Sirolimus-eluting stent in chronic total occlusion: the SICTO study

Coronary stenting can significantly reduce the restenosis and reocclusion rates after successful balloon angioplasty for chronic total occlusions (CTO). Nevertheless, recanalization of CTO remains among the worst predictors for in-stent restenosis and reocclusion. This multicenter, nonrandomized study assessed the safety and effectiveness of the CYPHER sirolimus-eluting stent in reducing angiographic in-stent late loss in totally occluded native coronary arteries. A total of 25 eligible patients were treated with the CYPHER sirolimus-eluting stent. Baseline clinical and angiographic data were collected and 6-month follow-up angiography and intravascular ultrasound (IVUS) were performed. Clinical follow-up was required at 30 days, 6, 12, 18, and 24 months. Study stent implantation was successful in all patients, with a mean stent length of 28.4 +/- 11 mm. Six-month angiographic outcomes showed that mean lumen diameter stenosis did not change (2.22 +/- 0.56 mm postprocedure; 2.26 +/- 0.60 mm at 6 months follow-up; P = NS). Similarly, mean percent diameter stenosis did not change significantly (15.7 +/- 8.6% postprocedure, 19.3 +/- 11% at follow-up; P = NS). The absolute late lumen loss was -0.03 +/- 0.28 mm with a 6-month in-stent restenosis rate of 0%. IVUS follow-up revealed in-stent obstruction volume of only 4.9 +/- 6.8%. Long-term clinical follow-up showed target lesion revascularization at 12 months was only 4%, with target vessel revascularization of only 12%. The CYPHER sirolimus-eluting stent was safe and effective in the treatment of CTO compared to historical data with bare metal stents.     

Six-month outcome after excimer laser coronary angioplasty for diffuse in-stent restenosis in native coronary arteries

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.     

Paclitaxel-eluting stent Taxcor: first application in man

AIM: The safety and efficacy of the second-generation paclitaxel-eluting stent with bioactive matrix Taxcor after implantation in de novo coronary lesions at 6 months is unknown. METHODS: In this single-center non-controlled study, 45 patients with mean de novo coronary lesions of 12.1+/-1.9 mm in length and mean reference diameter of 2.9+/-0.3 mm received the paclitaxel-eluting stent (Taxcor). Fifty stents were implanted. Clinical and angiographic follow-up were performed after 6 months. It was the first time that the Taxcor stent was applied in patients. RESULTS: Mean stent diameter was 3.0+/-0.3 mm and mean length 21.2+/-5.9 mm. Four patients did not consent to control angiography at 6 months. Mean minimal lumen diameter increased from 1.1+/-0.1 mm (pre-stent) to 2.7+/-0.3 mm (post-stent) and had slightly decreased to 2.4+/-0.6 mm at 6-month follow-up. Mean acute lumen gain was 1.6+/-0.3 mm. Mean reference-vessel diameter was 2.9+/-0.3 mm at all time points. Mean percentage-diameter stenosis decreased from 62.6%+/-5.6 (pre-stent) to 9.1+/-6.0% (post-stent) and had increased slightly to 18.4+/-6.5% after 6 months. Mean late lumen loss was 0.3+/-0.4 mm. All patients remained symptom-free during the 6-month follow-up with no cases of acute myocardial infarction or death reported. No procedure-related complications occurred and no acute or subacute stent thromboses were reported. Control angiography showed binary restenosis (percentage-diameter stenosis >50%) in one patient, in whom coronary intervention was performed subsequently. CONCLUSION: The paclitaxel-eluting stent Taxcor appeared to be effective and safe up to 6 months following implantation.     

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.     

