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8.4.2  Summary of Clinical Results out to 1 year (Interim Data Cutoff)

Of the total of 605 patients registered in ABSORB EXTEND as of December 3, 2012, 37-day 

(30 days ±7-day window), 194-day (180 days ±14-day window) and 393-day (365 days 

±28-day window) clinical follow-up data were available for 591, 537, and 450 subjects, 

respectively (

Table 6

). The composite endpoints are presented using the protocol definitions 

for MI. The component endpoints are based on non-hierarchical counts unless otherwise 

noted.

Table 6: ABSORB EXTEND Subject Counts of Ischemia-driven Adverse Events through  

393 Days (All Subjects Registered Population)

Events

ABSORB EXTEND 

0 – 37 Days  

(N = 591)

ABSORB EXTEND 

0 – 194 Days  

(N = 537)

ABSORB EXTEND 

0 – 393 Days  

(N = 450)

Hierarchical MACE

2.4% (14/591)

3.0% (16/537)

4.2% (19/450)

Hierarchical TVF

2.4% (14/591)

3.4% (18/537)

4.7% (21/450)

Non-Hierarchical Counts

  Cardiac Death

0.2% (1/591)

0.2% (1/537)

0.2% (1/450)

  MI

2.4% (14/591)

2.8% (15/537)

2.9% (13/450)

    QMI

0.7% (4/591)

0.6% (3/537)

0.9% (4/450)

    NQMI

1.7% (10/591)

2.2% (12/537)

2.0% (9/450)

  ID-TLR

0.3% (2/591)

0.6% (3/537)

1.8% (8/450)

  ID-non-TL TVR

0.0% (0/591)

0.6% (3/537)

0.9% (4/450)

Scaffold Thrombosis

0 – 30 days

0 – 194 days

0 – 393 days

  Definite

0.3% (2/591) 

0.4% (2/536)

0.7% (3/449)

  Probable

0.2% (1/591) 

0.2% (1/536)

0.2% (1/449)

  Definite / Probable

0.5% (3/591) 

0.6% (3/536)

0.9% (4/449)

Note:

 Subjects are only counted once for each type of event in each time period. 

Note:

 All table entries were calculated based on the data from data cut-off date of 

December 3, 2012. 

The 37-day MACE and TVF rates of 2.4% were driven by MI events (10 NQMI and 3 QMI 

hierarchically) that were all related to the target vessel. There was one cardiac death per 

ARC definition. The overall non-hierarchical MI rate at 37 days was 2.4% (14/591) (10 NQMI 

and 4 QMI). 

The MACE rate increased to 3.0% at 6 months, attributed mostly to the 15 hierarchical MI 

and 1 cardiac death. The TVF rate at 6 months was 3.4% (18/537 [1 cardiac death, 15 MI, 

and 2 ID-Non-TL TVR hierarchically]). One patient who died at day 108 was adjudicated 

as cardiac death per the ARC definition for cardiac death (0.2% at 194 days, 1/537). No 

Absorb BVS was implanted in the target lesion in this patient because there was difficulty 

in crossing the lesion with Absorb BVS. A metallic everolimus-eluting stent was implanted 

instead. Over the same period, the ID-TLR rate was 0.6% (3/537) due to the occurrence of 

two ID-TLR events by PCI and one ID-TLR event by CABG. The ID-non-TL TVR rate was 0.6% 

(3/537) due to the occurrence of two ID-non-TL TVR events by CABG and one ID-non-TL 

TVR event by PCI.

At 1 year, the MACE rate was 4.2% (19/450 [1 cardiac death, 13 MI (per protocol), and 

5 ID-TLR hierarchically]). The TVF rate was 4.7% (21/450 [1 cardiac death, 13 MI (per 

protocol), 5 ID-TLR, and 2 ID-non-TL TVR hierarchically]). The overall non-hierarchical MI 

rate (per protocol) at 393 days was 2.9% (13/450) (9 NQMI and 4 QMI).

8.4.3  Summary of Clinical Results out to 2 years (Interim Data Cutoff)

In the subset of first 250 patients that reached 2-year follow-up (758 days) (19 July 2013 

data cut), there was one case of cardiac death and the 758-day MACE and rate was low 

(7.3%). TLF and TVF rates were also low at 6.9% and 8.1%, respectively. Further, the ARC 

defined de probable scaffold thrombosis rate through 758-days for this population 

was 0.8%.

Table 7: ABSORB EXTEND Subject Counts of Ischemia-driven Adverse Events through  

758 Days (250 Subjects Registered Population)

Events

30 Days, 

N = 250

 

(30 ± 7 days)

6 Months,  

N = 250

 

(180 ± 14 days)

1 year,  

N = 250

 

(365 ± 28 days)

2 years, 

N = 250

 

(730 ± 28 days)

Hierarchical, 

Per protocol

MACE

2.0% (5/250)

2.8% (7/250)

4.4% (11/250)

7.3% (18/248)

TVF

2.0% (5/250)

3.2% (8/250)

4.8% (12/250)

8.1% (20/248)

TLF 

2.0% (5/250)

2.8% (7/250)

4.4% (11/250)

6.9% (17/248)

Non-

hierarchical 

counts

MI (per 

protocol)

2.0% (5/250)

2.4% (6/250)

2.8% (7/250)

4.0% (10/248)

Cardiac 

death

0.0% (0/250)

0.4% (1/250)

0.4% (1/250)

0.4% (1/248)

Ischemia-

driven 

TLR 

0.4% (1/250)

0.4% (1/250)

2.0% (5/250)

4.0% (10/248)

Ischemia-

driven non-

TL TVR 

0.0% (0/250)

0.4% (1/250)

0.8% (2/250)

2.0% (5/248)

Scaffold 

Thrombosis  

(ARC Def / 

Prob) 

0.4% (1/250)

0.4% (1/249)

0.8% (2/249)

0.8% (2/246)

1.  Data are % (number of subjects with event / number of subjects)

2.  TLR = target lesion revascularization, TV = target vessel

3.  MACE = major adverse cardiac events (composite endpoint of cardiac death, MI, 

ischemia-driven TLR)

4.  TLF = target lesion failure (composite endpoint of cardiac death, TVMI, ischemia-

driven TVR)

5.  TVF = target vessel failure (composite endpoint of cardiac death, MI, ischemia-driven 

TLR, ischemia-driven Non-TLR TVR)

Conclusion:

 The interim outcomes from ABSORB EXTEND further demonstrate the 12- and 

24-month safety and performance of Absorb BVS in a larger population of subjects where 

longer lesion can be treated. Patients will be followed for up to 3 years.

