[Stent coated with bovine pericardium: in vitro evaluation, in animals, and initial results in humans]. / Stent cubierto con pericardio bovino: evaluación in-vitro, en animales y resultados iniciales en el humano.

Covering a stent with a membrane (stent graft) allows treatment of diverse coronary abnormalities such as aneurysms, rupture and fistulas (which, until recently, required surgical therapy). A stent graft could also reduce embolic complications associated with angioplasty of saphenous vein grafts. The objective of this study is to evaluate bovine pericardium as a graft for conventional stents. In vitro testing of the bovine pericardium disclosed an elasticity of 15% and a resistance to rupture of 0.22 kg/mm2, well above the pressure commonly used during stent deployment. In 18 pigs, 29 of 32 (90.63%) attempts to implant stent grafts were successful. Histology of acute porcine studies revealed correct apposition of the stent graft to the vessel wall, subacute and chronic (10 days and 1 month) samples showed adequate endothelization and exclusion of proliferative media. Twenty stents were placed in 15 patients with a 100% success rate. Seven patients had coronary aneurysms and in all a complete exclusion of the aneurysm was obtained without complications. Fourteen patients have a follow-up of 6 or more months with evidence of clinical restenosis in 2 (14.28%), whereas angiographic follow-up in 9 patients, which included the 2 cases with recurrent angina, evidenced restenosis in 3 of 14 stents (21.4%), two of which were overlapped in the LAD of one patient and one corresponded to a series of 9 stents (in 5 patients) placed in saphenous vein grafts. It is concluded that bovine pericardium is a suitable material for stent-grafts and its efficacy to seal coronary aneurysms was demonstrated. These results warrant a larger comparative study to better define its restenosis rate and further delineate its usefulness in the treatment of diseased saphenous vein grafts.

Intravascular ultrasound-guided optimized stent deployment. Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study)

OBJECTIVES: A study was set up to validate the safety and feasibility of intravascular ultrasound-guided stenting without subsequent anticoagulation, and its impact on the 6 months restenosis rate. METHODS: The study was designed to be multicentred, prospective, and observational. RESULTS: One hundred and sixty-one patients with stable angina and a de novo coronary artery lesion were enrolled. In four patients, the implantation of a Palmaz-Schatz (with spiral bridge) stent had failed. One of these four patients died 3 days following bypass surgery. In two other patients, intravascular ultrasound assessment was not performed. One hundred and twenty-five of the remaining 155 patients (81%) were treated with aspirin (100 mg x day(-1)), because all three criteria for optimized stent expansion were met. Twenty-two of the remaining 38 patients (25%), in whom at least one criterion was not met were treated with aspirin and acenocoumarol (3 months, INR 2.5-3.5), while 16 patients only received aspirin. Stent thrombosis was documented in two patients (1.3%) for which repeat angioplasty was performed. During the hospital stay, there were no deaths or Q-wave myocardial infarctions. Five patients (3.2%) sustained a non-Q-wave myocardial infarction. During the follow-up period (198+/-38 days, complete for all patients, except one), one patient (0.6%) sustained a Q-wave myocardial infarction, one (0.6%) underwent bypass surgery, and repeat angioplasty was performed in nine patients (5.7%). In two of the nine patients, repeat angioplasty involved another lesion. Therefore, the target lesion revascularization rate during follow-up was 4.5% (seven patients). At quantitative coronary angiography, the minimal lumen diameter (mean+/-SD) increased from 1.12+/-0.34 mm before to 2.89+/-0.35 mm after stenting. Repeat angiography at 6 months was performed in 144 patients (92%). The minimal lumen diameter at follow-up was 2.12+/-0.67 mm. Restenosis (diameter stenosis of 50% or more) was documented in 12 patients or 8.3%. When the two patients with documented stent thrombosis are included, the restenosis rate amounts to 97%. CONCLUSIONS: These data confirm that, in selected patients, stents can safely be implanted without the use of systemic anticoagulation, provided optimal stent expansion is achieved. The exact role of intravascular ultrasound in the achievement of these results needs to be established by appropriately designed studies. In the meantime, intravascular ultrasound coupled with the Palmaz-Schatz stent incorporating a spiral bridge, may have contributed considerably to the immediate angiographic outcome, which in turn may explain the favourable clinical and angiographic outcome at 6 months.

