Does ticlopidine reduce reocclusion and other adverse events after successful balloon angioplasty of occluded coronary arteries? Results from the Total Occlusion Study of Canada (TOSCA).

OBJECTIVES: Ticlopidine reduces stent thrombosis and other adverse events among patients receiving coronary stents. Whether ticlopidine is beneficial after balloon angioplasty is unknown. Our purpose was to compare the clinical outcome of patients undergoing balloon angioplasty treated with both aspirin and ticlopidine versus aspirin alone. METHODS AND RESULTS: We performed a databank analysis of the Total Occlusion Study of Canada (TOSCA), a randomized trial with angiographic follow-up comparing the frequency of reocclusion after angioplasty of a subtotal or total coronary occlusion in patients receiving >/=1 heparin-coated Palmaz-Schatz stent versus balloon angioplasty alone. In TOSCA, 102 patients undergoing balloon angioplasty were treated with both aspirin and ticlopidine (generally for 15-30 days) and 94 were treated with aspirin alone, by physician preference. After 6 months, failure to sustain patency (less than Thrombolysis in Myocardial Infarction [TIMI] grade 3 flow on follow-up angiography) occurred in 23% of patients on ticlopidine and aspirin versus 16% of patients on aspirin alone (P =.21); the frequency of target vessel revascularization was also similar in the 2 groups (32% vs 25%, P =.27). Myocardial infarction was infrequent in both groups (2.0% vs 1.1%, respectively, P not significant). Patients treated with aspirin and ticlopidine had more adverse angiographic and procedural characteristics, including longer lesions and treatment lengths. Multivariate analysis to adjust for these and other differences failed to reveal a benefit of ticlopidine in maintaining patency and reducing adverse clinical events. CONCLUSIONS: After balloon angioplasty of a subtotal or total coronary occlusion, no reduction in adverse events was observed among patients in whom ticlopidine was added to aspirin, even after adjustment for clinical and lesion characteristics.

Improved clinical outcome after widespread use of coronary-artery stenting in Canada.

BACKGROUND: The introduction and refinement of coronary-artery stenting dramatically changed the practice of percutaneous coronary revascularization in the mid-1990s. We analyzed one-year follow-up data for all percutaneous coronary interventions performed in a large, unselected population in Canada to determine whether the use of coronary stenting has been associated with improved outcomes. METHODS: Prospectively collected data on all percutaneous coronary interventions performed on residents of British Columbia, Canada, between April 1994 and June 1997 were linked to province-wide health care data bases to provide the date of the following end points: subsequent target-vessel revascularization, myocardial infarction, and death. Baseline characteristics and procedural variables were identified and Kaplan-Meier survival curves were generated for 9594 procedures divided into seven groups, one for each sequential half-year period. RESULTS: The overall burden of coexisting illnesses remained stable throughout the study period. A large increase in the rate of coronary stenting (from 14.2 percent in the period from April to June 1994 to 58.7 percent in the period from January to June 1997) was associated with a significant reduction in the rate of adverse cardiac events at one year (from 28.8 percent to 22.8.percent; adjusted relative risk, 0.79; 95 percent confidence interval, 0.69 to 0.90; P<0.001). This reduction in adverse events was exclusively due to a large reduction in subsequent target-vessel revascularization (from 24.4 percent to 17.0 percent; adjusted relative risk, 0.72; 95 percent confidence interval, 0.62 to 0.83; P<0.001) without significant changes in the overall rates of myocardial infarction (5.4 percent, P=0.28) or death (3.9 percent, P=0.65). CONCLUSIONS: The need for target-vessel revascularization during one year of follow-up decreased after percutaneous coronary intervention during the mid-1990s. The reduction was coincident with the introduction and subsequent widespread use of coronary stenting.

Early and intermediate term clinical outcome after multiple coronary stenting.