8.5 

Propensity Score Adjusted Analysis of Absorb BVS System and XIENCE V

Rationale and Method:

 Abbott Vascular is using its large body of historical clinical data on 

XIENCE V stents as a control group for comparison against the currently available Absorb 

BVS clinical data utilizing the propensity score method. Propensity score analysis is a 

valid statistical method that is well accepted and commonly used in the clinical trial, and 

in scientific and statistical communities for the comparison of data from non-randomized 

studies. This approach adjusts for the baseline imbalance between the test and control 

groups, creates a better match between both groups, and hence, reduces real and potential 

bias in the comparative analysis. After propensity score adjustment, baseline characteristics 

between the two groups are more balanced, and therefore, the comparisons of the clinical 

outcomes become more reliable. Key results for a 6-month and a 1-year propensity analysis 

comparing Absorb BVS to XIENCE V data are presented using the inverse propensity score 

weighted (IPSW) method

1

2

. Propensity analysis at later time points will be conducted as 

additional data from ongoing trials become available. The results of this comparison are 

being confirmed through ongoing clinical trials.

8.5.1  6-month Propensity Analysis

Thirty-eight patients from ABSORB Cohort B Group 1 and 73 XIENCE V patients treated with 

3.0 x 18 mm stents from SPIRIT FIRST and SPIRIT II with 6-month QCA data are used for 

this 6-month analysis. Their unadjusted 6-month MACE rates are 2.63% (1/38) and 4.11% 

(3/73), respectively.

Results:

 The propensity score adjustment yielded adjusted sample sizes of 34 (Absorb BVS) 

and 66 (XIENCE V) from the 38 and 73, respectively, in the unadjusted arms. The adjusted 

data were more balanced in baseline patient demographics and angiographic characteristics 

between both arms. At 6 months, their clinical outcomes and angiographic results were 

comparable. The adjusted 6-month MACE rates were 2.01% (0.7/34) and 5.27% (3.5/66), 

respectively, for the Absorb BVS and XIENCE V arms (

Table 8

) with a lower MACE observed 

with Absorb BVS, a trend that is consistent with the results from the unadjusted groups.

Table 8: MACE at 6 Months from the IPSW-Adjusted Data

Clinical Outcomes at  

6 Months

Absorb BVS System 

(N = 34)

XIENCE V 

(N = 66)

p-value

MACE 

[95% CI]

2.01% (0.7)

[0.00%, 6.73%]

5.27% (3.5)

[0.00%, 10.66%]

0.44

The 6-month in-device late loss in the IPSW-adjusted arms was 0.14 ±0.18 mm for the 

Absorb BVS System vs. 0.12 ±0.26 mm for the XIENCE V EECSS, representing a non-

significant difference in outcomes between the Absorb BVS System and the XIENCE V EECSS 

(p = 0.68). Similarly, differences in the in-device % diameter stenosis, in-segment late loss, 

and in-segment % diameter stenosis were not significant between the two devices in this 

propensity score adjusted analysis (

Table 9

).

Table 9: Angiographic Outcomes at 6 Months from the IPSW-Adjusted Data

QCA Results at 6 Months

Absorb BVS System 

(N = 34)

XIENCE V 

(N = 66)

p-value

In-device % Diameter 

Stenosis 

17.59 ±8.61

15.27 ±9.50

0.24

In-segment % Diameter 

Stenosis 

23.87 ±9.48

23.83 ±12.23

0.99

In-device Late Loss (mm)

0.14 ±0.18

0.12 ±0.26

0.68

In-segment Late Loss (mm)

0.11 ±0.29

0.08 ±0.28

0.72

8.5.2  1-year Propensity Analysis

Prior to propensity adjustment, a total of 314 Absorb BVS pooled from Cohort B and an 

interim dataset from ABSORB EXTEND, and 905 XIENCE V patients pooled from SPIRIT 

FIRST, SPIRIT II, and SPIRIT III with 1-year follow-up were available, irrespective of the device 

sizes used for their treatment. Their unadjusted 1-year MACE rates are 5.41% (17/314) and 

5.64% (51/905), respectively.

Results:

 After the propensity adjustment, 282 Absorb BVS and 583 XIENCE V patients 

remained for the comparative analysis. An improved balance was achieved between both 

cohorts with the most striking changes observed in the lesion characteristics, which were 

no longer statistically different between Absorb BVS and XIENCE V cohorts. The MI, ID-TLR, 

MACE, and TLF (Target Lesion Failure defined as cardiac death, target vessel related MI and 

ID-TLR) rates were comparable between both adjusted cohorts at 37, 193, and 393 days. 

A summary of key 1-year outcomes is shown in 

Table 10.

 After adjustment, the MACE 

rates remained comparable, with a numerically lower rate obtained for Absorb BVS (4.15%, 

11.7/282) versus XIENCE V (5.63%, 32.8/583). The respective scaffold / stent thrombosis 

rates were not statistically different (0.40% vs. 0.52%, p = 0.80).

Table 10: Clinical Outcomes at 1 year from the IPSW-Adjusted Cohorts

Clinical Outcomes  

at 1 year

Absorb BVS 

(N = 282)

XIENCE V 

(N = 583)

p-value

MACE 

[95% CI]

4.15%  

[1.82%, 6.47%]

5.63%  

[3.76%, 7.50%]

0.35

MI 

[95% CI]

2.64%  

[0.77%, 4.51%]

2.52% 

[1.25%, 3.80%]

0.92

ID-TLR 

[95% CI]

1.95%  

[0.33%, 3.56%]

3.10%  

[1.70%, 4.51%]

0.33

TLF 

[95% CI]

4.15%  

[1.82%, 6.47%]

5.09%  

[3.30%, 6.87%]

0.54

Definite / Probable 

Scaffold / Stent 

Thrombosis  

[95% CI]

0.40%

[0.0%, 1.14%]

0.52%

[0.0%, 1.11%]

0.80

Discussion:

 The propensity score adjusted method achieved the intent of balancing the 

baseline characteristics between both XIENCE V and Absorb BVS groups from different 

ABSORB and SPIRIT trials. The adjusted results showed that Absorb BVS is comparable to 

the XIENCE V stent for in-stent late loss at 6 months and for clinical outcomes at 6 months 

and 1 year after implantation, and further confirms the comparability between Absorb BVS 

and XIENCE V in the above parameters found in the unadjusted data. 

2

  Rosenbaum PR. Model-based direct adjustment. J Am Stat Assoc. 1987;82:387–394.

8.5.3  2-year Propensity Analysis

As of the data cut-off on 19 July 2013, prior to propensity score matched analysis, a total 

of 250 Absorb BVS and 887 XIENCE V patients were available through 2 years. Following 

matching, 178 Absorb BVS and 293 XIENCE V patients remained for the comparative 

analysis.

