RADIAL VS FEMORAL ACCESS FOR CORONARY ANGIOGRAPHY AND INTERVENTION IN PATIENTS WITH ACS-( RIVAL) A RANDOMIZED ,PARALLEL GROUP, MULTICENTRE TRIAL.

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RADIAL VS FEMORAL ACCESS FOR CORONARY ANGIOGRAPHY
AND INTERVENTION IN PATIENTS WITH ACS-( RIVAL) A
RANDOMIZED ,PARALLEL GROUP, MULTICENTRE TRIAL.
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• Sanjit jolly, salim yusuf, john cairns et al.
• Lancet vol 377, april 23, 2011.

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BACKGROUND

• Small trials have suggested that radial access
  for percutaneous coronary intervention (PCI)
  reduces vascular complications and bleeding
  compared with femoral access.
• The study was aimed to assess whether radial
  access was superior to femoral access in ACS
  patients.

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• observational studies have suggested a lower risk
  of death and myocardial infarction with radial
  than with femoral access, but these analyses are
  limited because of potential confounding factors.
• Individual trials were small,single centred and
  underpowered to detect differences in important
  clinical events.

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METHODS- STUDY DESIGN AND PATIENTS

• Randomised parallel group,multicentre trial.
• The RIVAL trial first enrolled patients within an
  investigator-initiated randomised substudy of the
  the CURRENT-OASIS 7 trial.
• After the CURRENT-OASIS 7 trial was completed
  additional patients were enrolled in the RIVAL
  trial.

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INCLUSION CRITERIA

• Had an ACS with or without ST elevation
• Planned invasive approach.
• Interventional cardiologist was willing to
  proceed with either femoral or radial access(
  and had expertise for both, including 50 radial
  procedures-angios/intervention-within the
  previous year) .
• Normal Allens test.

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EXCLUSION CRITERIA

• Cardiogenic shock.
• Severe peripheral vascular disease precluding a
  femoral approach.
• Previous CABG with use of more than one internal
  mammary artery.

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DEFINITIONS

• The primary outcome was the occurrence of death,
  myocardial infarction, stroke, or non-CABG
  related major bleeding within 30 days.
• secondary outcomes were death, myocardial
  infarction, or stroke and non-CABG-related major
  bleeding at 30 days.
• Other secondary outcomes included major vascular
  access site complications at 48 h and 30 days,and
  PCI procedural success.

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MAJOR BLEEDING-DEFINED AS

• fatal
• resulted in transfusion of two or more units of
  red blood cells or equivalent whole blood
• caused substantial hypotension with the need for
  inotropes
• needed surgical intervention

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• caused severely disabling sequelae
• was intracranial and symptomatic or intraocular
  and led to significant visual loss
• led to a drop in haemoglobin of at least 50 g/L.

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• Acute Catheterization and Urgent Intervention
  strategy (ACUITY) non-CABG-related major bleeding
  was defined as RIVAL major bleeding, large
  haematomas, and pseudoaneurysms requiring
  intervention.

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MINOR BLEEDING-DEFINED AS

• bleeding events that did not meet the criteria
  for a major bleed and required transfusion of one
  unit of blood or modifi cation of the drug
  regimen(ie, cessation of antiplatelet or
  antithrombotic therapy).

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• Major vascular access complications were
  routinely recorded during hospital stay and at 30
  days in all patients and included pseudoaneuysms
  requiring closure,large hematoma( as judged by
  the investigator), AV fistula or ischemic limb
  requiring surgery.

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STATISTICAL ANAYSES

• Because of a lower than expected overall event
  rate for the primary outcome, in July, 2009, the
  sample size was increased from 4000 to 7000 by
  the RIVAL steering committee.

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• All patients were included in the fi nal
  intention-to-treat analyses, regardless of
  whether they crossed over to another access site
  or did not undergo PCI. A significance level of
  005 with two-sided test was used, and all
  analyses were done in SAS (version 9.1).

