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C. ----- Original Message ----- From: "Charles Brault" <[EMAIL PROTECTED]> To: "URG-L Mailing List" <[EMAIL PROTECTED]> Sent: Friday, August 22, 2003 1:34 AM Subject: URG-L: Angioplastie est sup�rieure � la thrombolyse ! Evidence builds for transfer PCI, with potential role for thrombolysis: DANAMI-2 and SIAM III Boston, MA and Bethesda, MD - Results of the DANAMI-2 trial, showing a strategy of transfer PCI to be superior to thrombolytics for AMI, have now been published in the August 21, 2003 issue of the New England Journal of Medicine.[1] Meanwhile, the SIAM III study, appearing this week in the August 20, 2003 issue of the Journal of the American College of Cardiology, suggests that transferring patients for immediate stenting following thrombolysis at a community hospital reduces cardiac events, compared with a conservative approach of delayed elective stenting.[2] An editorial accompanying DANAMI-2 says it is time to rethink the logistics of emergency care such that AMI patients are taken not to the closest hospital but to the closest center with primary angioplasty. Others say a facilitated PCI approach will likely win out in the end, regardless of where a patient first arrives with an MI. DANAMI-2: applicable results The Danish Multicenter Randomized Study on Fibrinolytic Therapy versus Acute Coronary Angioplasty in AMI 2 (DANAMI-2) results were first presented at the 2002 American College of Cardiology meeting, as reported by heartwire. Lead investigator Dr Henning R Andersen (Aarhus University Hospital, Denmark) also presented intermediate results at the XIVth World Congress of Cardiology in May 2002. In the interim, results from the PRAGUE 2 study, conducted throughout the Czech Republic, were reported at the 2002 European Society of Cardiology meeting, reaffirming the DANAMI-2 results. DANAMI-2 results A total of 1572 AMI patients participated in the DANAMI 2 trial and were randomized to either intravenous alteplase or primary angioplasty; 1129 patients were enrolled at referral hospitals and 443 patients were enrolled at five invasive-treatment centers. "In a large cohort, we found that primary angioplasty is superior to fibrinolysis for patients who have myocardial infarction with ST-segment elevation, even when patients are admitted to a local hospital without angioplasty capabilities and must be transported to an invasive-treatment center," the investigators write. Among patients randomized to angioplasty from a referral hospital, 8.5% died, had clinical evidence of reinfarction, or had a disabling strokethe primary composite end point of the studywithin 30 days of the initial AMI. By contrast, the primary end point was reached by 14.2% of patients randomized to thrombolysis at a referral hospital. These results were comparable to those of patients randomized at invasive-treatment centers. "The superiority of angioplasty over fibrinolysis was driven by a 75% reduction in the relative risk of clinical reinfarction, whereas the reduction in the risks of death and stroke did not reach statistical significance," Andersen et al write. Of note, the median time from the onset of symptoms to randomization was 135 minutes in the overall population, and the median distance that patients had to be transported between a referral and invasive hospital was 50 km (31 miles). A full 96% of patients were transferred from referral hospitals to invasive-treatment hospitals within two hours. One of the most important take-home messages of DANAMI-2, on top of the primary results of the study, was the sheer feasibility of a transfer PTCA strategy in a country with almost no angioplasty expertise before the trial. The five invasive-treatment hospitals had limited experience in performing primary angioplasty at the beginning of the study. Moreover, ambulance transfer time did not in itself add significantly to the overall delay between time of symptom onset and start of treatment. "This fact makes our results applicable to most Western communities and opens the way for more widespread use of primary angioplasty in the treatment of patients who have myocardial infarction with ST-segment elevation," Andersen et al write. In an editorial accompanying DANAMI-2, Dr Alice K Jacobs (University Medical Center, Boston, MA) asserts that the time has come "to discard the practice of transporting patients with AMI to the nearest hospital and to transport them preferentially to centers of excellence for primary PCI. . . . Moreover, now is the time for tertiary hospitals capable of performing primary angioplasty to offer it 24 hours a day, seven days a week."