Results:

 After propensity score matched adjustment, 2-year MACE and TLF rates remained 

similar between the Absorb BVS cohort and the XIENCE V cohort (6.7% vs. 8.9% for MACE, 

and 6.2% vs. 8.2% for TLF, respectively). The Absorb BVS cohort exhibited a trend of lower 

ID-TLR and cardiac death rate as compared to the XIENCE V cohort, although the differences 

were not significant. The 2-year TVF rate was also numerically lower in the Absorb BVS 

group (7.3% vs. 12.3%, p = 0.09). The adjusted definite / probable scaffold / stent 

thrombosis rates were similar between Absorb BVS and XIENCE V at 2 years (0.6%; 95% CI 

[0.01%, 3.09%] vs. 1.4%; 95% CI [0.37%, 3.46%], p=0.65). A summary of the key data is 

shown below in 

Table 11.

Table 11: Clinical Outcomes at 2 years from the IPSW-Adjusted Cohorts

Clinical Outcomes  

at 2 years

Absorb BVS 

(N = 178)

XIENCE V 

(N = 293)

p-value

Cardiac Death 

[95% CI]

0.0%

[0.00%, 2.05%]

1.4%

[0.37%, 3.46%]

0.30

MI  

[95% CI]

4.5%

[1.96%, 8.66%]

4.4%

[2.38%, 7.47%]

1.00

ID-TLR 

[95% CI]

3.4%

[1.25%, 7.19%]

3.8%

[1.89%, 6.62%]

1.00

TLF  

[95% CI]

6.2%

[3.12%, 10.79%]

8.2%

[5.32%, 11.94%]

0.47

MACE  

[95% CI]

6.7%

[3.53%, 11.48%]

8.9%

[5.88%, 12.73%]

0.49

TVF  

[95% CI]

7.3%

[3.95%, 12.17%]

12.3%

[8.76%, 16.60%]

0.09

Definite / Probable 

Scaffold / Stent 

Thrombosis  

[95% CI]

0.6%

[0.01%, 3.09%]

1.4%

[0.37%, 3.46%]

0.65

Note:

 Components (cardiac death, MI and ID-TLR) are presented as non-hierarchical.

Discussion:

 The comparability of Absorb BVS to XIENCE V demonstrated with in-scaffold / 

stent late loss at 6 months (Cohort B only), and clinical outcomes at 6 months, and 1 year 

were maintained through 2-years post implantation. The collective data confirms the 

comparability between Absorb BVS and XIENCE V based on propensity analyses.

8.6 

ABSORB II RCT 

8.6.1  Study Design 

The ABSORB II trial is a post-approval, randomized (Absorb BVS vs. XIENCE, 2:1), actively 

controlled, single-blind, multicenter trial conducted in Europe and New Zealand. Patients can 

be treated with a maximum of two 

de novo

 native coronary artery lesions. Scaffold sizes 

were selected based on proximal and distal Dmax (maximum diameter) by on-line QCA ≥ 

2.25 mm to ≤ 3.8 mm and lesion lengths ≤ 48 mm. The study sizes include 2.5 x 18 mm, 

2.5 x 28 mm, 3.0 x 18 mm, 3.0 x 28 mm, 3.5 x 12 mm, 3.5 x 18 mm, and 3.5 x 28 mm.

The co-primary endpoints are 1) vasomotion assessed by change in mean lumen diameter 

between pre- and post-nitrate at 3 years (superiority), and 2) minimum lumen diameter 

at 3 years post-nitrate minus minimum lumen diameter post-procedure post-nitrate (non-

inferiority, reflex to superiority). Patients will be clinically followed at 30 days, 180 days, and 

at 1, 2, and 3 years post-procedure. The morphological as well as functional response will 

be evaluated at 3 years based on imaging which will include angiography, IVUS / IVUS-virtual 

histology, and Lipiscan, with MSCT evaluation at 3 years.

8.6.2  Summary of Clinical Outcome Data

The ABSORB II RCT trial completed its enrolment on June 4, 2013 with a total of 501 

patients: Absorb BVS (N = 335); XIENCE (N = 166). One-year follow up data are 

summarized in this section.

As shown in 

Table 12,

 the overall safety and performance of the Absorb BVS were similar to 

the XIENCE. The 1-year TLF and MACE rates were comparable between the two device arms: 

4.8% vs. 3.0% for TLF (p = 0.3473); and 5.2% vs. 3.0% for MACE (p = 0.2832). Both 

Absorb BVS and XIENCE arms had no cardiac death, and low rates of MI, revascularizations, 

and stent thrombosis. These adverse cardiovascular event rates were generally comparable 

between the two treatment arms except for MI, which was trending higher in the Absorb 

BVS arm (4.5% vs. 1.2%, p = 0.0549) and for all revascularization, which was trending 

lower in the Absorb BVS arm (3.6% vs. 7.3%, p = 0.0758). The ARC definite stent / scaffold 

thrombosis rates were similar between BVS (0.6%) and XIENCE (0.0%) (p = 1.000). 

Table 12: Clinical Outcome through 1 year

Absorb BVS 

(N = 335)

XIENCE  

(N = 166)

Difference  

(95% CI)

p-value

Safety (Non-Hierarchical)

Death % 

0.0%

0.6%

-0.61%

[-3.35%, 0.65%]

0.33

Cardiac death % 

0.0%

0.0%

0.00%

[NA]

1.00

All MI 

4.5%

1.2%

3.33%

[-0.24%, 6.29%]

0.055

   QMI

0.6%

0.0%

0.61%

[-1.71%, 2.18%]

0.55

   NQMI

3.9%

1.2%

2.73%

[-0.77%, 5.55%]

0.095

Stent / Scaffold 

thrombosis (ARC definite)

0.6%

0.0%

0.6%

[11.7%, 2.16%]

1.00

Effectiveness (Non-Hierarchical)

ID-TLR 

1.2%

1.8%

-0.61%

[-4.08%, 1.61%]

0.69

ID-TVR, nonTLR

0.9%

1.8%

-0.91%

[-4.35%, 1.19%]

0.41

EL2103340 (4/24/15) 

Page 7 of 137

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Содержание Absorb GT1 Bioresorbable Vascular Scaffold...

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Страница 4: ...adequate lesion preparation or a lesion with greater than 40 residual stenosis after predilatation by visual estimation 6 0 PRECAUTIONS 6 1 Scaffold Handling Precautions For single use single insertio...

Страница 5: ...stem All other adverse events are included in section 7 2 Potential Adverse Events 7 2 Potential Adverse Events Adverse events that may be associated with PCI treatment procedures and the use of a cor...

Страница 6: ...e been reported through 4 years The overall MACE rate at 4 years was 10 1 and there have been no cases of cardiac death or scaffold thrombosis per protocol or per ARC definitions The 4 year full Cohor...

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Страница 8: ...are lifted Do not use if any defects are noted 10 4 3 Guide Wire Lumen Flush Flush the guide wire lumen with HepNS until fluid exits the guide wire exit notch Note Avoid manipulation of the scaffold w...

