Comparison of PRE-dilatation vs direct stenting in coronary treatment using the Medtronic AVE S670 Coronary Stent System (the PREDICT trial).

Current stent delivery systems make primary stenting (stent placement without predilatation) possible, but few controlled trials have been performed to evaluate the success, safety, cost saving, and potential benefit of this approach in reducing late restenosis. The Comparison of PRE-Dilatation Versus Direct Stenting In Coronary Treatment using the Medtronic AVE S670 Coronary Stent System trial was a 399-patient study comparing results with the Medtronic-AVE S670 stent to objective performance criteria based on prior approved stents, with subrandomization to direct stenting versus stenting after balloon predilatation. Overall, results with the S670 stent showed excellent success and safety, with delivery success of 99%, a 14-day adverse event rate of 6.8% (including 6.5% non–Q-wave myocardial infarction), and favorable angiographic (20%) and clinical (12%) restenosis rates. Direct stenting was successful in 92% of cases, with a 99.5% secondary success rate including additional pretreatment of initially unsuccessful direct-stenting attempts, and no increase in complications. There were modest (10%) savings in fluoroscopy time, contrast use, and a decrease in angioplasty balloon use (0.6 vs 1.3 balloons/case), but no reduction in clinical or angiographic restenosis. Patients treated later in the study, with a device that had less balloon extension beyond the edges of the stent, had slightly lower angiographic restenosis rates (19% vs 23%). In conclusion, the S670 stent showed excellent overall performance. Although direct stenting was safe and highly successful, it offered only modest cost savings, and no reduction in late restenosis compared with stenting after predilatation.     

Comparison of the efficacy of direct coronary stenting with sirolimus-eluting stents versus stenting with predilation by intravascular ultrasound imaging (from the DIRECT trial)

A direct coronary stenting technique using drug-eluting stents may decrease drug-eluting stent efficacy due to possible damage to the surface coating of the stent. The DIRECT is a multicenter, prospective, nonrandomized trial designed to evaluate the direct stenting strategy for the sirolimus-eluting Bx-Velocity stent compared with the historical control (SIRIUS trial, stenting with predilation). Volumetric and cross-sectional intravascular ultrasound analyses at 8-month follow-up were performed in 115 patients (DIRECT n= 64, control n = 51). Patient and lesion characteristics were comparable between groups. The DIRECT group achieved an equivalent uniform expansion index, defined as minimum stent area/maximum stent area x 100, compared with the control group (65.9 +/- 11.7 vs 63.1 +/- 12.7, p = NS). At 8-month follow-up, vessel, stent, lumen, and neointimal volume index (volume in cubic millimeters/length in millimeters) and percent neointimal volume were similar between the DIRECT and control groups (vessel volume index 13.9 +/- 4.40 vs 15.0 +/- 3.83; stent volume index 6.83 +/- 2.02 vs 6.94 +/- 2.04; lumen volume index 6.71 +/- 2.04 vs 6.81 +/- 2.07; neointimal volume index 0.14 +/- 0.24 vs 0.16 +/- 0.23; percent neointimal volume 3.73 +/- 6.97 vs 3.14 +/- 5.32, p = NS for all). In addition, in-stent neointimal hyperplasia distribution was significantly smaller near the distal stent edge (0.22 vs 0.098 mm(3)/mm, p = 0.01 for an average neointimal volume index within 3 mm from the distal stent edge). In conclusion, direct coronary stenting with the sirolimus-eluting Bx-Velocity stent is equally effective in terms of uniform stent expansion and long-term quantitative intravascular ultrasound results compared with conventional stenting using predilation. This strategy appears to be associated with less neointimal hyperplasia near the distal stent edge.     

Direct stent implantation using the EXPRESS Coronary Stent System: results of a multi-center feasibility study

The aim of this prospective, multicenter, single arm study was to assess the safety and feasibility of EXPRESS Coronary Stent implantation in native coronary arteries without balloon predilatation. Forty-two patients with de novo or restenotic lesions were enrolled, of which 38 were eligible for analysis. The coronary lesions were predominantly complex, occurring in arteries with a mean reference diameter of 2.80 +/- 0.49 mm. Technical and procedural success were achieved in 89.5% and 84% of the cases respectively. The mean minimal lumen diameter increased from 1.08 +/- 0.26 mm to 2.55 +/- 0.44 mm and diameter stenosis decreased from 61 +/- 7% to 13 +/- 8%. The primary endpoint of major adverse cardiac events at 30 days was 2.6% and was limited to only one event (target vessel revascularization, nontarget lesion). No other MACE were observed during the three-month follow-up period. Based on the findings of this study, direct stenting with the EXPRESS Stent appears feasible and is well tolerated.     

