Summary
Background
The transradial approach for percutaneous coronary intervention (PCI) is associated with a better outcome in myocardial infarction (MI), but patients with cardiogenic shock (CS) were excluded from most trials.
Aims
To compare outcomes of PCI for MI-related CS via the transradial versus transfemoral approach.
Methods
A prospective cohort of 101 consecutive patients admitted for PCI for MI-related CS were treated via the transradial ( n = 74) or transfemoral ( n = 27) approach. Cox proportional hazards models adjusted for prespecified variables and a propensity score for approach were used to compare mortality, death/MI/stroke and bleeding between the two groups. A complementary meta-analysis of six studies was also performed.
Results
Patients in the transradial group were younger ( P = 0.039), more often male ( P = 0.002) and had lower GRACE and CRUSADE scores ( P = 0.003 and 0.001, respectively) and rates of cardiac arrest before PCI ( P = 0.009) and mechanical ventilation ( P = 0.006). Rates of PCI success were similar. At a mean follow-up of 756 days, death occurred in 40 (54.1%) patients in the transradial group versus 22 (81.5%) in the transfemoral group (adjusted hazard ratio [HR]: 0.49, 95% confidence interval [CI] 0.28–0.84; P = 0.012). The transradial approach was associated with reduced rates of death/MI/stroke (adjusted HR: 0.53, 95%CI: 0.31–0.91; P = 0.02) and major bleeding (adjusted HR: 0.34, 95%CI: 0.13–0.87; P = 0.02). The meta-analysis confirmed the benefit of transradial access in terms of mortality (relative risk [RR]: 0.63, 95%CI: 0.58–0.68) and major bleeding (RR: 0.43, 95%CI: 0.32–0.59).
Conclusion
The transradial approach in the setting of PCI for ischaemic CS is associated with a dramatic reduction in mortality, ischaemic and bleeding events, and should be preferred to the transfemoral approach in radial expert centres.
Résumé
Contexte
L’accès par voie radiale pour l’angioplastie coronaire percutanée est associé à un meilleur pronostic dans le contexte de l’infarctus du myocarde mais les patients en choc cardiogénique ont été exclus de la plupart des études.
But
Il s’agit d’évaluer le pronostic des patients en choc cardiogénique en post-infarctus du myocarde traités par angioplastie par voie radiale en comparaison à la voie fémorale.
Méthodes
Une cohorte prospective de 101 patients consécutifs admis pour angioplastie pour un choc cardiogénique lié à un infarctus du myocarde ont été traités par voie radiale ( n = 74) ou fémorale ( n = 27). Un modèle de Cox ajusté sur des variables pré-spécifiées et un score de propension pour la voie d’abord ont été utilisés pour évaluer la mortalité, le critère combiné décès/infarctus/accident vasculaire cérébral et les saignements entre les 2 groupes. Une méta-analyse complémentaire incluant 6 études a également été réalisée.
Résultats
Dans le groupe radial, les patients étaient plus jeunes ( p = 0,03), plus souvent masculin ( p = 0,002), avaient un score de GRACE et de CRUSADE ( p = 0,002 et 0,001), un taux d’arrêt cardiaque avant angioplastie ( p = 0,009) et de ventilation mécanique ( p = 0,006) plus faible. Le succès des angioplasties était comparable entre les 2 groupes. Sur un suivi moyen de 756 jours, un décès est survenu chez 40 patients (54,1 %) dans le groupe radial contre 22 (81,5 %) dans le groupe fémoral (HR : 0,49 ; IC 95 % : 0,28–0,84 ; p = 0,01). La voie radiale était associée à une réduction du critère combiné décès/infarctus/accident vasculaire cérébral (HR : 0,53 ; IC 95 % : 0,31–0,91 ; p = 0,02) et des saignements majeurs (HR : 0,34 ; IC 95 % : 0,13–0,87 ; p = 0,02). La méta-analyse a confirmé le bénéfice de la voie radiale sur la mortalité (RR : 0,63 ; IC 95 % : 0,58–0,68) et les saignements majeurs (RR : 0,43 ; IC 95 % : 0,32–0,59).
