New Approaches To Coronary Intervention Research Articles

Application of the New York State PTCA mortality model in patients undergoing stent implantation

Objectives. We sought to compare outcomes of patients treated in the National Heart, Lung, and Blood Institute (NHLBI) Percutaneous Transluminal Coronary Angioplasty (PTCA) and New Approaches to Coronary Intervention (NACI) registries.Background. Coronary angioplasty has numerous shortcomings. New devices for performing coronary interventions have been introduced in an effort to improve clinical outcomes.Methods. Under the sponsorship of the NHLBI, a registry of consecutive patients treated with PTCA during 1985 to 1986 was established. In 1990, the NHLBI funded a second registry, the NACI. The two registries used the same data coordinating center to collect detailed baseline and follow-up information.Results. Patients enrolled in the NACI registry were older, had undergone more previous bypass surgery procedures and had more stenoses located in bypass grafts than patients in the NHLBI PTCA registry. Procedural success was achieved in 72.1% and 82.6% of patients in the PTCA and NACI registries, respectively; however, in-hospital and 1-year mortality rates were 1.0% versus 1.8% and 3.1% versus 5.9% for the PTCA versus NACI registries, respectively. After risk adjustment, there was no difference in 1-year mortality. Rates of target lesion revascularization (TLR) were 21.5% for the PTCA registry and 24.2% for the NACI registry. NACI registry patients had a higher risk for TLR and the composite end point of death, myocardial infarction or revascularization (relative risk 1.28 and 1.23, respectively). However, the NACI registry patients who received stents tended to have a lower adjusted TLR rate.Conclusions. This comparative study found no overall superiority of these newer devices in terms of patient survival or freedom from TLR after adjustment for baseline risk profiles. Although technologic improvements (especially improved stenting) continue, these observations highlight the importance of careful assessment of clinical results in the broad population of patients in whom interventions are used.

New Approaches to Coronary Intervention (NACI) Registry: History and Methods

The New Approaches to Coronary Intervention (NACI) registry was funded in 1990 by the National Heart, Lung, and Blood Institute to evaluate the safety and efficacy of new coronary interventional devices. The registry collected data from 39 clinical centers on 8 new devices: 3 atherectomy devices, 2 stents, 2 laser devices and the laser balloon. The original funding called for a total of 500 patients to be recruited for each device. One device (the laser balloon) was removed from use early in the recruitment period. Subsequent funding was obtained for an additional 500 patients treated with directional atherectomy, and 500 additional female patients who were recruited when the main recruitment had finished. When all recruitment was finished in March 1994, a total of 4,429 patients had been recruited. Consecutive patients treated with a new device at each clinical site were recruited regardless of underlying clinical condition or result. Patients were followed for 1 year by telephone contact at 6 weeks, 6 months and 1 year. Overall 1-year follow-up compliance was excellent at 96% of patients. The NACI database was designed to allow analysis of the complex relationships between patient, lesion and device. In particular, the mode of use of each device, the treatment order, and the outcome after each device attempt were recorded. All in-hospital clinical events were recorded as well as an assessment of the success of the procedure by the operator. The results of each telephone follow-up included any interim cardiac events, anginal status, and results of any subsequent angiograms or exercise test. Any repeat percutaneous procedures or bypass surgery on an NACI patient were recorded in the same detail as the original procedure. All data collected were subjected to extensive editing at the coordinating center to ensure both internal and external consistency. An angiographic core laboratory was also funded for NACI in 1992 to provide uniform analyses of procedural angiograms. Measurements were made at each step of the procedure, that is preprocedure, after each device use, and postprocedure. Both quantitative and qualitative measurements were made at each step using standardized definitions, enabling a complete description of the procedure to be analyzed. Angiograms were made available to the core laboratory for 89% of all initial procedures.