Latin American randomized trial of balloon angioplasty vs coronary stenting for small vessels (LASMAL): immediate and long-term results

PURPOSE: To assess the potential role of coronary stent to improved acute success and reduce late restenosis in lesions with reference diameter <2.9 mm using a bare metal stent specifically designed for small coronary vessels. There is controversy on the results among previous studies comparing bare metal stent implantation with conventional balloon percutaneous transluminal coronary angioplasty (PTCA). Differences in baseline characteristics, inclusion and exclusion criteria, and stent design may account for these discrepancies. METHODS: The population of this multicenter, multinational randomized study (LASMAL) consisted of 246 patients undergoing percutaneous coronary intervention of small vessel reference diameter. They were randomized into 2 strategies of percutaneous revascularization: elective primary stent (n = 124) or conventional balloon PTCA with provisional stenting (n = 122) in the presence of acute, threatened closure or flow-limiting dissections. RESULTS: The clinical success rate was significantly better for the stent group (98.3% vs 91.8%; P = 0.038). At 30 days follow-up, requirements of target vessel revascularization (TVR) (6.6% vs 0.8%; P = 0.018) and incidence of major adverse cardiac and cerebrovascular events (MACCE) (9.8% vs 2.4%; P = 0.01) was significantly lower in the stent strategy. Postpercutaneous coronary intervention minimal luminal diameter (MLD) was significantly larger in the stent group (2.3 +/- 0.2 mm vs 2.2 +/- 0.2 mm; P = 0.003). At follow-up, MLD in the stent group was larger than with PTCA (1.7 +/- 0.7 mm vs 1.5 +/- 0.7 mm, respectively; P = 0.035). Net gain was also significantly better with stent strategy (1.1 +/- 0.7 mm vs 0.8 +/- 0.7 mm, respectively; P = 0.002). Stenting resulted in a significant lower angiographic binary restenosis (20% vs 31%; P = 0.02) than PTCA. Furthermore, patients treated with stent were more frequently free from MACCE at 9-month follow-up (death, acute myocardial infarction [AMI], stroke, repeat revascularization procedures) than those treated initially with PTCA (82.2% vs 72% of PTCA, P = 0.046). CONCLUSIONS: The use of a specifically designed bare metal coronary phosphoril choline-coated stent as primary device during percutaneous interventions in small coronary arteries was associated with high procedural success and low in-hospital and 30-day follow-up complications. At long-term follow-up, patients initially treated with stents had lower angiographic restenosis rate and were more frequently free from major adverse cardiac events.     

Two-year outcomes after sirolimus-eluting stent implantation: results from the Sirolimus-Eluting Stent in de Novo Native Coronary Lesions (SIRIUS) trial.

OBJECTIVES: The purpose of this study was to examine the two-year clinical outcomes in patients enrolled in the Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS) study. BACKGROUND: The SIRIUS study was a double-blinded randomized study which demonstrated that sirolimus-eluting stents (SES) significantly improved angiographic results (at 8 months) and clinical outcomes (at 9 and 12 months) compared with bare-metal stents (BMS). METHODS: Patients with de novo native coronary artery lesions randomized to either SES (533 patients) or control BMS (525 patients) were followed for two years. RESULTS: Between one and two years, there were infrequent additional clinical events that were equally distributed between the sirolimus and control groups. After two years, target lesion revascularization was 5.8% and 21.3% in SES and control patients, respectively (p < 0.001), and major adverse cardiovascular events and target vessel failure rates were 10.1% versus 24.4% and 12.0% versus 26.7%, respectively (p < 0.0001 for both). There were no differences in death, myocardial infarction, and stent thrombosis between the two groups. CONCLUSIONS: Clinical outcomes two years after implantation of SES continue to demonstrate significant reduction in the need for repeat target lesion (and vessel) revascularization compared with BMS without evidence for either disproportionate late restenosis or late stent thrombosis.     

