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

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 S ociety angina class 111 (61%) or IV (39%) and incomplete response to other therapies were recruited from 13 centres. Patients were randomly assigned P TMR with a holmium:YAG laser plus continued medical treatment (n=110) or co ntinued medical treatment only (n=111). The primary endpoint was the exerci se tolerance at 12 months. Analyses were by intention to treat. Findings 11 patients died and 19 withdrew; 92 PTMR-group and 99 medical-tre atment-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 wit h 12.5 s (-67 to 125) with medical treatment only (p=0.008). On masked asse ssment, angina class was II or lower in 34.1% of PTMR patients compared wit h 13.0% of those medically treated. All indices of the Seattle angina quest ionnaire 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 trea tment 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 improv ed quality of life. Although there is controversy about the mechanism of ac tion, and the contribution of the placebo effect cannot be quantified, this unmasked study suggests that this palliative procedure provides some clini cal benefits in the defined population of patients.