Is Palmaz-Schatz stenting effective for second restenosis?

The long-term outcome after coronary stent placement in restenotic lesions after balloon angioplasty (percutaneous transluminal coronary angioplasty: PTCA)may be less favorable compared to stent treatment of de novo lesions, but the role of stents in restenotic lesions after 2 prior PTCA procedures is unknown. Elective Palmaz-Schatz stent placement was performed in 124 consecutive patients. Stents were placed in 70 patients(56%) in the native coronary arteries for de novo lesions(de novo group), in 33 patients (27%)for restenotic lesions after one prior PTCA(restenosis group), and 21 patients(17%)for restenotic lesions after 2 prior PTCA(second restenosis group). The 3 groups were well matched with respect to lesion type, lesion length, and reference diameter. Stent size was similar in the 3 groups. Follow-up angiograms taken about 6 months after stenting were available for all patients. The restenosis rate after stenting was similar for the de novo group and restenosis group(19% vs 27%, NS). The second restenosis group tended to have a higher restenosis rate after stenting than the de novo group(38% vs 19%, p = 0.06). The frequency of diffuse type in-stent restenosis of the second restenosis group tended to be higher than that of the de novo group(63% vs 13%, p = 0.08). Our results suggest that the restenosis rate after stenting was higher in patients with repeated restenosis. Therefore, other therapeutic methods should be considered.     

Randomized study to compare balloon angioplasty and elective stent implantation in venous bypass grafts: the Venestent study.

The aim of the study was to compare acute and long-term angiographic and clinical outcome of balloon angioplasty and elective stenting in de novo lesions in the body of a saphenous vein graft (SVG). A total of 150 patients, with de novo lesions in SVG, were randomly assigned to balloon angioplasty or elective Wiktor I stent implantation. The angiographic restenosis rate at 6-month follow-up was 32.8% in the balloon group and 19.1% in the stent group (P = 0.069). At 1-year follow-up, target vessel revascularization rate was 31.4% vs. 14.5% (P < 0.05), and event-free survival was 60.0% vs. 76.3% (P < 0.05) for the balloon and stent group, respectively. Elective stent implantation in de novo SVG lesions is associated with a significant lower target vessel revascularization rate and a significant higher event-free survival at 1-year follow-up as compared to balloon angioplasty.     

Influence of lesion length on restenosis after coronary stent placement

The length of a coronary lesion is a significant predictor of restenosis after balloon angioplasty. The influence of lesion length has not comprehensively been assessed after coronary stent placement. This study includes 2,736 consecutive patients with coronary stent placement. Only patients with recent or chronic occlusions before the intervention were excluded. Patients were divided in 2 groups: 573 patients with long lesions (≥15 mm) and 2,163 patients with short lesions (<15 mm). There were no significant differences between the groups with respect to the procedural success rate and incidence of subacute thrombosis. One-year event-free survival was lower in patients with long lesions (73.3% vs 80.0%, p = 0.001). Six-month angiography was performed in 82.5% of the eligible patients. The incidence of binary restenosis (≥50% diameter stenosis) was higher in patients with long lesions (36.9% vs 27.9%, p <0.001). Similarly, patients with long lesions presented more late lumen loss than those with short lesions (1.29 ± 0.89 vs 1.07 ± 0.77 mm, p <0.001). Multivariate models for both binary restenosis and late lumen loss demonstrated that lesion length was an independent risk factor for restenosis. The risk was further increased by multiple stent placement and overlapping stents that were also independent risk factors of restenosis. Stented segment length did not show any independent effect. Therefore, long lesions represent an independent risk factor for restenosis after coronary stent placement. The results of this study suggest that a possible way to reduce the risk is to cover the lesion with a minimal number of nonoverlapping stents.     

Does addition of estradiol improve the efficacy of a rapamycin-eluting stent? Results of the ISAR-PEACE randomized trial.