Procedural and follow up results with a new balloon expandable stent in unselected lesions.

OBJECTIVE: To assess the clinical and angiographic results of the first clinical application of a new balloon expandable stent, the NIR stent, characterised by high longitudinal flexibility and low profile before expansion, and by high radial support and minimal recoil and shortening after expansion. DESIGN: Single centre survey of unselected lesions in consecutive patients. SETTING: Tertiary referral centre. PATIENTS AND LESIONS: 93 stents of various length (9, 16, and 32 mm) were implanted in 64 lesions in 41 patients. Twenty lesions (31%) were longer than 15 mm, and 17 lesions (27%) were located in vessels with a diameter smaller than 2.5 mm. Extreme tortuosity of the proximal vessel was present in 15 lesions (23%). All patients were treated with aspirin and ticlopidine. All lesions were evaluated before and after treatment by quantitative angiography, and in 47 lesions (75%) the stent expansion was also controlled by intracoronary ultrasound. Clinical follow up was available in all patients and angiographic follow up was performed in 53 lesions (84%), at a mean (SD) interval of 5.4 (1.7) months. RESULTS: Deployment of the stent failed in two lesions (3%). Minimum lumen diameter increased from 1.01 (0.54) mm to 2.94 (0.49) mm, and diameter stenosis decreased from 66(15)% to 7(11)%. There was one in-hospital non-Q wave myocardial infarction, one sudden death after 40 days, and 17 target lesion revascularisations (27%). Angiographic restenosis (> or = 50% diameter stenosis) was documented in 19 lesions (36% of all lesions with angiographic follow up), with an average residual diameter stenosis of 43(21)% and minimum lumen diameter of 1.63 (0.74) mm. Restenosis was more common in vessels with a reference diameter < 2.5 mm (45%) and for lesions longer than 15 mm (46%). CONCLUSIONS: The NIR stent could be used successfully in most lesions, achieving optimal angiographic results with very few in-hospital or subacute cardiac events. The angiographic restenosis rate and need for target lesion revascularisation remained high in this unfavourable lesion subset, especially in small vessels and long lesions.

First international new intravascular rigid-flex endovascular stent study (FINESS): clinical and angiographic results after elective and urgent stent implantation. The FINESS Trial Investigators.

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

Treatment of spontaneous coronary artery dissection: report of three cases.

Spontaneous coronary artery dissection is an extremely rare cause of myocardial infarction. It has been reported mainly in young women during or after pregnancy. The prognosis and treatment of coronary dissection are not clear. We report three cases of spontaneous coronary artery dissection in young women. One of them was pregnant and one was 2 weeks after delivery. The dissection involved the left anterior descending artery (LAD) in two cases and the left main coronary artery in one case. There was no evidence of atherosclerosis on angiography or intracoronary ultrasound in any of the patients. Two of the women were treated by stent implantation with excellent results. This is the first known report of successful coronary stenting of spontaneous coronary artery dissection. The pregnant woman was not a candidate for stent implantation and underwent implantation of the left internal mammary to the LAD without cardiopulmonary bypass. She completed her pregnancy uneventfully.

Intracoronary stent insertion after balloon angioplasty of chronic total occlusions.

OBJECTIVES: This retrospective analysis was performed to assess the medium-term effectiveness of implanting intracoronary stents into chronic total occlusions that are successfully opened by balloon angioplasty. BACKGROUND: The value of percutaneous transluminal coronary angioplasty of chronic total occlusions is limited by a very high restenosis rate of 50% to 68%. Intravascular stents have been shown to reduce restenosis in a subset of patients with subtotal stenoses. It has not been demonstrated that the placement of stents into successfully opened chronic total coronary artery occlusions leads to lower rates of restenosis. METHODS: A consecutive series of patients with chronic total coronary occlusions successfully opened by balloon angioplasty received Palmaz-Schatz stents. Patients underwent clinical and angiographic follow-up at a mean of 6 months after stent insertion. Angiographic and clinical results were retrospectively analyzed. RESULTS: Fifty-nine patients underwent stenting of 60 chronic total coronary occlusions, with a 98% rate of successful stent deployment. Complications occurred in 5% of cases, all with subacute thrombosis. Angiographic follow-up was obtained in 88% of patients at a mean of 6 months and demonstrated an angiographic restenosis rate of 20%, with only one reocclusion. Among several variables examined, only the presence of a procedure-related moderate to severe dissection was associated with higher follow-up percent diameter stenoses and clinical events. At a mean of 14 months after stent insertion, 77% of patients remained free of symptoms or clinical events. CONCLUSIONS: The implantation of intracoronary stents into vessels with opened chronic total coronary occlusions is associated with favorable rates of angiographic restenosis and relief of symptoms. A randomized clinical trial comparing balloon angioplasty with stent-assisted balloon angioplasty in the treatment of chronic total coronary occlusions is indicated.

