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Background: The goal of treating patients with coronary artery disease is to improve survival and relieve symptoms. Several studies have compared the safety and efficacy of left main coronary artery (LMCA) stenting and coronary-artery bypass grafting in case control and randomized trials., Objective: In this study we present the long term outcome of stenting unprotected LMCA stenosis in day to day practice in unselected patients., Methods: One hundred and fifty eight patients were prospectively recruited with symptomatic unprotected LMCA stenosis undergoing percutaneous coronary intervention (PCI). Using the euroSCORE, each patient's surgical mortality risk was estimated. Study end-points were any major adverse cardiac event (MACE) defined as cardiac death, nonfatal myocardial infarction, or target lesion revascularization at follow-up with either CABG or repeat PCI., Results: The mean follow-up was 54 ± 25 months. The mean euroSCORE was 10.6 ± 13.4 (0.9-71) and the mean SYNTAX score was 39.6 ± 10.7 (10-65). The MACE rate was 11.4% at a mean follow up of 54 months. Six (3.8%) patients suffered postprocedure myocardial infarction. There were 24 (15%) deaths of which 12 were cardiac (mean euroSCORE 21.6 ± 5.5 P < 0.001). Repeat angiography was performed in 88 (55.7%) patients. Seven (4.4%) patients had in-stent restenosis; three occurred in BMS (P = 0.06). Two patients underwent revascularization with CABG and five had successful repeat PCI., Conclusion: In this on-going registry of high risk patients with LMCA stenosis, stenting was found to be safe and clinically effective in maintaining event-free survival., (Copyright © 2013 Wiley Periodicals, Inc.)

Aims: Smaller studies have previously shown promising results after Tryton Side Branch Stent™ (Tryton Medical, Durham, NC, USA) placement. However, these previous studies were limited by their small sample size and relatively short follow-up. We performed a patient-level pooled analysis to evaluate six-month and one year clinical outcomes of more than 900 patients who were enrolled in eight registries with the Tryton stent., Methods and Results: Data from eight Tryton registries, including 905 patients with 929 bifurcation lesions, were pooled on a patient level to form one dataset. The primary outcome was six-month target vessel failure (TVF), defined as the composite of cardiac death, any myocardial infarction, and clinically indicated target vessel revascularisation. Procedural success was defined as successful stent placement and no in-hospital major adverse cardiac events. Multivariable analysis was performed to determine independent predictors for one-year TVF. Follow-up data were available in 97%. Procedural success was 95% and TVF rate was 6.5% at six months and 8.5% at one year. Stent thrombosis occurred in 0.5% of patients. Left main coronary artery bifurcation lesion (HR 6.46) and main branch reference vessel diameter <3.0 mm (HR 2.62) were independent predictors for TVF., Conclusions: In the real world setting of registries including more than 900 patients, the use of the Tryton stent is associated with procedural and mid-term clinical results that compare very favourably with historical studies. The primary endpoint of TVF was primarily determined by reference vessel diameter of the main branch and left main bifurcation lesion location.

The RESTOR trial (R Stent Efficacy and Safety Trial by ORBUS) is an efficacy and safety evaluation of the R Stent for treatment of patients with a single de novo coronary lesion < 25 mm in length in a coronary artery of 2.75-4.0 mm diameter. This new stent utilizes a patented dual helix design for radial strength and flexibility. The aim of the study was to assess major adverse cardiac events (MACE) and angiographic outcome at 6 months after implantation. From May to December 2000 a total of 121 patients with symptomatic stable or unstable angina pectoris or documented silent ischemia and a significant single, de novo coronary lesion (average reference vessel diameter 2.84 +/- 0.54 mm, average lesion length 10.53 +/- 3.70 mm) were included in two Dutch centers. All patients were treated with clopidogrel 75 mg/day for 1 month and with aspirin greater than or equal to 100 mg/day. The angiographic success rate (< 30% diameter stenosis post-procedure) was 98.3%. Procedural success (angiographic success without in-hospital MACE) was 95.9%. The 6-month MACE rate was 12.4%. 101 of the 121 patients had an angiographic follow-up at 6 months. Minimal lumen diameter pre-/post-procedure and at follow-up was 0.98 +/- 0.37, 2.64 +/- 0.38 and 1.85 +/- 0.68 mm, respectively. The resulting binary restenosis rate in this population was 20.8%. The coronary R Stent is safe and effective as a primary device for the treatment of native coronary lesions in patients with stable or unstable angina pectoris, and well suitable as a platform for a drug eluting stent.

