declared |
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