Balloon expandable stent implantation after iatrogenic arterial dissection of the left subclavian artery.

A patient undergoing attempted angioplasty of a left internal mammary artery graft to left anterior descending coronary artery developed an iatrogenic dissection of the left subclavian artery, with symptoms of left arm claudication. A balloon expandable stent was inserted with an excellent angiographic result. The patient has remained free of symptoms or signs of decreased arm flow, with a patent subclavian artery demonstrated on angiography 8 months later. The excellent early-to-moderate term clinical and angiographic results support the efficacy of this technical approach.

Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance.

BACKGROUND: The placement of stents in coronary arteries has been shown to reduce restenosis in comparison to balloon angioplasty. However, clinical use of intracoronary stents is impeded by the risk of subacute stent thrombosis and complications associated with the anticoagulant regimen. To reduce these complications, the hypothesis that systemic anticoagulation is not necessary when adequate stent expansion is achieved was prospectively evaluated on a consecutive series of patients who received intracoronary stents. METHODS AND RESULTS: From March 1993 to January 1994, 359 patients underwent Palmaz-Schatz coronary stent insertion. After an initial successful angiographic result with < 20% stenosis by visual estimation had been achieved, intravascular ultrasound imaging was performed. Further balloon dilatation of the stent was guided by observation of the intravascular ultrasound images. All patients with adequate stent expansion confirmed by ultrasound were treated only with antiplatelet therapy (either ticlopidine for 1 month with short-term aspirin for 5 days or only aspirin) after the procedure. Clinical success (procedure success without early postprocedural events) at 2 months was achieved in 338 patients (94%). With an inflation pressure of 14.9 +/- 3.0 atm and a balloon-to-vessel ratio of 1.17 +/- 0.19, optimal stent expansion was achieved in 321 of the 334 patients (96%) who underwent intravascular ultrasound evaluation, with these patients receiving only antiplatelet therapy after the procedure. Despite the absence of anticoagulation, there were only two acute stent thromboses (0.6%) and one subacute stent thrombosis (0.3%) at 2-month clinical follow-up. Follow-up angiography at 3 to 6 months documented two additional occlusions (0.6%) at the stent site. At 6-month clinical follow-up, angiographically documented stent occlusion had occurred in 5 patients (1.6%). At 6-month clinical follow-up, there was a 5.7% incidence of myocardial infarction, a 6.4% rate of coronary bypass surgery, and a 1.9% incidence of death. Emergency intervention (emergency angioplasty or bailout stent) for a stent thrombosis event was performed in 3 patients (0.8%). The overall event rate was relatively high because of intraprocedural complications that occurred in 16 patients (4.5%). Intraprocedural complications, however, decreased to 1% when angiographically appropriately sized balloons were used for final stent dilations. There was one ischemic vascular complication that occurred at the time of the procedure and one ischemic vascular complication that occurred at the time of angiographic follow-up. By 6 months, repeat angioplasty for symptomatic restenosis was performed in 47 patients (13.1%). CONCLUSIONS: The Palmaz-Schatz stent can be safely inserted in coronary arteries without subsequent anticoagulation provided that stent expansion is adequate and there are no other flow-limiting lesions present. The use of high-pressure final balloon dilatations and confirmation of adequate stent expansion by intravascular ultrasound provide assurance that anticoagulation therapy can be safely omitted. This technique significantly reduces hospital time and vascular complications and has a low stent thrombosis rate.

