One-year clinical outcome after abciximab bolus-only compared with abciximab bolus and 12-hour infusion in the Randomized EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) Study

doi:10.1016/j.ahj.2008.02.006

American Heart Journal

Volume 156, Issue 1, July 2008, Pages 135-140

https://doi.org/10.1016/j.ahj.2008.02.006 Get rights and content

Background

Long-term clinical follow-up has shown a significant benefit after percutaneous coronary intervention (PCI) for abciximab bolus followed by 12-hour infusion over placebo or bolus-only. With contemporary techniques and clopidogrel pretreatment, it is unknown whether the 12-hour infusion is still associated with a clinical benefit. The purpose of this study is to compare 6- and 12-month clinical outcomes in patients treated after PCI with abciximab bolus-only and abciximab bolus followed by 12-hour infusion.

Methods

After a bolus of abciximab (0.25 mg/kg) and uncomplicated transradial coronary stenting, 1,005 patients were randomized either to same-day discharge and no infusion of abciximab (bolus-only group, n = 504) or to overnight hospitalization and 12 hours (0.125 μg/[kg min]) of abciximab infusion (bolus + infusion group, n = 501). The rate of major adverse cardiovascular events (MACE) was evaluated at 30 days, 6 months, and 12 months.

Results

At 30 days, the rate of MACE including death, myocardial infarction, and target vessel revascularization was similar in the 2 groups: 1.4% in the bolus-only group versus 1.8% in the bolus + infusion group (P = .63). At 6 months, the MACE rate was 5.6% in the 2 randomized groups. At 12 months, the MACE rate was also similar in both groups: 8.7% in the bolus-only group and 9.2% in the bolus + infusion group (hazard ratio 0.97, 95% CI 0.79-1.20, P = .80). Similar efficacy was also observed in several subgroups including higher-risk patients such as those with elevated troponin T before PCI.

Conclusions

In patients pretreated with clopidogrel and undergoing uncomplicated coronary artery stenting, there is no difference in the 6- and 12-month outcomes between patients treated with abciximab bolus-only versus those treated with bolus + infusion, a finding consistent with the initial 30-day outcomes.

Section snippets

Study population

The details of the EASY trial have been previously described.³ Briefly, patients referred for coronary angiography and possible PCI were enrolled at Laval Hospital from October 2003 to April 2005. Patients were excluded if they had ST-elevation MI within 72 hours or history of left ventricular ejection fraction ≤30%. Because of study design, contraindication for same-day discharge or abciximab administration was also an exclusion criterion. Except for a secondary branch in bifurcation lesions

Results

Enrolment in the study took place between October 15, 2003, and April 11, 2005. Overall, 1005 patients were randomized either to the bolus-only group or the bolus + infusion group. Clinical follow-up at 1 year was 100%. Baseline and procedural characteristics were similar in both randomized groups (Table I, Table II). The results of the primary composite end point analysis at 30 days have been previously reported in details.³ Briefly, the incidence of the primary end point was 11.1% in the

Discussion

In our study, we have shown for the first time that the initial clinical equivalence demonstrated at 30 days between abciximab bolus-only and bolus + infusion was maintained at 6 and 12 months. The use of a 12-hour abciximab infusion after the bolus was initiated in the EPIC trial and remained standard in all following studies.1, 2, 5, 6 Initial pharmacological studies have shown that a 0.25-mg/kg bolus of abciximab produced ≥80% platelet aggregation inhibition via occupancy of platelet

Conclusion

Our results suggest that after clopidogrel pretreatment and uncomplicated transradial coronary stenting, there is no difference in the 6- and 12-month outcomes between patients treated with abciximab bolus-only and those treated with bolus plus infusion, a finding consistent with the initial 30-day outcomes.