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Страница 19: ...bles celles du syst me XIENCE Les taux d ELC et d EICM 1 an taient comparables entre les deux bras utilisant le dispositif 4 8 contre 3 0 pour l ELC p 0 3473 et 5 2 contre 3 0 pour les EICM p 0 2832 A...

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Страница 26: ...e sea adecuada para garantizar que el armaz n no se dilate en exceso El l mite de dilataci n del armaz n es de 0 5 mm por encima del di metro nominal en todos los tama os de armaz n PRECAUCI N No sobr...

Страница 27: ...d L impianto dello scaffold va effettuato solo da medici che abbiano ricevuto un training appropriato Il posizionamento dello scaffold va eseguito soltanto nei centri ospedalieri dove sia possibile ef...

Страница 28: ...to dello scaffold densit del farmaco marker permanenti dello scaffold e struttura dello scaffold L Absorb GT1 BVS differisce dall Absorb BVS solo nel sistema di rilascio dello scaffold Il sistema di r...

Страница 29: ...perplasia neointimale nello scaffold la percentuale dell ostruzione dell area nello scaffold e l iperplasia neointimale erano minime rispettivamente 1 43 e 0 09 mm2 Nel corso del tempo si verificato u...

Страница 30: ...ggruppati dalla Coorte B e un set di dati provvisori di ABSORB EXTEND e 905 pazienti XIENCE V raggruppati da SPIRIT FIRST SPIRIT II e SPIRIT III con un follow up di 1 anno a prescindere dalle dimensio...

Страница 31: ...o 10 4 4 Preparazione del sistema di rilascio 1 Preparare un dispositivo di gonfiaggio siringa con mezzo di contrasto diluito 2 Collegare un dispositivo di gonfiaggio siringa al rubinetto quindi colle...

Страница 32: ...implantada do sistema de entrega da plataforma O sistema BVS Absorb GT1 possui um sistema de entrega da plataforma de troca r pida RX Dois marcadores proximais do eixo do sistema de entrega 95 cm e 10...

Страница 33: ...n o expandida s pode ser retra da para o cateter guia uma nica vez Uma plataforma n o expandida n o deve ser reintroduzida na art ria depois de ter sido retra da para o cateter guia N o se deve execut...

Страница 34: ...e na Nova Zel ndia No estudo de Coorte A ABSORB o BVS de Coorte A Absorb foi implantado em doentes com uma nica les o de novo da art ria coron ria nativa A inscri o come ou com o tamanho 3 0 x 12 mm...

Страница 35: ...p s 3 anos p 0 0001 Os resultados de OCT a 3 anos N 18 revelaram tamb m um aumento da plataforma entre 1 e 3 anos rea m dia da plataforma de 7 51 0 95 mm2 ap s 1 ano vs 8 64 2 15 mm2 ap s 3 anos p 0 0...

Страница 36: ...e 95 0 6 0 01 3 09 1 4 0 37 3 46 0 65 Nota Os componentes morte card aca EM e ID TLR s o apresentados de uma forma n o hier rquica Discuss o A comparabilidade entre o BVS Absorb e o XIENCE V demonstra...

Страница 37: ...ntes da implanta o reconfirmar a posi o correcta da plataforma em rela o les o alvo com os marcadores de bal o radiopacos 3 Implantar a plataforma pressurizando lentamente o sistema de entrega em incr...

Страница 38: ...och risk f r patient och eller anv ndarskada Inneh ll Ett 1 Absorb GT1 system med bioresorberbar vaskul r scaffold en 1 TagAlert temperaturmonitor F rvaring F rvaras vid eller under 25 C 77 F avvikel...

Страница 39: ...onar scaffold i nativa kransart rer inkluderar men r ej begr nsade till f ljande pl tslig k rlavst ngning komplikationer vid punktionsst llet allergisk reaktion eller verk nslighet mot kontrastmedel p...

Страница 40: ...n kohort B1 begr nsad neointimal hyperplasi i scaffolden volymobstruktionen VO var 1 2 N 40 och arean f r den neointimala hyperplasin var 0 08 mm2 N 40 Dessa resultat kan m ta sig med resultaten f r X...

Страница 41: ...64 0 77 4 51 2 52 1 25 3 80 0 92 ID TLR 95 KI 1 95 0 33 3 56 3 10 1 70 4 51 0 33 TLF 95 KI 4 15 1 82 6 47 5 09 3 30 6 87 0 54 Definitiv sannolik scaffold stenttrombos 95 KI 0 40 0 0 1 14 0 52 0 0 1 11...

Страница 42: ...strumentet ppna den roterande hemostasventilen s mycket som m jligt 5 Ladda b rarsystemet bakifr n p ledarens proximala del samtidigt som ledarens position bibeh lls ver m llesionen 6 F r in b rarsyst...

Страница 43: ...ioneren zoals bedoeld Veranderingen in mechanische fysische en of chemische eigenschappen door herhaald gebruik reiniging en of hersterilisatie kunnen de integriteit van het ontwerp en of de materiale...

Страница 44: ...vaatwand wanneer wordt besloten om de Absorb GT1 BVS bij een pati nt te implanteren die een geneesmiddel gebruikt waarvan bekend is dat het met everolimus interageert Everolimus voorgeschreven in oral...

Страница 45: ...ngiografisch vastgesteld verlies van 0 43 mm op de lange termijn gezien dit was meer dan eerder werd waargenomen bij de XIENCE V stent na 6 maanden SPIRIT FIRST en werd mogelijk veroorzaakt door bioac...

Страница 46: ...8 1 Daarnaast bedroeg het percentage zekere waarschijnlijke trombose in de steun tot aan 758 dagen voor deze populatie volgens de ARC definitie 0 8 Tabel 7 Aantallen pati nten met door ischemie veroo...

Страница 47: ...ische onderzoeken in combinatie met de actuele literatuur over geneesmiddel eluerende stents steunen en de specifieke behoeften van de individuele pati nt om aan de hand hiervan in hun algemene prakti...

Страница 48: ...1 mm en maximaal 4 mm overlappen om het risico van restenose in de ruimte tussen de steunen te voorkomen Om ervoor te zorgen dat er geen leemte tussen steunen ontstaat moeten de ballonmarkeringen van...

Страница 49: ...dotelialiserede stilladser kendes ikke p nuv rende tidspunkt 6 2 Anl ggelse af stilladset Forsigtighedsregler Fremf ringssystemet m ikke klarg res eller pr dilateres f r anl ggelse af stilladset udove...

Страница 50: ...af ca 101 patienter kohorte B p 12 kliniske centre i Europa og Asien Stillehavsomr det Egnethedskriterier Patienter p mindst 18 r med tegn p angina myokardieisk mi eller en positiv funktionstest kvin...