Coronary stenting or balloon angioplasty for chronic total coronary occlusions: the Taiwan experience (a single-center report)

The authors conducted this study to compare the restenosis and reocclusion rates of primary balloon angioplasty alone versus angioplasty followed by stenting in Taiwanese patients with chronic total occlusions. They also evaluated whether stenting reduced the incidence of restenosis and improved left ventricular function in these patients. From October 1998 to April 2000, a total of 294 patients with chronic total occlusion (Thrombolysis in Myocardial Infarction grade 0 flow) underwent recanalization using balloon angioplasty alone or followed by stent implantation. Of these, only 129 patients were included after procedural failure and patients lost to follow-up; 62 patients were placed in the stent group, while 67 patients were assigned to the percutaneous transluminal coronary angioplasty (PTCA) group. Coronary angiography was performed at baseline and at 6 months follow-up or earlier if angina or objective evidence of ischemia involving the target vessel or other vessels was present. Procedural success was 60%. Minimal lumen diameter increased significantly after stenting: 2.97 +/-0.41 vs 2.24 +/-0.41 (p < 0.001); 60% of patients in the stent group were free of restenosis, whereas only 33% in the PTCA group were free of restenosis at follow-up. Only 1 patient in the stent group had reocclusion, as opposed to 17 (25%) patients in the PTCA group (p < 0.001). The follow-up minimal lumen diameter (MLD) at 6 months was significantly larger in the stent group: 1.80 +/-0.85 mm vs 1.08 +/-0.82 mm (p < 0.001). Left ventricular function improved in the stent group, but not in the PTCA group (58.44 +/-16.58% to 63.60 +/-14.59% [p < 0.001] vs 54.13 +/-15.66% to 54.31 +/-15.60% [p = 0.885]). More patients had angina in the PTCA group than in the stented group 43 vs 29 (p = 0.053). The postprocedural MLD and reference vessel diameter (RVD) were the strong predictors of restenosis and follow-up MLD (p < 0.001). Stenting of chronically occluded arteries significantly reduced the incidence of reocclusion and restenosis, at the same time improving left ventricular function in these patients. This should be the procedure of choice after successful angioplasty of chronically occluded vessels.     

Clinical and angiographic performance of a new-generation modular stent design for treatment of de novo coronary lesions.

The objectives of the Race Car study were to assess the safety and efficacy of the Medtronic AVE S670 stent, a new-generation stent with a modular design consisting of interconnected sinusoidal rings allowing improved flexibility with good conformability and scaffolding. A total of 285 stents were implanted in 267 patients with (un)stable angina pectoris who underwent angioplasty of a single de novo lesion in a native coronary artery with a diameter between 3.0 and 4.0 mm. Available stent lengths were 9, 12, and 15 mm. The primary endpoint was the 6-month restenosis rate. Secondary endpoints were device and procedural success and major adverse cardiac event (MACE)-free survival at 1 and 6 months. All patients received the study stents and no other stents were used (angiographic success: 100%). Eight patients experienced a MACE during hospital admission (Q-wave MI in 2, non-Q-wave MI in 4, TLR in 2). A procedural success was obtained in 97% of the patients. There were no additional events at 1 month. The clinical endpoints encountered at 6 months were Q-wave MI in 1, bypass surgery in 3, and repeat angioplasty in 25 (MACE-free survival: 86.5%). Quantitative angiographic results were the minimum lumen diameter increased from 1.05 +/- 0.32 before to 2.73 +/- 0.39 mm after stent implantation. At follow-up, the loss in diameter was 0.74 +/- 0.50 mm. The loss index was 0.45 +/- 0.31 and restenosis rate was 13.4%. This study has demonstrated that the S670 stent in patients with (un)stable angina pectoris requiring intervention of a single lesion has a low acute and 6-month major event rate and a low angiographic restenosis rate.     

Long-term clinical outcome after implantation of medium Palmaz (biliary) stents in very large native coronary arteries.

