Late-Breaking Clinical Trial Abstracts
2003; Lippincott Williams & Wilkins; Volume: 108; Issue: 21 Linguagem: Inglês
10.1161/circ.108.21.2723
ISSN1524-4539
Tópico(s)Health Systems, Economic Evaluations, Quality of Life
ResumoHomeCirculationVol. 108, No. 21Late-Breaking Clinical Trial Abstracts Free AccessAbstractPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessAbstractPDF/EPUBLate-Breaking Clinical Trial Abstracts Originally published25 Nov 2003https://doi.org/10.1161/circ.108.21.2723Circulation. 2003;108:2723Heart Disease on the Mend: A Multifactor Risk Reduction Program in the Medically UnderservedWilliam Haskell, Kathy Berra, Annette Clark, Dianne Christopherson, Shauna Duff, Jan George, Linda Klieman, Jeff Myll, Stanford University School of MedicineBackground: Risk factors contributing to increased risk for cardiovascular disease (CVD) are well defined. Clinical trials have shown that multifactor risk reduction (MRR) reduces CVD morbidity and mortality. The challenge is to implement cost-effective MRR programs, especially for ethnic minority and low-income populations. Purpose: To test the effectiveness of an MRR program in the medically underserved. Methods: Persons at high risk for CVD were identified in settings where low-income patients obtain medical care in Santa Clara County, Calif. Medical history and clinical screening confirmed eligibility. Eligible participants were randomized (2:1—treatment [T] versus usual care [UC]) into the Heart Disease on the Mend (HDOM) yearlong MRR program. The MRR program used a physician-directed, nurse and dietitian case management approach that included lifestyle change and medical management. Results: Of the 149 persons randomized, 56% were female, with mean age of 57 years (s.d.=20.4). Ethnicity included 57% Hispanic, 10% Asian, 7% African American, 16% Caucasian, and 10% other. Patient fluency in English: none=45%, moderate=22%, and fluent=33%. Presence of type II diabetes (54%), dyslipidemia (67%), hypertension (70%), and obesity (38%) were the most common CVD risk factors at baseline. Data at 12 months were collected on 91% of patients. The MRR program produced significant reductions in major CVD risk factors during follow-up for T vs UC. Risk status was lower at follow-up (6-month plus 12-month values) for T vs UC (ANCOVA) for the following risk factors: TC (mg/dL)—UC=199, T=184 (P<0.01); LDL-C (mg/dL)—UC=116, T=104 (P<0.01); TC/HDL-C—UC=4.8, T=4.2 (P<0.001); Tg (mg/dL)—UC=193, T=174 (P=0.06); fasting glucose (mg/dL)—UC=142, T=129 (P<0.01); SBP (mm Hg)—UC=137, T=128 (P<0.001); DBP (mm Hg)—UC=81, T 77 (P 90-minute delay from randomization to intervention did not show any superiority of the “combo therapy” over abciximab alone. Conclusions: Pretreatment with reteplase plus abciximab is not superior to abciximab alone in patients with AMI who will undergo a PCI.Antiarrhythmic Effects of n-3 Polyunsaturated Fatty Acids in Survivors of Ventricular TachyarrhythmiasMerritt Raitt, William Connor, Cynthia Morris, Jack Kron, Blair Halperin, Sumeet Chugh, James McClelland, James Cook, Karen MacMurdy, Robert Swenson, Sonja Connor, Glenn Gerhard, Daniel Oseran, Christy Marchant, David Calhoun, Reed Snyder, John McAnulty, Oregon Health & Science University, Portland, OregonClinical studies of n-3 polyunsaturated fatty acids (n-3 PUFA) have noted a reduction in sudden cardiac death but no effect on myocardial infarction. This information and data from cellular and animal studies suggest that n-3 PUFA may have antiarrhythmic properties. Methods: We report the results of a multicenter, double-blinded, randomized, placebo-controlled trial of n-3 PUFA in 200 patients with an implanted defibrillator (ICD) and a recent episode of ventricular tachycardia (VT) or fibrillation (VF). No patients were taking an antiarrhythmic drug. Patients were randomized to receive fish oil (1.8 gram of n-3 PUFA, 42% EPA and 30% DHA in capsules) or placebo (olive oil capsules) daily, and were seen every 3 months for up to 2 years. All ICD therapy events were downloaded from the ICD for classification. Red blood cell membrane n-3 PUFA levels were measured to assess compliance and to correlate with efficacy. A subset of 49 patients had electrophysiologic studies to measure the ventricular effective refractory period, inducibility of VT or VF, and defibrillation threshold at baseline and after 3 