Incidence, predictors, and clinical impact of bleeding after transradial coronary stenting and maximal antiplatelet therapy

doi:10.1016/j.ahj.2008.09.010

American Heart Journal

Volume 157, Issue 1, January 2009, Pages 164-169

https://doi.org/10.1016/j.ahj.2008.09.010 Get rights and content

Background

Bleeding has recently emerged as predictor of early and late mortality after percutaneous coronary intervention (PCI) using femoral approach. Transradial PCI is associated with a lower risk of access-site complications than femoral approach. We evaluated the predictors of bleeding and the impact of major bleeding on death and major adverse cardiac events (MACE) after transradial PCI and maximal antiplatelet therapy.

Methods

In the EASY (EArly discharge after transradial Stenting of coronarY arteries) trial, 1,348 patients with acute coronary syndrome were enrolled and underwent transradial PCI. All patients received clopidogrel (90% ≥12 hours pre-PCI) and a bolus of abciximab before first balloon inflation. Univariate and multivariate analyses to identify predictors and prognostic impact of major bleeding on death and MACE (death, myocardial infarction, and target vessel revascularization) were performed.

Results

From the study population, 19 (1.4%) patients presented major bleeding. Patients with bleeding were older, had lower creatinine clearance, more often had 3-vessel disease and ≥3 dilated sites, and had longer procedures. Independent predictors of bleeding were creatinine clearance <60 mL/min (odds ratio [OR] 3.26, 95% confidence interval [CI] 1.10-8.67, P = .022), procedure duration (OR 2.95, 95% CI 1.12-8.31, P = .032), and sheath size (OR 5.34, 95% CI 1.44-34.65, P = .029). In patients with major bleeding, the incidence of MACE was higher at 30 days (37% vs 3%), 6 months (42% vs 8%), and 12 months (53% vs 12%; P < .0001 for all comparisons). By multivariate analysis, major bleeding was an independent predictive factor of 1-year mortality and MACE.

Conclusion

After transradial PCI and maximal antiplatelet therapy, the incidence of major bleeding remains low. Major bleeding is an independent predictive factor of adverse acute and 1-year outcomes, regardless of the access site.

Section snippets

Study population and study design

The details of the EASY trial have been previously described.¹¹ Briefly, patients referred for coronary angiography and possible PCI were enrolled from October 2003 to April 2005. Because of the study design, contraindication for same-day discharge such as ST-elevation myocardial infarction (MI) within 72 hours and history of left ventricular ejection fraction ≤30% or abciximab administration were exclusion criteria. Except for a secondary branch in bifurcation lesions or redilatation for

Results

From the 1,348 patients enrolled in the trial, 19 (1.4%) met the criteria of major bleeding according to the REPLACE-2 definitions (Table I). As previously reported, there was no difference in the incidence of major bleeding between abciximab bolus-only and bolus + infusion in the randomized groups, whereas more bleeding occurred in patients not randomized after PCI to same-day discharge.11, 14 Patients with major bleeding were older and less likely with dyslipidemia, and their creatinine

Discussion

Our unique findings can be summarized as follows: after transradial PCI and maximal antiplatelet therapy, (1) the incidence of major bleeding remains low (1.4%); (2) predictors of major bleeding are mostly procedure related; (3) major bleeding are not access-site related; (4) major bleeding is a strong independent predictor of 1-year death and MACE.