A Randomized Comparison between Everolimus-Eluting Stent and Cobalt Chromium Stent in Patients with Acute ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention Using Routine Intravenous Eptifibatide: The X-MAN (Xience vs. Multi-Link Stent in Acute Myocardial Infarction) Trial,A Pilot Study

The objective of this study is to determine the efficacy and safety of an everolimus-eluting stent (EES/Xience; Abbott Vascular, Santa Clara, CA) compared with a cobalt chromium stent (CoCr/Multi-Link Vision; Abbott Vascular) in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) with routine administration of eptifibatide infusion. This is a prospective, single center, randomized trial comparing EES (n = 75) and CoCr stent (n = 75) implantation in patients with acute STEMI undergoing primary PCI. Intravenous eptifibatide administration was mandatory by protocol in this pilot study. The primary efficacy endpoint was major adverse cardiac events (MACE) at 30 days, defined as the composite of death, reinfarction, and target vessel revascularization. Secondary safety endpoints were stent thrombosis at 30 days and in-hospital bleeding event. Acute reperfusion parameters were also assessed. One-month MACE rate did not differ between EES and CoCr group (1.3 vs. 1.3%, p = 1.0). No stent thrombosis cases were observed in the EES group. The groups did not differ with respect to in-hospital bleeding events (5 vs. 9%, p = 0.37), achievement of final thrombolysis in myocardial infarction flow 2 or 3 (p = 0.21), achievement of myocardial blush grade 2 or 3 (p = 0.45), creatine kinase-MB level at 8 to 12 hours after stenting (p = 0.29), and left ventricular ejection fraction (p = 0.21). This pilot study demonstrates that after one-month follow-up, the use of EES is as safe and effective as the use of CoCr stents in patients with acute STEMI undergoing primary PCI with routine administration of intravenous eptifibatide.     

Immunosuppressive Therapy for the Prevention of Restenosis after Coronary Artery Stent Implantation (IMPRESS Study)

OBJECTIVES: This study tested the effect of oral prednisone on clinical and angiographic restenosis rate after successful stent implantation in patients with persistent elevation of systemic markers of inflammation after the procedure. BACKGROUND: Experimental studies have shown that corticosteroids have the potential to reduce the inflammatory response associated with stent implantation. METHODS: Eighty-three patients undergoing successful stenting with C-reactive protein (CRP) levels >0.5 mg/dl 72 h after the procedure were randomized to receive oral prednisone or placebo for 45 days. The primary clinical end point was 12-month event-free survival rate (defined as freedom from death, from myocardial infarction, and from recurrence of symptoms requiring additional revascularization). The angiographic end points were restenosis rate and late loss at six months. RESULTS: Twelve-month event-free survival rates were 93% and 65% in patients treated with prednisone and placebo, respectively (relative risk [RR] 0.18, 95% confidence intervals [CI], 0.05 to 0.61, p = 0.0063). Six-month restenosis rate and late loss were lower in prednisone-treated than in placebo-treated patients (7% vs. 33%, p = 0.001, and 0.39 +/- 0.6 mm vs. 0.85 +/- 0.6 mm, p = 0.001, respectively). CONCLUSIONS: In patients with persistently high CRP levels after successful coronary artery stent implantation, oral immunosuppressive therapy with prednisone results in a striking reduction of clinical events and angiographic restenosis rate.     

Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents: 1-Year Outcomes from the Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial (RESET)

BACKGROUND: Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization. METHODS AND RESULTS: Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES (P(noninferiority)<0.0001, and P(superiority)=0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, P=0.77). An angiographic substudy enrolling 571 patients (EES, 285 patients and SES, 286 patients) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss (0.06±0.37 mm versus 0.02±0.46 mm, P(noninferiority)<0.0001, and P(superiority)=0.24) at 278±63 days after index stent implantation. CONCLUSIONS: One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035450.     

Randomized comparison of cilostazol vs clopidogrel after drug-eluting stenting in diabetic patients--clilostazol for diabetic patients in drug-eluting stent (CIDES) trial.