Clinical and angiographic outcome after Palmaz-Schatz stent implantation guided by intravascular ultrasound.

Intracoronary stents can be implanted with a low incidence of stent thrombosis (< 1%) when the stent procedure is guided by intravascular ultrasound. The long-term clinical and angiographic effects, however, have not been reported. This study assesses the 6 month clinical and angiographic results of a consecutive series of patients with intravascular ultrasound guided Palmaz-Schatz stent deployment that were not treated with subsequent anticoagulation after a successful stent implantation procedure. From March, 1993 to April 1994, 411 patients underwent Palmaz-Schatz stent implantation. There were 26 patients that had uncomplicated Palmaz-Schatz stent implantation that were treated with a standard anticoagulation regimen that are not evaluated in this study. Thus, this study includes an assessment of 385 patients that had either a successful intravascular ultrasound guided stent implantation procedure and did not receive post procedure anticoagulation or had a procedural complication. Procedural success was achieved in 369 patients (96%). Clinical success (procedure success without early post procedure event) was achieved in 363 patients (94%). There were 2 acute stent thrombosis events (0.5%) and 1 subacute stent thrombosis (0.3%) in the group of 369 patients with 454 lesions treated without anticoagulation. At 6 month clinical follow-up the incidence of myocardial infarction was 4.9% and the rate of coronary bypass surgery was 6.2%. There was a 2.1% incidence of death. Emergency intervention (emergency angioplasty or bailout stent implantation was necessary in 3 patients (0.8%). The total incidence of repeat percutaneous intervention was 11.4%. By 6 months clinical follow-up, major events had occurred in 19.2% of patients. The angiographic lesion restenosis rate, according to 50% diameter stenosis criteria, was 19%. The incidence of restenosis per patient was 22%. In conclusion, intravascular ultrasound guided Palmaz-Schatz can be performed without subsequent anticoagulation with a low incidence of stent thrombosis and acceptable clinical and angiographic outcome at 6 month clinical follow-up.

Benefit of intracoronary ultrasound in the deployment of Palmaz-Schatz stents.

OBJECTIVES: This study was designed to evaluate the changes in intrastent and angiographic dimensions when intravascular ultrasound imaging is used to direct the deployment of balloon-expandable Palmaz-Schatz stents in coronary arteries and saphenous vein grafts. BACKGROUND: Intravascular ultrasound provides more information than angiography in the imaging of intravascular structures. Previous studies have shown that obtaining a larger lumen (greater "acute gain") with coronary interventions such as stenting leads to less restenosis and subacute thrombosis. It is not clear whether the information obtained by intravascular ultrasound can be used to obtain a greater acute gain in lumen dimensions. METHODS: Forty consecutive patients undergoing Palmaz-Schatz stent implantation had intravascular ultrasound imaging performed after a good angiographic appearance was obtained. If the stent did not appear adequately expanded by intravascular ultrasound, or if the struts were poorly apposed to the arterial wall, further stent dilation with larger balloons or higher pressure inflations were performed. Twenty-nine patients had subsequent intravascular ultrasound imaging. Intrastent diameters and areas were compared from the initial to the final intravascular ultrasound studies. RESULTS: Of the 40 patients studied, only 5 (13%) had an adequate result by intravascular ultrasound despite an acceptable angiographic appearance in all patients. Six additional patients did not undergo subsequent intravascular ultrasound imaging. The other 29 patients all demonstrated a significant increase in intrastent minimal diameter (mean 19%), major diameter (11%) and cross-sectional area (34%) (p < 0.001 for all measurements). CONCLUSIONS: The use of intravascular ultrasound imaging in the deployment of balloon-expandable Palmaz-Schatz stents leads to a significant increase in intrastent dimensions (greater "acute gain").

Preliminary experience with intravascular ultrasound guided Palmaz-Schatz coronary stenting: the acute and short-term results on a consecutive series of patients.

