Anatomical patterns of patent foramen ovale (PFO): do they matter for percutaneous closure?

AIM: The aim of this study was to describe and classify the various anatomical pattern of patent foramen ovale (PFO) with transesophageal echocardiography (TEE) and to relate such classification to the selection of PFO closure devices. METHODS: This study enrolled 216 PFO patients (118 females) mostly with previous cryptogenic stroke or transitory ischemic attack (TIA) who underwent percutaneous closure of PFO with deep sedation under TEE control. Anatomical patterns were classified as follows: simple: PFO characterised by central/superior eccentric shunt or with a valve mechanism (45%); reduse: widely redundant septum primum (22%); ASA: atrial septal aneurysm (11%); EASA: entire atrial septal aneurysm (1.4%); CRIB: cribriform septum primum (9%); tunnel: tunnel between septum primum and secundum >10 mm (11%). Degree of right-to-left shunt, either at basal condition or at Valsalva manoeuvre, was classified as: 1=mild (45%); 2=moderate (42%); 3=severe (13%). Additional right-atrium anatomical features are also described. RESULTS: Procedure was successful in 100% of the cases. At follow-up recurrent TIA occurred in two patients. Residual shunts were present in 4.9% of the patients after Valsalva manoeuvre. Palpitations were reported in 4%. CONCLUSIONS: Closing the PFO choosing the device following strict anatomical criteria based on TEE assessment allowed excellent immediate and late results minimizing residual shunts.

Angiographical follow-up after radioactive "Cold Ends" stent implantation: a multicenter trial.

BACKGROUND: Radioactive stents with an activity of 0.75 to 12 microCi have shown >40% edge restenosis due to neointimal hyperplasia and negative remodeling. This trial evaluated whether radioactive Cold Ends stents might resolve edge restenosis by preventing remodeling at the injured extremities. METHODS AND RESULTS: The 25-mm long (15-mm radioactive center and 5-mm nonradioactive ends) Cold Ends stents had an activity of 3 to 12 microCi at implantation. Forty-three stents were implanted in 43 patients with de novo native coronary artery disease. Two procedural, 1 subacute, and 1 late stent thrombosis occurred. A restenosis rate of 22% was observed with a shift of the restenosis, usually occurring at the stent edges of radioactive stents, into the Cold Ends stents. The most severe restenosis occurred at the transition zone from radioactive to nonradioactive segments, a region located in dose fall-off. CONCLUSION: Cold Ends stents did not resolve edge restenosis.

Discrepancy between angiography and intravascular ultrasound when analysing small coronary arteries.

AIMS: A small reference diameter may be the consequence of high plaque burden and diffuse disease. The reference vessel diameter in small coronary arteries may vary according to the method of measurement used. We endeavoured to confirm the difference between data from examinations conducted using angiography with that revealed by intravascular ultrasound. METHODS AND RESULTS: Between March 1993 and October 1999, 344 consecutive patients with 419 lesions in small vessels (< or =2.75 mm, Small group) and 953 patients with 1161 lesions in large vessels (Large group) underwent intravascular ultrasound-guided percutaneous transluminal angioplasty in our Institution. The mean difference between the intravascular ultrasound and the angiographic reference diameter (Delta(IVUS-Angio)) was 1.3+/-0.5 mm in the Small group and 1.0+/-0.6 mm in the Large group (P<0.001). There was a stronger correlation between plaque burden and Delta(IVUS-Angio)in the Small group (r=0.80, P<0.001) than in the Large group (r=0.59, P<0.001). An Delta(IVUS-Angio)> or =0.30 mm occurred in 99.5% of cases in the Small group and in 90% in the Large group (P<0.001). An Delta(IVUS-Angio)> or =0.50 mm occurred in 96% of case in the Small group and 80% in the Large group (P<0.001). Predictors of Delta(IVUS-Angio)> or =0.50 in the Small group were: proximal or middle lesion site, vessel type (left anterior descending artery, diagonal and obtuse marginal branches) and female sex. An Delta(IVUS-Angio)> or =1.0 mm occurred in 71% of cases in the Small group and in 49% in the Large group (P<0.001). Predictors of Delta(IVUS-Angio)> or =1.0 mm in the Small group were: proximal or middle lesion site, female sex, and lesion length. CONCLUSIONS: A high percentage of vessels measuring < or =2.75 mm are large vessels with a high plaque burden. This condition is particularly prevalent in females, with lesions in the proximal or middle left anterior descending artery, and in obtuse marginal and diagonal branches.

