Transmyocardial revascularization: 5-year follow-up of a prospective, randomized multicenter trial.
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.
Allen
Keith B
KB
Department of Cardiothoracic Surgery, Indiana Heart Institute, Indianapolis, Indiana, USA. kallen2340@aol.com
Dowling
Robert D
RD
Angell
William W
WW
Gangahar
Deepak M
DM
Fudge
Tommy L
TL
Richenbacher
Wayne
W
Selinger
Samuel L
SL
Petracek
Michael R
MR
Murphy
Douglas
D
D000787:Angina Pectoris / Q000401:mortality / Q000601:surgery*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053685:Laser Therapy / Q000295:instrumentation; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009204:Myocardial Revascularization / Q000379:methods*; D016016:Proportional Hazards Models; D015996:Survival Rate