Intervencionismo coronario en lesiones severamente calcificadas

Intervencionismo coronario en
lesiones severamente
calcificadas
Jorge Palazuelos Molinero, MD, PhD
Hospital U. Central de la Defensa Gómez Ulla. Madrid
Casa del Corazón, 17 de septiembre de 2015
jpalaz@gmail.com

“The cardinal indication for plaque
modification is the calcific lesion, which, in
the absence of plaque modification, confers
an increased likelihood of procedural
failure, stent underdeployment, restenosis,
and major complications”
Moussa I et al. Am J Cardiol 2005;96:1242–7
Tomey et al. J Am Coll Cardiol Intv 2014;7:345–53
Bangalore et al. Catheter Cardiovasc Interv 2011;77:22–8
Current status of… calcium during PCI
Rev Esp Cardiol. 2008;61:1103-4

• High rates of short-term procedural success
(range 93.4% to 98.6%), superior to rates
reported separately in the absence of preceding
plaque modification
– Moussa I et al. Circulation 1997;96:128–36.
– Hoffmann R et al. Am J Cardiol 1998; 81:552–7.
– Kiesz RS et al. Catheter Cardiovasc Interv 1999;48:48–53.
Determining calcification severity
•Angiography < IVUS for detection of calcification,
but visible calcification on angiography predicts a
larger arc of calcification on IVUS.
•IVUS or OCT permits discrimination of superficial
(near the intima–lumen interface) and deep (at the
media/adventitia border) calcium
Moussa I. Am J Cardiol 2005; Mintz GS.Circulation 1995; Mehanna E. CircJ2013
Rev Esp Cardiol. 2009;62:585-6
Rev Esp Cardiol. 2005;58:1197-206

Determining calcification severity
•In practice, calcification severity is graded by
qualitative assessment of angiography
– Severe calcification defined by radio-opacities
noted without cardiac motion before contrast
injection, generally involving both sides of the
arterial wall.
– Moderate calcification defined by densities
noted only during the cardiac cycle before
contrast injection.
Moussa I. Am J Cardiol 2005. Mintz GS. Circulation 1995. Mehanna E. Circ J 2013

“Preparation and debulking of the lesion with
rotational atherectomy and special balloons,
cutting or scoring, may be useful in highly
calcified, rigid ostial lesions”

• CB is designed to create discrete
longitudinal incisions by a controlled
dilatation.
• Theoretically reduces the force needed to
dilate an obstructive lesion compared with
standard PTCA.
Current status of… Cutting Ballon (CB)

• Efficacy of cutting balloon angioplasty for lesions at
the ostium of the coronary arteries.
– Muramatsu T. J Invasive Cardiol 1999 Apr;11(4):201-6.
• Effectiveness of cutting balloon angioplasty for small
vessels less than 3.0 mm in diameter
– Muramatsu T. J Interv Cardiol 2002 Aug;15(4):281-6.
• Cutting balloon angioplasty for the prevention of
restenosis: results of the Cutting Balloon Global
Randomized Trial
– Mauri L. Am J Cardiol 2002;90:1079-83.
• Cutting balloon angioplasty and stent implantation for
aorto-ostial lesions: clinical outcome and 1y F-UP

Mauri L et al. Am J Cardiol 2002;90:1079-83
Cutting Balloon Global Randomized Trial
•N = 1,238 (617 CB vs 621 PTCA)
•Mean reference vessel diameter: 2.86 +/- 0.49 mm
•Mean lesion length 8.9 +/- 4.3 mm
• Procedural success: 92.9% vs 94.7% (p= 0.24)
• Coronary perforations: 0.8% vs 0% (p= 0,03)
•Primary EP (6m binary angiographic restenosis rate)
31.4% for CB and 30.4% for PTCA (p = 0.75)
•Freedom from TVR: 88.5% vs 84.6% (p= 0,04)
•Outcomes (270 days)
– MI: 4.7% vs 2.4% (p= 0,03)
– Death: 1.3% vs 0.3% (p= 0.06)
– MACE: 13.6 vs 15.1% (p= 0.34)

“CB did not reduce the rate of angiographic
restenosis. CB angioplasty should be reserved
for difficult lesions in which controlled
dilatation is believed to provide a better
acute result compared with PTCA alone”
• CB is designed to create discrete
longitudinal incisions by a controlled
dilatation.
• Theoretically reduces the force needed to
dilate an obstructive lesion compared with
standard PTCA.