The purpose of this study was to prospectively test the hypothesis that systemic anticoagulation is not needed following coronary stenting when adequate stent expansion is achieved and documented and other flow limitations eliminated. Intravascular ultrasound (IVUS) was used to confirm adequate stent expansion, which was defined as good plaque compression together with the achievement of an intrastent lumen cross-sectional area (CSA) that was greater than 40% of the average reference vessel CSA. In this prospective study, Palmaz-Schatz coronary stenting was performed on 343 lesions in 263 consecutive patients. Primary stenting was successful in 254 patients (96.6%) and 332 lesions (96.8%). All patients with successful primary stenting underwent IVUS imaging except nine patients (13 lesions) that did not have an IVUS evaluation for technical reasons and three patients (4 lesions) in which IVUS was unsuccessful. The initial IVUS performed after achieving an acceptable angiographic result revealed inadequate stent expansion in 191 patients (79%) and 244 lesions (77%). After further dilatation, final adequate stent expansion was accomplished in 230 patients and 301 lesions. These patients were treated with Ticlopidine 250 mg twice per day for 2 months and did not receive postprocedure anticoagulation. There was one acute stent thrombosis (0.3%) that occurred in a lesion with slow flow and an inadequately expanded stent. There was no subacute stent thrombosis and no bleeding or vascular complications. We conclude that when adequate stent expansion is achieved and confirmed and other flow limiting lesions eliminated, that systemic anticoagulation after the stent procedure is not necessary.

Survival after percutaneous transluminal coronary angioplasty in patients with severe left ventricular dysfunction.

To assess the effects of coronary angioplasty in patients with severe left ventricular dysfunction, the results of procedures, performed between 1987 and 1991, in 100 patients (90 male) with left ventricular function < or = 0.35 (range, 0.20 to 0.35) and anginal symptoms were analyzed. Mean age was 62 +/- 10 years (range, 38 to 85 years). Ninety-five patients had previous myocardial infarction and 27 patients had previous coronary artery bypass grafting. Unstable angina was present in 81 percent of patients. Single-vessel disease was present in 6 patients, double vessel was present in 31 patients, and triple-vessel disease was present in 63 patients. Percutaneous transluminal coronary angioplasty (PTCA) was attempted on 164 vessels, 27 of these with chronic total occlusion. The overall angiographic success rate was 84 percent. Myocardial infarction occurred in four patients, six patients underwent urgent coronary bypass surgery, and seven patients died of cardiac causes. There was a 9 percent incidence of total in hospital mortality. Major complications were significantly more frequent in patients with triple-vessel disease. Clinical success was achieved in 75 patients, 55 of these with incomplete revascularization. Long-term follow-up (mean, 19 +/- 7 months) was available in all patients with clinical success. Thirteen patients had repeated PTCA, 8 patients had coronary surgery, and 13 patients died. In conclusion, in patients with severe left ventricular dysfunction, acute complications and late mortality rate are high. Patients with triple-vessel disease are a higher risk subset and have no long-term benefits by PTCA.

A novel strategy for stent deployment in the treatment of acute or threatened closure complicating balloon coronary angioplasty. Use of short or standard (or both) single or multiple Palmaz-Schatz stents.

OBJECTIVES: The purpose of this study was to determine the immediate and long-term angiographic and clinical results of coronary stenting as a specific therapy for intracoronary dissection associated with acute or threatened closure complicating percutaneous transluminal coronary angioplasty. BACKGROUND: Published reports contain conflicting results with regard to the benefit of stent insertion for coronary dissection. In particular, there is a wide range in the reported rates of subacute occlusion. METHODS: Palmaz-Schatz stents were inserted in 56 patients who had significant dissections and acute or threatened closure complicating coronary angioplasty. An attempt was made to cover the entire site of the dissection with short or standard single or multiple Palmaz-Schatz stents. The use of the short stent allowed complete coverage of the dissection, specifically in situations such as marked vessel tortuosity or the need to place a stent distal to a deployed stent. RESULTS: A single stent was implanted in 24 patients and multiple stents were implanted in 32 patients. A total of 138 stents (78 standard, 60 short stents) were implanted. The primary clinical success rate was 88% (49 of 56 patients). Complications occurred in seven patients (12.5%): Three patients (5%) required urgent bypass surgery; two patients (4%) had a myocardial infarction; and two patients (4%) died. Subacute occlusion occurred in one patient (2%). Clinical follow-up was available in all patients at a mean of 10 +/- 4 months. Thirty-nine (80%) of 49 patients were clinically asymptomatic. Angiographic restenosis was found in 15 (36%) of 42 patients on angiographic follow-up performed a mean of 5 months (median 6) after the procedure in 86% of the eligible patients. Nine patients had successful repeat angioplasty, and two had elective bypass surgery. CONCLUSIONS: The strategy of coronary stenting to completely cover the lesion is an effective treatment for large coronary dissection complicating angioplasty. A total major complication rate of 12.5% may be acceptable for this high risk group.