Intracoronary stenting has been shown to improve acute and long-term clinical results compared with coronary angioplasty. However, clinical outcome after medium Palmaz biliary (PB) stent implantation in very large native coronary arteries (> 4 mm in diameter) is unknown. This study evaluated restenosis and long-term clinical outcome after PB stenting in large native coronary arteries. Between June 1993 and December 1998, 55 patients with 56 lesions were treated with PB stents. Intracoronary stent deployment was successful in all 56 vessels attempted (100%). The mean stenosis was reduced from 65% +/- 10% to 4% +/- 14%. In 48 of the 56 vessels (86%), vessel size was greater than 4.0 mm in diameter and the mean reference vessel diameter was 4.73 +/- 0.7 mm after stenting. Angiographic success was achieved in 100%. Five patients had postprocedural cardiac enzyme elevation. There was no periprocedural death, emergency coronary artery bypass surgery, repeat target lesion revascularization, or acute stent thrombosis. Long-term clinical follow-up at mean of 28 +/- 15 months was obtained in 96% of the patients. Clinical restenosis rate occurred in 18% of ostial (6/34) and 0% of nonostial (0/22) lesions (P < 0.0001) with an overall clinical restenosis rate of 11%. Repeat angioplasty were performed in these six patients. There were three cardiac and three noncardiac deaths. The overall event-free survival at 1 and 3 years was 92% +/- 4% and 80% +/- 6%, respectively. PB stent implantation in very large native coronary arteries can be performed with a high degree of procedural success and low in-hospital complications. The long-term clinical outcome of patients undergoing PB stenting is associated with excellent event-free survival. However, stenting of ostial lesions remains as an important factor for restenosis even in very large coronary artery stenting.     

Stents in total occlusion for restenosis prevention. The multicentre randomized STOP study. The Israeli Working Group for Interventional Cardiology.

AIMS: This multicentre randomized study set out to evaluate whether coronary stenting improves the results of successful balloon angioplasty for chronic total occlusion. Balloon angioplasty for chronic total occlusion has a high restenosis rate. Several reports have suggested that coronary stenting may decrease the likelihood of restenosis and reocclusion. METHODS AND RESULTS: Patients with total coronary artery occlusions who had an optimal PTCA result were randomized either to no further treatment or additional stent implantation. The AVE microstent was used and all patients were scheduled for a 1-, 3-, and 6-month clinical follow-up. Repeat coronary angiography to assess the rate and pattern of restenosis was performed at 6 months or earlier if clinically indicated. Ninety-six patients were enrolled in this study. The mean age was 59. 3+/-10.3 years and 15 were females. Forty-eight patients were randomized to the stent arm, receiving 52 stents (lengths 18-39 mm). Stent implantation was successful in all and there were no major procedure-related complications. Sixty-nine patients (72%) were restudied after 6 months. The binary restenosis rates (50%), in the PTCA arm were 70.9% with a minimal lumen diameter of 1.01+/-0.79 mm compared to 42.1% in the stent arm with a minimal lumen diameter of 1.63+/-1.02 mm (P=0.034). Reocclusion occurred in 7.9% in the stent group compared to 16.1% in the PTCA group. Restenosis in the PTCA group was focal in 88% of patients and occurred at the point of total obstruction (within 5 mm), compared to diffuse instent restenosis, which occurred in 54% of the patients in the stent group. CONCLUSION: Coronary stenting can significantly decrease the rate of restenosis and reocclusion of total occlusions. As restenosis in the stent group was more diffuse, care should be taken to implant short stents at the site of occlusion.     

Long-term clinical and angiographic follow-up after placement of Palmaz-Schatz coronary stent: a single center experience

The purpose of this study is to evaluate long-term clinical and angiographic follow-up results after placement of the Palmaz-Schatz stent and angiographic follow-up results of repeat interventions for stent restenosis. From June 1990 to September 1993, the Palmaz-Schatz stent was placed in 411 patients, 427 lesions. Follow-up angiography was performed in 307 lesions at 3-6 months and in 189 lesions at 1 year. Palmaz-Schatz stent implantation resulted in 97.2% procedure success and 94.6% clinical success. Stent thrombosis was observed in 2.2%. Angiographic restenosis rate was 16.3% at 3-6 months study. At 1 year study, "new" restenosis occurred only in 2.3%. Minimal lumen diameter did not change between 6 months and 1 year (2.32 +/- 0.51 mm vs 2.30 +/- 0.54 mm). With the mean follow-up interval of 22 +/- 9 months, cardiac event-free survival was achieved in 74.3%. Among 50 lesions with restenosis, stent restenosis occurred diffusely in 15 lesions (30%), focally inside the stent in 22 lesions (44%) and focally at the stent border in 13 lesions (26%). Repeat interventions were performed in 35 lesions. Restenosis at 3 months after repeat intervention was demonstrated in 9 (32.1%) out of 28 lesions restudied. Restenosis rate after repeat intervention for diffuse stent restenosis was significantly higher than that for focal in-stent restenosis (75% vs 7.7%). Palmaz-Schatz stent implantation was associated with a high initial success rate and a low late restenosis rate. Luminal renarrowing did not occur beyond 6 months up to 1 year.     