References (27)

E.J. Topol et al.
Multi-year follow-up of abciximab therapy in three randomized, placebo-controlled trials of percutaneous coronary revascularization
Am J Med
(2002)
C.P. Cannon et al.
American College of Cardiology key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes. A report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee)
J Am Coll Cardiol
(2001)
J.D. Marmur et al.
Benefit of bolus-only platelet glycoprotein IIb/IIIa inhibition during percutaneous coronary intervention: insights from the very early outcomes in the Evaluation of 7E3 for the Prevention of Ischemic Complications (EPIC) trial
Am Heart J
(2006)
D.E. Kandzari et al.
Influence of treatment duration with a 600-mg dose of clopidogrel before percutaneous coronary revascularization
J Am Coll Cardiol
(2004)
S.R. Steinhubl et al.
Optimal timing for the initiation of pre-treatment with 300 mg clopidogrel before percutaneous coronary intervention
J Am Coll Cardiol
(2006)
A.W. Bonz et al.
Effect of additional temporary glycoprotein IIb/IIIa receptor inhibition on troponin release in elective percutaneous coronary interventions after pretreatment with aspirin and clopidogrel (TOPSTAR trial)
J Am Coll Cardiol
(2002)
A.W. Chan et al.
Triple antiplatelet therapy during percutaneous coronary intervention is associated with improved outcomes including one-year survival: results from the Do Tirofiban and ReoPro Give Similar Efficacy Outcome Trial (TARGET)
J Am Coll Cardiol
(2003)
F.J. Neumann et al.
Effect of glycoprotein IIb/IIIa receptor blockade with abciximab on clinical and angiographic restenosis rate after the placement of coronary stents following acute myocardial infarction
J Am Coll Cardiol
(2000)
E.J. Topol et al.
Randomised trial of coronary intervention with antibody against platelet IIb/IIIa integrin for reduction of clinical restenosis: results at six months. The EPIC Investigators
Lancet
(1994)
K.M. Anderson et al.
Long-term mortality benefit with abciximab in patients undergoing percutaneous coronary intervention
J Am Coll Cardiol
(2001)

S.V. Manoukian et al.

Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial

J Am Coll Cardiol

(2007)

G.W. Stone et al.

Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial

Lancet

(2007)

Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. The EPIC Investigation

N Engl J Med

(1994)

Cited by (45)