There are no significant differences in long-term and event-free survival in patients who undergo stent implantation in different anatomic locations of the left main coronary artery. Predictors of long-term survival are age <65 years, normal left ventricular ejection fraction, and absence of an intra-aortic balloon pump.

Objectives: In this study, we assess the value of sirolimus eluting stent (SES) implantation in patients with complex in-stent restenosis (ISR)., Background: The treatment of ISR remains a therapeutic challenge, since many pharmacological and mechanical approaches have shown disappointing results. The SESs have been reported to be effective in de-novo coronary lesions., Methods: Sixteen patients with severe, recurrent ISR in a native coronary artery (average lesion length 18.4 mm) and objective evidence of ischemia were included. They received one or more 18 mm Bx VELOCITY SESs (Cordis Waterloo, Belgium). Quantitative angiographic and three-dimensional intravascular ultrasound (IVUS) follow-up was performed at four months, and clinical follow-up at nine months., Results: The SES implantation (n = 26) was successful in all 16 patients. Four patients had recurrent restenosis following brachytherapy, and three patients had totally occluded vessels preprocedure. At four months follow-up, one patient had died and three patients had angiographic evidence of restenosis (one in-stent and two in-lesion). In-stent late lumen loss averaged 0.21 mm and the volume obstruction of the stent by IVUS was 1.1%. At nine months clinical follow-up, three patients had experienced four major adverse cardiac events (two deaths and one acute myocardial infarction necessitating repeat target vessel angioplasty)., Conclusions: The SES implantation in patients with severe ISR lesions effectively prevents neointima formation and recurrent restenosis at four months angiographic follow-up.

Background: Early results of sirolimus-eluting stent implantation showed a nearly complete abolition of neointimal hyperplasia. The question remains, however, whether the early promising results will still be evident at long-term follow-up. The objective of our study was to evaluate the efficiency of sirolimus-eluting stent implantation for up to 2 years of follow-up., Methods and Results: Fifteen patients with de novo coronary artery disease were treated with 18-mm sirolimus-eluting Bx-Velocity stents (Cordis) loaded with 140 microg sirolimus/cm2 metal surface area in a slow release formulation. Quantitative angiography (QCA) and intravascular ultrasound (IVUS) were performed according to standard protocol. Sirolimus-eluting stent implantation was successful in all 15 patients. During the in-hospital course, 1 patient died of cerebral hemorrhage after periprocedural administration of abciximab, and 1 patient underwent repeat stenting after 2 hours because of edge dissection that led to acute occlusion. Through 6 months and up to 2 years of follow-up, no additional events occurred. QCA analysis revealed no significant change in stent minimal lumen diameter or percent diameter stenosis, and 3-dimensional IVUS showed no significant deterioration in lumen volume. In 2 patients, additional stenting was performed because of significant lesion progression remote from the sirolimus-eluting stent., Conclusion: Sirolimus-eluting stents showed persistent inhibition of neointimal hyperplasia for up to 2 years of follow-up.

The purpose of this study was to compare measurements by MetriCath to intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA). The MetriCath system consists of a low-pressure (200 mm Hg) balloon catheter connected to a pressure transducer and infusion pump linked to a computer that records pressure-volume curves. Cross-sectional area of blood vessels is obtained directly from the unrestrained and in-stent pressure-volume measurements. We compared stent cross-sectional area measurements by MetriCath, IVUS, and QCA in a porcine stented coronary artery model. Comparison of area measurements in 14 stents showed no significant differences between the three methods (P = 0.66). On average, values differed 0.37 +/- 0.60 mm(2) between MetriCath and QCA, 0.13 +/- 0.55 mm(2) between MetriCath and IVUS, and 0.22 +/- 0.80 mm(2) between IVUS and QCA. This corresponds to 6.2% +/- 10%, 3.0% +/- 9.0%, and 3.1% +/- 12.9% relative difference from the average of two corresponding measurements. Linear regression analysis showed excellent correlation between measurements (r = 0.99 for all comparisons). The differences in in-stent area measurements between MetriCath and both QCA and IVUS were small. Considering the ease and rapidity of obtaining MetriCath results, this technique may form an alternative to the others in evaluating stent expansion. Based on these findings, clinical evaluation seems warranted., (Copyright 2002 Wiley-Liss, Inc.)