months of therapy. Results: Patients treated with fish oil had an increase in their mean red cell membrane n-3 PUFA level from 4.7% of red cell fatty acid at baseline to 8.3% at 3 months (P<0.001). There was no significant change in placebo patients (4.5% to 4.6%). n-3 PUFA levels remained stable from 3 months through 24 months in both groups. There was a trend toward a higher incidence of VT/VF in patients randomized to fish oil. At 6 months, 1 year, and 2 years, 36%, 41%, and 60% of placebo patients had VT/VF compared to 47%, 51%, and 66% of patients randomized to fish oil (P=0.19). Among patients entered after an episode of VT, there was a significant increase in VT/VF in patients randomized to fish oil (P=0.007). There was a trend toward patients with the highest levels of n-3 PUFA having the highest incidence of VT/VF. An actuarial analysis of time to recurrent events showed that patients randomized to fish oil had significantly more events than patients randomized to placebo (P<0.01). There was no difference in the measured electrophysiologic parameters attributable to fish oil. Conclusion: n-3 PUFA do not have antiarrhythmic effects in survivors of ventricular tachyarrhythmias.Secondary Prevention Beyond Hospital Walls IntervenTion Trial In (WITTI) WomenBackground: Secondary prevention of coronary heart disease (CHD) extends survival and reduces recurrent CHD events and the need for revascularization, yet many patients do not reach optimal prevention goals. “Systems” approaches to improve adherence to comprehensive secondary prevention guidelines have not been rigorously tested. Methods: We conducted a randomized, controlled clinical trial among 304 women (mean age 62.3±12.4 years, 52% minorities) hospitalized with CHD to test the effect of a systematic intervention (SI) vs usual care to increase adherence to AHA secondary prevention goals. The SI group received counseling by a prevention facilitator/health educator about lifestyle, risk factor management, and preventive medications during hospitalization and were contacted on a regular basis for up to 6 months after discharge. The prevention facilitator also assisted with enrollment in cardiac rehabilitation. Progress reports regarding status of reaching prevention goals were sent to the women’s physician(s) at baseline and 6 weeks’ follow-up. Attainment of prevention goals (smoking cessation, weight management, physical activity, blood pressure <140/90 mm Hg, low-density lipoprotein [LDL] cholesterol 2/3 meeting other goals. Minority women were less likely than whites to meet the goals for blood pressure (OR=0.46, 95% CI=0.26–0.80), LDL cholesterol (OR=0.57, CI=0.33–0.94), and weight (OR=0.40, 95% CI=0.20–0.82) prior to the intervention. At 6 months, there was no significant difference in the summary score for goals met or in the proportion of individual goals achieved between the intervention and usual-care groups. Attainment of LDL goal remained <60% in both groups at 6 months. Minority women in the intervention group were 2.4× more likely (95% CI 1.13–5.03) to reach the blood pressure goal at 6 months compared to minority women in usual care. In a logistic regression model, the interaction term for ethnic status and group assignment was significant for achieving the blood pressure goal (P=0.009). Conclusion:A systematic intervention to improve CHD preventive care was insufficient to increase rates of adherence to secondary prevention guidelines over usual care in women overall; however, there was a benefit for blood pressure control among minority women. These data highlight the need for better methods to improve lifestyle and lipid control among women with heart disease, especially among minority women.Valsartan, Captopril, or Both in Myocardial Infarction Complicated by Heart Failure, Left Ventricular Dysfunction, or BothMarc A. Pfeffer, MD, PhD; John J.V. McMurray, MD; Eric J. Velazquez, MD; Jean-Lucien Rouleau, MD; Lars Køber, MD; Aldo P. Maggioni, MD; Scott D. Solomon, MD; Karl Swedberg, MD, PhD; Frans Van de Werf, MD, PhD; Harvey White, DSc; Jeffrey D. Leimberger, PhD; Marc Henis, MD; Susan Edwards, MS; Steven Zelenkofske, DO; Mary Ann Sellers, MSN; Robert M. Califf, MD; for the Valsartan in Acute Myocardial Infarction Trial Investigators*Background: Survivors of acute myocardial infarction complicated by heart failure and/or resulting in left