Author + information
- Received August 25, 2015
- Accepted January 28, 2016
- Published online May 9, 2016.
- Italo Porto, MD, PhDa,
- Leonardo Bolognese, MDb,∗ (, )
- Dariusz Dudek, MD, PhDc,
- Patrick Goldstein, MDd,
- Christian Hamm, MDe,
- Jean-François Tanguay, MDf,
- Jurrien ten Berg, MD, PhDg,
- Petr Widimský, MD, DrSch,
- Nicolas Le Gall, MSi,
- Anthony J. Zagar, MSj,
- LeRoy A. LeNarz, MDj,
- Debra Miller, RNj,
- Gilles Montalescot, MD, PhDk,
- ACCOAST Investigators
- aInterventional Cardiology Unit, Gemelli Hospital, Catholic University of the Sacred Heart, Rome, Italy
- bCardiovascular and Neurological Department, Azienda Ospedaliera Arezzo, Arezzo, Italy
- cInstitute of Cardiology, Jagiellonian University Medical College, University Hospital, Krakow, Poland
- dSAMU and Emergency Department, Lille University Hospital, Lille, France
- eKerckhoff Heart and Thoraxcenter, Bad Nauheim and Medical Clinic I, University of Giessen, Giessen, Germany
- fMontreal Heart Institute, Université de Montréal, Montreal, Ontario, Canada
- gDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands
- hThird Medical Faculty of Charles University and University Hospital Royal Vineyards, Prague, Czech Republic
- iinVentiv Health Clinical Canada, Burlington, Ontario, Canada
- jEli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana
- kUniversité Paris 06, ACTION Study Group, INSERM-UMRS 1166, Institut de Cardiologie, Pitié-Salpêtrière University Hospital, Paris, France
- ↵∗Reprint requests and correspondence:
Dr. Leonardo Bolognese, Dipartimento Cardiovascolare e Neurologico, Ospedale San Donato, Via Pietro Nenni, 52100, Arezzo, Italy.
Objectives This study assessed whether the choice of vascular access site influenced outcomes among non–ST-segment elevation myocardial infarction (NSTEMI) patients enrolled in the ACCOAST (A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non–ST-segment elevation myocardial infarction NCT01015287).
Background Transfemoral access (TFA) has been associated with the risk of bleeding and increased mortality that is elevated compared to transradial access (TRA) in acute coronary syndromes, although less consistently in NSTE acute coronary syndrome (NSTE-ACS) than in STE-ACS.
Methods The ACCOAST study evaluated a prasugrel loading dose of 60 mg given at the start of percutaneous coronary intervention (PCI) versus a split loading dose of 30 mg given at the time of diagnosis of NSTE-ACS (prior to coronary angiography), followed by 30 mg given at the start of PCI. In the study, choice of access site was at the investigator’s discretion. We compared ischemic and bleeding outcomes with TFA versus those with TRA, using propensity score correction.
Results Of 4,033 patients, 1,711 (42%) underwent TRA. Use of TRA varied widely by country. TFA was not associated with significant increases in noncoronary bypass graft (CABG)-related thrombolysis in myocardial infarction (TIMI) (hazard ratio [HR] for TFA = 1.46; 95% confidence interval [CI]: 0.59 to 3.62; p = 0.42), nor in GUSTO (Global Utilization Of Streptokinase and Tpa for Occluded arteries) or STEEPLE (Safety and Efficacy of Enoxaparin in PCI) major bleeding after propensity score correction. TFA, however, increased combined non-CABG TIMI major or minor bleeding (HR for TFA = 2.34; 95% CI: 1.17 to 4.69; p = 0.017). Primary ischemic outcomes did not differ by access site, albeit individual endpoint analysis suggested an association between TFA with an increase in urgent revascularizations and reduced risk of procedure-related stroke.