OBJECTIVES: This study aimed to assess the efficacy of a rapamycin plus 17-beta-estradiol-eluting stent versus a rapamycin-eluting stent in patients with coronary artery disease. BACKGROUND: Estradiol promotes rapid re-endothelialization of coronary stents in animal models, but it is not known whether combining this drug with rapamycin represents an improved drug-eluting stent technology in terms of reduced lumen renarrowing. METHODS: In this randomized study, we enrolled 502 patients with de novo lesions in native coronary arteries who were randomly assigned to receive either a polymer-free, estradiol plus rapamycin-eluting stent (ERES) (n = 252) or a polymer-free, rapamycin-eluting stent (RES) (n = 250). The primary end point was in-stent late lumen loss in the follow-up angiography. Secondary end points were binary angiographic restenosis, target lesion revascularization, combined incidence of death and myocardial infarction, and incidence of stent thrombosis during 1 year after randomization. The study was designed to test for the superiority of the ERES compared with the RES with respect to in-stent late lumen loss. RESULTS: Late lumen loss (0.52 +/- 0.58 mm vs. 0.51 +/- 0.58 mm, p = 0.83), the incidence of binary angiographic restenosis (17.6% vs. 16.9%, p = 0.85), the incidence of target lesion revascularization (14.3% vs. 13.2%, p = 0.72), the combined incidence of death and myocardial infarction (7.9% vs. 8.0%, p = 0.98), and the incidence of stent thrombosis (0.8% vs. 1.2%, p = 0.99) were not significantly different between the ERES group and the RES group. CONCLUSIONS: No apparent beneficial effect is obtained by adding estradiol to a polymer-free rapamycin-eluting stent during the first year after the procedure. (The ISAR-PEACE trial; http://clinicaltrials.gov/ct/show/NCT00402636?order=1; NCT00402636).     

Safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in the treatment of patients with de novo native coronary artery lesions: the SIRIUS 2.25 trial

Smaller reference vessel diameter is a recognized determinant of in-stent restenosis. The SIRIUS 2.25 trial was a prospective, nonrandomized study including 100 patients (mean age 63.4 years; 64% men, 40% with diabetes mellitus) assessing the safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in patients with de novo native coronary lesions. Using propensity score matching for gender, diabetes mellitus, left anterior descending artery target vessel, lesion length, and reference vessel diameter, the outcomes were compared with historical control groups (angioplasty and Palmaz-Schatz stent arms from the STRESS/BENESTENT I/II trials and the Bx Velocity bare metal stent arm from the RAVEL and SIRIUS trials having a reference vessel diameter <3 mm). Use of the 2.25-mm sirolimus-eluting Bx Velocity stent was associated with a high rate of procedural success (97%) and a low rate of in-hospital major adverse cardiac events (2%). The primary end point, 6-month in-lesion binary angiographic restenosis, occurred less frequently in patients treated with the 2.25-mm sirolimus-eluting Bx Velocity stent than in each of 3 historical controls (16.9% vs 30.6%, p = 0.12; 36.5%, p <0.001; 45.9%, p <0.001, respectively). This translated into lower rates of 6-month target lesion revascularization in the 2.25-mm sirolimus-eluting Bx Velocity stent group (4.0% vs 15.0% in each of 3 control groups, p = 0.01 to <0.001). By multivariate analysis, in-lesion binary restenosis was predicted by multiple implanted stents (odds ratio 10.4, p = 0.002). Four of 13 patients who developed restenosis (30.8%) had a diffuse pattern of restenosis. In the long lesion tertile (mean lesion length 19.5 mm), the in-lesion binary restenosis rate was 27.6%. In conclusion, use of the 2.25-mm sirolimus-eluting Bx Velocity stent was safe and provided favorable 6-month clinical outcomes. Use of multiple stents (in longer lesions) was an independent predictor of in-lesion restenosis.     

Three-year clinical follow-up results of intracoronary radiation therapy using a rhenium-188-diethylene-triamine-penta-acetic-acid-filled balloon system.

BACKGROUND: Intracoronary radiation therapy (IRT) prevents recurrent in-stent restenosis, but its long-term safety and efficacy remain uncertain. In the present study, the long-term clinical outcome of IRT using the rhenium-188 ((188)Re)-filled balloon system was evaluated. METHODS AND RESULTS: After successful catheter-based treatment of either a de novo or restenotic lesion, 187 patients were randomly assigned to either the radiation (N=104) or the control (N=83) group. The (188)Re-filled balloon system was designed to deliver 17.6 Gy to 1.0-mm tissue depth. Angiographic restenosis was significantly reduced with IRT at 9 months (18.9% vs 45.9%, p<0.001), but the incidence of major adverse cardiac events (MACE) including death, myocardial infarction, and target-vessel revascularization (TVR) by 3 years showed no difference. Lack of clinical benefit might be related to TVR caused by geographic miss (6/22, 28.6%), balloon-induced unhealed dissection (3/22, 13.6%) and late thrombosis (2/22, 9.1%). In the restenotic subgroup (N=39), the MACE rate within 3 years was significantly reduced with IRT (14.3% vs 54.5%, p=0.01). CONCLUSIONS: IRT using the (188)Re -filled balloon system is safe and technically feasible. Although IRT failed to show favorable outcomes for de novo lesion, the clinical benefits for restenotic lesions seem durable for 3 years. Furthermore, preventing geographic miss and dissection might improve long-term outcomes.     

