RESOLUTE INTEGRITY: CLINICAL EXPERIENCE€¦ · RESOLUTE INTEGRITY: CLINICAL EXPERIENCE . How to...

Francesco Burzotta

Institute of Cardiology, Catholic University of the Sacred

Heart, Rome - Italy

Provisional stenting: can we improve outcomes?

RESOLUTE INTEGRITY: CLINICAL EXPERIENCE

How to (theoretically) improve provisional stenting?

DES with best response to different

technical steps

Improved sequence of

technical interventions

IMPROVED PROCEDURAL OUTCOME IN BIFURCATION PCI

IMPROVED LATE CLINICAL OUTCOME IN BIFURCATION PCI

Procedural key points in the interaction between provisional

technique and stent

STENT CONFORMABILTY INTO THE MAIN VESSEL (MV)

-MISS-MATCH BETWEEN PROXIMAL AND DISTAL MV

-MV BENDINGS (OR PROXIMAL MV TO SIDE BRANCH BENDING)

SIDE BRANCH (SB) ACCESIBILITY AFTER MV STENTING

-EASINESS OF SB REWIRING/DILATION

-SB SCAFFOLDING AFTER DISTAL REWIRING AND KISSING

-SB CELLS DILATION AFTER DISTAL REWIRING AND KISSING





technique and stent





STENT CONFORMABILTY INTO THE MAIN VESSEL

*Burzotta, Trani (unpublished data)

Bench testing*: 3.5mm stent dilation with 7x20 mm balloon

0

2

4

6

8

Cypher Xience Endeavor Resolute

Taxus

MAX diameter (mm)


MV


LM POT

LM TRISSING


Prox LM

Prox LM stent edge

Mid LM stent





technique and stent





EASINESS OF SIDE BRANCH REWIRING/DILATION

RESOLUTE PLATFORM*

*Basalus et al. EuroIntervent 2011

RESOLUTE PLATFORM*

COMPARATIVE OVERVIEW

EASINESS OF SIDE BRANCH REWIRING/DILATION

*Basalus et al. EuroIntervent 2011

*Burzotta, Mortier et al. unpublished

SIDE BRANCH SCAFFOLDING AFTER POT, DISTAL REWIRING AND KISSING

Bench testing and virtual simulation of POT and kissing


*Burzotta, Mortier et al. unpublished

SB CELLS DILATION AFTER DISTAL REWIRING AND KISSING

(Resolute Integrity vs Resolute)

AFTER ALL THAT THEORETHICAL SPECULATIONS…

WHAT HAPPENS IN THE CLINICAL PRACTICE?



technical steps





Z-SEA-SIDE study

ACRONYM: Z-SEA-SIDE, Sirolimus vs Everolimus –eluting

stent randomized Assessment in bifurcated lesions and

clinical SIgnificance of residual siDE-branch stenosis

REGISTRATION: www.clinicaltrials.org (NCT00697372)

DESIGN: single centre, non sponsored, open label

prospective study comparing Resolute vs Cypher and

Xience in unselected bifurcated lesions

CO-INVESTIGATORS: Trani, Todaro, Mariani, Talarico,

Mongiardo, Mazzari, Porto, Niccoli, Leone, Tommasino,

Schiavoni, Crea

STUDY FLOW-CHART

225 CONSECUTIVE UNSELECTED PATIENTS WITH BIFURCATED LESION

UNDERGOING DES IMPLANTATION (only exclusion criteria:

contraindication to prolonged double antiplatelet therapy, STEMI, TIMI<3)

PERIOD 1 (150 PTS)

1:1 RANDOMIZATION TO

PROSPECTIVE EVALUATION OF PROCEDURAL PERFORMANCE

OFF-LINE, BLIND, 3DQCA ANALYSIS OF PROCEDURAL RESULTS WITH A

BIFURCATION-DEDICATED SOFTWARE

PERIOD 2 (75 PTS)

SYSTEMATIC IMPLANTATION OF

SES EES R-ZES

PCI with Provisional TAP-stenting strategy

RESULTS: PROCEDURAL

PERFORMANCE

STEPS OF PROVISIONAL-TAP

Need of guidewires different from

BMW for SB re-wiring

MV Stent according to

randomization / intention

SB re-wiring attempted (BMW)