It remains difficult to compare bleeding rates across studies in ACSs and after PCI because different definitions have been applied.¹⁵ The

Conclusion

In patients with maximal antiplatelet therapy and transradial PCI, the incidence of major bleeding appears lower than current experience with transfemoral approach. Regardless of the access site, major bleeding has a severe negative impact on early and late clinical outcomes after PCI. Because transradial access nearly completely abolishes significant access-site complications and related bleeding, further studies with transradial access and newer antithrombin regimen, like bivalirudin, are

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Another finding of this meta-analysis is the lower risk of EASY ≥II hematoma associated with DRA use compared with conventional RA use. Prior studies have shown that EASY ≥II hematoma is typically related to intramuscular bleeding secondary to vascular injury, while EASY <II hematoma is related to radial puncture.39,40 The overall incidence of EASY hematoma was about 10% in a recent study, and several predictors have been identified such as female sex, multiple puncture attempts, longer hemostasis time, intensive antiplatelet therapy, and more complex procedures.41
Emerging evidence from randomized clinical trials (RCTs) comparing distal radial access (DRA) with conventional radial access (RA) is available.
The aim of this study was to provide a quantitative appraisal of the effects of DRA) vs conventional RA for coronary angiography with or without intervention.
The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for RCT comparing DRA vs conventional RA for coronary angiography and/or intervention. Data were pooled by meta-analysis using a random-effects model. The primary endpoint was radial artery occlusion (RAO) at the longest available follow-up.
Fourteen studies enrolling 6,208 participants were included. Compared with conventional RA, DRA was associated with a significant lower risk of RAO, either detected at latest follow-up (risk ratio [RR]: 0.36; 95% CI: 0.23-0.56; P < 0.001; number needed to treat [NNT] = 30) or in-hospital (RR: 0.32; 95% CI: 0.19-0.53; P < 0.001; NNT = 28), as well as EASY (Early Discharge After Transradial Stenting of Coronary Arteries) ≥II hematoma (RR: 0.51; 95% CI: 0.27-0.96; P = 0.04; NNT = 107). By contrast, DRA was associated with a higher risk of access site crossover (RR: 3.08; 95% CI: 1.88-5.06; P < 0.001; NNT = 12), a longer time for radial puncture (standardized mean difference [SMD]: 3.56; 95% CI: 0.96-6.16; P < 0.001), a longer time for sheath insertion (SMD: 0.37; 95% CI: 0.16-0.58; P < 0.001), and a higher number of puncture attempts (SMD: 0.59, 95% CI: 0.48-0.69; P < 0.001).
Compared with conventional RA, DRA is associated with lower risks of RAO and EASY ≥II hematoma but requires longer time for radial artery cannulation and sheath insertion, more puncture attempts, and a higher access site crossover.
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Although manual pressure from an experienced operator is an effective method to obtain hemostasis, several compression devices have been developed to maximize accuracy and efficiency. Local hematomas may occur as a result of improper compression device application or device failure related to either misplacement or under-inflation of the device [38,39] (Fig. 4). It is important to emphasize that compression of the radial artery both proximally and distally to the puncture site must be performed because of retrograde flow from the palmar arch collaterals.
The transradial approach for cardiac catheterization, coronary angiography, and percutaneous intervention is associated with a lower risk of access site-related complications compared to the transfemoral approach. However, with increasing utilization of transradial access for not only coronary procedures but also peripheral vascular procedures, healthcare personnel are more likely to encounter radial access site complications, which can be associated with morbidity and mortality. There is significant heterogeneity in the reporting of incidence, manifestations, and management of radial access site complications, at least partly due to vague presentation and under-diagnosis. Therefore, physicians performing procedures via transradial access should be aware of possible complications and remain vigilant to prevent their occurrence. Intraprocedural complications of transradial access procedures, which include spasm, catheter kinking, and arterial dissection or perforation, may lead to patient discomfort, increased procedure time, and a higher rate of access site cross over. Post-procedural complications such as radial artery occlusion, hematoma, pseudoaneurysm, arteriovenous fistula, or nerve injury could lead to patient discomfort and limb dysfunction. When radial access site complications occur, comprehensive evaluation and prompt treatment is necessary to reduce long-term consequences. In this report, we review the incidence, clinical factors, and management strategies for radial access site complications associated with cardiac catheterization.