Stenting for in-stent restenosis.

Intravascular ultrasound studies have shown that additional stent implantation is the only percutaneous technique that allows for recovery of all the lumen area of the original implantation procedure. Despite this theoretical advantage, information on systematic additional stent implantation is still forthcoming, especially concerning the impact of new stent designs. This prospective study evaluated the efficacy of routine additional stent implantation for treatment of in-stent restenosis in 68 consecutive patients. Repeat stenting was successful in all cases, and second-generation tubular stents were used in 84% of patients. The mean additional stent length was 19.2 +/- 9.4 mm, and 15% of patients had multiple stent implantation. The postprocedure minimum lumen diameter was 3.11 +/- 0.41 mm, and the percentage residual stenosis was 2% +/- 7%. At a mean clinical follow-up of 10 +/- 8 months (follow-up rate 100%), the incidence of major adverse events was 21% (1 death, 13 target vessel revascularizations). Overall, angiographic restenosis rate was 32% (angiographic follow-up rate 79%). By multivariate analysis, the only predictors of recurrence after additional stenting were unstable angina at the second procedure (OR 8.70, 95% CI 1.50-50.33, P = 0.019), and early clinical recurrence after the first stent procedure (OR 4.83, 95% CI 1.13-20.71, P = 0.038). Additional stenting is a safe and effective treatment modality for the majority of patients with in-stent restenosis. Alternative treatments should be considered only for patients with in-stent restenosis presenting as unstable angina or early recurrence after a first stent procedure.     

Local delivery of nadroparin for the prevention of neointimal hyperplasia following stent implantation: results of the IMPRESS trial. A multicentre, randomized, clinical, angiographic and intravascular ultrasound study.

BACKGROUND: We hypothesized that intramural delivery of nadroparin, a low molecular weight heparin, would prevent in-stent restenosis by inhibiting neointimal hyperplasia in an angioplasty model free of arterial remodelling. METHODS AND RESULTS: In a prospective randomized multicentre trial, 250 patients submitted to balloon angioplasty followed by stent implantation were randomized into control group (no local drug delivery) or intramural delivery of nadroparin (2 ml of 2500 anti-Xa-units/ml with a microporous catheter). An ancillary intravascular ultrasound substudy was performed to supplement angiographic data with specific measurements of in-stent neointimal hyperplasia. The primary end-point was the late loss in minimal luminal diameter on the 6 month follow-up angiogram. Secondary end-points included feasibility and safety of local nadroparin delivery, and major adverse cardiac events at 8 weeks and 6 months follow-up. Local delivery of nadroparin was successful in 124 patients (99.2% success rate) and was not associated with an increase in stent thrombosis, coronary artery dissection, side branch occlusion, distal embolization or abrupt arterial closure. At angiographic follow-up, the late loss in lumen diameter was 0.84 +/- 0.62 mm in the control group compared to 0.88 +/- 0.63 mm in the nadroparin group (P=0.56). Angiographic restenosis rate (defined as a >50% diameter stenosis) did not differ in the control group (20%) compared to the nadroparin group (24%). The average area of neointimal tissue within the stent was 2.86 +/- 0.64 mm(2) vs 2.90 +/- 0.53 mm(2) (P=0.57), control vs nadroparin groups. There was no difference in major adverse cardiac events at any time (88.8% vs 89.6% event free survival at 6 months, control vs nadroparin). CONCLUSION: Intramural delivery of nadroparin with a microporous catheter after stent deployment was feasible and safe but had no effect in reducing restenosis or the occurrence of major adverse clinical events over 6 months.     

