Elsevier

The Lancet

Volume 354, Issue 9182, 11 September 1999, Pages 885-890
The Lancet

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Transmyocardial laser revascularisation compared with continued medical therapy for treatment of refractory angina pectoris: a prospective randomised trial

https://doi.org/10.1016/S0140-6736(99)08113-1Get rights and content

Summary

Background

Transmyocardial revascularisation (TMR) is an operative treatment for refractory angina pectoris when bypass surgery or percutaneous transluminal angioplasty is not indicated. We did a prospective randomised trial to compare TMR with continued medication.

Methods

We recruited 182 patients from 16 US centres with Canadian Cardiovascular Society Angina (CCSA) score III (38%) or IV (62%), reversible ischaemia, and incomplete response to other therapies. Patients were randomly assigned TMR and continued medication (n=92) or continued medication alone (n=90). Baseline assessments were angina class, exercise tolerance, Seattle angina questionnaire for quality of life, and dipyridamole thallium stress test. We reassessed patients at 3 months, 6 months, and 12 months, with independent masked angina assessment at 12 months.

Findings

At 12 months, total exercise tolerance increased by a median of 65 s in the TMR group compared with a 46 s decrease in the medication-only group (p<0·0001, median difference 111 s). Independent CCSA score was II or lower in 47·8% in the TMR group compared with 14·3% in the medication-only group (p<0·001). Each Seattle angina questionnaire index increased in the TMR group significantly more than in the medication-only group (p<0·001).

Interpretation

TMR lowered angina scores, increased exercise tolerance time, and improved patients' perceptions of quality of life. This operative treatment provided clinical benefits in patients with no other therapeutic options.

Introduction

Standard treatments for angina pectoris are effective for most patients. Some patients with advanced disease, however, become less responsive to medication but are not candidates for percutaneous transluminal coronary angioplasty or coronary-artery bypass grafting because the atherosclerotic lesions are too diffuse. These patients have frequent angina, limited exercise tolerance, and poor quality of life. Transmyocardial revascularisation (TMR) was developed to treat such patients.1 TMR is a surgical procedure that uses a laser to create channels through the myocardial wall to the ventricular chamber. Although there is controversy about the mechanism of action, early clinical trials of TMR in the USA with carbon-dioxide lasers showed encouraging results.2, 3, 4, 5 However, these results have been challenged because of high crossover rates and lack of masked assessment of symptoms. A subsequent study that used a carbon-dioxide laser but did not allow for crossover in the study design showed limited clinical benefits in patients with predominantly class III angina.6

We designed the Angina Treatments—Lasers and Normal Therapies in Comparison (ATLANTIC) prospective randomised study to compare TMR with continued medical therapy in patients with medically refractory angina.

Section snippets

Patients

We recruited 337 patients from 16 US centres who were assessed by their treating physician and referred for this study (figure 1). After a medical history was taken, the most recent angiogram reviewed, and informed consent obtained, patients underwent baseline testing. Tests were echocardiography, a dipyridamole thallium stress test, treadmill exercise-tolerance testing (Modified Bruce Protocol), and a self-administered Seattle angina questionnaire. The Seattle angina questionnaire consists of

Results

182 of 337 patients were enrolled (figure 1). The main reasons for exclusion were absence of objective evidence of ischaemia on dipyridamole thallium stress test (34), patient's decision not to participate (23), eligibility for coronary-artery bypass graft or percutaneous transluminal coronary angioplasty decided by the central laboratory (23), insufficient region of protected myocardium (20), absence of angina on exercise testing (20), and left-ventricular ejection fraction of less than 30%

Discussion

All previous studies of TMR have limited selection of patients to those with the most advanced forms of ischaemic heart disease and the worst symptoms, and those ineligible for standard interventions. Our entry criteria were intended to select such patients. Most of our patients had class IV angina and poor exercise tolerance and were in a stable stage of their disease. There was a high frequency of cardiac risk factors, previous myocardial infarctions, multiple previous invasive therapies, and

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