Conclusions In the ACCOAST trial, TFA did not significantly increase TIMI major bleeding, although TRA was associated with a reduction in TIMI major or minor bleeding. Further study is needed to determine whether wider application of radial approach to NSTE-ACS patients at high risk for bleeding improves overall outcomes. (A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction [ACCOAST]; NCT01015287)
Bleeding related to either access site or non-access site is an important adverse event in patients with acute coronary syndromes (ACS) undergoing cardiac catheterization and percutaneous coronary intervention (PCI) (1–3). Whereas non–access site-related hemorrhages carries an independent prognostic value, there is more controversy over the relevance of access site-related bleeding and on the role of transradial access (TRA), a strategy associated with a marked decrease in access site-related bleeding and vascular complications compared to transfemoral access (TFA) (2,4–6). In particular, there is relative agreement on the benefits of TRA in ST-segment elevation-ACS (STE-ACS) (7–10), whereas no clear picture emerges in the field of non–STE-ACS (NSTE-ACS). Indeed, in NSTE-ACS, the available randomized data do not show a beneficial impact of TRA on ischemic and hemorrhagic major endpoints (11), whereas registry derived publications (12,13) and subanalysis of randomized trials (14–17) are limited in their conclusions by the tendency of operators to adopt TRA in patients at lower bleeding risk and by the small size of the TRA group (as many of these trials were conducted mainly in the United States where TRA has only recently become popular) (18,19).
The ACCOAST (A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non–ST-segment elevation myocardial infarction) study was a multicenter, randomized trial conducted to appraise the efficacy (using ischemic endpoints) and safety (using bleeding endpoints) of pre-treatment with prasugrel, a potent P2Y12 inhibitor, in NSTE-ACS patients (20). Main results of the trial (21) and outcomes in the patients who underwent PCI (22) were published previously.
In a pre-specified subanalysis, we took advantage of the ACCOAST database to analyze ischemic and bleeding outcomes according to the access site used, with the aim of clarifying the role of TFA versus that of TRA in modern treatment of NSTE-ACS patients.
The ACCOAST trial was a prospective, randomized trial involving 4,033 patients with a diagnosis of NSTE-ACS and an elevated troponin level, who were randomized to receive either double-blind therapy with prasugrel or placebo at 171 centers in 19 countries. Briefly, randomization took place as soon as possible after diagnosis, and coronary angiography was scheduled within 2 to 48 h. In the pre-treatment arm, patients received a 30-mg loading dose and an additional 30-mg dose of prasugrel at the time of PCI once angiography had confirmed the indication for PCI. In the no-pre-treatment arm, a 60-mg loading dose of prasugrel was administered after angiography at the time of PCI. The first open-label maintenance dose of prasugrel was administered 18 to 24 h after PCI (20). The primary endpoint of the ACCOAST trial was time to first occurrence of cardiovascular death, myocardial infarction (MI), stroke, urgent revascularization, or GP IIb/IIIa inhibitor bailout through 7 days from randomization. For this subanalysis, we considered thrombolysis in MI (TIMI) major bleeding not related to coronary artery bypass graft (CABG) surgery as the primary safety endpoint (also through 7 days from randomization) and further classified TIMI major non–CABG-related bleeding (23) as either access site-related (e.g., local hematoma, retroperitoneal hemorrhage) or non–access site-related (e.g., intracranial, gastrointestinal, genitourinary, respiratory tract, pericardial or unknown) (4). Major bleeding complications were also assessed according to STEEPLE (Safety and Efficacy of Enoxaparin in PCI) (24) and GUSTO (Global Utilization Of Streptokinase and Tpa for Occluded arteries) definitions (9,25). Non-CABG major or minor bleeding was evaluated according to TIMI definition.
Investigators reported the first access site used (femoral, radial, or brachial) and the use of vascular closure devices for femoral access. In this analysis, we focused on patients who underwent coronary angiography through a radial or femoral access. Patients who had brachial or missing access site data were excluded. All patients provided written informed consent to participate in the ACCOAST trial, and the institutional review board or ethics committee of each participating site approved the trial.