OBJECTIVE: To examine the immediate and intermediate term clinical outcome of multiple coronary stenting. DESIGN: Consecutive patients were prospectively entered on a dedicated database. Follow up information was obtained from outpatient and telephone interviews with patients and family physicians. SETTING: A tertiary referral centre. PATIENTS: 140 consecutive patients underwent multiple coronary stenting between April 1994 and November 1996. Most patients had unstable coronary syndromes. MAIN OUTCOME MEASURES: Death, cerebrovascular accidents, myocardial infarction (MI), coronary artery bypass surgery (CABG), and repeat angioplasty (PTCA). RESULTS: The angiographic success rate was 100% and the clinical procedural success rate 93%. The mean (SD) follow up was 11.9 (7.2) months (range 2-32). The mean (SD) number of stents per patient was 2.4 (0.7). The mean (SD) number of lesions treated per patient was 1.4 (0.6). There were four in-hospital deaths (2.9%) and five patients (3.6%) had an MI before hospital discharge. All in-hospital deaths occurred in patients presenting with an acute MI and cardiogenic shock. Three patients (2.2%) had a late MI. One patient with stent thrombosis underwent emergency CABG. Three patients (2.2%) underwent late CABG. Eight patients (5.7%) had a repeat PTCA. Eighty three patients (61.5%) were asymptomatic at follow up and 121 (86.4%) were free from major clinical events. CONCLUSION: In an era of increased operator experience, high pressure stent deployment, and reduced anticoagulation with antiplatelet treatment alone, multiple coronary stenting may be performed with a high procedural success rate and good intermediate term outcome.

Multiple coronary stenting in unstable angina: early and late clinical outcomes.

We examined clinical outcomes in 110 consecutive patients with unstable angina who underwent multiple coronary stenting over a 32-mo period. The main outcome measures were death, stroke, myocardial infarction, bypass surgery, and repeat angioplasty. The angiographic success rate was 100%, and the procedural success rate was 96%. There were no in-hospital deaths and five (4.5%) patients had a myocardial infarction prior to discharge. There were four (3.6%) stent thromboses with one (0.9%) patient requiring urgent bypass surgery and two (1.8%) requiring repeat angioplasty. At late follow-up (11.9+/-7.1 mo), there was (0.9%) death and three patients (2.8%) suffered myocardial infarction. Three (2.8%) patients underwent late bypass surgery and five (4.6%) had a repeat angioplasty. At follow-up, 86% of patients were event free. We conclude that multiple coronary stenting in unstable angina may be performed with a high procedural success rate and good long-term outcome.

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.

Left main intervention revisited: early and late outcome of PTCA and stenting.

We reviewed our experience with 28 unselected, consecutive patients undergoing left main coronary artery (LMCA) angioplasty who had been considered unsuitable for coronary artery bypass graft surgery (CABG). Fourteen patients (50%) had a protected LMCA circulation. Balloon angioplasty was performed in 11 patients (39.3%), and stents were implanted in 17 patients (60.7%). The procedure was elective in 22 patients (78.6%) and acute in the setting of myocardial infarction/cardiogenic shock in 6 (21.4%). The mean follow-up duration was 15.9 +/- 12 months. There were 5 early (before hospital discharge) and 4 late deaths (total 32.1%), 1 myocardial infarction (3.6%), 6 repeat angioplasties (21.4%), and 3 subsequent CABG (10.7%). All 5 early deaths occurred in patients with cardiogenic shock and unprotected circulation. The results of our study suggest that when patients have prohibitive surgical risks, elective LMCA angioplasty and/or stenting may be undertaken with a high procedural success rate. However, our data do not support intervention in the presence of acute myocardial infarction/cardiogenic shock.

Comparison of bailout versus elective stenting: time to reassess our benchmarks of outcome.

The aim of this study was to compare the clinical outcome of elective and bailout stenting in an era of improved stent deployment techniques and antithrombotic therapy. We retrospectively analysed 136 consecutive patients undergoing stent implantation over a 15 mo period. There was no significant difference in the follow-up duration, length of hospital stay, or the total incidence of major complications between the two groups. Bailout stenting, as compared to elective stenting, was not associated with an increased incidence of in-hospital (no death vs. 1.4%, 4.6% non-Q myocardial infarction vs. 0%, 7.7% vascular complications vs. 7.0%) or late complications (no death vs. 1.4%, no non-Q myocardial infarction vs. 2.8%, 3.1% repeat angioplasty vs. 5.6%, 1.5% coronary artery bypass surgery vs. 1.4%). Stents can be implanted in cases of failed angioplasty with a success rate similar to that of elective stent implantation with a low incidence of complications and equivalent clinical outcome.

