Randomised trial of excimer laser angioplasty versus balloon angioplasty for treatment of obstructive coronary artery disease

Summary Background Excimer laser coronary angioplasty is reported to give excellent procedural results for treatment of complex coronary lesions, but this method has not been compared with balloon angioplasty in a randomised trial. Methods Patients (n=308) with stable angina and coronary lesions lon...

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Veröffentlicht in:The Lancet (British edition) 1996-01, Vol.347 (8994), p.79-84
Hauptverfasser: Appelman, Y.E.A, Piek, J.J, David, G.K, Tijssen, J.G.P, Koelemay, M.J, Strikwerda, S, de Feyter, P.J, Serruys, P.W, Montauban van Swijndregt, E.W.J, Margolis, J.R, Koolen, J.J
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container_end_page 84
container_issue 8994
container_start_page 79
container_title The Lancet (British edition)
container_volume 347
creator Appelman, Y.E.A
Piek, J.J
David, G.K
Tijssen, J.G.P
Koelemay, M.J
Strikwerda, S
de Feyter, P.J
Serruys, P.W
Montauban van Swijndregt, E.W.J
Margolis, J.R
Koolen, J.J
description Summary Background Excimer laser coronary angioplasty is reported to give excellent procedural results for treatment of complex coronary lesions, but this method has not been compared with balloon angioplasty in a randomised trial. Methods Patients (n=308) with stable angina and coronary lesions longer than 10 mm on visual assessment were included. 151 patients (158 lesions) were assigned randomly to laser angioplasty and 157 (167 lesions) to balloon angioplasty. The primary clinical endpoints were death, myocardial infarction, coronary bypass surgery, or repeat coronary angioplasty of the randomised segment during 6 months of follow-up. The primary angiographic end-point was the minimal lumen diameter at follow-up in relation to the baseline value (net gain), as determined by quantitative coronary angiography. Findings Laser angioplasty was followed by balloon angioplasty in 98% of procedures. The angiographic success rate was 80% in patients treated with laser angioplasty compared with 79% in patients treated with balloon angioplasty. There were no deaths. Myocardial infarction, coronary bypass surgery, and repeat angioplasty occurred in 4·6%, 10·6%, and 21·2%, respectively, of the patients in the laser angioplasty group compared with 5·7%, 10·8%, and 18·5% of the balloon angioplasty group. Net mean (SD) gain in minimal lumen diameter was 0·40 (0·69) mm in patients treated with laser angioplasty and 0·48 (0·66) mm in those treated with balloon angioplasty (p=0·34). The restenosis rate (>50% diameter stenosis) was 51·6% in the laser angioplasty group versus 41·3% in the balloon angioplasty group (p=0·13). Interpretation Excimer laser angioplasty followed by balloon angioplasty provides no benefit additional to balloon angioplasty alone with respect to the initial and long-term clinical and angiographic outcome in the treatment of obstructive coronary artery disease.
doi_str_mv 10.1016/S0140-6736(96)90209-3
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Methods Patients (n=308) with stable angina and coronary lesions longer than 10 mm on visual assessment were included. 151 patients (158 lesions) were assigned randomly to laser angioplasty and 157 (167 lesions) to balloon angioplasty. The primary clinical endpoints were death, myocardial infarction, coronary bypass surgery, or repeat coronary angioplasty of the randomised segment during 6 months of follow-up. The primary angiographic end-point was the minimal lumen diameter at follow-up in relation to the baseline value (net gain), as determined by quantitative coronary angiography. Findings Laser angioplasty was followed by balloon angioplasty in 98% of procedures. The angiographic success rate was 80% in patients treated with laser angioplasty compared with 79% in patients treated with balloon angioplasty. There were no deaths. Myocardial infarction, coronary bypass surgery, and repeat angioplasty occurred in 4·6%, 10·6%, and 21·2%, respectively, of the patients in the laser angioplasty group compared with 5·7%, 10·8%, and 18·5% of the balloon angioplasty group. Net mean (SD) gain in minimal lumen diameter was 0·40 (0·69) mm in patients treated with laser angioplasty and 0·48 (0·66) mm in those treated with balloon angioplasty (p=0·34). The restenosis rate (&gt;50% diameter stenosis) was 51·6% in the laser angioplasty group versus 41·3% in the balloon angioplasty group (p=0·13). Interpretation Excimer laser angioplasty followed by balloon angioplasty provides no benefit additional to balloon angioplasty alone with respect to the initial and long-term clinical and angiographic outcome in the treatment of obstructive coronary artery disease.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(96)90209-3</identifier><identifier>PMID: 8538345</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>London: Elsevier Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Angioplasty ; Angioplasty, Balloon, Coronary ; Angioplasty, Balloon, Laser-Assisted ; Biological and medical sciences ; Cardiovascular disease ; Clinical trials ; Coronary Angiography ; Coronary Disease - surgery ; Coronary Disease - therapy ; Coronary vessels ; Diseases of the cardiovascular system ; Female ; Follow-Up Studies ; Humans ; Lasers ; Lesions ; Male ; Medical research ; Medical sciences ; Middle Aged ; Myocardial infarction ; Radiotherapy. 