THE USE OF THE GIANTURCO-ROUBIN-INTRACORONARY-STENT - THE NEW-APPROACHES-TO-CORONARY-INTERVENTION (NACI) REGISTRY EXPERIENCE

The objective of this study is to compare the in-hospital and follow-u p outcome in patients receiving the Gianturco-Roubin stent (GRS) who w ere enrolled in the New Approaches to Coronary Intervention (NACI) reg istry. The GRS was approved by the US Food and Drug Administration (FD A) in August 1992 for the treatment of acute or threatened closure aft er a percutaneous intervention. The application of intracoronary stent ing has broadened substantially in the last few years, but less is kno wn about the use of this device for other indications. Since the NACI registry includes patients stented for other indications, a comparison of these groups with patients being stented for acute or threatened c losure was undertaken. A GRS was deployed in 497 NACI registry patient s. Of these, 466 patients received a GRS in 1 of 3 of the following wa ys: (1) 351 unplanned stenting after conventional angioplasty of the s ame lesion; (2) 54 after failed/suboptimal use of a new device in the same lesion; and (3) 61 in planned stenting procedures. This analysis focuses on these 3 patient subgroups and compares their in-hospital ou tcome and subsequent follow-up to 1 year. There were 520 stented segme nts in the 466 patients. The group with stenting after failed/suboptim al new-device use had a higher; incidence of myocardial infarction (MI ) and cardiogenic shock than either the patients with unplanned stenti ng after percutaneous transluminal coronary angioplasty (PTCA) or plan ned stenting (MI 22.2% vs 12.0% vs 0%, respectively, and cardiogenic s hock 5.6% vs 0.9% vs 0%, respectively; p <0.05). This group also had s ignificantly lower procedural success (58.7% vs 75.3% vs 81.5%, respec tively; p <0.05). Although not statistically significant, the requirem ent for transfusion was higher in the unplanned and new-device stented groups than in the planned group (10.5% vs 16.7% vs 1.6%, respectivel y). Likewise, the incidence of Q-wave MI was higher in the new-device group (22.2% vs 12% vs 0%, respectively; p <0.05). Despite a higher, i n-hospital complication rate in the unplanned groups, follow-up from d ischarge to 1 year showed similar outcome. In particular, percutaneous reintervention of the stented segment occurred in: 13.0% in the unpla nned after new device; 17.4% in the unplanned after PTCA; and 26.2% in the planned group. Although not statistically significant, the higher incidence of percutaneous target lesion revascularization in the plan ned group probably represents the greater incidence of restenotic lesi ons in this cohort. In this very heterogeneous group of patients, incl uding those with failure of another new device, the use of the GRS is associated with acceptable in-hospital and follow-up complication rate s, although complications were clearly greater when unplanned use of t he stent was needed, particularly after failure of another new device. Although the experience is small, patients having the GRS placed in a n elective fashion, i.e., the planned group, appear to experience lowe r in-hospital complication rates, although they have a higher rate of subsequent target lesion revascularization, in this group of predomina ntly restenotic lesions. (C) 1997 by Excerpta Medico, Inc.