Comparison of direct stenting versus conventional stent implantation on blood flow in patients with ST-segment elevation myocardial infarction

As compared with balloon angioplasty, stent implantation in treatment of acute myocardial infarction (AMI) reduces abrupt vessel closure, restenosis, and reocclusion rate. However, a few studies have demonstrated the safety and feasibility of direct stenting compared to conventional stent implantation technique. This study was designed to compare possible advantages of direct stenting with conventional stent implantation on immediate coronary blood flow and short-term clinical benefits in patients with AMI. Fifty patients with AMI who underwent mechanical revascularization were eligible for the study. The patients were randomly assigned to undergo either direct stenting (n = 25) or conventional stent implantation (n = 25). Before and after the procedure thrombolysis in myocardial infarction (TIMI) flow and postprocedural corrected TIMI frame count (cTFC) of the infarct-related artery were measured. There was no difference in TIMI flow distribution at baseline between the 2 groups. TIMI 3 flow rate significantly increased after procedure in both groups compared to baseline (p < 0.05). Postprocedural cTFC was found significantly lower in the direct stent arm compared to conventional stenting (p < 0.001). Both during and after the procedure the complication rate and procedural time were lower in the direct stenting arm. Direct stenting provides better immediate coronary blood flow and is a safe and feasible method compared with conventional stenting in patients with AMI. Improvement in coronary blood flow measured by the corrected TIMI frame count method may suggests a significant reduction of microvascular injury.     

Comparison of direct stenting with conventional stent implantation in acute myocardial infarction

Small studies have suggested that direct stenting without balloon predilatation in ST-segment elevation myocardial infarction may reduce microcirculatory dysfunction. To examine the clinical benefits of direct stenting in a large cohort of patients who underwent primary percutaneous coronary intervention treated with contemporary pharmacotherapy, the 1-year outcomes from the multicenter, randomized Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial were analyzed. A total of 3,602 patients with ST-segment elevation myocardial infarction who underwent primary percutaneous coronary intervention were enrolled. The present study cohort consisted of 2,528 patients in whom single lesions (excluding bypass grafts) were treated with stent implantation. At operator discretion, direct stenting was attempted in 698 patients (27.6%), and stenting was performed after predilatation in 1,830 patients (72.4%). Propensity-score matching was performed to reduce bias. Direct stenting was successful in 677 patients (97.0%). ST-segment resolution at 60 minutes after the procedure was improved in patients who underwent direct compared to conventional stenting (median 74.8% vs 68.9%, respectively, p = 0.01). At 1-year follow-up, direct compared to conventional stenting was associated with a significantly lower rate of all-cause death (1.6% vs 3.8%, p = 0.01) and stroke (0.3% vs 1.1%, p = 0.049), with nonsignificant differences in target lesion revascularization, myocardial infarction, stent thrombosis, and major bleeding. Death at 1 year remained significantly lower in the direct stenting group after multivariate adjustment (hazard ratio 0.42, 95% confidence interval 0.21 to 0.86, p = 0.02) and in a propensity score-based analysis (hazard ratio 0.92, 95% confidence interval 0.88 to 0.95, p = 0.02). In conclusion, compared to stent implantation after predilatation, direct stenting is safe and effective in appropriately selected lesions in patients with ST-segment elevation myocardial infarction who undergo primary percutaneous coronary intervention and may result in improved survival.     

Comparison of outcomes of direct stenting versus stenting after balloon predilation in patients with acute myocardial infarction (DIRAMI)

