OBJECTIVES This study was performed to assess whether angiography six month
s after coronary balloon angioplasty or stent implantation has an influence
on clinical management and one-year outcome.
BACKGROUND The Benestent LT study randomized 827 patients to balloon angiop
lasty or stent implantation. A subrandomization was undertaken allocating p
atients to six-month clinical follow-up (CF) or clinical and angiographic f
ollow-up (AF).
METHODS Seven hundred and six patients (349 CF and 357 AF) had no intercurr
ent angiography, so that restenosis and disease progression elsewhere remai
ned unknown until the time of six-month follow-up. These two groups, which
were well matched at enrolment, were compared with respect to symptoms, med
ication and major cardiac events defined as death, myocardial infarction an
d need for revascularization at six and 12 months.
RESULTS At six-month follow-up, 53 (15%) of the CF and 76 (21%) of the AF p
atients had stable angina (p = 0.041), while 5 (1%) and 4 (1%) had symptoms
of unstable angina. At 12-month follow-up, 44 (13%) patients in both group
s had stable angina, and only 1 patient in the CF group had unstable angina
. Seventy-seven patients (27 CF and 50 AF; p < 0.01) had major cardiac even
ts between 6 and 12 months. Of the 349 patients in the CF group, 21 underwe
nt repeal percutaneous transluminal coronary angioplasty or coronary artery
bypass graft surgery between 6 and 12 months, compared with 44 of the 357
patients in the AF group (relative risk 2.05 [1.24 to 3.37], p = 0.003).
CONCLUSIONS Patients who had AF six months after balloon angioplasty or ste
nt implantation experienced more repeat revascularization procedures than t
hose who had CF. They also had significantly more angina at six-month follo
w-up but this may be due to bias. (C) 1999 by the American College of Cardi
ology.