Radial Hemostasis Is Facilitated With a Potassium Ferrate Hemostatic Patch: The STAT2 Trial
2022, JACC: Cardiovascular Interventions
The aim of this trial was to test whether the potassium ferrate hemostatic patch (PFHP) as an adjunct to the TR Band (TRB) facilitated an early deflation protocol.
Shorter TRB compression times may reduce the rate of radial artery occlusion (RAO) and reduce observation time after transradial access.
A total of 443 patients were randomized to the TRB or PFHP + TRB, with complete TRB deflation attempted 60 minutes postprocedure. The primary outcome was the time to successful full deflation of the TRB without bleeding, with secondary outcomes of time to discharge and complications including hematoma, RAO, or bleeding requiring intervention beyond TRB reinflation.
Time to complete TRB deflation was 66 ± 14 minutes with the PFHP vs 113 ± 56 minutes for the TRB alone (P < 0.001). Minor rebleeding requiring TRB reinflation was much more frequent without the PFHP (0% vs 67.7%; P < 0.001) with 2.3 ± 1.3 additional reinflation and deflation attempts needed for hemostasis. Hematomas developed in 4.0% of the PFHP group and 6.8% of the TRB group (P = 0.20). RAO was rare (<1%), although 41% of patients received <5,000 U heparin. Among percutaneous coronary intervention patients, time to TRB deflation (68 ± 15 minutes vs 138 ± 62 minutes; P < 0.001) and composite complications (10.0% vs 24.2%; P = 0.04) were reduced with the PFHP.
Compared with the TRB alone, the PFHP facilitated early 60-minute TRB deflation following transradial catheterization, with a numeric reduction in vascular complications. RAO occurs rarely with early deflation regardless of heparin dose. (Comparing TR Band to StatSeal in Conjunction With TR Band II [StatSeal II]; NCT04046952)
Adoption of same day discharge following elective left main stem percutaneous coronary intervention
2020, International Journal of Cardiology
This study sought to investigate the safety and feasibility of same day discharge (SDD) practice and compare clinical outcomes to patients admitted for overnight stay (ON) undergoing elective left main stem (LMS) percutaneous coronary intervention (PCI). ON observation is still widely practiced in highly complex PCI as the standard of care, with no previous data comparing clinical outcomes in patients undergoing LMS PCI.
We analysed 6452 patients undergoing elective LMS PCI between 2007 and 2014 in England and Wales. Multiple logistic regressions and the BCIS risk model were used to study association between SDD and 30 day mortality.
SDD rates almost doubled from 19.9% in 2007 to 39.8% in 2014 for all LMS procedures and increased from 20.7% to 41.4% for unprotected LMS cases during the same study period. There was a significant increase in procedural complexity with higher use of rotational atherectomy, longer stents and multivessel PCI. SDD was not associated with increased 30 day mortality (OR 0.70 95%CI 0.30–1.65) in the overall LMS PCI cohort and the results were similar in unprotected LMS (OR 0.48 95%CI 0.17–1.41) and those requiring ON stay (OR 0.58 95%CI 0.25–1.34).
We did not find evidence that SDD is not safe or feasible in highly complex LMS PCI procedures despite increasing procedural complexity with no significant increase in 30 day mortality rates.
I'll Take My PCI to Go
2020, Cardiovascular Revascularization Medicine
The Feasibility and Safety of Ambulatory Percutaneous Coronary Interventions in Complex Lesions
2019, Cardiovascular Revascularization Medicine
The safety and feasibility of ambulatory PCI has been demonstrated in selected patients with “simple” lesions, but it is not well known whether it could be applied in more “complex” scenarios.
Main objective is to assess the feasibility and safety of ambulatory complex PCI. Prospective multicentre registry of 1047 consecutive patients planned for ambulatory trans-radial PCI. Outcomes in patients with “complex angioplasty” (CA group: 313 (30%)) were analysed and compared with those of “simple angioplasty” (SA group: 734, 70%). The feasibility (% of patients finally discharged) and safety (MACE at 24 h and at 1 month) were compared between groups. We also analyse admissions, visits to the emergency department and minor vascular complications.
Feasibility was higher for SA (80.6% vs. 63.6%, OR 1.89, 95% CI 1.52–2.35, p < 0.001). Ambulatory PCI was very safe in both groups. In CA no MACE occurred at 24 h (vs. 0.17% SA) or 30 days (vs. 0.68% in SA). There were also no differences in re-admissions, visits to the emergency department or minor vascular complications (there was a non-significant tendency to higher rate of radial occlusion at 1 month in the CA group, 5.5% vs. 2.7%, p: 0.07).
The feasibility of ambulatory PCI in selected patients with complex lesions is lower than in simple lesions, however when it is possible, it is as safe as in selected patients with simple lesions.
Same-Day Discharge After Elective Percutaneous Coronary Intervention: Insights From the British Cardiovascular Intervention Society
2019, JACC: Cardiovascular Interventions
Citation Excerpt :
