The use of the Gianturco-Roubin intracoronary stent: the New Approaches to Coronary Intervention (NACI) registry experience. 1997

L S Dean, and C J George, and D R Holmes, and J P Carrozza, and S B King, and R E Vlietstra, and J W Moses, and D Kereiakes, and G S Roubin
University of Alabama, Birmingham, USA.

The objective of this study is to compare the in-hospital and follow-up outcome in patients receiving the Gianturco-Roubin stent (GRS) who were enrolled in the New Approaches to Coronary Intervention (NACI) registry. The GRS was approved by the US Food and Drug Administration (FDA) in August 1992 for the treatment of acute or threatened closure after a percutaneous intervention. The application of intracoronary stenting has broadened substantially in the last few years, but less is known 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 closure was undertaken. A GRS was deployed in 497 NACI registry patients. Of these, 466 patients received a GRS in 1 of 3 of the following ways: (1) 351 unplanned stenting after conventional angioplasty of the same 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 outcome and subsequent follow-up to 1 year. There were 520 stented segments in the 466 patients. The group with stenting after failed/suboptimal new-device use had a higher incidence of myocardial infarction (MI) and cardiogenic shock than either the patients with unplanned stenting after percutaneous transluminal coronary angioplasty (PTCA) or planned stenting (MI 22.2% vs 12.0% vs 0%, respectively, and cardiogenic shock 5.6% vs 0.9% vs 0%, respectively; p < 0.05). This group also had significantly lower procedural success (58.7% vs 75.3% vs 81.5%, respectively; p < 0.05). Although not statistically significant, the requirement 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%, respectively). 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, in-hospital complication rate in the unplanned groups, follow-up from discharge to 1 year showed similar outcome. In particular, percutaneous reintervention of the stented segment occurred in: 13.0% in the unplanned 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 planned group probably represents the greater incidence of restenotic lesions in this cohort. In this very heterogeneous group of patients, including those with failure of another new device, the use of the GRS is associated with acceptable in-hospital and follow-up complication rates, although complications were clearly greater when unplanned use of the stent was needed, particularly after failure of another new device. Although the experience is small, patients having the GRS placed in an elective fashion, i.e., the planned group, appear to experience lower in-hospital complication rates, although they have a higher rate of subsequent target lesion revascularization, in this group of predominantly restenotic lesions.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D012008 Recurrence The return of a sign, symptom, or disease after a remission. Recrudescence,Relapse,Recrudescences,Recurrences,Relapses
D012042 Registries The systems and processes involved in the establishment, support, management, and operation of registers, e.g., disease registers. Parish Registers,Population Register,Parish Register,Population Registers,Register, Parish,Register, Population,Registers, Parish,Registers, Population,Registry
D003327 Coronary Disease An imbalance between myocardial functional requirements and the capacity of the CORONARY VESSELS to supply sufficient blood flow. It is a form of MYOCARDIAL ISCHEMIA (insufficient blood supply to the heart muscle) caused by a decreased capacity of the coronary vessels. Coronary Heart Disease,Coronary Diseases,Coronary Heart Diseases,Disease, Coronary,Disease, Coronary Heart,Diseases, Coronary,Diseases, Coronary Heart,Heart Disease, Coronary,Heart Diseases, Coronary
D004867 Equipment Design Methods and patterns of fabricating machines and related hardware. Design, Equipment,Device Design,Medical Device Design,Design, Medical Device,Designs, Medical Device,Device Design, Medical,Device Designs, Medical,Medical Device Designs,Design, Device,Designs, Device,Designs, Equipment,Device Designs,Equipment Designs
D005069 Evaluation Studies as Topic Works about studies that determine the effectiveness or value of processes, personnel, and equipment, or the material on conducting such studies. Critique,Evaluation Indexes,Evaluation Methodology,Evaluation Report,Evaluation Research,Methodology, Evaluation,Pre-Post Tests,Qualitative Evaluation,Quantitative Evaluation,Theoretical Effectiveness,Use-Effectiveness,Critiques,Effectiveness, Theoretical,Evaluation Methodologies,Evaluation Reports,Evaluation, Qualitative,Evaluation, Quantitative,Evaluations, Qualitative,Evaluations, Quantitative,Indexes, Evaluation,Methodologies, Evaluation,Pre Post Tests,Pre-Post Test,Qualitative Evaluations,Quantitative Evaluations,Report, Evaluation,Reports, Evaluation,Research, Evaluation,Test, Pre-Post,Tests, Pre-Post,Use Effectiveness
D005260 Female Females
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

Related Publications

L S Dean, and C J George, and D R Holmes, and J P Carrozza, and S B King, and R E Vlietstra, and J W Moses, and D Kereiakes, and G S Roubin
March 1994, Circulation,
L S Dean, and C J George, and D R Holmes, and J P Carrozza, and S B King, and R E Vlietstra, and J W Moses, and D Kereiakes, and G S Roubin
February 1996, The American journal of cardiology,
L S Dean, and C J George, and D R Holmes, and J P Carrozza, and S B King, and R E Vlietstra, and J W Moses, and D Kereiakes, and G S Roubin
January 1991, The Journal of invasive cardiology,
L S Dean, and C J George, and D R Holmes, and J P Carrozza, and S B King, and R E Vlietstra, and J W Moses, and D Kereiakes, and G S Roubin
July 1994, Nihon rinsho. Japanese journal of clinical medicine,
L S Dean, and C J George, and D R Holmes, and J P Carrozza, and S B King, and R E Vlietstra, and J W Moses, and D Kereiakes, and G S Roubin
November 1997, The American journal of cardiology,
L S Dean, and C J George, and D R Holmes, and J P Carrozza, and S B King, and R E Vlietstra, and J W Moses, and D Kereiakes, and G S Roubin
July 1994, Catheterization and cardiovascular diagnosis,
L S Dean, and C J George, and D R Holmes, and J P Carrozza, and S B King, and R E Vlietstra, and J W Moses, and D Kereiakes, and G S Roubin
January 1991, Indian heart journal,
L S Dean, and C J George, and D R Holmes, and J P Carrozza, and S B King, and R E Vlietstra, and J W Moses, and D Kereiakes, and G S Roubin
November 1997, The American journal of cardiology,
L S Dean, and C J George, and D R Holmes, and J P Carrozza, and S B King, and R E Vlietstra, and J W Moses, and D Kereiakes, and G S Roubin
August 1991, Catheterization and cardiovascular diagnosis,
L S Dean, and C J George, and D R Holmes, and J P Carrozza, and S B King, and R E Vlietstra, and J W Moses, and D Kereiakes, and G S Roubin
November 1994, Cardiology clinics,
Copied contents to your clipboard!