Bailout coronary stenting without anticoagulation or intravascular ultrasound guidance: Acute and six-month angiographic results in a series of 120 consecutive patients

The purpose of this study was to evaluate the feasibility, safety, and efficacy of bailout coronary stenting without anticoagulation or intravascular ultrasound guidance in patients with acute or unequivocal threatened closure after conventional angioplasty. One hundred twenty consecutive patients were prospectively enrolled according to the following criteria: 1) acute or threatened closure after balloon angioplasty; 2) reference vessel diameter ≥ 2.5 mm. All patients after stent implantation were on antiplatelet treatment with aspirin and ticlopidine. Four types of stents were used: Palmaz-Schatz (J&J), Gianturco-Roubin (Cook), Freedom (Global Therapeutics), and Microstent (AVE). Procedural results: a total of 206 stents were implanted in 134 target lesions with a stent deployment success rate of 100%; 44 target lesions were treated with multiple stent implantation; the mean luminal diameter after stenting was 3.14 ± 0.34 mm, and the mean final percent diameter stenosis was −2 ± 10%; the mean balloon to vessel ratio was 1.11 ± 0.15; the mean final pressure inflation was 13.9 ± 2.4 atm; an optimal angiographic result was achieved in 128 lesions (96%). In-hospital results: in-hospital recurrent ischemia occurred in 4 patients (3%); recurrent ischemia resulted directly in death in 1 patient, in nonfatal Q-waves infarction in 2 patients, and in emergency coronary artery surgery in 1 patient. Six-month clinical follow-up results: event free survival rate was 77%; 1 patient had non fatal infarction; the incidence of repeat revascularization procedures was 19%; there were no cardiac deaths. Angiographic follow-up results (follow-up rate 93%): the restenosis or reocclusion rate was 28%. Bailout coronary stenting without chronic anticoagulation treatment or intravascular ultrasound guidance may be considered a highly feasible and safe treatment for acute or threatened closure after failed angioplasty. Cathet. Cardiovasc. Diagn. 41:14–19, 1997. © 1997 Wiley-Liss, Inc.     

Initial clinical experience with the new EBI (BARD-XT) flexible coronary stent: Acute results and follow-up

The EBI (BARD-XT, C.R. Bard, Murray Hill, NJ) stent is a new radiopaque balloon expandable coronary stent with high resistance to external radial forces. It does not shorten significantly with expansion and allows stent implantation in bifurcation lesions. A total of 28 EBI stents were implanted in 23 lesions in 21 patients. Indications for stent implantation were acute closure in 1, threatened closure in 15, and electively in 7 lesions. In 2 cases, the lesion involved a bifurcation where a stent was implanted in both vessels. All patients received aspirin and ticlopidine. No anticoagulant therapy was given. The stenting procedure was successful in 22 of 23 lesions. No complications occurred with the exception of 1 patient with a thrombotic reocclusion within 1 hr after stent implantation and 1 patient with a temporary occlusion of a side branch. The mean minimal luminal diameter (MLD) increased from 0.74 ± 0.46 mm before balloon dilatation to 1.27 ± 0.62 mm before stent implantation and 2.32 ± 0.57 mm after stent implantation. Percent stenosis decreased from 71 ± 19% before angioplasty to 46 ± 25% after angioplasty to 5 ± 8% after stent implantation. MLD at the time of follow-up angiography after 4 months was 1.98 ± 0.77 mm and percent stenosis was 26 ± 21%. Restenosis of more than 50% occurred in 2 lesions. In these lesions, a second percutaneous transluminal coronary angioplasty was performed. Advantages of this stent are its flexibility together with an acceptable radial strength as well as enabling radiopacity without obscuring the arterial lumen. Stenting of bifurcation lesions is possible. Cathet. Cardiovasc. Diagn. 43:159–162, 1998. © 1998 Wiley-Liss, Inc.     

