EVALUATING NEW DEVICES - ACUTE (IN-HOSPITAL) RESULTS FROM THE NEW APPROACHES TO CORONARY INTERVENTION REGISTRY

Background To be used optimally, new interventional devices (stent, la sers, atherectomy catheters) must be carefully evaluated in terms of o ptimal patient and lesion selection, technique of use, expected acute success and complications, and long-term results. Sources for that inf ormation include single-center and multicenter (single-device) reports , although randomized trials may then be performed to provide a more d efinitive picture of any clinical benefits. One interim option, howeve r, consists of carefully collected registry data. The purpose of this article is to review data collected in the National Heart, Lung, and B lood Institute-funded New Approaches to Coronary Intervention (NACI) R egistry and to compare them with existing reports. Methods and Results NACI is an independent, investigator-driven effort that seeks to coll ect uniform data on patients undergoing treatment with one of several investigational devices and thereby provide an unbiased report of proc edure outcome. Between November 1990 and November 1992, 36 participati ng centers treated a total of 3201 lesions in 2835 patients, using one of seven study devices: directional atherectomy (1084 lesions), trans luminal extraction atherectomy (240 lesions), rotational atherectomy ( 349 lesions), Palmaz-Schatz stent (674 lesions), Gianturco-Roubin sten t (213 lesions), and the Advanced Interventional Systems (474 lesions) or Spectranetics (167 lesions) excimer lasers. Data on each procedure were recorded on a unique modular database that captured the reason f or (and interim result after) each device use. Device success (defined here as stenosis improvement by greater than or equal to 20% and a re sidual stenosis <50% after new device use) was 66.5% overall. Adjuncti ve angioplasty was used in 75.5% of lesions, either before (25.9%) or after (43.5%) new device use, yielding an overall lesion success (grea ter than or equal to 20% stenosis improvement with a final residual st enosis <50% after all devices) of 92.2%. Adjunctive angioplasty after new device use produced further enlargement in minimal lumen diameter (from 2.2 to 2.7 mm) and further reduction in residual stenosis (26.4% to 16.1%) compared with the results present after use of the new devi ces themselves. Major complications consisting of death (1.6%), Q-wave myocardial infarction (1.3%), or emergency bypass surgery (1.7%) occu rred in 4.0% of patients (range, 2.6% to 8.7% across devices). Procedu ral success, defined as lesion success in all new device-treated lesio ns without a major complication, was achieved in 90.8% of patients, wi th a median length of hospital stay of 4 days. Conclusions NACI illust rates the type of information that can be obtained in a registry forma t that examines the acute angiographic and clinical results of new dev ices according to uniform definitions. Although no registry can substi tute for formal interdevice trials, registries such as this can supple ment earlier single-center and multicenter reports. In doing so, they can help focus subsequent randomized interdevice comparisons on lesion types for which two or more devices have promising acute results. Giv en the substantial interdevice differences in baseline patient and les ion characteristics found in NACI, simple ''head-to-head'' comparison of the results of different devices might give misleading impressions and should be avoided unless such comparisons are restricted to carefu lly matched patient and lesion subgroups.