BACKGROUND: Previous studies have shown that cilostazol may not only prevent stent thrombosis, but may also have positive effect in the prevention of restenosis. However, the effect of cilostazol on restenosis after successful deployment of drug-eluting stent (DES) in patients with diabetes mellitus has not been evaluated. METHODS AND RESULTS: A total of 280 patients at 8 clinical sites were randomized. The patients (61.7+/-9.9 years old, 163 males) who underwent successful stenting were randomized to aspirin and cilostazol (group I, n=141, 61.2+/-9.6 years old) vs aspirin and clopidogrel (group II, n=139, 62.0+/-10.0 years old) after 1 month of aspirin, cilostazol, and clopidogrel combination treatment. There were no significant differences in baseline characteristics of the groups. The type of DES implanted did not differ between the groups. There were no differences in angiographic and procedural characteristics of the groups. Major adverse cardiac events, including acute and subacute stent thrombosis within 1 month, did not occur in either group. Cases of angiographic late stent thrombosis were 1 (0.9%) in group I and 1 (0.8%) in group II. Follow-up coronary angiography was performed in 237 patients (84.6%). Mean follow-up duration was 7.1 months. The rate of angiographic restenosis (stent plus 5-mm borders) was 9 (8.0%) in group I and 20 (16.1%) in group II, p=0.041). The minimal luminal diameter at follow-up period in group I was 2.55+/-0.63 mm compared with 2.41+/-0.83 mm in group II (p=NS). CONCLUSIONS: Combination therapy with aspirin and cilostazol for the prevention of stent restenosis is comparable or superior to that of aspirin and clopidogrel in diabetic patients who undergo DES implantation.     

Six-month Follow-up of Successful Stenting for Acute Dissection After Coronary Angioplasty: Comparison Between Slotted Tube (Palmaz-Schatz) and Flexible Coil (Gianturco-Roubin) Stent Designs

The aim of this study was to evaluate the influence that two different stent designs may have in late outcome following successful coronary stent implantation for acute dissection after balloon angioplasty. In the present study, 50 consecutive patients were matched to compare late outcome between the use of slotted tube (Palmaz-Schatz) and flexible coil (Gianturco-Roubin) stent designs (25 in each group). Group matching was performed according to vessel size, location of target lesion, and dissection type among patients undergoing successful coronary stenting to treat an acute dissection following balloon coronary angioplasty. Poststent minimal luminal diameter (2.46 ± 0.49 mm vs 2.35 ± 0.47 mm, not significant [NS]) and acute luminal gain (2.02 ± 0.61 mm vs 1.85 ± 0.56 mm, NS) were similar in slotted tube and flexible coil stent groups, respectively. However, at 6-month follow-up, late loss in luminal diameter was larger in lesions treated with a flexible coil stent (0.96 ± 0.75 mm vs 0.62 ± 0.55 mm, P = 0.05), and minimal luminal diameter was smaller in those lesions treated with a flexible coil stent (1.38 ± 0.87 mm vs 1.84 ± 0.63 mm, P < 0.05). Angiographic restenosis (> 50% diameter narrowing) occured in four lesions treated with a slotted tube stent (16%) compared to ten lesions treated with a flexible coil stent (40%, P < 0.05). The design of the coronary stent may have significant influence in the late lesion outcome. In patients with acute dissection following balloon coronary angioplasty, use of a slotted tube stent design (Palmaz-Schatz) may result in lower late loss and larger luminal diameter at 6-month follow-up than use of a flexible coil stent design (Gianturco-Roubin).     

The role of acute wall recoil and late restenosis: results of the OCBAS trial (Optimal Coronary Balloon Angioplasty with Provisional Stenting versus Primary Stent)

Early deterioration of minimal luminal diameter immediately after PTCA, has been associated with an increase of late restenosis. Lesions with no early loss after PTCA have a low restenosis rate. Coronary stents reduce restenosis in lesions exhibiting early wall recoil. The purpose of the OCBAS study was to compare two strategies during coronary interventions; provision vs. elective stenting. 116 patients with good PTCA results were randomized to stent ( n = 57) or to optimal PTCA ( n = 59). After randomization in PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting). 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 groups (0.63 &#45 0.59 vs. 0.26 &#45 0.44, respectively; P = 0.01). Hence, net gain with both techniques was similar (1.32 &#45 0.3 vs. 1.24 &#45 0.29 mm for the stent and 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 also 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). The strategy of the PTCA with delay angiogram and provisional stent if early loss occurs, had similar restenosis rate and TVR than universal use of bare stents.