“Rotational atherectomy might technically be
required in cases of tight and calcified lesions,
to allow subsequent passage of balloons and
stents. There is a resurgence in the use of
rotational atherectomy for the purpose of
optimal lesion preparation among patients
undergoing implantation of bioresorbable stents”

ISR 27-38%
BMS
ISR 38%
Rota
alone DES
1st Published registry
Current status of… Rotational Atherectomy
2015, 33
2014, 29
2013, 32
2012, 28
2011, 23
2010, 22
2009, 17
2008, 15
2007, 16
2006, 17
2005, 23
1987 2015
Resultados por año (PubMed)

“The cardinal indication for rotational
atherectomy is the calcific lesion,
which, in the absence of plaque
modification, confers an increased
likelihood of procedural failure, stent
underdeployment, restenosis, and
major complications”
Moussa I et al. Am J Cardiol 2005;96:1242–7
Tomey et al. J Am Coll Cardiol Intv 2014;7:345–53
Bangalore et al. Catheter Cardiovasc Interv 2011;77:22–8

CORTE DIFERENCIAL
Elastic tissue is able to
deflect out of the way
Elastic tissue space
Elastic
tissue
deflects
Direction
of motion
Diamond
crystal
Inelastic tissue is
unable to deflect out of
the way
Inelastic tissue space
Direction
of motion
Diamond
crystal
Forceful
mechanical
breakdown
of matter
post-PTCA post-Rotablator®
Función: mov.circunferencial
(mov. longitudinal + velocidad)
Beneficios: avance del dispositivo en vasos estrechos,
tortusoso y calcificados.

Memoria histórica
• Rota feasability: NACI registry (1997)
• Comparison of different debulking
strategies with POBA: ERBAC (1997)
• Rota vs POBA: COBRA (2000), DART
• Rota vs POBA before stenting: SPORT
• Rota vs POBA in ISR: BARASTER (2000)
• Technical/procedural questions: STRATAS
(2001)

Indications
1) calcified lesions
2) left main stenoses
3) lesions in proximal/mid segments of LAD/RCA
4) circumflex with short trunk, or small angle of
origin
5) ostial sites
6) long length lesions
7) smooth contour

Absolutes Contraindications
1) Dissections
2) Thrombus
3) Slow-flow or no-flow
4) impossibility of inserting the guidewire
RelativEs Contraindications
1) vessel tortuosity
2) angular lesions
3) excessively calcified vessels
4) vein graft disease

• AR ayuda a la correcta expansión del stent
• Tan K et al. J Am Coll Cardiol 1995; 25: 855-65.
• Hofmann R et al. Eur Heart J 1998; 19: 1224-31.
• Furuicchi S et al. Eurointervention 2009; 5: 370-4.
• Beneficio clínico de la AR en el tratamiento
de lesiones coronarias calcificadas
• Khattab. J Interv Cardiol 2007; 20: 100-6.
• Kawaguchi. Cardiovasc Revasc Med 2008; 9: 2-8.
• Mangiacapra F. Eurointervention 2010
• Dardas P. Hellenic J Cardiol 2011; 52: 399-406.
• Benezet J. J Invasive Cardiol 2011; 23: 28-32.
• AR en TCI
• Garcia-Lara et al. Catheter Cardiovasc Interv 2011, Nov 25
Aposición y expansión del stent

• Lesiones calcificadas y fibróticas
suponen en sí mismas un desafío
• Alteraciones del dispositivo
• liberación, daño recubrimiento y/o polímero
• Fracaso en el implante
• infraexpansión del stent y malaposición: RIS y TS
¿Y esto importa¿Y esto importa…?…?

a. Infraexpansión: morfología elíptica del stent
(calcio superficial) con flap de la íntima.
b. Malaposición: intimal tear (rama lateral?)
Tanigawa J. Circ J 2008; 72: 157-60.

