Results of the study to determine rotablator and transluminal angioplasty strategy (STRATAS).

Rotational atherectomy is used to debulk calcified or complex coronary stenoses. Whether aggressive burr sizing with minimal balloon dilation (<1 atm) to limit deep wall arterial injury improves results is unknown. Patients being considered for elective rotational atherectomy were randomized to either an "aggressive" strategy (n = 249) (maximum burr/artery >0.70 alone, or with adjunctive balloon inflation < or = 1 atm), or a "routine" strategy (n = 248) (maximum burr/artery < or =0.70 and routine balloon inflation > or =4 atm). Patient age was 62 +/- 11 years. Fifty-nine percent routine and 60% aggressive strategy patients had class III to IV angina. Fifteen percent routine and 16% aggressive strategy patients had a restenotic lesion treated; lesion length was 13.6 versus 13.7 mm. Reference vessel diameter was 2.64 mm. Maximum burr size (1.8 vs 2.1 mm), burr/artery ratio (0.71 vs 0.82), and number of burrs used (1.9 vs 2.7) were greater for the aggressive strategy, p <0.0001. Final minimum lumen diameter and residual stenosis were 1.97 mm and 26% for the routine strategy versus 1.95 mm and 27% for the aggressive strategy. Clinical success was 93.5% for the routine strategy and 93.9% for the aggressive strategy. Creatine kinase-myocardial band (CK-MB) was >5 times normal in 7% of the routine versus 11% of the aggressive group. CK-MB elevation was associated with a decrease in rpm of >5,000 from baseline for a cumulative time >5 seconds, p = 0.002. At 6 months, 22% of the routine patients versus 31% of the aggressive strategy patients had target lesion revascularization. Angiographic follow-up (77%) showed minimum lumen diameter to be 1.26 mm in the routine group versus 1.16 mm in the aggressive group, and the loss index 0.54 versus 0.62. Dichotomous restenosis was 52% for the routine strategy versus 58% for the aggressive strategy. Multivariable analysis indicated that left anterior descending location (odds ratio 1.67, p = 0.02) and operator-reported excessive speed decrease >5,000 rpm (odds ratio 1.74, p = 0.01) were significantly associated with restenosis. Thus, the aggressive rotational atherectomy strategy offers no advantage over more routine burr sizing plus routine angioplasty. Operator technique reflected by an rpm decrease of >5,000 from baseline is associated with CK-MB elevation and restenosis.

Acute results and long-term outcome of transluminal extraction catheter atherectomy for saphenous vein graft stenoses.

Distal embolization of atheroma and thrombus is a major concern when performing balloon angioplasty in coronary saphenous vein grafts (SVGs). The transluminal extraction catheter (TEC) is designed to remove this material and may improve the safety of percutaneous treatment of SVG disease. We assessed the acute results and long-term outcome of 67 patients (mean age 65.6 +/- 8.1 years; range 47-83 years) who underwent 73 separate TEC atherectomy procedures. Eighty-eight SVG lesions were treated (mean age 8.7 +/- 3.8 years from bypass surgery). Procedural success (< 50% final diameter stenosis and absence of major complications) was obtained in 63 patients (86%). Adjunctive balloon angioplasty and/or directional coronary atherectomy was required in 69 of the procedures (95%). Major complications, occurring in 8 patients (11%), were acute closure in 4 (5%), resulting in Q-wave myocardial infarction in 3 and urgent bypass surgery in 1, and distal embolization in 4 (5%; 1 associated with Q-wave myocardial infarction). Angiographic follow-up was available for 50 patients and restenosis was present in 26 (52%). These data suggest TEC atherectomy can be performed in SVGs with an acceptable procedural risk, but restenosis remains a significant limitation which will require other strategies to overcome.

Intracoronary thrombectomy: a new approach to total occlusion.

After initial failure with conventional angioplasty of a total right coronary artery occlusion, we were successful in obtaining patency using a combination of intracoronary thrombectomy and thrombolysis. This represents the first report of this technique in the therapy of total right coronary occlusions.