Omar Santaera

In-Hospital and Late Results of Coronary Stents Versus Conventional Balloon Angioplasty in Acute Myocardial Infarction (GRAMI trial)☆

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.

Coronary Stenting Decreases Restenosis in Lesions With Early Loss in Luminal Diameter 24 Hours After Successful PTCA

BACKGROUND Early loss of minimal luminal diameter (MLD) after successful percutaneous transluminal coronary angioplasty (PTCA) is associated with a higher incidence of late restenosis. METHODS AND RESULTS Sixty-six patients (66 lesions) with > 0.3 mm MLD loss at 24-hour on-line quantitative coronary angiography were randomized into two groups: 1, Gianturco-Roubin stent (n = 33) and 2, Control, who received medical therapy only (n = 33). All lesions were suitable for stenting. Baseline demographic, clinical, and angiographic characteristics were similar in the two groups. Restenosis (> or = 50% stenosis) for the overall group occurred in 32 of 66 patients (48.4%) at 3.6 +/- 1-month follow-up angiography. Restenosis was significantly greater in group 2 than in group 1 (75.7% versus 21.2%, P < .001). Vascular complications (21.2% versus 0%) and length of hospital stay (7.3 +/- 1 versus 2.4 +/- 0.5 days, P < .01) were higher for the stent group. Although at follow-up there were no differences in mortality or incidence of acute myocardial infarction between the two groups, patients in the control group had a higher incidence of repeat revascularization procedures (73% versus 21%, P < .001). CONCLUSIONS In patients with successful PTCA but reduced luminal diameter demonstrated by repeat angiography at 24 hours, the Gianturco-Roubin stent appears to reduce angiographic restenosis at follow-up.

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

Coronary stenting in patients undergoing percutaneous transluminal coronary angioplasty during acute myocardial infarction

591,740 in the stent versus US

Early decrease in minimal luminal diameter after successful percutaneous transluminal coronary angioplasty predicts late restenosis

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.

Percutaneous coronary intervention with oral sirolimus and bare metal stents has comparable safety and efficacy to treatment with drug eluting stents, but with significant cost saving: long-term follow-up results from the randomised, controlled ORAR III (Oral Rapamycin in ARgentina) study

Although coronary stenting has been useful in the treatment of patients with suboptimal results, abrupt closure, and threatening occlusion after percutaneous transluminal coronary angioplasty (PTCA), its use in patients with acute myocardial infarction (AMI) is controversial because of the presence of intracoronary thrombus. In this study intracoronary stenting was used to treat suboptimal results and complications in 30 patients (35 lesions) undergoing PTCA during AMI. There were 28 men and 2 women, mean age 58 +/- 12 years. Thirteen patients (43%) had undergone rescue PTCA because of unsuccessful thrombolysis. Four patients had Killips grade IV, 5 Killips grade III, and 21 Killips grade < or = 2 heart failure. Stents were placed in the 35 lesions because of suboptimal result (n = 19), early loss (n = 9), abrupt closure (n = 2), and coronary dissection with threatening occlusion (n = 5). All stents were deployed successfully. In-hospital complications included 1 in-hospital death (3.0%); no patient required emergency coronary artery bypass graft surgery. One patient (3.0%) developed abrupt closure and was successfully treated with PTCA and intracoronary thrombolysis. Vascular complications requiring blood transfusion developed in 3 of 30 patients (10%). At 11.8 months (range 4 to 24) follow-up, there were no deaths or myocardial infarction. One patient underwent coronary artery bypass grafting. The remaining patients were free of angina at follow-up. Thus, intracoronary stents can be used successfully to treat both suboptimal results and complications occurring in patients undergoing PTCA during AMI.

Randomized Comparison of Cost-Saving and Effectiveness of Oral Rapamycin Plus Bare-Metal Stents With Drug-Eluting Stents: Three-Year Outcome From the Randomized Oral Rapamycin in Argentina (ORAR) III Trial

Eighty-eight patients underwent serial coronary arteriography before, immediately after, 24 hours after and 7 +/- 2 months after successful percutaneous transluminal coronary angioplasty (PTCA) of 102 lesions. Severity of coronary obstruction was measured using quantitative digital angiography. Three groups of lesions were defined when comparing angiograms recorded immediately after and 24 hours after PTCA: group I--lesions with either no change or < or = 10% increase in arterial diameter stenosis after PTCA (n = 71); group II--lesions with > 10% increase in diameter stenosis after PTCA (n = 19); and group III--patients with total occlusion (n = 12). There were no significant differences in the severity of stenosis before or immediately after PTCA among the 3 groups of lesions. Twenty-four hours after PTCA the diameter stenosis was 14.2 +/- 6.3% in group I, 34.7 +/- 8.1% in group II and 100 in group III (p < 0.0001). At 7.1 +/- 2 months after PTCA the diameter stenosis was 21.2 +/- 16.8% in group I, 61.3 +/- 1.1% in group II, and 98.5 +/- 1.3% in group III (p < 0.0001). Restenosis (> or = 50% stenosis diameter) at follow-up per lesion was significantly greater in group II than in group I (73.6 vs 9.8%) (p < 0.0001). Thus, early angiographic study after successful PTCA stratifies lesions into angiographic subsets with low (group I) and high (group II) risk of coronary restenosis.

