Trial Update 2

Advanced Angioplasty 2006

Trial Update 2Other Trials

Alun Harcombe

from 1 April: Nottingham University Hospitals NHS Trust

NO CONFLICT OF INTEREST TO DECLARE


Other Trials

• LE MANS

• SENIOR PAMI

• PROXIMAL


Early Conclusion

• Left Main Stenting Safe and Feasible, might avoid some morbidity and improve ejection fraction

• Elderly patients do quite badly with heart attacks – however managed, unless they’re not that elderly

• Proximal protection for vein grafts is quite good when it is possible and it works


LE MANS

• Dr Pawel Buszman

Silesian Medical School, Katowice, Poland

• First Randomised Trial in Modern Era:

Unprotected LMS Stenting vs CABG





LE MANS Endpoints

• Primary:– LVEF– functional capacity– angina status (12 months)

• Secondary – major adverse cardiac events (MACE)– hospital length of stay– survival– any major adverse events (MAEs)

• any MACE, procedure-related infection, bleeding, or renal or respiratory insufficiency.


LE MANS

PCI CABGRegistry 163 184Randomised 52 53Age 60 61Distal LM 58 62DES (<3.8) 35% 62% LIMAVessels 2.3±0.8 2.9 ±0.8 Grafts


Events by 30 days

PCI CABG

Death 0 2 ns

AMI 1 2 ns

CVA 0 2 ns

HF 1 4 ns

Repeat revasc. 0 1 ns

Any MACE 2 90.028


Results

Outcomes CABG, n (%) PCI, n (%) p

Any MACE (<30 days)

9 (20.7) 2 (3.8) 0.028

Any MAE (<30 days)

19 (35.8) 3 (5.8) 0.0001

Any MACE(30 d-12 mo)

11 (20) 11 (21) NS


Ejection Fraction


Comments

• LV function estimates – not blinded– applies if LV impaired to begin with?

• Low rate of DES usage

• Small single centre study

• LMS stenting a reasonable option?– The era of data has begun


Senior PAMI

• Senior Primary Angioplasty in Myocardial Infarction: International multi-centre randomised

• Dr Cindy Grines

William Beaumont Hospital

Royal Oak

Michigan

USA



Senior PAMI• Aged ≥70years

– Acute MI symptoms 30 minutes to 12 hours 1mm ST elevation, or LBBB– Eligible for lytic therapy

• Excluded: – SBP >180 mm Hg or DBP>100 mm Hg – Warfarin, INR>1.4– Cardiogenic shock

• Randomised to Thrombolysis or Transfer to Cardiac Catheter Laboratory for PCI

• International, multi-centre• Stopped early (slow recruitment, 47 short of 530)


Senior PAMI Demographics

PCI Lytic p valueAge 78 ±6 77 ±6 0.47

range 70-99 70-101

Female 42% 40% 0.54

Hypertension 65% 67% 0.65

Diabetes (all T2DM)

25% 20% 0.22

Impaired mobility

6.1% 1.8% 0.16

Dementia 5.7% 0.0% 0.0003


Senior PAMI PresentationPCI

(n=252)Lytic

(n=229)p value

CP to ED

(median mins)

155 148 0.38

CP to Rx

(median mins)

237 210(+ reperf. time)

0.014

Infarct: Inferior

Anterior/LBBB

49

48

60

41

0.22

0.12

Diuretic in ED 8.8 3.5 0.018


PCI ArmMultivessel Disease

2 vessel

3 vessel

LM/4 vessel

77%31.2%

40%

5.6%

Initial TIMI: 0

1-2

3

80%

12.1%

8.2%

No PCI (1 patient died, 13 risky anatomy/LMS, 4 <70%stenosis)

8%

Post PCI: TIMI 0

1-2

3

CABG

4.3%

9.6%

86.1%

3.6%


Thrombolytic Arm

Lytic given (99.6%) Streptokinase

TNK, tPA, rPA

37.6%

62%

Clinical Reperfusion 65%

Non-protocol Cath: <12hrs

In-hospital

21%

51%

Non-protocol PCI In-hospital 37%

CABG 4.4%


Senior PAMI 30 Day Events

10

13

0.82.2 1.6

5.4

11.313

11.6

18

0

2

4

6

8

10

12

14

16

18

Death ReMI D/CVA/ReMI

PCI (n=252)

Lytic (n=229)

DisablingCVA

Death/dCVA

0.48 0.26

0.039

0.57 0.05

%


Senior PAMI 30 Day Events by Age

7.1

11.3

7.7

12

7.7

17

0

5

10

15

20

25

%

Death Death/CVA D/CVA/reMI

PCI Lytic

19

16

20

16

22 22

0

5

10

15

20

25

%

Death D/CVA D/CVA/reMI

PCI Lytic

0.0093

70-80yrs (n=381) >80yrs (n=130)


Conclusions

• Primary PCI effective at reducing combined endpoint, but not primary endpoint of death or disabling stroke

• In sub-group of very elderly PCI may have no advantage at all– Lysis followed by rescue where needed?

• Main PCI advantages:– Avoid intracranial bleeding– Reduce re-infarction & recurrent ischaemia


Points

• Selected population, slow recruitment– No prior CVAs– Warfarin and hypertension exclusions

• Event rates low in lytic arm– Lower dose heparin regimes (60u/kg, max

4000u)

• High rates of invasive investigation, rescue and later PCI (&CABG) in lytic arm

• Lytic ineligible patients?


Proximal Trial

Proximal Protection during Saphenous Vein Graft Intervention using the Proxis Embolic Protection System: A Randomised Prospective Multicenter Trial

Campbell RogersBrigham and Womens Hospital, Boston














Conclusions

• Left main stenting – here to stay

• Primary PCI – up to 80yrs age

• Proxis – good for embolic protection in

distal lesions



30 Day Outcomes: Research/T-Search

Pre-DES Group DES Group P* (n=86) (n=95)

Death 6 (7) 10 (11) 0.60Nonfatal MI 8 (9) 4 (4) 0.24Death/nonfatal MI 14 (16) 14 (15) 0.84TVR 2 (2) 0 (0) 0.22Repeated PCI 1 (1) 0 (0)CABG 1 (1) 0 (0)Any event 16 (19) 14 (15) 0.56Stent thrombosis 0 (0) 0 (0)1

*By Fisher exact test. Angiographically documented.

Circulation. 2005 Nov 1;112(18) Valgimigli M et al

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&itool=PubMed_Abstract&term=%22Valgimigli+M%22%5BAuthor%5D

Documents

Trial Update 2