Antiplatelet therapy alone is safe and effective after coronary stenting: observations of a transition in practice.

OBJECTIVE: To evaluate the safety and efficacy of transition in practice after coronary stenting to antiplatelet therapy alone compared with anticoagulation with warfarin. DESIGN: Retrospective analysis of coronary stent management in a tertiary Canadian centre. PATIENTS: A total of 136 consecutive patients (146 lesions) were analyzed who underwent Palmaz-Schatz coronary stenting over a 15-month period and were treated with anticoagulation with warfarin (56 patients) or antiplatelet therapy alone with ticlopidine and acetylsalicylic acid (80 patients) during the transition in poststenting therapy in the authors' practice. Treatment was continued for 30 days in both groups. High pressure stent deployment was used in the majority of cases (greater than 90%), and use of intravascular ultrasound was infrequent (less than 12%). MAIN RESULTS: At 30 days, there were no clinical manifestations of stent thrombosis, coronary artery bypass surgery or repeat angioplasty in either group. One death occurred in the antiplatelet group. Periprocedural non-Q wave myocardial infarction occurred in two patients in the antiplatelet group and in one patient in the warfarin group. There was a significantly higher incidence of vascular complications in the warfarin group than in the antiplatelet group (14.3% versus 2.5%, respectively, P = 0.04). The length of hospital stay was significantly shorter in the antiplatelet group than in the warfarin group (3.0 +/- 1.8 versus 6.7 +/- 2.6 days, respectively, P < 0.001). CONCLUSIONS: Reduced anticoagulation with antiplatelet therapy alone after coronary stenting, despite infrequent use of intravascular ultrasound, is an effective and safe strategy with a low rate of vascular complications, a relatively short hospital stay and a low incidence of clinical manifestations of stent thrombosis.

Case report: A new guidewire for coronary rotational ablation.

We report three cases using a new guidewire designed for coronary rotational ablation. The tips are .014 in diameter and available in different degrees of flexibility. The improved torquability of these guidewires may improve the success rate of coronary rotablation in select cases.

Experience of immediate stenting, perfusion balloon and secondary stenting in failed angioplasty.

OBJECTIVE: To present a comparative analysis of the immediate and short term experience of stent implantation as the initial treatment for failed angioplasty (immediate stenting) with the staged approach of prolonged inflation with a perfusion balloon followed by stent implantation if prolonged inflation was unsuccessful (secondary stenting). DESIGN: Retrospective analysis of the outcome of 90 consecutive patients from a single institution undergoing one of these treatment strategies for failed angioplasty. INTERVENTIONS AND MAIN RESULTS: The initial treatment for failed angioplasty was prolonged inflation with a perfusion balloon in 59 and immediate stent implantation in 31 patients. Angiographic success (less than 50% residual and normal flow) was achieved in 24 of 59 (41%) with the perfusion balloon (mean duration of inflation 12.2 +/- 8.3 mins) and in 30 of 31 (97%) with immediate stent implantation (P = 0.0001). Of the 35 patients in whom the perfusion balloon was unsuccessful secondary stenting was attempted in 27, with angiographic success in 24 (89%). Stent thrombosis occurred in four (13%) of the immediate stent group and in three (13%) of the secondary stent group. Acute ischemia compatible with vessel occlusion occurred in one (4%) of the perfusion balloon alone group following an initially successful result. One month following the procedure, 23 (72%) of the patients treated with perfusion balloon alone, 26 (84%) of the immediate stent group and 21 (78%) of the secondary stent group had a successful outcome and were free from major complications. CONCLUSION: Immediate stent implantation and the staged approach of prolonged inflation with a perfusion balloon followed by secondary stent implantation if prolonged inflation was unsuccessful yielded similar results.

Thrombosis and restenosis after stenting in failed angioplasty: comparison with elective stenting.

