RESEARCH, REDUCE RESEARCH, REDUCE III, III,

X-AMINE ST, COOL-MI X-AMINE ST, COOL-MI

Azfar ZamanAzfar Zaman

Freeman Hospital, NewcastleFreeman Hospital, Newcastle

1. R1. Rapamycin apamycin EEluting luting SStent tent EEvaluated valuated AAt t RRotterdam otterdam

CCardiology ardiology HHospitalospital RationaleRationale

Sirolimus eluting stents reduce Sirolimus eluting stents reduce restenosis and reinterventionrestenosis and reintervention

Increased risk of early and late stent Increased risk of early and late stent thrombosis thrombosis

Are SES safe and effective in a Are SES safe and effective in a thrombogenic environment post thrombogenic environment post STEMI?STEMI?

RESEARCH

Recruitment Recruitment

96 patients with STEMI enrolled as 96 patients with STEMI enrolled as part of part of registryregistry of SES implantation of SES implantation in Rotterdamin Rotterdam

ACT>300 (200-250 with IIb/IIIa)ACT>300 (200-250 with IIb/IIIa)

Clopidogrel between 3-6 monthsClopidogrel between 3-6 months

RESEARCH

ResultsResults MACE (MACE (death, nonfatal MI, reinterventiondeath, nonfatal MI, reintervention) + 6 m ) + 6 m

angiogram angiogram mean age 57ymean age 57y, , IIb/IIIa in 46.9%IIb/IIIa in 46.9% ref. diameter ref. diameter 2.73 2.73 ± 0.59± 0.59, length , length 16.9 ± 16.9 ±

9.959.95 mm mm

No early or late stent thrombosesNo early or late stent thromboses

No reinterventions and no restenosisNo reinterventions and no restenosisRESEARCH

RelevanceRelevance

Single centre registry data but Single centre registry data but unrestrictedunrestricted

NICE (DES >15NICE (DES >15mmmm/<3/<3mmmm) “except if MI in ) “except if MI in preceding 24h or evidence of thrombus”preceding 24h or evidence of thrombus”

Supporting evidence for safe use (of Supporting evidence for safe use (of sirolimus) in MI – “need larger studies”sirolimus) in MI – “need larger studies”

RESEARCH

2. Re2. Restenosis Restenosis Reduduction by ction by CCutting Balloon utting Balloon EEvaluation valuation

IIIIII RationaleRationale

Failure of CB to reduce angiographic Failure of CB to reduce angiographic or clinical outcomes in ISR (versus or clinical outcomes in ISR (versus standard balloon)standard balloon)

Can predilation with CB versus Can predilation with CB versus standard balloon before bare metal standard balloon before bare metal stent deployment reduce restenosis ?stent deployment reduce restenosis ?

REDUCE III

RecruitmentRecruitment

Randomised, multicentre (Japan)Randomised, multicentre (Japan)

521 patients521 patients

Mean age 65 yearsMean age 65 years

REDUCE III

ResultsResults

REDUCE III

End-pointEnd-point CBCB

N=228N=228POBAPOBA

N=224N=224pp

lesion lesion length(mm)length(mm)

14.414.4±5.4±5.4 15.215.2±5.±5.33

nsns

vessel diametervessel diameter 3.333.33±0.38±0.38 3.27±0.3.27±0.44

nsns

MACEMACE 12.3%12.3% 16.1%16.1% nsns

Restenosis at Restenosis at 6m6m

11.8%11.8% 19.1%19.1% 0.00.033

RelevanceRelevance

A role for cutting balloon……at last?A role for cutting balloon……at last?

DES for “NICE” lesions, CB plus DES for “NICE” lesions, CB plus BMS for others BMS for others

Promising…….2 years too late?Promising…….2 years too late?

REDUCE III

3. X3. X-Sizer in -Sizer in AMIAMI patients for patients for NNegligible egligible EEmbolization mbolization

and optimal and optimal STST resolution resolution RationaleRationale

TIMI-3 flow after PCI for AMI is TIMI-3 flow after PCI for AMI is criteria for successcriteria for success

But may not have myocardial But may not have myocardial perfusion due to distal embolisationperfusion due to distal embolisation

Thrombectomy can improve Thrombectomy can improve myocardial perfusion as assessed by myocardial perfusion as assessed by ST resolutionST resolution

X-AMINE ST

RecruitmentRecruitment

AMIAMI 12 hours 12 hours in patients NOT in patients NOT receivingreceiving

thrombolysisthrombolysis

56% received IIb/IIIa56% received IIb/IIIa

200 patients, 6 month follow-up200 patients, 6 month follow-up

X-AMINE ST

ResultsResults

No difference in No difference in clinical outcomes clinical outcomes

EndEnd

pointpointCC X-SiX-Si pp

ST-res ST-res MeanMean

MedMed

>50%>50%

6.8 6.8 mmmm

4.94.9

53.1%53.1%

8.5m8.5mmm

7.57.5

67.4%67.4%

nsns

0.0360.036

0.0520.052

Slow, Slow, no no flowflow

1616 4.14.1 0.0120.012

TIMI 3TIMI 3

EmbolEmbolii

89%89%

10%10%95.7%95.7%

2.1%2.1%nsns

0.0060.006

TimeTime

(min)(min)4545±2±255

5555±2±288

0.0030.003X-AMINE ST

RelevanceRelevance

Complementary therapy to Complementary therapy to antithrombotics in AMIantithrombotics in AMI

Await longer term clinical outcomes Await longer term clinical outcomes datadata

Useful in patients in whom Useful in patients in whom antithrombotics should be kept to a antithrombotics should be kept to a minimumminimum X-AMINE

ST

4. Cool4. Cooling as an Adjunctive Therapy to Percutaneous ing as an Adjunctive Therapy to Percutaneous Intervention in Patients with Acute Intervention in Patients with Acute MMyocardial yocardial

IInfarctionnfarction

RationaleRationale In animal MI models, hypothermia reduces In animal MI models, hypothermia reduces

metabolic demand and infarct sizemetabolic demand and infarct size mild hypothermia inhibits platelet mild hypothermia inhibits platelet

aggregationaggregation

test safety and efficacy of cooling (<35ºc) test safety and efficacy of cooling (<35ºc) as adjunctive therapy to primary PCI for as adjunctive therapy to primary PCI for AMI compared to PCI aloneAMI compared to PCI alone

COOL-MI

RecruitmentRecruitment

357 patients enrolled: prospective, 357 patients enrolled: prospective, randomisedrandomised

Acute MI < 6 hAcute MI < 6 h

End-point - infarct size at 30 daysEnd-point - infarct size at 30 days

COOL-MI

ResultsResults

No difference in end-point of infarct No difference in end-point of infarct sizesize

Incidence of shock higher in cooling Incidence of shock higher in cooling armarm

Benefit in anterior MI cooled to <35ºcBenefit in anterior MI cooled to <35ºc

COOL-MI

RelevanceRelevance

Nil (at present)Nil (at present)

More effective rapid cooling needed More effective rapid cooling needed

((difficult in humans because of large thermal massdifficult in humans because of large thermal mass))

Further work in anterior MI Further work in anterior MI

Beta blockers?Beta blockers?COOL-MI

Thank youThank you