A Randomized Comparison of Transradial and Transfemoral Approaches for Coronary Angiography and PTCA...

A Randomized Comparison of Transradial and Transfemoral Approaches for Coronary

Angiography and PTCA in Octogenarians: OCTOPLUS study

Y. Louvard, H. Benamer, P. Garot, D. Hildick-Smith, M. Monchi, T. Lefevre, M. Hamon for the OCTOPLUS study group

ICPS Massy, CHU “Cote de Nacre” Caen, La Roseraie Aubervilliers, CHU Henri Mondor Creteil, France, Brighton and Sussex UH Brighton, England

Aim of the study

This prospective multicentric randomized study was carried out to assess the potential advantages of Transradial (TRA) approach in Octogenarians for diagnostic and intervention procedures

Study Centers

Participating centers: ICPS, Institut hospitalier Jacques Cartier

and Hopital Claude Galien, Massy and Quincy, France (Y. Louvard, C. Loubeyre, P. Garot, T. Lefevre, O. Tavolaro, P. Dumas)

CHU Cote de Nacre, Caen, France (M. Hamon, S. Rigattieri R. Sabatier, G. Grollier)

Hopital Europeen de Paris « La Roseraie », Aubervilliers, France (H. Benamer)

Brighton and Sussex University Hospital, Brighton, UK (D. Hildick-Smith)

Primary Endpoint

Composite approach-related vascular complications leading to a discharge delay:

Vascular surgery, any transfusion, Hb loss > 3g/ 100ml or Ht loss > 10%, acute leg or hand ischemia, false aneurysm, forearm compartment syndrome, other vascular complication leading to discharge delay

Secondary Endpoints

Secondary endpoints:

Previously described approach-related vascular complications plus: hematoma > 3 cms in diameter, cholesterol embolism, TIA or stroke, radial artery occlusion

Coronary angiography and PTCA success rates, complications, procedural and X-Ray exposure times, contrast medium volume

Cost analysis: equipment use for diagnosis and intervention, complication related extra-costs (compression device, hospital stay, biological analysis, echo-doppler, transfusion, surgery…)

Inclusion / Exclusion criteria, Randomization

377 Octogenarian patients randomized, after informed consent, to Radial or Femoral approach using a blinded allocation list for each center

Excepted: - double mammary coronary grafting - known occlusion of 2 femoral or arm arteries - previous approach failure For coronary angiography and/or PCI, whatever the

clinical presentation (including AMI) Before: - femoral pulse evaluation - Hand blood supply evaluation

Statistics

Mean + SD

Percentage

Mean comparison with t-test

Percentage comparison with X²

Primer of biostatistics 3.01, Stanton A Glantz

Independent vascular complication predictive factors by multivariate logistic regression analysis

Population: clinical data (1)

Femoral Radial p value

n= 185 192

Age (y) 83.0+3.1 82.6+2.7 ns

Male (%) 50.8 55.2 ns

Dyslipidemia (%) 43.2 36.5 ns

Hypertension (%) 65.2 57.8 ns

Diabetes (%) 18.4 8.9 0.011

Smoking (%) 5.4 5.2 ns

Weight (%) 68+10 68+12 ns

Height (%) 164+8 164+9 ns

Creatininemia (µmole/L) 114+50 108+40 ns


n= 185 192

Previous MI (%) 21.6 15.6 Ns

Previous PCI (%) 24.3 14.6 0.024

Previous Bypass surg. (%) 10.8 7.9 Ns

Previous Coro. Angio. (%) 35.7 27.1 Ns


39%

11%22%

11%

5%

12%

non ST elevated ACS

ST elevated ACS

Stable angina

Post MI

Valvular surgery

Misc.

35%

10%16%15%

12%12%

Femoral Radial



n= 192 185

Aspirin (%) 78.3 74.0 ns

Vitamin K – (%) 4.9 6.9 ns

LMWH (%) 5.5 8.5 ns

GPIIb/IIIa – (%) 10.3 13.3 ns

Thrombolytics < 24h 2.2 4.3 ns



n= 185 192

Coronary angiography (n / %)