As TFA versus TRA was not a randomized comparison and was therefore subject to selection bias, baseline characteristics were compared to identify factors associated with investigator choice of access site. Baseline characteristics, concomitant treatments, procedural characteristics, and outcomes were reported as mean ± SD or medians (25th, 75th percentiles) for continuous variables and percentages for discrete variables. The Wilcoxon rank sum test was used to test differences between groups for continuous variables, and the chi-square or Fisher test was used for discrete variables. A 5% level of significance was used. Comparisons of efficacy were performed based on time to first event. Primary efficacy analysis was based on time from randomization to the first occurrence of the primary composite endpoint based on a 2-sided log-rank test. Time-to-event analyses for efficacy and safety outcomes for this subanalysis were performed through 7 days from randomization. Rates are Kaplan-Meier estimates. An estimated hazard ratios (HR) and 95% confidence intervals (CI) for TFA versus TRA were obtained from a Cox proportional hazards model, and a 2-sided p value was obtained by the log-rank test.
Because the use of TRA or TFA access was not randomized and therefore subject to selection bias, we used multivariate logistic regression modeling to determine a patient’s propensity to undergo femoral access at cardiac catheterization. The model included patient and baseline clinical factors most strongly associated with the choice of access for cardiac catheterization (Online Appendix). Subsequently, proportional hazards model with access site and quintile of estimated propensity score as a covariate were used to estimate HRs and 95% CIs for safety and efficacy endpoints through multivariate Cox proportional hazards regression, thus accounting for possible access selection bias. Analyses were conducted for the entire (all-patient) ACCOAST population and for the PCI cohort. A sensitivity analysis was conducted using a 1:1 greedy matching algorithm (26), and results of that analysis were similar to those of the original stratified (nonmatched) propensity analyses with respect to ischemic and bleeding outcomes for both the all-patient population and the PCI cohorts (data not shown).
Overall, 3,987 of the 4,033 patients (99%) in the ACCOAST trial had valid access site data and were included in this analysis. Patients undergoing TRA were younger, less frequently hypertensive, and less frequently from Eastern Europe than from Western Europe, Israel, or Canada. They also had slightly, albeit significantly, lower Global Registry of Acute Coronary Events (GRACE) and CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation) scores at presentation and minor rates of renal impairment. Prevalence of previous MI, CABG, or PCI was also lower in the TRA group. Several other differences in the angiographic and PCI characteristics, as well as in medical therapy, were present between TRA and TFA (Tables 1 and 2). Of note, the anticoagulant regimen used more often included multiple antithrombin drugs in the TRA arm.
Approximately 69% of the patients in both groups underwent PCI; 6% had CABG; and 25% received only medical management (Figure 1). The median delay between randomization and angiography was similar between the groups. Among the patients who had TFA, a closure device was used in approximately 40% of procedures.
In the PCI group, planned and unplanned GP IIb/IIIa inhibitor therapy was used in 15% of patients, with only approximately 5% bailout situations (not significant between groups). The duration of the PCI procedure was slightly shorter in the TRA group.
Regional variation in the use of radial access
There were marked regional variations in the rate of use of the TRA approach (Online Table 1). It was most frequently used in France and least frequently used in Turkey and Germany.
Access site and ischemic endpoints
Patients treated with TRA had primary ischemic endpoint rates similar to those of patients treated using TFA, in both the entire population and the patients who underwent PCI (Tables 3 and 4). Regarding the components of the aggregate endpoint, TFA appeared to reduce the risk of stroke and increase the risk of urgent revascularization in the entire population. The association between TFA and reduced stroke risk appeared limited to the patients who did not have PCI, whereas in the PCI population, TFA was associated with increased risk of MI and showed a trend for increased risk of urgent revascularization. These associations were not significantly changed by propensity score correction, with the exception of the increased risk of MI associated with TFA, which became nonsignificant.
