David J Cohen

Saint Luke's Health System (KS, USA), Kansas City, Kansas, United States

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Publications (403)3516.98 Total impact

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    ABSTRACT: Aims: In the dual antiplatelet therapy (DAPT) study, continued thienopyridine beyond 12 months after drug-eluting stent placement was associated with increased mortality compared with placebo. We sought to evaluate factors related to mortality in randomized patients receiving either drug-eluting or bare metal stents in the DAPT study. Methods and results: Patients were enrolled after coronary stenting, given thienopyridine and aspirin for 12 months, randomly assigned to continued thienopyridine or placebo for an additional 18 months (while taking aspirin), and subsequently treated with aspirin alone for another 3 months. A blinded independent adjudication committee evaluated deaths. Among 11 648 randomized patients, rates of all-cause mortality rates were 1.9 vs. 1.5% (continued thienopyridine vs. placebo, P = 0.07), cardiovascular mortality, 1.0 vs. 1.0% (P = 0.97), and non-cardiovascular mortality, 0.9 vs. 0.5% (P = 0.01) over the randomized period (Months 12-30). Rates of fatal bleeding were 0.2 vs. 0.1% (P = 0.81), and deaths related to any prior bleeding were 0.3 vs. 0.2% (P = 0.36), Months 12-33). Cancer incidence did not differ (2.0 vs. 1.6%, P = 0.12). Cancer-related deaths occurred in 0.6 vs. 0.3% (P = 0.02) and were rarely related to bleeding (0.1 vs. 0, P = 0.25). After excluding those occurring in patients with cancer diagnosed before enrolment, rates were 0.4 vs. 0.3% (P = 0.16). Conclusion: Bleeding accounted for a minority of deaths among patients treated with continued thienopyridine. Cancer-related death in association with thienopyridine therapy was mainly not related to bleeding and may be a chance finding. Caution is warranted when considering extended thienopyridine in patients with advanced cancer. Trial registration: clinicaltrials.gov Identifier: NCT00977938.
    European Heart Journal 11/2015; DOI:10.1093/eurheartj/ehv614 · 15.20 Impact Factor
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    ABSTRACT: Aims: Recent cost-effectiveness analyses of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) have been limited by a short time horizon or were restricted to the US healthcare perspective. We, therefore, used individual patient-level data from the SYNTAX trial to evaluate the cost-effectiveness of PCI versus CABG from a European (Dutch) perspective. Methods and results: Between 2005 and 2007, 1800 patients with three-vessel or left main coronary artery disease were randomised to either CABG (n=897) or PCI with drug-eluting stents (DES; n=903). Costs were estimated for all patients based on observed healthcare resource usage over 5 years of follow-up. Health state utilities were evaluated with the EuroQOL questionnaire. A patient-level microsimulation model based on Dutch life-tables was used to extrapolate the 5-year in-trial data to a lifetime horizon. Although initial procedural costs were lower for CABG, total initial hospitalisation costs per patient were higher (€17 506 vs €14 037, p<0.001). PCI was more costly during the next 5 years of follow-up, due to more frequent hospitalisations, repeat revascularisation procedures and higher medication costs. Nevertheless, total 5-year costs remained €2465/patient higher with CABG. When the in-trial results were extrapolated to a lifetime horizon, CABG was projected to be economically attractive relative to DES-PCI, with gains in both life expectancy and quality-adjusted life expectancy. The incremental cost-effectiveness ratio (ICER) (€5390/quality-adjusted life year (QALY) gained) was favourable and remained <€80 000/QALY in >90% of the bootstrap replicates. Outcomes were similar when incorporating the prognostic impact of non-fatal myocardial infarction and stroke, as well as across a broad range of assumptions regarding the effect of CABG on post-trial survival and costs. However, DES-PCI was economically dominant compared with CABG in patients with a SYNTAX Score ≤22 or in those with left main disease. In patients for whom the SYNTAX Score II favoured PCI based on lower predicted 4-year mortality, PCI was also economically dominant, whereas in those patients for whom the SYNTAX Score II favoured surgery, CABG was highly economically attractive (ICER range, €2967 to €3737/QALY gained). Conclusions: For the broad population with three-vessel or left main disease who are candidates for either CABG or PCI, we found that CABG is a clinically and economically attractive revascularisation strategy compared with DES-PCI from a Dutch healthcare perspective. The cost-effectiveness of CABG versus PCI differed according to several anatomic factors, however. The newly developed SYNTAX Score II provides enhanced prognostic discrimination in this population, and may be a useful tool to guide resource allocation as well. Trial registration number: Clinical trial unique identifier: NCT00114972 (http://www.clinical-trials.gov).