Contribution of early lumen loss after balloon angioplasty for in-stent restenosis to lumen loss at follow-up.

The treatment of in-stent restenosis using balloon angioplasty alone often produces excellent early results, but is associated with high rate of recurrence. Previous studies have demonstrated significant tissue reintrusion shortly after the treatment of in-stent restenosis with balloon angioplasty. The study was designed to elucidate the contribution of early lumen loss 6 hr after balloon angioplasty to lumen loss at follow-up. We prospectively performed quantitative coronary angiography and intravascular ultrasound in 12 patients with in-stent restenosis before intervention, after the final procedure, 6 hr later (5.6 +/- 1.4 hr), and at follow-up (7.7 +/- 2.3 months). Compared with immediately after balloon angioplasty, by 6 hr postintervention, the minimum lumen diameter (MLD) and lumen cross-sectional area had decreased significantly (2.48 +/- 0.44 to 2.01 +/- 0.57 mm, P = 0.01, and 7.0 +/- 1.2 to 5.5 +/- 1.4 mm2, P = 0.004, respectively). Furthermore, the MLD decreased further between 6 hr postintervention and long-term follow-up (2.01 +/- 0.57 to 1.55 +/- 0.64 mm; P = 0.001). Patients who showed recurrence of restenosis at follow-up had greater early lumen loss than patients without recurrence of restenosis (0.71 +/- 0.31 vs. 0.23 +/- 0.13 mm; P = 0.006). Diffuse lesions had greater early lumen loss compared to focal lesions (0.75 +/- 0.35 vs. 0.28 +/- 0.13 mm; P = 0.008). Early lumen loss is common after the treatment of in-stent restenosis by balloon angioplasty. Within the first 6 hr postintervention, 32% +/- 29% of acute lumen gain is lost, and early lumen loss contributed to 42% +/- 18% of total lumen loss at follow-up.     

Angiographic and clinical outcome of a new self-expanding intracoronary stent (RADIUS): results from multicenter experience in Japan.

The RADIUS coronary stent featuring a multisegmented slotted tube design and self-expanding nitinol delivery system has a high radial force and flexibility, uniform expansion, and contours to the shape of the vessel. Successful stent deployment was achieved in 104 stable angina patients (106 lesions; 44% LAD, 19% circumflex, and 37% RCA). Mean minimal lumen diameter (MLD) increased from 0.77 +/- 0.46 mm to 2.88 +/- 0.61 mm and mean percent diameter stenosis (% DS) decreased from 73 +/- 14% to 6 +/- 13% immediately after the procedure. At 6-month follow-up, two patients (2%) underwent urgent target revascularization, and cerebral bleeding occurred in one patient (1%). Angiographic follow-up was performed in 94 lesions (89%) and mean MLD and mean % DS were 2.08 +/- 0.92 mm and 30% +/- 24%, respectively. Stent restenosis (>50% diameter stenosis at follow-up) was observed in 16 (17%) of all lesions. The high success rate for stent deployment, low incidence of major adverse cardiac event, and lower restenosis rate after stent implantation indicate that the RADIUS stent is useful for coronary intervention.     

Long-Term Restenosis After Multiple Stent Implantation: A Quantitative Angiographic Study

