Angiographic and IVUS Results From First-in-Man Bioabsorbable Stent Evaluat
Angiographic and IVUS Results From First-in-Man Bioabsorbable Stent Evaluat
Drug-eluting stents (DES) dramatically reduce restenosis rates after percutaneous coronary intervention. However, the permanent metallic implants may impair coronary imaging with MRI or CT, can hinder surgical revascularization, prevent positive remodeling, and predispose the vessel to late stent thrombosis.
Recent reports also have indicated that there may be an increased risk of late stent thrombosis with DES compared with bare-metal stents (BMS). In a meta-analysis of 14 clinical trials that randomized 6,675 patients to paclitaxel- or sirolimus-eluting stents versus BMS, there was a significant increase in the incidence of very late thrombosis (>1 year following the index procedure) associated with DES use compared to BMS placement.
Stents are in development to address these problems; some stents contain newer drug-eluting agents while others feature new designs and new stent material. At the ACC 2007 i2 Summit, Serruys and colleagues reported a first-in-man study assessing the safety and overall performance of a bioabsorbable stent that, if effective, could eliminate several of the problems associated with metallic stents.
The ABSORB trial evaluated the Bioabsorbable Everolimus-Eluting Coronary Stent System, placed in a single de novo coronary artery lesion. Researchers evaluated device efficacy, procedural success in terms of ease of deployment and safety, major adverse cardiac events (MACE), and stent thrombosis at 30 and 180 days.
At 30 days in the ABSORB trial, device and procedural success was very high 93.5% device success and 100% procedural success and no patients experienced MACE or stent thrombosis. At 6 months, rates of MACE continued to be low (3.3%, one patient with non-Q wave MI at 46 days postprocedure) and still no stent thrombosis. Ninety-day results, presented May 22, 2007 at EuroPCR, showed no additional MACE nor stent thrombosis.
Drug-eluting stents (DES) dramatically reduce restenosis rates after percutaneous coronary intervention. However, the permanent metallic implants may impair coronary imaging with MRI or CT, can hinder surgical revascularization, prevent positive remodeling, and predispose the vessel to late stent thrombosis.
Recent reports also have indicated that there may be an increased risk of late stent thrombosis with DES compared with bare-metal stents (BMS). In a meta-analysis of 14 clinical trials that randomized 6,675 patients to paclitaxel- or sirolimus-eluting stents versus BMS, there was a significant increase in the incidence of very late thrombosis (>1 year following the index procedure) associated with DES use compared to BMS placement.
Stents are in development to address these problems; some stents contain newer drug-eluting agents while others feature new designs and new stent material. At the ACC 2007 i2 Summit, Serruys and colleagues reported a first-in-man study assessing the safety and overall performance of a bioabsorbable stent that, if effective, could eliminate several of the problems associated with metallic stents.
The ABSORB trial evaluated the Bioabsorbable Everolimus-Eluting Coronary Stent System, placed in a single de novo coronary artery lesion. Researchers evaluated device efficacy, procedural success in terms of ease of deployment and safety, major adverse cardiac events (MACE), and stent thrombosis at 30 and 180 days.
At 30 days in the ABSORB trial, device and procedural success was very high 93.5% device success and 100% procedural success and no patients experienced MACE or stent thrombosis. At 6 months, rates of MACE continued to be low (3.3%, one patient with non-Q wave MI at 46 days postprocedure) and still no stent thrombosis. Ninety-day results, presented May 22, 2007 at EuroPCR, showed no additional MACE nor stent thrombosis.