Objectives: We sought to assess the relationship between completeness of revascularization and adverse events at one year in the ARTS (Arterial Revascularization Therapies Study) trial., Background: There is uncertainty to what extent degree of completeness of revascularization, using up-to-date techniques, influences medium-term outcome., Methods: After consensus between surgeon and cardiologist regarding the potential for equivalence in the completeness of revascularization, 1,205 patients with multivessel disease were randomly assigned to either bypass surgery or stent implantation. All baseline and procedural angiograms and surgical case-record forms were centrally assessed for completeness of revascularization., Results: Of 1,205 patients randomized, 1,172 underwent the assigned treatment. Complete data for review were available in 1,143 patients (97.5%). Complete revascularization was achieved in 84.1% of the surgically treated patients and 70.5% of the angioplasty patients (p < 0.001). After one year, the stented angioplasty patients with incomplete revascularization showed a significantly lower event-free survival than stented patients with complete revascularization (i.e., freedom from death, myocardial infarction, cerebrovascular accident and repeat revascularization) (69.4% vs. 76.6%; p < 0.05). This difference was due to a higher incidence of subsequent bypass procedures (10.0% vs. 2.0%; p < 0.05). Conversely, at one year, bypass surgery patients with incomplete revascularization showed only a marginally lower event-free survival rate than those with complete revascularization (87.8% vs. 89.9%)., Conclusions: Complete revascularization was more frequently accomplished by bypass surgery than by stent implantation. One year after bypass, there was no significant difference in event-free survival between surgically treated patients with complete revascularization and those with incomplete revascularization, but patients randomized to stenting with incomplete revascularization had a greater need for subsequent bypass surgery.

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.

Aims: Coronary stenting is limited by a 10%-60% restenosis rate due to neointimal hyperplasia. Sirolimus is a macrocyclic lactone agent that interacts with cell-cycle regulating proteins and inhibits cell division between phases G1 and S1. The hypothesis tested in this study is that local delivery of sirolimus with an eluting stent can prevent restenosis., Methods and Results: Fifteen patients were treated with 18 mm sirolimus eluting BX VELOCITY stents. Quantitative angiography and three-dimensional quantitative intravascular ultrasound were performed at implantation and at the 6 months follow-up. All stent implantations were successful. One patient died on day 2, of cerebral haemorrhage and one patient suffered a subacute stent occlusion due to edge dissection (re-PTCA, CKMB 42). At 9 months no further adverse events had occurred and all patients were angina free. Quantitative coronary angiography revealed no change in minimal lumen diameter and percent diameter stenosis and hence no in-lesion or in-stent restenosis. Quantitative intravascular ultrasound showed that intimal hyperplasia volume and percent obstruction volume at follow-up were negligible at 5.3 mm(3)and 1.8%, respectively. No edge effect was observed in the segments proximal and distal to the stents., Conclusion: Implantation of a sirolimus-eluting stent seems to effectively prevent intimal hyperplasia., (Copyright 2001 The European Society of Cardiology.)

Background: Studies have reported benefit of oral therapy with the phosphodiesterase inhibitor, trapidil, in reducing restenosis after coronary angioplasty. Coronary stenting is associated with improved late outcome compared with balloon angioplasty, but significant neointimal hyperplasia still occurs in a considerable proportion of patients. The aim of this study was to investigate the safety and efficacy of trapidil 200 mg in preventing in-stent restenosis., Methods: Patients with a single native coronary lesion requiring revascularization were randomized to placebo or trapidil at least 1 h before, and continuing for 6 months after, successful implantation of a coronary Wallstent. The primary end-point was in-stent neointimal volume measured by three-dimensional reconstruction of intravascular ultrasound images recorded at the 6 month follow-up catheterization., Results: Of 312 patients randomized at 21 centres in nine countries, 303 (148 trapidil, 155 placebo) underwent successful Wallstent implantation, and 139 patients (90%) in the placebo group and 130 (88%) in the trapidil group had repeat catheterization at 26+/-2 weeks. There was no significant difference between trapidil and placebo-treated patients regarding in-stent neointimal volume (108.6+/- 95.6 mm(3)vs 93.3+/-79.1 mm(3);P=0.16) or % obstruction volume (38+/-18% vs 36+/-21%;P=0.32), in angiographic minimal luminal diameter at follow-up (1.63+/-0.61 mm vs 1.74+/-0.69 mm;P=0.17), restenosis rate (31% vs 24%;P=0.24), cumulative incidence of major adverse cardiac events at 7 months (22% vs 20%;P=0.71) or anginal complaints (30% vs 24%;P=0.29)., Conclusion: Oral trapidil 600 mg daily for 6 months did not reduce in-stent hyperplasia or improve clinical outcome after successful Wallstent implantation and is not indicated for this purpose., (Copyright 2001 The European Society of Cardiology.)