The results of Palmaz-Schatz stent implantation in failed angioplasty in 60 consecutive patients were compared with those of elective stent implantation in 100 consecutive patients. Stent implantation was successful in all of the failed group and in 99% of the elective. Stent thrombosis occurred in 16.7% of the failed group and 2% of the elective (p = 0.001). In the failed angioplasty group, stent thrombosis was associated with a greater frequency of preprocedure complex morphology (40% vs 12% in the nonthrombosis group, p = 0.05), persistent uncovered dissection after stenting (60% vs 14%, p = 0.004), and greater residual stenosis (39.9% +/- 25.3% vs 24.9% +/- 13.08%, p = 0.008) after stenting. Vessel patency was reestablished by angioplasty in 5 of 10 with stent thrombosis. Of these 5 patients, however, 2 suffered repeat stent thrombosis; 1 died suddenly four months later; and restenosis occurred in the remaining 2. Follow-up angiography was performed in 98% of the elective group at 6.3 +/- 2.6 months and 96% of the failed angioplasty group at 6.4 +/- 2.1 months. Restenosis (> or = 50% stenosis) occurred in 32% of the elective group and 50% of the failed angioplasty group (p = 0.041). Multiple logistic regression analysis identified multiple stent implantation (F = 6.75, p = 0.01) and triple-vessel disease (F = 3.46, p = 0.06) as independent positive predictors of restenosis. In conclusion, stent implantation in cases of failed angioplasty could be performed with a success similar to that of elective stent implantation but was associated with a greater frequency of stent thrombosis and restenosis.

Pros and cons of perfusion balloons in failed angioplasty.

Prolonged inflation with perfusion balloons is commonly used in failed angioplasty. The objective of this study was to determine the angiographic outcome of 59 consecutive patients treated with prolonged inflation with perfusion balloons as the primary treatment for failed angioplasty. Angiographic success (< 50% stenosis and normal flow) was achieved in 41%. Angiographic success was greater in the left anterior descending coronary artery (67% versus 33% for non-left anterior descending involvement, P = .044) and was less in complex dissections (25% versus 75% for no dissection or simple dissections, P = .025). Angiographic deterioration occurred in 37.5% of the successful group and 77% of the unsuccessful group (P = .002) and was more frequent in the right coronary artery (88% versus 50% for non-right coronary involvement, P = .007) and complex dissections (92% versus 38% for no dissection or simple dissections, P = .0001). Thus, in a group of patients with unsuccessful outcome following conventional balloon angioplasty, success with the perfusion balloon was modest. Furthermore, angiographic deterioration was frequently observed following unsuccessful prolonged inflation.

Restenosis following elective implantation of single Palmaz-Schatz stents in de-novo lesions in native vessels.

BACKGROUND: Restenosis is the main limitation of long-term success after coronary angioplasty. Intracoronary stent implantation may reduce restenosis by producing a larger initial lumen and eliminating recoil. The objective of this study was to determine the frequency of and features associated with restenosis after elective single Palmaz-Schatz stent implantation in de-novo lesions in native vessels. METHODS: Eighty consecutive patients were studied. Angiographic follow-up was performed in 79 out of 80 (99%) 6.5 +/- 3.4 months after the procedure. Angiographic measurements were performed using an automated computerized quantitative angiographic analysis system. RESULTS: Restenosis (> or = 50% stenosis) at follow-up occurred in 26 out of 79 patients (33%). The frequency of complex lesion morphology was higher (50% versus 19% American College of Cardiology/American Heart Association classification B2; P = 0.005), the reference vessel diameter larger (3.0 +/- 0.5 mm versus 2.8 +/- 0.6 mm, P = 0.049), and the lesion length longer (10.9 +/- 3.5 mm versus 8.5 +/- 3.5 mm, P = 0.009) in the restenosis group compared with the non-restenosis group. The population was divided into three groups according to the reference vessel diameter: (1) greater than 3.0 mm (n = 27), (2) 2.5-3.0 mm (n = 29), and (3) less than 2.5 mm (n = 22). One patient was excluded from this subgroup analysis because of difficulty in determining the reference vessel diameter before the procedure. The restenosis rates were 52%, 37%, and 11%, respectively, for the three groups (P = 0.02). The relative acute gain was greater in the smaller vessels, (0.66 in the < 2.5 mm vessels, 0.53 in the 2.5-3.0 mm vessels, and 0.48 in the > 3.0 mm vessels; P = 0.006). This was associated with a relative oversizing of the final stent balloon in the smaller vessels (balloon-to-vessel ratio of 1.33 in the vessels < 2.5 mm diameter, 1.16 in the 2.5-3.0 mm vessels, and 0.98 in the > 3.0 mm vessels; P = 0.001). CONCLUSION: The frequency of restenosis in single electively implanted Palmaz-Schatz stents in de-novo lesions in native vessels was 33%. The degree of restenosis was lower in smaller vessels, in which a better initial result was associated with relative oversizing of the final stent balloon. More aggressive dilation within the stented segment may result in a lower restenosis rate.