Conclusion
La voie radiale pour l’angioplastie coronaire dans le cadre du choc cardiogénique d’origine ischémique est associée à une réduction majeure de la mortalité, des événements ischémiques et hémorragiques et doit être préférée à l’approche fémorale dans les centres radialistes experts.
Background
Cardiogenic shock (CS), with a reported incidence of 4–7%, is the leading cause of death in patients with acute myocardial infarction (MI) . The randomized SHOCK trial showed that a strategy of early revascularization, with surgery or percutaneous coronary intervention (PCI), was associated with higher survival rates than a strategy of initial medical stabilization. The rate of PCI in CS patients has increased markedly since the publication of these results .
The advantage of the transradial approach for PCI over transfemoral access in the setting of ST-segment elevation myocardial infarction has been reported by different trials . In a recent meta-analysis , transradial PCI was associated with a decreased risk of mortality and major bleeding compared with transfemoral PCI. Recent European Society of Cardiology guidelines for the management of patients with ST-elevation MI state that radial access for PCI should be preferred if performed by an experienced radial operator , and a recent expert consensus paper suggested the use of transradial procedures if the radial artery is palpable in patients with CS . However, most studies excluded patients with CS, and the use of transradial PCI in CS has been scarcely assessed.
The aim of our study was to compare outcomes – major adverse cardiac events and bleeding complications – in a cohort of consecutive patients with ischaemic CS treated with transradial versus transfemoral PCI in a radial-first centre. We also performed a meta-analysis of the current and similar published studies evaluating the outcome of PCI in CS based on vascular access site.
Methods
Patient selection
Between April 2004 and December 2011, 6245 patients were referred to our hospital for PCI for MI. Radial access was the default approach for performing PCI in our centre during the whole period in all settings. PCI was performed by experienced interventional cardiologists for both transradial (>200 radial PCIs/year/operator) and transfemoral access. Among all the patients, 408 (6.5%) were diagnosed with CS before angiography. The criteria for CS were systolic blood pressure <90 mmHg for at least 30 minutes or the need for supportive measures to maintain a systolic blood pressure >90 mmHg and end-organ hypoperfusion (cool extremities or urine output <30 mL/hour with a heart rate >60 beats per minute) . Only patients with CS of ischaemic origin occurring before angiography with an indication for PCI were included. We excluded patients with CS of other aetiologies and those who could have undergone angiography through one of the approaches only (extracorporeal membrane oxygenation before PCI, patients with bilateral mammary artery or radial coronary bypass grafts, severe peripheral artery disease or radial arteriovenous fistula). Both vascular access and intra-aortic balloon pump (IABP) use were at the discretion of the operators. Patients’ initial clinical characteristics, including GRACE and CRUSADE scores , pharmacological treatment, IABP status, details of the procedure, and clinical evolution during the course of the patients’ hospital stay and after discharge, were collected.
Procedure
The use of antiplatelet agents, anticoagulants and glycoprotein IIb/IIIa inhibitors was at the treating physician’s discretion, consistent with current guidelines. All PCI procedures were retrospectively reviewed by two independent interventional cardiologists, to collect supplementary procedural characteristics. Successful PCI was defined as a residual diameter stenosis of <30% and a thrombolysis in myocardial infarction (TIMI) 3 flow in the culprit vessel after the procedure. After the procedure, femoral access closure was managed by manual compression ( n = 9; 33.3%), vascular closure device ( n = 6; 22.2%) or replacement by IABP ( n = 12; 44.4%). In the case of a radial approach, haemostasis was achieved with a compressive device (TR Band; Terumo, Tokyo, Japan).
