XIENCE Sierra vs. Synergy

To date, the hypothesis of biodegradable-polymer DES (BP-DES) reducing long-term events or showing a healing benefit remains to be proven1. When considering XIENCE and the Synergy BP-DES, the respective bodies of clinical safety and efficacy data, DAPT data and healing data illustrate the difference.

Safety with XIENCE Stent Thrombosis Rates

XIENCE has demonstrated 0% stent thrombosis rates in multiple, high quality clinical trials from 30 days out to 5 years.

0
1
2
3
4
5
6
7
8
9

%
ST

Absorb II6 4 Years

Includes patients with complex lesions n=501

0
1
2
3
4
5
6
7
8
9

%
ST

Absorb China7 2 Years

Includes patients with complex lesions n=475

0
1
2
3
4
5
6
7
8
9

%
ST

StopDapt8,9 1 Year

3-month DAPT n=1,519

0
1
2
3
4
5
6
7
8
9

%
ST

Twente10
1 Year

Real-world patients n=1,391

0
1
2
3
4
5
6
7
8
9

%
ST

Platinum Plus11 1 Month

Real-world patients n=2,985

NOTE: Results from clinical trials are not directly comparable. Information provided for educational purposes only.

 

Additional meta analyses studies—such as those by Bangalore and Palmerini show lower definite stent thrombosis rates with XIENCE vs. Synergy and other BP-DES.

STR Rates

“The results of the study reported here suggest no advantage of biodegradable polymer stents compared with newer generation durable polymer stents.”   

— sripal bangalore, MD

XIENCE has consistently demonstrated low ST rates from 30 days to 5 years in complex, all-comer populations, as shown in this graph. 

ARC Definite Stent Thrombosis
Xience Competitor
30 days PLATINUM PLUS
(n = 2,980)
vs. Promus Element

0.0%

0.5%

p = 0.03
RESOLUTE
ALL COMERS
(n = 2,292)
vs. Endeavor Resolute

0.1%

0.8%

p = 0.01
1 year TWENTE
(n = 1.391)
vs. Endeavor Resolute

0.0%

0.6%

p = 0.12
RESOLUTE
ALL COMERS
(n = 2,292)
vs. Endeavor Resolute

0.3%

1.2%

p = 0.01
BIOSCIENCE
(n = 2,119)
vs. Orsiro

0.4%

0.9%

2 years SORT OUT IV
(n = 2,774)
vs. Cypher

0.2%

0.9%

p = 0.02
BIOSCIENCE
(n = 2,119)
vs. Orsiro

0.8%

1.1%

3 years LESSON 1
(n = 2,684)
vs. Cypher

0.5%

1.6%

p = 0.01
COMPARE
(n = 1,800)
vs. Taxus

1.1%

3.6%

p = 0.0007
5 years RESOLUTE
ALL COMERS
(n = 2,292)
vs. Endeavor Resolute

0.8%

1.6%

p = 0.08

5.0%

4.5%

4.0%

3.5%

3.0%

2.5%

2.0%

1.5%

1.0%

0.5%

0.0%

 

NOTE: Results from clinical trials are not directly comparable. Information provided for educational purposes only.

 

Reduced DAPT: Which Stents Are Included in ACC/AHA Guidelines

The XIENCE stent has been studied in more than 100,000 patients in more than 100 trials, which is almost 10 times more than Synergy2.

Accordingly, the 2016 ACC/AHA DAPT guidelines were formulated primarily using data from XIENCE DAPT data. BP-DES were not included in the revised 2016 ACC/AHA guidelines that allow for 3 month DAPT in certain patients due to their not yet being approved for use.

XIENCE Sierra Vs. Synergy Polymer Integrity

The XIENCE Sierra fluoropolymer promotes safety with thromboresistance.14-16  

It also is designed to be strong, yet flexible. Upon expansion, the Synergy stent’s biodegradable polymer exhibits cracking and degradation, as seen in this representative image.5  Read more about polymer differences

Synergy Polymer Integrity

XIENCE Sierra @ 25x
XIENCE Sierra (3.5 x 18 mm)
25x magnification at max expansion of 5.5 mm
XIENCE Sierra @ 150x
XIENCE Sierra (3.5 x 18 mm)
150x magnification at max expansion of 5.5 mm

XIENCE Sierra coating remains intact at maximum post-dilatation expansion of 5.5 mm from 3.5 mm

Synergy @ 25x
Synergy (3.5 x 20 mm)
25x magnification at max expansion of 4.25 mm
XIENCE Sierra @ 150x
Synergy (3.5 x 20 mm)
150x magnification at max expansion of 4.25 mm

Synergy coating shows multiple cracks with delamination at its max expansion of 4.25 mm from 3.5 mm

 

AP2947114-WBU Rev A

* Thienopyridine was discontinued within 4 months in 94.7% of patients in the STOPDAPT trial.