Safety, success, and restenosis after elective coronary implantation of the Palmaz-Schatz stent in 100 patients at a single center.

We report the immediate safety, efficacy, and 6-month angiographic follow-up after elective implantation of the Palmaz-Schatz stent (Johnson & Johnson Interventional Systems, Warren, N.J.) in the first 100 consecutive patients at a single center. Patients with suitable cardiac anatomy and no contraindications to anticoagulation were prospectively entered into the study. One hundred two stents were successfully implanted in 99 patients. The mean diameter stenosis was 70% +/- 11% before implantation and was reduced to 20% +/- 11% after stent implantation. There were no deaths, Q-wave myocardial infarcts, urgent bypass operations, or strokes during the procedure or follow-up period. Stent thrombosis occurred in two patients; in both vessel patency was successfully accomplished by balloon angioplasty. There were three gastrointestinal hemorrhages, two of which required transfusion. Angiographic follow-up was performed in 98% of patients at 6.3 +/- 2.6 months after the procedure. Restenosis (> or = 50% stenosis within or immediately adjacent to the stent) occurred in 32%. Stent restenosis was associated with male sex (36% vs 7% for female subjects; p = 0.03) and stent implantation in a restenosis lesion (47% vs 25% for de novo lesions; p = 0.03); it was inversely associated with current cigarette smoking (0% vs 36% for nonsmokers; p = 0.02). In conclusion, the Palmaz-Schatz stent can be electively implanted with high success and low complication rates. The restenosis rate appears to be similar to that of balloon angioplasty.

Double Marker ACX II: a new balloon catheter for coronary stent delivery.

We report our initial experience using the Double Marker ACX II for intracoronary stent deployment in 22 patients, 10 of whom were elective stents and 12 of whom were stented for complications following failed coronary angioplasty. The overall success rate was 95 percent. This dilatation catheter offers advantages which include accurate stent deployment with a double marker system, the option of using a delivery sheath, and the ability to deliver multiple stents with the same balloon catheter.

Coronary rotational ablation for unsuccessful angioplasty due to failure to cross the stenosis with a dilatation catheter.

Attempted coronary angioplasty of a right coronary artery sub-total occlusion was unsuccessful due to failure to cross the lesion with the dilatation catheter. Both fixed-wire and over-the-wire systems were tried. Coronary rotational ablation was successful in reducing the stenosis and allowing successful angioplasty.

Right internal mammary artery graft angioplasty through a right brachial artery approach using a new custom guide catheter: a case report.

Angioplasty of right internal mammary artery grafts may present problems because of the variable origin of the mammary artery and its angulation from the subclavian artery. We report a case of successful angioplasty using a custom designed guide catheter, after failed attempts using conventional guide catheters.

Balloon expandable stents for acute closure post failed coronary angioplasty: case report and review of the literature.

Abrupt closure of a dominant right coronary artery occurred in a patient 1 h post coronary angioplasty. Angiography revealed a long spiral dissection involving the mid to distal segment of the right coronary artery. Four intracoronary balloon expandable stents were deployed to 'tack up' the dissection and recanalize the occluded artery. Six month follow-up angiography revealed continued patency of the stented segment. Balloon expandable stents may be an effective alternative to coronary bypass surgery in the treatment of acute closure following coronary angioplasty.