Outstanding Performance of CYPHER(reg) Sirolimus-eluting Coronary Stent in Highly Challenging Patient Cases

Main Category: Cholesterol
Also Included In: Cardiovascular / Cardiology
Article Date: 26 May 2004 - 1:00 PDT

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Data from four new international clinical studies suggest the potential for the CYPHER(reg) Sirolimus-eluting Coronary Stent to treat higher-risk and more challenging blockages in coronary arteries, including small vessel blockages, chronic total occlusions, in-stent restenosis and multi-vessel disease. Data were reported during late-breaking clinical trials sessions at the EuroPCR Congress.

The CYPHER(reg) Stent is the first-approved drug-eluting stent. Cordis Corporation, a Johnson & Johnson company, sponsored the trials.

"These data provide further support for the ability of the CYPHER(reg) Stent to access extremely challenging coronary blockages, including small vessels and chronic total occlusions," said Dennis Donohoe, M.D., worldwide vice president of Clinical and Regulatory Affairs, Cordis Corporation. "These results are similar to those seen in previous randomized trials and registries involving the CYPHER(reg) Stent."

SVELTE (Small Coronary Arteries) Study

Presenting the eight-month data from the multi-center, non-randomized, historically controlled study in patients with de novo (first-time) coronary artery lesions in small vessels (2.25 mm-2.75 mm) with long lesions (15-30 mm) treated with the CYPHER(reg) Stent (SVELTE), Professor Eduardo Sousa, Institute Dante Pazzanese, Sao Paulo, Brazil, revealed a target lesion revascularization (retreatment) rate of zero percent in the difficult setting of small vessels with longer lesions.

A total of 101 patients received the CYPHER(reg) Stent in the study. Results were compared to matched subgroups from the U.S. SIRIUS Trial.

Commenting on the results, Professor Sousa said, "The CYPHER(reg) Stent, performed extremely well in small vessels with long lesions." He added, "This study provides important new data on the CYPHER(reg) Stent in the treatment of small coronary arteries."

Other results from SVELTE include an in-stent binary restenosis rate of 3.2 percent, in-segment binary restenosis rate of 6.3 percent and an overall MACE (major adverse cardiac event) rate of five percent out to eight-month follow-up.

SICTO (Chronic Total Occlusions) Study

Results from the SICTO, a 25-patient feasibility Study (Sirolimus-eluting stent in Chronic Total Occlusion) involving the CYPHER(reg) Stent in the treatment of CTO - chronic total occlusions (defined as a 100 percent obstruction of a coronary artery) were very encouraging. Dr. Yaron Almagor, Jesselson Heart Centre, Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel, reported a target lesion revascularization rate of zero percent, MACE rate of zero percent and a target vessel revascularization rate of eight percent.

Commenting on these results Dr. Almagor said, "When compared to historical data from trials involving the use of bare metal stents, these results suggest that the CYPHER(reg) Stent could be an excellent clinical resource in treating this highly challenging type of blockage."

TROPICAL (in-stent restenosis) Study

Commenting on the results of the TROPICAL Study comparing the CYPHER(reg) Stent to intravascular brachytherapy (low dose radiation), for the treatment of in-stent restenosis (reblockage), principal investigator Professor Franz-Josef Neumann, Medical Clinic, Herz-Zentrum, Bad Krozingen, Germany said, "In the treatment of in-stent restenosis, the CYPHER(reg) Sirolimus-eluting Stents provided an average in-lesion late loss of <0.1mm.

"Compared with the treatment of in-stent restenosis, brachytherapy, the CYPHER(reg) Stent substantially reduced angiographic restenosis and the need for target vessel revascularisation (repeat treatment)," he added.

Professor Neumann reported an in-lesion late loss (vessel renarrowing) of 0.08mm in the CYPHER(reg) Stent-treated patients (n=162) versus 0.68mm previously reported in the GAMMA I & II (221 patients) (p <0.0001), randomized, multi-center, placebo-controlled clinical trials evaluating the efficacy of gamma radiation treatment for in-stent restenosis. Both the CYPHER(reg) Stent and the CYPHER(reg) SELECT(reg) Stent are the first stents to receive CE Mark approval for the treatment of in-stent restenosis.

Other study results included:

Binary Restenosis - CYPHER(reg) Stent: 9.7 percent; GAMMA I & II Studies: 40.3 percent

MACE - CYPHER(reg) Stent: 3.7 percent; GAMMA I & II Studies: 18.8 percent

Target Lesion Revascularization - CYPHER(reg) Stent: 2.5 percent; GAMMA I & II Studies: 14.0 percent

Late Thrombosis (clots) at 180 days - CYPHER(reg) Stent: 0.6 percent; GAMMA I & II Studies: 3.9 percent

ARTS II (Sirolimus-eluting stents versus Coronary Artery Bypass Graft (CABG) in the treatment of multivessel disease) Study:

The effectiveness of coronary stent implantation using the CYPHER(reg) Stent with that of surgery was first observed in ARTS I and measured as MACCE (Major Adverse Coronary and Cerebral Event) free survival at one-year. Reporting the preliminary (one-month) results of ARTS II, a multicenter trial involving 606 patients from 45 European centers, Professor Patrick Serruys, The Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands revealed a total MACCE rate of 2.8 percent for patients treated with the CYPHER(reg) Stents in ARTS II as compared with 4.1 percent (CABG) and 8.2 percent Percutaneous Intervention (PCI) in ARTS I.

Professor Serruys also reflected on the more challenging patient population treated in ARTS II as compared to ARTS I. In ARTS II the number of diabetic patients treated with the CYPHER(reg) Stent was 26.2 percent as compared to 15.9 percent (CABG) and 18.7 percent (PCI) in ARTS I, the historical control for ARTS II. Professor Serruys also revealed the marked difference in the number of patients presenting with hypertension (67.3 percent ARTS II versus 45.0 CABG and 44.7 percent PCI in ARTS I) and hyperlipidemia (74 percent ARTS II versus 57.6 percent CABG and 58 percent PCI in ARTS I).

Professor Serruys stated, "Despite more extensive disease and treatment, the overall MACCE rate and its itemized components are systematically lower in ARTS II than in ARTS I. The overall MACCE rate of ARTS II appears to be equivalent to the surgical arm of ARTS I."

About CYPHER(reg) Stent

With more than 42 clinical trials completed or in progress, the CYPHER(reg) Stent remains the most studied drug-eluting stent today with the largest body of clinical evidence demonstrating the long-term safety and efficacy of its drug and polymers. As in these latest trials to be presented at EuroPCR, the CYPHER(reg) Stent has been shown to significantly reduce recurrent blockage of arteries from that seen with conventional bare metal stents.

About Cordis Corporation

For more than 40 years, Cordis Corporation, a Johnson & Johnson company, has pioneered less-invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis Corporation the world's leading developer and manufacturer of breakthrough products in the interventional cardio-vascular field. Today, more than 7,000 Cordis Corporation employees worldwide share a strong commitment to continue the company's groundbreaking work in the fight against vascular disease.

http://www.jnj.com

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