the radial approach to percutaneous coronary intervention is associated with a lower risk for...

The Radial Approach to Percutaneous The Radial Approach to Percutaneous Coronary Intervention Is Associated With a Coronary Intervention Is Associated With a Lower Risk for Complications Regardless of Lower Risk for Complications Regardless of

Radial Procedure Volume: A Report From Radial Procedure Volume: A Report From the American College of Cardiology- the American College of Cardiology-

National Cardiovascular Data RegistryNational Cardiovascular Data Registry

Sunil V. Rao MD FACC, Fang-Shu Ou MS, Tracy Y. Wang Sunil V. Rao MD FACC, Fang-Shu Ou MS, Tracy Y. Wang MD, Richard E. Shaw PhD, Ralph Brindis MD, John S. MD, Richard E. Shaw PhD, Ralph Brindis MD, John S.

Rumsfeld MD PhD, Eric D. Peterson MD MPHRumsfeld MD PhD, Eric D. Peterson MD MPH

Author Disclosure InformationAuthor Disclosure InformationAuthor Disclosure InformationAuthor Disclosure Information

•Financial disclosureFinancial disclosure– None of the authors have financial None of the authors have financial

disclosures related to this presentationdisclosures related to this presentation

•Unlabeled/unapproved uses disclosureUnlabeled/unapproved uses disclosure– nonenone

Advantages & Disadvantages of Advantages & Disadvantages of Radial ApproachRadial Approach

Advantages & Disadvantages of Advantages & Disadvantages of Radial ApproachRadial Approach

•AdvantagesAdvantages1,2,31,2,3

– Potentially lower risk Potentially lower risk for bleeding and for bleeding and vascular vascular complicationscomplications

– Patient comfortPatient comfort

– Shorter procedure Shorter procedure time (one catheter time (one catheter used for both the used for both the Right and Left Right and Left Coronary Arteries)Coronary Arteries)

•DisadvantagesDisadvantages– Potentially steep Potentially steep

learning curvelearning curve– Not all patients are Not all patients are

candidates (abnormal candidates (abnormal Allen’s Test)Allen’s Test)

– Can be technically Can be technically difficult (spasm, difficult (spasm, tortuosity, recurrent tortuosity, recurrent loop)loop)

– Potentially lower Potentially lower procedural success procedural success (less guide support)(less guide support)

11Mann T, et al. J Am Coll Cardiol 1998;32:572– 6.Mann T, et al. J Am Coll Cardiol 1998;32:572– 6.22Louvard Y, et al. Catheter Cardiovasc Interv 2001;52:181–7.Louvard Y, et al. Catheter Cardiovasc Interv 2001;52:181–7.33Kiemeneij F, et al. J Am Coll Cardiol 1997;29:1269 –75.Kiemeneij F, et al. J Am Coll Cardiol 1997;29:1269 –75.

11Mann T, et al. J Am Coll Cardiol 1998;32:572– 6.Mann T, et al. J Am Coll Cardiol 1998;32:572– 6.22Louvard Y, et al. Catheter Cardiovasc Interv 2001;52:181–7.Louvard Y, et al. Catheter Cardiovasc Interv 2001;52:181–7.33Kiemeneij F, et al. J Am Coll Cardiol 1997;29:1269 –75.Kiemeneij F, et al. J Am Coll Cardiol 1997;29:1269 –75.

Selected prior studies comparing Selected prior studies comparing femoral & radial approachesfemoral & radial approaches

Selected prior studies comparing Selected prior studies comparing femoral & radial approachesfemoral & radial approaches

•Mann T, et. al. Mann T, et. al. JACCJACC 1998 1998– 142 ACS patients undergoing stenting randomized to 142 ACS patients undergoing stenting randomized to

radial vs. femoral approachradial vs. femoral approach– No difference in procedure success, but significantly No difference in procedure success, but significantly

lower access site complications (0% radial vs. 4% lower access site complications (0% radial vs. 4% femoral, P<0.01)femoral, P<0.01)

•Mann T, et. al. Mann T, et. al. CCI CCI 20002000– ““Natural” randomization of 218 pts. to femoral with Natural” randomization of 218 pts. to femoral with

closure device vs. radial based on operator call closure device vs. radial based on operator call scheduleschedule

– No difference in procedure success but significantly No difference in procedure success but significantly lower access site complications, and higher rate of lower access site complications, and higher rate of same-day ambulation with radial approachsame-day ambulation with radial approach

Limitations of prior studiesLimitations of prior studiesLimitations of prior studiesLimitations of prior studies

•Small sample sizesSmall sample sizes

•Generally involved experienced Generally involved experienced operators operators

•Relatively older dataRelatively older data

Aims & GoalsAims & GoalsAims & GoalsAims & Goals

• To determine the variation in use of the To determine the variation in use of the radial radial

approach to PCI in clinical practiceapproach to PCI in clinical practice

• To compare the incidence of procedural To compare the incidence of procedural

complications between femoral and radial complications between femoral and radial

approaches to PCI in clinical practiceapproaches to PCI in clinical practice– Bleeding and vascular outcomesBleeding and vascular outcomes– Procedural successProcedural success