Due to recent advances in stent design, stenting without balloon predilation (direct stenting) has become more extensively used in patients with acute myocardial infarction (AMI). We performed a randomized study with broad inclusion criteria and early randomization after presentation to compare direct stenting with stenting after balloon predilation in patients with AMI. A total of 248 patients was randomized. After exclusion of patients not suitable for stenting, the final study group comprised 217 patients. Direct stenting strategy was feasible in 88% of patients with no meaningful complications. Final Thrombolysis In Myocardial Infarction grade 3 flow (96% vs 94%), final Thrombolysis In Myocardial Infarction myocardial perfusion grade 2 or 3 (68% vs 61%), and average ST-segment resolution after the procedure (49% vs 51%) were similar in the direct stenting and predilation groups, respectively (p = NS). Rate of in-stent restenosis was higher in the direct stenting group (30% vs 16%, p = 0.024), which was due to a worse angiographic result after the procedure. At 5 years, a composite of cardiac death, reinfarction, and target lesion revascularization had occurred in 39% in the direct stenting group and 34% in the predilated group (p = 0.40). In conclusion, although at 5 years clinical outcome did not differ significantly between groups, direct stenting was associated with a higher incidence of in-stent restenosis at 1 year. Direct stenting did not improve epicardial and myocardial reperfusion indexes. Direct stenting strategy should not be recommended in all patients with AMI as an alternative strategy to stenting after predilation.     

X-sizer for thrombectomy in acute myocardial infarction improves ST-segment resolution: results of the X-sizer in AMI for negligible embolization and optimal ST resolution (X AMINE ST) trial

OBJECTIVES: We sought to compare, in a prospective randomized multicenter study, the effect of adjunctive thrombectomy using X-Sizer (eV3, White Bear Lake, Minnesota) before percutaneous coronary intervention (PCI) versus conventional PCI in patients with acute myocardial infarction (AMI) for <12 h and Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 to 1. The primary end point was the magnitude of ST-segment resolution after PCI. BACKGROUND: Despite a high rate of TIMI flow grade 3 achieved by PCI in patients with AMI, myocardial reperfusion remains relatively low. Distal embolization of thrombotic materials may play a major role in this setting. METHODS: We conducted a prospective, randomized, multicenter study in patients with AMI <12 h and initial TIMI flow grade 0 to 1 who were treated with primary PCI. The magnitude of ST-segment resolution 1 h after PCI was the primary end point. RESULTS: A total of 201 patients were included. Treatment groups were comparable by age (61 +/- 13 years), diabetes (22%), previous MI (8%), anterior MI (52%), onset-to-angiogram (258 +/- 173 min), and glycoprotein IIb/IIIa inhibitor use (59%). The magnitude of ST-segment resolution was greater in the X-Sizer group compared with the conventional group (7.5 vs. 4.9 mm, respectively; p = 0.033) as ST-segment resolution >50% (68% vs. 53%; p = 0.037). The occurrence of distal embolization was reduced (2% vs. 10%; p = 0.033) and TIMI flow grade 3 was obtained in 96% vs. 89%, respectively (p = 0.105). Myocardial blush grade 3 was similar (30% vs. 31%; p = NS). Six-month clinical outcome was comparable (death, 6% vs. 4% and major adverse cardiac and cerebral events, 13% vs. 13%, respectively). By multivariate analysis, independent predictors of ST-segment resolution >50% were: younger age, non-anterior MI, use of the X-Sizer, and a short time interval from symptom onset. CONCLUSIONS: Reducing thrombus burden with X-Sizer before stenting leads to better myocardial reperfusion, as illustrated by a reduced risk of distal embolization and better ST-segment resolution.     

Intracoronary thrombectomy improves myocardial reperfusion in patients undergoing direct angioplasty for acute myocardial infarction

OBJECTIVES: We sought to evaluate the effects of mechanical thrombectomy on myocardial reperfusion during direct angioplasty for acute myocardial infarction (AMI). BACKGROUND: Embolization of thrombus and plaque debris may occur during direct angioplasty for AMI. This may lead to distal vessel or side branch occlusion and to obstructions in the microvascular system, resulting in impaired myocardial reperfusion. Mechanical thrombectomy is used to reduce distal embolization. METHODS: Ninety-two patients with AMI and angiographic evidence of intraluminal thrombus were randomized to either intracoronary thrombectomy followed by stenting or to a conventional strategy of stenting. Thrombectomy was performed using the X-Sizer catheter (EndiCOR Inc., San Clemente, California). Myocardial reperfusion was assessed by myocardial blush and ST resolution. RESULTS: Postprocedure Thrombolysis in Myocardial Infarction-3 flow was not different between groups (93.5% vs. 95.7%, p = 0.39). Myocardial blush-3 was observed in 71.7% of patients undergoing thrombectomy and in 36.9% of patients undergoing conventional strategy (p = 0.006). ST-segment resolution >or=50% occurred more often in patients undergoing thrombectomy (82.6% vs. 52.2%, p = 0.001). By multivariate analysis, adjunctive thrombectomy was an independent predictor of blush-3 (odds ratio, 3.27; 95% confidence interval, 1.06 to 10.05; p = 0.039). CONCLUSIONS: Intracoronary thrombectomy as adjunct to stenting during direct angioplasty for AMI improves myocardial reperfusion as assessed by myocardial blush and ST resolution.     

