Aim: In an attempt to improve the stent's safety and effectiveness, development of drug-eluting stents (DES) continues, with new materials and geometry. XLIMUS (CARDIONOVUM GmbH, Germany) is a new DES with the following potential advantages 1) excellent stent platform; 2) biodegradable polymer; and 3) potent antiproliferative drug (sirolimus).
Methods: In this pilot study, we assessed the safety and efficacy of percutaneous coronary interventions (PCI) using the new XLIMUS DES in patients undergoing elective PCI in native coronary vessels for complex de novo lesions, including: 1) severe calcification; 2) severe tortuosity; and 3) chronic total occlusion (CTO).
Results: A total of 53 consecutive patients with 59 lesions were analyzed. Severe calcifications occurred in 21% of patients; severe tortuosity in 45%, and CTO in 34%. The device success was obtained in 52 (98%) patients and in 58 (98%) lesions. Globally, the XLIMUS DES was successfully implanted by conventional PCI techniques on the first try with a single guidewire in 48/53 (90.5%) patients and 54/59 (91.5%) lesions. Additional techniques to facilitate stent delivery (i.e., buddy wire, anchoring-balloon, or Guideliner catheter) were required in 5 lesions. In one case the XLIMUS DES finally failed to cross the target lesion.
Conclusion: This prospective, single-center pilot study suggests that the tracking and lesion crossing performance quality of the XLIMUS DES ensures treatment of complex coronary artery lesions.