Efficacy and safety of a double‐coated paclitaxel‐eluting coronary stent: The EUCATAX trial

AIMS Previous randomised studies have shown a significant reduction in restenosis when oral rapamycin (OR) is administered to patients undergoing bare metal stent (BMS) implantation. How this regimen compares to drug eluting stents (DES) is unknown. METHODS AND RESULTS Two-hundred patients with de novo coronary lesions were randomised to treatment with OR plus BMS (100 pts) or with DES (100 pts). OR was given as a bolus of 10 mg per day before PCI followed by daily doses of 3 mg during following 13 days. Primary endpoints were to compare hospital, follow-up and overall cost at one, two, three and five years of follow-up. The secondary endpoints included death, myocardial infarction (MI) and stroke and were analysed as major adverse cardiovascular events (MACCE). Target vessel (TVR) and target lesion revascularisation (TLR) were independently analysed. Costs included procedural resources, hospitalisation, medications, repeat revascularisation procedures and professional fees. Baseline demographic, clinical and angiographic characteristics were similar. At 18.3 +/- 7 months of follow-up, the initial strategy of OR plus BMS resulted in significant cost saving when compared to DES (p=0.0001). TLR rate was 8.2% with DES and 7.0% with OR plus BMS (p=0.84), similarly no differences in TVR rate in both groups was seen (10.6% and 10.5% in OR and DES group respectively, p=0.86). Non-inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios. CONCLUSIONS A strategy of OR plus BMS is cost saving compared to DES in patients undergoing PCI for de novo coronary lesions.

Second vs. First generation drug eluting stents in multiple vessel disease and left main stenosis: Two‐year follow‐up of the observational, prospective, controlled, and multicenter ERACI IV registry

Objectives: The Oral Rapamycin in ARgentina (ORAR) III trial is a randomized study comparing a strategy of oral rapamycin (OR) plus bare‐metal stent (BMS) versus a strategy of drug‐eluting stents (DES) in patients with de novo coronary lesions. The purpose of this study was to assess the 3 years cost‐effectiveness outcome of each strategy. Background: OR after BMS has been associated with reduction of target vessel revascularization (TVR) although its value in long‐term efficacy in comparison with DES is unknown. Methods: In three hospitals in Buenos Aires, Argentina, 200 patients were randomized to OR plus BMS (n = 100) or DES (n = 100). Primary objectives were costs and effectiveness. Cost analysis included in‐hospital and follow‐up costs. Safety was defined as the composite of death, myocardial infarction (MI), and stroke. Efficacy was defined as TVR. Results: Baseline characteristics between groups were similar. The 3‐year follow‐up rate was 99%. Cardiac mortality was 2% and 5% in OR group and DES group, respectively (P = 0.44). The composite of death, MI and stroke rate was 11% in OR group and 20% in DES group (P = 0.078). TVR rate was 14.5% in OR group and 17.6% in DES group (P = 0.50), respectively. Three year cumulative costs were significantly lower in the OR arm as compared to the DES arm (P = 0.0001) and DES strategy did not result cost‐effective according to the non‐inferiority test. Conclusions: At 3 years follow‐up, there were no differences in effectiveness between the two strategies, and DES strategy was not more cost‐effective as compared to OR plus BMS.

Safety and feasibility of balloon-expandable stent implantation for the treatment of type I endoleaks following endovascular aortic abdominal aneurysm repair.

Objectives: The aim of this study was the comparison of a new double‐coated paclitaxel‐eluting coronary stent with bare‐metal stent (BMS) in patients undergoing percutaneous coronary intervention. Background: Stent coating with biodegradable polymers as a platform for elution of drugs has the potential for complete elution of drugs and for decreasing the risk of late complications. Methods: Multicenter randomized trial comparing a paclitaxel‐eluting stent (PES) coated with a biodegradable polymer and glycocalyx with the equivalent BMS. We randomly assigned 422 patients with de novo coronary lesions to PES (211 patients) or to BMS (211 patients). Primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction, and target vessel revascularization. Clinical secondary end points were target vessel revascularization, target lesion revascularization, stent thrombosis (ST), and major adverse cardiovascular events (MACE). Angiographic secondary end points were late loss and binary restenosis. Results: At 1 year of follow‐up, TVF rate was 9.5% in the PES group and 17.1% in the BMS group (P = 0.02), and MACE rate was 10% in PES and 19% in BMS arm (P = 0.009). All other secondary end points were reached but ST. ST rate was low and similar in both study arms. Conclusions: The study shows that patients treated with PES with dual coating technology had significantly lower incidence of TVF and MACE than those treated with BMS design; however, longer follow‐up should be necessary to assess true advantages of this technology compared with the previous one.