Angiographic no-reflow phenomenon and plaque characteristics by virtual histology intravascular ultrasound in patients with acute myocardial infarction

OBJECTIVE: This study aimed to evaluate the relationship between the occurrence of the angiographic no-reflow phenomenon in patients with acute myocardial infarction (AMI) and the preintervention plaque composition as assessed by virtual histology intravascular ultrasound (VH-IVUS). BACKGROUND: The angiographic no-reflow phenomenon is an adverse prognostic factor in patients with AMI. METHOD: We enrolled consecutive 50 patients with ST-elevation AMI was treated by primary stent implantation. All culprit lesions were imaged by VH-IVUS before stent implantation. The angiographic no-reflow phenomenon was defined as a decrease in final TIMI flow grade compared with TIMI flow grade before stent implantation. RESULTS: Eight of 50 patients developed angiographic no-reflow after stent implantation. Gray-scale intravascular ultrasound (IVUS) showed significantly larger external elastic membrane volume and plaque burden in the no-reflow group. VH-IVUS showed a trend toward larger percentage of fibro-fatty plaque volume in the no-reflow group than in the reflow group (23.1 +/- 3.5 vs. 17.0 +/- 1.1%, P = 0.05). The presence of "marble"-like image, mainly consisting of fibro-fatty and fibrous plaque (plaque volume of fibro-fatty + fibrous >80% and containing fibro-fatty plaque volume >10%) was associated with angiographic no-reflow (P = 0.02). Corrected TIMI frame counts of the cases with "marble"-like image were significantly larger than the cases without it (46.8 +/- 5.6 vs. 27.4 +/- 2.3, P = 0.01). CONCLUSION: The culprit lesions with large plaque burden, or with "marble"-like image by VH-IVUS, are associated with the angiographic no-reflow phenomenon in patients with AMI.     

Conventional versus direct stenting in AMI: effect on immediate coronary blood flow

There are no data regarding the potential benefits of direct stenting in the setting of AMI. The aim of this study was to evaluate the impact of direct stenting on the angiographic results and compare it to conventional stenting performed in the setting of AMI. We reviewed our institutional interventional database and identified 44 patients who had undergone stenting in the setting of AMI (29 primary and 15 rescue angioplasty). Patients were then divided into two groups; group A consisted of patients who had undergone conventional stenting (23 patients) and group B those who had undergone direct stenting (21 patients). Angiographic success was defined as TIMI flow grade 2. The baseline TIMI 0-1 flow was higher in group A compared to group B (74% vs. 24%; p < 0.05). TIMI flow rates before stenting (after balloon predilation in group A and after guidewire crossing in group B) and angiographic success (TIMI flow 2) after stenting were similar in both groups (p > 0.05). However, the final TIMI 3 flow were significantly better in group B after stenting (65% vs. 95%; p < 0.05). Although there was no no re-flow in group B, three patients in group A had no re-flow after balloon predilatation of lesions with baseline TIMI 2 flow. There was a statistical tendency to a higher TIMI 3 flow in patients treated with direct stenting in the setting of AMI. Direct stenting strategy in thrombus containing lesions seems to be a safe and feasible approach in avoiding no re-flow.     