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Secondary efficacy endpoints of the study were the separate endpoints of the primary endpoint (switch of cannulation method and switch of access site), time for cannulation, total procedure time, number of attempts (defined as forward passes separated by pullbacks) for successful cannulation, and number of skin punctures (this is different from attempts, since several attempts can be performed through a single skin puncture). Safety endpoints were the incidence of hematomas EASY class III or more [7] and the incidence of RAO at discharge, documented with duplex ultrasonography. If an access site switch was performed, despite successful sheath insertion, due to radial artery spasm, tortuosity or other reasons, this was recorded, but not considered as an endpoint.
To evaluate the efficacy of radial artery cannulation with needle versus cannula over needle during transradial coronary angiography and intervention.
Five hundred patients scheduled to undergo transradial catheterization were randomized between the two methods. Primary endpoint of the study was the combined endpoint of switching to another access site due to inability of successful sheath insertion or switching to another method of cannulation (from needle to cannula over needle and vice versa).
The primary end point was met in 12 patients (4.8%) from the needle group and 14 patients (5.6%) from the cannula over needle group (p = 0.695). There were no differences in switching of cannulation method [10 (4.0%)% versus 11 (4.4%), p = 0.831], switching of access site [6 (2.8%) versus 9 (3.6%), p = 0.441), time for artery cannulation [1.20 (0.80–2.20) min versus 1.26 (1.01–2.39) min, p=0.152], total procedure time [15.05 (9.47–29.03) min versus 19.14 (10.13–32.02) min, p=0.112] number of attempts [2 (1–4) versus 2 (1–5), p=0.244] and number of skin punctures [1 (1–2) versus 1 (1–2), p=0.399] before successful radial artery cannulation. There were no differences recorded in the safety endpoints of EASY grade III or more radial hematomas [2 (0.8%) versus 1 (0.4%), p = 1.000] or the incidence of radial artery occlusion after the procedure [9 (3.6% versus 16 (6.8%), p = 0.358].
Radial artery cannulation with needle and cannula over needle seems to be equal in terms of efficacy and safety.
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The experience with the transradial approach in percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) in the United States is limited. We looked at the safety and feasibility of a home-made sheathless transradial technique (STT) with regular 8Fr catheters in CTO PCI. In March 2013, we developed an 8Fr STT for CTO PCI. We compared 119 patients who had the STT versus 122 treated with a standard transradial or transfemoral approach. The primary outcomes of interest were major vascular or bleeding site access complications. In a subgroup of patients with bilateral transradial approach, we assessed and compared radial patency 3 to 6 months after the procedure. Technical success rate of the CTO PCI was 93% in both groups. There were no major vascular or bleeding complications in the STT group. Radial hematomas were frequent but grade III occurred in 4 patients (3%) treated with the STT, not different to the incidence in the other group. The STT did not result in any increase in procedure time, contrast use, or radiation dose. Radial Doppler follow-up in 28 patients revealed 2 occlusions (7.1%) on the 8Fr shealthless side and one on the 6Fr side. In conclusion, our STT with regular 8Fr guides for CTO PCI is feasible, safe, and associated with low complication rate. We show that the hybrid CTO PCI nowadays can be performed through transradial access in the majority, with limited use of transfemoral approach.

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

: Results have been presented in part during scientific sessions of the American Heart Association (New Orleans, November 8-12, 2008) and published in abstract form (Circulation 2008;118:S638).

: Registered Clinical Trial #: NCT001169819.

View full text

Clinical InvestigationInterventional CardiologyIncidence, predictors, and clinical impact of bleeding after transradial coronary stenting and maximal antiplatelet therapy

Background

Methods

Results

Conclusion

Section snippets

Study population and study design

Results

Discussion

Conclusion

Lancet

Am J Cardiol

J Am Coll Cardiol

Am J Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Am Heart J

Am Heart J

Am J Cardiol

Am J Cardiol

Clinical Investigation
Interventional Cardiology
Incidence, predictors, and clinical impact of bleeding after transradial coronary stenting and maximal antiplatelet therapy