Outcomes
The primary endpoint of the study was the occurrence of death. Secondary major endpoints were the occurrence of the composite of death, stroke or new MI, major bleeding and net clinical benefit. Cardiac death was defined as any death due to a cardiac cause. Deaths from unknown cause were considered as cardiac. New MI was defined as new ischaemic symptoms lasting >20 minutes and new or recurrent ST-segment elevation or depression >1 mV in at least two contiguous leads, associated with a new >20% increase in cardiac biomarkers levels, not attributable to the evolution of the index MI.
Minor and major bleedings were defined according to the TIMI definition . Bleeding was further categorized as access site related or non-access site related. Follow-up data (rehospitalization for heart failure, blood transfusions and new revascularization) were collected. New revascularization was defined as any revascularization procedure performed because of angiographic stenosis or thrombosis associated with clinical and/or objective evidence of myocardial ischaemia. Net clinical benefit was defined by the composite of death, stroke, MI or major bleeding.
The patients, their families or their general practitioner and/or cardiologist were contacted in December 2012 to assess clinical follow-up after discharge in-hospital survivors.
Meta-analysis
We conducted a systematic literature review by formal searches of the MEDLINE electronic database covering the period from January 2000 to June 2014. Relevant studies were identified using a combination of medical subject headings, including the following terms: ‘cardiogenic shock’, ‘myocardial infarction’, ‘PCI’, ‘vascular access’, ‘transradial access’ and ‘radial approach’. References from reviews and selected articles were also reviewed for potential relevant citations. Studies were selected by two independent reviewers (V.R. and A.L.). We restricted our analysis to studies that met all of the following inclusion criteria: outcome comparison of transradial and transfemoral access for PCI in CS patients; and available data on mortality. Exclusion criteria were ongoing studies and irretrievable data. The endpoints were all-cause death, major bleeding and transfusion.
Statistical analysis
Groups were defined by transradial or transfemoral approach. Continuous variables are expressed as mean values ± standard deviations and were compared using Student’s test. Categorical variables are expressed as numbers of patients and percentages and were compared using the χ 2 test. The Kaplan-Meier estimator and log-rank test were used to compare survival between the two groups. A Cox proportional hazards model adjusted for prespecified variables (age, sex, previous peripheral vascular disease, GRACE score, CRUSADE score [for bleeding only] and need for IABP) was used for the primary analysis to assess mortality, combined endpoints of death/stroke/recurrent MI, bleeding and net clinical benefit, in the two groups. A complementary analysis was performed using a Cox proportional hazards model adjusted for the prespecified variables as well as deciles of the propensity score for choosing radial access. The propensity score was calculated using a logistic regression model that included the following prespecified variables: age, sex, diabetes mellitus, cigarette smoker, weight, history of peripheral vascular disease, vitamin K antagonist treatment and systolic blood pressure.
The results of the meta-analysis are presented as relative risks with 95% confidence intervals (CIs). Outcomes from individual studies were combined using the Mantel-Haenszel fixed-effect (primary analysis) and random-effect (sensitivity analysis) models. The fixed-effect model’s relative risks are reported in the text. All tests were two-tailed and a P -value of <0.05 was considered statistically significant.
R software, version 3.0.0 (2013-04-03) for MacOS (R Foundation for Statistical Computing, Vienna, Austria) was used for statistical analysis and meta-analysis.
Results
A total of 101 consecutive patients were included, of whom 74 (73.3%) were treated by the transradial approach and 27 (26.7%) by the transfemoral approach. Patients’ clinical characteristics and treatments are detailed in Table 1 . Patients aged >75 years accounted for 41.6% ( n = 42) of the cohort, with a similar distribution between groups.