Randomized comparison of balloon angioplasty versus silicon carbon-coated stent implantation for de novo lesions in small coronary arteries

The objectives of this study were to compare the short- and long-term clinical and angiographic outcomes of conventional balloon angioplasty versus elective silicon carbide-coated stent implantation in de novo lesions in small coronary arteries (<3.0 mm). Angioplasty of small coronary arteries is associated with high restenosis rates. The beneficial effects of stent implantation on restenosis rates and clinical outcomes have been suggested by observational studies. However, randomized trials comparing balloon angioplasty with stenting show conflicting results. A total of 496 patients with a de novo stenosis in a coronary artery, with a diameter between 2.0 and 3.0 mm, were randomly assigned to balloon angioplasty (n = 246) or stent implantation (n = 250). One-year clinical and 6-month angiographic follow-up were performed. Baseline characteristics were similar for the 2 groups, with 16% having diabetes and 77% complex lesions (type B or C). Crossover to stents occurred in 29% of patients randomized to balloon angioplasty. At 6 months, angiographic restenosis rates were 25% versus 21% for the angioplasty and stent groups, respectively (p = NS). One-year clinical follow-up showed no difference in occurrence of major adverse cardiac events. Elective silicon carbon-coated stent implantation in small coronary arteries is safe and effective, with no beneficial effect on angiographic or clinical outcome compared with balloon angioplasty with provisional stenting.     

Long-term angiographic and clinical outcome after implantation of a ballon-expandable stent in the native coronary circulation

Objectives. The purpose of this study was to examine the long-term clinical and angiographic outcome after coronary implantation.Background. Previous reports haw shown a discordance between the excellent initial angiographic results and subsequent adverse clinical events after coronary artery stenting.Methods. Single Palmaz-Schatz stents were electively implanted in the native coronary arteries of 300 consecutive patients. Angiograms were obtained at baseline, after balloon angioplasty, after stent implantation and at 6 months after implantation. Films were analyzed by a panel of engiographers utilizing en automated edge detection program, Clinical events, including death, myocardial infarction, coronary bypass surgery and repeat angioplasty, were recorded for 1 year.Results. Although there were no acute in-laboratory vessel closures, stent thrombosis occurred in 14 patients (4.7%) at a mean ±SD of 5 ± 3 days after implantation. Two hundred fifty-eight (90%) of 286 eligible patients had follow-up angiography at 6.1 ± 2.2 months after stent implantation. Minimal lumen diameter increased from 0.80 ± 039 mm at baseline to 1.65 +- 0.51 mm after angioplasty and further increased to 2.55 ± 0.49 mm after stent placement (p = 0.0001). At follow-up there was a 0.85-mm late loss in lumen diameter, with a final minimal lumen diameter at 6 months of 1.70 ± 0.71 mm. Restenosis, defined as ≥ 50% diameter stenosis at follow-up, occurred in 14% of patients with previously untreated lesions and in 39% of patients with previous angioplasty (p < 0.001). Clinical events after 1 year for the entire group of 300 patients included death in 0.7%, myocardial infarction in 3.7%, bypass grafting in 8% and repeat angioplasty in 13%. Freedom from any adverse clinical event was 80% for all treated patients and 87% for those with previously untreated lesions.Conclusions. Elective use of this balloon-expandable stent in the native coronary circulation is associated with a low restenosis rate by quantitative angiography in previously untreated lesions and a favorable clinical outcome with an excellent event-free survival rate at 1 year.     

Evaluation of long stent implantation in diffuse coronary lesions for octogenarians

Objective To evaluate angiographic and clinical outcomes of≥20mm long stents or overlapped stent implantation in diffuse coronary lesions for octogenarians, in comparison with patients under sixty. Methods Two groups (Group O: 47 lesions in 44 octogenarians, aged 81±3 years; Group Y: 64 lesions in 58 patients under sixty, aged 54±4 years) were compared with a 6-month follow-up. Results Success rate of the procedures was 100%. None had in-hospital major adverse cardiac events (MACE). There was no significant difference in angiographic restenosis between the groups at follow-up (Group O vs Group Y, 29.8% vs 26.6% , P = NS) . The revascularization of target vessel and MACE was less in Group Y, but these showed no statistical significance (15.6% vs 23.4% and 20.7% vs 25.0%, respectively). Conclusions Long stent implantation for diffuse coronary lesions in octogenarians appears safe and feasible, with high procedural success and favorable long-term outcomes. (J Geriatr Cardiol 2005;2( 1):29-35).     

Implantation of the peripheral Wallstent for diffuse lesions in coronary arteries and vein grafts

The Wallstent (Schneider, Bulach, Switzerland) is available in different lengths without much compromise in flexibility and radial support compared to some other stents. We treated 24 patients (26 vessels) with diffuse coronary lesions or vein graft lesions with intravascular ultrasound-guided peripheral Wallstent implantation. Average balloon pressure during stent optimization was 16.4 ± 2.7 atm. The stents could be successfully implanted in 24 vessels. Minimal lumen diameter and percent diameter stenosis after stenting were 3.60 ± 0.62 mm and −8 ± 13%, respectively. Average stent length was 63.7 ± 22.7 mm. There was one procedure-related complication. After stenting, all patients were treated only with antiplatelet agents. During 1-month follow-up, there was one subacute stent thrombosis due to incomplete coverage of a distal dissection. These preliminary results show the feasibility of this novel approach in selected lesions. © 1996 Wiley-Liss, Inc.     