CathPCI dataCathPCI dataCathPCI dataCathPCI data

• > 2,000,000 Patient Admissions> 2,000,000 Patient Admissions

• > 800,000 PCI procedures> 800,000 PCI procedures

• 150,000 records a quarter150,000 records a quarter

• CathPCI averages include institutions who pass CathPCI averages include institutions who pass

inclusion threshold criteriainclusion threshold criteria– Average Pass Rate is 92%+Average Pass Rate is 92%+

MethodsMethodsMethodsMethods

• 305,425 PCI procedures in the CathPCI Registry (2004- 305,425 PCI procedures in the CathPCI Registry (2004-

2006) analyzed to evaluate variation in use of radial 2006) analyzed to evaluate variation in use of radial

approach to PCI (r-PCI) and outcomes across centersapproach to PCI (r-PCI) and outcomes across centers

• Multivariable logistic regression with general estimating Multivariable logistic regression with general estimating

equation was used to evaluate the adjusted association equation was used to evaluate the adjusted association

between r-PCI use & procedural complications between r-PCI use & procedural complications

(procedural success, bleeding & vascular outcomes)(procedural success, bleeding & vascular outcomes)

• DefinitionsDefinitions– Bleeding: Access site, Retroperitoneal, GI, GU, OtherBleeding: Access site, Retroperitoneal, GI, GU, Other– Vascular: Access site occlusion, Peripheral Vascular: Access site occlusion, Peripheral

embolization, Dissection, Pseudoaneurysmembolization, Dissection, Pseudoaneurysm

ResultsResultsResultsResults

• r-PCI accounted for 1.33% of the total r-PCI accounted for 1.33% of the total

procedures (N=4,074) with marked variation in procedures (N=4,074) with marked variation in use across centers use across centers

• Patients who underwent r-PCI had higher Patients who underwent r-PCI had higher

BMI & more often had peripheral vascular BMI & more often had peripheral vascular disease disease

• Compared with f-PCI, r-PCI had longer Compared with f-PCI, r-PCI had longer

fluoroscopy time (13.20 vs. 11.50 minutes, fluoroscopy time (13.20 vs. 11.50 minutes,

p<0.0001) but did not involve more contrast p<0.0001) but did not involve more contrast use) use)

Results - r-PCI use across centersResults - r-PCI use across centersResults - r-PCI use across centersResults - r-PCI use across centers

0

10

20

30

40

50

60

70

80

90

100

0-9.9 10-19.9 20-29.9 30-39.9 > 40%

% r-PCI

% H

os

pit

als

Rao SV, et al. J. Am. Coll. Cardiol. Intv. 2008;1;379-386Rao SV, et al. J. Am. Coll. Cardiol. Intv. 2008;1;379-386Rao SV, et al. J. Am. Coll. Cardiol. Intv. 2008;1;379-386Rao SV, et al. J. Am. Coll. Cardiol. Intv. 2008;1;379-386

Results - UnadjustedResults - UnadjustedResults - UnadjustedResults - Unadjusted

4 .1 7

0 .9 6

0 .1 5

5 .1 1

1 .0 6

2 .3 8

0

1

2

3

4

5

6

B leed in g V ascu lar P ro ced u refa ilu re

%R ad ia l

F em o ra l

Radial N=4074Femoral N=301351

P<0.001 P<0.0001 P=0.69


Results - Complications by r-PCI Results - Complications by r-PCI volumevolume

Results - Complications by r-PCI Results - Complications by r-PCI volumevolume


Results - Multivariable modeling Results - Multivariable modeling (femoral PCI as reference)(femoral PCI as reference)

Results - Multivariable modeling Results - Multivariable modeling (femoral PCI as reference)(femoral PCI as reference)

1.0 Higher risk for any complicationLower risk for any complication

Unadjusted

Adjusted forpatient differences

Adjusted forpatient & procedure

differences

Adjusted for center clustering in each modelAdjusted for center clustering in each model


LimitationsLimitationsLimitationsLimitations

• Observational non-randomized analysisObservational non-randomized analysis– Reflects clinical practiceReflects clinical practice

• Unmeasured confounders may be presentUnmeasured confounders may be present

• The Results seen may be driven by high The Results seen may be driven by high

volume r-PCI operators at low r-PCI volume r-PCI operators at low r-PCI

volume centersvolume centers

ConclusionsConclusionsConclusionsConclusions

• r-PCI use is infrequent overall and varies across r-PCI use is infrequent overall and varies across

centerscenters

• r-PCI is independently associated with a lower risk r-PCI is independently associated with a lower risk

for bleeding and vascular complicationsfor bleeding and vascular complications– Adjusted for patient & procedure differencesAdjusted for patient & procedure differences– Adjusted for clustering within centersAdjusted for clustering within centers

• There is no significant difference between the two There is no significant difference between the two

approaches with respect to procedural successapproaches with respect to procedural success

ConclusionsConclusionsConclusionsConclusions

• Even at centers with relatively low use of r-Even at centers with relatively low use of r-

PCI, complication rates are lower PCI, complication rates are lower

compared with the femoral approachcompared with the femoral approach

• These contemporary data corroborate prior These contemporary data corroborate prior

smaller studies and suggest that wider use smaller studies and suggest that wider use

of r-PCI can improve the safety of PCIof r-PCI can improve the safety of PCI

the radial approach to percutaneous coronary intervention is associated with a lower risk for...

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