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RESULTS

• Between June 6, 2006, and Nov 3, 2010, 7021
  patients were enrolled from 158 hospitals in 32
  countries. 142 of 597 CURRENT-OASIS 7 sites
  participated in RIVAL and these sites enrolled
  3831 (45) of 8515 of patients from CURRENT-OASIS
  7 into RIVAL.

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• 3190 additional patients were enrolled after
  CURRENT-OASIS 7 was completed.
• 3507 of 7021 patients were randomly assigned to
  radial access and 3514 to femoral access.

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• 7005 (998) of 7021 patients underwent
  diagnostic coronary angiography.
• 4660 (664) of 7021 patients had PCI and 599
  (85) had coronary bypass surgery
• The overall rates of access site crossover were
  76 in the radial group versus 20 in the
  femoral group.

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RESONS FOR CROSSOVER IN THE RADIAL GROUP

• radial spasm in 80 (50).
• radial artery loop in 20 (13)
• subclavian tortuosity in 31 (19)

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REASONS FOR CROSSOVER IN THE FEMORAL GROUP

• femoral iliac tortuosity in ten (06)
• peripheral vascular disease in nine (06)

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• The primary outcome of death, myocardial
  infarction,stroke, or non-CABG-related major
  bleeding at 30 days occurred in 37 of patients
  in the radial access group and 40 in the
  femoral access group .

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• The difference between groups in the secondary
  outcomes of death, myocardial infarction, or
  stroke at 30 days (p090), and non-CABG related
  major bleeding(p023) were not significant.

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• In a posthoc analysis, when a bleeding definition
  from the ACUITY trial was used, the rate was
  significantly less with radial than with femoral
  access (plt00001).
• significant reduction in the secondary endpoint
  of vascular access site complications with radial
  compared with femoral access(plt.0001)

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• Symptomatic radial occlusion needing medical
  attention and ultrasound confi rmation occurred
  in six patients (02) in the radial group, but
  none of these patients needed surgical
  intervention

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• Access site major bleeding occurred in six (02)
  patients in the radial group compared with 12
  (03) in the femoral group (hazard ratio HR
  050, 95 CI 013133

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• The most common origin of non-CABG bleeding was
  gastrointestinal (21 of 57 37), followed by
  cardiac tamponade (six of 57 11), and
  intracranial haemorrhage(five of 57 9).
• There were no reported cases of compartment
  syndrome in either group.

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• In exploratory analyses, when outcomes were
  analysed by the access site used to complete the
  procedure, the primary outcome did not differ
  between radial and femoral access (34 radial vs
  41 femoral HR 083,95 CI 065106 p014).

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• The rates of death,myocardial infarction, or
  stroke were also similar (31 radial vs 33
  femoral HR 092, 95 CI 071119 p052)
• however, the rate of non-CABG related major
  bleeding was lower with radial access (06 vs
  10, HR 053, 95 CI 030092 p0025).

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• There were no significant interactions between
  the effects on the primary outcome of the access
  site groups and the prespecified subgroups of
  age, sex, and body mass index .
• There was no significant interaction by whether
  patients were recruited within the CURRENT OASIS
  7 study versus later .

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• In the centres with radial PCI volumes in the
  upper tertile, there seemed to be a benefit of
  radial versus femoral access for the primary
  outcome, with no such benefit in middle or low
  tertiles (interaction p0021

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• Patients with STEMI benefitted more from radial
  access with regards the primary outcome than did
  those with NSTE-ACS (interaction p0025)
• In patients with STEMI, there was a benefit with
  radial access for the composite of death,
  myocardial infarction,and stroke (interaction
  p0011), and death (interaction p0001

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• About 3 of patients in each group had persistent
  pain at the access site for over 2 weeks.

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DISCUSSION

• In patients with ACS undergoing coronary
  angiography,radial access did not reduce the
  primary outcome of death, myocardial infarction,
  stroke, or non-CABG related major bleeding
  compared with femoral access.