Treatment of simple and complex coronary stenosis using rotational ablation followed by low pressure balloon angioplasty.

High speed coronary rotational ablation followed by adjunctive low pressure coronary balloon angioplasty was used in 166 patients. Complex lesions were present in 63% of patients. Clinical success was achieved in 157 patients (95%). Angiographic success rate was 10% in A lesions, 95% in B1 lesions, 98% in B2 lesions, and 93% in C lesions. Mean vessel lumen diameter has increased from 0.4 mm to 1.4 mm after rotational ablation and to 2.3 mm following adjunctive balloon angioplasty. Left ventricular dysfunction, the presence of total occlusion, and the severity of stenosis before the procedure were predictive of clinical failure. There were three abrupt vessel closures (1.8%) with one Q wave myocardial infarction. Non-Q wave myocardial infarction occurred in 14 patients (8.4%) and three patients died during hospitalisation (1.8%). We conclude that rotational atherectomy followed by adjunctive low pressure balloon angioplasty gives comparable high success rates in different coronary lesions.

Coronary stenting: single institution experience with the initial 100 cases using the Palmaz-Schatz stent.

We studied 100 patients who had coronary implantation of Palmaz-Schatz stents in our institution from November 1989 until March 1991. A total of 126 standard and 6 short stents were implanted. The patients' mean age was 58 +/- 5 years, and 97 were males. The indications were lesions with high risk of restenosis (29 patients), restenosis (27 patients), suboptimal result of angioplasty (24 patients), dissection (16 patients), and recanalized chronic total occlusion (6 patients). In 17 patients a brachial cut-down approach was used. Stents were correctly placed in 98 patients. Stent related complications occurred in 9 patients: major ischemic complications in 7 patients (acute myocardial infarction in 2 patients, emergency bypass surgery in 3 patients and emergency angioplasty in 2 patients); in 3 of these patients there was a subacute closure of the stent and in 2 patients there were delivery problems. Vascular complications at the site of arterial puncture occurred in 3 patients (some patients had more than one complication). A learning curve was observed. There was a decrease in the complication rate with the higher number of patients treated: 28% for the first 50 patients and 6% for the last 50 patients. Clinical follow-up was available in all patients. Of the 92 patients eligible for follow-up (7 +/- 2 months), 69 patients were asymptomatic and 23 had recurrence of angina: 19 patients for stent restenosis and 4 patients for coronary artery disease progression. Follow-up angiogram was done in 79/92 (86%) patients: 21 had restenosis (27%).(ABSTRACT TRUNCATED AT 250 WORDS)

Coronary stenting with a balloon-expandable stent after the recanalization of chronic total occlusions.

To diminish the restenosis rate after successful recanalization of chronic total coronary occlusion, we have implanted the Palmaz-Schatz stent in 6 patients. All procedures were successfully done without major complications. The angiographic follow-up at 6 months showed restenosis in one asymptomatic patient who had had 2 stents implanted. Five other patients had no evidence of restenosis.

Initial experience with the disarticulated (one-half) Palmaz-Schatz stent: a technical report.

We developed an alternative method to stent suitable lesions located in anatomical settings considered to be too complex for regular Palmaz-Schatz stent placement. This method consists of using a disarticulated (one-half) Palmaz-Schatz stent. Eight patients underwent stenting utilizing this method. The left anterior descending was stented in five patients, the right coronary artery in one patient, the proximal and mid shaft of a vein graft in one patient, and a protected left main coronary artery in one patient. In all patients the stents were placed in addition to full stents. In four patients, 1 1/2 stents were placed; two patients had 2 1/2 stents; one patient had 3 1/2 stents and the last patient had a total of 5 stents placed (1 full stent and 8 half stents). One patient had 8 disarticulated stents placed. All half stents prepared for delivery were successfully deployed to the pre-designated angiographic site without complication.