Safety and Efficacy of Angiographic Guided Elective Palmaz-Schatz Stent Implantation Without Coumadin: Comparison of Stent Implantation and Angioplasty

This study was designed to evaluate the safety and efficacy of routine high-pressure Palmaz-Schatz coronary stenting in patients with symptomatic coronary heart disease with only angiographic guidance without coumadin for poststenting treatment. Intracoronary stenting reduces restenosis rate after coronary angioplasty. High pressure stent deployment with intravascular ultrasound guidance reduces the incidence of stent thrombosis, despite reduction of anticoagulation. However, the feasibility of routine stent implantation with only angiographic guidance and without coumadin for poststenting treatment has not yet been determined. Patients undergoing coronary angioplasty for symptomatic coronary heart disease received stent implantation for abrupt or threatening vessel occlusion, vessel dissection without compromised antegrade blood flow (but at high risk for subacute occlusion and early restenosis), unsatisfactory angioplasty result with > 30% residual stenosis, and elective stent implantation in de novo lesions, restenotic lesions, and lesions in bypass grafts. Quantitative coronary analysis was performed before the procedure, immediately after, and at follow-up 6 ± 1 (SD) months later. This patient group was matched for clinical and angiographic characteristics with those patients who underwent balloon angioplasty during the same period. Patients who underwent coronary stenting had larger net gain (1.95 ± 1.0 vs 1.42 ± 0.9; P < 0.001) resulting in a larger minimal luminal diameter (2.48 ± 1.19 vs 1.78 ± 1.01; P < 0.001) at follow-up as compared with balloon angioplasty. Restenosis, defined as > 50% diameter stenosis at follow-up, occurred in 35.0% in the PTCA group and in 16.1% in the stent group (P < 0.001). Subacute stent thrombosis occured in one patient (0.8%) due to angiographically evident suboptimal stent expansion. Routine coronary high pressure Palmaz-Schatz stenting with angiographie guidance without coumadin for poststenting treatment represents a safe and effective option in patients with symptomatic coronary heart disease without increasing the incidence of (sub)acute stent thrombosis.     

Immediate and medium-term outcomes following the treatment of very long (> or =50 mm) chronic total coronary artery occlusions

OBJECTIVE: The follow-up patency rates and associated clinical and angiographic variables following stenting of very long (> or =50 mm) and chronic (>6 months) total coronary artery occlusive lesions are not well documented. The aim of the present study was to evaluate the early results and mid-term outcomes following angioplasty of such lesions. METHODS: Between January 2000 and June 2002, we treated 278 chronic coronary occlusions. Of these, eighty-nine occlusions (89 patients) were with lesions > or =50 mm long; these patients constituted the study population. RESULTS: Mean duration of occlusion was 7 +/- 2 months (range, 6-13 months). Procedural success was obtained in 81 patients. A total of 211 coronary stents (2.6 +/- 1.1 stents/patient) were implanted, and mean stent length was 59 +/- 9 mm. In 3 patients, TIMI flow 1-2 was observed after stent implantation. Thus, the angiographic success was considered to be 78/89 patients (87.6%). Periprocedural major adverse cardiac events occurred in 6 patients (6.7%). Clinical success was obtained in 74 patients (83%). During a 9.6 +/- 2 month follow-up, forty-three patients (55.1%) remained angina free, thirty-two (41%) had recurrence of angina, three patients (3.9%) had a new myocardial infarction and no deaths were reported. Target vessel revascularization was required in 34 patients (43.6%). Angiographic follow-up was obtained in 70 patients (90%) at a mean of 7.4 +/- 2 months. Restenosis was observed in 36 patients (51%), six of whom had reocclusion. A significant correlation was observed between the need for reintervention and stent length (R 0.52), residual stenosis (R 0.73) and diabetes mellitus (0.68). CONCLUSION: Although coronary artery stenting for very long (> or =50 mm) chronically occlusive lesions is feasible, safe and associated with a low incidence of periprocedural adverse clinical events, these complex and expensive procedures still have a high 6-month restenosis rate. These results might be significantly improved with the advent of drug-eluting stents.     