Elective high pressure stent implantation in focal coronary lesions has a high procedural success and low incidence of restenosis in comparison with balloon angioplasty. For the treatment of diffusely diseased coronary arteries, however, a high incidence of subacute thrombosis and late restenosis has been reported. The aim of this study was the prospective evaluation of procedural and long-term outcome after implantation of multiple stents. In a consecutive series of 48 patients, 48 lesions were treated with the implantation of 120 stents (2.5 ± 1.0 stents/lesion). Stent implantation was performed electively in 15%, for dissection in 56%, and for suboptimal balloon angioplasty result in 29% of patients. The lesion length before stenting, including balloon angioplasty induced dissections, was 28.5 ± 9.8 mm (range 20–62), the mean length of the stented segment was 40 ± 16 mm. The procedure was successful in 45 patients (95%). Procedural related complications included two urgent bypass operations (4%) and one transmural myocardial infarction (2%). Two subacute stent thrombosis events (4%) occurred, both in-hospital, 1 and 3 days after implantation. Follow-up was obtained in 43 eligible patients at 6.4 ± 1.3 months, revealing an overall restenosis rate of 30% (13 patients). Quantitative angiography (CAAS II, edge detection algorithm) showed a minimal lumen diameter of 0.93 ± 0.28 mm (diameter stenosis 62%± 13%) before treatment, 2.81 ± 0.26 mm (diameter stenosis –4 ± 13%) after stenting, and 1.79 ± 0.58 mm (diameter stenosis 30%± 20%) at follow-up. Predictors of restenosis were not identified. Thus, multiple stent implantation has high procedural success and the late restenosis of long lesions after multiple stents compares favorably with balloon angioplasty.     

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.     

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.     

A randomized trial of elective stenting after balloon recanalization of chronic total occlusions.

OBJECTIVES: The aim of this study was to assess the role of Wiktor stent implantation after recanalization of chronic total coronary occlusions with regard to the clinical and angiographic outcome after six months. BACKGROUND: Beside the common use of stents in clinical practice, the number of stent indications proven by randomized trials is still limited. METHODS: Eighty-five patients with a thrombolysis in myocardial infarction grade 0 chronic coronary occlusion were examined. After standard balloon angioplasty, the patients were randomly assigned to stent implantation, or percutaneous transluminal coronary angioplasty (PTCA) alone (no further intervention). Quantitative coronary angiography was performed at baseline and after six months. RESULTS: The minimal lumen diameter did not differ immediately after recanalization (stent group 1.61 +/- 0.30 mm vs. PTCA group 1.65 +/- 0.36 mm), and increased after stent implantation to 2.51 +/- 0.41 mm. After six months, the stent group still had a significantly greater lumen (1.57 +/- 0.59 vs. 1.06 +/- 0.90 mm; p < 0.01) and a significantly lower restenosis and reocclusion rate (32% and 3%) compared with the PTCA group (64% and 24%); restenosis analysis according to treatment was 72% (PTCA) versus 29% (stent, p < 0.01). Late loss was equal in both groups. At follow-up, the stent patients had a better angina class (p < 0.01), and fewer cardiac events (p < 0.03). A meta-analysis including this trial and three other controlled trials with the Palmaz-Schatz stent showed concordant results. CONCLUSIONS: Stent implantation after reopening of a chronic total occlusion provides a better angiographic result, corresponding to a better clinical outcome with fewer recurrence of symptoms and reinterventions after six months.     

The 5A6A polymorphism in the promoter of the stromelysin-1 (MMP3) gene as a risk factor for restenosis.

AIMS: Intracoronary ultrasound studies in humans show that chronic remodelling rather than neointimal hyperplasia is the mechanism of restenosis. Stent implantation limits this remodelling process and significantly reduces restenosis. MMP3 (Stromelysin-1), a member of the matrix metalloproteinase family may play a role in this remodelling. We used a functional polymorphism (with alleles designated 5A or 6A) in the promoter of the MMP3 gene to examine the possible role of MMP3 in restenosis. METHODS AND RESULTS: Genotypes were determined in a series of consecutive patients who underwent conventional balloon coronary angioplasty without stenting (n=287) or who also had successful implantation of a Palmaz-Schatz stent (stent) (n=198). For all patients restenosis was estimated at 6 months using quantitative computer-assisted angiography. The minimal luminal diameters before and after the procedures did not differ significantly between genotypes. At follow-up in the patients without stent, those with the 6A6A genotype had an increased degree of restenosis after coronary angioplasty compared to those with one or more 5A alleles, with a greater diameter stenosis (52+/-21% vs 45+/-19%, P=0.012), and a greater late loss (0.58+/-0.59 mm vs 0.38+/-0.59 mm, P=0.038). By contrast, in the stented patients MMP3 genotype was not associated with any angiographically determined measure of vessel dimensions. CONCLUSIONS: These data imply the involvement of MMP3 in chronic remodelling after conventional balloon angioplasty, and suggest that the 6A6A MMP3 genotype is a genetic susceptibility factor for restenosis after angioplasty without stenting.     

