aim of the study
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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
Femoral Radial p value
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
Population: clinical data (2)
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
Population: clinical data (3)
Femoral Radial p value
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
Population: clinical data (4)
Femoral Radial p value
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
Femoral Radial p value
n= 175 180
Normal 14.9 17.2 ns
1 vessel disease 26.5 19.4 ns
2 vessel disease 20.7 25.6 ns
3 vessel disease 38.4 37.8 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)
Femoral Radial p value
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
Femoral Radial p value
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
Femoral Radial p value
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
Femoral Radial p value
n= 88 103
COMPOSITE END-POINT (%) 4.5 1 ns
Vasc. Surgery (%) 0 1 ns
Transfusion (%) 1.1 1.0 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
*Large hematoma: hospital discharge delay*Large hematoma: hospital discharge delay
Femoral Radial p value
n= 97 89
COMPOSITE END-POINT (%) 8.2 2.2 ns
Vasc. Surgery (%) 0 0.5 ns
Transfusion (%) 2.1 1.1 ns
Hb drop > 3g/DL (%) 4.1 0 ns
False aneurysm compression (%) 1.0 0 ns
Large hematoma* (%) 7.2 2.1 ns
Hematoma (%) 12.4 4.5 0.1
CVA (%) 0 0 ns
*Large hematoma: hospital discharge delay*Large hematoma: hospital discharge delay
Primary endpoint (Intention to treat analysis): PCI
Secondary endpoints: coronary angiography
Femoral Radial p value
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
Femoral Radial p value
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
Femoral Radial p value
n= 186 190
COMPOSITE END-POINT (%) 7.5 0.5 0.001
Vasc. Surgery (%) 0.5 0 ns
Transfusion (%) 2.7 0 0.067
Hb drop > 3g/DL (%) 4.4 0 0.01
False aneurysm compression (%) 1.6 0 ns
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
*Large hematoma: hospital discharge delay*Large hematoma: hospital discharge delay
Primary endpoint (per protocol analysis): coronary angiography
Femoral Radial p value
n= 89 101
COMPOSITE END-POINT (%) 5.6 0 0.051
Vasc. Surgery (%) 0 0 ns
Transfusion (%) 1.1 0 ns
Hb drop > 3g/DL (%) 3.5 0 ns
False aneurysm compression (%) 1.1 0 ns
Large hematoma* (%) 5.6 0 0.051
Hematoma (%) 10.3 1.9 0.034
CVA (%) 1.2 0 ns
*Large hematoma: hospital discharge delay*Large hematoma: hospital discharge delay
Femoral Radial p value
n= 97 89
COMPOSITE END-POINT (%) 9.3 1.1 0.031
Vasc. Surgery (%) 0 0 ns
Transfusion (%) 3.1 0 ns
Hb drop > 3g/DL (%) 4.1 0 ns
False aneurysm compression (%) 1.0 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
*Large hematoma: hospital discharge delay*Large hematoma: hospital discharge delay
Radial Femoral
Closure+
Femoral
Closure-
n= 89 56 41
COMPOSITE END-POINT (%) 1.1 5.4 14.6
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
*Large hematoma: hospital discharge delay*Large hematoma: hospital discharge delay
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: + 6.5%Radial: + 6.5%
Radial: + 6.5%Radial: + 6.5%
Radial: + 12.7%Radial: + 12.7%
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