Cutting balloon angioplasty for treatment of calcified coronary lesions.

The aim of the study was to evaluate the feasibility, safety, and efficacy of cutting balloon angioplasty in treatment of angiographically moderate and severe calcified coronary lesions. Thirty-seven calcified coronary lesions (29 patients) detected by angiography were dilated with cutting balloon. Predilatation with plain balloon was performed in 27 (73.0%) lesions and stent was implanted in 23 (62.2%) lesions following cutting balloon. Acute gain following cutting balloon in predilated lesions was compared to the acute gain following plain balloon predilatation. For predilated lesions, acute gain after cutting balloon was significantly greater compared with plain balloon predilatation (1.51 +/- 0.49 vs. 0.77 +/- 0.42; P = 0.01). This result was achieved with larger size and lower pressure of cutting balloon compared with plain balloon (3.28 +/- 0.46 vs. 2.94 +/- 0.55, P = 0.01; 10.38 +/- 1.64 vs. 13.19 +/- 3.63, P = 0.001, respectively). The final gain following cutting balloon dilatation was significantly higher than the expected gain obtained by using a plain balloon of the same size (1.51 +/- 0.49 vs. 0.93 +/- 0.48; P < 0.0001), which was inflated at significantly higher pressure compared with cutting balloon. When we compared acute gain following cutting balloon in lesions with and without predilatation, we found no significant difference (P = 0.31). Angiographic success was achieved in 36 (97.3%) lesions and procedural success in 33 (89.1%) lesions. In-hospital major adverse cardiac event (MACE) occurred in three (10.3%) patients. Follow-up MACE was reported from three (10.3%) patients. In conclusion, cutting balloon angioplasty is feasible and safe in treatment of angiographically moderate and severe calcified lesions. Dilating efficiency of cutting balloon seems to be greater compared with a plain balloon of the same size, which was inflated at significantly higher pressure compared with cutting balloon. These results can be achieved with low in-hospital MACE and are associated with a good long-term outcome.

Intravascular ultrasound-guided percutaneous transluminal coronary angioplasty with provisional spot stenting for treatment of long coronary lesions.

OBJECTIVES: The purpose of this study was to evaluate the approach of intravascular ultrasound (IVUS)-guided percutaneous transluminal coronary angioplasty (PTCA) with spot stenting (SS) for the treatment of long coronary lesions. BACKGROUND: Treating long coronary lesions with balloon angioplasty results in suboptimal short- and long-term outcomes. Full lesion coverage with traditional stenting (TS) has been associated with a high restenosis rate. METHODS: We prospectively evaluated a consecutive series of 130 long lesions (>15 mm) in 101 patients treated with IVUS-guided PTCA and SS. The results were compared with those of TS in a matched group of patients. Coronary angioplasty was performed with a balloon to vessel ratio of 1:1, according to the IVUS media-to-media diameter of the vessel at the lesion site, to achieve prespecified IVUS criteria: lumen cross-sectional area (CSA) > or =5.5 mm(2) or > or =50% of the vessel CSA at the lesion site. The stents were implanted only in the vessel segment where the criteria were not met. RESULTS: In the SS group, stents were implanted in 67 of 130 lesions, and the mean stent length was shorter than that of lesions in the matched TS group (10.4 +/- 13 mm vs. 32.4 +/- 13 mm, p < 0.005). The 30-day major adverse cardiac event (MACE) rate was similar (5%) for both groups. Angiographic restenosis was 25% with IVUS-guided SS, as compared with 39% in the TS group (p < 0.05). Follow-up MACE and target lesion revascularization rates were lower in the SS group than in the TS group (22% vs. 38% [p < 0.05] and 19% vs. 34% [p < 0.05], respectively). CONCLUSIONS: Intravascular ultrasound-guided SS for the treatment of long coronary lesions is associated with good acute outcome. Angiographic restenosis and follow-up MACE rates were significantly lower than those with TS.

Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational atherectomy, additional stent implantation and balloon angioplasty.

OBJECTIVES: The purpose of the study was to determine whether cutting balloon angioplasty (CBA) has advantages over other modalities in treatment of in-stent restenosis (ISR). BACKGROUND: Controversies exist regarding optimal treatment for ISR. Recently, CBA emerged as a tool in management of ISR. METHODS: A total of 648 lesions treated for ISR were divided into four groups according to the treatment strategy: CBA, rotational atherectomy (ROTA), additional stenting (STENT), and percutaneous transluminal coronary angioplasty (PTCA). Following the matching process, 258 lesions were entered into the analysis. RESULTS: Baseline clinical and angiographic characteristics were similar among the groups (p = NS). Acute lumen gain was significantly higher in the STENT group (2.12 +/- 0.7 mm), whereas in the CBA group the gain was similar to one achieved following ROTA and following PTCA (1.70 +/- 0.6 vs. 1.79 +/- 0.5 mm and 1.56 +/- 0.7 mm, respectively; p = NS). The lumen loss at follow-up was lower for the CBA versus ROTA and versus STENT (0.63 +/- 0.6 vs. 1.30 +/- 0.8 mm and 1.36 +/- 0.8 mm, respectively; p < 0.0001), yielding a lower recurrent restenosis rate (20% vs. 35.9% and 41.4%, respectively; p < 0.05). By multivariate analysis, CBA (odds ratio [OR] = 0.17; confidence interval [CI], 0.06 to 0.51; p = 0.001) and diffuse restenosis type at baseline (OR = 2.07; CI, 1.15 to 3.71; p = 0.02) were identified as predictors of target lesion revascularization. CONCLUSIONS: We conclude that CBA is a safe and efficient technique for treatment of ISR, with immediate results similar to atheroablation and better clinical and angiographic outcomes at follow-up. This approach might be implemented as a viable option in management of focal ISR and to prepare diffuse ISR for brachytherapy treatment.

Cerebral protection with filter devices during carotid artery stenting.

BACKGROUND: Distal embolization of debris during percutaneous carotid artery stenting may result in neurological deficit. Filter devices for cerebral protection potentially reduce the risk of embolization. METHODS AND RESULTS: Elective carotid stent implantation using 3 different types of distal filter protection devices was attempted in 88 consecutive lesions (84 patients) in the internal carotid artery that had >70% diameter stenosis (mean, 78.7+/-10.7%). Procedures were performed in 3 different centers. The mean age of the patients was 69+/-8 years, 75% were men, and 35.7% had neurological symptoms. In 86 lesions, a stent was successfully implanted (97.7%). In 83 of these 86 procedures (96.5%), it was possible to position a filter device. In 53% of filters, there was macroscopic evidence of debris. Collected material consisted of lipid-rich macrophages, fibrin material, and cholesterol clefts. Neurological complications during the procedure, in the hospital, and at 30 days of clinical follow-up occurred in only one patient (1.2%). This patient suffered a minor stroke that resolved within 1 week. Two major adverse cardiac events (2.3%) occurred during the 30 days of follow-up. CONCLUSIONS: Filter protection during carotid artery stenting seems feasible and safe. In the present series, the incidence of neurological complications was low.