Effectiveness of distal protection with the GuardWire Plus during primary angioplasty for acute myocardial infarction

OBJECTIVES: To evaluate the effectiveness of distal protection with the GuardWire Plus during primary angioplasty in patients with acute myocardial infarction. METHODS: Thirty-eight consecutive patients undergoing stent implantation with distal protection using the GuardWire Plus (DP-group) were compared with a matched control group undergoing conventional stent implantation after balloon angioplasty without distal protection (NDP-group). Microvascular circulation after revascularization was assessed by Thrombolysis in Myocardial Infarction (TIMI) flow grade, myocardial blush grade (MBG), serum creatine kinase peak release, and ST resolution. Left ventricular ejection fraction was measured by echocardiography at discharge. Follow-up quantitative coronary angiography and left ventriculography were performed 6 months after percutaneous coronary intervention. Quantitative coronary angiography data, restenosis rate, target lesion revascularization rate and follow-up left ventricular ejection fraction were also compared between the two groups. RESULTS: No significant differences were observed in baseline clinical and angiographic characteristics between the two groups. The TIMI flow grade 3 (DP-group 81.6% vs NDP-group 57.9%)and MBG 3 (57.9% vs 30.6%)were significantly greater in the DP-group respectively (p < 0.05). Post procedural ST-segment resolution > or = 50% was found in a significantly higher percentage of patients in the DP-group (68.4% vs 42.1%, p < 0.05). Left ventricular ejection fraction at discharge was significantly greater in the DP-group (55.5 +/- 8.5% vs 45.7 +/- 11.1%, p < 0.05). However, 6 months after the percutaneous coronary intervention, no significant difference was observed between the two groups. Restenosis rate and target lesion revascularization rate were similar in the two groups. CONCLUSIONS: Distal protection with the GuardWire Plus improved the microvascular circulation as assessed by TIMI flow grade, MBG, and ST resolution. Furthermore, left ventricular ejection fraction at discharge was improved.     

Relation of stent overexpansion to the angiographic no-reflow phenomenon in intravascular ultrasound-guided stent implantation for acute myocardial infarction

The angiographic no-reflow phenomenon is observed in some patients during stent implantation for acute myocardial infarction (AMI). We attempted to clarify the influence of stent overexpansion and plaque morphology on the angiographic no-reflow phenomenon in AMI patients who underwent intravascular ultrasound (IVUS)-guided stent implantation. We assessed the thrombolysis in myocardial infarction (TIMI) flow grade in the coronary angiographic findings, and quantitative and qualitative IVUS findings, in a total of 90 patients who underwent IVUS-guided stenting for AMI. The patients were divided into two groups according to the stent-to-artery ratio: overexpansion group (ratio 1.2) and non-overexpansion group (ratio <1.2). Angiographic no-reflow (defined as TIMI flow grade <3) in stent implantation was observed in 15 patients (17%). Angiographic no-reflow was more frequently observed in the overexpansion group than in the non-overexpansion group (32% vs 11%, P = 0.0312). Patients with no-reflow had more lipid pool-like images or fissure/dissection than those without. In the overexpansion group, a lipid pool-like image and fissure/dissection were more frequently observed in patients with no-reflow. The rate of target lesion revascularization (TLR) in the overexpansion group was significantly lower than that in the non-overexpansion group during the follow-up period (10% vs 18%, P = 0.0476), but the incidence of pump failure in the overexpansion group was higher than that in the non-overexpansion group during the hospital course (28% vs 14%, P = 0.0358). Stent overexpansion in AMI patients is related to a higher incidence of angiographic no-reflow, especially if the lesion has a lipid pool-like image or fissure/dissection, although there is a tendency for lower TLR.     

Comparison of rheolytic thrombectomy before direct infarct artery stenting versus direct stenting alone in patients undergoing percutaneous coronary intervention for acute myocardial infarction

This randomized trial compared rheolytic thrombectomy before direct infarct artery stenting with direct infarct artery stenting alone in 100 patients with a first acute myocardial infarction (AMI). The primary end point of the study was early ST-segment elevation resolution, and the secondary end points were corrected Thrombolysis In Myocardial Infarction (TIMI) frame count, infarct size, and 1-month clinical outcome. The primary end point rates were 90% in the thrombectomy group and 72% in the placebo group (p = 0.022). Randomization to thrombectomy was independently related to the primary end point (odds ratio 3.56, p = 0.032). The corrected Thrombolysis In Myocaridal Infarctions (TIMI) frame count was lower in the thrombectomy group (18.2 +/- 7.7 vs 22.5 +/- 11.0, p = 0.032), and infarct size was smaller in the thrombectomy group (13.0 +/- 11.6% vs 21.2 +/- 18.0%, p = 0.010). At 1 month, there were no major adverse cardiac events. Rheolytic thrombectomy before routine direct infarct-related artery (IRA) stenting is highly feasible and provides more effective myocardial reperfusion in patients undergoing percutaneous coronary intervention for AMI.     