175 / 94.6 180 / 93.7 ns

+ « Ad hoc » PCI (n /%) 87 / 47.0 77 / 40.1 ns

Total PCI (n / %) 97 / 52.4 89 / 46.6 ns

Procedures

Coronary angiography results


n= 175 180

Normal 14.9 17.2 ns

1 vessel disease 26.5 19.4 ns



Prox LAD stenosis 46.7 48.9 ns

Left main stenosis 10.7 16.3 ns

LVEF 58+14 59+13 ns

PCI procedures (1)


n= 97 89

Dilated lesions (n) 1.5+0.7 1.4+0.8 ns

Dilated vessels (n) 1.2+0.5 1.2+0.4 ns

GPIIb/IIIa per proced. / Total (%) 12.4 10.5 ns

ACT (sec.) 250+62 277+106 ns

Femoral hemostatic devices 51.4 6.7 <0.000


n= 97 89

Primary success (%) 95.8 96.6 ns

Em. Bypass (%) 3.1 0 ns

Q MI (*Exc. ST+ ACS)(%) 23.7 (0) 21.3 (0) ns

Non Q MI (**Exc. ACS)(%) 16.7 (5.2) 14.6 (1.1) ns

In-hospital Death (%) 3.2 4.3 ns

CK (UI) 401+803 518+869 ns

Excepted in patients presenting with *acute (<24h) or recent ST elevated ACS,Excepted in patients presenting with *acute (<24h) or recent ST elevated ACS,Excepted in patients presenting with **any ACS Excepted in patients presenting with **any ACS

PCI procedures (2)

Femoral Radial P value

Lesions n= 143 128 ns

LAD (%) 42.0 45.3 ns

Circomflex (%) 23.1 16.4 ns

RCA (%) 24.5 31.2 ns

LM (%) 2.8 2.3 ns

PCI procedures (3)

Femoral Radial P value

Lesions n= 143 128 ns

Restenosis (%) 9.9 3.2 0.051

Acute occlusion (%) 13.4 4.2 0.015

CTO (%) 8.8 6.0 ns

Stent (%) 90.9 95.3 ns

Stent number (n) 1.3+0.7 1.2+0.6 ns

Direct stenting (%) 43.9 57.0 0.051

Max. balloon diameter (mm) 3.2+1.5 3.2+0.6 ns

Max. balloon pressure (atm) 14+3 15+3 ns

Angiographic success (%) 97.1 97.6 ns

PCI procedures (4)

Approach changes

RADIAL group: Coronary angiography (n) 18 Right Radial to Femoral (n) 15 Right Radial to Left Radial (n) 2 Left Radial to Right Radial (n) 1 PCI (n) 2 Radial to Femoral (ad hoc)(n) 2 (1)FEMORAL group Coronary angiography (n) 15 Femoral to Radial (n) 13 Right Femoral to Left (n) 2 Femoral to Brachial (n) 1 PCI (n) 2 Femoral to Radial (ad hoc)(n) 2 (0)

Approach changes

Primary endpoint: Intention to treat analysis


n= 185 192

COMPOSITE END-POINT (%) 6.5 1.6 0.029

Vasc. Surgery (%) 0 0.5 ns

Transfusion (%) 1.6 1.0 ns

Hb drop > 3g/DL (%) 3.8 0.5 0.063

False aneurysm compression (%) 1.1 0.5 ns

Arm or leg ischemia (%) 0 0 ns

Forearm compartment syndrom (%) 0 0 ns

Large hematoma* (%) 6.5 1.6 0.031

Hematoma (%) 11.4 3.5 0.003

CVA (%) 0.6 0 ns

*Large hematoma: hospital discharge delay*Large hematoma: hospital discharge delay

