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Background: In 1998, the International EECP Patient Registry (IEPR) was organized to document patient characteristics, safety, and efficacy during the treatment period, and long-term outcomes. All centers with EECP facilities were invited to join the voluntary Registry. The Registry population comprises all patients starting EECP therapy for treatment of angina pectoris in participating centers., Hypothesis: The study was undertaken to determine whether EECP is a safe and effective treatment for patients with angina pectoris regardless of their suitability for revascularization by more conventional techniques., Methods: After 18 months of operation, 43 clinical centers representing over half of clinical sites using the EECP system contributed cases. The data reported here were collected before the first EECP treatment and upon completion of final treatment. EECP can be used for patients ineligible for either coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI), as well as for those who prefer noninvasive treatment to avoid or delay revascularization. In this report, patients considered to be candidates for revascularization are compared with those not considered suitable., Results: Of the 978 patients analyzed, 70% had Canadian Cardiovascular Society Classification class III or IV angina before starting treatment, and 62% used nitroglycerin. Most (81%) had been previously revascularized, and 69% were considered unsuited for either PCI or CABG at the time of starting EECP. A full treatment course (usually 35 h) was completed in 86%, of whom 81% reported improvement of at least one angina class immediately after the last treatment., Conclusion: In a broad patient population, EECP has been shown to be a safe and effective treatment.

Enhanced external counterpulsation (EECP) is used to noninvasively treat refractory angina patients, including those with a history of heart failure. The International EECP Patient Registry was used to examine the benefit and safety of EECP treatment, including a 6-month follow-up, in 1,957 patients, 548 with a history of heart failure. The heart failure cohort was older, with more females, a greater duration of coronary artery disease, more prior infarcts and revascularizations. Significantly fewer heart failure patients completed the course of EECP, and exacerbation of heart failure was more frequent, though overall major adverse cardiac events (MACE, i.e. death, myocardial infarction, revascularization) during treatment were not significantly different. The angina class improved in 68%, with comparable quality of life benefit, in the heart failure cohort. At 6 months, patients with congestive heart failure maintained their reduction in angina but were significantly more likely to have experienced a MACE end point., (Copyright 2001 S. Karger AG, Basel)

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.

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.

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 (> or =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 [kappa] = 0.42), only fair agreement was found between site and core laboratory estimation of lesion ulceration (kappa = 0.33); thrombus (kappa = 0.30); and eccentricity (kappa = 0.27); with poor agreement for angulation (kappa = 0.16); and proximal vessel tortuosity (kappa = 0.03). Agreement for qualitative morphology was better for repeated core laboratory readings of lesion eccentricity (kappa = 0.75); angulation (kappa = 0.72); thrombus (kappa = 0.68); proximal vessel tortuosity (kappa = 0.66); and calcification (kappa = 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) 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 > or =20% improvement) was achieved in 87.8%, with a lesion success rate (postprocedural residual stenosis <50% and > or =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.

Background: 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., Methods: 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., Results: 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., Conclusion: 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.