    Heart (British Cardiac Society) 11/2015; DOI:10.1136/heartjnl-2015-307578 · 5.60 Impact Factor

  • Journal of the American College of Cardiology 11/2015; 66(19):2104-2113. DOI:10.1016/j.jacc.2015.08.873 · 16.50 Impact Factor
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    ABSTRACT: Background: Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown. Objectives: This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. Methods: We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test. Results: At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions. Conclusions: The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461).
    Journal of the American College of Cardiology 10/2015; DOI:10.1016/j.jacc.2015.09.063 · 16.50 Impact Factor
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    ABSTRACT: Objective: Within the context of a prospective randomized trial (SWIFT PRIME), we assessed whether early imaging of stroke patients, primary with CT perfusion, can estimate the size of the irreversibly injured ischemic core and the volume of critically hypoperfused tissue. We also evaluated the accuracy of ischemic core and hypoperfusion volumes for predicting infarct volume in patients with the target mismatch profile. Methods: Baseline ischemic core and hypoperfusion volumes were assessed prior to randomized treatment with IV tPA-alone vs. IV tPA + endovascular therapy (Solitaire stent-retriever) using RAPID automated post-processing software. Reperfusion was assessed with angiographic TICI scores at the end of the procedure (endovascular group) and Tmax >6s volumes at 27-hours (both groups). Infarct volume was assessed at 27-hours on non-contrast CT or MRI. Results: 151 patients with baseline imaging with CT perfusion (79%) or multimodal MRI (21%) were included. The median baseline ischemic core volume was 6 ml (IQR 0-16). Ischemic core volumes correlated with 27-hour infarct volumes in patients who achieved reperfusion (r = 0.58, P <0.0001). In patients who did not reperfuse (<10% reperfusion), baseline Tmax>6s lesion volumes correlated with 27-hour infarct volume (r=0.78; P=0.005). In Target mismatch patients, the union of baseline core and early follow-up Tmax>6s volume (i.e. predicted infarct volume) correlated with the 27-hour infarct volume (r=0.73; P<0.0001); the median absolute difference between the observed and predicted volume was 13 ml. Interpretation: Ischemic core and hypoperfusion volumes, obtained primarily from CT perfusion scans, predict 27-hour infarct volume in acute stroke patients who were treated with reperfusion therapies. This article is protected by copyright. All rights reserved.