Primary endpoint (Intention to treat analysis): coronary angiography


n= 88 103

COMPOSITE END-POINT (%) 4.5 1 ns

Vasc. Surgery (%) 0 1 ns


Hb drop > 3g/DL (%) 3.5 1 ns

False aneurysm compression (%) 1.1 1 ns

Large hematoma* (%) 4.5 1 ns

Hematoma (%) 10.5 1.9 0.027

CVA (%) 1.2 0 ns



n= 97 89

COMPOSITE END-POINT (%) 8.2 2.2 ns

Vasc. Surgery (%) 0 0.5 ns


Hb drop > 3g/DL (%) 4.1 0 ns


Large hematoma* (%) 7.2 2.1 ns

Hematoma (%) 12.4 4.5 0.1

CVA (%) 0 0 ns


Primary endpoint (Intention to treat analysis): PCI

Secondary endpoints: coronary angiography


n= 175 180

Selective LCA angio. (%) 99.4 100 ns

N° of catheters (n) 1.1+0.4 1.2+0.5 ns

Selective RCA angio. (%) 97.1 98.8 ns

N° of catheters (n) 1.1+0.4 1.1+0.5 ns

Total N° of coro. cath. (n) 2.2+0.9 2.1+0.9 ns

Procedural time (min.) 15.9+9.5 18.5+10.5 0.015

X-Ray exposure time (min.) 4.5+3.7 6.0+4.4 <0.001

Contrast medium (cc) 114+62 119+61 ns


n= 97 89

N° of guiding catheters (n) 1.8+1.1 1.6+0.9 ns

Procedural time (Min.) 33.8+22.6 34.6+21.6 ns

X-Ray exposure time (Min.) 10.7+9.8 11.6+9.4 ns

Contrast medium (cc) 165+119 150+110 ns

Secondary endpoints: PCI

Random Actual Procedure Surg Transf F. aneur Hb >- 3g/DL

Comments

RAD RAD Coro+PCI

RAD FEM Coro+PCI X

RAD FEM Coro X X X X

FEM FEM Coro X X Anuria, Death

FEM FEM Coro X X

FEM FEM Coro

FEM FEM Coro

FEM FEM Coro+PCI

FEM FEM Coro+PCI X

FEM FEM Coro+PCI

FEM FEM Coro+PCI

FEM FEM Coro+PCI X X X ICU 8d

FEM FEM Coro+PCI X X Renal failure, ICU 13d

FEM FEM Coro+PCI

FEM FEM Coro+PCI

* All patients had large hematoma* All patients had large hematoma

Primary endpoint events*

Radial to Femoral (%) 8.9 - coronary angiography (%) 8.3

- PCI (%) 2.2

Femoral to Radial (%) 8.1 - coronary angiography (%) 8.6

- PCI (%) 2.1

Cross over

Primary endpoint, Per protocol analysis


n= 186 190


Vasc. Surgery (%) 0.5 0 ns

Transfusion (%) 2.7 0 0.067

Hb drop > 3g/DL (%) 4.4 0 0.01


Arm or leg ischemia (%) 0 0 ns

Forearm compartment syndrom (%) 0 0 ns

Large hematoma* (%) 7.6 0.5 0.001

Hematoma (%) 10.9 3.7 0.013

CVA (%) 0.6 0 ns


Primary endpoint (per protocol analysis): coronary angiography


n= 89 101

COMPOSITE END-POINT (%) 5.6 0 0.051


Transfusion (%) 1.1 0 ns

Hb drop > 3g/DL (%) 3.5 0 ns


Large hematoma* (%) 5.6 0 0.051

Hematoma (%) 10.3 1.9 0.034

CVA (%) 1.2 0 ns



n= 97 89



Transfusion (%) 3.1 0 ns

Hb drop > 3g/DL (%) 4.1 0 ns


Large hematoma* (%) 8.2 1.1 0.055

Hematoma (%) 11.3 5.6 ns

CVA (%) 0 0 ns

Primary endpoint (per protocol analysis):PCI


Radial Femoral

Closure+

Femoral

Closure-

n= 89 56 41


Vasc. Surgery (%) 0 0 0

Transfusion (%) 0 0 7.3

Hb drop > 3g/DL (%) 0 0 9.8

False aneurysm compression (%) 0 0 2.4

Large hematoma* (%) 1.1 5.4 7.3

Hematoma (%) 5.6 7.1 17.1

0.006;0.006; 0.014 0.014

Primary endpoint (per protocol analysis):PCI and closure devices


Predictors of vascular complications in octogenarians: multivariate analysis

Twenty-eight data elements selected for analysis

Predictors by univariate analysis:

femoral approach (p<0.001)

small size (p<0.005)

female gender (p<0.009)

thienopyridine treatment (p<0.09)

thrombolysis within 24 hours (p<0.015).

Predictors of the primary endpoint by multivariate analysis:

femoral approach OR: 22.2 95% CI: 2.4-207.9 p=0.007 thrombolysis w/in 24 h OR: 19.5 95% CI: 2.2-172 p=0.007

patient height <158 cm* OR: 6.4 95% CI: 2.0-20.4 p=0.02

11stst height quartile height quartile

Conclusion (1)

Combined end-point of all approach related vascular complications leading to prolonged hospital stay is significantly lower in Octogenarian randomized to Transradial approach for Coronary angiography and/or PCI compared to Transfemoral approach

Approach related vascular complications are more severe in Femoral randomized group and occur mainly in patients actually approached through Femoral artery (cross overs)

Per-protocol analysis shows a higher occurrence rate of the combined end-point and significant blood loss in procedures performed through Femoral artery and a trend for a lower transfusion rate

Conclusion (2)

As in younger patients, for coronary angiography, in intention-to-treat analysis, procedural and X-Ray exposure times are slightly but significantly longer in the Transradial group without differences in contrast medium and equipment use

As in youger patients, for PCI, there is no difference in Procedural and X-Ray exposure times, contrast medium volume and equipment use

Conclusion (3)

Transradial approach is an effective way to reduce the rate of vascular complications related to coronary angiography and PCI in the high risk octogenarian population

