Percutaneous transmyocardial laser revascularisation for severe angina: the PACIFIC randomised trial. Potential Class Improvement From Intramyocardial Channels.

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Title: Percutaneous transmyocardial laser revascularisation for severe angina: the PACIFIC randomised trial. Potential Class Improvement From Intramyocardial Channels.
Authors: Oesterle SN (AUTHOR), Sanborn TA (AUTHOR), Ali N (AUTHOR), Resar J (AUTHOR), Ramee SR (AUTHOR), Heuser R (AUTHOR), Dean L (AUTHOR), Knopf W (AUTHOR), Schofield P (AUTHOR), Schaer GL (AUTHOR), Reeder G (AUTHOR), Masden R (AUTHOR), Yeung AC (AUTHOR), Burkhoff D (AUTHOR), Oesterle, S N (AUTHOR), Sanborn, T A (AUTHOR), Ali, N (AUTHOR), Resar, J (AUTHOR), Ramee, S R (AUTHOR), Heuser, R (AUTHOR)
Source: Lancet. 11/18/2000, Vol. 356 Issue 9243, p1705-1710. 6p.
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 lower 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. [ABSTRACT FROM AUTHOR]
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  Data: Percutaneous transmyocardial laser revascularisation for severe angina: the PACIFIC randomised trial. Potential Class Improvement From Intramyocardial Channels.
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  Data: <searchLink fieldCode="AR" term="%22Oesterle+SN%22">Oesterle SN</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sanborn+TA%22">Sanborn TA</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ali+N%22">Ali N</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Resar+J%22">Resar J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ramee+SR%22">Ramee SR</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Heuser+R%22">Heuser R</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Dean+L%22">Dean L</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Knopf+W%22">Knopf W</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Schofield+P%22">Schofield P</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Schaer+GL%22">Schaer GL</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Reeder+G%22">Reeder G</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Masden+R%22">Masden R</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Yeung+AC%22">Yeung AC</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Burkhoff+D%22">Burkhoff D</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Oesterle%2C+S+N%22">Oesterle, S N</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sanborn%2C+T+A%22">Sanborn, T A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ali%2C+N%22">Ali, N</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Resar%2C+J%22">Resar, J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ramee%2C+S+R%22">Ramee, S R</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Heuser%2C+R%22">Heuser, R</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 11/18/2000, Vol. 356 Issue 9243, p1705-1710. 6p.
– Name: Abstract
  Label: Abstract
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  Data: <bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Findings: </bold>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 lower 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.<bold>Interpretation: </bold>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. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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