[3] She adds that strategies for combined pharmacologic and mechanical reperfusion "hold promise," but that issues of bleeding risk must be resolved. Andersen et al concur, noting, "there has been great interest in 'facilitated' angioplasty involving the use of a reduced dose of a fibrinolytic drug in combination with more aggressive antithrombotic treatment before angioplasty," although "trials dealing with such strategies have not yet provided convincing evidence of their effectiveness." INSIGHTS FROM SIAM III A new addition to the literature on this topic is the Southwest German Study in Acute MI III (SIAM III), a small German study of 163 AMI patients initially treated with thrombolysis at community hospitals with no onsite cath-lab facilities. SIAM III randomized trial participants to either hospital transfer and immediate stenting within six hours of thrombolysis or delayed, elective stenting approximately two weeks after AMI. Dr Bruno Scheller (Universit�t des Saarlands, Homburg/Saar, Germany) and colleagues compared a primary end point of death, reinfarction, ischemic events, and target lesion revascularization at six months in the immediate and delayed stenting groups. Before randomization, all patients received two 10 MU boluses of reteplase, 30 minutes apart, 250 mg of intravenous aspirin, plus a bolus of 5000 IU heparin followed by a heparin infusion of 1000 IU/hour. The authors report that the composite primary end point was significantly reduced in the immediate stenting group, a result driven largely by the reduction in ischemic events (rehospitalizations, unplanned angiography, and intractable angina). Major bleeding complications were similar between the two groups. Nineteen patients initially randomized to delayed intervention ended up undergoing early angiography within five days of thrombolysis due to electrocardiographic evidence of ischemia. "In summary, immediate transfer of patients to centers for coronary angiography and stenting within six hours after thrombolysis for AMI is safe and improves event-free survival, in particular recurrent ischemia as well as LV function, compared with elective stenting later on," Scheller and colleagues write. In an editorial accompanying Scheller et al's study, Dr Raymond G McKay (Hartford Hospital, CT) points out that SIAM III "illustrates many of the problems commonly observed in treating STEMI patients from the community hospital."[4] These include a longer-than-recommended time to thrombolysis and time to angiography, an "unacceptable" incidence of recurrent ischemic events, deaths, and reinfarction at 30 days in the delayed stenting group, and a less-than-ideal TIMI flow grade 3 at two weeks in the same patients. The 8.6% incidence of major bleeding in all patients was also "unacceptably high," McKay says. "Apart from these limitations, however, the SIAM III study does rekindle ongoing interest in the facilitated PCI concept," McKay concludes. What is needed, he adds, are more data to clarify the efficacy and safety of the facilitated PCI approach. "Such an approach is clearly needed for all patients, but particularly for the STEMI patients presenting to the community hospital without immediate access to a catheter-based therapy." Passed the point where benefits outweigh risks To heartwire, McKay hedged his bets in favor of combined pharmacologic and interventional therapy, despite questions of bleeding risk or initial hospital admission. "I think that the facilitated PCI approach will probably win, regardless of whether the patient presents to a community hospital or to a tertiary center with on-site cath lab. From the results of DANAMI-2 and PRAGUE 2 and the other community hospital studies, it's clear that patients who present to a community hospital have a door-to-balloon time that is really going to be excessive. So while they are waiting for definitive revascularization in the cath lab, there needs to be an attempt to open the infarcted vessel." The benefits even extend to patients who report first to an invasive center, McKay said. "Even in the tertiary hospital setting, I think the advantages of the adjunctive pharmacotherapy are also quite apparent. Early reperfusion while waiting to get to the cath lab is more common with the adjunctive pharmacotherapy, the TIMI 3 flow is more commonly seen, and the outcomes of the intervention are perhaps better because of improved visualization and fewer embolic episodes." He believes bleeding risk, the last major obstacle to facilitated PCI, is fast becoming a thing of the past. "At this point in the game, catheter technique has improved with smaller catheters, better groin closure devices, and lower doses of heparin . . . and I think there is still more to learn with thrombolytics and GP IIb/IIIa inhibitors, but I think we've passed the point where the benefit