A Prospective, Randomized Trial of Paclitaxel-Eluting Balloons Versus Everolimus-Eluting Stents in...
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A Prospective, Randomized Trial of Paclitaxel-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With Coronary In- Stent Restenosis of Drug-Eluting Stents: The RIBS IV Clinical Trial Fernando Alfonso MD, PhD, FESC Fernando Alfonso MD, PhD, FESC Hospital Universitario “La Princesa” Madrid. Hospital Universitario “La Princesa” Madrid. Spain Spain On Behalf of the RIBS IV Investigators On Behalf of the RIBS IV Investigators RIBS IV
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Transcript of A Prospective, Randomized Trial of Paclitaxel-Eluting Balloons Versus Everolimus-Eluting Stents in...
A Prospective, Randomized Trial of Paclitaxel-Eluting Balloons Versus
Everolimus-Eluting Stents in Patients With Coronary In-Stent Restenosis of Drug-
Eluting Stents:
The RIBS IV Clinical Trial
A Prospective, Randomized Trial of Paclitaxel-Eluting Balloons Versus
Everolimus-Eluting Stents in Patients With Coronary In-Stent Restenosis of Drug-
Eluting Stents:
The RIBS IV Clinical Trial
Fernando Alfonso MD, PhD, FESCFernando Alfonso MD, PhD, FESCHospital Universitario “La Princesa” Madrid. Spain Hospital Universitario “La Princesa” Madrid. Spain
On Behalf of the RIBS IV InvestigatorsOn Behalf of the RIBS IV Investigators
Fernando Alfonso MD, PhD, FESCFernando Alfonso MD, PhD, FESCHospital Universitario “La Princesa” Madrid. Spain Hospital Universitario “La Princesa” Madrid. Spain
On Behalf of the RIBS IV InvestigatorsOn Behalf of the RIBS IV Investigators
RIBS IVRIBS IV
Background:
Treatment of patients with DES-ISR remains a challenge
In this setting, DES provide better results than classical coronary interventions.
Drug-eluting balloons (DEB) are also very effective in patients with BMS-ISR and DES-ISR, with results superior to those obtained by conventional BA and equivalent to those seen with 1st Generation DES
However, the value of DEB compared with 2nd Generation DES in patients with DES-ISR remains unknown
Treatment of patients with DES-ISR remains a challenge
In this setting, DES provide better results than classical coronary interventions.
Drug-eluting balloons (DEB) are also very effective in patients with BMS-ISR and DES-ISR, with results superior to those obtained by conventional BA and equivalent to those seen with 1st Generation DES
However, the value of DEB compared with 2nd Generation DES in patients with DES-ISR remains unknown
RIBS IVRIBS IV
RIBS IV: (Restenosis Intra-stent: DEB vs EES)Multicenter, Prospective, Randomized
Investigators´ Driven InitiativeUnrestricted Grants:
B. Braun & Abbott Vascular
Investigators´ Driven InitiativeUnrestricted Grants:
B. Braun & Abbott Vascular
1.- ALICANTE H U General.2.- ASTURIAS H U Central Asturias.3.- BADAJOZ H U Infanta Cristina.4.- BALEARES H U Son Espases. 5.- BARCELONA H U Bellvitge.6.- BARCELONA H U Clínico.7.- BARCELONA H U Santa Cruz y San Pablo.8.- BARCELONA H U Valle de Hebrón.9.- CANTABRIA H U Marqués de Valdecilla.10.- CORUÑA H U Juan Canalejo. 11.- GRANADA H U Virgen de las Nieves.12.- MADRID H U Doce de Octubre.13.- MADRID H U La Paz. 14.- MADRID H U La Princesa. 15.- MADRID H U Puerta de Hierro. 16.- MADRID H U Clínico San Carlos.17.- MALAGA H U Carlos Haya.18.- MALAGA H U Virgen de la Victoria.19. TOLEDO H U Virgen de la Salud Toledo.20.- VALENCIA H U Clínico.21.- VALENCIA H U General. 22.- VIGO H U Meixoeiro. 23.- ZARAGOZA H U Miguel Servet.
1.- ALICANTE H U General.2.- ASTURIAS H U Central Asturias.3.- BADAJOZ H U Infanta Cristina.4.- BALEARES H U Son Espases. 5.- BARCELONA H U Bellvitge.6.- BARCELONA H U Clínico.7.- BARCELONA H U Santa Cruz y San Pablo.8.- BARCELONA H U Valle de Hebrón.9.- CANTABRIA H U Marqués de Valdecilla.10.- CORUÑA H U Juan Canalejo. 11.- GRANADA H U Virgen de las Nieves.12.- MADRID H U Doce de Octubre.13.- MADRID H U La Paz. 14.- MADRID H U La Princesa. 15.- MADRID H U Puerta de Hierro. 16.- MADRID H U Clínico San Carlos.17.- MALAGA H U Carlos Haya.18.- MALAGA H U Virgen de la Victoria.19. TOLEDO H U Virgen de la Salud Toledo.20.- VALENCIA H U Clínico.21.- VALENCIA H U General. 22.- VIGO H U Meixoeiro. 23.- ZARAGOZA H U Miguel Servet.