Predictors of re-occlusion after successful recanalization of chronic total occlusion.

UNLABELLED: The objective of this study was to highlight the incidence and predictors of re-occlusion after successful recanalization of chronic total coronary occlusions. METHODS AND RESULTS: Following successful recanalization and stent implantation in 716 coronary lesions (665 patients) with chronic total occlusion, four hundred and five (56.6%) lesions (375 patients) underwent repeat angiography within 6 months. Restenosis (> or = 50% lumen narrowing) was observed in 151 (37.3%) lesions; forty-three (10.6%) of these lesions had complete re-occlusion and constituted the study population. In this group, final angiographic minimal lumen diameter (MLD) was 2.6 +/- 0.51 mm and final percent diameter stenosis was 18 +/- 11. Univariate analysis revealed significant correlation between re-occlusion and restenotic lesions, final balloon diameter, final percent diameter stenosis, final angiographic MLD, number of stents per lesion and total stent length. By multivariate analysis, the only independent predictor of re-occlusion was total stent length (OR = 1.46, 95% CI = 1.12-1.82; p = 0.0069). CONCLUSION: Re-occlusion occurs in about 11% of cases after stenting chronic total occlusion. The most important predictor of re-occlusion seems to be stent length.

Directional atherectomy prior to stenting in bifurcation lesions: a matched comparison study with stenting alone.

The ideal catheter-based intervention for treatment of coronary lesions at bifurcation site still has to be defined. The aim of the study was to assess the acute and long-term outcome after treatment of bifurcation lesions with directional atherectomy (DCA) and stenting in comparison with stenting alone. Thirty-one consecutive patients treated for bifurcation coronary lesions (62 lesions) with DCA and stenting in at least one branch (DCA group) were compared with a matched group of 31 patients with bifurcation coronary lesions (62 lesions) treated with stenting alone in at least one branch (non-DCA group). Procedural success was 87.1% in the DCA group compared with 100% in the non-DCA group (P = 0.03). In-hospital major adverse cardiac events (MACE) occurred only in the DCA group (12.9% vs. 0%, P = 0.03), mainly non-Q-wave myocardial infarction. After the procedure, minimum lumen diameter (MLD) and acute gain were significantly greater (P = 0.004 and P = 0.05, respectively) and % diameter stenosis was significantly lower (P = 0.05) in the main branch in the DCA group. At follow-up angiogram, MLD in the main branch was still significantly greater in the DCA group compared to the non-DCA group (2.31 vs. 1.65, respectively, P = 0.04), with no significant difference in late loss and loss index between the two groups. Restenosis rate was 28.8% in the DCA group vs. 43.5% in the non-DCA group (P = 0.13). The incidence of follow-up MACE was 29% in the DCA group compared with 48.4% in the non-DCA group, mainly due to target lesion revascularization. In conclusion, treatment of bifurcation coronary lesions with DCA and stenting was associated with greater acute gain after the procedure and greater MLD at follow-up in the main branch compared with stenting alone. Procedural myocardial infarction was more frequent in the DCA group. Restenosis rates and follow-up MACE were lower following DCA and stenting, without reaching any statistical significance.

Predictors of diffuse and aggressive intra-stent restenosis.