SB stent implantation

followed by final kissing (TAP)

Kissing inflation performed

ANY SB “TROUBLE”

(composite of green items)

Failure of SB dilation

Failure of SB re-wiring

SB flow <3 after MV stent

P

6 (8.0%) 3 (4.0%) 1(1.3%)

52 (69.3%) 55 (73.3%) 58 (77.3%)

12 (16.0%) 8 (10.7%) 3 (4.0%)

1 (1.3%) 1 (1.3%) 0

2 (2.7%) 3 (4.0%) 0

7 (9.3%) 8 (10.7%) 3 (4.0%)

75 (100%) 75 (100%) 75 (100%) ns

0.11

ns

ns

ns

50 (66.7%) 51 (68.0%) 55 (73.3%)

6 (8.0%) 6 (8.0%) 10 (13.3%)

ns

ns

0.01

0.05

<0.01

RESULTS: 3DQCA

ANGIOGRAPHIC RESULTS

P

BE

FO

RE

PC

I M

AIN

VE

SS

EL

PO

ST

-PC

I

SID

E B

RA

NC

H

PO

ST

PC

I SB area stenosis

SB MLD at ostium*

Angle modification

SB Min. Lum area

* pre-defined end-point

MV area stenosis

SB Min. Lum area

MV Min. Lum. Area

SB area stenosis

Bifurcation angle

80.0% 75.8% 75.5%

1.0 mm2 1.2 mm2 1.2 mm2

50.2% 54.6% 50.5%

1.7 mm2 2.0 mm2 2.1 mm2

65° 67° 64°

ns

ns

ns

ns

ns

MV area stenosis

MV MLD prox to bif

MV MLD distal to bif

MV Min. Lum area

29.3% 30.7% 31.4%

5.2 mm2 5.8 mm2 5.7 mm2

2.9 mm 3.1 mm 3.0 mm

2.8 mm 3.0 mm 2.9 mm

ns

ns

ns

ns

0.07

0.01

43.9% 39.5% 36.3%

2.4 mm2 3.3 mm2 3.5 mm2

1.8 mm 2.7 mm 2.7 mm

-5.3° -4.4° -3.2° ns



technical steps





LATE CLINICAL OUTCOME IN BIFURCATION PCI WITH RESOLUTE

RESULTS DERIVED FROM RESOLUTE TRIALS

RESULTS FROM A LARGE “REAL-WORLD” REGISTRY

For OMA distribution only. © 2012 Medtronic, Inc. All rights reserved. 10051776DOC_1A 05/12

Enrollment Complete - In Follow Up

RESOLUTE1 Non-RCT First-in-Human (R=139) 5 yr

RESOLUTE AC2,3 1:1 RCT vs. Xience V (R=1140; X=1152) 3 yr

Non-RCT Observational (R=2349) 2 yr

2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402) 2 yr RESOLUTE US5

2.5 – 3.5 mm Non-RCT (R=100) vs. Hx Control RESOLUTE Japan 2 yr

R Japan SVS 2.25 Non-RCT vs. PG (R=65) < 1yr

38 mm sub-study Non-RCT vs. PG (R=114) < 1yr

RESOLUTE Asia Non-RCT Observational (R=312) < 1yr

RI-US Registry Post-approval study (R=230) plan

RESOLUTE US

RESOLUTE Global Clinical Program

Enrolling / Planning

1:1 RCT vs. Taxus (R=200; T=200) R-China RCT < 1yr

RESOLUTE Int4

R-China Registry Non-RCT Observational (R=1800) < 1yr

2 All-comer Trials Allowed Enrollment of Bifurcation Lesions

1Meredith IT, et al. EuroIntervention. 2010;5:692-7. 2Serruys PW, et al. N Engl J Med. 2010;363:136-46. 3Silber S, et al. Lancet. 2011;377:1241-47. 4Neumann FJ, et al. EuroIntervention. 2012;7(10):1181-8. 5Yeung AC, et al. JACC. 2011;57:1778-83.