“OCT clearly showed how HCL behave when treated
with PTCA or RA. It is a challenge to achieve
optimal stent expansion and strut apposition but is
necessary to realize the full benefit of DES”

ROTABLATOR and RESTENOSIS STUDY (R&R)
• Diseño
100 pt (103 lx); B/C lx: 85%; escalonado; b/a ratio 0.65-0.75;
• Complicaciones
–CABG 1%, qMI and death 0%, non-qMI 3%
–6 month F/U: 15% clinical, 28% angiographic RS
“RS may be mediated by deep wall trauma. RA
removes atherosclerotic plaque without disruption of
the internal elastic lamina avoiding deep wall trauma”
Braden, oral presentation, TCT 2000
Abordaje y preparación de la lesión
“RA with a moderately aggressive debulking followed
by low pressure BA is associated with excellent
results, low stent implantation and RS rates”

Abordaje y preparación de la lesión
DOCTORS
27.5%
39.8%

¿BMS vs DES? ¿Importa?
•It is unclear whether RA improves outcomes with
DES.
•In theory, preparation of a smooth cylindrical
lumen might facilitate superior stent deployment
and reduced restenosis. This benefit has not yet
been shown.
•Results are inconsistent in observational studies
and difficult to interpret because of selection
biases in RA assignment (calcification, disease
severity), which may influence outcomes.
•Long-term benefit was again absent in the recent
ROTAXUS study

Son malos resultados en la era previa al DES
Buena idea, pero…
DES vs BMS

ROTA+BMS y ROTA-DES es lo mismo…?ROTA+BMS y ROTA-DES es lo mismo…?
Khattab AA et al. J Interv Cardiol. 2007; 20 (2): 100-6
DES vs BMS

“Rotational atherectomy in the drug-eluting
stent era: a single-centre experience”
• 158 pt (236 lesiones): DES, BMS, no stent
• DES:112 pt,158 lx / BMS:19 pt,28 lx / NS: 27 pt,50 lx
• Éxito inicial: 96.4%
• Indicación de AR
• Primera elección: 84%;
• Bail-out: 16%
• Preservar rama lateral: 25%
• Debulking CTO: 5.5%
• RIS: 3%
• DES no fue implantado en 46 pt (23%) por diámetro de
referencia < 2.25 o > 3.75 mm
Schwartz BG et al. J Invasive Cardiol 2011; 23: 133-9.
Rota + BMS
TLR 22.5%
Rota + DES
TLR 10.2%
vs

DES vs BMS en lesiones complejas
Dardas P. Hellenic J Cardiol 2011; 52: 399-406.
Vaso tratado
Tasa de MACCE (%)
• Rota+DES > Rota+BMS
• Rota+ACTP no mejor
ACTP: TLR 40%
N = 184
Tipo de lesión

“Rotational atherectomy in drug eluting stent era”
DES vs BMS
Parece que NO ES LO MISMO
Rathore et al. Catheter Cardiovasc Interven 2010;75:919-27

“Rotational atherectomy in drug eluting stent era”
• MACE: 2.9%; QMI: 1.3%; nQMI: 5.3%; UPCI:0.4%
• DES vs BMS: RR 50% at 6-9m
• B.restenosis: 11 vs 28% (p = 0,001)
• TLR: 10.6 vs 25% (p < 0.001)
Rathore et al. Catheter Cardiovasc Interven 2010;75:919-27
IVUS: 96.5%

240 patients con seguimiento intrahospitalario completo
Seguimiento angiográfico a
9 meses in 80.5% (N=190)
Seguimiento clínico a 9
meses en 96.2% (N=227)
1:1 randomizacion
PTCA + PES
(N=120)
Rota + PES
(N=120)
- 2 patients muerte intra-hosp
- 6 patients renegaron consent
- 5 patients pérdidos en seg
240 patientes randomizados entre Agosto de 2006 y Marzo de
2010 de 3 únicos centros en Alemania
Pero no
todo es
tan bonito
Abdel-Wahab M, et al. Catheter Cardiovasc Interv 2013

