Clinical usefulness of the Driver^® stent in a retrospective, collaborative, multicenter, open-label study in Japanese real-world patients with coronary artery disease and the drug-eluting stent era

Abstract

The objectives of the present study were to determine predictors for target lesion revascularization (TLR) and to examine the clinical usefulness of the Driver^® stent (a cobalt alloy, modular-type) in Japanese patients with coronary artery disease. Data on 631 Japanese patients including 241 with stable angina and 361 with acute coronary syndrome—who had been implanted with the Driver^® stent (805 lesions) between August 2004 and February 2005—were collected retrospectively; 95.0 and 81.7% of these lesions were de novo and ACC/AHA classification B2/C type, respectively. Early angiography of 622 patients revealed 1) the preprocedural minimal lumen diameter (MLD) of 0.80 ± 0.51 mm, with lesion lengths of 17.1 ± 7.3 mm, and 2) the postprocedural MLD of 2.95 ± 0.55 mm, with MLD gains of 2.14 ± 0.68 mm. At 270 days of clinical follow-up, the incidences of major adverse cardiac events (MACE), TLR, and early stent thrombosis (ST) were 18.8, 14.7, and 0.2%, respectively; the TLR rate decreased statistically significantly to 5.3 and 5.9% when implanting the Driver^® stent (3.5 and 4.0 mm) and by IVUS, respectively. Absence rate of diabetes mellitus, presence rate of AMI, presence rate of stent diameters of ≥3.5 mm, and presence rate of IVUS-guided PCI showed lower TLR rates, with statistically significant differences. Uni- and multivariate analyses revealed that AMI and stent diameter (≥3.5 mm) are significant predictors for TLR (0.048 and 0.047, respectively), indicating that physicians are recommended to consider these variables when selecting candidate real-world patients for IVUS-guided PCI.