Comparison of directional coronary atherectomy and stenting versus stenting alone for the treatment of de novo and restenotic coronary artery narrowing

Late lumen loss after directional coronary atherectomy (DCA) is mainly determined by arterial remodeling. We hypothesized that stent implantation after optimal lesion debulking could be an effective approach to reduce restenosis. A total of 753 patients with de novo or restenotic coronary lesions were prospectively randomized to DCA plus stenting (n = 381) or stenting alone (n = 372). The patients were followed for 12 months. Procedural success was achieved in 91.5% versus 97.3% (p = 0.0007) of patients treated with DCA plus stent versus stent alone. Optimal atherectomy (<20% residual stenosis) was achieved in 26.5% of patients. The final minimal luminal diameter and the acute gain were similar in the 2 groups. There was no increase in 30-day major adverse cardiac events in the DCA plus stent group (3.9% vs 2.4%, p = 0.30). The primary end point, angiographic restenosis at 8 months, occurred in 26.7% of patients treated with DCA plus stents and in 22.1% of patients treated with stents alone (p = 0.237). Clinical follow-up to 1 year showed no difference in mortality (1.3% vs 0.8%, p = 0.725), acute myocardial infarction (4.2% vs 3.5%, p = 0.706), and target vessel failure (composite of death, Q-wave myocardial infarction, and target vessel revascularization) (23.9% vs 21.5%, p = 0.487) between patients with DCA plus stents and those with stents alone. This study failed to support the hypothesis that DCA before stenting lowers the angiographic restenosis rate compared with stents alone. At 12-month follow-up, there were no significant differences between the 2 groups in rates of death, reinfarction, or target vessel failure.     

Subacute thrombosis with antiplatelet treatment in a non-selected population of intracoronary stents: incidence and predictors

INTRODUCTION: After coronary stenting, the incidence of subacute stent thrombosis have been reduced to 0% using aspirin and ticlopidine, in studies with selected populations and intracoronary ultrasounds. OBJECTIVE: To evaluate the incidence and predictors of subacute stent thrombosis in a nonselected population, using antithrombotic therapy. METHODS: We studied 285 stents, consecutively and successfully implanted in 268 lesions of 226 patients. We used high pressure balloon inflation without intracoronary ultrasound. Post-stenting protocol included aspirin and ticlopidine during four weeks with no anticoagulation. We defined subacute stent thrombosis as death, acute myocardial infarction myocardial infarction or angiographic occlusion of stent, with TIMI flow 0-1, after the first 24 hours and during the first month. RESULTS: Four patients presented events (1.7%): Three nonfatal myocardial infarction after discharge, with documented angiographic thrombosis of stent, and one death due to in-hospital myocardial infarction. All three non-fatal AMI, occurred in vessels less than 3 mm (p = 0.07) and in patients taking aspirin without ticlopidine (p < 0.001). After discharge, three (17%) of 18 patients with inadvertent discontinuation of ticlopidine presented subacute stent thrombosis, in contrast to none of 25 patients taking ticlopidine without aspirin. Excluded patients with discontinuation of ticlopidine, the incidence of subacute stent thrombosis was 0.5%. CONCLUSION: After intracoronary stenting in a nonselected population, using antithrombotic treatment with aspirin and ticlopidine, we may expect a rate of subacute stent thrombosis about 1%. Ticlopidine seems to have the main role in preventing subacute stent thrombosis, above all in predisposing circumstances as small vessels.     