    Annals of Neurology 10/2015; DOI:10.1002/ana.24543 · 9.98 Impact Factor
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    ABSTRACT: Objectives This study investigates the effects of glycoprotein IIb/IIIa inhibitors (GPIs) on outcomes after percutaneous coronary intervention (PCI). Background Ischemic complications are reduced after PCI when a GPI is added to heparin. However, there are limited data on the safety and efficacy in contemporary PCI. Methods We used the National Cardiovascular Data Registry CathPCI Registry data to assess the association between GPI use and PCI outcomes for acute coronary syndrome between July 2009 and September 2011. The primary outcome was all-cause in-hospital mortality. The secondary outcome was major bleeding. To adjust for potential bias, we used multivariable logistic regression, propensity-matched (PM) analysis, and instrumental variable analysis (IVA). Results There were 970,865 patients included; 326,283 (33.6%) received a GPI. Unadjusted mortality and major bleeding were more common with a GPI (2.4% vs. 1.4% and 3.7% vs. 1.5%, respectively; p < 0.001 for both). In contrast, GPI use was associated with lower mortality on adjusted analyses; relative risks range from 0.72 (95% confidence interval [CI]: 0.50 to 0.97) with IVA to 0.90 (95% CI: 0.86 to 0.95) with PM. The association of GPI use with bleeding remained in adjusted analyses (multivariable relative risk: 1.93, 95% CI: 1.83 to 2.04; PM relative risk: 1.83, 95% CI: 1.74 to 1.92; and IVA relative risk: 1.53, 95% CI: 1.27 to 2.13). Subgroup analysis revealed enhanced risk reduction with ST-segment elevation myocardial infarction, high predicted mortality, and heparin-based anticoagulation. Conclusions In unselected acute coronary syndrome patients undergoing PCI, GPI use was associated with reduced in-hospital mortality and increased bleeding. In the modern era of PCI, there may still be a role for the judicious use of GPIs.
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    ABSTRACT: Background: Although platelet function and pharmacogenomic testing have been studied in clinical trials, their adoption into contemporary practice is unknown. Methods: We studied patterns of platelet function and pharmacogenomic testing among 10,048 patients with acute myocardial infarction treated with percutaneous coronary intervention at 226 US hospitals in the TRANSLATE-ACS observational study between April 2010 and October 2012, excluding those receiving research protocol-mandated testing. Inverse probability-weighted propensity adjustment was used to compare 1-year bleeding and major adverse cardiac event risks between patients with and without testing. Results: Overall, 337 (3.4%) patients underwent predischarge platelet function testing, whereas 85 (0.9%) underwent pharmacogenomic testing; 82% and 93% of hospitals never performed any platelet function or pharmacogenomic testing, respectively. Patients undergoing testing were more likely to be on an adenosine diphosphate receptor inhibitor preadmission or to have percutaneous coronary intervention of a previously treated lesion. Tested patients were more likely than nontested patients to be switched from clopidogrel to prasugrel/ticagrelor (25.7% vs 9.7%, P < .001) and were more likely to be on prasugrel/ticagrelor 6 months postdischarge (33.8% vs 25.1%, P < .001). No significant differences in 1-year bleeding and major adverse cardiac event risks were observed between tested and nontested patients (adjusted hazard ratios 1.06 [95% CI 0.68-1.65] and 1.21 [95% CI 0.94-1.54], respectively). Conclusions: Platelet function and pharmacogenomic testing are rarely performed in contemporary myocardial infarction patients in the United States. When tested, patients were more likely to be treated with higher-potency adenosine diphosphate receptor inhibitors, yet no significant differences in longitudinal outcomes were observed.
    American heart journal 09/2015; 170(4):706-14. DOI:10.1016/j.ahj.2015.06.021 · 4.46 Impact Factor
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    ABSTRACT: Background: Drug-eluting stents (DES) reduce restenosis, as compared with bare-metal stents (BMS); however, the relationship between stent type and health status is unknown. We examined whether stent type was associated with health status outcomes in patients undergoing percutaneous coronary intervention (PCI). Methods and results: We evaluated 6- and 12-month health status in 2,694 patients with acute myocardial infarction (AMI) enrolled in the TRIUMPH and PREMIER registries who underwent PCI with DES (n = 1,361) or BMS (n = 1,333). Health status was assessed with the Seattle Angina Questionnaire, Medical Outcomes Study Short Form-12, and Patient Health Questionnaire depression scale. Propensity matching was performed to account for baseline differences in patient characteristics, resulting in a comparison cohort of 784 patients treated with DES and 784 patients treated with BMS. Both groups experienced significant improvements in health status at 6 and 12 months after PCI. Drug-eluting stent use was associated with a small improvement in Seattle Angina Questionnaire quality of life and functional limitation scores at 6 months (3.6 [95% CI 0.96-6.21], P = .007, and 3.8 [1.55-6.01], P < .001, respectively), but not at 12 months (2.3 [-0.46 to 5.03], P = .10, and 0.3 [-2.04 to 2.48], P = .85, respectively). Conclusions: In patients with AMI undergoing PCI, DES use was associated with transient but unsustained health status benefits over 12 months after AMI.