ventricular dysfunction are at heightened risk for subsequent death and major nonfatal cardiovascular events. Inhibition of the renin-angiotensin system with an angiotensin-converting enzyme (ACE) inhibitor has consistently been demonstrated to result in reductions in these risks by approximately 20%. The development of angiotensin II receptor blockers (ARB) offers a new, more specific, and theoretically more complete pharmacological mode to inhibit the adverse influence of angiotensin II. The objective of the trial is to determine whether the use of the ARB valsartan alone or in addition to captopril offers a clinical advantage compared to a proven ACE inhibitor. Methods:Patients with acute myocardial infarction (0.5 to 10 days), which was complicated by either left ventricular dysfunction or acute heart failure or both, were randomized to valsartan (4909 patients), valsartan plus captopril (4885 patients), or captopril (4909 patients). The primary end point was death from any cause. Results:During a median follow-up of 24.7 months, 979 patients in the valsartan group died, as did 941 patients in the valsartan-and-captopril group and 958 patients in the captopril group (hazard ratio in the valsartan group as compared with the captopril group, 1.00; 97.5% confidence interval, 0.90 to 1.11; P=0.98; hazard ratio in the valsartan-and-captopril group as compared with the captopril group, 0.98; 97.5% confidence interval, 0.89 to 1.09; P=0.73). The upper limit of the one-sided 97.5% confidence interval for the comparison of the valsartan group with the captopril group was within the prespecified margin for noninferiority with regard to mortality (P=0.004) and with regard to the composite end point of fatal and nonfatal cardiovascular events (P<0.001). The valsartan-and-captopril group had the most drug-related adverse events. With monotherapy, hypotension and renal dysfunction were more common in the valsartan group, and cough, rash, and taste disturbance were more common in the captopril group. Conclusions: Valsartan is as effective as captopril in reducing risk of death as well as subsequent heart failure and myocardial infarction in patients who are at high risk for cardiovascular events after myocardial infarction. Combining valsartan with captopril increased the rate of adverse events without improving survival. In these patients, valsartan should be considered as a clinically effective alternative to an ACE inhibitor.Acute and Chronic Therapeutic Impact of a Vasopressin 2 Antagonist in Congestive Heart Failure (ACTIV in CHF): A Placebo-Controlled Trial in Patients Hospitalized With Heart FailureMihai Gheorghiade, Christopher M. O’Connor, Kirkwood F. Adams, Jr, Wendy A. Gattis, Alejandro Barbagelata, Uri Elkayam, Frank McGrew, Jalal K. Ghali, Raymond L. Benza, Marc Klapholz, Cesare Orlandi, for the ACTIV Trial InvestigatorsBackground: In the US, there are 1 million admissions/year for heart failure (HF) with a 20% to 30% readmission rate within 60 days. Often, these patients are volume overloaded. Diuretics (D) are the mainstay of therapy; however, they cause electrolyte abnormalities. Tolvaptan (TLV) is an oral, daily vasopressin V2 receptor blocker that is known to decrease body weight (BW) in HF patients without adversely affecting electrolytes or renal function. Methods: Three hundred twenty patients hospitalized in US and Argentina with HF were randomized within 72 hours of admission to once-daily placebo (PLC) or TLV 30 mg, 60 mg, or 90 mg that was continued for 60 days, in addition to standard therapy that included D (97%), ACE inhibitors (80%), digoxin (70%), and β-blockers (40%). The primary end points were changes in BW at 24 hours and worsening HF (death, hospitalization, or unscheduled visit for HF) within 60 days after randomization. Results: Greater BW reductions at 24 hours were observed in all TLV patients compared to PLC (2.0 vs 0.9 kg) (P=0.0003). There were no differences in worsening HF at 60 days between the two groups. All-cause mortality was 5.4% and 8.7% in the in TLV and PLC groups, respectively (P=0.18). In patients with hyponatremia ( 29 mg/dL, and severe congestion, the mortality was 13.2% vs 18.7%, 9.1% vs 20%, and 5.5% vs 17.8%, in the TLV and PLC groups, respectively. Conclusion: TLV in addition to standard therapy decreases BW at 24 hours, with no changes in worsening HF at 60 days. The