Effect of preinfarction angina pectoris on microcirculation in patients with reperfused acute myocardial infarction

Preinfarction angina pectoris has been suggested in some studies to have a beneficial effect on left ventricular function after acute myocardial infarction (AMI). The precise mechanisms of this protection have not been fully elucidated. The effect of preinfarction angina on myocardial tissue perfusion also needs to be clarified. In this study, we investigated the influence of preinfarction angina on microvasculatory damage by using ST-segment resolution and pressure-derived collateral flow index (CFIp) as a marker of microcirculatory perfusion. METHODS: We studied 41 patients with a first AMI in whom thrombolysis in myocardial infarction (TIMI) grade 3 flow in the infarct-related artery was established by thrombolytic therapy. The percent resolution of ST-segment deviation (deltasigma ST) after thrombolysis was determined. All of the patients had TIMI grade 3 flow in IRA at the coronary angiography, which was done a mean of 4 days after AMI. Intracoronary pressure measurements and stent implantation to the IRA were performed. After angiography, CFIp was calculated as the ratio of simultaneously measured coronary wedge pressure-central venous pressure (Pv) to mean aortic pressure-Pv. RESULTS: Patients with preinfarction angina pectoris had greater percent deltasigma ST than those without PA (67 +/- 18% vs. 44 +/- 24%, p = 0.03).The mean of the coronary wedge pressure (16.4 +/- 7.4 compared with 23.2 +/- 9.4, P < 0.03) and the pressure-derived collateral flow index (0.15 +/- 0.10 compared with 0.22 +/- 0.08, P < 0.03) were significantly lower in patients with preinfarction angina compared to those without. CONCLUSION: Preinfarction angina is associated with a greater degree of ST-segment resolution and lower CFI-p in patients with TIMI-3 reflow after thrombolysis. These findings suggest that a protective effect of preinfarction angina against reperfusion injury may result in greater ST resolution and lower CFIp after AMI.     

Expansion of the Multilink-Tristar stent after direct implantation and predilatation: comparison of clinical,angiography and intravascular ultrasound parameters

Coronary stenting has become the primary therapeutic option for many coronary lesions. As opposed to conventional stenting the advantages of direct stenting are a reduction of procedural time, radiation exposure and costs. However, data about the incidence of in-stent restenosis are so far not available. It was the aim of this prospective study to compare the expansion of the Multilink stent after direct stenting and predilatation by quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS). Between January 2000 and June 2001, 82 patients were assigned to direct stenting (46 lesions) or predilatation (40 lesions) in lesions of coronary arteries > 3 mm. The procedural success rate was 92% in patients undergoing direct stenting. The baseline clinical characteristics were similar in both groups. The comparison of the angiographic data shows that direct stenting was performed in lesions with a lower degree of stenosis (71 +/- 12% vs 79 +/- 11%, p = 0.01) and that significantly shorter stents were used (14.4 +/- 3.0 vs 17.8 +/- 4.1 mm, p = 0.0007). The mean stenosis length was not significantly different in either group (10.5 +/- 3.4 vs 11.7 +/- 4.3 mm, n.s.). The QCA data after stent implantation show no differences of either implantation technique. Stent expansion was assessed by IVUS estimation of the proximal, distal and minimal in stent area. The minimal in-stent area (9.53 +/- 3.23, mm2 vs 8.65 +/- 1.96 mm2, n.s.) and the stent symmetry index (0.88 vs 0.88 n.s.) were not different in either patient group. These results indicate that in this subset of selected coronary lesions > 3 mm, elective stent implantation with and without predilatation effectively can achieve comparable stent expansion as assessed by QCA and IVUS. In comparison to conventional stent implantation stents, which were implanted without predilatation, were significantly shorter to cover the same lesion length.     

Direct stenting in angiographically apparent thrombus-containing lesions.