Acute and Long-Term Outcome After Palmaz-Schatz Stenting: Analysis From the New Approaches To Coronary Intervention (NACI) Registry

The randomized Stent Restenosis Study (STRESS) and Belgium Netherlands Stent (Benestent) trials established that elective use of Palmaz-Schatz stents (PSSs) in native coronary arteries with de novo lesions is associated with increased procedural success and reduced restenosis. However there are other clinical indications for which stents are commonly used (unplanned use, vein grafts, restenosis lesions) that are not addressed in these studies. From 1990–1992, 688 lesions in 628 patients were treated with PSSs in the New Approaches to Coronary Intervention (NACI) registry. Angiographic core laboratory readings were available for 543 patients (595 lesions, of which 106 were stented for unplanned indications, 239 were in saphenous vein bypass grafts, and 296 were previously treated). The cohort of patients in whom stents were placed for unplanned indications had more women, current smokers, and had a higher incidence of recent myocardial infarction (MI). Patients who underwent stenting of saphenous vein grafts were older, had a higher incidence of diabetes mellitus, unstable angina, prior MI, and congestive heart failure. Lesion success was similar in all cohorts (98%), but procedural success was significantly higher for planned stenting (96% vs 87%; p <0.01). Predictors of adverse events in-hospital were presence of a significant left main stenosis and stenting for unplanned indication. The incidence of target lesion revascularization by 30 days was significantly higher for patients undergoing unplanned stenting due to a higher risk for stent thrombosis. Recent MI, stenting in native lesion, and small postprocedural minimum lumen diameter independently predicted target lesion revascularization at 30 days. Independent predictors of death, Q-wave myocardial infarction, or target lesion revascularization at 1 year included severe concomitant disease, high risk for surgery, left main disease, stenting in the left main coronary artery, and low postprocedure minimum lumen diameter.

Frequency and Predictors of Major In-hospital Ischemic Complications After Planned and Unplanned New-Device Angioplasty From the New Approaches to Coronary Intervention (NACI) Registry

The purpose of this study was to determine the frequency and predictors of major in-hospital ischemic complications after planned and unplanned procedures with new angioplasty devices from the New Approaches to Coronary Intervention (NACI) registry. The NACI registry is a multicenter, voluntary reporting of consecutive patients undergoing new-device angioplasty procedures using atherectomy catheters, stents, or lasers. This registry affords the opportunity to evaluate the performance of new angioplasty devices during elective and urgent circumstances. The study population consisted of 3,340 patients with 3,733 lesions (2,921 in native coronary arteries and 812 in saphenous vein grafts [SVGs], who were treated with new devices over a 3.5-year period and had their angiograms analyzed independently at a central angiographic core laboratory. Their in-hospital course and multivariate predictors of the complications in planned and unplanned procedures, further divided into native and SVG lesions, were evaluated. In 82.2% of native coronary artery lesions and 96.9% of SVG lesions, the procedure with a device had been planned due to unfavorable lesion characteristics for PTCA. In the remaining lesions, device use was unplanned, and was performed mainly to treat a suboptimal result (59–80.4%) after percutaneous transluminal coronary angioplasty (PTCA), and less frequently after important complications of PTCA including abrupt closure and PTCA failure. In native artery cohort, major in-hospital ischemic complications (death, Q-wave myocardial infarction [MI], or emergency coronary artery bypass surgery) occurred in 2.7% of the planned and 9.9% of the unplanned procedures (p <0.001), whereas in SVG such complications occurred in 3.6% of the planned and 8.7% of unplanned procedures (p = 0.21). Multivariate analysis revealed several predictors of major ischemic complications from planned native coronary artery device use: post-MI angina (odds ratio = 2.83); severe concomitant noncardiac disease (odds ratio = 2.5); multivessel disease (odds ratio = 1.75); and de novo lesions (odds ratio = 2.3). Multivariate predictors of major complications in unplanned native coronary artery procedures included high surgical risk (odds ratio = 3.08), and tortuous lesion (odds ratio = 2.41). In SVG lesions, the independent predictors of major complications for planned procedures included age (odds ratio = 1.09), high surgical risk (odds ratio = 4.34), and thrombus (odds ratio = 2.62). In native and SVG lesions, rates of major complications of planned procedures was acceptable (2.7–3.67%), but unplanned use of a new device was associated with a significantly higher rate of in-hospital complications (≃9%). Multivariate predictors for major ischemic complications included both clinical and lesion characteristics, and differed for native versus SVG lesions, as well as for planned versus unplanned procedures.