RESOLUTE All Comers

N = 1140 (R-ZES arm)

Bifurcations

N = 190

Bifurcations

N = 512

RESOLUTE International

N = 2349

Bifurcations N = 702

1 Year Follow-up n = 695 (99.0%)

2 Year Follow-up n = 688 (98.0%)

Patient Flowchart

RESOLUTE Pooled – Bifurcation Subset


% N = 702 patients,

1087 lesions

Lesion location

LAD 64.8

LCX 33.5

RCA 21.9

Left main 6.4

De novo 97.3

B2/C 73.2

Thrombus (angiographically visible) 9.4

Total occlusions (TIMI 0) 10.9

Lesion Characteristics



(1,1,1)

29.4%

(1,1,0)

8.4%

(1,0,1)

3.7%

(0,1,1)

7.1%

(1,0,0)

4.1%

(0,1,0)

9.1%

(0,0,1)

3.0%

Medina Classification*

RESOLUTE Bifurcation Subset

*Medina classification only available in RESOLUTE All Comers (R-AC) trial; n = 296 lesions


% N = 702 patients,

1087 lesions

Double guidewires 63.9

Main vessel stented 98.0

Side branch stenting 19.1

Bifurcation technique

Culotte 5.4

Mini-crush\Crush 25.9

T 38.8

Simultaneous Kissing Stent 7.5

V 9.5

Other 12.9

Kissing balloon post-dilatation (R-INT only) 78.4

Procedure Characteristics II



0

Time After Initial Procedure (months)

Cu

mu

lati

ve

In

cid

en

ce

of

TL

F

6 12 18 24

20%

16%

12%

0%

8%

4%

9.4%

Patients with Bifurcation

Patients without Bifurcation

12.6%

Patients at risk

Bifur 702 683 637 614 596

%CI 2.6% 7.7% 10.3% 11.8% 12.6%

No Bifur 2773 2745 2622 2547 2458

%CI 1.0% 4.5% 6.4% 8.2% 9.4%

Target Lesion Failure (Cardiac Death, TV-MI, TLR) to 2 Years



6.2%

0 6 12 18 24

Patients at risk

TLR 702 701 663 641 623

%CI 0% 3.0% 4.9% 5.9% 6.2%

TLR


20%

16%

12%

0%

8%

4%

Target Lesion Revascularization to 2 Years

RESOLUTE Pooled – Bifurcation Subset C

um

ula

tive

Incid

enc

e o

f

Reva

scula

riza

tion

TLR is ischemia driven.

4.9%


% 1 Year n = 695

2 Years n = 688

Death (all) 2.3 4.1

Cardiac death 1.6 2.6

Target vessel MI 5.9 6.4

Q Wave 1.3 1.6

Non Q wave 4.6 4.8

Cardiac death + target vessel MI 7.1 8.4

ARC Def/Prob ST (all) 2.0 2.3

Early (≤ 30 days) 2.0 2.0

Late (31-360 days) 0.1 0.1

Very Late (>360 days) -- 0.3

TLR 4.9 6.1

TVR 6.2 8.3

TLF (cardiac death, target vessel MI, TLR) 10.4 12.6

TVF (cardiac death, target vessel MI, TVR) 11.5 14.5

MACE (death, MI, TLR, emergent CABG) 11.4 14.4

Clinical Outcomes at 1 and 2 Years



Cu

mu

lati

ve

In

cid

en

ce

of

T

LR

5.7%

7.6%

Patients at risk

1 Stent 539 538 510 494 479

%CI 0% 3.0% 4.5% 5.3% 5.7%

>1 Stent 163 163 153 147 144

%CI 0% 3.1% 6.3% 7.6% 7.6%


0% 0 6 12 18 24

Patients with 1 Stent Implanted

Patients with >1 Stent Implanted

20%

16%

12%

0%

8%

4%

TLR by Number of Stents to 2 Years


TLR is ischemia driven.