The data regarding the potential benefits of direct stenting in the setting of angiographically apparent thrombus-containing lesions are scarce. The aim of this study was to evaluate the impact of direct stenting on the angiographic results in the setting of thrombus. We reviewed our institutional interventional database and identified 30 patients who had undergone stenting in the setting of angiographically apparent thrombus-containing lesions (33% unstable angina pectoris, 67% acute myocardial infarction). The majority of patients had a baseline TIMI 2 and 3 flow (80%). Of the 6 patients (20%) who had TIMI 0-1 flow at baseline, four of them achieved a TIMI 2 flow immediately after crossing the lesion with a 0.014 guidewire. Although the remaining 2 patients had TIMI 1 flow, as distal opacification beyond the stenosis was obtained we successfully implanted the stents directly. All stents were successfully implanted without any crossing failure or stent loss. There was no "no re-flow", with a final TIMI 3 flow rate in 93%. In 1 patient with TIMI 2 flow after stenting, TIMI 3 flow was obtained after intracoronary verapamil. In 2 patients (7%, TIMI 2 flow), a final TIMI 3 flow could not be achieved despite intracoronary nitroglycerin and verapamil. There was no stent loss and imprecise stent placement. There were no in-hospital deaths, repeat interventions or coronary artery bypass graft surgeries. However, two patients had undergone mitral valve replacement due to severe mitral regurgitation. Eight patients with recurrent ischemia had control angiography; stents were found to be patent in all 8 patients. Two patients experienced recurrent myocardial infarction (6.6%). Direct stenting strategy in thrombus-containing lesions seems to be a safe and feasible approach in avoiding no re-flow. We believe that benefits observed with direct stenting in this study should be compared to conventional stenting in the same setting with a randomized study.     

The SIRIUS-DIRECT trial: a multi-center study of direct stenting using the sirolimus-eluting stent in patients with de novo native coronary artery lesions.

OBJECTIVE: To assess the safety and efficacy of direct stenting using the sirolimus-eluting BX Velocitytrade mark stent in patients with coronary lesions. BACKGROUND: Although direct coronary stenting has become a widespread practice, there have been no systematic assessments of direct stenting with drug-eluting stents. METHODS: Total of 225 patients with identical inclusion and exclusion criteria as the original SIRIUS trial were enrolled in this prospective single-arm study. They were compared in a no-inferiority design with 412 similar patients from the SIRIUS trial who had sirolimus-eluting stents deployed after predilatation and were preassigned to angiographic follow-up evaluation. RESULTS: Direct stenting was successful in 85.8% of the patients. Compared with the predilatation group, direct stenting was associated with shorter median procedure duration (33 min vs. 45 min, P < 0.001). Angiographic follow-up at 8 months revealed similar late loss (in-stent-0.19 +/- 0.47 mm vs. 0.17 +/- 0.44 mm, and in-lesion-0.23 +/- 0.41 mm vs. 0.24 +/- 0.47 mm) and similar frequency of binary restenosis (in-stent-4.6% vs. 3.2% and in-lesion-6.1% vs. 8.9%) between the two treatment strategies. However, stent-edge restenosis was lower with direct stenting than in the predilatation control group (2.1% vs. 6.9%, P = 0.02). At 12-months, there were no significant differences in target lesion revascularization (3.7% vs. 5.1%, P = ns) or composite major adverse cardiac events (7.0% vs. 8.3%, P = ns). CONCLUSIONS: In patients similar to those treated in the SIRIUS trial, direct stenting using sirolimus-eluting stents achieves excellent short- and long-term clinical and angiographic results with shorter procedure time and less frequent stent edge restenosis compared with predilation stent implantation techniques.     

A comparison of systematic stenting and conventional balloon angioplasty during primary percutaneous transluminal coronary angioplasty for acute myocardial infarction

OBJECTIVES

In a multicenter, randomized trial, systematic stenting using the Wiktor stent was compared to conventional balloon angioplasty with provisional stenting for the treatment of acute myocardial infarction (AMI).

BACKGROUND

Primary angioplasty in AMI is limited by in-hospital recurrent ischemia and a high restenosis rate.

METHODS

A total of 211 patients with AMI <12 h from symptom onset, with an occluded native coronary artery, were randomly assigned to systematic stenting (n = 101) or balloon angioplasty (n = 110). The primary end point was the binary six-month restenosis rate determined by core laboratory quantitative angiographic analysis.