Excimer Laser Coronary Angioplasty: The New Approaches to Coronary Intervention (NACI) Experience

In the New Approaches to Coronary Intervention (NACI) registry, 887 patients were electively treated with excimer laser coronary angioplasty (ELCA) for coronary artery disease. The Advanced Interventional System (AIS) system was used in 487 cases; the Spectranetics system, in 400. The mean age was 63.4 years. Most patients had unstable angina (60.3%); 43.7% had a prior myocardial infarction; and 18.6% were high risk or inoperable patients. Mean ejection fraction was 55.4%. A total of 1,000 lesions were treated in the 887 patients. Of the 1,000 lesions treated with ELCA in the 887 patients, 36% were in the right coronary artery; 33%, left anterior descending; 13%, circumflex; 3%, left main; and 16.6%, vein graft. By angiographic core laboratory analysis available for 752 (85%) patients with 839 lesions, lesions were 12.76 mm long. The minimum lumen diameter increased to 1.29 mm after the laser and finally to 1.95 mm after adjunctive percutaneous transluminal coronary angioplasty (PTCA) (which was performed in 93% of all lesions), with a final residual stenosis of 32.1% and Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow in 95%. Dissections of grades B, C, or D were seen after 22.0% of initial laser attempts, and postlaser perforations were noted in 2.6%. Additional such dissections accumulated after adjunctive PTCA but the perforation rate remained low. Procedural success was achieved in 84% of patients, but 1.2% died, 0.7% experienced Q-wave myocardial infarction (MI), and 2.7% required emergency bypass surgery. Multiple logistic regression analysis could not identify any independent predictors of these in-hospital complications. One-year mortality was 5.7% and the cumulative incidence of Q-wave MI was 1.5%. Coronary artery bypass graft (CABG) surgery was performed in 15.0% of patients whereas 25.5% required repeat percutaneous intervention with a target lesion revascularization rate of 31%. Independent predictors of death, Q-wave MI, or target lesion revascularization (which, combined, occurred in 35.6% of patients) were the absence of prior MI, ELCA in the circumflex, perforation after the procedure, and small (<2 mm) final minimal lumen diameter. Considering the large number of patients with high-risk lesions, laser angioplasty was performed with excellent procedural success rates and a reasonable incidence of major complications.

Predictors of Acute and Long-Term Outcome With Transluminal Extraction Atherectomy: The New Approaches to Coronary Intervention (NACI) Registry

The New Approaches to Coronary Intervention (NACI) registry was established to define the role of new coronary devices in overcoming the limitations of balloon angioplasty. The purpose of the present study was to evaluate the acute and long-term efficacy of the transluminal extraction catheter (TEC) device utilizing data from the NACI registry and identify clinical and anatomic patient subsets who may benefit from this device. From 1990–1994, >4,300 patients from 39 clinical sites enrolled consecutive patients treated with one of the 7 new devices to the NACI registry. The study population consists of 331 patients (385 lesions) treated with planned TEC as the sole new device. Of these patients, 243 (292 lesions) were treated for saphenous vein graft (SVG) disease and 88 (93 lesions) for native disease. Patients undergoing SVG treatment were older and more likely to be male. They had lower ventricular function, more unstable angina, and a higher incidence of congestive heart failure. Multivessel disease was more prevalent in the SVG cohort, as was evidence of thrombus before treatment. Although device success was achieved in 50% of SVG lesions and 41% of native lesions, lesion success was achieved in 90% and 78%, respectively, after adjunctive balloon angioplasty, and procedure success rates were 86% and 79%, respectively. The in-hospital major complication (death/Q-wave myocardial infarction/emergency coronary artery bypass graft [CABG] surgery) rate was higher in the SVG cohort (6.2% vs 2.3%), mainly due to higher mortality rate (5.3% vs 1.1%). Multivariate analysis showed that SVG was not an independent predictor for either an in-hospital major complication or clinical failure. The risk factors for major in-hospital complications were history of congestive heart failure (odds ratio = 3.17) and thrombus (odds ratio = 3.36). For clinical failure the risk factors were diabetes (odds ratio = 1.88), thrombus (odds ratio = 2.08), and calcium (odds ratio = 3.09). One-year rates of death, Q-wave myocardial infarction, or any repeat revascularization were 51% in the SVG cohort and 41% in the native cohort. Following adjustment, patients treated for SVG disease did not have a higher risk when compared with those treated for native disease. The factors significantly associated with this composite event at 1 year are male (relative risk = 1.41), patients with history of congestive heart failure (relative risk = 1.56), and total occlusions (relative risk = 1.52). This study shows that for both SVG and native cohorts, device success rates were low with TEC alone, but acceptable lesion success rates were achieved when adjunctive PTCA was used. In-hospital as well as 1-year major complications were higher in the SVG cohort. However, after adjusting for other risk factors, SVG attempt was not significantly associated with either in-hospital or 1-year events.