A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions: final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study

OBJECTIVES: We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm). BACKGROUND: Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length. METHODS: A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) <30% by on-line quantitative coronary angiography (QCA). "Bail-out stenting" was performed for flow-limiting dissections or >50% DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms. RESULTS: Bailout stenting was necessary in 149 patients (34%) and was associated with a significantly increased risk of peri-procedural infarction (p < 0.02). Among the 288 randomized patients, the mean lesion length was 27+/-9 mm, and the vessel diameter was 2.78+/-0.52 mm. The procedural success rate was 90% for the 143 patients assigned to BA alone (control group), as compared with 93% in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p < 0.001) and led to reduced angiographic restenosis (27% vs. 42%, p = 0.022). Freedom from MACE at nine months was 77% in both groups. CONCLUSIONS: A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months.     

Very long sirolimus-eluting stent implantation for de novo coronary lesions

Long-length stenting has a poor outcome when bare metal stents are used. The safety and efficacy of the sirolimus-eluting stent (SES) in long lesions has not been evaluated. Therefore, the aim of the present study was to evaluate the clinical and angiographic outcomes of SES implantation over a very long coronary artery segment. Since April 2002, all patients treated percutaneously at our institution received a SES as the device of choice as part of the Rapamycin Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. During the RESEARCH registry, stents were available in lengths of 8, 18, and 33 mm. The present report includes a predefined study population consisting of patients treated with >36-mm-long stented segments. Patients had a combination of >or=2 overlapping stents at a minimum length of 41 mm (i.e., one 33-mm SES overlapping an 8-mm SES) to treat native de novo coronary lesions. The incidence of major cardiac adverse events (death, nonfatal myocardial infarction, and target lesion revascularization) was evaluated. The study group comprised 96 consecutive patients (102 lesions). Clinical follow-up was available for all patients at a mean of 320 days (range 265 to 442). In all, 20% of long-stented lesions were chronic total occlusions, and mean stented length per lesion was 61.2 +/- 21.4 mm (range 41 to 134). Angiographic follow-up at 6 months was obtained in 67 patients (71%). Binary restenosis rate was 11.9% and in-stent late loss was 0.13 +/- 0.47 mm. At long-term follow-up (mean 320 days), there were 2 deaths (2.1%), and the overall incidence of major cardiac events was 8.3%. Thus, SES implantation appears safe and effective for de novo coronary lesions requiring multiple stent placement over a very long vessel segment.     

First International New Intravascular Rigid-Flex Endovascular Stent Study (FINESS): Clinical and Angiographic Results After Elective and Urgent Stent Implantation

Objectives. The purpose of this study was to determine the feasibility, safety and efficacy of elective and urgent deployment of the new intravascular rigid-flex (NIR) stent in patients with coronary artery disease.Background. Stent implantation has been shown to be effective in the treatment of focal, new coronary stenoses and in restoring coronary flow after coronary dissection and abrupt vessel closure. However, currently available stents either lack flexibility, hindering navigation through tortuous arteries, or lack axial strength, resulting in suboptimal scaffolding of the vessel. The unique transforming multicellular design of the NIR stent appears to provide both longitudinal flexibility and radial strength.Methods. NIR stent implantation was attempted in 255 patients (341 lesions) enrolled prospectively in a multicenter international registry from December 1995 through March 1996. Nine-, 16- and 32-mm long NIR stents were manually crimped onto coronary balloons and deployed in native coronary (94%) and saphenous vein graft (6%) lesions. Seventy-four percent of patients underwent elective stenting for primary or restenotic lesions, 21% for a suboptimal angioplasty result and 5% for threatened or abrupt vessel closure. Fifty-two percent of patients presented with unstable angina, 48% had a previous myocardial infarction, and 45% had multivessel disease. Coronary lesions were frequently complex, occurring in relatively small arteries (mean [±SD] reference diameter 2.8 ± 0.6 mm). Patients were followed up for 6 months for the occurrence of major adverse cardiovascular events.Results. Stent deployment was accomplished in 98% of lesions. Mean minimal lumen diameter increased by 1.51 ± 0.51 mm (from 1.09 ± 0.43 mm before to 2.60 ± 0.50 mm after the procedure). Mean percent diameter stenosis decreased from 61 ± 13% before to 17 ± 7% after intervention. A successful interventional procedure with <50% diameter stenosis of all treatment site lesions and no major adverse cardiac events within 30 days occurred in 95% of patients. Event-free survival at 6 months was 82%. Ninety-four percent of surviving patients were either asymptomatic or had mild stable angina at 6 month follow-up.Conclusions. Despite unfavorable clinical and angiographic characteristics of the majority of patients enrolled, the acute angiographic results and early clinical outcome after NIR stent deployment were very promising. A prospective, randomized trial comparing the NIR stent with other currently available stents appears warranted.     