Results
PTCA+ PES
* The intention to treat analysis revelead = angio success
** Overall strategy success

Rota + PES
n = 123
PTCA + PES
n = 132
P
Value
Before procedure
Lesion length (mm) 19.56±9.64 18.63±9.70 0.44
Reference vessel diameter (mm) 2.67±0.41 2.77±0.37 0.04
Minimal lumen diameter (mm) 1.01±0.36 1.10±0.39 0.05
Diameter stenosis (%) 62.05±11.92 60.18±12.74 0.17
Immediately after procedure
Minimal lumen diameter (mm)
In-stent 2.58±0.37 2.56±0.40 0.61
In-segment 2.27±0.50 2.27±0.49 0.98
Diameter stenosis (%)
In-stent 10.43±5.25 11.82±5.21 0.03
In-segment 17.68±8.98 19.38±16.67 0.18
Acute gain (mm)
In-stent 1.57±0.43 1.46±0.46 0.03
In-segment 1.26±0.54 1.17±0.53 0.18
QCA data: Index procedure

p = 0.01
QCA data:
9mo Stent-LLL
ROTAXUS study limitations
•missing angiographic FUP in 1 in 5 patients
•insufficient power to compare clinical outcomes
•a preponderance of moderately calcified lesions
•confounding factors in the RA group
– Crossover: 4.2 vs 12.3%
– longer lesion length
– lower maximum predilation balloon pressure

¿BMS vs DES? ¿Importa?
•Prior studies: RA+PTCA+BMS
– Tran T. Catheter Cardiovasc Interv 2008;72:650–62
•Today, DES account for most implanted stents
– Krone RJ. J Am Coll Cardiol Intv 2010;3:902–10
•DES > BMS
– improved outcomes after RA
– intermediate and long-term outcomes
– MACE are lower with DES compared with BMS
– TLR < 10% within 1-2 years
– This is consistent with broader trials of DES vs BMS
and propensity matched comparison of DES vs BMS in
Current status of Rotational Atherectomy
Definitivamente
NO ES LO
MISMO

RA facilitates procedural success in complex PCI
– B2/C type lesions (ACC/AHA)
• Levin TN. Cathet Cardiovasc Diagn 1998;45:122–30.
• Reifart N. Circulation 1997;96:91–8.
– Ostial lesions
• Tan RP. Catheter Cardiovasc Interv 2001;54:283–8.
• Koller PT. Cathet Cardiovasc Diagn 1994;31:255–60.
• Zimarino M. Cathet Cardiovasc Diagn 1994;33:22–7.
– Bifurcation lesions
• Main vessel:
– Karvouni E. Catheter Cardiovasc Interv 2001;53:12–20.
– Tsuchikane E. J Am Coll Cardiol 2007;50:1941–5.
• Side-vessel:
– Nageh T. Cardiology 2001;95:198–205.
– Ito H. J Invasive Cardiol 2009;21:598–601.
– CTO
• Tsuchikane E. Int J Cardiol 2008;125:397–403.

“Preparation and debulking of the lesion with RA
and special balloons, cutting or scoring, may be
useful in highly calcified, rigid ostial lesions”
Current status of RA… in Ostial Disease
• In ostial coronary lesions, caution is essential
before proceeding to PCI
– Coronary spasm (has to be absent)
– Severity: FFR may be valuable in borderline lesions
– In ostial LAD/LCx stenoses
a decision must be made on whether to attempt precise positioning of
the stent at the ostium of the artery or whether stenting across the
LCx/LAD ostium into the LM artery is preferable.
• Assessment with IVUS/OCT may be helpful

• In the current DES era, RA has largely been
supplanted by: BA, DEB, CB, DES, CABG
• Benefits of RA, when used for ISR, likely depend
on the mechanism of restenosis
– is most beneficial for removal intimal hyperplasia and
less effective for radial expansion of an
underexpanded stent
• If RA is contemplated for use in DES ISR, pre-
treatment imaging with IVUS or OCT may be
warranted to first elucidate the mechanism of
restenosis
Dangas GD. J Am Coll Cardiol 2010;56:1897–907
Current status of RA… in ISR