is outweighing the risk." 1. NEJM August 21st, conclusion A Comparison of Coronary Angioplasty with Fibrinolytic Therapy in Acute Myocardial Infarction "Conclusions A strategy for reperfusion involving the transfer of patients to an invasive-treatment center for primary angioplasty is superior to on-site fibrinolysis, provided that the transfer takes two hours or less." 2. Journal of the American College of Cardiology, August 20th. Beneficial effects of immediate stenting after thrombolysis in acute myocardial infarction Objectives The Southwest German Interventional Study in Acute Myocardial Infarction (SIAM III) investigated potentially beneficial effects of immediate stenting after thrombolysis as opposed to a more conservative treatment regimen. Background Treatment of acute myocardial infarction (AMI) by thrombolysis is compromised by Thrombolysis In Myocardial Infarction (TIMI) 3 flow rates of only 60% and high re-occlusion rates of the infarct-related artery (IRA). Older studies showed no benefit of coronary angioplasty after thrombolysis compared with thrombolytic therapy alone. This observation has been challenged by the superiority of primary stenting over balloon angioplasty in AMI. Methods The SIAM III study was a multicenter, randomized, prospective, controlled trial in patients receiving thrombolysis in AMI (<12 h). Patients of group I were transferred within 6 h after thrombolysis for coronary angiography, including stenting of the IRA. Group II received elective coronary angiography two weeks after thrombolysis with stenting of the IRA. Results A total of 197 patients were randomized, 163 patients fulfilled the secondary (angiographic) inclusion criteria (82 in group I, 81 in group II). Immediate stenting was associated with a significant reduction of the combined end point after six months (ischemic events, death, reinfarction, target lesion revascularization 25.6% vs. 50.6%, P = 0.001). Conclusions Immediate stenting after thrombolysis leads to a significant reduction of cardiac events compared with a more conservative approach including delayed stenting after two weeks. ---------------------------------- Have any systems received questions based on the last paragraph especially? A major study of heart attack treatment shows that reaming clogged arteries with angioplasty is more effective than clearing them with drugs, a finding likely to intensify debate over the best way to treat the 1.1 million people who have heart attacks each year. Angioplasty is so much more effective than clot-busting drugs -- which are used routinely because they can be given anywhere -- that 40% more heart attack patients would survive and avoid major complications if they could obtain the procedure within an hour and a half, the research shows. The Danish study, in today's New England Journal of Medicine, is the latest to prompt U.S. doctors and health-care providers to rethink how they supply emergency heart attack care. Most U.S. hospitals don't provide emergency angioplasties because the procedure requires additional equipment and staff. The USA, unlike Denmark, doesn't have a national health system designed to rush patients to hospitals that perform emergency angioplasties. As a result, doctors are reluctant to risk delaying crucial treatment. ''The time of transport is absolutely critical,'' says Sidney Smith, professor of cardiology at The University of North Carolina-Chapel Hill, who adds that the study provides an ''excellent demonstration of how a rapid transport system and hospitals working together can achieve good results.'' The Danish researchers compared the two heart attack treatments in 1,129 patients. They found that 14% of patients treated with clot-busters died or had another heart attack or stroke. Only 8% of those treated with angioplasty had major complications. That may be difficult to achieve in the USA, where the average ''door to balloon time'' -- the time it takes to get a patient from home into the angioplasty suite -- is about three hours. In the Danish study, the time was half that. Smith says heart specialists, hospitals and ambulance services are discussing setting up a regional heart attack treatment network. ''There's a real opportunity for progress,'' he says. __________________________________ Do you Yahoo!? Yahoo! SiteBuilder - Free, easy-to-use web site design software http://sitebuilder.yahoo.com --- URG-L Pour modifier votre adresse de courriel sur URG-L, envoyez un avis a [EMAIL PROTECTED] en indiquant votre nouvelle adresse ainsi que l'ancienne et le nom de la liste. --- URG-L Pour modifier votre adresse de courriel sur URG-L, envoyez un avis a [EMAIL PROTECTED] en indiquant votre nouvelle adresse ainsi que l'ancienne et le nom de la liste.