Efficacy of Coronary Stenting Versus Balloon Angioplasty in Small Coronary Arteries

Objectives. The goal of this study was to compare the efficacy of elective stent implantation and balloon angioplasty for new lesions in small coronary arteries.Background. Palmaz-Schatz stents have been designed and approved by the Food and Drug Administration for use in coronary arteries with diameters ≥3.0 mm. The efficacy of elective stent placement in smaller vessels has not been determined.Methods. By quantitative coronary angiography, 331 patients in the Stent Restenosis Study (STRESS) I–II were determined to have a reference vessel <3.0 mm in diameter. Of these, 163 patients were randomly assigned to stenting (mean diameter 2.69 ± 0.21 mm), and 168 patients were assigned to angioplasty (mean diameter 2.64 ± 0.24 mm). The primary end point was restenosis, defined as ≥50% diameter stenosis at 6-month follow-up angiography. Clinical event rates at 1 year were assessed.Results. Baseline clinical and angiographic characteristics were similar in the two groups. Procedural success was achieved in 100% of patients assigned to stenting and in 92% of patients assigned to angioplasty (p < 0.001). Abrupt closure within 30 days occurred in 3.6% of patients in both groups. Compared with angioplasty, stenting conferred a significantly larger postprocedural lumen diameter (2.26 vs. 1.80 mm, p < 0.001) and a larger lumen at 6 months (1.54 vs. 1.27 mm, p < 0.001). Restenosis (≥50% diameter stenosis at follow-up) occurred in 34% of patients assigned to stenting and in 55% of patients assigned to angioplasty (p < 0.001). At 1 year, event-free survival was achieved in 78% of the stent group and in 67% of the angioplasty group (p = 0.019).Conclusions. These findings suggest that elective stent placement provides superior angiographic and clinical outcomes than balloon angioplasty in vessels slightly smaller than 3 mm.     

Titanium-nitride-oxIde-coated stents multicenter registry in diaBEtic patienTs: the TIBET registry

We sought to explore the immediate clinical and angiographic results of the Titan^? stent implantation in diabetic patients, as well as the major adverse cardiac events (MACE) at 6-month follow-up. We enrolled 156 consecutive diabetic patients admitted to undergo percutaneous intervention for at least one significant (50%) coronary lesion. All lesions were treated with the Titan^? stent implantation according to the contemporary interventional techniques. Patients were prospectively followed-up for at least 6?months. The primary endpoint was MACE at 6-month follow-up [cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR)]. Secondary endpoints included angiographic and clinical procedural success, in-hospital MACE, TLR at 6-month follow-up, and stent thrombosis. The mean age was 66.7?±?9.6?years, (68.4% males). A total of 197 Titan^? stents were implanted in 163 lesions. Direct stenting was performed in 45.2% of the cases. The mean stent diameter was 3.1?±?0.61?mm, and the mean length was 18.0?±?8.9?mm. Average stent deployment pressure was 13.9?±?4.2 bars. Angiographic procedural success was achieved in 154 (98.7%) cases, and clinical procedural success was achieved in 153 (98.1%) cases. One patient developed in-hospital non-Q-wave MI following the procedure. Clinical follow-up was completed in 155 (99.4%) patients. Three patients (1.9%) died of a cardiac or unknown cause, and two (1.3%) developed MI. TLR was performed in 11 patients (7.1%). Cumulative MACE at 6-month follow-up occurred in 16 (10.3%) patients. No patient suffered stent thrombosis. Titan^? stent implantation in diabetic patients achieves an excellent immediate clinical and angiographic outcome, with a low incidence of MACE at mid-term follow-up.     