Endovascular stents for coarctation of the aorta: initial results and intermediate-term follow-up.

OBJECTIVES: The aim of this study was to evaluate the use of endovascular stents in native and recurrent coarctation of the aorta (CoA). BACKGROUND: Stents have been used successfully in various locations. Their use in CoA can be an alternative to surgery or balloon angioplasty (BA). METHODS: Thirty-four patients with CoA (13 native and 21 re-coarctation after surgery or BA) with a mean age of 16 +/- 8 years (range 4 to 36 years) underwent attempted stent implantation between 1993 and 1999. Successful outcome was defined as peak systolic pressure gradient after stent implantation < 20 mm Hg. RESULTS: Stents were implanted in 33/34 patients, and successful outcome occurred in 32/33 patients. Peak systolic pressure gradient decreased from 32 +/- 12 mm Hg to 4 +/- 11 mm Hg (p < 0.001). Coarctation site to descending aorta diameter ratio increased from 0.46 +/- 0.16 to 0.92 +/- 0.16 (p < 0.001). Two patients underwent successful stent re-dilation 16 and 21 months after initial implantation. Six patients (18%) developed complications, including two patients who underwent surgery. Follow-up for 29 +/- 17 months (range: 5 to 81 months) demonstrated no evidence of re-coarctation, aneurysm formation, stent displacement or fracture. Systolic blood pressure (SBP) decreased from 136 +/- 21 mm Hg before stent placement to 122 +/- 19 mm Hg at follow-up (p = 0.002). The SBP gradient decreased from 39 +/- 18 mm Hg to 4 +/- 6 mm Hg, and peak Doppler gradient decreased from 51 +/- 26 mm Hg to 13 +/- 11 mm Hg at follow-up (p < 0.001). CONCLUSIONS: Intravascular stent placement for native and recurrent CoA has excellent results in the short and intermediate terms. Long-term outcome remains to be evaluated.     

Randomized comparison of coronary stenting with optimal balloon angioplasty for treatment of lesions in small coronary arteries.

AIMS: Angioplasty of lesions in small coronary arteries remains a significant problem because of the increased risk of restenosis. The aim of this study was to compare the efficacy of elective coronary stent placement and optimal balloon angioplasty in small vessel disease. METHODS: One hundred and twenty patients with lesions in small coronary arteries (de novo, non-ostial lesion and reference diameter <3 mm) were randomly assigned to either balloon angioplasty or elective stent placement (7-cell NIR stent). The primary end-point was restenosis at 6 months follow-up. Optimal balloon angioplasty was defined as diameter stenosis less than or = 30% and the absence of major dissection after the angioplasty, and crossover to stenting was allowed. RESULTS: Baseline clinical and angiographic characteristics were similar in the two groups. Procedure was successful in all patients, and in-hospital events did not occur in any patient. However, 12 patients in the angioplasty group were stented because of suboptimal results or major dissection. Postprocedural lumen diameter was significantly larger in the stent group than in the angioplasty group (2.44 +/- 0.36 mm vs 2.14 +/- 0.36, P<0.05, respectively), but late loss was greater in the stent group (1.12 +/- 0.67 mm vs 0.63 +/- 0.48, P<0.01, respectively). The angiographic restenosis rate was 30.9% in the angioplasty group, and 35.7% in the stent group (P = ns). Clinical follow-up was available in all patients (15.9 +/- 5.7 months) and clinical events during the follow-up were similar in both groups. CONCLUSIONS: These results suggest that optimal balloon angioplasty with provisional stenting may be a reasonable approach for treatment of lesions in small coronary arteries.