Current status of RA… in ISR
Sharma SK (ROSTER). Am Heart J 2004. Vom Dahl J (ARTIST). Circulation 2002
In-stent restenosis (ISR): ROTA vs POBA
ROSTER (Randomized Trial of Rotational Atherectomy
Versus Balloon Angioplasty for Diffuse In-Stent
Restenosis)
200 pt with IVUS confirmed diffuse ISR
RA (intimal hyperplasia area): reduction in repeat stenting (10%
vs. 31%, p< 0.001) and TLR (32% vs. 45%, p= 0.042) at 12m of FUP
ARTIST trial (Angioplasty Versus Rotational Atherectomy
for Treatment of Diffuse In-Stent Restenosis)
RA (stent expansion):
higher incidence of binary restenosis (65% vs. 51%, p= 0.039) at
6m (radial expansion of an underexpanded stent)
BENEFIT
NO BENEFIT

• 159 pt. BMS
• Diámetro de referencia 2.36±0.49 mm
• Reestenosis rate: 44.2% y TLR 33%
• Late loss 0.55±0.69 mm J Interven Cardiol 2003;16: 315-22
VASOS
PEQUEÑOS

Clinical experience with rotational atherectomy in
patients with severe left ventricular dysfunction
• N = 23 (17 hombres) / FEVI media: 21.3%
• Éxito inicial: 100%
• Eventos:
• Mortalidad intrahospitalaria: 4.3% (r/AR: 0%)
• Infarto periprocedimiento: 13% (3 pt)
• MACE 30 días: 0%
“The transient effect of RA on ventricular function
did not adversely affect short-term outcomes in our
study population. These results suggest that RA,
when performed by experienced operators, is safe
and feasible in patients with severe LV dysfunction”
Ramana RK. J Invasive Cardiol. 2006 Nov;18(11):514-8.

Registro de utilización de
ROTABLATOR en intervenciones
coronarias en hospitales españoles
www.proyectowilma.com
REGISTRO ROTABLATORREGISTRO ROTABLATOR
¿Cuál es el presente…?

Registro de utilización de ROTABLATOR en
intervenciones coronarias en hospitales españoles
Age (mean; SD) 74.9 (8.7)
Gender
•Male (n = 511)
•Female (n = 167)

75.4
24.6
Weight (mean; SD) 76.1 (14.2)
Height (mean; SD) 164.5 (9.6)
Body Mass Index (mean; SD) 28.6 (12)
Tobacco (%) 53.1
HTA (%) 83.7
Diabetes mellitus (%) 53.1
Dyslipidemia (%) 70.7
LVEF ≤ 44% (%) 27.3
Moderate/severe mitral regurgitation (%) 21.2
Prior Myocardial Infarction (%) 30.4
Prior PCI (%) 31.1
Prior CABG (%) 10.3
Prior Stroke (%) 11.4
Renal dysfunction (%) 28.9
Peripheral vascular disease (%) 24.6
Características
demográficas y
clínicas basales

TIPOS DE PACIENTES: Clínica

Sheath, 6F (%) 57.9
Approach (%)
Radial artery 56
Femoral artery 44
Co-adjuvant therapy (%)
Heparin 90.9
Bivaluridine 9.3
GP inhibitors 7.1
Right dominance (%) 92.2
Multivessel disease (≥2) (%) 62
Left Main LAD LCX RCA
Prevalence of disease (n, %) 93 (13.7) 493 (72.7) 321 (47.3) 416 (61.4)
Nº Lx 1 (.2) 1.6 (.8) 1.4 (.6) 1.5 (.7)
Lx length 12 (4.5) 27.9 (16.2) 21.5 (13.4) 28.1 (18.6)
Diameter 3.7 (.5) 2.8 (.4) 2.6 (.5) 3 (.6)
Treated with RA [n (%)] 63 (9.9) 382 (60.1) 89 (14) 191 (30.7)
Características angiográficas basales

Datos Coronariografía (2)

