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Transmyocardial revascularization: 5-year follow-up of a prospective, randomized multicenter trial
Keith B Allen1, Robert D Dowling, William W Angell
1Department of Cardiothoracic Surgery, Indiana Heart Institute, Indianapolis, Indiana, USA. kallen2340@aol.com
Insights
Transmyocardial revascularization (TMR) significantly improved survival and sustained angina relief in "no-option" patients with diffuse coronary artery disease over 5 years. TMR offers a superior long-term treatment option compared to medical management alone.
Area of Science:
- Cardiology
- Surgical Innovation
- Clinical Outcomes Research
Background:
- Transmyocardial revascularization (TMR) showed promise in 1-year trials for angina relief, reduced hospitalizations, and improved exercise tolerance.
- This study focuses on
- no-option
- patients with diffuse coronary artery disease, evaluating long-term outcomes.
Purpose of the Study:
- To assess the 5-year mortality and angina class in patients with refractory class IV angina.
- To compare transmyocardial revascularization (TMR) against continued medical management in this patient cohort.
Main Methods:
- A prospective randomized trial involving 212 patients with refractory class IV angina.
- Patients were randomized to receive holmium:yttrium-aluminum-garnet TMR (n=100) or medical management (n=112).
- Follow-up included all-cause mortality and angina class assessment by blinded evaluators over a mean of 5.7 years.
Main Results:
- Transmyocardial revascularization (TMR) patients experienced sustained angina relief, with mean scores improving from 4.0 to 1.2 at 5 years (p < 0.001).
- 88% of TMR patients achieved a two or more class improvement in angina versus 44% in the medical management group (p < 0.001).
- Kaplan-Meier survival at 5 years was 65% for TMR versus 52% for medical management (p = 0.05), with a significantly reduced risk of late death for TMR patients.
Conclusions:
- Five-year follow-up confirms significantly increased survival for patients randomized to transmyocardial revascularization (TMR).
- The substantial angina relief achieved with TMR is sustained long-term, outperforming medical management alone.
- TMR represents a viable, effective treatment for select
- no-option
- patients with diffuse coronary artery disease.
Background:
In prospective randomized trials at 1 year, transmyocardial revascularization (TMR) provided superior relief of angina, decreased rehospitalizations, and improved exercise times. We evaluated 5-year mortality and angina class in "no-option" patients with diffuse coronary artery disease randomized to TMR or continued medical management.
Methods:
Two hundred twelve patients with refractory class IV angina who were not candidates for conventional therapy were randomized to receive holmium:yttrium-aluminum-garnet TMR (n = 100) or continued medical management (n = 112) at nine centers. Follow-up included all-cause mortality along with angina class assessment by blinded evaluators. Mean follow-up was 5.7 +/- 0.8 years.
Results:
Mean angina scores for TMR patients were 4.0 +/- 0.0 at baseline, 1.5 +/- 1.4 at 1 year, and 1.2 +/- 1.1 at a mean of 5 years (p < 0.001). After an average of 5 years, a significantly greater proportion of TMR than medical management patients experienced two or more class improvement in angina (88% versus 44%; p < 0.001). Kaplan-Meier intention-to-treat survival at 5 years was 65% versus 52% (TMR versus medical management; p = 0.05). Cumulative hazard curves demonstrated a significantly reduced risk of late death for TMR patients; average annual mortality beyond 1 year was 8% versus 13% (TMR versus medical management; p = 0.03).
Conclusions:
Five-year follow-up of prospectively randomized, no-option class IV angina patients demonstrated significantly increased Kaplan-Meier survival in patients randomized to TMR. The significant angina relief observed 12 months after sole therapy TMR was sustained long term and continued to be superior to that observed for patients maintained on continued medical management alone.