In order to better clarify the relationship between access site and stroke, we undertook a post hoc subanalysis of the patients who had had a stroke within 1 week from randomization. Sixteen patients had strokes in the population receiving either TRA or TFA access through 7 days; 12 patients (0.7%) in the TRA and 4 (0.2%) in the TFA group (p = 0.009). Of these patients, 6 underwent PCI (4 TRA, 2 TFA), 6 had medical management (5 TRA, 1 TFA), and 4 underwent CABG (3 TRA, 1 TFA). When strokes where grouped as most likely related to catheterization (within 24 h from procedure) or not related (>24 h), 9 cases (0.5%) were related to catheterization in the TRA group (4 PCI, 3 medical management, 2 CABG) and 1 case (0.04%) in the TFA group (PCI) (p = 0.003).
Access site and bleeding endpoints
In unadjusted comparisons, TFA was associated with a significantly increased risk of non–CABG-related TIMI major bleeding, stemming mainly from the nearly complete abolition of access-site related TIMI major bleeding in the TRA group (0.1% in the entire population and 0.2% in the PCI group). In the all-patient population, however, major bleeding defined with different metrics (GUSTO or STEEPLE) was not significantly increased in the TFA group, whereas the association between TFA and an increase in TIMI major or minor bleeding was largely significant. In the PCI population, TFA also appeared to be associated with increased risk of major bleeding as defined by the STEEPLE investigators, whereas the association with increased GUSTO major bleeding was nearly significant (p = 0.07).
When propensity score quintiles were included in the Cox proportional hazards analysis, the associations of TFA with major bleeding became not significant, whereas significance was maintained for the association of TFA with TIMI major or minor bleeding, which were tripled in the TFA group undergoing PCI (Tables 5 and 6).
The ACCOAST study is the landmark trial in patients with moderate-to-high risk NSTE-ACS, demonstrating that a strategy of pre-treatment with the potent, fast-acting inhibitor P2Y12 at diagnosis is not beneficial for patients who undergo coronary angiography between 4 and 24 h from diagnosis. Pretreatment with prasugrel, 30 mg, did not reduce the rate of ischemic events and was associated with an increased risk of TIMI major bleeding (21). An important observation, namely the absence of statistical interaction between pre-treatment and choice of arterial access in both the entire population (21) and in the PCI study (22) has already been made, meaning that TRA, a strategy known to minimize access site-associated bleeding, did not offset the harmful effects of pre-treatment. We aimed to assess the independent effect of TRA on risks of bleeding and ischemia in the ACCOAST population, attempting to clarify the controversy over the use of TRA in NSTEMI patients by using data from a contemporary trial, with low use of GP IIb/IIIa inhibitors. The main results of our study may be summarized as follows:
1. In the ACCOAST trial, TRA was commonly used but was used preferentially in patients at lower risk for ischemic and bleeding complications.
2. Access site variability was associated mainly with region and country.
3. Despite almost abolishing access-site complications, the association between TRA and reduced major bleeding (using different metrics) was attenuated after propensity score adjustment, whereas the association between TRA and TIMI major or minor bleeding rate remained significant.
4. Access site was not associated with different rates of primary ischemic endpoint, although subtler differences were evident in associations between access site and individual components of this endpoint, including a disturbing signal associating TRA with higher incidence of stroke.
The main baseline differences between TRA and TFA patients in the ACCOAST trial are consistent with the “risk-treatment paradox” of TRA described previously (27), meaning that patients who might gain more from TRA-induced reduction of access site-related bleeding, such as older and sicker people, are least likely to receive it, because of imbalance in the adoption of TRA approach across operators or because many operators are still in their learning curve, preferentially choosing lower-risk patients. This paradox, however, is less evident in this modern trial than in older registries and trial subanalyses (14–17,28), as we did not observe a sex bias, and CRUSADE and GRACE scores, indicating overall bleeding and ischemic risks, were only marginally lower in the TRA group. We believe, however, that extensive correction using propensity score ensures that these baseline differences have a limited impact on subsequent elaborations regarding the study endpoints.