Страница 51: ...95 mm2 efter 1 r vs 8 64 2 15 mm2 efter 3 r p 0 0008 Lumenarealet forblev relativt konstant 6 01 1 29 mm2 efter 1 r vs 6 09 1 67 mm2 efter 3 r p 0 679 Kararealet blev ikke m lt da OCT ikke kan afgr ns...

Страница 52: ...en morfologiske samt funktionelle respons vil blive vurderet efter 3 r baseret p billeddiagnostik som vil omfatte angiografi IVUS IVUS virtuel histologi og LipiScan med MSCT vurderet efter 3 r 8 6 2 O...

Страница 53: ...vis det er n dvendigt kan fremf ringssystemet s ttes under tryk igen eller under yderligere tryk for at sikre fuldst ndig apposition af stilladset til arteriev ggen D k hele l sionen og det omr de der...

Страница 54: ...3 3 0 28 6F 0 070 1 8 mm 7 709 16 1621 73 3 5 12 6F 0 070 1 8 mm 6 608 16 1621 73 3 5 18 6F 0 070 1 8 mm 6 608 16 1621 73 3 5 23 6F 0 070 1 8 mm 6 608 16 1621 73 3 5 28 6F 0 070 1 8 mm 6 608 16 1621 7...

Страница 55: ...europa eu www fda gov 8 0 ABSORB BVS Absorb GT1 BVS Absorb BVS 8 0 Absorb BVS Absorb GT1 BVS Absorb BVS Absorb GT1 BVS Absorb BVS Absorb GT1 RX Abbott Vascular Absorb GT1 Absorb Absorb GT1 BVS Absorb...

Страница 56: ...ECSS SPIRIT FIRST First In Man 0 43 mm N 26 A 180 IVUS B1 VO 1 2 N 40 0 08 mm2 N 40 XIENCE V EECSS SPIRIT FIRST VO 8 0 N 21 NIH 0 56 mm2 N 21 VO 5 3 N 25 NIH 0 29 mm2 N 25 IVUS 6 6 60 1 22 mm2 N 37 6...

Страница 57: ...E V Absorb BVS 6 1 Absorb BVS XIENCE V inverse propensity score weighted IPSW 1 8 5 1 6 B 1 ABSORB 73 XIENCE V 3 0 x 18 mm SPIRIT FIRST SPIRIT II QCA 6 6 MACE 6 2 63 1 38 4 11 3 73 34 Absorb BVS 66 XI...

Страница 58: ...5 5 2 73 7 49 0 76 0 13 TLR 1 2 1 8 0 61 4 08 1 61 0 69 TVR nonTLR 1 8 3 6 1 82 6 28 0 67 0 23 NTVR 1 8 3 6 1 82 6 00 1 05 0 23 3 6 7 3 3 64 8 88 0 39 0 076 TLF TVMI ID TLR 4 8 3 0 1 82 2 46 5 18 0 3...

Страница 59: ...trznaczyniowej IVUS i OCT po 180 dniach 1 roku 2 oraz 3 latach 8 3 4 Om wienie 8 4 ABSORB EXTEND 8 4 1 Metodologia i stan obecny 8 4 2 Zestawienie wynik w klinicznych z okresu 1 roku z odci ciem danyc...

Страница 60: ...zenie pow oki kontaminacj lub od czenie rusztowania od balonika systemu zak adania Nale y u ywa wy cznie odpowiedniego rodka do nape niania balonika Nie nale y u ywa do tego celu powietrza ani innych...

Страница 61: ...rdziowy Obrz k obwodowy Wysi k op ucnowy Zapalenie p uc Gor czka Wysypka Niewydolno nerek Zaka enia g rnych dr g oddechowych Zaka enie dr g moczowych ylna choroba zakrzepowo zatorowa Wymioty Powik ani...

Страница 62: ...w grupie A N 26 Po 180 dniach wyniki badania IVUS w grupie B1 pokaza y ograniczony przerost neointimy w rusztowaniu zmniejszenie obj to ci VO wynios o 1 2 N 40 a powierzchnia przerostu neointimy wynos...

Страница 63: ...wia o nieznamienn statystycznie r nic w wynikach pomi dzy systemem Absorb BVS i XIENCE V EECSS p 0 68 Podobnie wyniki w zakresie rednicy stenozy w urz dzeniu p nej utraty wiat a w segmencie i rednicy...

Страница 64: ...dokonywany jest na podstawie decyzji lekarza 10 4 Przygotowanie urz dzenia 10 4 1 Zdejmowanie opakowania Uwaga Torebka foliowa stanowi steryln barier Produkt sterylny jest zawarty w tej jednej torebce...

Страница 65: ...haemia okozta mell khat sok jelentkeztek 393 napos id szak alatt az sszes regisztr lt alany 8 4 3 A klinikai eredm nyek sszefoglal sa a 2 vig el zetes adatok 7 t bl zat ABSORB EXTEND alanyok akikn l i...

Страница 66: ...teljesen elfedje az Absorb GT1 BVS rendszert Minden hirtelen elz r d st a k rh z s rg ss gi ell t si protokolljai szerint kell kezelni Megjegyz s A s rg ss gi behelyez seket megfelel m ret f mes ever...

Страница 67: ...l MI vagy ischaemia miatti TLR n 3 3 1 3 4 1 3 4 1 3 4 1 3 4 1 3 4 1 rt masztromb zis 0 0 0 0 0 0 Megjegyz sek A nevez kiz rja azokat az alanyokat akiknek nincsenek ut nk vet si adataik s akikn l a k...

Страница 68: ...i vizsg l helyr l Minden beteg eset ben maximum k t k l nb z epicardialis v red nyben lev de novo nat v koszor r l zi t kezelnek Azok a betegek ker lhetnek be a ABSORB EXTEND vizsg latba akikn l a c l...

Страница 69: ...kus sz m t sok Hal l 0 0 0 6 0 61 3 35 0 65 0 33 Sz vhal l 0 0 0 0 0 00 NA 1 00 MI sszesen 4 5 1 2 3 33 0 24 6 29 0 055 QMI 0 6 0 0 0 61 1 71 2 18 0 55 NQMI 3 9 1 2 2 73 0 77 5 55 0 095 Sztent rt masz...

Страница 70: ...s a vezet kat tert egy egys gk nt kell elt vol tani Ezt k zvetlen fluoroszk pi s ellen rz s mellett kell v gezni 7 Szor tsa meg a forg v rz sg tl szelepet Ezzel az rt masz k szen ll a kinyit sra 10 6...

Страница 71: ...tila jej adekv tn apozice Sn te t m riziko po kozen opory P i zav d n zav d c ho syst mu do c vy na n j neaplikujte podtlak M e to zp sobit uvoln n opory z balonku Neot ejte katetrem o v ce ne jednu 1...

