Clinical Research
Impact of Access Site on Bleeding and Ischemic Events in Patients With Non–ST-Segment Elevation Myocardial Infarction Treated With Prasugrel: The ACCOAST Access Substudy

https://doi.org/10.1016/j.jcin.2016.01.041Get rights and content
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Abstract

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)

Key Words

acute coronary syndrome(s)
bleeding
percutaneous coronary intervention
transradial access

Abbreviations and Acronyms

ACS
acute coronary syndrome(s)
HR
hazard ratio
MI
myocardial infarction
NST-ACS
non–ST-segment elevation ACS
PCI
percutaneous coronary intervention
TRA
transradial access
TFA
transfemoral access

Cited by (0)

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.