Home > Interventional Cardiology, Journal Club > Journal Club 11 February 2015

Journal Club 11 February 2015

Paper

Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina

Presenter

AB

Summary

BACKGROUND

Many patients with coronary artery disease who are not candidates for revascularization
have refractory angina despite standard medical therapy. The balloonexpandable,
stainless steel, hourglass-shaped, coronary-sinus reducing device creates
a focal narrowing and increases pressure in the coronary sinus, thus redistributing
blood into ischemic myocardium.

METHODS

We randomly assigned 104 patients with Canadian Cardiovascular Society (CCS)
class III or IV angina (on a scale from I to IV, with higher classes indicating greater
limitations on physical activity owing to angina) and myocardial ischemia, who
were not candidates for revascularization, to implantation of the device (treatment
group) or to a sham procedure (control group). The primary end point was the proportion
of patients with an improvement of at least two CCS angina classes at
6 months.

RESULTS

A total of 35% of the patients in the treatment group (18 of 52 patients), as compared
with 15% of those in the control group (8 of 52), had an improvement of at
least two CCS angina classes at 6 months (P = 0.02). The device was also associated
with improvement of at least one CCS angina class in 71% of the patients in the
treatment group (37 of 52 patients), as compared with 42% of those in the control
group (22 of 52) (P = 0.003). Quality of life as assessed with the use of the Seattle
Angina Questionnaire was significantly improved in the treatment group, as compared
with the control group (improvement on a 100-point scale, 17.6 vs. 7.6 points;
P = 0.03). There were no significant between-group differences in improvement in
exercise time or in the mean change in the wall-motion index as assessed by means
of dobutamine echocardiography. At 6 months, 1 patient in the treatment group
had had a myocardial infarction; in the control group, 1 patient had died and 3 had
had a myocardial infarction.

CONCLUSIONS

In this small clinical trial, implantation of the coronary-sinus reducing device was
associated with significant improvement in symptoms and quality of life in patients
with refractory angina who were not candidates for revascularization.

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