Aims: To prospectively evaluate the influence of stent length on 6 month clinical and angiographic outcome, in patients with native coronary lesions up to 45 mm in length, undergoing elective Magic Wallstent implantation., Methods and Results: On the basis of pre-procedural angiography, 276 patients (aged 61.3+/-10.2 years; 78.6% male; 41.7% unstable angina) with a total of 302 lesions were prospectively assigned to one of five different length categories of Magic Wallstent. Angiography in multiple matched projections before and after implantation and at 6 months follow-up was analysed at the core laboratory. Primary end-points for the efficacy analysis were cumulative incidence of major adverse cardiac events and quantitative coronary angiography analysis 6 months after stent implantation. Magic Wallstent implantation was successful in 301 of 302 lesions and in 98.6% a residual stenosis <20% by online quantitative coronary angiography was achieved. At 30 days, 6.2% (1.8% subacute occlusion) of patients had experienced major adverse cardiac events, 27.5% at 6 months and 30.4% at 9 months. Angiographic restenosis occurred in 37%. Restenosis rates for the mini, extra-short, short, medium and long Wallstent groups were 25.9%, 25%, 22.6%, 36.2% and 67.5%, respectively. Multivariate analysis revealed stent length to be independently associated with greater angiographic restenosis and major adverse cardiac events., Conclusions: While shorter Magic Wallstents provided late outcomes comparable with short balloon-expandable stents, excessive restenosis with longer Wallstents should obviate their use in elective percutaneous intervention. Long coronary lesions provide a challenging substrate for emerging antirestenosis therapies, such as stent coatings and brachytherapy., (Copyright 2001 The European Society of Cardiology.)

The aim of the study was to determine the safety and efficacy of the second-generation ACS Multi-Link Duet coronary stent system for the treatment of single, symptomatic, de novo, native coronary artery lesions. Between February and June 1998, 427 patients (69.3% male, 51.5% class 3 or 4 angina, 20.1% diabetic, 43.6% hyperlipidemia) were included at 38 centers in this prospective observational study. All patients received ticlopidine 500 mg/day for 1 month and aspirin > or =100 mg/day. The Duet stent was available in 8, 18, and 28 mm length and 3.0, 3.5, and 4.0 mm diameter. After adequate predilatation, stents were successfully implanted, at up to 16 atm, in 99.3% of patients. Mean vessel diameter by core laboratory quantitative coronary angiography was 3.0 +/- 0.53 mm and postprocedural minimum luminal diameter was 2.79 +/- 0.43 mm (12% +/- 9.3% diameter stenosis). At 30 days, 96.7% of patients were event-free and at 6 months 88.1% remained free of major adverse cardiac events. The restenosis rate was 18.1%. The ACS Duet stent was safely implanted in >99% of target lesions by a diverse group of international investigators. With late outcomes at least comparable to the best published results, this stent platform provides safe and effective percutaneous treatment of obstructive coronary artery disease. Cathet Cardiovasc Intervent 2001;54:25-33., (Copyright 2001 Wiley-Liss, Inc.)

Aims: This study is the contribution by the Thoraxcenter, Rotterdam, to the European(32)P Dose Response Trial, a non-randomized multicentre trial to evaluate the safety and efficacy of the radioactive Isostent in patients with single coronary artery disease., Methods and Results: The radioactivity of the stent at implantation was 6--12 microCi. All patients received aspirin indefinitely and either ticlopidine or clopidogrel for 3 months. Quantitative coronary angiography measurements of both the stent area and the target lesion (stent area and up to 5 mm proximal and distal to the stent edges) were performed pre- and post-procedure and at the 5-month follow-up. Forty-two radioactive stents were implanted in 40 patients. Treated vessels were the left anterior descending coronary artery (n=20), right coronary artery (n=10) or left circumflex artery (n=10). Eight patients received additional non-radioactive stents. Lesion length measured 10+/-3 mm with a reference diameter of 3.07+/-0.69 mm. Minimal lumen diameter increased from 0.98+/-0.53 mm pre-procedure to 2.29+/-0.52 mm (target lesion) and 2.57+/-0.44 mm (stent area) post-procedure. There was one procedural non-Q wave myocardial infarction, due to transient thrombotic closure. Thirty-six patients returned for angiographical follow-up. Two patients had a total occlusion proximal to the radioactive stent. Of the patent vessels, none had in-stent restenosis. Edge restenosis was observed in 44%, occurring predominantly at the proximal edge. Target lesion revascularization was performed in 10 patients and target vessel revascularization in one patient. No additional clinical end-points occurred during follow-up. The minimal lumen diameter at follow-up averaged 1.66+/-0.71 mm (target lesion) and 2.12+/-0.72 (stent area); therefore late loss was 0.63+/-0.69 (target lesion) and 0.46+/-0.76 (stent area), resulting in a late loss index of 0.65+/-1.15 (target lesion) and 0.30+/-0.53 (stent area)., Conclusion: These results indicate that the use of radioactive stents is safe and feasible, however, the high incidence of edge restenosis makes this technique currently clinically non-applicable., (Copyright 2001 The European Society of Cardiology.)