effects of TLV on mortality in patients hospitalized with HF are being tested in an ongoing international trial (Effects of Vasopressin antagonists in hEart failuRE: outcome Study with Tolvaptan; EVEREST).1PLCTLV 30 mgTLV 60 mgTLV 90 mgMI indicates myocardial infarction; SBP, systolic blood pressure; and HR, heart rate.No. patients80788478Age, y62 ±1460 ±1462 ±1462 ±13Male, %75686079History of MI, %43353536Hypertension, %75766968Diabetes, %46504546SBP, mm Hg116 ±20123 ±23119 ±17119 ±22HR, bpm84 ±1586 ±1783 ±1585 ±18EF, %24 ±825 ±724 ±824 ±8Edema, %59687175Rales, %78758179Randomized Controlled Clinical Trial of Intracoronary Autologous Bone Marrow Cell Transfer Post Myocardial InfarctionKai C. Wollert, Gerd P. Meyer, Joachim Lotz, Stefanie Ringes-Lichtenberg, Christiane Breidenbach, Peter Lippolt, Lubomir Arseniev, Thomas Korte, Burkhard Hornig, Michael Galanski, Bernd Hertenstein, Arnold Ganser, Helmut Drexler, Departments of Cardiology and Angiology (K.C.W., G.P.M., S.R.-L., C.B., P.L., T.K., B.H., H.D.), Radiology (J.L., M.G.), and Hematology and Oncology (L.A., B.H., A.G.), Hannover Medical School, Hannover, GermanyExperimental data and small, open, uncontrolled clinical feasibility studies have suggested that transplantation of autologous bone marrow cells (BMC) to the ischemic area may enhance LV function after myocardial infarction (MI). However, data from prospectively designed, controlled clinical trials are lacking. We performed a randomized, controlled trial in patients after acute ST-elevation MI and successful primary or rescue percutaneous coronary intervention (PCI). The change in left ventricular ejection fraction (LVEF), as determined by magnetic resonance imaging (MRI; assessed by two investigators blinded for treatment assignment), 5 to 6 months after MI as compared to baseline was defined as the primary end point. Patients with hypokinesia or akinesia of ≥2/3 of the LV anterior, septal, lateral, or inferior wall (as determined by angiography immediately after PCI) were eligible for the trial. After providing informed consent, patients were randomized to the control (CON, n=30) and BMC (n=30) groups and underwent MRI to determine baseline LVEF. In the BMC group, 128±33 mL of bone marrow was then obtained. Nucleated BMC were enriched by 4% gelatin-polysuccinate sedimentation and were transplanted (4 to 8 days post MI) into the infarct-related coronary artery through the central lumen of an over-the-wire balloon catheter (25±9 ×108 nucleated BMC, 9.5±6.3 ×106 CD34pos cells). After 5 to 6 months, MRI was repeated in all patients. There were no significant differences between the CON and BMC groups with regard to age, infarct localization, time to PCI (median 8.0 vs 9.8 h), maximum creatine kinase levels, and baseline LVEF (51.3±9.3 vs 50.0±10.0%). After 5 to 6 months, LVEF in the CON and BMC groups had improved by 0.7±8.1% and 6.7±6.5%, respectively (P<0.01, all data are shown as mean±SD). There was no evidence for proarrhythmic effects in the BMC group, as determined by repeated Holter monitoring and an electrophysiological study 5 to 6 months after BMC transplantation. The results from this randomized, controlled trial indicate that intracoronary transplantation of autologous BMC is safe and enhances LV function in patients post MI and successful PCI.The PRIMO-CABG Study: Pexelizumab for the Reduction of Infarction and MOrtality in Coronary Artery Bypass Graft surgeryEdward D. Verrier, Div. Cardiothoracic Surgery University of Washington, Seattle, Wash on Behalf of the PRIMO-CABG Steering Committee and the PRIMO-CABG InvestigatorsBackground: PRIMO-CABG was a Phase III, randomized, double-blind, placebo-controlled study of pexelizumab on all-cause mortality or myocardial infarction (MI) in patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass. Methods: Approximately 3100 patients were enrolled at 205 centers in N America and W Europe. Patients underwent CABG with or without concomitant valve surgery. The primary end point was a composite of the incidence of death or MI (death/MI) through day 30 in the CABG-only population (n=2746). Secondary analyses included death/MI in the CABG-only population at day 4, death/MI in the overall study population (n=3099) at day 4 and day 30, and death at day 90. Six different analyses of myocardial infarction were also prespecified as a sensitivity analysis. Results: