Acute results of directional coronary atherectomy in the balloon versus optimal atherectomy trial (BOAT) pilot phase

Coronary Artery Disease

Volumn 7, Issue 4, 1996, Pages 290-293

  Baim, Donald S ^a,b   Cutlip, Donald ^a   Ho, Kalon K L ^a   Popma, Jeffrey J ^a   Senerchia, Cindy ^a   Kuntz, Richard E ^a  

^a Cardiovascular Data Analysis Center   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

Author keywords

clinical trials; coronary angioplasty; coronary atherectomy

Indexed keywords

CREATINE KINASE MB;

ADULT; ANGIOCARDIOGRAPHY; ARTERY INTIMA PROLIFERATION; ATHERECTOMY; BLOOD VESSEL DIAMETER; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY CIRCUMFLEX BRANCH; CORONARY ARTERY OBSTRUCTION; ECHOGRAPHY; HEART INFARCTION; HUMAN; LEFT ANTERIOR DESCENDING CORONARY ARTERY; MAJOR CLINICAL STUDY; MORTALITY; PERFORATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESTENOSIS; REVIEW; RIGHT CORONARY ARTERY; SAFETY; TRANSLUMINAL CORONARY ANGIOPLASTY;

EID: 0029759336     PISSN: 09546928     EISSN: None     Source Type: Journal    
DOI: 10.1097/00019501-199604000-00004     Document Type: Review

References (12)

1. Simpson JB: How atherectomy began: a personal history. Am J Cardiol 1993, 72:3E-5E.
2. Topol EJ, Leya F, Pinkerton CA, et al.: A comparison of directional atherectomy with coronary angioplasty in patients with coronary artery disease. N Engl J Med 1993, 329:221. Primary report of the CAVEAT, in which conservative atherectomy device sizing and prohibition of balloon post-dilatation led to a 29% post-treatment stenosis and lumen diameters only slightly larger than those provided by balloon angioplasty, with minimal reduction in late restenosis. Multivariate analysis, however, did show the importance of post-treatment lumen diameter as a predictor of freedom from restenosis.
3. Adelman AG, et al.: A comparison of directional atherectomy with balloon angioplasty for lesions of the left anterior descending coronary artery. N Engl J Med 1993, 329:228.
4. Garratt KN, Holmes DR Jr, Bell MR, Bresnahan JF, Kaufman UP, Vliestra RE, et al.: Restenosis after directional coronary atherectomy: differences between primary atheromatous and restenosis lesions and influence of subintimal tissue resection. J Am Coll Cardiol 1990, 16:1665.
5. Kuntz RE, Safian RD, Levine MJ, Reis GJ, Diver DJ, Baim DS: Novel approach to the analysis of restenosis following three new coronary interventions. J Am Coll Cardiol 1992,19:1493.
6. Kuntz RE, Gibson CM, Nobuyoshi M, Baim DS: A generalized model of restenosis following conventional balloon angioplasty, stenting, and directional atherectomy. J Am Coll Cardiol 1993,21:15. Analysis of 524 lesions treated with Palmaz-Schatz stenting, directional atherectomy, or conventional balloon angiplasty shows that the most important prediction of freedom from restenosis is the size of the post-treatment lumen diameter, rather than the specific device used to obtain that lumenal enlargement. This paper was an important milestone in the development of the 'bigger is better' paradigm.
7. Kuntz RE, Hinohara T, Safian RD, Selmon MR, Simpson JB, Baim D: Restenosis following directional coronary atherectomy: the effects of luminal diameter and deep wall excision. Circulation 1992,86:1394.
8. Penny WF, Schmidt DA, Safian RD, Erny RE, Baim DS: Insights into the mechanism of luminal improvement after directional coronary atherectomy. Am J Cardiol 1991,67:435.
9. Gordon PC, Kugelmass AD, Cohen DJ, Breall JA, Friedrich SP, Carrozza JP, et al.: Balloon postdilation can safely improve the results of successful (but suboptimal) directional coronary atherectomy. Am J Cardiol 1993,72:71E. In 42% of successful directional atherectomy procedures, the result was observed to be sub-optimal in terms of a 17% residual stenosis after maximal safe tissue removal Balloon post-dilatation produced further lumen enlargement and reduced residual stenosis to 9%, without causing procedural complication. This combined approach of tissue removal followed by balloon dilatation came to be called 'optimal' atherectomy, and has subsequently been tested in the OARS and BOAT trials, as described.
10. Fishman RF, Kuntz RE, Carrozza JP, Miller MJ, Senerchia CC, Schnitt SJ, et al.: Long term results of directional coronary atherectomy: predictors of restenosis. J Am Coll Cardiol 1992,20:1101. Single center experience with 225 directional atherectomy procedures performed in 1988-1991 showed a mean residual stenosis of 7%, with a low incidence of major complications and an angiographic restenosis rate of 32% (compared with 50% in CAVEAT). The discrepancy between the CAVEAT results and reports such as this stimulated the development of the BOAT trial.
11. Umans VA, Keane D, Foley D, Boersman E, Melkert R, Serruys PW: Optimal use of directional coronary atherectomy is required to ensure long-term angiographic benefit: a study with matched procedural outcome after atherectomy and angioplasty. J Am Coll Cardiol 1994,24:1652.
12. Kugelmass AD, Cohen DJ, Moscucci M, Piana RN, Senerchia C, Kuntz RE, et al.: Elevation of creatine myocardial isoform following otherwise successful directional coronary atherectomy and stenting. Am J Cardiol 1994,74:748-754. Elevation of the post-procedural CK-MB is more common than expected in patients who have undergone otherwise successful and uncomplicated stenting on directional atherectomy, and more common than seen after conventional balloon angioplasty in randomized trials like CAVEAT and BOAT. This paper shows that low-order elevations of CK-MB (< 5 x normal) appear to carry no deleterious long-term consequences, but the issue is being evaluated further in the 1 000 patient BOAT trial.