Steering Committee. QCA & Clinical Events CommitteeUnder the Auspices PCI WG Spanish Society of Cardiology
Coordinator Center: HU Clínico San Carlos. Madrid.
Steering Committee. QCA & Clinical Events CommitteeUnder the Auspices PCI WG Spanish Society of Cardiology
Coordinator Center: HU Clínico San Carlos. Madrid.
23
4
3
1
17
18
2
8
567
910
11
13
1215
1614
21
20
22
19
RIBS IVRIBS IV
Inclusion / Exclusion Criteria
Informed consent Age 20 - 85 y DES ISR (> 50% stenosis) Angina or silent ischemia ISR amenable for BA & Stent
Informed consent Age 20 - 85 y DES ISR (> 50% stenosis) Angina or silent ischemia ISR amenable for BA & Stent
Inclusion:Inclusion:
Stent Related: Stent location undefined ISR <1 Month Thrombus Vessel diameter < 2 mm ISR length > 30 mm ISR outside the Stent
General: Life expectancy < 1 y Female in childbearing age Problems FU angiography Intolerance ASA/Clopidogrel LVEF < 25%
Stent Related: Stent location undefined ISR <1 Month Thrombus Vessel diameter < 2 mm ISR length > 30 mm ISR outside the Stent
General: Life expectancy < 1 y Female in childbearing age Problems FU angiography Intolerance ASA/Clopidogrel LVEF < 25%
Exclusion:Exclusion:
RIBS IVRIBS IV
309 Pts DES-ISRRandomization
Inclusion CriteriaInformed Consent
Rx CentralizedStratification: ISR Length & Edge
154 PtsDEB
155 PtsEES
3 Died12 Refused3 Died12 Refused
139 PtsAngio FU
4 Died 18 Refused
4 Died 18 Refused
133 PtsAngio FU Mean: 279 days
(Median: 248) Mean: 279 days(Median: 248)
Mean: 266 days(Median: 246)
Mean: 266 days(Median: 246)
(272 Patients: 90% of Eligible)(272 Patients: 90% of Eligible)
QCAQCAPrimary
End-pointPrimary
End-point
100% Angiographic Success 100% Angiographic Success
SeQuent Please (B. Braun)
Xience Prime(Abbott Vascular)
RIBS IVRIBS IV(Januray 2010 – August 2013)(Januray 2010 – August 2013)
QCA: In-Segment AnalysisReference Diameter
DEBDEBEESEES
0
0,5
1
1,5
2
2,5
3
p = 0. 21p = 0. 21
2.67+0.52.67+0.5 2.59+0.52.59+0.5
Lesion Length
0
2
4
6
8
10
12
14
16
p = 0.56p = 0.56
10.7+510.7+5 10.4+610.4+6
(mm)(mm)
CAAS II SystemCAAS II System
RIBS IVRIBS IV
QCA: In-Segment Analysis
0
0,5
1
1,5
2
2,5
0
0,5
1
1,5
2
2,5
MLD-FUMLD-FU DEBEES
SegSeg
p = 0.004p = 0.004
2.031.80
LesionLesionp < 0.0001 p < 0.0001
(mm)(mm)
1.892.20
MLD-FUMLD-FU
(mm)(mm)
In-Segment(Primary Endpoint)
In-Segment(Primary Endpoint)
In-LesionIn-Lesion
RIBS IVRIBS IV
Cumulative Frequency Distribution Curves
(%) Stenosis(%) StenosisIn-SegmentIn-Segment Intention to Treat Intention to Treat
(%)(%)
0
20
40
60
80
100
-20 -10 0 10 20 30 40 50 60 70 80 90 100
PREPREPOSTPOSTp < 0.001p < 0.001
p = 0.009p = 0.009
__DEBDEB
__EESEES
RE15 (11%)27 (19%)p = 0.06
RR (95%CI) 1.44 (0.94-2.20)
RE15 (11%)27 (19%)p = 0.06
RR (95%CI) 1.44 (0.94-2.20)
FUFU
RIBS IVRIBS IV
Late Loss
In-Segment Analysis (QCA)
Kolmogorov-Smirnov <0.05Kolmogorov-Smirnov <0.05
DEBEES
0.18+0.6 vs 0.30+0.6 mm
(mm)
* median (IQR); Mann-Whitney “U”* median (IQR); Mann-Whitney “U”
*p = 0.06*p = 0.06
(-0.18 – 0.65)(-0.18 – 0.65)
0.060.06 0.140.14(-0.20 – 0.40)(-0.20 – 0.40)