    American heart journal 09/2015; 170(4):796-804.e3. DOI:10.1016/j.ahj.2015.07.021 · 4.46 Impact Factor

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    ABSTRACT: Vascular complications remain an important consideration when selecting access for delivery of large endovascular devices. With the advent of transcatheter aortic valve replacement, transapical access has become an acceptable technique when transfemoral or direct transaortic access is contraindicated. We report the use of the transapical approach during thoracic aortic endovascular repair in 2 patients, one of which included concomitant delivery of a transcatheter aortic valve replacement device. To our knowledge, this is the first reported case of a hybrid single-stage transcatheter aortic valve replacement and thoracic aortic endovascular repair using transapical access. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
    The Annals of thoracic surgery 08/2015; 100(2):723-7. DOI:10.1016/j.athoracsur.2014.10.024 · 3.85 Impact Factor
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    ABSTRACT: This study describes short-term and mid-term outcomes of nonagenarian patients undergoing transfemoral or transapical transcatheter aortic valve replacement (TAVR) in the Placement of Aortic Transcatheter Valve (PARTNER)-I trial. From April 2007 to February 2012, 531 nonagenarians, mean age 93 ± 2.1 years, underwent TAVR with a balloon-expandable prosthesis in the PARTNER-I trial: 329 through transfemoral (TF-TAVR) and 202 transapical (TA-TAVR) access. Clinical events were adjudicated and echocardiographic results analyzed in a core laboratory. Quality of life (QoL) data were obtained up to 1 year post-TAVR. Time-varying all-cause mortality was referenced to that of an age-sex-race-matched US population. For TF-TAVR, post-procedure 30-day stroke risk was 3.6%; major adverse events occurred in 35% of patients; 30-day paravalvular leak was greater than moderate in 1.4%; median post-procedure length of stay (LOS) was 5 days. Thirty-day mortality was 4.0% and 3-year mortality 48% (44% for the matched population). By 6 months, most QoL measures had stabilized at a level considerably better than baseline, with Kansas City Cardiomyopathy Questionnaire (KCCQ) 72 ± 21. For TA-TAVR, post-procedure 30-day stroke risk was 2.0%; major adverse events 32%; 30-day paravalvular leak was greater than moderate in 0.61%; and median post-procedure LOS was 8 days. Thirty-day mortality was 12% and 3-year mortality 54% (42% for the matched population); KCCQ was 73 ± 23. A TAVR can be performed in nonagenarians with acceptable short- and mid-term outcomes. Although TF- and TA-TAVR outcomes are not directly comparable, TA-TAVR appears to carry a higher risk of early death without a difference in intermediate-term mortality. Age alone should not preclude referral for TAVR in nonagenarians. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
    The Annals of thoracic surgery 08/2015; 100(3). DOI:10.1016/j.athoracsur.2015.05.021 · 3.85 Impact Factor
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    ABSTRACT: When transcatheter aortic valve replacement (TAVR) cannot be carried out through transfemoral access, alternative access TAVR is indicated. The purpose of this study was to explore inhospital and 1-year outcomes of patients undergoing alternative access TAVR through the transapical (TA) or transaortic (TAo) techniques in the United States. Clinical records of 4,953 patients undergoing TA (n = 4,085) or TAo (n = 868) TAVR from 2011 to 2014 in The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry were linked to Centers for Medicare and Medicaid Services hospital claims. Inhospital and 1-year clinical outcomes were stratified by operative risk; and the risk-adjusted association between access route and mortality, stroke, and heart failure repeat hospitalization was explored. Mean age for all patients was 82.8 ± 6.8 years. The median STS predicted risk of mortality was significantly higher among patients undergoing TAo (8.8 versus 7.4, p < 0.001). When compared with TA, TAo was associated with an increased risk of unadjusted 30-day mortality (10.3% versus 8.8%) and 1-year mortality (30.3% versus 25.6%, p = 0.006). There were no significant differences between TAo and TA for inhospital stroke rate (2.2%), major vascular complications (0.3%), and 1-year heart failure rehospitalizations (15.7%). Examination of high-risk and inoperable subgroups showed that 1-year mortality was significantly higher for TAo patients classified as inoperable (p = 0.012). Patients undergoing TAo TAVR are older, more likely female, and have significantly higher STS predicted risk of mortality scores than patients operated on by TA access. There were no risk-adjusted differences between TA and TAo access in mortality, stroke, or readmission rates as long as 1 year after TAVR. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