Coronary intervention in the diabetic patient: improved outcome following stent implantation compared with balloon angioplasty

BACKGROUND: Diabetic patients undergoing coronary interventional procedures are at increased risk of restenosis and adverse clinical events. The relative impact of stents compared with balloon angioplasty on the outcome of percutaneous intervention in diabetics remains controversial. HYPOTHESIS: The goal of this study was to determine whether stent placement was superior to balloon angioplasty in reducing restenosis of diabetic patients undergoing coronary intervention. METHODS: The STRESS Trial was a prospective randomized comparison of stent placement and balloon angioplasty in the treatment of new native coronary lesions. Of 594 randomized patients. 92 (16%) were diabetic. In this substudy analysis of the STRESS Trial, the outcomes after stenting and balloon angioplasty in diabetic patients were compared. The primary endpoint was restenosis as determined by angiography at 6 months. Clinical outcomes at 1 year were assessed. RESULTS: Procedural success was achieved in 82% of diabetic patients assigned to angioplasty and in 100% assigned to stenting (p < 0.01). Compared with angioplasty, stenting resulted in a larger postprocedural lumen diameter (2.34 +/- 0.44 vs. 1.87 +/- 0.52 mm, p < 0.001) and greater acute luminal gain (1.61 +/- 0.47 vs. 1.06 +/- 0.46 mm, p < 0.001). At 6 months, stenting conferred a larger lumen (1.69 +/- 0.57 vs. 1.38 +/- 0.60 mm, p = 0.03) and greater net luminal gain (0.97 +/- 0.55 vs. 0.52 +/- 0.52 mm, p < 0.001). Restenosis occurred in 60% of the angioplasty group and in 24% of the stent group (p < 0.01). This was accompanied by a lower need for repeat target vessel revascularization after stenting (31 vs. 13%, p < 0.03). CONCLUSIONS: Compared with balloon angioplasty, stent placement in diabetic patients with focal de novo lesions resulted in superior procedural results, reduced restenosis, and improved clinical outcome with fewer repeat revascularization procedures.     

Usefulness of minimum stent cross sectional area as a predictor of angiographic restenosis after primary percutaneous coronary intervention in acute myocardial infarction (from the HORIZONS-AMI Trial IVUS substudy)

HORIZONS-AMI was a prospective dual-arm randomized trial of different antithrombotic regimens and stent types in patients with ST-segment elevation myocardial infarction. A formal intravascular ultrasound (IVUS) substudy enrolled 464 patients with baseline and 13-month follow-up at 36 centers. Of them, 318 patients with 355 lesions were evaluated for this study. Angiographic restenosis occurred in 45 of 355 lesions (12.7%). Bare-metal stent use (45.5% vs 21.2%, p <0.001) and diabetes mellitus (29.5% vs 10.9%, p <0.001) were more prevalent in patients with versus without restenosis. Postprocedure IVUS minimum lumen area (5.6 mm(2), 5.0 to 6.1, vs 6.7 mm(2), 6.5 to 6.9, p <0.001), minimum stent area (5.7 mm(2), 5.1 to 6.3, vs 6.9 mm(2), 6.6 to 7.1, p <0.001), and reference average lumen area (7.7 mm(2), 6.8 to 8.6, vs 9.7 mm(2), 9.3 to 10.1, p <0.001) were smaller in restenotic versus nonrestenotic lesions. By multivariable analysis, minimum stent area was an independent predictor of angiographic restenosis (odds ratio 0.75, 95% confidence interval 0.61 to 0.93, p = 0.009) in addition to diabetes, bare-metal stent use, and longer stent length. Attenuated plaque behind the stent struts had a trend to predict less binary restenosis (p = 0.07). In conclusion, a smaller IVUS minimum stent area was an independent predictor of angiographic restenosis after primary percutaneous intervention in patients with ST-segment elevation myocardial infarction, similar to patients with stable coronary artery disease.     

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.     

Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement

Objectives. The objectives of this study were to analyze the clinical and angiographic outcome of diabetic patients with successful coronary stent placement and to compare these results with those achieved after stenting in nondiabetic patients.

Background. The outcome of diabetic patients treated with stent placement due to coronary artery disease has not been assessed comprehensively.

Methods. This study analyzes a consecutive series of patients with successful stent placement comprising 715 patients with diabetes and 2,839 patients without diabetes. Clinical one year follow-up and angiographic control at 6 months were part of the protocol. Death, myocardial infarction and target lesion revascularization were considered as adverse events. An automated edge detection system was used for the angiographic assessment. The primary clinical endpoint was event-free survival at one year. The primary angiographic endpoint was restenosis rate at 6 months (≥50% diameter stenosis).

Results. Event-free survival was significantly lower in diabetic than in nondiabetic patients (73.1 vs. 78.5%, p < 0.001). Survival free of myocardial infarction was also significantly reduced in the diabetic group (89.9 vs. 94.4% in nondiabetics, p < 0.001). The incidence of both restenosis (37.5 vs. 28.3%, p < 0.001) and stent vessel occlusion (5.3 vs. 3.4%, p = 0.037) was significantly higher in diabetic patients. Diabetes was identified as an independent risk factor for adverse clinical events and restenosis in multivariate analyses.

Conclusions. Patients with diabetes mellitus have a less favorable clinical outcome at one year after successful stent placement as compared to the nondiabetic patients. The clinical follow-up was characterized by a higher incidence of death, myocardial infarction and reinterventions. Diabetic patients also demonstrated an increased risk for restenosis.     

Clinical outcomes after sirolimus-eluting stent implantation for de novo saphenous vein graft lesions.

The purpose of this study was to evaluate the clinical outcome of patients undergoing sirolimus-eluting stent implantation for de novo lesions within saphenous vein grafts (SVGs). Although the incidence of restenosis following sirolimus-eluting stenting (SES) of native coronary arteries is low, the efficacy of SES to treat de novo lesions within SVGs has not been well studied. A total of 35 patients underwent SES implantation of 39 lesions during 36 procedures. All patients had a minimum follow-up of 6 months following the index procedure. The mean bypass graft age was 10.1 +/- 6.5 years (range, 0-23 years). In-hospital major adverse cardiac events [death, myocardial infarction, thrombosis, or target vessel revascularization (TVR)] occurred in four patients (11%). Clinical follow-up was obtained in 100% of patients (mean follow-up, 7.5 +/- 2.2 months). There was one cardiac death, presumed due to stent thrombosis. TVR occurred in only two patients (6%). Myocardial infarction (MI) occurred in four patients (11%), all attributable to a nontarget vessel. The combined endpoint of death, MI, or TVR occurred in seven patients (20%). Freedom from death, nonfatal MI, thrombosis, or any revascularization was 65%. Early experience indicates sirolimus-eluting stents for de novo saphenous vein graft lesions have a low (6%) rate of clinically driven target vessel revascularization. By 7-month follow-up, event-free survival is limited primarily by disease in nontarget vessels.     

Clinical and angiographical results of the use of the EPHESOS stent in patients with coronary artery atherosclerosis

The Ephesos is a new balloon-expandable, stainless steel, tubular stent with multicellular design. This open nonrandomized study assesses the immediate and long-term clinical and angiographic outcomes after Ephesos implantation in patients with native coronary artery disease. The Ephesos was implanted in 168 patients with 198 de novo lesions. Most patients (56%) had unstable angina, and 38% of lesions were type B2-C. The mean lesion length was 12.5-/+7.2 mm, and 29% of lesions were >15 mm in length. No stent deployment failure occurred, as well as acute or subacute stent thrombosis. In-hospital non-Q-wave myocardial infarction occurred in 2 patients. The 6-month event-free survival was 83.9%. Two patients with no restenosis in the target vessel died of fatal infarction due to abrupt closure of a nontarget vessel. The 6-month angiographic follow-up was obtained in 164 patients (98%) (192 lesions). The loss index was 0.27-/+0.25. Angiographic restenosis rate was 12%. Twenty patients with restenosis had repeat target lesion revascularization. The results of this study indicate a potential benefit of EPHESOS for the prevention of stent thrombosis and restenosis in these relatively high-risk patients.     

