Angiographic and procedural outcome after coronary angioplasty in high-risk subsets using a decremental diameter (tapered) balloon catheter. Tapered Balloon Registry Investigators.

The angiographic and clinical outcomes of 115 patients (129 lesions) treated at 11 clinical centers using a decremental diameter (tapered) balloon catheter were evaluated. The presence of marked tapering of the reference vessel, lesion location involving a bifurcation or anastomosis of a saphenous vein graft, or total coronary occlusion where estimation of the distal vessel size was difficult were indications for this device. The tapered balloon was used as the initial dilatation device in 62 patients (73 narrowings), and as a secondary device in 53 patients (56 narrowings). Lesions selected for tapered balloon angioplasty were generally complex (95% had > or = 1 and 60% had > or = 2 adverse morphologic features). Vessel diameters were larger in the proximal reference segments (3.07 +/- 0.52 mm) than in distal ones (2.48 +/- 0.45 mm) (p<0.001). After tapered balloon angioplasty, the minimal lumen diameter increased from 0.85 +/- 0.34 mm to 2.13 +/- 0.50 mm (p<0.001), and the percent diameter stenosis decreased from 69 +/- 12% to 24 +/- 12% (p<0.001). Coronary dissections occurred in 20% of lesions; they were severe in 4% (National Heart, Lung, and Blood Institute grade C to F). Abrupt closure occurred in 4.3% of patients (2.6% immediate; 1.7% delayed). Procedural success was obtained in 110 patients (96%); major complications (in-hospital death, myocardial infarction, or emergency coronary bypass surgery) occurred in 3 patients (2.7%). Coronary angioplasty using the tapered balloon catheter appears to be a safe and effective technique for the treatment of complex lesion subsets, particularly those involving coronary arteries with marked segmental tapering.