Stenting of Nonacute Total Coronary Occlusions: Predictors of Late Angiographic Outcome

Objectives. This study was designed to determine and assess factors predictive of the intermediate-term outcome of stenting of nonacute total coronary occlusions.Background. Balloon angioplasty of recanalized coronary occlusions is associated with a combined restenosis/reocclusion rate of up to 65%. Adjunctive stenting holds the potential to reduce this rate significantly. However, variables affecting the late angiographic outcome of coronary stenting in the setting of a total occlusion have not been elucidated sufficiently.Methods. Coronary stenting was performed in 143 consecutive patients with a nonacute total occlusion; 120 of these patients (84%), with a total of 121 occlusions, underwent repeat angiography within 6 months and comprised the study group. High pressure stent implantation aimed to cover the site of the occlusion as well as adjacent diameter stenoses ≥70% and all possibly induced dissections. Pertinent angiographic and procedural variables obtained at the time of the intervention were entered into a multivariate logistic regression analysis model to assess their influence on the angiographic outcome at follow-up.Results. Mean preinterventional reference lumen diameter for the 121 vessels was 2.99 ± 0.53 mm (mean ± SD); occlusion length ranged from 4 to 44 mm (median of 7.7). After balloon angioplasty, dissections were found in 80% of patients. Lesions were covered with stents a median of 16 mm in length (range 8 to 53). The minimal lumen diameter (MLD) achieved after stenting was 2.89 ± 0.48 mm. After a median follow-up period of 4.5 months, mean MLD was assessed at 1.91 ± 0.90 mm, corresponding to a loss index of 0.34 ± 0.31. There were 27 vessels with a nonocclusive restenosis ≥50% and 8 with a reocclusion, for a combined restenosis/reocclusion rate of 29%. Factors found to adversely influence angiographic outcome were a post-stenting MLD ≤2.54 mm, a stented vessel segment length >16 mm, a balloon/vessel diameter ratio for final stent expansion ≤1.00 and the presence of a dissection after balloon angioplasty.Conclusions. Compared with previous reports on stand-alone balloon angioplasty, stenting of nonacute total coronary occlusions lowers the 6-month restenosis/reocclusion rate to ∼30%. The late procedural outcome is independently and statistically significantly influenced by the MLD after stenting, the length of the stented vessel segment, the balloon/vessel diameter ratio for final stent expansion and the incidence of dissections after balloon angioplasty.     

Intravascular ultrasonic predictors of angiographic restenosis after long coronary stenting

The intravascular ultrasound (IVUS) criteria for stent optimization have not been determined in stenting long lesions. We evaluated the predictors of angiographic restenosis and compared it with stent lumen cross-sectional area (CSA) and stent length between short (stent length <20 mm) and long (> or =20 mm) coronary stenting. IVUS-guided coronary stenting was successfully performed in 285 consecutive patients with 304 native coronary lesions. Six-month follow-up angiogram was performed in 236 patients (82.8%) with 246 lesions (80.9%). Results were evaluated using conventional (clinical, angiographic, and IVUS) methods. The overall angiographic restenosis rate was 22.8% (56 of 246 lesions) (short stent 17.6% vs. long stent 32.2%, p = 0.009). Using multivariate logistic regression analysis, the independent predictors of angiographic restenosis were the IVUS stent lumen CSA (odds ratio 1.51, 95% confidence intervals 1.18 to 1.92, p = 0.001) and stent length (odds ratio 0.95, 95% confidence intervals 0.91 to 1.00, p = 0.039). The angiographic restenosis rate was 54.8% for stent lumen CSA of <5.0 mm2 (short stent 37.5% vs. long stent 73.3%, p = 0.049), 27.4% for CSA between 5.0 and 7.0 mm2 (short stent 24.1% vs. long stent 31.7%, p = 0.409), 10.5% for CSA between 7.0 and 9.0 mm2 (short stent 10.0% vs. long stent 12.5%, p = 0.772), and 11.4% for stent lumen CSA of > or =9.0 mm2 (short stent 10.4% vs. long stent 13.3%, p = 0.767) (p = 0.001). Compared with short coronary stenting, long coronary stenting is effective treatment modality to cover long lesions with comparable long-term clinical outcomes in cases of stent lumen CSA of > or =7.0 mm2. Regardless of the stent length, the most important factor determining angiographic restenosis was the IVUS stent lumen CSA in relatively large coronary artery lesions.     

