Study Shows CYPHER Sirolimus-Eluting Coronary Stent Yields Strong Results Without Pre-dilatation
The CYPHER™ Sirolimus-eluting Coronary Stent yields the same strong patient outcomes with or without balloon pre-dilatation, according to results of the DIRECT trial presented today at the American College of Cardiology 53rd Scientific Session. The 225-patient, nonrandomized study, funded by Cordis Corporation, a Johnson & Johnson company, compared the results of “direct stenting” (stent placement without balloon pre-dilatation) to those obtained using conventional balloon pre-dilatation in the previously reported SIRIUS trial. The DIRECT trial is being conducted under an Investigational Device Exemption in the United States. The CYPHER Stent is currently labeled for use with balloon pre-dilatation.
“The exceptional results obtained without the use of balloon pre-dilatation are testament to the deliverability and outstanding performance of the CYPHER Stent,” said Principal Investigator Jeffrey Moses, M.D., Lenox Hill Hospital and the Cardiovascular Research Foundation, New York, NY. “Our findings indicate that in patients who meet the criteria for direct stenting, it’s possible to omit pre-dilatation and obtain outcomes equivalent to, and in some instances better than those documented in earlier CYPHER Stent studies.”
Overall Findings
Dr. Moses said DIRECT trial findings for in-stent late lumen loss-considered the most reliable indicator of successful interventional therapy-compared favorably with those documented in the SIRIUS trial, which used balloon pre-dilatation (0.18 mm for DIRECT patients vs 0.17 mm for SIRIUS patients). In-lesion late loss in patients who underwent direct stenting was very low (0.21 mm) and similar to that seen in the SIRIUS trial.
CYPHER™ Sirolimus-eluting Coronary Stent Yields Outstanding Results Without Pre-dilatation
In-stent and in-lesion restenosis rates (3.6% and 6.0%, respectively) in the DIRECT trial also compared favorably to in-stent and in-lesion restenosis rates in the SIRIUS trial (3.2% and 9.1%, respectively).
Substantial Reduction in Peri-Stent Restenosis
Dr. Moses described an overall 47% reduction in stent-margin restenosis (“peri-stent restenosis”) below that observed in the SIRIUS trial, which he attributed to improved stent implantation technique and the avoidance of vessel injury that occurs with pre-dilatation.
Excellent Outcomes in Diabetic Patients
Eight-month angiographic in-stent and in-lesion restenosis rates were 0% for the 16 insulin-dependent patients in the DIRECT trial vs 10.5% (in-stent restenosis) and 35% (in-lesion restenosis) for the 25 insulin-dependent patients in the SIRIUS trial.
The insulin-dependent subsets in the DIRECT and SIRIUS trials also showed differences in late lumen loss. In-stent and in-lesion late loss were 0.20 mm for the insulin-dependent DIRECT trial patients compared with 0.33 mm in-stent late loss and 0.58 mm in-lesion late loss for insulin-dependent SIRIUS trial patients.
The target lesion revascularization rate (TLR, which is a measure of the need for retreatment) at 180 days was 0% (0/16) for the insulin-dependent patients in the DIRECT trial compared to the 8.0% (2/25) for the insulin-dependent patients in the SIRIUS trial.
Dr. Moses said findings for the overall diabetic patient group (insulin-dependent plus non-insulin-dependent) in the DIRECT trial compared very favorably to those for the overall diabetic patient subgroup in the SIRIUS trial (in-stent late loss: 0.25 mm vs. 0.28 mm and in-lesion late loss: 0.26 mm vs. 0.4 mm). The TLR rate at 180 days for the total diabetic population was 2.9% (2/70) in the DIRECT trial and 4.8% (5/105) in the SIRIUS trial.
Dr. Moses described the results for the 70 diabetic patients -16 insulin-dependent and 54 non-insulin dependent-included in the DIRECT trial as “especially impressive.” He said the excellent outcomes in these patients were attributable, at least in part, to increased vigilance to optimal stenting technique by the investigators.
CYPHER™ Sirolimus-eluting Coronary Stent Yields Outstanding Results Without Pre-dilatation
About the CYPHER™ Stent
Developed and manufactured by Cordis Corporation, the CYPHER Stent is currently available in more than 80 countries and has been used by doctors to treat more than 400,000 patients in the U.S. and over 550,000 patients worldwide. With more than 40 clinical trials conducted or in progress worldwide, the CYPHER 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 polymer. In clinical trials, the CYPHER Stent has been shown to reduce reblockage in the arteries by more than 90 percent over a conventional bare metal stent.
