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Angiographic success rates (85 to 95%) following conventional balloon PCI in 5

diabetics are similar to nondiabetics. The composite endpoint of mortality, nonfa- J

tal MI, and urgent target vessel revascularization (TVR) was 11.0% in diabetics a

& u compared with 6.7% in nondiabetics, respectively (p < 0.01) based on registry data derived from the National Heart, Lung and Blood Institute. Higher mortality rates were seen in diabetics (3.2%) compared with nondiabetics (0.5%; p < 0.05). However, lower mortality rates (<0.5%)—comparable to rates in nondiabetics— have also been reported.

2. Short- and Long-Term Follow-Up

High restenosis rates (up to 63% in some series) have been reported after balloon PCI in diabetic patients. Late clinical outcomes after balloon angioplasty in diabetics are also frequently unfavorable. Stein and coworkers reported that the 5-year Mi-free survival rate was lower and that the subsequent revascularization was more frequent among 1333 diabetics compared with 9300 nondiabetics undergoing balloon PCI. Likewise, Kip et al. showed that the 9-year mortality was twice as high in diabetic patients treated with balloon angioplasty compared to nondiabetics (35.9 vs. 17.9%), respectively, with significantly higher rates of MI and repeat revascularization.

In the Bypass Angioplasty Revascularization Investigation (BARI) trial, post-balloon angioplasty 5-year survival was 73.3% in diabetics compared with 91.3% in nondiabetics (p < 0.0001). The benefit of CABG surgery was most evident in the non-insulin-requiring DM patients. More recently, the BARI investigators have reported 7-year outcomes. These results show that, for the entire study group of 1873 patients, the composite trial primary endpoint favors improved clinical outcomes in the patients who were randomized to CABG surgery, compared to balloon PCI; Kaplan-Meier estimates of 7-year survival for the total population were 84.4% for CABG and 80.9% for balloon PCI (p = 0.043). Further post hoc analyses of these findings indicate that all of the benefit associated with CABG surgery occurs in the diabetic subgroup; among the 353 patients with treated DM, the 7-year survival rate was 76.4% for CABG surgery versus 55.7% for balloon PCI (p = 0.0011). Among the remaining 1476patients without treated DM, survival was virtually identical by assigned treatment (86.4% for CABG vs. 86.8% for balloon angioplasty; p = 0.72). Despite similar survival, the balloon PCI group had substantially higher subsequent revascularization rates than the CABG group (59.7% vs. 13.1%; p < 0.001).

Similar results were observed in the Coronary Angioplasty versus Bypass Revascularization Investigation (CABRI) trial. A trend toward superiority of |

CABG was observed in the BARI registry, even though CAD was less extensive in balloon PCI than in surgical patients.

On the other hand, better results after CABG were not observed in the small <j subgroup of diabetics enrolled in the first Randomized Intervention Treatment of Angina One (RITA-1) study and in the Emory Angioplasty Surgery Trial (EAST). J

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