Страница 72: ...edeno p ekryt m pomoc stentu XIENCE V vhodn d lky a pokud nen tento stent k dispozici mus se pou t stent CYPHER vylu uj c sirolimus bailout se syst mem Absorb BVS nebylo p pustn Postdilatace byla prov...

Страница 73: ...po 3 letech N 18 rovn odhalily zv t en opory mezi 1 a 3 lety st edn plocha opory 7 51 0 95 mm2 po 1 roce vs 8 64 2 15 mm2 po 3 letech p 0 0008 Plocha lumen z stala relativn konstantn 6 01 1 29 mm2 v 1...

Страница 74: ...18 mm a 3 5 x 28 mm Koprim rn endpointy byly 1 vazomotorika vyhodnocen podle zm ny st edn ho pr m ru lumen pre a postnitr t po 3 letech nad azen a 2 minim ln pr m r lumen po 3 letech post nitr t m nus...

Страница 75: ...mu lze napomoci pou it m rutinn angiografie intravaskul rn ho ultrazvuku IVUS nebo optick koherentn tomografie OCT 8 Postdilataci pomoc nonkompliantn ho balonku se doporu uje prov st podle pokyn uvede...

Страница 76: ...rme sistemi damar i ine girerken yerle tirme sistemi zerinde negatif bas nca neden olmay n Bu iskelenin balondan kmas na neden olabilir Katetere bir 1 tam d n ten fazla tork uygulamay n Absorb GT1 BVS...

Страница 77: ...trombus i eren hedef damar hedef damar veya yan dalda klinik olarak nemli ba ka lezyonlar Tedavi Stratejisi Hedef lezyonun n dilatasyonu zorunluydu Absorb BVS nin planlanan st ste binmesine izin veri...

Страница 78: ...k Klinik Sonu lar n zeti Ge ici Veri Kesme 2 y ll k 758 g n 19 Temmuz 2013 veri kesintisi takibe ula an ilk 250 hastan n alt grubunda bir kardiyak l m vakas vard ve 758 g nl k MACE ile oran d kt 7 3 T...

Страница 79: ...performans XIENCE ile benzerdir Bir y ll k TLF ve MACE oranlar iki cihaz kolu aras nda kar la t r labilirdir TLF i in 4 8 e kar 3 0 p 0 3473 ve 5 2 ye kar MACE i in 3 0 p 0 2832 Ne Absorb BVS ne de X...

Страница 80: ...n yap lan segment iskelenin izin verilebilir geni leme s n rlar dahilinde oldu u s rece esnek olmayan nominal iskele ap ndan 0 5 mm ye kadar geni bir balonla postdilatasyon yap lmas nerilir skele geom...

Страница 81: ...tiu cievnej v stu e na zaistenie primeranej apoz cie v stu e Zn i to riziko po kodenia v stu e Pri zav dzan zav dzacieho syst mu do cievy nevystavujte zav dzac syst m podtlaku To m e sp sobi posunutie...

Страница 82: ...krit ri vyl enia aorto osti lne umiestnenie av hlavn umiestnenie do 2 mm od za iatku avej prednej zostupnej vetvy LAD alebo avej cirkumflexnej vetvy LCX nadmern skr tenie proxim lne k l zii alebo v r...

Страница 83: ...sa zv il av ak zostal minim lny po 2 rokoch 1 43 oproti 2 11mm2 p 0 0001 a stredn prierez l menu zostal nezmenen Okrem toho sa stredn v stu ov plocha zv ila zo 7 47 na 8 24 mm2 p 0 0155 od z kroku do...

Страница 84: ...ke 11 Tabu ka 11 Klinick v sledky po 2 rokoch z kohort s pravou IPSW Klinick v sledky po 2 rokoch Absorb BVS N 178 XIENCE V N 293 Hodnota p Srdcov smr 95 CI 0 0 0 00 2 05 1 4 0 37 3 46 0 30 IM 95 CI 4...

Страница 85: ...Tento postup vykon vajte pomocou priamej fluoroskopickej vizualiz cie 7 Utiahnite oto n hemostatick ventil V stu je teraz pripraven na rozvinutie 10 6 Postup rozvinutia 1 UPOZORNENIE Vn torn priemer...

Страница 86: ...ro mm mm in vitro RBP atm kPa atm kPa 2 5 8 6F 0 070 1 8 mm 6 608 16 1621 68 2 5 12 6F 0 070 1 8 mm 6 608 16 1621 68 2 5 18 6F 0 070 1 8 mm 6 608 16 1621 68 2 5 23 6F 0 070 1 8 mm 6 608 16 1621 68 2 5...

Страница 87: ...sorb GT1 BVS everolimus 7 0 7 1 ABSORB MI Q Q TLR PCI MACE MI TLR ID TLR 8 0 Absorb BVS 7 2 7 2 PCI L PLLA D L PDLLA TIA everolimus 1 5 mg 10 mg SPC 1 2 3 4 5 everolimus 10 everolimus 1 2 3 4 5 everol...

Страница 88: ...56 2 1 3 B 6 2009 6 9 1 2 3 IVUS 2 1 1 3 2 5 8 3 2 B 5 4 ABSORB 101 5 B ITT 30 6 9 1 2 3 4 N 101 N 101 N 101 N 101 N 100 N 100 N 99 0 0 0 0 0 0 0 MI n 2 0 2 3 0 3 3 0 3 3 0 3 3 0 3 3 0 3 3 0 3 MI Q 0...

Страница 89: ...XTEND 30 N 250 30 7 6 N 250 180 14 1 N 250 365 28 2 N 250 730 28 MACE 2 0 5 250 2 8 7 250 4 4 11 250 7 3 18 248 TVF 2 0 5 250 3 2 8 250 4 8 12 250 8 1 20 248 TLF 2 0 5 250 2 8 7 250 4 4 11 250 6 9 17...

Страница 90: ...55 MI Q 0 6 0 0 0 61 1 71 2 18 0 55 MI Q 3 9 1 2 2 73 0 77 5 55 0 095 ARC 0 6 0 0 0 6 11 7 2 16 1 00 TLR 1 2 1 8 0 61 4 08 1 61 0 69 TVR 0 9 1 8 0 91 4 35 1 19 0 41 NTVR 1 5 2 4 0 91 4 65 1 56 0 49 2...

Страница 91: ...iei ale ecografiei intravasculare IVUS i ale tomografiei n coeren optic OCT la 180 de zile 1 2 i 3 ani 8 3 4 Discu ii 8 4 ABSORB EXTEND 8 4 1 Metodologie i situa ia actual 8 4 2 Rezumatul rezultatelor...

Страница 92: ...a efectuat anterior brahiterapie a leziunii int sau a utiliz rii brahiterapiei pentru restenozarea zonei tratate din interiorul unui EVS Absorb GT1 At t brahiterapia vascular c t i EVS Absorb GT1 modi...