OBJECTIVES: This study was performed to investigate the causes of diffuse and aggressive intra-stent restenosis. BACKGROUND: Although restenosis is usually considered to be a dichotomous variable, there is clinical relevance to the severity of restenosis. It is not known which variables are predictive of diffuse or aggressive intra-stent restenosis. METHODS: A consecutive series of 456 coronary lesions with in-stent restenosis was evaluated for the type of restenosis using quantitative coronary angiography. Restenosis was defined as > or = 50% diameter stenosis at follow-up angiography, diffuse restenosis as a follow-up lesion length > or = 10 mm and aggressive restenosis as either an increase in lesion length from the original lesion or a restenotic narrowing tighter than the original. Clinical, anatomic and procedural characteristics were evaluated for lesions associated with these types of restenosis. RESULTS: Diffuse restenosis was associated with a smaller reference artery diameter, longer lesion length, female gender, longer stent length and the use of coil stents. Aggressive restenosis was more common in women, with the use of Wallstents and with long stent to lesion length ratios. Aggressive restenosis occurred earlier and was more closely associated with symptoms and myocardial infarctions than nonaggressive restenotic lesions. CONCLUSIONS: Markers for diffuse restenosis were also important markers for the presence of any restenosis. A long stent to lesion length ratio is an important marker for aggressive restenosis. When severe forms of in-stent restenosis occur, they tend to present earlier and with more symptoms, including myocardial infarction. More careful consideration of the type of in-stent restenosis may aid in identifying when alternative strategies may be useful.

Characterization of total occlusions with intracoronary ultrasound: the importance of the duration of occlusion.

OBJECTIVE: To assess the impact of the occlusion duration on the characteristics of coronary occlusive plaques. BACKGROUND: The percutaneous recanalization of chronic total coronary occlusions is a technically demanding and yet often unsuccessful procedure due to unfavorable morphological changes described by histology but not well defined in vivo. METHODS: Thirty-five consecutive total occlusions of > or = 1 month duration in previously untreated native coronary arteries were studied using intracoronary ultrasound following dilatation with a 1.5 mm balloon. Plaque characteristics of lesions with an occlusive duration of > or = 3 months (old occlusions) and those of < 3 months (recent occlusions) were then compared. The ultrasound cross-section where there was maximal plaque accumulation at the site of occlusion was analyzed for its qualitative and quantitative characteristics. The lesion remodeling index was defined as the vessel area at occlusion divided by the vessel area at a proximal reference. RESULTS: The old occlusion group comprised 11 lesions whereas 16 lesions were found in the recent occlusion group; the occlusion duration was undetermined in the remaining 8 lesions, and the mean occlusion duration was found to be 4.9 +/- 4.3 months, over a range of 1 36 months. The baseline clinical and angiographic characteristics were similar in the 2 groups. The lesion remodeling index was found to be significantly lower in older occlusions than in the more recent occlusions (0.75 +/- 0.14 vs. 1. 06 +/- 0.25; p = 0.007) and the duration of the occlusion also correlated with the length of calcified segment as determined by ultrasound (p = 0.040), and with a smaller angiographic proximal reference diameter (p = 0.043). CONCLUSION: Long-standing occlusions undergo lesion shrinkage and exhibit more extensive calcification.

Coronary stenting beyond standard indications. Immediate and follow-up results.

BACKGROUND: Coronary stent has become an accepted treatment modality for selected indications. However, the literature shows diverse results when indications for coronary stenting are different from those tested in large randomized trials. The purpose of this study was to determine immediate and follow-up clinical and angiographic results in patients treated with coronary stenting for indications not specifically tested in large randomized trials. METHODS: Coronary stents were implanted in a total of 2060 lesions (1757 patients) in seven groups with expanded indications: left main coronary lesions, calcified lesions, small vessels (< 3 mm in size), small vessels with diffuse disease, large vessels with diffuse disease, and bifurcation lesions treated with stents in both branches or with one stent implanted only in the major branch. Stents were implanted using high balloon pressure for final inflation and in most cases with intravascular ultrasound. Clinical follow-up was achieved in 96% of patients at a mean time of 12+/-7 months. RESULTS: Primary success (range 89-96%) and acute complications (range 5.7-13%) were comparable in all groups. At follow-up, the mortality rate was highest in the group of left main stenting (12.5%) but 20% of these patients had coronary stenting on non-elective basis. The restenosis rates ranged between 16-43%. The restenosis rate was highest in the group of bifurcation lesions with stent implantation in both vessels leading to a major adverse cardiac event (MACE) rate of 62% in this group. However, the survival rate at 1 and 2 years in the overall study group was 97 and 96%, and the event free survival was 76 and 74%, respectively. The procedure-related predictors of MACE were: final intravascular ultrasound result, use of stents with non-slotted tube morphology, final stent percent stenosis, and vessel size. CONCLUSIONS: Coronary stenting beyond standard indications is feasible, with acceptable primary success and complication rates. However, the overall MACE rates were relatively high (34-62%), in particular for the indication of bifurcation lesions with stents implanted in both vessels.