  1. Kufner S, et al. "Ten-Year Clinical Outcomes From a Trial of Three Limus-Eluting Stents With Different Polymer Coatings in Patients With Coronary Artery Disease" Circulation 2018
  2. Data on file at Abbott. Synergy patient number as calculated November 2018.
  3. SPIRIT II (n=223), SPIRIT III (n=669), SPIRIT IV (n=2,458), SPIRIT V (n=1,662), SPIRIT Women (n=1,506), XIENCE V USA (n=6,516), XIENCE V India (n=931), COMPARE (n=897), STOPDAPT (n=1,525). Natsuaki M, et al. “One-year outcome of a prospective trial stopping dual antiplatelet therapy at 3 months after everolimus-eluting cobalt-chromium stent implantation: ShorT and Optimal duration of Dual AntiPlatlet
  4. Natsuaki M, et al. “One-year outcome of a prospective trial stopping dual antiplatelet therapy at 3 months after everolimus-eluting cobalt-chromium stent implantation: ShorT and Optimal duration of Dual AntiPlatlet Therapy after everolimus-eluting cobalt chromium stent (STOPDAPT) trial.” Cardiovasc Interv and Ther 2015. There are several important limitations in the current study. First, and most importantly, this study was not a randomized controlled trial, but a single-arm study comparing with a historical control group. We could not draw any definitive conclusions from a single-arm study. The current study was designed as a pilot study to investigate the safety of 3-month DAPT in patients receiving G2-DES, because the study sponsor had planned a large randomized controlled trial comparing 3 months versus longer DAPT duration after G2-DES implantation. Second, selection bias toward inclusion of patients with lower ischemic risk should be considered when interpreting the result of this study. Multivariable analysis could not fully adjust the measured and unmeasured confounders. Third, detailed information of PCI such as final balloon size, balloon dilatation pressure and intravascular ultrasound use was not collected in this study. Finally, we could not exclude the possibility of underreporting of the clinical events in this investigator-driven study. However, the method of follow-up data collection was exactly the same in the STOPDAPT as in the RESET.
  5. Data on file at Abbott.
  6. Chevalier B et al. Four-year follow-up of the randomised comparison between an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II Trial). EuroIntervention January 2018.
  7. Gao R, et al. ABSORB China: Two-Year Clinical Results. TCT 2016.
  8. Natsuaki M, et al. One-year outcome of a prospective trial stopping dual antiplatelet therapy at 3 months after everolimus-eluting cobalt-chromium stent implantation: ShortT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent (STOPDAPT) trial. Cardiovasc Interv Ther. 2016;31:196–209. doi: 10.1007/s12928-015-0366-9. [Link: www.ncbi.nlm.nih.gov/pmc/articles/PMC4923071/] ARC Definite Stent Thrombosis definition used for STOPDAPT.
  9. Thienopyridine was discontinued within 4 months in 94.7% of patients in the STOPDAPT trial. There are several important limitations in the current study. First, and most importantly, this study was not a randomized controlled trial, but a single-arm study comparing with a historical control group. We couldnot draw any definitive conclusions from a single-arm study. The current study was designed as a pilot study to investigate the safety of 3-month DAPT in patients receiving G2-DES, because the study sponsor had planned a large randomized controlled trial comparing 3 months versus longer DAPT duration after G2-DES implantation. Second, selection bias toward inclusion of patients with lower ischemic risk should be considered when interpreting the result of this study. Multivariable analysis could not fully adjust the measured and unmeasured confounders. Third, detailed information of PCI such as final balloon size, balloon dilatation pressure and intravascular ultrasound use was not collected in this study. Finally, we could not exclude the possibility of underreporting of the clinical events in this investigator-driven study. However, the method of follow-up data collection was exactly the same in the STOPDAPT as in the RESET.
  10. von Birgelen C, et al. A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting XIENCE V stents in real-world patients: the TWENTE Trial. JACC. 2012;59(15):1350-1361. doi: 10.1016/j.jacc.2012.01.008. 
  11. Fajadet J, et al. PLATINUM PLUS 30-day Poster. TCT 2012. ARC Definite/Probable Stent Thrombosis definition used for PLATINUM PLUS.
  12. Bangalore S, et al. Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis. BMJ. 2013;347:f6625. doi: doi.org/10.1136/bmj.f6625
  13. Palmerini T, et al. Clinical outcomes with bioabsorbable polymer- versus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis.  J Am Coll Cardiol. 2014;63(4):299-307. doi: 10.1016/j.jacc.2013.09.061.
  14. Palmerini T, et al. "Stent thrombosis with drug-eluting and bare-metal stents: Evidence from a comprehensive network meta-analysis." Lancet 2012.
  15. Bangalore S, et al. "Short- and Long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117,762 patient-years of follow-up from randomized trials." Circulation 2012

  16. Otsuka F, et al. "Acute thrombogenicity of a durable polymer everolimus-eluting stent relative to contemporary drug-eluting stents with biodegradable polymer coatings assessed ex vivo in a swine shunt model. JACC 2015YEAR

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