Background: Restenosis after conventional stenting is almost exclusively caused by neointimal hyperplasia. Beta-particle-emitting radioactive stents decrease in-stent neointimal hyperplasia at 6-month follow-up. The purpose of this study was to evaluate the 1-year outcome of (32)P radioactive stents with an initial activity of 6 to 12 microCi using serial quantitative coronary angiography and volumetric ECG-gated 3D intravascular ultrasound (IVUS)., Methods and Results: Of 40 patients undergoing initial stent implantation, 26 were event-free after the 6-month follow-up period and 22 underwent repeat catheterization and IVUS at 1 year; they comprised half of the study population. Significant luminal deterioration was observed within the stents between 6 months and 1 year, as evidenced by a decrease in the angiographic minimum lumen diameter (-0.43+/-0.56 mm; P:=0.028) and in the mean lumen diameter in the stent (-0.55+/-0. 63 mm; P:=0.001); a significant increase in in-stent neointimal hyperplasia by IVUS (18.16+/-12.59 mm(3) at 6 months to 27.75+/-11. 99 mm(3) at 1 year; P:=0.001) was also observed. Target vessel revascularization was performed in 5 patients (23%). No patient experienced late occlusion, myocardial infarction, or death. By 1 year, 21 of the initial 40 patients (65%) remained event-free., Conclusions: Neointimal proliferation is delayed rather than prevented by radioactive stent implantation. Clinical outcome 1 year after the implantation of stents with an initial activity of 6 to 12 microCi is not favorable when compared with conventional stenting.

This study evaluated the intermediate-term follow-up after excimer laser coronary angioplasty (ELCA) and adjunctive percutaneous transluminal coronary angioplasty (PTCA) in patients with diffuse in-stent restenosis (lesion length >10 mm). Clinical and angiographic follow-up were performed at 6 months. Quantitative coronary angiography performed at 3 stages-during stent implantation, before and after ELCA + PTCA, and at follow-up-included measurements of the minimum lumen diameter (MLD) and percent diameter stenosis (DS). Sixteen consecutive patients were included. The (median + range) stent length was 36 mm (range 15 to 105), with a restenotic lesion length of 32 mm (range 10 to 90). After ELCA + PTCA, the MLD increased from 0.60 +/- 0.41 to 2.28 +/- 0.50 mm, whereas the DS decreased from 76 +/- 16% to 22 +/- 8%. Despite adjunctive high-pressure PTCA, the MLD after ELCA + PTCA remained smaller than the MLD after initial stent implantation, (2.28 +/- 0. 50 mm vs 2.67 +/- 0.32 mm, p = 0.014). Adverse events included ELCA-related acute coronary occlusion in 4 patients and a per-procedural intracerebral hematoma in 1. At 6 months, there was recurrence of angina in all patients. Angiographic follow-up was completed in 13 patients (87%), showing a reocclusion in 6 (46%), a >50% DS in 6 (MLD 1.03 +/- 0.87 mm, DS 68 +/- 24%), and a distal de novo lesion in 1. Despite satisfactory acute angiographic results, the recurrence of significant restenosis in all patients suggests that ELCA + PTCA is not a suitable stand-alone therapy for diffuse in-stent restenosis of long stented segments.

Currently, several different designs of coronary stents are available. However, only a few of the new generation stents have been investigated in large randomized trials. Mechanical behavior of first-generation stents (Palmaz-Schatz, Gianturco-Roubin) may not be applied to the new designs. We investigated the chronic mechanical behavior (recoil) of 2 stents recently approved by the Food and Drug Administration (MULTILINK and NIR). Forty-eight patients with single-stent implantation (23 MULTILINK and 25 NIR) were assessed by means of volumetric 3-dimensional intravascular ultrasound analysis after the procedure and at 6-month follow-up. In addition, volumetric assessment of neointimal formation was performed. No significant chronic stent recoil was detected in both groups (delta MULTILINK stent volume: +5.6+/-41 mm3 [p = NS] and delta NIR stent volume + 2.1+/-26 mm3 [p = NS]). A similar degree of neointimal formation at 6 months was observed between the 2 stents (MULTILINK 46+/-31.9 mm3 vs NIR 39.9+/-27.6 mm3, p = NS). In conclusion, these 2 second-generation tubular stents did not show chronic recoil and appeared to promote similar proliferative response after implantation in human coronary arteries.

