The PACIFIC Trial

	6/99 - Percutaneous myocardial revascularization (PMR) is
quickly becoming a way to manage patients with severe coronary
artery disease (CAD) that does not respond to the best medical
therapy. In patients for whom further angioplasty or bypass surgery
is no longer an option, PMR may be a way to treat ischemia.
	Dr. Stephen Oesterle presented the 6-month results of the
Potential Angina Class Improvement From Intramyocardial Channels
(PACIFIC) Trial.
	Two hundred twenty-one patients with class 3-4 angina were
given either PMR plus medical therapy or aggressive medical therapy.
Patients with an EF less than 30%, Q-wave heart attack within 3
months, non-Q-wave herat attack within 6 weeks, unstable angina
within 2 weeks, or severe aortic stenosis were not allowed in the
study. Patients getting PMR had 10 to 15 channels made via a YAG
laser. The patients were followed for one year with the primary
endpoints angina score and exercise tolerance.
	Average age for both groups was 62 years old and 86% were
male. Diabetes was present in 48% of the PMR group and 41% of the
control group. High blood pressure was present in 67% of the PMR
group and 75% of controls. Prior heart attack was present in 65%
of the PMR group and 68% of control patients. Prior angioplasty or
bypass surgery was done in 86% of the PMR patients and 96% of
controls.

	After 3 months of follow-up, 70% of the PMR patients had
class 0-2 angina, while less than 15% of control patients had class
0-2 angina. Impressively, 46% of the patients having PMR had an
improvement in at least two angina classes, versus 6% of patients
treated with medical therapy alone. These results were essentially
maintained at 6 months of follow-up.
	Exercise duration also improved in the PMR group. At 3
months, the PMR group had an approximate 25% increase in treadmill
exercise time. At 6 months, the PMR group exercised 30% longer
compared to baseline. The control patients had a 5% improvement in
exercise duration at 3 and 6 months.

	Adverse events did happen. After 6 months of follow-up, 8
deaths (7%) occurred in the PMR group, and 2 (2%) in the control
group. Complications during the actual PMR were rare. There were no
deaths, no heart attacks and no strokes during th eproicedure itself.
One patient developed complete heart block and required permanent
pacemaker implantation.

Conclusions: After reviewing the 6-month follow-up of the PACIFIC
trial, it appears that PMR is safe and has little procedural mortality
or complications. Patients assigned to PMR had a significant
improvement in angina scores and had a significant increase in
treadmill exercise time. We await the 12-month follow-up data.
PMR may be a promising way for managing patients with refractory
angina who are not candidates for further angioplasty or bypass
surgery.