Comparison of debulking followed by stenting versus stenting alone for saphenous vein graft aortoostial lesions: immediate and one-year clinical outcomes

OBJECTIVES: We compared in-hospital and one-year clinical outcomes in patients undergoing debulking followed by stent implantation versus stenting alone for saphenous vein graft (SVG) aortoostial lesions. BACKGROUND: Stent implantation in SVG aortoostial lesions may improve procedural and late clinical outcomes. However, the impact of debulking before stenting in this complex lesion subset is unknown. METHODS: We studied 320 consecutive patients (340 SVG aortoostial lesions) treated with Palmaz-Schatz stents. Debulking with excimer laser or atherectomy was performed in 133 patients (139 lesions) before stenting (group I), while 187 patients (201 lesions) underwent stent implantation without debulking (group II). Procedural success and late clinical outcomes were compared between the groups. RESULTS: Overall procedural success (97.6%) was similar between the groups. Procedural complications were also similar (2.2% for group I and 2.6% for group II). At one-year follow-up, target lesion revascularization (TLR) was 19.4% for group I and 18.2% for group II (p = 0.47). There was no difference in cumulative death or Q wave myocardial infarction between the groups. Overall cardiac event-free survival was similar (69% for group I and 68% for group II). By Cox regression analysis, the independent predictors of late cardiac events were final lumen cross-sectional area (CSA) by intravascular ultrasound (IVUS) (p = 0.001) and restenotic lesions (p = 0.01). Similarly, final IVUS lumen CSA (p = 0.0001) and restenotic lesions (p = 0.006) were found to predict TLR at one year. CONCLUSIONS: These results suggest that, in most patients with SVG aortoostial lesions, debulking before stent implantation may not be necessary.     

Evaluation of the safety and effectiveness of renal artery stenting after unsuccessful balloon angioplasty: the ASPIRE-2 study

OBJECTIVES: This study sought to define the safety and durability of renal stenting after suboptimal/failed renal artery angioplasty in patients with suspected renovascular hypertension. BACKGROUND: Few prospective multicenter studies have detailed the safety, efficacy, and long-term clinical benefits of renal artery stent revascularization in hypertensive patients with aorto-ostial atherosclerotic renal artery lesions. METHODS: This non-randomized study enrolled 208 patients with de novo or restenotic > or = 70% aorto-ostial renal artery stenoses, who underwent implantation of a balloon-expandable stent after unsuccessful percutaneous transluminal renal angioplasty (PTRA), which was defined as a > or = 50% residual stenosis, persistent translesional pressure gradient, or a flow-limiting dissection. The primary end point was the nine-month quantitative angiographic or duplex ultrasonography restenosis rate adjudicated by core laboratory analysis. Secondary end points included renal function, blood pressure, and cumulative incidence of major adverse events and target lesion revascularization at 24 months. RESULTS: The stent procedure was immediately successful in 182 of 227 (80.2%) lesions treated. The nine-month restenosis rate was 17.4%. Systolic/diastolic blood pressure decreased from 168 +/- 25/82 +/- 13 mm Hg (mean +/- standard deviation) at baseline to 149 +/- 24/77 +/- 12 mm Hg at 9 months (p < 0.001 vs. baseline), and 149 +/- 25/77 +/- 12 mm Hg at 24 months (p < 0.001 vs. baseline). Mean serum creatinine concentration was unchanged from baseline values at 9 and 24 months. The 24-month cumulative rate of major adverse events was 19.7%. CONCLUSIONS: In hypertensive patients with aorto-ostial atherosclerotic renal artery stenosis in whom PTRA is unsuccessful, Palmaz (Cordis Corp., Warren, New Jersey) balloon-expandable stents provide a safe and durable revascularization strategy, with a beneficial impact on hypertension.     

Outcome of percutaneous hybrid coronary revascularization: bare metal stents jeopardize the benefit of sirolimus-eluting stents in the real world