Contemporary percutaneous treatment of saphenous vein graft stenosis: immediate and late outcomes.

PURPOSE: The aim of this study was to evaluate the immediate and long-term outcomes following percutaneous treatment of an unselected series of saphenous vein graft (SVG) lesions. METHODS AND RESULTS: Consecutive interventions on 129 saphenous vein graft lesions in 101 patients were reviewed. Stents were implanted in 114 lesions (88%), which included the use of polytetrafluoroethylene-covered stents in 22 lesions (17%) and abciximab in 20 patients (20%). Angiographic success was achieved in 125 lesions (97%). In-hospital major adverse cardiac events (MACE) occurred in 11 patients (11%), with myocardial infarction being the most frequent event. Treatment of degenerated SVG lesions and SVG lesions with larger reference diameters correlated with the incidence of in-hospital MACE [odds ratio (OR) = 7.69 and 2.65, respectively; 95% confidence interval (CI) = 1.80Eth 32.8 and 0.99Eth 7.10, respectively)]. Clinical follow-up was achieved in all patients at 25 +/- 21 months. Successful revascularization to all three distributions of the major coronary arteries negatively correlated [relative risk (RR) = 0.43; 95% CI = 0.20Eth 0.92)], while treatment of a degenerated SVG positively correlated (RR = 1.92; 95% CI = 1.05Eth 3.51) with the occurrence of follow-up MACE. A final effective blood supply to the anterior wall and a higher left ventricular ejection fraction was found to negatively correlate with the occurrence of follow-up death (RR = 0. 20 and 0.61, respectively; 95% CI = 0.06Eth 0.60 and 0.41Eth 0.90, respectively). CONCLUSION: Treatment of SVG lesions continues to be associated with a high incidence of myocardial infarction, particularly in cases of degenerated SVG lesions. An effective blood supply to the anterior wall and a higher left ventricular ejection fraction were protective for the occurrence of death during the follow-up period.

Left internal mammary artery graft perforation repair using polytetrafluoroethylene-covered stents.

The increase in the use of the left internal mammary artery (LIMA) as graft of choice to the left anterior descending coronary artery for conventional and minimally invasive coronary artery bypass surgery has led to an increased incidence of LIMA pathologic lesions early after surgery. The lesion, commonly located in the body of the LIMA graft, is usually caused by mechanical injury during harvesting of the vessel. In this context, percutaneous intervention with stent implantation can be complicated by vessel rupture, which usually requires emergency surgical repair. We describe two cases of stent implantation in newly placed LIMA grafts complicated by vessel rupture, which were successfully repaired using polytetrafluoroethylene-covered stents.

Effectiveness and complications of vascular access closure devices after interventional procedures.

BACKGROUND: Vascular closure devices are designed to obtain a fast hemostasis of the vascular access site after diagnostic and interventional procedures. This result should be obtained with a low incidence of complications. METHODS: A retrospective, non-randomized study was performed to evaluate the success rate and vascular complications associated with the use of two different vascular sealing devices [Angio-Seal (Daig Corporation, Minnetonka, Minnesota) and Prostar (Perclose, Inc., Redwood City, California)] after interventional procedures. RESULTS: Eight-hundred and twenty-seven devices were used (245 Angio-Seal and 582 Prostar). Angio-Seal success rate was 92% with a 2.5% rate of vascular complications; Prostar success rate was 89% with a 3.4% rate of vascular complications. Multivariate logistic regression analysis identified advanced age (p < 0.05) and lower weight (p < 0.05) as independent predictors of vascular complications associated with Angio-Seal use, while diabetes (p < 0.05) was found to be a predictor of vascular complications in the Prostar group. Abciximab use and larger sheath size were not associated with an increased probability of vascular complications. CONCLUSION: Angio-Seal and Prostar obtain a fast vascular access hemostasis after interventional procedures, with a low incidence of major vascular complications.