We report three cases of successful implantation of three different stents specially designed for bifurcation lesions, guided by intracoronary ultrasound. The BARD and AVE are true bifurcated stents for side-branch access and the NIR-Side Royal is a single modified NIR stent with an aperture to allow provisional bifurcation stenting. These designs introduce a new era in percutaneous management of coronary bifurcation lesions. Cathet. Cardiovasc. Intervent. 49:105-111, 2000., (Copyright 2000 Wiley-Liss, Inc.)

Objective: To describe the long term clinical outcome (up to 11 years) after coronary stenting., Design: A single centre observational study encompassing 1000 consecutive patients with a first stent implantation (1560 stents) between 1986 and 1996, who were followed for at least one year with a median follow up of 29 months (range 12-132 months)., Results: Up to July 1997 the cumulative incidence of the major adverse cardiac events (MACE) of death, non-fatal acute myocardial infarction, coronary artery bypass grafting, and repeat percutaneous transluminal coronary angioplasty was 8.2%, 12.8%, 13.1%, and 22.4%, respectively. Survival at one, three, and five years was 95%, 91%, and 86%, respectively. Comparison of MACE incidence during the "anticoagulant era" and the "ticlopidine era" revealed significantly improved event free survival with ticlopidine (27% v 13%; p < 0.005). Multivariable analyses showed that ejection fraction < 50% (relative risk (RR) 4. 1), multivessel disease (RR 3.0), diabetes (RR 2.9), implantation in saphenous vein graft (RR 2.1), indication for unstable angina (RR 1. 9), and female sex (RR 1.7) were independent predictors of increased mortality after stenting. Independent predictors of any MACE were multivessel stenting (RR 2.0), implantation in saphenous bypass graft (RR 1.6), diabetes (RR 1.5), anticoagulant treatment (versus ticlopidine and aspirin) (RR 1.5), bailout stenting (RR 1.5), multivessel disease (RR 1.4), and multiple stent implantation (RR 1. 5)., Conclusions: Long term survival and infarct free survival was good, particularly in non-diabetic men with single vessel disease and good ventricular function, who had a single stent implanted in a native coronary artery. A dramatic improvement was observed in event free survival, both early and late, with the replacement of anticoagulation by ticlopidine. This, of course, cannot be separated from improved stent implantation techniques between 1986 and 1995. Ultimately, almost 40% of the patients experienced an adverse cardiac event (mainly repeat intervention) in the long term. New advances in restenosis treatments and in secondary prevention must be directed at this aspect of patient management after stenting.

Percutaneous therapy of coronary bifurcated lesions is associated with greater risk of acute complications and late restenosis. Numerous innovative techniques using various stent types have been proposed. We report the first clinical use of a truly bifurcated stent (Bard XT Carina). The implantation procedure, favorable medium-term angiographic and 1-year clinical follow-up of the first human use in a 43-year-old female are illustrated with angiography and intravascular ultrasound. As a single prosthesis that effectively covers the bifurcation, this stent presents appealing alternative for the treatment of coronary bifurcation lesions when compared to methods that involve multiple-stent implantation. Cathet. Cardiovasc. Intervent. 47:361-369, 1999., (Copyright 1999 Wiley-Liss, Inc.)

Adjunct high-pressure balloon inflations following the delivery of oversized self-expandable Wallstents may affect their implied late, postprocedural self-expansion. Consequently, we examined 15 "Magic" Wallstents, which were implanted following a strategy of stent oversizing and subsequent adjunct high-pressure balloon inflations (16 +/- 2 atm; all > or = 12 atm). The excellent radiographic visibility of this stent permitted reliable quantitative coronary angiographic measurement of both lumen and stent dimensions (before and after stenting, and at follow-up). At follow-up, extent and distribution of in-stent neointimal proliferation were evaluated with volumetric intravascular ultrasound. Between postintervention and follow-up examination, mean stent diameter increased from 3.7 +/- 0.4 to 4.2 +/- 0.4 mm (p <0.0001); there was no significant difference in late stent expansion between proximal, mid-, and distal stent subsegments. Late stent expansion showed a significant (reverse) relation to maximum balloon size (r = -0.56, p <0.04), but not with follow-up lumen size or late lumen loss. On average, 52 +/- 18% of the stent was filled with neointimal ingrowth; neointimal volume/cm stent length was 64 +/- 22 mm3. Both late stent expansion (r = 0.36, p <0.02) and maximum balloon pressure (r = 0.41, p <0.001) were related to neointimal volume/cm stent but not to follow-up lumen size. Thus, despite high-pressure implantation, Wallstents showed significant late self-expansion, which resulted in larger stent dimensions at follow-up that assisted in accommodating in-stent neointimal proliferation. Conversely, late stent expansion had a significant relation to the extent of in-stent neointimal ingrowth. Beneficial and disadvantageous effects of the late stent expansion appear to be balanced, because a relation to late lumen loss or follow-up lumen dimensions was not found to be present.