    The Annals of thoracic surgery 07/2015; 100(5). DOI:10.1016/j.athoracsur.2015.05.010 · 3.85 Impact Factor
  • Dawish I Naji · Adnan Chhatriwalla · David J Cohen · Michael L Main ·

    07/2015; DOI:10.1530/ERP-15-0016
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    ABSTRACT: Objectives: The study objectives were to (1) compare the safety of high-risk surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves (PARTNER) I trial with Society of Thoracic Surgeons national benchmarks; (2) reference intermediate-term survival to that of the US population; and (3) identify subsets of patients for whom aortic valve replacement may be futile, with no survival benefit compared with therapy without aortic valve replacement. Methods: From May 2007 to October 2009, 699 patients with high surgical risk, aged 84 ± 6.3 years, were randomized in PARTNER-IA; 313 patients underwent surgical aortic valve replacement. Median follow-up was 2.8 years. Survival for therapy without aortic valve replacement used 181 PARTNER-IB patients. Results: Operative mortality was 10.5% (expected 9.3%), stroke 2.6% (expected 3.5%), renal failure 5.8% (expected 12%), sternal wound infection 0.64% (expected 0.33%), and prolonged length of stay 26% (expected 18%). However, calibration of observed events in this relatively small sample was poor. Survival at 1, 2, 3, and 4 years was 75%, 68%, 57%, and 44%, respectively, lower than 90%, 81%, 73%, and 65%, respectively, in the US population, but higher than 53%, 32%, 21%, and 14%, respectively, in patients without aortic valve replacement. Risk factors for death included smaller body mass index, lower albumin, history of cancer, and prosthesis-patient mismatch. Within this high-risk aortic valve replacement group, only the 8% of patients with the poorest risk profiles had estimated 1-year survival less than that of similar patients treated without aortic valve replacement. Conclusions: PARTNER selection criteria for surgical aortic valve replacement, with a few caveats, may be more appropriate, realistic indications for surgery than those of the past, reflecting contemporary surgical management of severe aortic stenosis in high-risk patients at experienced sites.
    The Journal of thoracic and cardiovascular surgery 06/2015; 150(3). DOI:10.1016/j.jtcvs.2015.05.073 · 4.17 Impact Factor
  • Stéphane Rinfret · Suzanne J Baron · David J Cohen ·

    Journal of the American College of Cardiology 06/2015; 65(23):2508-2510. DOI:10.1016/j.jacc.2015.04.041 · 16.50 Impact Factor
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    ABSTRACT: In the Placement of AoRTic TraNscathetER Valve (PARTNER) randomized controlled trial (RCT), which represented the first exposure to transapical transcatheter aortic valve replacement (TA-TAVR) for many clinical sites, high-risk patients undergoing TA-TAVR derived similar health-related quality of life (HRQoL) outcomes when compared with surgical aortic valve replacement (SAVR). With increasing experience, it is possible that HRQoL outcomes of TA-TAVR may have improved. We evaluated HRQoL outcomes at 1-, 6-, and 12-month follow-ups among 875 patients undergoing TA-TAVR in the PARTNER nonrandomized continued access (NRCA) registry and compared these outcomes with those of the TA-TAVR and SAVR patients in the PARTNER RCT. HRQoL was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short-Form 12, and the EuroQoL-5D, with the KCCQ overall summary score serving as the primary end point. The NRCA TA-TAVR and RCT TA-TAVR and SAVR groups were generally similar. The primary outcome, the KCCQ summary score, did not differ between the NRCA TA-TAVR and the RCT TA-TAVR group at any follow-up timepoints, although there were small differences in favor of the NRCA cohort on several KCCQ subscales at 1 month. There were no significant differences in follow-up HRQOL between the NRCA-TAVR and the RCT SAVR cohorts on the KCCQ overall summary scale or any of the disease-specific or generic subscales. Despite greater experience with TA-TAVR in the NRCA registry, HRQoL outcomes remained similar to those of TA-TAVR in the original RCT cohort and no better than those with SAVR. These findings have important implications for patient selection for TAVR when transfemoral access is not an option. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894. © 2015 American Heart Association, Inc.
