| Abstract: | In a prospective, randomized, and double-blinded protocol, the effect of oral diltiazem (180 mg) over placebo on the restenosis rate was assessed in 189 consecutive patients (150 males. 39 females, 57.6 ± 8.4 years) eligible for follow-up angiography after 3.6 ± 0.6 months (diltiazem 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%). Restenosis rate (> 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 patients). Diltiazem was superior to placebo in all vessels: (1) left anterior descending coronary artery: 21.6% vs. 32.7%, (2) right coronary artery: 25% vs 46.7%; and (3) left circumflex. 16.7% vs 36%. The benefit 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 the 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 analysis, the effect was apparent in both sexes, independent from concomitant therapy, regardless of whether or not coronary artery disease had progressed in segments other than the dilated ones. Thus, in this limited series of patients, diltiazem significantly reduced the number and extent of restenosis. Confirmation in a larger cohort is necessary . |
