Percutaneous transmyocardial laser revascularisation for severe angina: The PACIFIC randomised trial

Stephen N. Oesterle, Timothy A. Sanborn, Nadir Ali, Jon R Resar, Stephen R. Ramee, Richard Heuser, Larry Dean, William Knopf, Peter Schofield, Gary L. Schaer, Guy Reeder, Ronald Masden, Alan C. Yeung, Daniel Burkhoff

Research output: Contribution to journalArticle

Abstract

Background: Percutaneous transmyocardial laser revascularisation (PTMR) is a proposed catheter-based therapy for refractory angina pectoris when bypass surgery or angioplasty is not possible. We undertook a randomised trial to assess the safety and efficacy of this technique. Methods: 221 patients with reversible ischaemia of Canadian Cardiovascular Society angina class III (61%) or IV (39%) and incomplete response to other therapies were recruited from 13 centres. Patients were randomly assigned PTMR with a holmium:YAG laser plus continued medical treatment (n=110) or continued medical treatment only (n=111). The primary endpoint was the exercise tolerance at 12 months. Analyses were by intention to treat. Findings: 11 patients died and 19 withdrew; 92 PTMR-group and 99 medical-treatment-group patients completed the study. Exercise tolerance at 12 months had increased by a median of 89.0 s (IQR -15 to 183) with PTMR compared with 12.5 s (-67 to 125) with medical treatment only (p=0.008). On masked assessment, angina class was II or tower in 34.1% of PTMR patients compared with 13.0% of those medically treated. All indices of the Seattle angina questionnaire improved more with PTMR than with medical care only. By 12 months there had been eight deaths in the PTMR group and three in the medical treatment group, with similar survival in the two groups. Interpretation: PTMR was associated with increased exercise tolerance time, low morbidity, lower angina scores assessed by masked reviewers, and improved quality of life. Although there is controversy about the mechanism of action, and the contribution of the placebo effect cannot be quantified, this unmasked study suggests that this palliative procedure provides some clinical benefits in the defined population of patients.

Original languageEnglish (US)
Pages (from-to)1705-1710
Number of pages6
JournalThe Lancet
Volume356
Issue number9243
StatePublished - Nov 18 2000

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Transmyocardial Laser Revascularization
Exercise Tolerance
Therapeutics
Placebo Effect
Intention to Treat Analysis
Solid-State Lasers
Angina Pectoris
Angioplasty
Ischemia
Catheters
Quality of Life
Morbidity
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Oesterle, S. N., Sanborn, T. A., Ali, N., Resar, J. R., Ramee, S. R., Heuser, R., ... Burkhoff, D. (2000). Percutaneous transmyocardial laser revascularisation for severe angina: The PACIFIC randomised trial. The Lancet, 356(9243), 1705-1710.

Percutaneous transmyocardial laser revascularisation for severe angina : The PACIFIC randomised trial. / Oesterle, Stephen N.; Sanborn, Timothy A.; Ali, Nadir; Resar, Jon R; Ramee, Stephen R.; Heuser, Richard; Dean, Larry; Knopf, William; Schofield, Peter; Schaer, Gary L.; Reeder, Guy; Masden, Ronald; Yeung, Alan C.; Burkhoff, Daniel.

In: The Lancet, Vol. 356, No. 9243, 18.11.2000, p. 1705-1710.