Objective: This study evaluates the feasibility, reliability and reproducibility of electrocardiogram (ECG)-gated intravascular ultrasound (IVUS) image acquisition during automated transducer withdrawal and automated three-dimensional (3D) boundary detection for assessing on-line the result of coronary stenting., Background: Systolic-diastolic image artifacts frequently limit the clinical applicability of such automated analysis systems., Methods: In 30 patients, after successful angiography-guided implantation of 34 stents in 30 target lesions, we carried out IVUS examinations on-line with the use of ECG-gated automated 3D analyses and conventional manual analyses of two-dimensional images from continuous pullbacks. These on-line measurements were compared with off-line 3D reanalyses. The adequacy of stent deployment was determined by using ultrasound criteria for stent apposition, symmetry and expansion., Results: Gated image acquisition was successfully performed in all patients to allow on-line 3D analysis within 8.7 +/- 0.6 min (mean +/- SD). Measurements by on-line and off-line 3D analyses correlated closely (r > or = 0.95), and the minimal stent lumen differed only minimally (8.6 +/- 2.8 mm2 vs. 8.5 +/- 2.8 mm2, p = NS). The conventional analysis significantly overestimated the minimal stent lumen (9.0 +/- 2.7 mm2, p < 0.005) in comparison with results of both 3D analyses. Fourteen stents (41%) failed to meet the criteria by both 3D analyses, all of these not reaching optimal expansion, but only 7 (21%) were detected by conventional analysis (p < 0.02). Intraobserver and interobserver comparison of stent lumen measurements by the automated approach revealed minimal differences (0.0 +/- 0.2 mm2 and 0.0 +/- 0.3 mm2) and excellent correlations (r = 0.99 and 0.98, respectively)., Conclusions: ECG-gated image acquisition after coronary stent deployment is feasible, permits on-line automated 3D reconstruction and analysis and provides reliable and reproducible measurements; these factors facilitate detection of the minimal lumen site.

To clarify the current role of balloon angioplasty in interventional cardiology, in an era of increasing development of new devices, especially stents, we performed a retrospective comparative evaluation within the well-known BENESTENT trial. We defined a balloon angioplasty result of diameter stenosis less than 30% by quantitative angiography a 'stent-like' result and compared 6-month angiographic and 1-year clinical outcome with patients undergoing Palmaz-Schatz stent implantation. Patients having a so-defined 'stent-like' result had similar angiographic and clinical outcomes to patients receiving a stent. It is concluded that achievement of a postangioplasty diameter stenosis less than 30% may be considered clinically equivalent to the average result of Palmaz-Schatz stent implantation.

Objectives: This study was designed to compare the long-term clinical and angiographic effects of successful directional atherectomy and stent implantation and to examine whether restenosis is related to the mechanism of lumen improvement as well as the extent of lumen gain., Background: Directional atherectomy and coronary stent implantation have been shown to achieve a more optimal immediate result that may lead to a more favorable long-term angiographic outcome and fewer target vessel revascularizations than does angioplasty. However, it remains to be determined whether one of the devices used in these interventions provides consistently better results than the other., Methods: To allow meaningful comparisons a prospectively collected series of 117 patients successfully treated with atherectomy were individually matched with a prospectively collected series of 117 patients successfully treated with stent implantation. Matching for baseline characteristics identified patients with identical lesion location and lesion severity, and immediate and late angiographic and clinical outcome were compared. To evaluate the possibility of a procedure effect on restenosis, patients were further matched for both immediate angiographic outcome and baseline characteristics, providing 150 matched patients for comparison. As confirmatory analysis, multivariate models were constructed to predict late lumen diameter., Results: Matching resulted in two comparable groups with equivalent baseline clinical and stenosis characteristics (n = 117 pairs). Atherectomy led to a smaller immediate gain than stenting and, because late loss was similar in both groups, stenting resulted in a larger late lumen (1.96 +/- 0.51 vs. 1.66 +/- 0.55 mm, p < 0.0001). When patients were matched for immediate gain and baseline characteristics (n = 75 pairs), lumen loss was more pronounced after atherectomy, and thus the minimal lumen diameter at follow-up differed significantly between the two groups (1.66 +/- 0.53 vs. 1.90 +/- 0.47 mm, p = 0.004). This beneficial angiographic effect of stenting was accompanied by a reduced need for repeat interventions. Multivariate analysis confirmed the independent effect of the interventional device used, whereby less loss and greater lumen diameter at follow-up were predicted for stent implantation than for atherectomy., Conclusions: Successful stent implantation provided a more favorable long-term angiographic outcome and lower rates of restenosis and need for target lesion revascularization than did atherectomy. This favorable effect of stenting not only is related to a larger, immediate gain, but also seems to attenuate late lumen loss.