The ACCOAST trial, in which the median time from randomization to angiography was approximately 4 h, represents a unique opportunity to ascertain the effect of TRA in the context of modern treatment of NSTE-ACS patients increasingly treated with early intervention and aggressive antiplatelet therapy as those with STE-ACS. Whereas in the latter group the benefits of TRA have reached almost uniform consensus (4,29), prognostic improvement and even consistent reductions in bleeding events have not yet been unquestionably documented in NSTE-ACS. Indeed, in the NSTE-ACS cohort of the randomized RIVAL (Radial Vs femoral access for coronary intervention) study (5,063 patients) (30), TRA was not associated with improvement in ischemic endpoints, and there were no differences in RIVAL- or GUSTO-defined major bleeding rate. A benefit only appeared if the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) definition of major bleeding was used, that included access-site hematomas “larger than expected” (11). Similarly, in a substudy analysis of the EARLY (Early Glycoprotein IIb/IIIa Inhibition In Non–ST-Segment Elevation) study, where >9,000 patients with NSTE-ACS underwent early intervention, TRA (used in around 10% of patients) was not associated with reductions in 5-day TIMI major and GUSTO severe bleeding endpoints (17). A substudy of the ACUITY trial, involving almost 12,000 patients, noted that TRA (used in <7% of the trial population) was associated with reductions in ACUITY-defined major bleeding when compared with TFA (15). In the PRESTO (Prevention of REStenosis with Tranilast and its Outcomes) study, examining 1070 patients (TRA used in 26%), combined in-hospital TIMI major or minor bleeding were significantly reduced with TRA, albeit ischemic endpoints and mortality were not different (16). Finally, a substudy of the OASIS-5 (Organization for the Assessment of Strategies for Ischemic Syndromes) trial showed that TRA (used in around 10% of trial patients) was associated with a significant reduction of defined major bleeding (14). Very recently, the randomized MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) study has demonstrated that TRA reduces Bleeding Academic Research Consortium (BARC) 3 to 5 bleeding in ACS, leading to less cardiac mortality, albeit no significant effect on TIMI major, TIMI minor, and on TIMI major or minor bleeding was observed (6). Importantly, although data from the nested randomized NSTE-ACS subgroup of the trial have not yet been published in detail, the TRA benefit on BARC 3 or 5 bleeding rate seems blunted in this subset (6).
Compared with previous data, our analysis combines the benefit of a large use of TRA, not reserved to a minority of patients as in other nonrandomized analyses, while also enrolling a higher risk subset than the randomized NSTE-ACS arm of the RIVAL trial, in which only 62% of patients had positive cardiac enzymes (30).
Our post hoc finding that TRA does not reduce major bleeding defined according to the TIMI, GUSTO or STEEPLE definitions (12) is shared by many of the aforementioned studies. Our interpretation is inherently related to the low overall rate of significant bleeding, as well to the good management of the femoral access seen in the ACCOAST trial. Indeed, TRA patients had a rate of TIMI major access site-related bleeding of 0.1% (one-fifth of all TIMI major bleeding), compared to a remarkable 0.6% (comprising half of all TIMI major bleeding) in the TFA group. These rates, especially in the TFA group, were not changed in the patients who underwent PCI and were similar to those observed in the randomized RIVAL trial. Thus, a careful management of femoral access in the context of a low use of GP IIb/IIIa inhibitors has largely reduced the gap between the 2 strategies, probably to a point where demonstrating that TRA lowers even access-site related TIMI major bleeding (that, by definition, requires a decrease of >5 g/dl hemoglobin) would require extremely large sample sizes. This explanation is supported by the MATRIX trial (6), in which TIMI major bleeding and even combined TIMI major or minor bleeding were not significantly reduced by TRA, which was superior to TFA only when using the more sensitive BARC definition (31), which emphasizes both clinically and laboratory measured bleeding and has organ-specific nuance.