BACKGROUND: In an effort to contain procedural costs while limiting the risk of in-stent restenosis, hybrid percutaneous revascularization (ie, stenting with at least one sirolimus-eluting stent [SES] and at least one bare metal stent [BMS] in the same patient) is felt to be a cost-effective alternative to exclusive SES use. OBJECTIVE: To describe the outcome of hybrid percutaneous revascularization for the treatment of patients with multiple coronary artery lesions. METHODS AND RESULTS: Fifty-six patients (42 men; mean age [+/- SEM] 64+/-2) underwent hybrid stenting (average of 1.2 SES/patient and 1.3 BMS/patient). SES were used to treat lesions at higher restenotic potential, including longer lesions, smaller target vessels and bifurcation lesions (mean stent length [+/- SEM] was 21.1+/-1.2 mm for SES and 16.0+/-0.6 mm for BMS; stent diameter mean [+/- SEM] was 2.9+/-0.0 mm for SES and 3.1+/-0.1 mm for BMS; bifurcation lesions were 43% for SES and 7% for BMS; all P<0.01). At nine months of clinical follow-up, no death or myocardial infarction was reported. Twenty-one patients underwent clinically driven repeat coronary angiography at a mean (+/- SEM) of 8+/-1 of months (range two to 12 months) follow-up. Target lesion revascularization procedures were recorded in six patients (11%) for nine lesions (6%). Of these lesions, seven were categorized after blinded analysis as due to in-BMS restenosis and two to in-SES restenosis (P=0.01); three patients (5.4%) underwent reangioplasty for de novo lesions. There was one case of acute in-SES thrombosis. SES showed significantly less neointimal hyperplasia (late lumen loss was 0.4+/-0.1 mm for SES and 1.3+/-0.1 mm for BMS; loss index was 0.15+/-0.05 for SES and 0.48+/-0.05 for BMS; all P<0.001). CONCLUSIONS: The use of SES resulted in less neointimal hyperplasia even when used to treat lesions at higher risk for restenosis based on angiographic characteristics. BMS implantation significantly limits this beneficial effect, compromising the outcome of hybrid percutaneous coronary revascularization.     

Long (> or = 25 mm) stents for long coronary artery lesions. A safe conduct or a bridge too far for the interventional cardiologist?

OBJECTIVE: Increased restenosis rates have been reported after stenting long lesions with multiple standard length stents. Long slotted tube stents have become available for the treatment of long lesions or dissections.To compare clinical outcome after the use of long Multi-Link stents in long coronary lesions versus standard length Multi-Link stents in Benestent type lesions. METHODS AND RESULTS: We evaluated clinical outcome (six months) of 147 consecutive patients in whom one or more > or = 25 mm long Multi-Link stents were successfully deployed.The results were compared with the West-2 registry in which a 15 mm Multi-Link stent was used. The patients with long stents had more complex lesions and unstable symptoms. Target lesion revascularization after six months follow-up was comparable with that observed after implantation of a standard length stent (6.9% vs. 6.1%, p = 0.81). Overall cardiac event-free survival was similar for both groups (89.7% vs. 91.5%, p = 0.73). CONCLUSIONS: Patients treated with one or more long (> or = 25 mm) Multi-Link stents have a similar event-free survival and an equivalent target lesion repeat revascularization risk after six months than patients treated with a standard length stent.     

SMART: The microstent's ability to limit restenosis trial.

In this randomized, prospective, multicenter trial (n = 661) of patients with de novo or restenotic coronary lesions, 330 patients received the MicroStent(R) II (MSII), and 331 received the Palmaz-Schatz (PS) stent. The short-term procedural success rates were 94.4% and 95.7%, respectively (P = 0.47). The 30-day cumulative incidence of major adverse events [death, myocardial infarction, CVA, target lesion revascularization (TLR)] was 6.4% for the MSII and 4.5% for the PS stent (P = 0.31). The in-stent binary restenosis rate at 6 months was 25.2% for the MSII and 22.1% for the PS stent (P = 0.636). Using Kaplan-Meier estimates, the incidence of clinically driven TLR was 8.9% for the MSII and 9.2% for the PS stent at 180 days; at 270 days, it was 12.8% and 12.1%, respectively (P = 0.83). MSII and the PS stents were comparable with respect to short-term procedural success, complications, and late clinical and angiographic restenosis.     

Angiographic results of the first human experience with the Biolimus A9 drug-eluting stent for de novo coronary lesions

This report describes angiographic findings of the first-in-human evaluation of the Biolimus A9 drug-eluting stent (Biolimus stent) in the treatment of noncomplex coronary lesions. In total, 120 patients with 122 de novo coronary lesions (2.75- to 4.00-mm vessels, < or = 24-mm lesion length) were prospectively randomized in a 2:1 ratio to receive the Biolimus stent (n = 80, 82 lesions) or the control uncoated stent (n = 40). Baseline lesion and angiographic characteristics were similar between groups. At 6-month follow-up, late lumen loss was significantly decreased with the Biolimus stent in the stent (0.26 +/- 0.43 vs 0.74 +/- 0.45 mm, p < 0.001) and in the segment (0.14 +/- 0.45 vs 0.40 +/- 0.41 mm, p = 0.004). In-stent restenosis was 3.9% in the Biolimus stent group versus 7.7% in the control group (p = 0.40). There was no exaggerated hyperplasia at the proximal and/or distal edge of the stent.     

