Go EASY: Transradial PCI is safe, effective, and not as complicated as myth would have it
Dallas, TX - Results of the
EASY trial should spur wider use of transradial PCI followed by same-day hospital discharge, experts say. The EASY trial, showing that a combination of transradial PCI and a single bolus of
abciximab (ReoPro, Centocor, Eli Lilly) is just as safe and effective as transradial PCI with bolus abciximab followed by 12-hour perfusion, were presented as a late-breaking trial here at the
American Heart Association Scientific Sessions 2005. The results were previously reported by
heartwire at the
Canadian Cardiovascular Congress 2005 (CCS 2005) last month.
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Dr Olivier F Bertrand
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"The combination of transradial PCI and single-bolus ReoPro is safe and facilitates outpatient PCI in a wide spectrum of patients," lead investigator Dr Olivier F Bertrand (Laval Hospital, Quebec, QC) said again today. Switching to this strategy could offer "significant advantages in terms of bed occupancy and cost," he added.
Commenting on the study for heartwire, Dr Timothy Gardner (Christiana Care Health Services, Wilmington, DE) pointed out that physicians have known for some time that the centers focusing on transradial PCI, like Bertrand's, have excellent safety and efficacy records, yet uptake of the procedure has been slow.
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Dr Timothy Gardner
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"It's trickier," Gardner said. "It's sort of like when the surgeons started doing arterial grafts and a lot of people wouldn't do them. And others said, well, if it's better, why aren't we all doing them? And the answer is, it's technically more demanding and there is a fear of creating circulatory problems to the hand, particularly in diabetics."
Also interviewed by heartwire, Bertrand referred to the "myth" of increased complexity and complications with the transradial approach, something he says that is simply no longer the case. Indeed, major bleeding rates in EASY were extremely low, with only four patients in the bolus-only group and one patient in the bolus-plus-perfusion group having a major bleed.
| EASY does it . . . again |
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The results Bertrand presented today mirrored those presented to a largely Canadian audience at the CCS 2005 meeting, as reported by heartwire. In a nutshell, EASY enrolled over 1300 patients who were treated by transradial PCI and a bolus of abciximab, then randomized to no perfusion and same-day discharge or 12-hour abciximab perfusion and next-day discharge. A total of 343 patients were deemed unsuitable for same-day discharge, due primarily to arterial dissection, suboccluded branch vessels, or TIMI flow <3 or thrombus poststenting.
At 30 days, a combined end point of death, urgent revascularization, repeat hospitalization, major bleeding, access-site complications, or severe thrombopenia was not statistically different between the bolus-only and bolus-plus-perfusion groups, although in both groups, adverse event rates were statistically lower than those of the registry group. In a secondary end point comprising death, MI, or target vessel revascularization at six months, again there were no different between the two groups.
Outcomes in EASY
End point
| Bolus-only (%)
| Bolus+perfusion (%)
| Registry (%)
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30 days
| | | |
Death
| 0
| 0
| -
|
Non-Q-wave MI
| 1
| 1.8
| -
|
Q-wave MI
| 0.4
| 0
| -
|
Revascularization
| 1
| 0
| -
|
Repeat hospitalization
| 5
| 3
| -
|
Major bleeding
| 0.5
| 0.2
| -
|
Access site complications
| 4.8
| 4.2
| -
|
Severe thrombopenia
| 0.6
| 0.6
| -
|
Primary end point
| 13.5
| 10.2
| 26.8
|
6 months
| | | |
Secondary end point
| 5.9
| 5.6
| 20.3
|
To download table as a slide, click on slide logo below
"Reopro as a single bolus is noninferior to the standard bolus plus perfusion after uncomplicated coronary stenting at 30 days and six months," Bertrand concluded.
In a press conference before the late-breaking presentation, Bertrand emphasized that there remains little reason for operators not to opt for transradial access in appropriate patients undergoing PCI, namely patients without dissection, thrombus, or abnormal blood flow. His center has done more than 30 000 cases and operators there boast complication rates of less than 2%.
-SW
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