In the ACCOAST study, nonetheless, even after propensity score correction, TFA remained associated with a significant tripling of TIMI major or minor bleeding with respect to TRA in patients undergoing PCI, resembling the increased risk afforded by prasugrel pre-treatment in the same subset (22), indicating an overall positive effect of TRA on bleeding.
Regarding ischemic endpoints, the conflicting reduced risk of urgent revascularization and increased risk of stroke associated with TRA may derive either from unmeasured confounders, not fully eliminated by propensity score correction, or from true differences. Of note, there have been previous reports of both TRA-induced increased and decreased risk of stroke, with pathophysiological associations related to the different pathway travelled by catheter and guides when the this access is used (32). A recent meta-analysis of the published studies, however, has failed to show any difference between TRA and TFA in terms of stroke incidence (33), and no excess of stroke has been reported in the large, randomized RIVAL (30) and MATRIX (6) trials. This important discrepancy will therefore require further investigation.
The most important limitation of this analysis is that patients were not randomized by radial versus femoral access, and populations were thus unbalanced by access site with respect to important risk factors. Although we believe that we have controlled for the effect of measured confounders, the effect of unmeasured confounders is harder to quantify. Another important limitation was the absence of data regarding access site switch, as the only recorded data in ACCOAST was related to the first approach used. Whereas it is well known that “switch” patients are at higher risk of vascular complications (34), most analyses, including those of the MATRIX and RIVAL trials, have used an intention-to-treat approach, and no correction for switching has been applied.
In addition, measurements of TRA volume for center and for operator, an important contributor to the outcome of TRA (17), are not available and could not be included in the propensity score correction. Country, however, a rougher measure of “radialism,” has been included in the propensity score to take into account regional TRA variability.
Finally, we are not able to report data for the newest BARC (30) definition of bleeding, used in the recent MATRIX trial (6), as it was not pre-specified in the ACCOAST protocol (20) and thus was not prospectively adjudicated.
In a medium-to-high risk NSTE-ACS population with low levels of GP IIb/IIIa inhibitor use, major adverse cardiac ischemic events occurred at a low rate and were not influenced by access site. However, non-CABG TIMI major or minor bleeding was lower with TRA. The reduced risk of urgent revascularization and increased risk of stroke seen with the TRA approach deserve further study.
WHAT IS KNOWN? Modern treatment of non ST-elevation acute coronary syndromes (NSTE-ACS) is based on rapid coronary angiography and on the administration of powerful antiplatelet and anticoagulant drugs. TRA may provide improved outcomes compared with transfemoral access in this patient group.
WHAT IS NEW? In a medium-to-high risk NSTE-ACS population studied in the ACCOAST trial, major adverse cardiac ischemic events were not influenced by access site; however, non-CABG TIMI major or minor bleeding was lower with TRA.
WHAT IS NEXT? TRA should be considered in NSTE-ACS patients at increased risk of bleeding while the reduced risk of urgent revascularization and the increased risk of stroke seen with TRA approach deserve further study.