The number of patients experiencing adverse events (AE) was similar in both treatment groups (85.2% placebo, 85.5% pexelizumab). The most frequent AEs in both groups were atrial fibrillation, nausea, pleural effusion, postprocedural pain, anemia, hypotension, and postoperative wound infection. There was a nonsignificant reduction in the primary end point of death/MI in CABG-only patients at day 30 (P=0.069). For the overall study population, there was significant reduction of death/MI at Day 30 (P=0.030). The death/MI composite was significantly reduced in the CABG-only (P=0.014) and overall study populations (P=0.008) at day 4. There was a trend toward a reduction in death with pexelizumab in the overall population (P=0.096) at 90 days. Pexelizumab significantly reduced myocardial infarction and myocardial injury in both the CABG-only and overall population. Conclusions:Pexelizumab significantly reduced early and late postoperative myocardial infarction in all populations. In the overall study population, pexelizumab significantly reduced death or MI, showing a durable effect through day 90. Pexelizumab was safe and well tolerated. Treatment Effect in CABG-Only and Overall Study PopulationsCABG OnlyAll PatientsPL (n=1368)PEX (n=1378)RRPPL (n=1546)PEX (n=1553)RRPPEX indicates pexelizumab; PL, placebo; and RR, relative risk reduction.Death/MI (day 4), %10.07.4260.01411.99.1240.008Death/MI (day 30), %11.89.8180.06914.011.5180.030MI (day 4), %9.36.7270.01211.18.4240.010MI (day 30), %10.38.1220.03612.09.8180.042Death (day 90), %4.03.2190.2824.83.6250.096A Randomized Controlled Trial Comparing Safety and Efficacy of Rectilinear Biphasic Versus Monophasic Defibrillators in Out-of-Hospital Cardiac Arrest: ORBITLaurie J. Morrison, MD, FRCPC; Paul Dorian, MD, FRCPC; Jennifer Long, MSc; Marian J. Vermeulen, MHSc; Brian Schwartz, MD, CCFP-EM; Bruce Sawadsky, MD, CCFP-EM; Jamie Frank, BA, EMT-P; Bruce Cameron, EMT-P; Robert Burgess, EMT-P; Jennifer Shield, BA EMT-P; Paul Bagley, EMT-P; Vivien Mausz, EMT-P; James Brewer, Bruce Lerman, MD; on behalf of the ORBIT Investigators; Prehospital and Transport Medicine Research Program, Sunnybrook and Women’s, University of Toronto, Toronto, Ontario, CanadaA recent meta-analysis suggests first shock efficacy for ventricular fibrillation conversion is equal when lower biphasic energy levels are compared with 200J monophasic. The objective of this study was to compare the safety and efficacy of ascending rectilinear biphasic defibrillation (120J, 150J, 200J) with conventional monophasic defibrillation (200J, 300J, 360J) in the termination of ventricular fibrillation (VF) and pulseless ventricular tachycardia (VT) in patients with out-of-hospital cardiac arrest (OHCA) treated by EMT-P paramedics. This was a randomized, controlled trial employing block randomization of device assignment to ambulance station. A blinded Outcome Validation Committee adjudicated all end points. There were 4532 OHCA and 540 with presumed VT or VF. The station randomization compliance was 95%. The data entry error rate was <1%. The loss to follow-up rate for monophasic vs biphasic (n=217 vs 219) was 2% vs 3%. The patients in the 2 groups respectively (blinded analysis) were similar for age (mean [SD]) (67.1 [15.8] vs 67.0 [14.6]), sex (157 vs 155 male [72% : 71%]), VF as initial rhythm (190 vs 190 [88% : 87%]), EMS response interval (7.7 [4.1] vs 7.7 [3.7]), down time (10.6 [4.4] vs 10.9 [4.9]), bystander witnessed (144 vs 146 [67% : 67%]), EMS witnessed (19 vs 20 [9% : 9%]), bystander CPR (69 vs 81 [33% : 38%]), amiodarone (96 vs 86 [44% : 39%]), and different for prior defibrillation (49 vs 34 [23% : 16%]), P=0.05. Conversion to organized electrical activity after one shock was 55 vs 67 (26% : 32%), P=0.2, and after 1 to 3 shocks was 98 vs 119 (45% : 54%), P=0.06. Conversion for first highest energy setting shock was 30 vs 49 (14% : 23%), P=0.02. The rate of return of spontaneous circulation was the same in both groups: 88 vs 90 (41% : 41%). Survival outcomes were alive to emergency department (123 vs 125 [57% : 57%]), at 24 hours (46 vs 50 [22% : 23%]), and at 30 days (14 vs 15 [7% : 7%]). Cerebral Performance Category scores were “Good” (11 vs 16 [9% : 13%]) and “Moderate to Coma” (7 vs 3 [6% : 2%]), P=0.29, with no adverse events. Conclusion: The biphasic waveform was superior for highest energy