Influence of Gender on In-Hospital Clinical and Angiographic Outcomes and on One-Year Follow-Up In the New Approaches to Coronary Intervention (NACI) Registry

Higher complication rates and lower success rates for treatment of women compared with men have been reported in prior studies of coronary angioplasty and in most early reports of outcome with new coronary interventional devices. In multivariate analysis this has been attributed largely to older age and other unfavorable clinical characteristics. These results are reflected in the current guidelines for coronary angioplasty. Women in prior studies have also had different distributions of vessel and lesion characteristics, but the influence of these differences on the outcome of new-device interventions have not been adequately evaluated. This article evaluates the influence of gender on clinical and angiographic characteristics, interventional procedure and complications, angiographic success, and clinical outcomes at hospital discharge and 1-year follow-up, as observed in the New Approaches to Coronary Intervention (NACI) registry. The NACI registry methodology has been reported in detail elsewhere in this supplement. This study focuses on the 90% of patients—975 women and 1,880 men—who had planned procedures with a single new device and also had angiographic core laboratory readings. Women compared with men were older, had more recent onset of coronary ischemic pain that was more severe and unstable, and had more frequent histories of other adverse clinical conditions. The distributions of several but not all angiographic characteristics before intervention were considered more favorable to angioplasty outcome in women. Differences were observed in device use and procedure staging. Angiographically determined average gain in lumen diameter after new-device intervention, with or without balloon angioplasty, was significantly less in women (1.38 mm) than in men (1.53 mm; p <0.001); this 0.15 mm difference is consistent with the 0.16-mm smaller reference vessel lumen diameter of women. However, final percent diameter stenoses and TIMI flow and lesion compliance characteristics were similar. Among procedural complications, only treatment for hypotension, blood transfusion, and vascular repair occurred more often in women. More women than men were clinically unstable (2.1% vs 1.1%) or went directly to emergent coronary artery bypass graft surgery (CABG; 1.2% vs 0.6%) on leaving the interventional laboratory. However, in-hospital death (1.4% vs 1.1%), Q-wave myocardial infarction (MI) (0.9% vs 1.1%), and emergent CABG (1.5% vs 1.0%, for women and men, respectively) were not significantly different. Nonemergent CABG was more frequent in women (1.8% vs 0.9%; p <0.05) and length of hospital stay after device intervention was longer (4.4 days vs 3.8 days in men; p <0.01). In both univariate and multivariate analyses gender did not emerge as a significant variable in relation to the combined endpoint, death, Q-wave MI, or emergent CABG at hospital discharge. At 1-year follow-up more women than men reported improvement in angina (70% vs 62%) and fewer women than men had had repeat revascularization (32% vs 36%). Similar proportions were alive and free of angina, Q-wave MI and repeat revascularization (46% of women vs 45% of men). Although several procedure-related complications were more frequent in women than men after coronary interventions with new devices, no important disadvantages were observed for women in the rates of major clinical events at hospital discharge and at 1-year clinical follow-up. Additional studies are needed to evaluate the complex interplay of clinical, vessel, and lesion characteristics on success and complications of specific interventional techniques and to determine whether gender, per se, is a risk factor and whether gender specific interventional strategies may be beneficial.