ICP
Wire Left Main LAD LCX RCA
Type [n (%)]
Floppy 584 (80.1) 51 (81) 316 (82.7) 71 (79.8) 146 (74.9)
Support 145 (19.9) 12 (19) 66 (17.3) 18 (20.2) 49 (25.1)
Advance [n (%)]
Directly 321 (44) 38 (60.3) 174 (45.5) 40 (44.9) 69 (35.4)
OTW-B 143 (19.6) 9 (14.3) 80 (20.9) 16 (18) 38 (19.5)
Microcatheter 265 (36.4) 16 (25.4) 128 (33.5) 33 (37.1) 88 (45.1)
Burr
Advance [n (%)]
Directly 550 (79.5) 54 (85.7) 293 (81.2) 59 (70.2) 144 (78.3)
Predilated 142 (20.5) 9 (14.3) 68 (18.8) 25 (29.8) 40 (21.7)
Burr number [n (%)]
≤ 1 601 (83.5) 53 (84.1) 314 (82.2) 73 (82) 161 (82.6)
≥ 2 119 (16.5) 10 (15.9) 64 (16.8) 13 (14.6) 32 (16.4)
Burr size [n (%)]
≤ 1.5 mm 645 (92.2) 54 (85.7) 346 (91.5) 78 (90.7) 167 (86.5)
≥ 1.75 mm 54 (7.8) 5 (50) 23 (35.9) 6 (46.2) 20 (62.6)
Speed (rpm) (M; SD)
164724
(14948)
164772
(15237)
163884
(15400)
165392
(14564)
164848
(14594)
PTCA post RA [n (%)] 670 (91.2) 56 (88.9) 351 (91.9) 81 (91) 182 (93.3)
Compliant Ballon 37 (50.3) 23 (41.1) 171 (48.7) 50 (61.7) 93 (51.1)
Non-Compliant B 333 (49.7) 33 (58.9) 180 (51.3) 31 (38.3) 89 (48.9)
Stent 725 63 (8.6) 382 (52.6) 89 (12.2) 191 (26.3)
Type (n, %)
Bare metal stent 139 (19.1) 11 (11.7) 47 (12.8) 20 (23.5) 61 (31.9)
Drug-eluting stent
Limus 476 (65.6) 46 (74.2) 268 (73) 52 (61.2) 110 (57.6)
Taxol 90 (12.4) 5 (8.1) 52 (7.7) 13 (15.3) 20 (10.5)
Diameter (Me, ICA) (mm) 3.1 (1.9) 3.5 (.2) 2.8 (2.5) 2.9 (2.2) 3.2 (2.7)
Length (Me, ICA) (mm) 25 20.7 (29) 27.3 (89) 25.2 (52) 27.1 (79)

• Guía más usada: La normal: floppy
• Acceso directo bastante frecuente, incluso en la coronaria derecha
• IVUS (7,9%): TCI: 2,2%, DA: 4,1%, CX: 0,7% y CD: 0,9%
Vaso
Uso de
una oliva
(%)
Oliva más
usada (%)
Intercambio
guía tras
rotablator
% ACTP-
Balón
postRota
% Balón
NO
compliat.
Stent más
utilizado
%
Postdilat.
TC 81,6% 1,5 (44,9%) 75,5% 85,7% 59,5
Limus
(77,1%)
75%
DA 84% 1,5 (49,1%) 72,5% 90,2% 49%
Limus
(73,5%)
54,5%
CX 81,7% 1,5 (50%) 76,1% 91,5% 0%
Limus
61,2%)
50,7%
CD 81,6% 1,5 (50%) 80,9% 94,9%
43,4%
CuttingB
(20,2%)
Limus
(57,8%)
51,9%
Rotablación: otras cuestiones técnicas

Éxito clínico
Sí: 97,1% (663)
No: 2,9% (15)
Muerte: 6 (0,8%)
I.Rn.A: 1 (fallece a los 5 días)
No flow: 2 (disfunción VI severa; EAP basal)
Perforación: 2
EAP: 1
Infarto: 11 (1,6%)
Perdida de rama lateral: 3
recuperada: 2 (1 con síntomas)
no recuperada: 1 (síntomas)
Asintomático (elevación enzimática): 9
Otros:
EAP: 2 (0,2%)
AIT: 2 (0,2%)
HIC: 1 (0,1%) www.proyectowilma.com

