Chronic Total Occlusion (CTO) Data

“If you look at what interventional cardiologists are doing today in the cardiac cath lab, it’s nowhere near the same as it was 5 years ago. Five years ago we were not doing CTOs to the degree we’re doing today.” 

— David Rizik, MD

For years patients with chronic total occlusions (CTO) posed a challenge for physicians implanting bare metal stents (BMS), since restenosis was common in this population.1 First generation drug-eluting stents (DES) improved results, yet the risk of very late stent thrombosis (ST) remained.

XIENCE is designed to offer peak performance in increasingly complex lesions such as CTOs—with a ST rate of 0.7%.2

Moreover, XIENCE Sierra provides ultra low crimped stent profile3, best in class deliverability and excellent stent retention3 for safely crossing challenging anatomy.


PRISON IV Trial Examines XIENCE for CTO

The Orsiro hybrid sirolimus-eluting stent (SES), a biodegradable polymer DES (BP-DES), was designed to overcome possible drawbacks of earlier generations of DES. The PRISON IV trial—a prospective, multicenter randomized trial—looked at XIENCE vs Orsiro in CTO patients.2


XIENCE Outperforms Orsiro in CTOs—Lack of Non-Inferiority for SES2

“We chose the most reputable stent, . . .  XIENCE, to challenge the novel Orsiro sirolimus-eluting stent [SES] in this complex lesion subset. . . . This trial failed to show non-inferiority of the SES. . . . Furthermore, the rate of binary restenosis was statistically significantly higher with the SES [Orsiro].”

— Koen Teeuwen, MD, PRISON IV Trial2 

 

PRISON Primary Endpoint: In-Segment Late Lumen Loss (mm) at 9 Months 

Primary Endpoint: In Segment Late Lumen Loss at 9 months (mm) 

In a XIENCE vs Orsiro comparison, Orsiro failed to reach non-inferiority compared to XIENCE due to this difference in late lumen loss.

 

XIENCE Outperforms Orsiro in CTOs—Restenosis and TLR2

In examining XIENCE compared to Orsiro, the Orsiro arm revealed:

  • Significantly higher binary restenosis
  • Higher clinically driven target lesion revascularization (TLR)
 

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† Bench test data shows that XIENCE Sierra performed better in crossability and was not statistically different in trackability and pushability compared to Resolute Onyx and SYNERGY stents. Bench test results may not necessarily be indicative of clinical performance. Test performed by and data on file at Abbott. Testing performed on XIENCE Sierra Everolimus Eluting Coronary Stent System (3.0 x 18 mm) n=5, SYNERGY Stent System (3.0 x 20 mm) n=5, Resolute Onyx Stent System (3.0 x 18 mm) n=5. Catheter performance crossability test measures average force to cross a challenging lesion model.


‡ Increased maximum expansion compared to other XIENCE Everolimus Eluting Coronary Stent System.

* SES Orsiro strut thickness is 60 µm for stent diameters ≤ 3.0 mm, and 80 µm for stent diameters > 3.0 mm.

  1. Rahel BM, et al. Am Heart J. 2004;147:e16-e20.
  2. Teeuwen K, et al. PRISON IV Trial. JACC Cardiovasc Interv. 2016. doi: 10.1016/ j.jcin.2016.10.017. 
  3. Test performed by and data on file at Abbott. XIENCE Sierra Everolimus Eluting Coronary Stent System (3.0 x 18 mm) n=5, SYNERGY Stent System (3.0 x 20 mm) n=5, Resolute Onyx Stent System (3.0 x 18 mm) n=5.


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