LATE CLINICAL OUTCOME IN BIFURCATION PCI WITH RESOLUTE

RESULTS DERIVED FROM RESOLUTE TRIALS

RESULTS FROM A LARGE “REAL-WORLD” REGISTRY

First multicentre experience with Resolute in bifurcations

EFFICACY OF RESOLUTE STENT FOR THE TREATMENT OF BIFURCATED CORONARY STENOSIS OF DIFFERENT COMPLEXITY: A REAL-WORLD ITALIAN MULTICENTRE

REGISTRY

F Burzottaa, A Tommasinoa, F Summariab, R Patrizib,

A Colomboc, A Latibc, M De Vitad, F Della Roveree, M Turturof, A Manzolig, Ielasi Ah, C Larosai, C Trania.

a Cardiology Department, Catholic University of Sacred Heart, Rome Italy, b Cardiology Department, Policlinico Casilino, Rome Italy, c San Raffaele Scientific Institute, Milan Italy, d Cardiology Department, Morgagni Hospital, Forlì Italy, e Cardiology Department, Ospedale Galliera, Genova Italy f Cardiology Department, di Venere Hospital, Bari Italy, g Cardiology Department, San Giovanni Addolorata Hospital, Rome Italy h Cardiology Department, Multimedica Hospital, Castellanza Italy i Cardiology Department, Lorenzo Bonomo Hospital, Andria Italy

• From August 2008 to March 2012, 9 Italian Centers prospectively collected data on pts with coronary artery disease treated by PCI with implantation of at least one R-ZRS.

• Patients receiving ZRS to treat a bifurcated lesion entered the present study.

• Pts were prospectively followed by phone contact at 1, 6, 12, 24, 36 and 48 months:

– to assess the occurrence of major adverse cardiac events (MACE; cardiac death, non-fatal myocardial infarction, TLR , TVR and ST defined according to the ARC criteria).

Methods

Italian ClinicalService® project:

• A national medical care project aimed at evaluating and improving the use of implantable cardiac devices in clinical practice

• The project consists of a shared environment for the collection, management, analysis and reporting of data from patients wearing Medtronic implantable devices

• An independent physician steering committee prospectively identifies key clinical questions on a yearly basis for analysis and publication

• A charter assigns the ownership of data to the centers and governs the conduct and relationship of the steering committee and Medtronic

• ClinicalTrials.gov identifier: NCT01007474

Methods

Patients with bifurcations 527

Maximum FU lenght (months) 48.5

Mean FU lenght (months) 20.2

Study population

Silent Ischemia

16%

Stable Angina

38%

ACS

46%

PCI Indication

Baseline Clinical Characteristics

Characteristics All (n=527)

Age (years) 66.1 (11)

Male 407 (77.2%)

Diabetes 152 (28.9%)

Current smoker 108 (20.5%)

Hypertension 410 (78%)

Previous AMI 140 (27%)

Previous PCI-CABG 166 (31.5%)

PCI

CABG

PCI+CABG

122 (23.1%)

31 (5.9%)

13 (2.5%)

Angio Characteristics

LM 17.3%

LAD-Diag 47.0%

LCx-OM 24.2%

RCA 8.4%

Medina – 001 4.3%

Medina – 010 18.8%

Medina – 100 8.0%

Medina – 011 8.3%

Medina – 101 Medina - 110

7.8%

22.7%

Medina – 111

30.3%

Angiographic Characteristics

SIMPLE

INTERMEDIATE

COMPLEX

BIFURCATION COMPLEXITY

Procedural Characteristics: stenting technique

88%

64%

5.9%

2.2%

1.2%

1.5%

1.0%

Single stent 88%

Double stent 12%

Double stenting by bifurcation complexity

4.9%

10.7%

23.3%

Cardiac death 1.9%

MI 3.6%

TLR 5.1%

TVR 6.1%

Stent thrombosis 1.0%

MACE 12.0%

Adverse events during (average 20 months) follow-up

MACE-FREE SURVIVAL

Free

do

m f

rom

MA

CE

(%)

0

25

50

75

100

Months since stent implant

0 3 6 9 12 15 18 21 24 27 30 33 36

No. at Risk 527 499 448 410 383 295 259 256 222 114 95 90 65

88.0%

By stenting technique

By bifurcation complexity

Fre

ed

om

fro

m M

AC

E (

%)

0

25

50

75

100


0 3 6 9 12 15 18 21 24 27

ComplessaIntermediaSemplice

P = 0.19

No. at Risk

Complessa

Intermedia

Semplice

0 0 0 0 0 0 0 0 0 0

162 155 147 138 130 101 87 86 74 40

188 177 154 141 131 98 89 87 76 40

143 139 125 112 105 85 76 76 67 32

Complex Intermediate Simple

91.1% 94%

88.9%

P = 0.19

Overall population

MACE-FREE SURVIVAL

Overall population

Free

do

m f

rom

MA

CE

(%)

0

25

50

75

100


0 3 6 9 12 15 18 21 24 27 30 33 36

No. at Risk 527 499 448 410 383 295 259 256 222 114 95 90 65

88.0%

Fre

ed

om

fro

m M

AC

E (%

)

0

25

50

75

100


0 3 6 9 12 15 18 21 24 27

SingleDouble

P = 0.011

No. at Risk

.