Éxito angiográfico
Sí: 95,9% (650)
No: 4,1% (28)
Relacionado con el procedimiento: 21 (3%)
Imposibilidad procedimiento: 8 (1,1%)
Fallo avance guía y/o balón: 6
Fractura de stent: 1
Perdida de stent: 1
Disección coronaria: 6 (0,8%)
Perforación coronaria: 3 (0,4%)
Taponamiento cardiaco: 2 (0,29%)
Pérdida de rama lateral: 1 (0,14%)
Trombosis subaguda: 1 (0,14%)
Relacionado con rotablator: 7 (1%)
Fallo avance guía y/o oliva: 2 (0,29%)
Atrapamiento oliva: 2 (0,29%)
Pérdida de rama lateral: 2 (0,29%)
Disección: 1 (0,14%) www.proyectowilma.com

Time
(days)
0 7 30 180 270 365 540 730 1132
Populati
on
678 609 581 478 410 348 158 90 0
Events 2 6 7 10 11 12 21 25 28
Supervivencia
acumulada libre
de MACE
Time
(days)
0 3 40 157 159 373 411 425 68
5
70
6
72
4
72
7
Populati
on
625 601 553 480 477 322 263 250 10
8
98 91 90
Events 1 2 3 4 5 6 7 8 9 10 11 12
IC 95%: 1100
(1081 – 1118) days
IC 95%: 1049
(1016 – 1083) days
Supervivencia
acumulada libre
de Muerte

¿Cuál es el futuro…? CONSENSO EUROPEO
The aim… to a standardized protocol on the
correct performance of rotational
atherectomy… in training programmes and in
daily procedures, and… to correct the
erroneous perception of rotational
atherectomy as an exclusive technique.

POBA vs Cutting
¿Cuál es el futuro…?

POBA vs Cutting
Hipótesis: ROTACUT > ROTAPOBA before DES.
Métodos: IVUS/OCT en los casos de AR.
Endpoint: Min stent CSA; Min stent MLD; Acute gain
ROTA-LIMUS
Historia: > ganancia aguda con AR; peor LLL: con PES
LLL 0.4mm (ROTAXUS)
Hipótesis: DES (limus) última generación.
Métodos: IVUS/OCT
Endpoint: Eficacia (IVUS/OCT): In-stent LLL 9m
¿Cuál es el futuro…?

Hipothesis: AR no inferior a técnica convencional
Methods: Medina lesions: 1,0,0 / 1,1,0 / 0,1,0
Primary Endpoint
MACE: death, infarction, repeat revascularization
(target vessel revascularization), urgent surgery
requirement; their combination and mortality due any
cause.
Secondary endpoints
A) angiographic outcomes:
a. success rate periprocedure and yearly check-up.
b. angiographic complications rate.
B) clinical variables: prevalence of MACE. As well the
incidence of stroke, haemorrhages with or without the
need for transfusion, renal insufficiency.
¿Cuál es el futuro…? BIFURCATOR

¿Qué CONCLUSIONES podemos sacar?
• AR logra en lesiones complejas mejores éxitos
clínicos y angiográficos (+ baratos??) que la ICP
convencional a corto-medio y largo plazo
• Queda mucho por saber:
– IVUS / OCT
– SBO, Rotacut, R-Limus...
• Indicaciones:
– Calcificación
– TCI
– Ostial
– Bifurcaciones
- “Indilatables”
- Lesiones largas
- CTO
- Vasos pequeños
- ISR

Modificado de Tomey et al. J Am Coll Cardiol Intv 2014;7:345–53
PCI
Angiographic calcification
Moderate SevereMild
IVUS / OCT
Rotational
Atherectomy
strategy
Non-Rotational
Atherectomy
strategy
Mild Severe
ostial/Bf/small/diffuse

¡¡ Gracias !!
jpalaz@gmail.com

Intervencionismo coronario en lesiones severamente calcificadas

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