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• However, radial access significantly reduced
  vascular access complications compared with
  femoral access, with similar PCI success rates,
  and was more commonly preferred by patients for
  subsequent procedures.

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• In the RIVAL trial, low rates of major bleeding
  overall were reported in patients treated with
  femoral access compared with previous studies,
  possibly because of improvements in technology
  (smaller diameter sheaths) and more experience.

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• Retroperitoneal bleeding leading to a major bleed
  occurred in only 01 of patients in the femoral
  access group. This low rate suggests that the
  operators in the trial were highly skilled in
  femoral access.

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• There are several possible explanations for not
  finding a statistically significant reduction in
  non-CABG-related major bleeding with radial
  access.
• Rigorous definition of a major bleed.
• only a third of all major bleeding events were
  classed as having been at a vascular access site
  most originated from gastrointestinal,
  intracranial, pericardial,or other sites, and
  bleeds at these sites would not be expected to be
  altered by the method of angiography.

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• Third, the femoral access site group had a much
  lower than anticipated risk of major bleeding
  (09),lower than that reported in most recent
  trials of ACS patients undergoing an early
  invasive strategy.
• The rate of femoral access site bleeding might
  have been low because operators participating in
  RIVAL were experienced, high volume
  interventional cardiologists, with a median PCI
  volume of 300 cases per year

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• A potentially important finding of this trial was
  that radial access seemed to be beneficial
  compared with femoral access in centres
  undertaking a high number of radial procedures.
  These centres had lower crossover rates.

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• That the converse was not found is important
  femoral access was not superior to radial access
  at high volume femoral centres. Experience and
  expertise might be particularly important with
  radial access.

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• Another potentially important finding was that,
  among patients with STEMI, radial access seemed
  to reduce the incidence of the primary outcome
  and the secondary outcomes of death, myocardial
  infarction, or stroke, and overall mortality.

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• Acute and short-term hemodynamic effects of
  metoprolol in Eisenmenger syndrome A preliminary
  observational study
• Americal Heart Journal-Volume 161,Issue 5, May
  2011.
• Ramakrishnan,Vyas, Kothari et al.

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BACKGROUND

• Progressive heart failure and sudden cardiac
  death are the common causes of death in
  Eisenmenger syndrome. ß-Blockers may be useful in
  Eisenmenger syndrome, but the safety and efficacy
  are not proven. The objective of the study was to
  evaluate the hemodynamic effects and safety of
  metoprolol in Eisenmenger syndrome.

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METHODS

• Fifteen patients of Eisenmenger syndrome with a
  mean age of 22.6 (8.9) years were studied.
• Hemodynamic parameters were measured at
  baseline, after 15 mg of intravenous metoprolol
  and 6 weeks after oral metoprolol (25 mg/d for 2
  weeks and 50 mg/d for 4 weeks).

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RESULTS

• Intravenous metoprolol was well tolerated,
  although there was a significant decrease in
  pulmonary and systemic blood flows.
• The calculated pulmonary vascular resistance
  index (23.3 8.6 to 27.4 10.6 Wood U, P 
  .005) and systemic vascular resistance index
  (34.9 9.9 to 41.9 13.5 Wood U, P  .005)
  increased significantly.
• After 6 weeks of oral metoprolol, the pulmonary
  artery mean pressure declined significantly (79.9
  12.9 to 73.4 14.0 mm Hg, P  .04), which was
  associated with a slight decrease in mean aortic
  pressures as compared with baseline. The
  6-minutes walk distance increased (401.2 99.9
  to 462.5 81.7 m, P  .005).

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CONCLUSIONS

• Preliminary observations suggest that metoprolol
  is safe and well tolerated in selected patients
  with Eisenmenger syndrome. Acute hemodynamic
  worsening recovers in the short term, and the
  exercise capacity improves in most patients.
  Larger studies are warranted.