Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): immediate and long-term follow-up results.

OBJECTIVE: This study sought to compare two strategies of revascularization in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. A good immediate angiographic result with provisional stenting was considered to occur only if early loss in minimal luminal diameter (MLD) was documented at 30 min post-PTCA angiography. BACKGROUND: Coronary stenting reduces restenosis in lesions exhibiting early deterioration (>0.3 mm) in MLD within the first 24 hours (early loss) after successful PTCA. Lesions with no early loss after PTCA have a low restenosis rate. METHODS: To compare angiographic restenosis and target vessel revascularization (TVR) of lesions treated with coronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n=57) or to optimal PTCA (n=59). After randomization in the PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting). RESULTS: Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had a follow-up angiographic study: 98.2% in the stent and 94.9% in the PTCA group. Immediate and follow-up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1.5 mm; p < 0.03). However, late loss was significantly higher in the stent than the PTCA group (0.63+/-0.59 vs. 0.26+/-0.44, respectively; p=0.01). Hence, net gain with both techniques was similar (1.32< or =0.3 vs. 1.24+/-0.29 mm for the stent and the PTCA groups, respectively; p=NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; p=NS) and TVR (17.5% in stent vs. 13.5% in PTCA; p=NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group (p=NS). Overall costs (hospital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTCA group (p < 0.02). CONCLUSIONS: The strategy of PTCA with delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.

In-hospital and late results of coronary stents versus conventional balloon angioplasty in acute myocardial infarction (GRAMI trial). Gianturco-Roubin in Acute Myocardial Infarction.

One hundred four patients presenting with acute myocardial infarction < 24 hours after onset were randomized to 2 groups: group I (n = 52) was treated with balloon angioplasty followed electively with Gianturco Roubin II stents, and group II was treated with conventional balloon angioplasty alone (n = 52). All lesions were suitable for stenting. Baseline clinical, demographic, and angiographic characteristics were similar in the 2 groups. Procedural success was defined as no laboratory death or emergent coronary bypass, Thrombolysis In Myocardial Infarction (TIMI) trial 2 or 3 flow after the procedure in a culprit vessel, and a residual stenosis < or = 30% for coronary angioplasty and < 20% for stent. Procedural success was 98% in group I versus 94.2% in group II, p = NS. Thirteen patients in group II (25%) had bailout stenting during the initial procedure. Adverse in-hospital events including either death, nonelective coronary bypass, recurrent ischemia, and reinfarction occurred in 3.8% in group I versus 19.2% in group II, p = 0.03. Repeat angiography performed routinely before hospital discharge revealed TIMI 3 flow in the infarct-related artery in 98% in group I versus 83% in group II, p < 0.03. At late follow-up, event-free survival was significantly better in the stent (83%) than in the coronary angioplasty (65%) group (p = 0.002). The procedural in-hospital and late outcomes of this randomized study demonstrate that balloon angioplasty followed electively by coronary stents can be used as the primary modality for patients undergoing coronary interventions for acute myocardial infarction, increasing TIMI 3 flow, reducing in-hospital adverse events, and improving late outcome compared with balloon angioplasty alone.