Conclusion (4)

Radial vs Femoral coronary angiography: Procedural and X-Ray times

0 5 10 15 20 25

OCTOPLUS

MEAN

Moriyama

Labrunie

Monsegu

Louvard

Pezzano

Radial Procedure Femoral Procedure Radial X-Ray Femoral X-Ray

Radial: + 30%Radial: + 30%

Radial: + 10.6%Radial: + 10.6%Radial: + 20.8%Radial: + 20.8%

Radial: + 13.2%Radial: + 13.2%

Radial vs Femoral PCI: Procedural and X-Ray times

0 10 20 30 40 50

OCTOPLUS

MEAN

Gôrge

Kiemeneij

Tift Mann

Radial Procedure Femoral Procedure Radial X-Ray Femoral X-Ray




Radial: - 1%Radial: - 1%

In-Hospital Complications After Multiple Coronary Stenting in Patients >80 Years Old vs <80 Years Old

<80 Yrs > 80 Yrs p Value

(n 894) (n 75)

Death (%) 0.6 2.7 0.10

Cardiac death (%) 0.3 1.3 0.3

Q-wave myocardial infarction (%) 0.1 0 1.0

Urgent coronary bypass (%) 0.6 0 1.0

Non–Q-wave myocardial infarction (%) 20 33 0.008

Pulmonary edema (%) 1.7 8.1 0.004

Acute renal failure (%) 3.5 4.3 0.73

Neurologic event (%) 2.4 6.8 0.04

Vascular complications* (%) 7.3 13.9 0.006

Kobayashi Lenox Hill Hosp. Am J Cardiol 2003;92:443–446

*major hematoma (ht decrease 15%), AV fistula, pseudoaneurysm, retroperitoneal bleeding, *major hematoma (ht decrease 15%), AV fistula, pseudoaneurysm, retroperitoneal bleeding, surgical repair. GPIIbIIIa inhibitors: 6.8%surgical repair. GPIIbIIIa inhibitors: 6.8%

Impact of Access Site Hematoma With Transfusion in Patients Undergoing Percutaneous Coronary Intervention

6613 PCI (98-00)(NHLBI Registry): hematoma w transfusion 1.8% (97% femoral)

Predictors: Older age, Lower BMI, Female sex, renal disease, HTN, Acute MI, 3-VD, GPIIb/IIa -, Postprocedure heparin

Independent predictors: Older age, female sex, thrombotic lesion, 3-VD, renal disease, emergent PCI, and prior aspirin

Procedural death: 10.3% w HWT 1.2% w/o HWT p <0.001 death/MI: 18.1% 3.55% <0.001

HWT is a predictor of death/MI (OR = 3.49; 95% CI: 1.98-6.14)

J. Slater Am J Cardiol 2003 (suppl) 92: 18L J. Slater Am J Cardiol 2003 (suppl) 92: 18L

Coronary Artery Stenting in the Aged

Pooled analysis of 6,186 patients in six recent multicenter trials

> 80 < 80 p value

N= 301 (4.9%) 5885

Death (%) 1.33 0.10 0.001

Myocardial infarction (%) 9.63 7.56 0.18

QMI (%) 0.33 0.68 0.72

Non-QMI (%) 9.30 6.88 0.13

Vascular complications$ (%) 4.98 1.19 0.001

Surgery vasc. Compl. (%) 0.33 0.34 1.00

Bleeding with transfusion* (%) 4.98 1.00 0.001

Chauhan, J Am Coll Cardiol 2001;37:856–62

$access site-related hematoma >4 cm, pseudoaneurysm, AV fistula, retroperitoneal bleed or $access site-related hematoma >4 cm, pseudoaneurysm, AV fistula, retroperitoneal bleed or vascular surgical repair; * blood loss requiring transfusion; GPIIbIIIa: 7.6%vascular surgical repair; * blood loss requiring transfusion; GPIIbIIIa: 7.6%

Predictors of Vascular and/or Bleeding in Aged

Variable Univariate Multivariable

Odds Ratio Odds Ratio

(95% CI) (95% CI)

Age (per decade) 1.07 (1.05,1.09) 1.06 (1.04,1.08)

In-hosp. Re-revascularization 7.91 (3.29,18.97) 9.94 (3.93,25.15)

Female gender 4.40 (2.97,6.64) 3.49 (2.31,5.27)

Diabetes 1.25 (0.81,1.92) —

Unstable angina 1.39 (0.96,2.02) —

c = 0.759, Hosmer-Lemeshow x2 p = 0.377Chauhan, J Am Coll Cardiol 2001;37:856–62

Outcome Trends in the Elderly Undergoing Percutaneous Coronary Interventions: Results in 7,472 Octogenarians

