A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease

Martin B. Leon, Ran Kornowski, William E. Downey, Giora Weisz, Donald S. Baim, Robert O. Bonow, Robert Hendel, David J. Cohen, Ernest Gervino, Roger Laham, Nicholas J. Lembo, Jeffrey W. Moses, Richard E. Kuntz

Research output: Contribution to journalArticle

118 Citations (Scopus)

Abstract

OBJECTIVES: This study was a randomized, patient- and evaluator-blinded, placebo-controlled trial in patients treated using percutaneous myocardial laser revascularization. BACKGROUND: Previous studies using similar therapies have been confounded by placebo bias. METHODS: A total of 298 patients with severe angina were randomly assigned to receive low-dose or high-dose myocardial laser channels or no laser channels, blinded as a sham procedure. The primary end point was the change in exercise duration from baseline examination to six months. RESULTS: The incidence of 30-day death, stroke, myocardial infarction, coronary revascularization, or left ventricular perforation occurred in two patients in the placebo, eight patients in the low-dose, and four patients in the high-dose groups (p = 0.12); 30-day myocardial infarction incidence was higher in patients receiving either low-dose or high-dose laser (nine patients) compared with placebo (no patients, p = 0.03). At six months, there were no differences in the change in exercise duration between those receiving a sham (28.0 s, n = 100), low-dose laser (33.2 s, n = 98), or high-dose laser (28.0 s, n = 98, p = 0.94) procedure. There were also no differences in the proportion of patients improving to better than Canadian Cardiovascular Society class III angina symptoms at six months. The follow-up visual summed stress single-photon-emission computed tomography scores were not significantly different from baseline in any group and were no different between groups. The modest improvement in angina symptoms assessed by the Seattle Angina Questionnaire also was not statistically different among the arms. CONCLUSIONS: Treatment with percutaneous myocardial laser revascularization provides no benefit beyond that of a similar sham procedure in patients blinded to their treatment status.

Original languageEnglish
Pages (from-to)1812-1819
Number of pages8
JournalJournal of the American College of Cardiology
Volume46
Issue number10
DOIs
StatePublished - Nov 15 2005
Externally publishedYes

Fingerprint

Myocardial Revascularization
Coronary Disease
Lasers
Randomized Controlled Trials
Placebos
Myocardial Infarction
Exercise
Incidence
Single-Photon Emission-Computed Tomography
Therapeutics
Stroke

ASJC Scopus subject areas

  • Nursing(all)

Cite this

A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease. / Leon, Martin B.; Kornowski, Ran; Downey, William E.; Weisz, Giora; Baim, Donald S.; Bonow, Robert O.; Hendel, Robert; Cohen, David J.; Gervino, Ernest; Laham, Roger; Lembo, Nicholas J.; Moses, Jeffrey W.; Kuntz, Richard E.

In: Journal of the American College of Cardiology, Vol. 46, No. 10, 15.11.2005, p. 1812-1819.

Research output: Contribution to journalArticle

Leon, MB, Kornowski, R, Downey, WE, Weisz, G, Baim, DS, Bonow, RO, Hendel, R, Cohen, DJ, Gervino, E, Laham, R, Lembo, NJ, Moses, JW & Kuntz, RE 2005, 'A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease', Journal of the American College of Cardiology, vol. 46, no. 10, pp. 1812-1819. https://doi.org/10.1016/j.jacc.2005.06.079
Leon, Martin B. ; Kornowski, Ran ; Downey, William E. ; Weisz, Giora ; Baim, Donald S. ; Bonow, Robert O. ; Hendel, Robert ; Cohen, David J. ; Gervino, Ernest ; Laham, Roger ; Lembo, Nicholas J. ; Moses, Jeffrey W. ; Kuntz, Richard E. / A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease. In: Journal of the American College of Cardiology. 2005 ; Vol. 46, No. 10. pp. 1812-1819.
@article{e106185d02c74035b4f63a7bf629f8e0,
title = "A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease",
abstract = "OBJECTIVES: This study was a randomized, patient- and evaluator-blinded, placebo-controlled trial in patients treated using percutaneous myocardial laser revascularization. BACKGROUND: Previous studies using similar therapies have been confounded by placebo bias. METHODS: A total of 298 patients with severe angina were randomly assigned to receive low-dose or high-dose myocardial laser channels or no laser channels, blinded as a sham procedure. The primary end point was the change in exercise duration from baseline examination to six months. RESULTS: The incidence of 30-day death, stroke, myocardial infarction, coronary revascularization, or left ventricular perforation occurred in two patients in the placebo, eight patients in the low-dose, and four patients in the high-dose groups (p = 0.12); 30-day myocardial infarction incidence was higher in patients receiving either low-dose or high-dose laser (nine patients) compared with placebo (no patients, p = 0.03). At six months, there were no differences in the change in exercise duration between those receiving a sham (28.0 s, n = 100), low-dose laser (33.2 s, n = 98), or high-dose laser (28.0 s, n = 98, p = 0.94) procedure. There were also no differences in the proportion of patients improving to better than Canadian Cardiovascular Society class III angina symptoms at six months. The follow-up visual summed stress single-photon-emission computed tomography scores were not significantly different from baseline in any group and were no different between groups. The modest improvement in angina symptoms assessed by the Seattle Angina Questionnaire also was not statistically different among the arms. CONCLUSIONS: Treatment with percutaneous myocardial laser revascularization provides no benefit beyond that of a similar sham procedure in patients blinded to their treatment status.",
author = "Leon, {Martin B.} and Ran Kornowski and Downey, {William E.} and Giora Weisz and Baim, {Donald S.} and Bonow, {Robert O.} and Robert Hendel and Cohen, {David J.} and Ernest Gervino and Roger Laham and Lembo, {Nicholas J.} and Moses, {Jeffrey W.} and Kuntz, {Richard E.}",
year = "2005",
month = "11",
day = "15",
doi = "10.1016/j.jacc.2005.06.079",
language = "English",
volume = "46",
pages = "1812--1819",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "10",