Reliability of the Quantitative Angiographic Measurements in the New Approaches to Coronary Intervention (NACI) Registry: A Comparison of Clinical Site and Repeated Angiographic Core Laboratory Readings

To assess the agreement of clinical site and angiographic core laboratory readings obtained in the New Approaches to Coronary Intervention (NACI) registry, we reviewed the angiographic results obtained in 787 lesions assessed both by the sites and the core laboratory, including 135 lesions analyzed twice (≥2 months apart) by the angiographic core laboratory. Although moderate agreement was demonstrated between the clinical site and angiographic core laboratory for qualitative lesion morphology such as lesion calcium (kappa [κ] = 0.42), only fair agreement was found between site and core laboratory estimation of lesion ulceration (κ = 0.33); thrombus (κ = 0.30); and eccentricity (κ = 0.27); with poor agreement for angulation (κ = 0.16); and proximal vessel tortuosity (κ = 0.03). Agreement for qualitative morphology was better for repeated core laboratory readings of lesion eccentricity (κ = 0.75); angulation (κ = 0.72); thrombus (κ = 0.68); proximal vessel tortuosity (κ = 0.66); and calcification (κ = 0.64). Quantitative angiographic measurements correlated moderately between the clinical site using the digital caliper method and the core laboratory using the automated edge-detection method, including preprocedural percentage diameter stenosis (intraclass correlation [R] = 0.50) and postprocedural percentage diameter stenosis (R = 0.63). Repeated core laboratory readings had almost perfect agreement, with R ranging from 0.88 for postprocedural percentage diameter stenosis to 0.93 for reference vessel diameter and pre- and postprocedural minimal lumen diameters. Repeated angiographic core laboratory readings provided highly consistent quantitative and qualitative morphologic results in the NACI registry, but the core laboratory readings varied substantially from those obtained at the clinical site. More standardized angiographic analytic criteria and core laboratory feedback to investigators may improve agreement between the clinical sites and the angiographic core laboratory in subsequent studies.

Directional Coronary Atherectomy (DCA): A Report from the New Approaches to Coronary Intervention (NACI) Registry

Directional coronary atherectomy (DCA) with the Simpson coronary atherocath seeks to debulk rather than simply displace obstructive tissue and is a means of enlarging the stenotic coronary lumen. This report from the New Approaches to Coronary Intervention (NACI) registry describes the experience of 1,196 patients who underwent DCA as the sole treatment for either native vessel or vein graft lesions. Device success (post-DCA residual stenosis <50% and ≥20% improvement) was achieved in 87.8%, with a lesion success rate (postprocedural residual stenosis <50% and ≥20% improvement) of 94.0%. The mean resultant stenosis after all interventions (by core laboratory) was 19%. Significant in-hospital complications occurred in 2.8% of patients with DCA attempts, including death 0.6%, Q-wave myocardial infarction (MI) 1.5%, and emergent coronary artery bypass graft surgery (CABG) 2.8%. At 1-year follow-up, cumulative mortality was 3.6%, with repeat revascularization in 28% (repeat percutaneous transluminal coronary angioplasty, 20.1%; CABG, 10.6%). This reflected percutaneous or surgical revascularization of the original lesion (target lesion revascularization) in 22.6% of patients. Subgroup analysis showed a lower lesion success rate and an increased complication rate for unplanned use, vein graft treatment, and treatment of a de novo (vs a restenotic) lesion. Multivariate analysis shows that diabetes mellitus, unstable angina, treatment of a restenotic lesion, and greater residual stenosis after the initial procedure were independent predictors of the composite endpoint of death/Q-wave MI/target lesion revascularization by 1-year follow-up. Among these generally favorable acute and 1-year results, the NACI directional atherectomy data confirm the “bigger is better” hypothesis: that lesions with a lower residual stenosis after a successful procedure had significantly fewer target lesion revascularizations between 30 days and 1 year, with no increase in major adverse events.

Problems in the Evaluation of New Devices for Coronary Intervention: What Have We Learned Since 1989?

