Clinical outcomes of patients more than one year following randomization in the Canadian Coronary Atherectomy Trial (CCAT).

BACKGROUND: The Canadian Coronary Atherectomy Trial (CCAT) assessed, in a randomized comparison, the clinical and angiographic outcomes following atherectomy with those following balloon angioplasty for the treatment of de novo lesions in the proximal one-third of the left anterior descending artery (LAD). Although the procedural success rate was somewhat higher and the postprocedure lumen larger in patients treated with atherectomy, lumen dimensions, restenosis rates and clinical outcomes were similar in the two groups at six months. To determine whether late differences emerged between the groups, clinical follow-up was obtained at a median of 18 (range 10 to 31) months after randomization. METHODS AND RESULTS: Patients were contacted monthly by telephone for the first six months. Subsequent follow-up information was obtained in 272 (99%) of the 274 randomized patients via a clinic visit or telephone interview with the patient and/or a relative. Additional information was obtained from the referring physician as required. There were no differences in adverse events between the two groups during follow-up. In patients randomized to atherectomy compared with balloon angioplasty, death occurred in 1.5% versus 2.2% (cardiac death 0.7% versus 0.7%); myocardial infarction in 5.1% versus 5.9% (Q wave 1.5% versus 1.5%); coronary bypass surgery in 13.1% versus 12.6%; and repeat target lesion intervention in 22.6% versus 21.5%. Persistent or recurrent Canadian Cardiovascular Society class III/IV angina not treated by a further intervention was present in 1.5% versus 2.2%. The combined end-point of death or nonfatal myocardial infarction occurred in nine (6.6%) versus 11 (8.1%) patients and any adverse cardiac event in 50 (36.5%) versus 53 (39.3%). Multivariate logistic regression indicated that unstable angina, reference vessel size and preprocedure minimum lumen diameter were the only variables independently associated with adverse events. CONCLUSIONS: The initial choice of directional atherectomy or balloon angioplasty had no impact on clinical outcome over a period of 18 months in this patient population. With either technique, just over 60% of patients with proximal LAD disease experienced sustained symptomatic improvement without an adverse event following a single procedure, and 80% achieved this status following a repeat percutaneous intervention.

Comparison of fixed-wire and over-the-wire balloon dilatation systems for percutaneous transluminal coronary angioplasty.

There is controversy concerning the relative safety and efficacy of the 2 currently available percutaneous transluminal coronary angioplasty dilatation systems--fixed-wire (FW) and over-the-wire (OW). A randomized, prospective trial comparing the 2 systems was performed to examine this controversy. Of 1,513 patients undergoing percutaneous transluminal coronary angioplasty at 3 centers between June 1990 and October 1991, 602 (40%) fulfilled the eligibility criteria for the study. There were 643 lesions, of which 327 were randomized to FW and 316 to OW systems. There was no difference in the success rate between FW (92%) and OW (94%) systems. Inability to cross with a wire was infrequent with either system (FW: 1.8%; and OW: 1.6%). Inability to cross with a balloon when the wire crossed the lesion did not occur. An FW system was successful in 6 cases (1.9%) in which the OW system had been unsuccessful, whereas an OW system succeeded in 14 (4.3%) after the FW system had been unsuccessful (p = NS). Time to cross stenoses was 200 +/- 21 and 233 +/- 22 seconds, procedural time was 21 +/- 1.3 and 21 +/- 1.0 minutes, fluoroscopy time was 6.7 +/- 0.4 and 7.1 +/- 0.4 minutes, contrast used was 89.0 +/- 4.2 and 84.0 +/- 3.5 ml, and number of cine runs was 5.9 +/- 3.0 and 6.3 +/- 3.4 in the FW and OW systems, respectively. Complications were infrequent with either system (FW: 10.4%; and OW: 9.5%). Acute closure occurred in 1.8 and 2.2% of cases in the FW and OW systems, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

A comparison of directional atherectomy with balloon angioplasty for lesions of the left anterior descending coronary artery.

BACKGROUND: Restenosis is a major limitation of coronary angioplasty. Directional coronary atherectomy was developed with the expectation that it would provide better results than angioplasty, including a lower rate of restenosis. We undertook a randomized, multicenter trial to compare the rates of restenosis for atherectomy and angioplasty when used to treat lesions of the proximal left anterior descending coronary artery. METHODS: Of 274 patients referred for first-time, non-surgical revascularization of lesions of the proximal left anterior descending coronary artery, 138 were randomly assigned to undergo atherectomy and 136 to undergo angioplasty; 257 of 265 eligible patients (97 percent) underwent follow-up angiography at a median of 5.9 months. Computer-assisted quantitative measurements of luminal dimensions were determined from the angiograms obtained before and immediately after the procedure and at follow-up. The primary end point of restenosis was defined as stenosis of more than 50 percent of the vessel's diameter at follow-up. RESULTS: Quantitative analysis showed that the procedural success rate was higher in patients who underwent atherectomy than in those who had angioplasty (94 percent vs. 88 percent, P = 0.061); there was no significant difference in the frequency of major in-hospital complications (5 percent vs. 6 percent). At follow-up, the rate of restenosis was 46 percent after atherectomy and 43 percent after angioplasty (P = 0.71). Despite a larger initial gain in the minimal luminal diameter with atherectomy (mean [+/- SD], 1.45 +/- 0.47 vs. 1.16 +/- 0.44 mm; P < 0.001), there was a larger late loss (0.79 +/- 0.61 vs. 0.47 +/- 0.64 mm; P < 0.001), resulting in a similar minimal luminal diameter in the two groups at follow-up (1.55 +/- 0.60 vs. 1.61 +/- 0.68, P = 0.44). The clinical outcomes at six months were not significantly different between the two groups. CONCLUSIONS: The role of atherectomy in percutaneous coronary revascularization remains to be fully defined. However, as compared with angioplasty, atherectomy did not result in better late angiographic or clinical outcomes in patients with lesions of the proximal left anterior descending coronary artery.

Intracardiac electrography in endocardial cushion defects.

Conduction of the sino-atrial impulse from the high right atrium to the ventricles was studied by intracardiac electrography in 21 unoperated patients, age 3 months to 11 years, with endocardial cushion defects (ECD). The high right atrium-to-low right atrium conduction time was prolonged in 15 of 18 subjects (mean 57 +/- 20 msec). The low right atrium-to-His bundle conduction time (LRA-H) was normal in 16 of 17 subjects (mean 82 +/- 30 msec), prolonged in one. The His-to-ventricle conduction time (H-V) was normal in 16 of 17 subjects (mean 37 +/- 8 msec), equivocally short in one. Nine patients with ECD, age 3 to 21 years, were studied postoperatively. One had an acquired complete atrioventricular block in the His bundle. Two had prolonged LRA-H and two prolonged LRA-H and two prolonged H-V. The surface ECG failed to identify accurately either prolonged atrioventricular conduction or the site of prolongation.

Marfan syndrome with coronary artery lesions in a North American Indian.

Marfan syndrome has not been well documented in North American Indians. A 19-year old Ojibwa man had evidence of this syndrome -- specifically, tall stature, long, thin extremities (particularly, fingers and toes), increased urinary excretion of hydroxyproline, aortic aneurysm, aortic regurgitation and pathologic evidence of aortic rupture and alastic tissue fragmentation. Intimal hyperplasia was present in the extramural coronary arteries, while the intramural arteries, usually thought to be involved, were normal.