Research output: Contribution to journalArticle

Oesterle, SN, Sanborn, TA, Ali, N, Resar, JR, Ramee, SR, Heuser, R, Dean, L, Knopf, W, Schofield, P, Schaer, GL, Reeder, G, Masden, R, Yeung, AC & Burkhoff, D 2000, 'Percutaneous transmyocardial laser revascularisation for severe angina: The PACIFIC randomised trial', The Lancet, vol. 356, no. 9243, pp. 1705-1710.
Oesterle SN, Sanborn TA, Ali N, Resar JR, Ramee SR, Heuser R et al. Percutaneous transmyocardial laser revascularisation for severe angina: The PACIFIC randomised trial. The Lancet. 2000 Nov 18;356(9243):1705-1710.
Oesterle, Stephen N. ; Sanborn, Timothy A. ; Ali, Nadir ; Resar, Jon R ; Ramee, Stephen R. ; Heuser, Richard ; Dean, Larry ; Knopf, William ; Schofield, Peter ; Schaer, Gary L. ; Reeder, Guy ; Masden, Ronald ; Yeung, Alan C. ; Burkhoff, Daniel. / Percutaneous transmyocardial laser revascularisation for severe angina : The PACIFIC randomised trial. In: The Lancet. 2000 ; Vol. 356, No. 9243. pp. 1705-1710.
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abstract = "Background: Percutaneous transmyocardial laser revascularisation (PTMR) is a proposed catheter-based therapy for refractory angina pectoris when bypass surgery or angioplasty is not possible. We undertook a randomised trial to assess the safety and efficacy of this technique. Methods: 221 patients with reversible ischaemia of Canadian Cardiovascular Society angina class III (61{\%}) or IV (39{\%}) and incomplete response to other therapies were recruited from 13 centres. Patients were randomly assigned PTMR with a holmium:YAG laser plus continued medical treatment (n=110) or continued medical treatment only (n=111). The primary endpoint was the exercise tolerance at 12 months. Analyses were by intention to treat. Findings: 11 patients died and 19 withdrew; 92 PTMR-group and 99 medical-treatment-group patients completed the study. Exercise tolerance at 12 months had increased by a median of 89.0 s (IQR -15 to 183) with PTMR compared with 12.5 s (-67 to 125) with medical treatment only (p=0.008). On masked assessment, angina class was II or tower in 34.1{\%} of PTMR patients compared with 13.0{\%} of those medically treated. All indices of the Seattle angina questionnaire improved more with PTMR than with medical care only. By 12 months there had been eight deaths in the PTMR group and three in the medical treatment group, with similar survival in the two groups. Interpretation: PTMR was associated with increased exercise tolerance time, low morbidity, lower angina scores assessed by masked reviewers, and improved quality of life. Although there is controversy about the mechanism of action, and the contribution of the placebo effect cannot be quantified, this unmasked study suggests that this palliative procedure provides some clinical benefits in the defined population of patients.",
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AU - Sanborn, Timothy A.

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AU - Resar, Jon R

AU - Ramee, Stephen R.

AU - Heuser, Richard

AU - Dean, Larry

AU - Knopf, William

AU - Schofield, Peter

AU - Schaer, Gary L.

AU - Reeder, Guy

AU - Masden, Ronald

AU - Yeung, Alan C.

AU - Burkhoff, Daniel

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N2 - Background: Percutaneous transmyocardial laser revascularisation (PTMR) is a proposed catheter-based therapy for refractory angina pectoris when bypass surgery or angioplasty is not possible. We undertook a randomised trial to assess the safety and efficacy of this technique. Methods: 221 patients with reversible ischaemia of Canadian Cardiovascular Society angina class III (61%) or IV (39%) and incomplete response to other therapies were recruited from 13 centres. Patients were randomly assigned PTMR with a holmium:YAG laser plus continued medical treatment (n=110) or continued medical treatment only (n=111). The primary endpoint was the exercise tolerance at 12 months. Analyses were by intention to treat. Findings: 11 patients died and 19 withdrew; 92 PTMR-group and 99 medical-treatment-group patients completed the study. Exercise tolerance at 12 months had increased by a median of 89.0 s (IQR -15 to 183) with PTMR compared with 12.5 s (-67 to 125) with medical treatment only (p=0.008). On masked assessment, angina class was II or tower in 34.1% of PTMR patients compared with 13.0% of those medically treated. All indices of the Seattle angina questionnaire improved more with PTMR than with medical care only. By 12 months there had been eight deaths in the PTMR group and three in the medical treatment group, with similar survival in the two groups. Interpretation: PTMR was associated with increased exercise tolerance time, low morbidity, lower angina scores assessed by masked reviewers, and improved quality of life. Although there is controversy about the mechanism of action, and the contribution of the placebo effect cannot be quantified, this unmasked study suggests that this palliative procedure provides some clinical benefits in the defined population of patients.

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