setting conversion and not superior for conversion to an organized rhythm after first shock or 1 to 3 shocks in a study with 0.86 power to find a 15% significant difference if one existed. This study is not generalizable to all biphasic defibrillators and defibrillation protocols, as it uses the rectilinear waveform in an ascending protocol.Stroke Prevention Using the Oral Direct Thrombin Inhibitor Ximelagatran in Patients with Nonvalvular Atrial Fibrillation (SPORTIF V)The Executive Steering Committee on behalf of the SPORTIF V InvestigatorsBackground: Anticoagulation with warfarin prevents ischemic stroke in patients with nonvalvular atrial fibrillation (AF), but routine coagulation monitoring, dose adjustments, and bleeding risk limit use. The oral direct thrombin inhibitor ximelagatran represents a potential alternative anticoagulant. Objective: To establish whether oral ximelagatran is noninferior to dose-adjusted warfarin, within a margin of 2%/year, for prevention of stroke and systemic embolic events. Methods: Patients with AF and at least 1 stroke risk factor (n=3922) were randomized to receive adjusted-dose warfarin (target INR 2.0 to 3.0) or fixed-dose oral ximelagatran (36 mg twice daily). Treatment allocation was double blind; patients in the ximelagatran group underwent sham testing and dose variations of dummy warfarin to mimic INR management. The protocol was otherwise identical to the open-label SPORTIF III trial. The primary end point was all strokes (ischemic and hemorrhagic) and systemic embolic events, based on independent, blinded, centrally adjudicated assessment. Primary analysis was based on establishing noninferiority according to intention-to-treat (ITT). Results: During 6405 patient-years exposure (mean 20 months), 88 patients developed primary events. The INR on warfarin (mean 2.4±0.8) was within target range (2.0 to 3.0) 68% of the time and in the extended range (1.8 to 3.2) 83% of the time. Primary event rates were 1.2%/year in the warfarin group and 1.6%/year in the ximelagatran group, an absolute difference of 0.45%/year (95% CI −0.13, 1.03; P=0.13), demonstrating the noninferiority of ximelagatran. By on-treatment analysis, the absolute difference in primary event rates was 0.55%/year (−0.06, 1.16; P=0.089), and when all-cause mortality was included with the primary events, the rate difference between groups by ITT was 0.10%/year (95% CI −0.97, 1.18; P=0.86). Rates of disabling or fatal stroke, hemorrhagic stroke, and major bleeding did not differ significantly between groups, but combined minor and major bleeding were lower with ximelagatran (47%/year vs 37%/year; P<0.0001). Serum alanine aminotransferase levels rose transiently above 3 times the upper limit of normal in 6.0% of patients on ximelagatran (0.8% of patients on warfarin; P<0.001) within the first 6 months of treatment but generally returned toward baseline levels whether or not treatment was continued. An 80-year-old patient developed fatal gastrointestinal hemorrhage after corticosteroid treatment for hepatitis associated with ximelagatran treatment. Conclusions: In this large, double-blind trial involving high-risk patients with AF, fixed-dose, oral ximelagatran was at least as effective as well-controlled warfarin for prevention of stroke and systemic embolic events and resulted in less bleeding, confirming the results of the SPORTIF III open-label trial.The Public Access Defibrillation (PAD) TrialThe Public Access Defibrillation Trial Investigators Presenter: Joseph P. Ornato, MDIntroduction: Over 460 000 Americans die each year from out-of-hospital cardiac arrest (OOH-CA). The purpose of the Public Access Defibrillation (PAD) Trial was to determine whether laypersons trained and equipped to call 9–1–1, perform cardiopulmonary resuscitation (CPR), and use automated external defibrillators (AEDs) in public and residential locations, compared with laypersons trained only to call 9–1–1 and perform CPR, could increase survival for patients experiencing OOH-CA. Methods:This prospective, community-based, multicenter clinical trial randomized 993 community units at 21 US and 3 Canadian sites to receive volunteer training in CPR (CPR only) or CPR with defibrillation capability (CPR+AED). All volunteer rescuers were laypersons. A 2- to 4-hour course, mostly American Heart
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