| All ( n = 101) | Radial ( n = 74) | Femoral ( n = 27) | P | |
|---|---|---|---|---|
| Baseline patient characteristics | ||||
| Age (years) | 68.0 ± 13.0 | 67.0 ± 13.6 | 73.0 ± 10.3 | 0.039 |
| Men | 69 (68.3) | 57 (77.0) | 12 (44.4) | 0.002 |
| Risk factors | ||||
| Systemic hypertension | 55 (54.5) | 39 (52.7) | 16 (59.3) | 0.56 |
| Diabetes mellitus | 29 (28.7) | 18 (24.3) | 11 (40.7) | 0.11 |
| Hyperlipidaemia | 42 (41.6) | 31 (41.9) | 11 (40.7) | 0.92 |
| Current cigarette smoker | 28 (27.7) | 23 (31.1) | 5 (18.5) | 0.21 |
| Family history of premature coronary disease | 12 (11.9) | 10 (13.5) | 2 (7.4) | 0.40 |
| Body mass index (kg/m 2 ) | 26.9 ± 4.9 | 27.3 ± 5.1 | 25.9 ± 4.1 | 0.21 |
| History | ||||
| Myocardial infarction | 14 (13.9) | 9 (12.2) | 5 (18.5) | 0.41 |
| Coronary artery bypass | 2 (2.0) | 2 (2.7) | 0 (0) | 0.39 |
| PCI | 10 (9.9) | 7 (9.5) | 3 (11.1) | 0.81 |
| Peripheral vascular disease | 9 (8.9) | 6 (8.1) | 3 (11.1) | 0.64 |
| Vitamin K antagonist treatment | 7 (6.9) | 5 (6.8) | 2 (7.4) | 0.91 |
| Presenting characteristics | ||||
| Creatinine clearance rate (mL/min) | 55.8 ± 27.0 | 58.4 ± 25.5 | 48.6 ± 29.9 | 0.11 |
| Clearance <30 mL/min | 14 (13.9) | 5 (6.8) | 9 (33.3) | 0.001 |
| Systolic blood pressure (mmHg) | 77.4 ± 14.2 | 78.6 ± 13.0 | 73.9 ± 16.7 | 0.14 |
| Diastolic blood pressure (mmHg) | 49.3 ± 12.6 | 50.6 ± 12.2 | 45.5 ± 13.1 | 0.07 |
| Heart rate (beats per minute) | 80.6 ± 31.8 | 77.5 ± 31.6 | 89 ± 31.2 | 0.11 |
| Cardiac arrest before PCI | 26 (25.7) | 14 (18.9) | 12 (44.4) | 0.009 |
| Shock at admission | 55 (54.5) | 40 (54.1) | 15 (55.6) | 0.89 |
| Time between shock and PCI (hours) | 3.8 ± 10.6 | 4.1 ± 11.9 | 3.1 ± 5.5 | 0.67 |
| Mechanical ventilation | 56 (55.4) | 35 (47.3) | 21 (77.8) | 0.006 |
| LVEF at presentation (%) | 36.9 ± 13.3 | 37.3 ± 14.3 | 35.9 ± 10.3 | 0.64 |
| GRACE score | 250.8 ± 34.1 | 244.7 ± 31.3 | 267.4 ± 36.5 | 0.003 |
| CRUSADE score | 5.1 ± 12.2 | 48.7 ± 11.3 | 57.4 ± 12.5 | 0.001 |
| ST-segment elevation | 91 (90.1) | 67 (90.5) | 24 (88.9) | 0.81 |
| Treatment | ||||
| Aspirin | 101 (100) | 74 (100) | 27 (100) | – |
| Clopidogrel | 99 (98.0) | 72 (97.3) | 27 (100) | 0.39 |
| Prasugrel | 2 (2.0) | 2 (2.7) | 0 (0) | 0.39 |
| Unfractionated heparin | 87 (86.1) | 63 (85.1) | 24 (88.9) | 0.63 |
| Enoxaparin | 4 (4.0) | 4 (5.4) | 0 (0) | 0.22 |
| Fondaparinux | 7 (6.9) | 5 (6.8) | 2 (7.4) | 0.91 |
| Bivalirudin | 1 (1.0) | 1 (1.4) | 0 (0) | 0.54 |
| Glycoprotein IIb/IIIa inhibitor | 35 (34.7) | 28 (37.8) | 7 (25.9) | 0.27 |
| Prehospital fibrinolysis a | 39 (42.9) | 31 (46.3) | 8 (33.3) | 0.26 |
| IABP | 71 (70.3) | 51 (68.9) | 20 (74.1) | 0.62 |
| Before PCI | 30 (29.7) | 25 (33.8) | 5 (18.6) | 0.07 |
| Duration (days) | 3.5 ± 1.9 | 3.44 ± 1.9 | 3.8 ± 2.1 | 0.82 |
| Inotropic drugs | 94 (93.1) | 68 (91.9) | 26 (96.3) | 0.44 |
Procedure
Angiographic findings and PCI procedures are summarized in Table 2 , showing similar rates of procedural success (overall PCI success rate of 70.3%). Final TIMI 3 flow was observed in 81 patients (80.2%) and did not differ between groups (62 patients in the transradial group versus 19 patients in the transfemoral group; P = 0.13). There were no crossovers between the groups.