Endoluminal stenting of narrowed saphenous vein grafts: long-term clinical and angiographic follow-up

From April 1986 through April 1993, 58 intracoronary stents (41 Wall and 17 Wiktor stents) were implanted for the treatment of saphenous vein graft stenosis in 40 symptomatic patients. The indication was a primary stenosis in 44 and restenosis in 14 procedures. In-hospital complications were subacute stent thrombosis (2%), myocardial infarction (2%), and emergency coronary artery bypass grafting (CABG) (2%). Complications during a mean follow-up period of 42±27 months were restenosis (35% by patient, 33% by lesion), myocardial infarction (12%), late bypass grafting (12%), and death (7%). On quantitative coronary angiographic analysis, the mean minimal luminal diameter (and its confidence interval) increased from 1.3 mm (1.1–1.5 mm, preprocedure) to 2.9 mm (2.7–3.1 mm, postprocedure) and 2.2 mm (2.0–2.5 mm, 6 months follow-up, 95% angiographic follow-up). Progression of the underlying coronary artery disease and restenosis were the main reasons for a continual decline of the proportion without cardiac event on a Kaplan-Meier estimate. Restenosis occurred in one-third of cases beyond the first 6 months of follow-up. A relative risk ratio analysis for restenosis, performed on 14 variables, disclosed an increased risk for the following variables: (1) stenting of the proximal, distal or anastomosis part of the vein graft (relative risk 2.41, confidence interval: 1.28–3.59), (2) the implantation of stents <4.5 mm (2.59, 1.18–4.00), and (3) stenting of a redo–CABG vein graft (2.37, 1.17–3.58). Saphenous vein graft stenting seems to be characterized by excellent immediate clinical and angiographic results; in particular, stent thrombosis is rare. In this study, it appears that restenosis rates are lower than after conventional balloon angioplasty, but several procedural factors are related to an increased restenosis risk. Despite a lasting success in the majority of stented lesions, the estimated proportion without cardiac event is low at 5 years follow-up. Progression of the underlying coronary artery disease, a non-procedure-related event, constitutes the major limitation of saphenous vein graft stenting. © 1994 Wiley-Liss,Inc..     

Bailout Palmaz-Schatz coronary stenting in 39 patients with occlusive dissection complicating conventional Angioplasty

The purpose of this study was to evaluate feasibility, safety, and efficacy of bailout Palmaz-Schatz stenting in a series of 39 patients with coronary dissection associated with acute or unequivocal threatened closure complicating conventional angioplasty. No anatomical characteristics other than reference vessel diameter < 3 mm were considered as contraindications for bailout coronary stenting. Stringent criteria were adopted in defining optimal results (<10% residual stenosis, no angiographic evidence of residual dissection), suboptimal results (>10% residual stenosis or angiographic evidence of residual dissection), deployment failure (failure to deploy the stent because of poor trackability or persistent occlusion despite stent deployment). A total of 49 stents and 7 half-stents were implanted in 36 patients (range 1–5; mean 1.45 ± 0.84). Successful stenting without in-hospital death, urgent or semielective coronary surgery, stent thrombosis, or Q-wave myocardial infarction was achieved in 33/39 patients (85%). A suboptimal result was associated with an increased risk of in-hospital recurrence of ischemia and other related major adverse events (2/5 patients with suboptimal results vs. 1/31 patients with complete deployment success; P < 0.05). Multiple stents implantation did not carry a significant risk of major cardiac adverse events. The results of this study suggest that bailout Palmaz-Schatz stenting may be considered a stand-alone treatment of coronary dissection if an optimal acute angiographic result is achieved. © 1995 Wiley-Liss, Inc.     

Angiographic and clinical outcome following coronary stenting of small vessels: A comparison with coronary stenting of large vessels

Objectives. Stent implantation reduces restenosis in vessels ≥3 mm compared with balloon angioplasty, but few data are available for stents implanted in vessels <3 mm. The aim of this study was to evaluate immediate and follow-up patient outcomes after stent implantation in vessels <3 mm compared to stent implantation in vessels ≥3 mm.Methods. Between March 1993 and May 1996, a total of 1,298 consecutive patients (1,673 lesions) underwent coronary stenting. The study population was divided into two groups based on angiographic vessel diameter. In case of multivessel stenting, patients were randomly assigned only one lesion. Group I included 696 patients (696 lesions) in whom stents were implanted in vessels ≥3 mm, and group II included 602 patients (602 lesions) in whom stents were implanted in vessels <3 mm.Results. There was no difference in procedural success (95.4% in group I and 95.9% in group II), or subsequent subacute stent thrombosis (1.5% in group I and 1.4% in group II, p = NS). The postprocedure residual diameter stenosis was 3.31 ± 12.4% in group I and −2.45 ± 16.2% in group II. Angiographic follow-up was performed in 75% of patients, restenosis occurred in 19.9% of patients in group I and 32.6% in group II (p <0.0001). Absolute lumen gain was significantly higher in group I compared to group II, but absolute late lumen loss was similar in the two groups (1.05 ± 0.91 mm in group I vs. 1.11 ± 0.85 mm in group II, p = NS). Subsequently, the loss index was more favorable in group I (0.45 vs. 0.56; p = 0.0006). Independent predictors of freedom from restenosis by multivariate logistic regression in the total population were: larger baseline reference diameter (odds ratio 2.032 p = 0.006), larger postprocedure minimal stent cross-sectional area (odds ratio 1.190, p = 0.0001) and shorter lesions (odds ratio 1.037, p = 0.01). At long-term clinical follow-up, patients with small vessels had a lower rate of event-free survival (63% vs. 71.3%, p = 0.007).Conclusions. Coronary stenting can be performed in small vessels with a high success rate and low incidence of stent thrombosis. However, the long-term angiographic and clinical outcome of patients undergoing stent implantation in small vessels is less favorable than that of patients with large vessels.     