The objectives of this study are to review the problems associated with the evaluation of new devices, the progress made in that evaluation process since 1989, and the role played by the New Approaches to Coronary Intervention (NACI) registry. In 1988–1989, the first wave of new coronary devices (stents, atherectomy, laser catheters) were entering clinical investigation. It seemed unlikely that the small manufacturer-run registries used to gain approval for earlier balloon catheters would be adequate to evaluate the host of complex new devices, each of which might be used for a restricted set of anatomic indications. Moreover, the wide range of arbitrary definitions then in use for fundamental outcomes (such as success, complication, and restenosis), effectively precluded meaningful device-to-device comparisons. Against this backdrop, the NACI registry was formed with National Heart, Lung, and Blood Institute funding to provide an independent and standardized evaluation of the first 8 new devices under evaluation in the United States, across the broad range of their application. The registry employed a unique modular form set to track the sequence of events during complex cases in which serial new devices and balloon angioplasty might be used, either in a planned way, or an unplanned way (to treat complications or suboptimal results). Outcomes were subjected to standardized criteria for (1) the reason for device use (planned, unplanned); (2) success (device, lesion, and procedural success); (3) complications (a) major (death, Q-wave myocardial infarction, and emergency coronary artery bypass grafting); or (b) other (groin complications, non–Q-wave myocardial infarction, etc.); and (4) clinical restenosis (any subsequent revascularization, target lesion revascularization). Separate funding for an angiographic core laboratory was obtained in 1992, which analyzed 3,936 (88.9%) of the 4,429 films obtained on patients enrolled between November 1990 and March 1994. The NACI registry has addressed a broad range of problems inherent in the evaluation of new devices for coronary intervention. Whereas the approval process has moved progressively towards randomized clinical trials (and away from registries), the NACI registry offers a unique view of current practice, outside the narrow scope of the limited number of randomized trials that have been performed to date. This article shows, however, that we have learned about more than the devices themselves since 1989—we have also learned about the importance of knowing the reason for device use, using precise definitions of endpoint variables, understanding the financial and reimbursement ramifications of new device trials, and upholding strict investigator ethics during the conduct of such evaluations.

High-Speed Rotational Atherectomy of Human Coronary Stenoses: Acute and One-Year Outcomes From the New Approaches to Coronary Intervention (NACI) Registry

High-speed rotational atherectomy (RA) is a new percutaneous procedure for treatment of coronary stenoses that operates by the unique mechanism of plaque abrasion. This article reports acute (in-hospital) outcomes and 1-year follow-up in a large cohort of patients treated with this device by NACI investigators. A total of 525 patients with 670 lesions treated with RA form the substrate of this report. Patients tended to be older (mean age 64.8 years) than those in previously reported series of percutaneous transluminal coronary angioplasty (PTCA), with more extensive disease and more complex lesions. Calcification was present in 54% of lesions, and eccentricity in 41%. Balloon angioplasty postdilation was performed after RA in 88% of cases. Angiographic and procedural success (angiographic success without death, Q-wave myocardial infarction [MI] or emergency coronary artery bypass graft [CABG] surgery) rates were 89% and 88%, respectively. Acute in-hospital events included 4 deaths (1%) and 1 emergency CABG surgery (0.4%). MI occurred in 6% of patients, consisting predominantly of non–Q-wave MI (5%). After RA, angiographic complications included coronary dissection (12%), abrupt closure (5%), side branch occlusion (3%), and distal embolization (3%). Most of these were resolved after postdilation except for coronary dissection, which was present in 15% of lesions treated. Mean length of stay was 3 days. At 1-year follow-up, 27% of patients required target lesion revascularization and 30% had experienced death, Q-wave MI, or target lesion revascularization. Preprocedural characteristics that independently predicted 1-year death, Q-wave MI, or target lesion revascularization were male gender, high risk for surgery, target lesions that were proximal to or in bifurcations, eccentric, long, or highly stenosed. RA, even when applied to lesions of traditionally unfavorable morphology, appears to provide reasonable procedural and angiographic success rates. Restenosis and progression of disease contribute to subsequent clinical and procedural events.

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-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.

934-23 Reproducibility of Qualitative and Quantitative Angiographic Findings in the New Approaches to Coronary Intervention (NACI) Registry

