Balloon-expandable intraluminal stents were used to treat iliac artery stenoses or occlusions that failed to respond to conventional balloon angioplasty. One hundred seventy-one procedures were performed in 154 patients, of whom 48 had a limb at risk for amputation. Thirty-six had severe and 70 had moderate intermittent claudication. At the latest follow-up examination (average, 6 months; range, 1–24 months), 137 patients demonstrated clinical benefit, 113 of whom had become asymptomatic. Eleven patients showed no initial benefit, and six improved initially but later developed new vascular symptoms. Complications occurred in 18 patients. In three patients, complications were directly related to the device. Two occlusions were successfully recanalized, and an intramural collection of contrast material secondary to balloon perforation evolved favorably. The remaining patients had groin hematoma (n = 6), distal embolization (n = 4), extravasation (n = 2), transient renal failure (n = 1), pseudoaneurysm at the puncture site (n = 1), or subintimal dissection (n = 1). All stents have remained patent to the latest follow-up examination without evidence of migration or aneurysm formation.
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.