Clinical and angiographic outcome after coronary arterial stenting with the carbostent

The Carbostent is a new balloon-expandable, stainless steel, tubular stent with innovative multicellular design and unique turbastratic carbon coating (Carbofilm). This open nonrandomized 2-center study assesses the immediate and long-term clinical and angiographic outcomes after Carbostent implantation in patients with native coronary artery disease. The Carbostent was implanted in 112 patients with 132 de novo lesions. Most patients (55%) had unstable angina, and 38% of lesions were type B2-C. The mean lesion length was 12.5 +/- 7.0 mm, and 29% of lesions were > 15 mm in length. No stent deployment failure occurred, as well as acute or sub-acute stent thrombosis. The 6-month event-free survival was 84 +/- 4%. One patient with a stented right coronary artery and no restenosis at the angiographic follow-up died after 6 months of fatal infarction due to abrupt closure of a nontarget vessel. In-hospital non-Q-wave myocardial infarction occurred in 1 patient, and 11 patients had repeat target lesion revascularization (target lesion revascularization rate 10%). The 6-month angiographic follow-up was obtained in 108 patients (96%) (127 lesions). Angiographic restenosis rate was 11%. The loss index was 0.29 +/- 0.28. The results of this study indicate a potential benefit of Carbostent for the prevention of stent thrombosis and restenosis in these relatively high-risk patients. A larger trial is being planned to confirm these promising results.     

A randomised trial of endoluminal reconstruction comparing the NIR stent and the Wallstent in angioplasty of long segment coronary disease: results of the RENEWAL Study

BACKGROUND: The role of coronary stents in reducing the incidence of acute complications and late restenosis after angioplasty has been established in randomized studies focusing on simple, short coronary lesions. The development of long coronary stents has provided a safe and predictable means of treating long coronary lesions, but this carries with it a higher risk of restenosis. By comparing the outcome of treating long lesions with two different stent types, we aimed to assess the influence of stent design rather than the nature of long lesions per se on the relatively high restenosis rates in this subgroup. METHODS: This study was designed to assess procedural complications and 6-month restenosis rates in a randomized trial comparing a slotted tube stent with a self-expanding stent for the treatment of long coronary lesions. Randomization of vessels to either stent occurred after successful balloon angioplasty. Intravascular ultrasound (IVUS) was used to assess and optimize stent deployment. The patients were restudied angiographically and by IVUS at 6 months. RESULTS: A total of 82 patients (85 vessels) were recruited (slotted tube stent, n = 44 vessels; self-expanding stent, n = 41 vessels). Successful deployment occurred in 41 (100%) of 41 of the self-expanding stent group and 41 (93%) of 44 of the slotted tube stent group. There was no difference in lesion length between the two groups (slotted tube stent, 26.6 +/- 6.9 [SD] mm; self-expanding stent, 28.7 +/- 9.8 [SD] mm; P = .2), but the mean length of the self-expanding stent was greater than that of the slotted tube stent (41.6 +/- 18.8 [SD] mm vs 35.4 +/- 16.2 [SD] mm, respectively; P < .05). There was no significant difference in the rate of major events between the two groups at 6-month follow-up. The angiographic restenosis rate at follow-up was less in the slotted tube stent group, but this did not reach statistical significance (26% vs 46%, respectively; P = .1) and the target lesion revascularization rate was similar for both groups (7.9% vs 7.7%, respectively; P = .8). IVUS assessment of plaque/stent ratios suggested a greater plaque burden in the self-expanding stent compared with the slotted tube stent at follow-up (0.42 +/- 1.2 [SD] vs 0.3 +/- 0.08 [SD]), but this was not statistically significant (P = .1). CONCLUSIONS: Long stents can be safely and successfully deployed in long segment coronary disease, with an acceptable 6-month target lesion revascularization rate. Our results showed a trend toward lower angiographic restenosis and a lesser in-stent plaque burden at follow-up in the slotted tube stent compared with the self-expanding stent. This suggests that stent design may influence the restenotic process in long coronary lesions.