Outcome Age >80 Age <80 Odds Ratio p Value

N= 7472 102236 (95% CI)

Death 3.8 (3.4–4.2) 1.1 (1.0–1.1) 3.6 (3.2–4.1) 0.001

Procedural success 84 (83–85) 89 (89–89) 0.65 (0.60–0.70) 0.001

Death/MI/CVA 4.9 (4.4–5.4) 1.9 (1.9–2.0) 2.6 (2.3–2.9) 0.001

Q wave MI 1.9 (1.5–2.3) 1.3 (1.2–1.3) 1.5 (1.2–1.9) 0.001

CVA 0.58 (0.38–0.78) 0.23 (0.2–0.26) 2.5 (1.7–3.6) 0.001

Renal failure 3.2 (2.7–3.7) 1.0 (0.96–1.1) 3.1 (2.6–3.8) 0.001

Vascular complication 6.7 (6.0–7.5) 3.3 (3.2–3.5) 2.1 (1.9–2.4) 0.001

Urgent revasc. 4.4 (4.0–4.9) 4.5 (4.4–4.6) 0.98 (0.88–1.1) 0.770

Total LOS† 5.1+5.3 3.7+4.3 NA 0.001

Postprocedure LOS† 3.6+4.6 2.6+3.8 NA 0.001

Batchelor J AmColl Cardiol 2000;36:723–30Batchelor J AmColl Cardiol 2000;36:723–30

Relative odds with 95% CI for each year compared with 1994. The ORs presented have Relative odds with 95% CI for each year compared with 1994. The ORs presented have been adjusted for the seven variables in the multivariable mortality risk model.been adjusted for the seven variables in the multivariable mortality risk model.

Batchelor J AmColl Cardiol 2000;36:723–30Batchelor J AmColl Cardiol 2000;36:723–30

Outcome Trends in the Elderly Undergoing Percutaneous Coronary Interventions: Results in 7,472 Octogenarians

Predicting vascular complications in percutaneous coronary interventions

18,137 PCI pts in northern New England (1997-1999); vascular complication* 2.98%Variables associated with increased risk in the multivariate analysis Age >or=70 OR 2.7 Female sex OR 2.4Body surface area <1.6 m OR 1.9History of congestive heart failure OR 1.4Chronic obstructive pulmonary disease OR 1.5Renal failure OR 1.9Lower extremity vascular disease OR 1.4Bleeding disorder OR 1.68Emergent priority OR 2.3Myocardial infarction OR 1.7Shock OR 1.86>or=1 type B2 lesions OR 1.32 type C lesions OR 1.7 3-vessel PCI OR 1.5Thienopyridines OR 1.4Glycoprotein IIb/IIIa inhibitors OR 1.9

Piper WD Am Heart J. 2003 Jun;145(6):1022-9Piper WD Am Heart J. 2003 Jun;145(6):1022-9

*Vascular complications: access-site injury requiring treatment or bleeding requiring transfusion*Vascular complications: access-site injury requiring treatment or bleeding requiring transfusion

Complications of Cardiac Catheterization in Octogenarians

(94-97), 5737 inpatient Cardiac Catheterization: 5.9% octogenarians

In-hospital post Cardiac catheterization complications

Age <80 Age >80

N= 5399 338 p Value

Male (%) 65 51 <0.001

Emergency CABG (%) 0.6 1.2 NS

Post CC MI (%) 0.2 0.9 0.02

Inpatient death (%) 0.8 4.4 <0.001

CVA (%) 0.2 0.3 NS

Groin hematoma (%) 0.6 3.6 <0.001

Pseudoaneurysm (%) 0.4 1.2 0.04

Surgery for pseudo. (%) 0.0 0.3 0.001

Retroperitoneal bleed (%) 0.1 0.0 NS

SztoSzto Am J Cardiol 1998; 84(supp1 6A): 25SAm J Cardiol 1998; 84(supp1 6A): 25S

Complication rates related to cardiac catheterization in 1070 consecutive patients older than 80 years

1070 consecutive patients > 80 years

1295 cardiac catheterizations (1995-2000)

Access site related complications (pts): 2.7%

13 extensive hematoma

10 pseudoaneurysms

4 AV fistulas

1 embolus to the popliteal artery

= 6 transfusion and 10 surgical repair

NiebauerNiebauer Eur Heart Journal 2001; 22, Abstr. page 202 Eur Heart Journal 2001; 22, Abstr. page 202

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A Randomized Comparison of Transradial and Transfemoral Approaches for Coronary Angiography and PTCA...

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