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Clinical Outcomes

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Xience™ Stent Clinical Outcomes

Stent choice matters. And a wealth of clinical evidence supports the safety of the XIENCE™ Stent, which is why experts consider XIENCE™ Stent to be the gold standard among DES.1

In addition, reproducible procedural outcomes are a proven quality of XIENCE™ DES performance,2 delivering consistent patient safety with low complication rates3

When choosing XIENCE™ Stent, interventional cardiologists (ICs) can know that the optimal outcomes they achieved in the cath lab will persist far into the future—not only treating stenosed vessels but enabling patients to have a better quality of life.4

There’s a Whole World of Evidence to Support the XIENCE™ Stent

XIENCE™ Stent is the world's leading DES, with over 15 million implants.5

Cardiologists have chosen XIENCE™ Stent for more than 15 million implants, making XIENCE™ Stent the world's leading DES
Cardiologists have chosen XIENCE™ Stent for over 120 clinical trials
Cardiologists have chosen XIENCE™ Stent for over 125,000 patients
Cardiologists have chosen XIENCE™ Stent for over 10 years


Substantial clinical data continue to provide evidence that XIENCE™ DES can effectively treat a broad spectrum of patients.1 Given the best in class deliverability and the expanded treatment options of XIENCE Sierra™ Stent,7 it is an excellent choice for complex patients. 

Key XIENCE™ Stent Clinical Trials

XIENCE 28 & XIENCE 90 Data

XIENCE™ Stent—with either 1-month or 3-month dual antiplatelet therapy (DAPT)—reduced severe bleeding with no increase in ischemic events.8

Short DAPT: Reduced Severe Bleeding8

With DAPT halted at either 1 month and 3 months, XIENCE™ Stent showed less severe bleeding, at 6 months and 12 months, vs earlier XIENCE™ Stent data

XIENCE 28: BARC 3-5 BLEEDING

Between 1 and 6 months
With DAPT halted at either 1 month and 3 months, XIENCE™ Stent showed less severe bleeding, at 6 months and 12 months, vs earlier XIENCE™ Stent data

XIENCE 90: BARC 3-5 BLEEDING

Between 3 and 12 months

Note: PS stratified analysis for BARC 3-5 bleeding was not pre-specified.
Note: BARC 2-5 was a powered secondary endpoint.

Short DAPT: No Increase in Ischemic Events in High Bleeding Risk (HBR) Patients8

With short DAPT data from both 1 month and 3 months, XIENCE™ Stent showed less severe bleeding than earlier XIENCE™ Stent findings

XIENCE 28: 1-month DAPT in HBR Patients
XIENCE 28: All Deaths or MI

Between 1 and 6 months
With short DAPT data from both 1 month and 3 months, XIENCE™ Stent showed less severe bleeding than earlier XIENCE™ Stent findings

XIENCE 90: 3-month DAPT in HBR Patients
XIENCE 90: All Deaths or MI

Between 3 and 12 months

CARDIOBASE Registry: XIENCE™ Stent vs Synergy‡
XIENCE™ Stent outperforms Synergy‡ with short-term safety outcomes in real-world patients.9

Short-Term Data with XIENCE™ Stent and Synergy‡


XIENCE™ Stent: Significantly Lower Acute Definite Stent Thrombosis vs Synergyǂ9

75% Less acute definite stent thrombosis with XIENCE™ Stent System compared to Synergyǂ

XIENCE™ Stent results in 75% less acute definite stent thrombosis vs Synergyǂ
Propensity-matched analysis from a single-center registry.