Although previous research has shown the safety of SDD (3,12,13,29), many of the studies have been derived from health care systems in which SDD is not commonplace and were derived from low-risk cohorts from which complex PCI cases were excluded. For example, many of the randomized controlled studies have excluded elderly patients (10,15), those with complex disease such as chronic total occlusion, LMS or prior coronary artery bypass graft surgery (10,15), or those with impaired left ventricular function (10,11). Hence such data may not reflect outcomes of contemporary higher risk cohorts that are SDD cases.
The aim of this study was to evaluate national temporal trends in same-day discharge (SDD) and compare clinical outcomes with those among patients admitted for overnight stay undergoing elective percutaneous coronary intervention (PCI) for stable angina.
Overnight observation has been the standard of care following PCI, with no previous national analyses around changes in practice or clinical outcomes from health care systems in which SDD is the predominant practice for elective PCI.
Data from 169,623 patients undergoing elective PCI between 2007 and 2014 were obtained from the British Cardiovascular Intervention Society registry. Multiple logistic regressions and the British Cardiovascular Intervention Society risk model were used to study the association between SDD and 30-day mortality.
The rate of SDD increased from 23.5% in 2007 to 57.2% in 2014, with center SDD median prevalence varying from 17% (interquartile range: 6% to 39%) in 2007 to 66% (interquartile range: 45% to 77%) in 2014. The largest independent association with SDD was observed for radial access (odds ratio: 1.69; 95% confidence interval: 1.65 to 1.74; p < 0.001). An increase in 30-day mortality rate over time for the SDD cases was observed, without exceeding the predicted mortality risk. According to the difference-in-differences analysis, observed 30-day mortality temporal changes did not differ between SDD and overnight stay (odds ratio: 1.15; 95% confidence interval: 0.294 to 4.475; p = 0.884).
SDD has become the predominant model of care among elective PCI cases in the United Kingdom, in increasingly complex patients. SDD appears to be safe, with 30-day mortality rates in line with those calculated using the national risk prediction score used for public reporting. Changes toward SDD practice have important economic implications for health care systems worldwide.
Accelerated patent hemostasis using a procoagulant disk; a protocol designed to minimize the risk of radial artery occlusion following cardiac catheterization
2019, Cardiovascular Revascularization Medicine
Radial artery occlusion flowing cardiac catheterisation has been linked to flow reduction and prolonged compression. We investigate whether these factors can be optimised following transradial cardiac catheterisation by using an accelerated band removal protocol facilitated by a haemostasis promoting pad, in combination with a patent haemostasis technique.
In this single centre prospective study, 389 consecutive patients undergoing TRA for coronary angiography or angioplasty were randomised to two haemostasis protocols: use of a Helix™ compression device alone (HC) or in combination with a haemostatic pad (StatSeal® disc) and an accelerated haemostasis protocol (AC). A patent haemostasis technique was employed in both study arms. The primary efficacy endpoint was the time to haemostasis and the secondary safety outcome was access site related complications: re-bleeding, haematoma and radial artery patency assessed within 24 h using reverse Barbeau's Test (BT).
Between May and Nov 2017, 191 patients were randomised to receive HC and 198 patients to AC. Compression time was significantly higher with HC as compared to AC (165.8 ± 63.1 versus 79.7 ± 41.2 min, p < 0.001). There were no significant differences in re-bleeding and RAO between groups (3.7% versus 5.6%, p = 0.37 and 6.3% versus 4.1%, p = 0.33) respectively. Incidence of haematoma was higher in AC group (4.7% versus 12.1%, p = 0.009).
A reduction in radial artery compression time can be achieved by using Statseal in association with an accelerated haemostasis protocol without increasing the risk of access site bleeding and RAO. The combination of reduced compression time combined with maintained radial flow via patent haemostasis has the potential to reduce the risk of radial occlusion after transradial catheterisation.

View all citing articles on Scopus

: This study was designed as investigator-initiated trial and funded by unrestricted grants from Eli-Lilly, Bristol-Myers-Squibb/Sanofi-Aventis, Régie Régionale de Québec, and Corporation de l'Institut de cardiologie de Québec. O. F. Bertrand and P. Poirier are research-scholars from Quebec Foundation for Health Research.

View full text

Clinical InvestigationInterventional CardiologyOne-year clinical outcome after abciximab bolus-only compared with abciximab bolus and 12-hour infusion in the Randomized EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) Study

Background

Methods

Results

Conclusions

Section snippets

Study population

Results

Discussion

Conclusion

Am J Med

J Am Coll Cardiol

Am Heart J

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Lancet

J Am Coll Cardiol

J Am Coll Cardiol

Lancet

Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. The EPIC Investigation

N Engl J Med

Clinical Investigation
Interventional Cardiology
One-year clinical outcome after abciximab bolus-only compared with abciximab bolus and 12-hour infusion in the Randomized EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) Study