    Circulation Cardiovascular Quality and Outcomes 06/2015; 8(4). DOI:10.1161/CIRCOUTCOMES.114.001335 · 5.66 Impact Factor
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    ABSTRACT: Little is known about how clinicians use platelet function testing to guide choice and dosing of adenosine diphosphate receptor inhibitor (ADPri) therapy in routine community practice. The Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (ACS)-Prospective, Open Label, Antiplatelet Therapy Study (TRANSLATE-POPS) was a cluster-randomized trial in which 100 hospitals were assigned access to no-cost platelet function testing versus usual care for acute myocardial infarction patients treated with percutaneous coronary intervention. In both arms, ADPri treatment decisions were left up to the care team. The primary end point was the frequency of ADPri therapy adjustment before discharge. Secondary end points included 30-day rates of major adverse cardiovascular events and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries-defined bleeding events. Platelet function testing was performed in 66.9% of patients treated in intervention sites versus 1.4% of patients in usual care sites. Intervention arm patients were more likely to have ADPri therapy adjustment than usual care patients (14.8% versus 10.5%, P=0.004; odds ratio 1.68, 95% confidence interval 1.18-2.40); however, there were no significant differences in 30-day major adverse cardiovascular events (4.8% versus 5.4%, P=0.73; odds ratio 0.94, 95% confidence interval 0.66-1.34) or bleeding (4.3% versus 4.2%, P=0.33; odds ratio 0.86, 95% confidence interval 0.55-1.34). One-year outcomes were also not significantly different between groups. An as-treated analysis showed higher incidence of ADPri therapy adjustment among intervention arm patients who received platelet function testing than untested usual care arm (16.4% versus 10.2%, P<0.0001), but no significant differences in major adverse cardiovascular events or bleeding. TRANSLATE-POPS found that when clinicians routinely used platelet function testing, they were more likely to adjust their choice or dosing of ADPri therapy; yet with few changes in therapy overall, significant differences in clinical outcomes were not seen. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01088503. © 2015 American Heart Association, Inc.
    Circulation Cardiovascular Interventions 06/2015; 8(6):e001712. DOI:10.1161/CIRCINTERVENTIONS.114.001712 · 6.22 Impact Factor
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    Dataset: NEJM

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    ABSTRACT: Background: Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, less than 40% regain functional independence when treated with intravenous tissue plasminogen activator (t-PA) alone. Thrombectomy with the use of a stent retriever, in addition to intravenous t-PA, increases reperfusion rates and may improve long-term functional outcome. Methods: We randomly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone (control group) or to undergo endovascular thrombectomy with the use of a stent retriever within 6 hours after symptom onset (intervention group). Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large ischemic-core lesions. The primary outcome was the severity of global disability at 90 days, as assessed by means of the modified Rankin scale (with scores ranging from 0 [no symptoms] to 6 [death]). Results: The study was stopped early because of efficacy. At 39 centers, 196 patients underwent randomization (98 patients in each group). In the intervention group, the median time from qualifying imaging to groin puncture was 57 minutes, and the rate of substantial reperfusion at the end of the procedure was 88%. Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at 90 days over the entire range of scores on the modified Rankin scale (P<0.001). The rate of functional independence (modified Rankin scale score, 0 to 2) was higher in the intervention group than in the control group (60% vs. 35%, P<0.001). There were no significant between-group differences in 90-day mortality (9% vs. 12%, P=0.50) or symptomatic intracranial hemorrhage (0% vs. 3%, P=0.12). Conclusions: In patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, thrombectomy with a stent retriever within 6 hours after onset improved functional outcomes at 90 days. (Funded by Covidien; SWIFT PRIME ClinicalTrials.gov number, NCT01657461.).