With the increasing clinical application of new devices for percutaneous coronary revascularization, maximization of the acute angiographic result has become widely recognized as a key factor in maintained clinical and angiographic success. What is unclear, however, is whether the specific mode of action of different devices might exert an additional independent effect on late luminal renarrowing. The purpose of this study was to investigate such a difference in the degree of provocation of luminal renarrowing (or 'restenosis propensity') by different devices, among 3660 patients, who had 4342 lesions successfully treated by balloon angioplasty (n = 3797), directional coronary atherectomy (n = 200), Palmaz-Schatz stent implantation (n = 229) or excimer laser coronary angioplasty (n = 116) and who also underwent quantitative angiographic analysis pre- and post-intervention and at 6-month follow-up. To allow valid comparisons between the groups, because of significant differences in coronary vessel size (balloon angioplasty = 2.62 +/- 0.55 mm, directional coronary atherectomy = 3.28 +/- 0.62 mm, excimer laser coronary angioplasty = 2.51 +/- 0.47 mm, Palmaz-Schatz = 3.01 +/- 0.44 mm; P < 0.0001), the comparative measurements of interest selected were the 'relative loss' in luminal diameter (RLoss = loss/vessel size) to denote the restenosis process, and the 'relative lumen at follow-up' (RLfup = minimal luminal diameter at follow up/vessel size) to represent the angiographic outcome. For consistency, lesion severity pre-intervention was represented by the 'relative lumen pre' (RLpre = minimal luminal diameter pre/vessel size) and the luminal increase at intervention was measured as 'relative gain' (relative gain = gain/ vessel size). Differences in restenosis propensity between devices was evaluated by univariate and multivariate analysis. Multivariate models were constructed to determine relative loss and relative lumen at follow-up, taking account of relative lumen pre-intervention, lesion location, relative gain, vessel size and the device used. In addition, model-estimated relative loss and relative lumen at follow-up at given relative lumen pre-intervention relative gain and vessel size, were compared among the four groups. Significant differences were detected among the groups both with respect to these estimates, as well as in the degree of influence of progressively increasing relative gain, on the extent of renarrowing (relative loss) and angiographic outcome (relative lumen at follow-up), particularly at higher levels of luminal increase (relative gain). Specifically, lesions treated by balloon angioplasty or Palmaz-Schatz stent implantation (the predominantly 'dilating' interventions) were associated with more favourable angiographic profiles than directional atherectomy or excimer laser (the mainly 'debulking' interventions). Significant effects of lesion severity and location, as well as the well known influence of luminal increase on both luminal renarrowing and late angiographic outcome were also noted. These findings indicate that propensity to restenosis after apparently successful intervention is influenced not only by the degree of luminal enlargement achieved at intervention, but by the device used to achieve it. In view of the clinical implications of such findings, further evaluation in larger randomized patient populations is warranted.

Luminal renarrowing after successful coronary angioplasty is now recognised as a continuously distributed process which is determined largely by the extent of luminal increase achieved at angioplasty. In this study an alternative analytical approach is applied to determine whether luminal renarrowing following coronary intervention is related to the mechanism of luminal increase (ie by balloon, by atherectomy, by a self-expanding stainless steel mesh stent, or by a balloon-expandable tantalum coil stent). The results confirm the known proportional relationship between luminal renarrowing during follow-up and luminal improvement at intervention, regardless of the device used. However, significant differences were observed between the devices, which may reflect device-specific characteristics of the hyperplastic response to vessel injury and may have clinical implications.