European high-activity (32)P radioactive stent experience.

Brachytherapy by implantation of a radioactive stent is an alternative approach to catheter-based systems to reduce restenosis. The pilot clinical trials using 32P radioactive b-emitting stents at low-to-intermediate activity (0.5Eth 3.0 mCi) showed that restenosis at 6 months was not different from that of currently available non-radioactive stents. The evaluation of the efficacy in reducing restenosis of radioactive stents with higher activities (3Eth 24 mCi) started in Europe (Milan, Rotterdam and Vienna) between 1998 and 1999. In the Milan and Rotterdam experience, 32P radioactive stents with an activity of 3Eth 12 mCi demonstrated a reduction of intra-stent restenosis to < 4%. However, a high-edge restenosis > 30% was observed in the first 1Eth 3 mm outside the stent margins. This edge effect might be due to a low dose of radiation at the stent margins combined with systematic balloon injury in the reference segments. The hypothesis that a further increase in stent activity (12Eth 21 mCi) associated with a reduced balloon injury outside the stent could solve the problem of edge restenosis was not confirmed by the Milan experience; edge restenosis still occurred in 26% of the lesions treated by a single 32P radioactive stent, even if a nonaggressive stent implantation strategy was used. Two approaches under investigation to solve the problem of edge restenosis are: 1) lengthening the stent with a non-radioactive stent (cold-ends stent) to prevent negative remodeling; and 2) extending the area of irradiation beyond the balloon-injured area by an increased activity at the stent ends (hot-ends stent).

Coronary stenting versus balloon angioplasty in small coronary artery with complex lesions.

The impact of stenting on small vessels (< 3.0 mm) with complex lesions (B2-C) is still controversial. Restenosis rate in this population is high (> 40%). We compared early and late outcome of patients with complex coronary lesions in small vessel treated with traditional coronary angioplasty (angioplasty group) and with elective stent implantation (stent group). Angioplasty group (n = 97) and stent group (n = 112) were comparable for all clinical and angiographic characteristics. All patients in the two groups had clinical and angiographic follow-up. Major adverse cardiac events (MACE) and restenosis rate were evaluated. No patients in the two groups experienced in-hospital death or bypass surgery. Myocardial infarction occurred in four patients in the angioplasty group and in seven patients in the stent group (P = 0.36). No patients in either the angioplasty or the stent group had acute stent thrombosis, whereas subacute stent thrombosis occurred in only one patients of the stent group (0.9%). Long-term MACEs (20 +/- 4 month) were not different in the two groups (angioplasty group 39% vs. stent group 44%, P = 0.35). Target lesion revascularization rate was 33% in the angioplasty group and 34% in the stent group (P = 0.50). Restenosis rate was not statistically different in the two groups (stent group 41% vs. angioplasty group 38%, P = 0.41). In conclusion, compared to balloon angioplasty, elective stent implantation in small vessels with complex lesions does not improve early and late outcome. Cathet. Cardiovasc. Intervent. 50:390-397, 2000.

Cutting balloon angioplasty for the treatment of in-stent restenosis.

The results using the Cutting Balloon for the treatment of in-stent restenosis may be superior to those of conventional percutaneous transluminal coronary angioplasty (PTCA) or even the combination of PTCA preceded by rotational atherectomy. The reasons for these possible differences are not yet well defined. The case we report suggests that the Cutting Balloon achieves a better final result than conventional PTCA, by making the tissue more amenable to being pushed outward through the stent struts.