Evidence Backs Safety & Efficacy Of Cypher Stent

EHM News Bureau - Mumbai

One year follow-up data from the world’s largest completed drug-eluting stent registry, consisting of more than 15,000 patients, found that the Cypher demonstrates the same level of safety and efficacy in clinical practice as in randomised, controlled clinical trials.

Specifically, the e-Cypher (SM) registry found that real-world treatment with the Cypher stent in a wide range of patients — including a large number of patients with diabetes (28.6 per cent) — resulted in low rates in the need for repeat procedures (target lesion revascularisations or TLR), major adverse cardiovascular events (MACE) such as heart attack and death, and in-stent blood clots (late stent thrombosis).

“The SM registry has given us extremely positive real world data, that suggests excellent safety and efficacy outcomes of the Cypher® Stent across a broad range of complex patient populations,” says Dr Ashok Seth, Chairman, Max Devki Devi Heart and Vascular Institute, New Delhi. Dr Seth led the Advisory board for the e-Cypher Registry in the Asia Pacific region.

The registry reported that the overall patient population had cumulative MACE and TLR rates at 12 months of 5.8 per cent and 3.1 per cent, respectively, which are in line with data received from randomised clinical trials of the Cypher stent. The registry found that the rate of stent thrombosis with the Cypher stent was 0.87 per cent at one year and did not appear to be affected by total stent length or termination of dual antiplatelet therapy. At one year follow- up, 57 per cent of patients were no longer on dual antiplatelet therapy.

In addition, several other studies point towards the safety and efficacy of the Cypher stent. According to a study published in the Journal of the American College of Cardiology earlier this year, the Cypher stent may reduce re-blockage (restenosis) and the occurrence of major adverse cardiac events in patients with complex coronary artery lesions without increasing the risk of blood clots (thrombosis). The Scandstent study (Stenting of Coronary Arteries in Non-Stress/Benestent Disease) is the only randomised study examining the Cypher® Stent against bare metal stents that includes complex patients, defined as patients with blockages longer than 15 millimeters, side-branch lesions, ostial lesions, and lesions angled at greater than 45 degrees (angulated lesions).

According to another study, the ISAR-SMART Trial - a prospective, randomised clinical trial of small coronary vessels - the Cypher® Stent outperformed the Taxus Stent in three key endpoints that are utilised to assess efficacy: late lumen loss (primary endpoint), restenosis and target lesion revascularisation (secondary). The stent has also demonstrated positive results in other small vessel studies such as SES SMART, a randomised, multi-centre prospective trial and SVELTE, a multi-centre historical controlled study that assessed efficacy in treating small coronary vessels.