Страница 93: ...orb se poate estima c performan a EVS Absorb GT1 va fi similar cu cea a EVS Absorb Prin urmare datele provenite din studiile clinice pentru EVS Absorb sunt prezentate pe scurt n aceast sec iune 8 1 St...

Страница 94: ...m2 p n la 1 an 6 33 1 17 mm2 n urma OCT nu a existat nicio modificare semnificativ a suprafe ei medii i minime a e afodajului dup procedur i p n la 1 an N 21 S a nregistrat o reducere a suprafe ei lum...

Страница 95: ...a i din Cohorta B i un set de date interimare din cadrul ABSORB EXTEND i 905 pacien i XIENCE V extra i din cadrul SPIRIT FIRST SPIRIT II i SPIRIT III cu monitorizare de 1 an indiferent de dimensiunile...

Страница 96: ...lui de ghidare Not Evita i manevrarea e afodajului c nd sp la i lumenul firului de ghidare deoarece acest lucru poate afecta amplasarea e afodajului pe balona 10 4 4 Preg tirea sistemului de amplasare...

Страница 97: ...e n cateterul de ghidare ntregul sistem trebuie retras n bloc Consulta i sec iunea 6 4 Retragerea e afodajului sistemului M suri de precau ie pentru instruc iuni specifice de retragere a sistemului de...

Страница 98: ...GT1 Absorb GT1 Absorb 94 Absorb GT1 Absorb GT1 Absorb GT1 10 7 Absorb GT1 6 4 Absorb GT1 6 3 Absorb GT1 6 4 1 30 2 3 4 5 1 1 5 2 6 5 9 1 6 6 XIENCE PRIME Absorb GT1 3 2500 SAR 2 0 15 Absorb GT1 Absorb...

Страница 99: ...72 1 75 6 75 5 8 2 ABSORB A 8 2 1 A 30 7 2006 18 2006 Absorb de novo 3 0 x 12 3 0 x 18 2 30 180 270 1 18 2 3 4 5 VH 180 2 18 2 ABSORB 5 8 2 2 5 5 ID TLR 3 4 4 Q 2 21 QCA 42 46 Absorb 6 5 Academic Res...

Страница 100: ...18 SPIRIT FIRST 1 2 N 54 1 43 0 09 2 6 31 0 95 2 1 6 33 1 17 2 1 n 21 1 34 0 67 2 20 2 26 9 1 2 1 B B1 0 27 n 38 1 B2 B SPIRIT II 0 33 n 83 XIENCE V 2 n 33 Absorb 6 2 6 42 7 08 2 p 0 0001 6 36 6 85 2...

Страница 101: ...scular XIENCE V Absorb 6 1 Absorb XIENCE V IPSW 1 2 8 5 1 6 6 38 1 ABSORB 73 XIENCE V 3 0x18 SPIRIT FIRST SPIRIT II QCA 6 MACE 6 2 63 1 38 4 11 3 73 34 Absorb 66 XIENCE V 38 73 6 6 2 01 0 7 34 5 27 3...

Страница 102: ...29 0 055 Q 0 6 0 0 0 61 1 71 2 18 0 55 Q 3 9 1 2 2 73 0 77 5 55 0 095 ARC 0 6 0 0 0 6 11 7 2 16 1 00 1 2 1 8 0 61 4 08 1 61 0 69 Absorb N 335 XIENCE N 166 95 P 0 9 1 8 0 91 4 35 1 19 0 41 1 5 2 4 0 91...

Страница 103: ...3 4 5 6 7 10 6 1 in vitro 2 3 2 5 30 1 1 16 1621 4 5 Absorb GT1 6 30 10 8 7 O T 8 10 7 10 7 1 0 5 0 5 0 5 2 5 3 00 3 00 3 50 3 5 4 00 2 Absorb GT1 1 4 Absorb GT1 Absorb GT1 3 10 8 1 30 2 3 4 5 6 1 5...

Страница 104: ...ytt inen Ota TagAlert monitori laatikosta ja h vit paikallisten s nn sten mukaan B Ei saa k ytt 2 0 TOIMITUSTAPA Steriili T m laite on steriloitu elektronisuihkus detysmenetelm ll Pyrogeenit n Ei saa...

Страница 105: ...ptiini simetidiini danatsoli CYP3A4 n induktorit jotka saattavat v hent everolimuusil kkeen m r antibiootit esim rifampisiini rifabutiini epilepsial kkeet esim karbamatsepiini fenobarbitaali fenytoiin...

Страница 106: ...t l keaineella oli positiivinen vaikutus uudelleenahtautumisen est misess 2 vuoden seurannassa angiografiatulokset osoittivat hyv ksytt v tukirakenteen menetyst 0 48 mm 2 vuoden j lkeen ja v h ist muu...

Страница 107: ...mukainen ei hierarkkinen kokonais MI m r oli 2 9 13 450 9 NQMI ja 4 QMI tapahtumaa 8 4 3 2 vuoden ajalta saatujen kliinisten tulosten yhteenveto tietojen v lianalyysi Ensimm isten 250 potilaan alaryhm...

Страница 108: ...2 vuoden seurannassa 8 2 5 Tutkimusl yd sten tarkastelu Pysyv n metalli implantin puuttuminen verisuonikudoksesta voi helpottaa kohdesuonen ahtauman tai sivuhaarojen my hemmin joko perkutaanisin tai k...

Страница 109: ...laajennetaan liikaa Tukirakenteen nimellisl pimitta Laajentamisraja 2 5 mm 3 00 mm Laajennuksen j lkeinen enimm isl pimitta 3 00 mm 3 50 mm Laajennuksen j lkeinen enimm isl pimitta 3 5 mm 4 00 mm Laa...

Страница 110: ...krives i avsnitt 10 4 4 Klargj ring av utleggingssystemet Utf r en omhyggelig m ling av diameteren p referansem llesjonen for unng overekspansjon av stillaset og dermed sikre god stillasplassering Det...

Страница 111: ...aorto ostial plassering venstre hovedplassering innenfor 2 mm fra utgangspunktet for LAD eller LCX sterk vridning proksimalt for eller i lesjonen ekstrem vinkling 90 sterk forkalkning restenose fra t...

Страница 112: ...for de 45 pasientene i kohort B1 og etter 1 r og 3 r for de 56 pasientene i kohort B2 Totalt har Absorb BVS systemet vist akutt suksess 98 prosedyresuksess og 100 enhetssuksess og sikkerhet opptil 3...

Страница 113: ...sienter Absorb BVS N 335 XIENCE N 166 Data fra ett rig oppf lging er oppsummert i dette avsnittet Som vist i Tabell 12 var den totale sikkerheten og ytelsen til Absorb BVS tilsvarende XIENCE De 1 rige...