Single

Double

0 0 0 0 0 0 0 0 0 0

452 434 387 353 328 250 218 216 184 94

68 58 54 51 49 39 38 37 35 18


91.8%

82.8%

P = 0.01

TLR-FREE SURVIVAL

Overall population


By bifurcation complexity

Fre

ed

om

fro

m T

LR_

Eve

nt

(%)

0

25

50

75

100


0 3 6 9 12 15 18 21 24 27


P = 0.29

No. at Risk

Complessa

Intermedia

Semplice

0 0 0 0 0 0 0 0 0 0

162 156 148 139 131 102 88 87 75 41

188 178 156 142 132 99 90 88 77 40

143 140 126 114 107 86 77 77 68 33


93%

92.5%

97.1%

Free

do

m f

rom

TLR

_Eve

nt

(%)

0

25

50

75

100


0 3 6 9 12 15 18 21 24 27 30 33 36

No. at Risk 527 502 452 414 387 298 262 259 225 116 97 93 67

92.7%

P = 0.29

Free

do

m f

rom

TLR

_Eve

nt

(%)

0

25

50

75

100


0 3 6 9 12 15 18 21 24 27

SingleDouble

P = 0.0095

No. at Risk

.

Single

Double

0 0 0 0 0 0 0 0 0 0

452 436 390 356 331 253 221 219 187 96

68 59 55 52 50 39 38 37 35 18


94.5%

87.1%

TLR-FREE SURVIVAL

Overall population

Free

do

m f

rom

TLR

_Eve

nt

(%)

0

25

50

75

100


0 3 6 9 12 15 18 21 24 27 30 33 36

No. at Risk 527 502 452 414 387 298 262 259 225 116 97 93 67

92.7%

P <0.01

STENT THROMBOSIS-FREE SURVIVAL

Overall population By bifurcation complexity

Free

do

m f

rom

Tro

m (

%)

0

25

50

75

100


0 3 6 9 12 15 18 21 24 27


P = 0.77

No. at Risk

Complessa

Intermedia

Semplice

0 0 0 0 0 0 0 0 0 0

162 157 149 142 134 106 93 92 78 44

188 181 163 150 140 106 98 96 82 42

143 140 127 115 108 86 78 78 69 33

98.8%

99.1%

99.5%


Free

do

m f

rom

Tro

m (

%)

0

25

50

75

100


0 3 6 9 12 15 18 21 24 27 30 33 36

No. at Risk 527 506 461 426 399 309 276 273 234 121 103 98 70

99%

P =NS

STENT THROMBOSIS-FREE SURVIVAL

Overall population By stenting technique

Free

do

m f

rom

Tro

m (

%)

0

25

50

75

100


0 3 6 9 12 15 18 21 24 27

SingleDouble

P = 0.64

No. at Risk

.

Single

Double

0 0 0 0 0 0 0 0 0 0

452 437 395 363 338 260 232 230 194 101

68 62 59 57 55 43 41 40 37 18

99.1%

98.5%

Free

do

m f

rom

Tro

m (

%)

0

25

50

75

100


0 3 6 9 12 15 18 21 24 27 30 33 36

No. at Risk 527 506 461 426 399 309 276 273 234 121 103 98 70

99%

P =NS

Simple

MACE BY BIFURCATION COMPLEXITY AND STENTING TECHNIQUE

Intermediate Complex

5%

10%

15%

20%

single stent double stent

MACE rate RR 6.5

RR 2.1

RR 2.4

CONCLUSIONS

the use of last generation ZRS is associated with excellent performance in provisional stenting procedures and with promising clinical outcome in a wide spectrum of bifurcated lesions complexity

MACE IN DOUBLE STENTING PATIENTS ACCORDING TO SETTING

OF SB STENTING

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