}

TY - JOUR

T1 - A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease

AU - Leon, Martin B.

AU - Kornowski, Ran

AU - Downey, William E.

AU - Weisz, Giora

AU - Baim, Donald S.

AU - Bonow, Robert O.

AU - Hendel, Robert

AU - Cohen, David J.

AU - Gervino, Ernest

AU - Laham, Roger

AU - Lembo, Nicholas J.

AU - Moses, Jeffrey W.

AU - Kuntz, Richard E.

PY - 2005/11/15

Y1 - 2005/11/15

N2 - OBJECTIVES: This study was a randomized, patient- and evaluator-blinded, placebo-controlled trial in patients treated using percutaneous myocardial laser revascularization. BACKGROUND: Previous studies using similar therapies have been confounded by placebo bias. METHODS: A total of 298 patients with severe angina were randomly assigned to receive low-dose or high-dose myocardial laser channels or no laser channels, blinded as a sham procedure. The primary end point was the change in exercise duration from baseline examination to six months. RESULTS: The incidence of 30-day death, stroke, myocardial infarction, coronary revascularization, or left ventricular perforation occurred in two patients in the placebo, eight patients in the low-dose, and four patients in the high-dose groups (p = 0.12); 30-day myocardial infarction incidence was higher in patients receiving either low-dose or high-dose laser (nine patients) compared with placebo (no patients, p = 0.03). At six months, there were no differences in the change in exercise duration between those receiving a sham (28.0 s, n = 100), low-dose laser (33.2 s, n = 98), or high-dose laser (28.0 s, n = 98, p = 0.94) procedure. There were also no differences in the proportion of patients improving to better than Canadian Cardiovascular Society class III angina symptoms at six months. The follow-up visual summed stress single-photon-emission computed tomography scores were not significantly different from baseline in any group and were no different between groups. The modest improvement in angina symptoms assessed by the Seattle Angina Questionnaire also was not statistically different among the arms. CONCLUSIONS: Treatment with percutaneous myocardial laser revascularization provides no benefit beyond that of a similar sham procedure in patients blinded to their treatment status.

AB - OBJECTIVES: This study was a randomized, patient- and evaluator-blinded, placebo-controlled trial in patients treated using percutaneous myocardial laser revascularization. BACKGROUND: Previous studies using similar therapies have been confounded by placebo bias. METHODS: A total of 298 patients with severe angina were randomly assigned to receive low-dose or high-dose myocardial laser channels or no laser channels, blinded as a sham procedure. The primary end point was the change in exercise duration from baseline examination to six months. RESULTS: The incidence of 30-day death, stroke, myocardial infarction, coronary revascularization, or left ventricular perforation occurred in two patients in the placebo, eight patients in the low-dose, and four patients in the high-dose groups (p = 0.12); 30-day myocardial infarction incidence was higher in patients receiving either low-dose or high-dose laser (nine patients) compared with placebo (no patients, p = 0.03). At six months, there were no differences in the change in exercise duration between those receiving a sham (28.0 s, n = 100), low-dose laser (33.2 s, n = 98), or high-dose laser (28.0 s, n = 98, p = 0.94) procedure. There were also no differences in the proportion of patients improving to better than Canadian Cardiovascular Society class III angina symptoms at six months. The follow-up visual summed stress single-photon-emission computed tomography scores were not significantly different from baseline in any group and were no different between groups. The modest improvement in angina symptoms assessed by the Seattle Angina Questionnaire also was not statistically different among the arms. CONCLUSIONS: Treatment with percutaneous myocardial laser revascularization provides no benefit beyond that of a similar sham procedure in patients blinded to their treatment status.

UR - http://www.scopus.com/inward/record.url?scp=27644537111&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=27644537111&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2005.06.079

DO - 10.1016/j.jacc.2005.06.079

M3 - Article

VL - 46

SP - 1812

EP - 1819

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 10

ER -