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

摘要: Summary Background Percutaneous transmyocardial laser revascularisation (PTMR) is a proposed catheter-based therapy for refractory angina pectoris when bypass surgery or angioplasty not possible. We undertook randomised trial to assess the safety and efficacy of this technique. Methods 221 patients with reversible ischaemia Canadian Cardiovascular Society class III (61%) IV (39%) incomplete response other therapies were recruited from 13 centres. Patients randomly assigned PTMR holmium:YAG plus continued medical treatment (n=110) only (n=111). The primary endpoint was exercise tolerance at 12 months. Analyses by intention treat. Findings 11 died 19 withdrew; 92 PTMR-group 99 medical-treatment-group completed study. Exercise months had increased median 89·0 s (IQR -15 183) compared 12·5 (−67 125) (p=0·008). On masked assessment, II lower in 34·1% 13·0% those medically treated. All indices Seattle questionnaire improved more than care only. By there been eight deaths group three group, similar survival two groups. Interpretation associated time, low morbidity, scores assessed reviewers, quality life. Although controversy about mechanism action, contribution placebo effect cannot be quantified, unmasked study suggests that palliative procedure provides some clinical benefits defined population patients.