News | March 31, 2008

SPIRIT II Explores Long-Term Performance of Xience V Stent

April 1, 2008 — Early results of the SPIRIT II study showed that the XIENCE V sstent was superior to the Taxus stent in six-month findings on angiography and trended better on one- year clinical outcomes. Now, a new analysis shows that after two years, the investigational everolimus- coated XIENCE V stent may continue to hold a clinical edge over its paclitaxel-coated competitor.

The two-year findings of the SPIRIT II study are being reported today in a Late-Breaking Clinical Trials session at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit (SCAI-ACCi2) in Chicago. SCAI-ACCi2 is a scientific meeting for practicing cardiovascular interventionalists sponsored
by the Society for Cardiovascular Angiography and Interventions (SCAI) in partnership with the American College of Cardiology (ACC).

Patrick W. Serruys, M.D., Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands, led the SPIRIT II study. He and his colleagues recruited 300 patients from 28 medical centers in Europe, New Zealand and India who needed stenting of up to two new coronary lesions. Patients were randomly assigned to treatment with the XIENCE V everolimus-eluting stent or the Taxus paclitaxel-eluting stent.

The study primarily set out to document any differences in the amount of arterial tissue that grew into the stents at six months (in-stent late loss). As previously reported, the results were significantly better for the XIENCE V stent when compared to the Taxus stent. At one-year follow-up, the combined rates
of major adverse cardiac events (MACE), consisting of cardiac death, heart attack and repeat procedure to treat the target lesion, trended better in the XIENCE V group.

New data from a late-stage evaluation report demonstrates that the XIENCE V stent continues to show a trend toward improved clinical outcomes compared to the Taxus stent at two years, however, the trial was not statistically powered to show differences in clinical endpoints. The overall MACE rate at two
years was 40 percent lower in patients treated with the XIENCE V stent (6.6 percent vs. 11.0 percent in the Taxus group). Repeat procedures to treat the target lesion were performed in 3.8 percent and 6.8 percent of patients, respectively, a 44 percent reduction favoring the XIENCE V stent. Similarly, the
rates of heart attack were 2.8 percent and 5.5 percent, respectively, a 49 percent reduction, and the rates of cardiac death were 0.5 percent and 1.4 percent, respectively, a 64 percent reduction. There was no difference in the rates of blood clotting inside the stent, or stent thrombosis, at two years.

In the 117 patients who had follow-up angiography at two years, there was no significant difference in the rates of re-narrowing of at least 50 percent (binary restenosis) within the stents (2.1 percent with the XIENCE V stent vs. 2.9 percent with the Taxus stent). In-stent late loss was virtually identical (0.33 mm
vs. 0.34 mm, on average, respectively).

For more information: www.scai-acci2.org

Related Content

Videos | Stents | September 11, 2018
This is an animation showing how the dedicated bifurcation stent developed by Advanced Bifurcation Systems (ABS) is d
Elixir Medical Corporation Unveils Transformational DynamX Stent Featuring Adaptive Segments that Uncage the Stented Artery
News | Stents | January 25, 2018
January 25, 2018 – Elixir Medical Corporation, a leader in the development of breakthrough adaptive remodeling techno
The TIDES-ACS results show us that the Optimax stent is noninferior in patients with acute coronary syndrome compared to Synergy.

The presentation of the ESC late-breaker TIDES-ACS results show us that the Optimax stent is noninferior in patients with acute coronary syndrome compared to Synergy.

News | Stents | November 24, 2017
November 24, 2017 – During a late-breaking session at the European Society of Cardiology (ESC) 2017 meeting, presente
News | Stents | November 10, 2017
Cordis, a Cardinal Health company, recently unveiled a comprehensive interventional cardiology portfolio, which now...
OCT comparison between the Combo vs. Xience stents in the HARMONEE study.

OCT comparison between the Combo vs. Xience stents in the HARMONEE study.

Feature | Stents | November 08, 2017
November 8, 2017 – New results from the HARMONEE Japan/U.S.
FDA Approves COBRA REDUCE Trial of 14-Day DAPT With CeloNova Stent
News | Stents | October 27, 2017
CeloNova BioSciences Inc. announced the U.S. Food and Drug Administration (FDA) approved expansion of CeloNova's...
CeloNova Cobra Pzf stent
Technology | Stents | March 02, 2017
March 2, 2017 — The U.S. Food and Drug Administration (FDA) cleared CeloNova BioSciences Inc.
OCT, intravascular imaging, stent, good stent apposition on vessel wall, TRANSFORM-OCT study

An OCT image showing good stent strut apposition against the vessel wall.

News | Stents | January 13, 2017
January 13, 2017 — Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
EXCEL Trial, TCT 2016, drug-eluting stents, CABG, surgery left main heart disease, LMCAD

Gregg W. Stone, M.D., presenting the EXCEL data at TCT 2016 during a standing room only late-breaking trial session.

Feature | Stents | January 12, 2017 | Dave Fornell
The biggest news from the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting this past fall was the results
Biotronik's Osiro stent, prison IV trial

Biotronik's Osiro ultra-thin strut, sirolimus-eluting stent.

News | Stents | November 09, 2016
November 9, 2016 – Results from a randomized, multicenter trial failed to show non-inferiority of hybrid, ultra-thin
Overlay Init