Primary stenting of de novo lesions in small coronary arteries: A prospective,pilot study

Technical advancement and new anti-thrombotic regimens have recently shown so much improvement in the results of coronary stenting that the conventional contra-indication for stenting in small coronary arteries (<3 mm) needs to be revised. We undertook a prospective pilot study of elective Palmaz-Schatz stenting in de novo lesions located in coronary arteries of less than 3 mm diameter. Fifty consecutive patients (63 ± 9 years) with stable (n = 38) and unstable angina (n = 12) were included. Philips-DCI quantitative coronary analysis was used to measure reference diameter, minimal lumen diameter and percent diameter stenosis before PTCA, after stenting and at 6-month angiographic follow-up study. All measurements were performed after intracoronary injection of nitroglycerin (300 μg). All patients received ticlopidine (250 mg/day) and aspirin (100 mg/day). The mean lesion length was 9 ± 3 mm. The balloon size used for stent delivery was 2.75 mm in 30 patients and 2.5 mm in 20 patients and the mean balloon inflation pressure used for stent deployment was 12 ± 2 atm. All stents were deployed successfully. In-hospital complications occurred in two patients, diagonal branch occlusion at day 2 requiring emergency PTCA in one and a hematoma at the femoral puncture site requiring surgery in the other. Major adverse cardiac event (MACE) rate remained 2% (nonfatal infarct in one). Follow-up angiography (n = 46, 92%) at 6 ± 3 months showed a 30% restenosis rate. Target vessel revascularization (TVR) rate was 13%. We conclude that elective stenting in small coronary arteries is feasible and involves an acceptable risk of restenosis. Cathet. Cardiovasc. Diagn. 45:235–238, 1998. © 1998 Wiley-Liss, Inc.     

Balloon angioplasty for the treatment of coronary in-stent restenosis: immediate results and 6-month angiographic recurrent restenosis rate

Objectives. The purpose of this prospective study was to evaluate the immediate results and the 6-month angiographic recurrent restenosis rate after balloon angioplasty for in-stent restenosis.Background. Despite excellent immediate and mid-term results, 20% to 30% of patients with coronary stent implantation will present an angiographic restenosis and may require additional treatment. The optimal treatment for in-stent restenosis is still unclear.Methods. Quantitative coronary angiography (QCA) analyses were performed before and after stent implantation, before and after balloon angioplasty for in-stent restenosis and on a 6-month systematic coronary angiogram to assess the recurrent angiographic restenosis rate.Results. Balloon angioplasty was performed in 52 patients presenting in-stent restenosis. In-stent restenosis was either diffuse (≥ 10 mm) inside the stent (71%) or focal (29%). Mean stent length was 16 ± 7 mm. Balloon diameter of 2.98 ± 0.37 mm and maximal inflation pressure of 10 ± 3 atm were used for balloon angioplasty. Angiographic success rate was 100% without any complication. Acute gain was lower after balloon angioplasty for in-stent restenosis than after stent implantation: 1.19 ± 0.60 mm vs. 1.75 ± 0.68 mm (p = 0.0002). At 6-month follow-up, 60% of patients were asymptomatic and no patient died. Eighteen patients (35%) had repeat target vessel revascularization. Angiographic restenosis rate was 54%. Recurrent restenosis rate was higher when in-stent restenosis was diffuse: 63% vs. 31% when focal, p = 0.046.Conclusions. Although balloon angioplasty for in-stent restenosis can be safely and successfully performed, it leads to less immediate stenosis improvement than at time of stent implantation and carries a high recurrent angiographic restenosis rate at 6 months, in particular in diffuse in-stent restenosis lesions.