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Methods Patients (n=308) with stable angina and coronary lesions longer than 10 mm on visual assessment were included. 151 patients (158 lesions) were assigned randomly to laser angioplasty and 157 (167 lesions) to balloon angioplasty. The primary clinical endpoints were death, myocardial infarction, coronary bypass surgery, or repeat coronary angioplasty of the randomised segment during 6 months of follow-up. The primary angiographic end-point was the minimal lumen diameter at follow-up in relation to the baseline value (net gain), as determined by quantitative coronary angiography. Findings Laser angioplasty was followed by balloon angioplasty in 98% of procedures. The angiographic success rate was 80% in patients treated with laser angioplasty compared with 79% in patients treated with balloon angioplasty. There were no deaths. Myocardial infarction, coronary bypass surgery, and repeat angioplasty occurred in 4·6%, 10·6%, and 21·2%, respectively, of the patients in the laser angioplasty group compared with 5·7%, 10·8%, and 18·5% of the balloon angioplasty group. Net mean (SD) gain in minimal lumen diameter was 0·40 (0·69) mm in patients treated with laser angioplasty and 0·48 (0·66) mm in those treated with balloon angioplasty (p=0·34). The restenosis rate (&gt;50% diameter stenosis) was 51·6% in the laser angioplasty group versus 41·3% in the balloon angioplasty group (p=0·13). Interpretation Excimer laser angioplasty followed by balloon angioplasty provides no benefit additional to balloon angioplasty alone with respect to the initial and long-term clinical and angiographic outcome in the treatment of obstructive coronary artery disease.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Angioplasty</subject><subject>Angioplasty, Balloon, Coronary</subject><subject>Angioplasty, Balloon, Laser-Assisted</subject><subject>Biological and medical sciences</subject><subject>Cardiovascular disease</subject><subject>Clinical trials</subject><subject>Coronary Angiography</subject><subject>Coronary Disease - surgery</subject><subject>Coronary Disease - therapy</subject><subject>Coronary vessels</subject><subject>Diseases of the cardiovascular system</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Lasers</subject><subject>Lesions</subject><subject>Male</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Myocardial infarction</subject><subject>Radiotherapy. 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Methods Patients (n=308) with stable angina and coronary lesions longer than 10 mm on visual assessment were included. 151 patients (158 lesions) were assigned randomly to laser angioplasty and 157 (167 lesions) to balloon angioplasty. The primary clinical endpoints were death, myocardial infarction, coronary bypass surgery, or repeat coronary angioplasty of the randomised segment during 6 months of follow-up. The primary angiographic end-point was the minimal lumen diameter at follow-up in relation to the baseline value (net gain), as determined by quantitative coronary angiography. Findings Laser angioplasty was followed by balloon angioplasty in 98% of procedures. The angiographic success rate was 80% in patients treated with laser angioplasty compared with 79% in patients treated with balloon angioplasty. There were no deaths. Myocardial infarction, coronary bypass surgery, and repeat angioplasty occurred in 4·6%, 10·6%, and 21·2%, respectively, of the patients in the laser angioplasty group compared with 5·7%, 10·8%, and 18·5% of the balloon angioplasty group. Net mean (SD) gain in minimal lumen diameter was 0·40 (0·69) mm in patients treated with laser angioplasty and 0·48 (0·66) mm in those treated with balloon angioplasty (p=0·34). The restenosis rate (&gt;50% diameter stenosis) was 51·6% in the laser angioplasty group versus 41·3% in the balloon angioplasty group (p=0·13). Interpretation Excimer laser angioplasty followed by balloon angioplasty provides no benefit additional to balloon angioplasty alone with respect to the initial and long-term clinical and angiographic outcome in the treatment of obstructive coronary artery disease.</abstract><cop>London</cop><pub>Elsevier Ltd</pub><pmid>8538345</pmid><doi>10.1016/S0140-6736(96)90209-3</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record>
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ispartof The Lancet (British edition), 1996-01, Vol.347 (8994), p.79-84
issn 0140-6736
1474-547X
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source MEDLINE; Elsevier ScienceDirect Journals Complete; Business Source Complete
subjects Adult
Aged
Aged, 80 and over
Angioplasty
Angioplasty, Balloon, Coronary
Angioplasty, Balloon, Laser-Assisted
Biological and medical sciences
Cardiovascular disease
Clinical trials
Coronary Angiography
Coronary Disease - surgery
Coronary Disease - therapy
Coronary vessels
Diseases of the cardiovascular system
Female
Follow-Up Studies
Humans
Lasers
Lesions
Male
Medical research
Medical sciences
Middle Aged
Myocardial infarction
Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
Recurrence
Treatment Outcome
title Randomised trial of excimer laser angioplasty versus balloon angioplasty for treatment of obstructive coronary artery disease
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