XIENCE™ Stent: Significantly Lower Target Lesion Revascularization (TLR) at 1 Month vs Synergyǂ9

Suggests favorable economic benefits* for XIENCE Stent vs. Synergyǂ in clinical practice

*Driven by reduction in additional procedures and hospitalizations

Compared to Synergyǂ, XIENCE™ Stent results in significantly lower TLR, and therefore economic benefits for clinical practice
Target Lesion Revascularization

IDEAL-LM Data: Long-Term Complex Patient Data on XIENCE™ Stent vs Synergy‡

In the left main subset of patients, the IDEAL-LM findings also reveal that the XIENCE™ Stent outperforms Synergy‡ at 2 years10


Left Main Patients: XIENCE™ Stent Shows Significantly Lower Long-Term Definite Stent Thrombosis vs Synergyǂ10

XIENCE Stent
0% Stent Thrombosis

Compared to Synergyǂ, XIENCE™ Stent patient safety data show significantly lower long-term definite stent thrombosis.
Definite Stent Thrombosis

RESOLUTE All-Comers (RAC) Randomized Trial: XIENCE™ Stent vs Resolute‡

Safety data from RAC real-world patients also reveal that XIENCE™ Stent outperforms Resolute.‡11


XIENCE™ Stent: Significantly Lower Early Definite Stent Thrombosis vs Resoluteǂ11

88% less definite stent thrombosis with XIENCE™ Stent compared to Resoluteǂ

Compared to Resoluteǂ, XIENCE™ Stent patient safety data show 88% less definite stent thrombosis at 1 month
Definite Stent Thrombosis


XIENCE™ Stent: Significantly Lower Late Definite Stent Thrombosis vs Resoluteǂ11

75% less definite stent thrombosis with XIENCE™ Stent compared to Resoluteǂ

Note: Primary endpoint for non-inferiority was met by Resoluteǂ compared with XIENCE™ Stent. The primary endpoint of target lesion failure (TLF) was a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization at 12 months.

Compared to Resoluteǂ, XIENCE™ Stent patient safety data show 75% less definite stent thrombosis at 1 year
Definite Stent Thrombosis

References:

  1. Zanchin C, et al. JACC Cardiovasc Interv. 2019;12(17):1665-1675. Serruys P, et al. N Engl J Med. 2010;363:136-146. Shiomi H, et al. JACC Cardiovasc Interv. 2019;12:637-647. Kufner S, et al. Circulation. 2019:139(3):325-333. Palmerini T, et al. Lancet. 2013;379:1393-1402. Bangalore S, et al. Circulation. 2012;125:2873-2891. Bangalore S, et al. Circ Cardiovasc Interv. 2013;6(6):378-390. Pilgrim T, et al. Lancet. 2014;384:2111-2122. Pilgrim T, et al. Lancet. 2018;392:737-746. Data on file at Abbott.
  2. Saito S, et al. Eur Heart J. 2014;35:2021-2031. Saito S, et al. EuroIntervention. 2019;15(11):e1006-e1013. Natsuaki M, et al. J Am Coll Cardiol. 2013;62:181-190. Stone G, et al. Lancet 2018;392:1530-1540.
  3. Zanchin C, et al. JACC Cardiovasc Interv. 2019;12(17):1665-1675. Serruys P, et al. N Engl J Med. 2010;363:136-146. Shiomi H, et al. JACC Cardiovasc Interv. 2019;12:637-647. Kufner S, et al. Circulation. 2019:139(3):325-333.
  4. Baron SJ, et al. J Am Coll Cardiol. 2017;70:3113-3122.
  5. Data on file at Abbott. 15 million implants is based on DES data through Q1 2020.
  6. Kufner S, et al. Circulation. 2019:139(3):325-333.
  7. Tests performed by and data on file at Abbott. XIENCE Sierra™ 3.0 x 18 mm, n=5; Synergy‡ 3.0 x 20 mm, n=5; Resolute‡ Onyx 3.0 x 18 mm, n=5. XIENCE Sierra™ IFU – increased maximum expansion compared to other XIENCE™ Stent products.
  8. Mehran R, et al. TCT Connect 2020, XIENCE 28/90.
  9. Zanchin C. et al. JACC Cardiovasc Interv. 2019;12(17):1665-1675.
  10. Van Geuns RJ, et al. TCT 2019, IDEAL-LM.
  11. Serruys P, et al. N Engl J Med. 2010;363:136-146.

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