RESULTS

Angiographic success (Thrombolysis in Myocardial Infarction [TIMI] flow grade 3 and residual diameter stenosis <50%) was achieved in 86% of the patients in the stent group and in 82.7% of those in the balloon angioplasty group (p = 0.5). Compared with the 3% cross-over in the stent group, cross-over to stenting was required in 36.4% of patients in the balloon angioplasty group (p = 0.0001). Six-month binary restenosis (≥50% residual stenosis) rates were 25.3% in the stent group and 39.6% in the balloon angioplasty group (p = 0.04). At six months, the event-free survival rates were 81.2% in the stent group and 72.7% in the balloon angioplasty group (p = 0.14), and the repeat revascularization rates were 16.8% and 26.4%, respectively (p = 0.1). At one year, the event-free survival rates were 80.2% in the stent group and 71.8% in the balloon angioplasty group (p = 0.16), and the repeat revascularization rates were 17.8% and 28.2%, respectively (p = 0.1).

CONCLUSIONS

In the setting of primary angioplasty for AMI, as compared with a strategy of conventional balloon angioplasty, systematic stenting using the Wiktor stent results in lower rates of angiographic restenosis.     

Impact of stenting and abciximab in patients with diabetes mellitus undergoing primary angioplasty in acute myocardial infarction (the CADILLAC trial)

We sought to determine the benefits of stent implantation and abciximab in patients with diabetes mellitus and acute myocardial infarction (AMI) who underwent primary angioplasty. In a 2-by-2 factorial design, 2,082 patients with AMI were randomly assigned to balloon angioplasty versus stenting, with or without abciximab. Diabetes was present in 346 patients (16.6%). The primary end point was the composite incidence of death, disabling stroke, reinfarction, and ischemic target vessel revascularization (TVR). The primary end point at 1 year occurred significantly more frequently in diabetic than nondiabetic patients (21.9% vs 16.8%, p <0.02), driven by increased rates of death (6.1% vs 3.9%, p = 0.04) and TVR (16.4% vs 12.7%, p = 0.07). Among patients with diabetes, TVR at 1 year was significantly reduced with routine stenting compared with balloon angioplasty (10.3% vs 22.4%, p = 0.004), with no differences in death, reinfarction, or stroke. Angiographic restenosis was also greatly reduced in diabetics randomized to stenting (21.1% vs 47.6%, p = 0.009). No beneficial effects were apparent with abciximab in diabetic patients at 1 year. Despite the improved outcomes with stenting in patients with diabetes, 1-year mortality remained increased in diabetic patients who received stents compared with nondiabetics (8.2% vs 3.6%, p = 0.005). Thus, routine stent implantation in diabetic patients with AMI significantly reduces restenosis and enhances survival free from TVR, independent of abciximab use, although survival remains reduced compared with survival in nondiabetic patients regardless of reperfusion modality.     

Diabetes and coronary stent implantation: experience from a reference center in interventional cardiology

We evaluated the influence of diabetes mellitus (DM) on clinical outcomes in patients with coronary artery disease treated with stent implantation. Between 1996 and 2000, 934 stents were implanted in 893 patients in our institution; 23% of them had DM. Clinical and angiographic characteristics and clinical outcomes of the patients with and without DM were prospectively included in a computerized database. Diabetics were older (61.5 +/- 10 vs. 59.8 +/- 11 years; p = 0.04) and had a higher prevalence of hypertension (69% vs. 62%; p = 0.09). The procedural clinical success rate (successful coronary stenting with residual stenosis < 30%, TIMI 3 flow and no in-hospital adverse clinical event) was lower in the diabetic group (88% vs. 92%; p = 0.05). In the 1-year follow up, diabetic patients showed higher rates of new target vessel revascularization (12.3% vs. 8%; p = 0.06), death (5.4% vs. 2.5%; p = 0.03) and major adverse cardiovascular events (MACE, new angioplasty, surgery, acute myocardial infarction or death: 16.3% vs. 9.3%; p = 0.003). Diabetes was independently associated to 1-year MACE on multivariate analysis (OR: 2.00; IC: 1.25-3.24; = 0.004). We concluded that DM is associated with higher complication and restenosis rates and a higher risk of long-term major cardiovascular events in patients treated with coronary stent implantation.