| All ( n = 101) | Radial ( n = 74) | Femoral ( n = 27) | P | |
|---|---|---|---|---|
| Angiography | ||||
| Right radial approach | 98 (97) | 72 (97.3) | 26 (96.3) | 0.79 |
| MVD | 78 (77.2) | 58 (78.4) | 20 (74.1) | 0.41 |
| LM stenosis >50% | 21 (20.8) | 16 (21.6) | 5 (18.5) | 0.73 |
| Culprit coronary artery | ||||
| LAD | 48 (47.5) | 33 (44.6) | 15 (55.6) | 0.33 |
| LCx | 8 (7.9) | 6 (8.1) | 2 (7.4) | 0.91 |
| RCA | 31 (30.7) | 24 (32.4) | 7 (25.9) | 0.53 |
| LM | 13 (12.9) | 10 (13.5) | 3 (11.1) | 0.75 |
| Saphenous graft | 1 (1.0) | 1 (1.4) | 0 (0) | 0.54 |
| Approach | ||||
| ≤6 French | 98 (97.0) | 74 (100) | 24 (88.9) | 0.004 |
| Number of diagnostic catheters | 1.0 ± 0.8 | 1.1 ± 0.9 | 0.7 ± 0.7 | 0.38 |
| PCI | ||||
| Number of PCI catheters | 1.6 ± 0.8 | 1.5 ± 0.7 | 1.7 ± 0.8 | 0.16 |
| Thrombectomy | 12 (11.9) | 11 (14.9) | 1 (3.7) | 0.13 |
| Bare-metal stent | 79 (78.2) | 54 (73.0) | 25 (92.6) | 0.034 |
| Number of stents | 1.7 ± 0.8 | 1.6 ± 0.8 | 2.0 ± 0.9 | 0.21 |
| Number of revascularized vessels | 1.2 ± 0.4 | 1.2 ± 0.4 | 1.2 ± 0.4 | 0.79 |
| Complete revascularization | 67 (66.3) | 51 (68.9) | 16 (59.3) | 0.36 |
| Procedure success | 71 (70.3) | 54 (73.0) | 17 (63.0) | 0.33 |
| Procedure time (minutes) a | 72.2 ± 40.3 | 72.6 ± 38.8 | 71.0 ± 45.8 | 0.87 |
| Fluoroscopy time (minutes) b | 14.9 ± 9.8 | 15.6 ± 9.8 | 12.7 ± 9.8 | 0.24 |
| Contrast media volume (mL) c | 221.6 ± 102.8 | 231.4 ± 108.8 | 192.9 ± 78.0 | 0.15 |
| Complications | ||||
| No-reflow | 13 (12.9) | 11 (14.9) | 2 (7.4) | 0.32 |
| Coronary dissection | 2 (2.0) | 2 (2.7) | 0 (0) | 0.39 |
| Side-branch occlusion | 3 (3.0) | 1 (1.4) | 2 (7.4) | 0.11 |
| Distal embolization | 6 (5.9) | 4 (5.4) | 2 (7.4) | 0.71 |
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