4,00
3,00
2,00
1,00
0,00
-1,00
4,003,002,001,000,00-1,00
30
20
10
0
4,003,002,001,000,00-1,00
30
20
10
0
RIBS IVRIBS IV
Events at Final FU (1 Year)
0
5
10
15
20
C Death (4)C Death (4) AMI (7)+AMI (7)+ CABG TLR (2)CABG TLR (2) PCI TLR (25)PCI TLR (25)
22
66
2222 11
Intention to Treat Intention to Treat
MACE (Cardiac Death, MI, TLR): Non-exclusiveMACE (Cardiac Death, MI, TLR): Non-exclusive
55
+ 3 Definitive ST Thrombosis (1 EES y 2 DEB [all after re-PCI & stenting])+ 3 Definitive ST Thrombosis (1 EES y 2 DEB [all after re-PCI & stenting])
1 Year FU 309 P (100%); FU Time 360+35 days
1919
11
MACE (Exclusive)MACE (Exclusive) p = 0.009HR 0.39 (95%CI 0.19-0.83) p = 0.009HR 0.39 (95%CI 0.19-0.83) EES: 10 (7%)EES: 10 (7%)
DEB: 24 (16%)DEB: 24 (16%)
RIBS IVRIBS IV
Clinical Follow-up:
00 11 22 33 44 55 66 77 88 99 1010 1111 121200
2020
4040
6060
8080
100100%%
Time (months)Time (months)
Freedom from TLRFreedom from TLR
__
EESEES__ DEBDEB
1 Year FU 309 P (100%); FU Time 360+35 days
Breslow, p = 0.008Log Rank, p = 0.008Breslow, p = 0.008Log Rank, p = 0.008
96%96%
87%87%
RIBS IVRIBS IV
Clinical Follow-up:
00 11 22 33 44 55 66 77 88 99 1010 1111 121200
2020
4040
6060
8080
100100%%
Time (months)Time (months)
Freedom from MACE (Cardiac Death, MI, TVR)Freedom from MACE (Cardiac Death, MI, TVR)
__
EESEES__ DEBDEB
1 Year FU 309 P (100%); FU Time 360+35 days
Breslow, p = 0.047Log Rank, p = 0.044Breslow, p = 0.047Log Rank, p = 0.044
90%90%
82%82%
RIBS IVRIBS IV
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
DEB vs BA in the RIBS Trials
Late LossLate Loss
DEB RIBS IVDEB RIBS IV
0.14+0.50.14+0.5
0.77+0.70.77+0.7 p < 0.05p < 0.05
(QCA) In-Segment Analysis(QCA) In-Segment Analysis
DEB RIBS VDEB RIBS V
0
0,5
1
1,5
2
2,5
MLD FUMLD FU(mm)(mm)(mm)(mm)
BA RIBS IBA RIBS I BA RIBS IIBA RIBS II
1.52+0.71.52+0.7
2.01+0.62.01+0.6
1.52+0.71.52+0.7
0.73+0.70.73+0.7p < 0.01p < 0.01
BA RIBS IBA RIBS I BA RIBS IIBA RIBS II DEB RIBS IVDEB RIBS IVDEB RIBS VDEB RIBS V
1.80+0.61.80+0.6
0.30+0.60.30+0.6
RIBS IVRIBS IV
BMS-ISRBMS-ISR BMS-ISRBMS-ISRDES-ISRDES-ISR DES-ISRDES-ISR
Conclusions:
In patients with DES-ISR EES provide superior late angiographic results than DEB (MLD 1ry end-point)
In these patients EES also provide better late clinical results, driven by a significant reduction in the rate of TLR
Treatment of DES-ISR remains challenging and associated with poorer clinical and angiographic results than treatment of BMS-ISR. Further studies (more patients & longer follow-up) are still warranted in this adverse setting.
In patients with DES-ISR EES provide superior late angiographic results than DEB (MLD 1ry end-point)
In these patients EES also provide better late clinical results, driven by a significant reduction in the rate of TLR
Treatment of DES-ISR remains challenging and associated with poorer clinical and angiographic results than treatment of BMS-ISR. Further studies (more patients & longer follow-up) are still warranted in this adverse setting.
RIBS IVRIBS IV