This trial was sponsored by Daiichi-Sankyo Company, Ltd., and Eli Lilly and Co. The coordinating center was the ACTION Study Group, Institute of Cardiology of Pitié-Salpêtrière Hospital. ACCOAST trial data from the primary study were collected, managed, and analyzed by a clinical research organization contracted by the sponsors according to the protocol and a pre-defined statistical analysis plan. Dr. Porto has received consulting and lecture fees from AstraZeneca, Boston Scientific, St. Jude Medical, Terumo, and Volcano. Dr. Bolognese has received fees for board membership from Daiichi-Sankyo and Eli Lilly; consulting fees from Daiichi-Sankyo; and lecture fees from Daiichi-Sankyo, Eli Lilly, Menarini, Abbott, AstraZeneca, and Iroko Cardio International. Dr. Dudek has received consulting and lecture fees from Abbott, Adamed, Adyton Medical Polska, Abiomed Europe, AstraZeneca, Biotronik, Balton, Bayer, Braun, BioMatrix, Boston Scientific, Boehringer Ingelheim, Bracco, Bristol-Myers Squibb, Comesa Polska, Cordis, Cook, Covidien Polska, DRG MedTek, Eli Lilly, EuroCor, Hammermed, GE Healthcare, GlaxoSmithKline, Inspire-MD, Iroko Cardio International, Medianet, Medtronic, The Medicines Company, Meril Life Sciences, Merck Sharp & Dohme, Orbus-Neich, Pfizer, Possis, ProCardia Medical, Promed, REVA Medical, Sanofi, Siemens, Solvay, Stentys, St. Jude Medical, Terumo, Tyco, and Volcano. Dr. Goldstein has received fees for board membership from Boehringer Ingelheim, The Medicines Company, Daiichi-Sankyo, and Eli Lilly; consulting fees from Boehringer Ingelheim, Bayer, Sanofi, and AstraZeneca; lecture fees from Boehringer Ingelheim, The Medicines Company, Daiichi-Sankyo, Bayer, Sanofi, AstraZeneca, and Eli Lilly; payment for the development of educational presentations from Boehringer Ingleheim and AstraZeneca; and travel support from AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, The Medicines Company, and Sanofi. Dr. Hamm has received payment for board membership from AstraZeneca, Medtronic, and Boehringer Ingelheim; consulting and lecture fees from Medtronic, Boehringer Ingelheim, Eli Lilly, The Medicines Company, Abbott Vascular, Bayer, Sanofi, Boston Scientific, Correvio, Roche Diagnostics, Pfizer, Cordis, Daiichi-Sankyo, and GlaxoSmithKline; and lecture fees from AstraZeneca and Merck. Dr. Tanguay has received consulting fees from Eli Lilly, AstraZeneca, Abbott Vascular, Roche, and GlaxoSmithKline; lecture fees from Bayer, Sanofi, Eli Lilly, AstraZeneca, Abbott Vascular, Pfizer, and Bristol-Myers Squibb; and grant support from Eli Lilly, AstraZeneca, Roche, Hexacath, Ikaria, Abbott Vascular, GlaxoSmithKline, Roche, and Sanofi. Dr. ten Berg has received fees for board membership from AstraZeneca; consulting fees from AstraZeneca, Eli Lilly, and Merck; and lecture fees from AstraZeneca, Eli Lilly, and The Medicines Company. Dr. Widimsky has received consulting and lecture fees from Eli Lilly and Daiichi-Sankyo. Mr. Le Gall is an employee of inVentiv Health Company, whose work is funded by Eli Lilly. Mr. Zagar, Dr. LeNarz, and Ms. Miller are employees and shareholders of Eli Lilly and Company. Dr. Montalescot has received consulting fees from Bayer, Boehringer Ingelheim, Cardiovascular Research Foundation, Europa Organisation, the Gerson Lehrman Group, Iroko Cardio International, Lead-Up, Luminex, McKinsey & Company, Inc., Remedica, Servier, TIMI Study Group, WebMD, Wolters Kluwer Health, Bristol-Myers Squibb, AstraZeneca, Biotronik, Eli Lilly, The Medicines Company, Menarini Group, Roche, Sanofi, Pfizer, Daiichi-Sankyo, and Medtronic; and grant support from Bristol-Myers Squibb, AstraZeneca, Biotronik, Eli Lilly, The Medicines Company, Menarini Group, Sanofi, Pfizer, Roche, Accumetrics, Medtronic, Abbott Laboratories, Daiichi-Sankyo, Nanosphere Inc., and Stentys.
- Abbreviations and Acronyms
- acute coronary syndrome(s)
- hazard ratio
- myocardial infarction
- non–ST-segment elevation ACS
- percutaneous coronary intervention
- transradial access
- transfemoral access
- Received August 25, 2015.
- Accepted January 28, 2016.
- American College of Cardiology Foundation
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