M. Unverdorben et al., DILTIAZEM REDUCES RESTENOSIS AFTER PERCUTANEOUS TRANSLUMINAL CORONARYANGIOPLASTY, Journal of interventional cardiology, 9(4), 1996, pp. 287-295
In a prospective, randomized, and double-blinded protocol, the effect
of oral diltiazem (180 mg) over placebo on the restenosis rate was ass
essed in 189 consecutive patients (150 males, 39 females, 57.6 +/- 8.4
years) eligible for follow-up angiography after 3.6 +/- 0.6 months (d
iltiazem 90.4%, placebo 89.6%). Pre-PTCA stenoses were similar in both
groups (diltiazem 83.9%; placebo 84.4%). Immediately after PTCA, the
remaining stenoses were identical in both groups (22.6% vs 22.8%). At
follow-up angiography there was a highly significant difference (P < 0
.01) in favor of diltiazem (minimal lumen diameter 38.6% vs 50.3%). Re
stenosis rate (greater than or equal to 50% stenosis or loss of > 50%
of the initial gain) was significantly (P < 0.03) reduced by diltiazem
(18[21.4%] of 84 patients) compared to placebo (33 [38.4%] of 86 pati
ents). Diltiazem was superior to placebo in all vessels: (1) left ante
rior descending coronary artery: 21.6% vs. 32.7%, (2) right coronary a
rtery: 25% vs 46.7%; and (3) left circumflex: 16.7% vs 36%. The benefi
t of diltiazem was most pronounced in calcified plaques (33.3% vs 47.1
%), in diabetics (15% vs 46.2%), in hypercholesterolemia (20.4% vs 44.
2%, P < 0.05), in rite age range of 41-50 years (21.4% vs 44.4%), and
in patients with CCS Class 2 (11.1% vs 64%, P < 0.01). In stratified a
nalysis, the effect was apparent in both sexes, independent from conco
mitant therapy, regardless of whether or nor coronary artery disease h
ad progressed in segments other than the dilated ones. Thus, in this l
imited series of patients, diltiazem significantly reduced the number
and extent of restenosis. Confirmation in a larger cohort is necessary
.