Страница 114: ...kontakt med arterieveggen 5 Ved behov kan utleggingssystemet trykksettes p nytt eller trykksettes mer for sikre fullstendig anleggelse av stillaset mot arterieveggen Dekk hele lesjonen og det ballongb...

Страница 115: ...ino enot Rapid Exchange Kiirvahetus tr apmai a Greitasis keitimas Hitra izmenjava Non pyrogenic Mittep rogeenne Nepirog ns Nepirogeninis Apirogeno Separate collection for waste electrical electronic...

Страница 116: ...d pol meer pol L laktiidist PLLA toes mis on kaetud antiproliferatiivse ravimi everoliimuse ja pol meer pol D L laktiidi PDLLA seguga suhtes 1 1 Everoliimuse kogus toesel on esitatud tabelis 1 Tabel 1...

Страница 117: ...ainet sest see v ib p hjustada eba htlast laienemist ja takistada toese paigaldamist Toese implantatsiooni tohivad teha ainult vastava v lja ppega arstid Toese implantatsiooni tohib teha vaid haiglate...

Страница 118: ...rselt protseduurij rgse ja 180 p eva vahelisel ajal aga suurenesid arvuliselt 180 p eva ja 2 aasta vahelisel ajal 8 2 4 Vasomotoorse talitluse tulemused 2 aastasel j lgimisel Ravitud toestatud segmen...

Страница 119: ...onile koos struktuurse tervikluse v henemisega See n htus on bioresorbeeruvate vaskulaarsete toeste ainulaadne omadus v rreldes IVUS i metalliliste DES ide sari piltdiagnostikaga kus valendiku hilisem...

Страница 120: ...eduuri ohte ja eeliseid ning antiagregatiivse ravi enneaegse v i ajutise l petamisega kaasnevat v imalikku ohtu Patsiente kellel antiagregatiivne ravi tuleb enneaegselt l petada t sise aktiivse verejo...

Страница 121: ...UST rge laiendage toest le dilatatsiooni piiri mis on 0 5 mm le nimidiameetri lelaiendamine v ib toest kahjustada Toese nimidiameeter Dilatatsiooni piir 2 5 mm 3 00 mm Maksimaalne j reldilatatsiooni d...

Страница 122: ...t mu uzman gi ievelciet vad t jkatetr Ja ievelkot korpusu vad t jkatetr k d br d j tama neierasta pretest ba karkasa pieg des sist ma un vad t jkatetrs j iz em k vienota ier ce Tas j veic ar tie as vi...

Страница 123: ...mm boj juma garums 8 mm p c vizu l v rt juma papla in ts l dz 14 mm 3 0 x 18 mm karkasam stenozes diametrs DS 50 un 100 trombol zes miokarda infarkt Thrombolysis in Myocardial Infarction TIMI pl sma...

Страница 124: ...ve 15 MI un 2 ID Non TL TVR hierarhiski Viens pacients kur nomira 108 dien tika iek auts kardi l s n ves sarakst atbilst gi kardi l s n ves ARC defin cijai 0 2 194 dien s 1 537 pacienta m r a boj jum...

Страница 125: ...mos kas ietvers angiogr fiju IVUS IVUS virtu lo histolo iju un Lipiscan k ar MSCT izv rt anu p c 3 gadiem 8 6 2 Kl nisko rezult tu datu kopsavilkums P t jum ABSORB II RCT re istr cija tika pabeigta 20...

Страница 126: ...6 2 Karkaso d jimas Atsargumo priemon s 6 3 Naudojimas kartu atliekant kitas proced ras 6 4 Karkaso sistemos i mimas Atsargumo priemon s 6 5 Po implantacijos Atsargumo priemon s 6 6 MRT galimyb 6 7 V...

Страница 127: ...m ir kreipiam j kateter kaip vien prietais Tai darykite tiesiogiai steb dami fluoroskopu Karkaso vedimo sistemos perpl timo balion lio i traukimas i i pl sto karkaso 1 Prip timo prietaisu sudar neigia...

Страница 128: ...mo kraujagysl je Tod l vizualin s OKT savyb s matomos atramos ne visuomet rodo rezorbcijos nebuvim ta iau OKT matomos atramos nebuvimas patvirtina rezorbcij Spind io forma buvo tolygi su lygiais ai ki...

Страница 129: ...emin s ne TL TVR da nis buvo 0 6 3 537 d l 2 i emini ne TL TVR vyki atlikus AKJO ir 1 i emin s ne TL TVR vykio atlikus PCI pasirei kimo 1 ais metais MACE da nis buvo 4 2 19 450 1 kardialin mirtis 13...

Страница 130: ...enduojamas gydymas antiagregantais yra tinkamas PCI pasirinkimas Po PCI jeigu rekomenduojama chirurgin ar dant proced ra reikia pasverti rizik ir naud d l galim pavoj susijusi su gydymo antiagregantai...

Страница 131: ...orta B pri klini nem presku anju ABSORB 8 3 1 Metodologija in trenutno stanje 8 3 2 Klini ni izidi za celotno kohorto B Tabela 5 Hierarhi ni klini ni izidi za kohorto B populacija predvidena za zdravl...

Страница 132: ...ije sestavljeni iz sr ne smrti miokardnega infarkta revaskularizacije ciljne lezije zaradi ishemije so navedeni v poglavju 8 0 Klini ne preiskave sistema biolo ko razgradljivih ilnih nosilcev Absorb B...

Страница 133: ...kov smrt MI kakr na koli revaskularizacija TLR TVR NTVR En preiskovanec je uradno prekinil sodelovanje v tudiji po 6 mesecih Pri tem preiskovancu je bila prav tako izvedena revaskularizacija ciljne le...

Страница 134: ...nkov obse nega slikanja Zdravljene lezije so nekoliko kompleksnej e od lezij vklju enih v presku anja pred tudijo ABSORB Dovoljena je obravnava dalj ih lezij z uporabo na rtovanega prekrivanja biolo k...

Страница 135: ...godka sta 1 vazomocija ocenjena glede na spremembo povpre nega premera lumna od pred nitrati in po nitratih pri 3 letih superiornost in 2 minimalni premer lumna pri 3 letih po nitratih minus premer lu...

Страница 136: ...manj na nazivni tlak Na splo no je cilj sprejete prakse za etni tlak pri name anju ki dose e notranji premer nosilca ki je pribli no 1 1 kratnik referen nega premera ile POZOR Ne presezite nazivnega t...

Страница 137: ...eland CUSTOMER SERVICE TEL 800 227 9902 FAX 800 601 8874 Outside USA TEL 951 914 4669 Outside USA FAX 951 914 2531 2015 Abbott MANUFACTURED BY Abbott Vascular Temecula CA 92591 USA EL2103340 4 24 15 P...

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