    New England Journal of Medicine 04/2015; 372(24). DOI:10.1056/NEJMoa1415061 · 55.87 Impact Factor

Publication Stats

19k Citations
3,516.98 Total Impact Points


  • 2007-2015
    • Saint Luke's Health System (KS, USA)
      Kansas City, Kansas, United States
    • University of Missouri - Kansas City
      • • "Saint Luke's" Mid America Heart Institute
      • • Department of Internal Medicine
      Kansas City, Missouri, United States
    • Cornell University
      Итак, New York, United States
  • 1988-2015
    • Columbia University
      • • Department of Medicine
      • • College of Physicians and Surgeons
      New York, New York, United States
  • 2014
    • University of Toronto
      Toronto, Ontario, Canada
  • 2006-2014
    • St. Luke's Hospital
      CID, Iowa, United States
  • 2004-2014
    • University of Missouri
      Columbia, Missouri, United States
    • Baylor College of Medicine
      Houston, Texas, United States
    • Royal Brompton and Harefield NHS Foundation Trust
      Harefield, England, United Kingdom
  • 2013
    • Baylor Health Care System
      Dallas, Texas, United States
  • 2007-2013
    • CUNY Graduate Center
      New York, New York, United States
  • 2012
    • Saint Louis University
      • Division of Cardiology
      Сент-Луис, Michigan, United States
    • Erasmus Universiteit Rotterdam
      Rotterdam, South Holland, Netherlands
  • 2008-2012
    • St. Luke's Hospital (MO, USA)
      Saint Louis, Michigan, United States
    • St. Luke School of Medicine
      Kansas City, Missouri, United States
    • Mercer University
      Atlanta, Michigan, United States
  • 2011
    • University of Oklahoma Health Sciences Center
      • Section of Cardiology
      Oklahoma City, Oklahoma, United States
  • 2010
    • University of British Columbia - Vancouver
      Vancouver, British Columbia, Canada
    • Baystate Medical Center
      Springfield, Massachusetts, United States
  • 2009
    • Christiana Care Health System
      Wilmington, Delaware, United States
  • 1995-2009
    • Beth Israel Deaconess Medical Center
      • Department of Medicine
      Boston, Massachusetts, United States
  • 2002-2006
    • Boston Biomedical Research Institute
      Boston, Massachusetts, United States
    • University of Ottawa
      Ottawa, Ontario, Canada
    • Lenox Hill Hospital
      New York, New York, United States
    • Virginia Mason Medical Center
      Seattle, Washington, United States
    • Cardiovascular Research Foundation
      New York City, New York, United States
  • 2005
    • St. Michael's Hospital
      Toronto, Ontario, Canada
    • Boston Scientific
      Boston, Massachusetts, United States
  • 1992-2005
    • New York Presbyterian Hospital
      • • Department of Pain Medicine
      • • Department of Transplantation
      New York City, New York, United States
  • 1993-2004
    • Harvard Medical School
      • Department of Medicine
      Boston, Massachusetts, United States
  • 1992-2004
    • Harvard University
      • Department of Health Policy and Management
      Cambridge, Massachusetts, United States
  • 2003
    • Duke University
      Durham, North Carolina, United States
  • 1987
    • Brigham and Women's Hospital
      • Department of Medicine
      Boston, Massachusetts, United States