To assess the reliability of qualitative morphologic and quantitative angiographic measurements from the NACI Registry Angiographic Core Laboratory, repeat analysis of 135 lesions was performed &gt;2 months after the initial analysis. Pre- and post-procedural lesion morphology was evaluated by a trained technician utilizing standardized criteria; all readings were then reviewed at a separate sitting by an expert panel. Quantitative angiographic analysis was performed using contrast-filled guiding catheters and a validated edge-detection system (ImageComm). Reproducibility for lesion morphology was graded as poor-slight (k = 0.0-0.2), fair (k = 0.21-0.40), moderate (k = 0.41-0.60), substantial (k = 0.61-0.80), and almost perfect (k = 0.81-1.00). lntraclass (R) and Pearson (r) correlation coefficients are provided for quantitative angiographic measurements. Reading #1 Reading #2 Kappa (k) ±SE Pre-Procedural (%) Total Occlusion/Eccentricity 3.0/58 3.0/61 1.00/0.75 0/0.06 Angulation/Thrombus 18/9.0 17/6.0 0.72/06.8 0.08/0.12 Tortuosity/Calcification 3.0/5.3 1.5/8.3 0.66/0.64 0.22/0.13 Post-Procedural (%) Any Dissection/Staining 8.6/2.6 8.6/1.7 0.89/0.80 0.08/0.20 TIMI &lt;3/Spasm 5.1/3.4 4.3/1.7 0.71/0.66 0.16/0.23 Ectasia/Lumen Irregularity 6.9/6.0 5.2/6.0 0.55/0.54 0.17/0.17 Thrombus/Haziness 2.6/12.0 2.6/15.4 0.32/0.28 0.25/0.12 Quantitative Angiography Reading #1 Reading #2 Δ ± SD R/r Reference Diameter mm 2.77 ± 0.64 2.78 ± 0.64 017 ± 0.16 0.93/0.93 Pre-MLD, mm 087 ± 0.68 0.91 ± 0.66 0.19 ± 018 0.93/0.93 Pre-% Diameter Stenosis 69 ± 20 68 ± 20 6 ± 6 0.91/0.91 Final- MLD, mm 2.23 ± 0.85 2.13 ± 0.83 0.22 ± 0.22 0.93/0.94 Final-% Diameter Stenosis 22 ± 21 25 ± 21 7 ± 7 0.88/0.90 We conclude that Core Laboratory measurements of pre-procedural morphology, post-procedural dissection (±staining), and quantitative angiographic indices are highly reproducible in the NACI Registry, although reliability is lower for selected findings, including post-procedural thrombus and haziness.

Baseline characteristics and therapeutic goals in the New Approaches to Coronary Intervention (NACI) registry.

The New Approaches to Coronary Intervention (NACI) voluntary registry was designed to study the use, safety, and efficacy of new percutaneous transluminal interventional devices including directional coronary atherectomy, the transluminal extraction catheter, the rotablator, the Palmaz-Schatz stent, the Gianturco-Roubin stent, the Advanced Interventional Systems (AIS) laser, and the spectranetics laser. To date, more than 3800 consecutive patients treated for the first time with a new device at 41 centers have been entered into the registry. Complete detailed information about the patient, lesions, device characteristics, reasons for device selection, and procedural data, such as adjunctive use of conventional balloon angioplasty (PTCA), was available for the first 2835 patients. The registry shows that 88% of the 3233 attempts with a new device were intended as a definitive treatment of target lesions, frequently in combination with adjunctive PTCA. The remaining 12% of attempts with a new device were unplanned, prompted by unexpected complications, unsuccessful attempts, or suboptimal results with PTCA. Although there was some overlap in the indications for selecting a given interventional device, the variation from device to device was sufficiently large to caution users against any direct comparison of either safety or efficacy between devices without careful attention to the differences in baseline patient and lesion characteristics, treatment plans, and the circumstances of device use. This report provides the first comprehensive overview of how new interventional devices are currently being used in the treatment of coronary artery lesions at the 41 centers participating in the NACI registry.

The naci registry: An instrument for the evaluation of new approaches to coronary intervention

The New Approaches to Coronary Intervention (NACI) Registry was developed to collect in-depth data about patients whose coronary artery lesions are being treated with new interventional techniques such as atherectomy, stents, and laser devices. The NACI Registry database distinguishes among several possible "modes" for device use, such as preparatory, planned definitive, and bailout use. Common definitions are used for data collection across all devices, and device-specific forms are used to record procedural details. NACI's unique modular form design facilitates thorough data collection, even for the most complex treatment scenarios. The database structure allows for data analysis at the patient, procedure, lesion, and device levels, as required to perform in-depth analyses of the immediate and long-term success of new devices. Once adequate knowledge of basic device performance has been collected, the Registry structure can also allow expeditious planning and performance of randomized trials comparing a new device to conventional PTCA.