Primary stenting of occluded native coronary arteries II--rationale and design of the PRISON II study: a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of chronic total coronary occlusions

Primary intracoronary stent placement after successfully crossing chronic total occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. Whether sirolimus-eluting stents are superior to bare metal stents in CTO is unknown. In this prospective randomized trial, bare metal stent implantation will be compared with sirolimus-eluting stent implantation for the treatment of CTO. A total of 200 patients will be followed up for 12 months with angiographic follow-up at 6 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is the binary angiographic restenosis and reocclusion rate.     

One-year clinical and angiographic follow-up after primary stenting

INTRODUCTION AND OBJECTIVES: The late reocclusion or restenosis rate of the infarct related artery is frequent after primary angioplasty. An implanted stent may be able to improve the coronary angioplasty results and long-term outcome of these patients. We present the clinical and angiographic outcome of a cohort of patients treated with primary stenting. PATIENTS AND METHODS: A group of 74 consecutive patients with acute myocardial infarction treated with primary angioplasty and stenting were followed for one year. An angiographic control was performed at the 6th month of follow-up in 91% of patients to assess the restenosis and reocclusion rates of the infarct-related artery. RESULTS: There were eight in-hospital deaths and three during follow-up (mortality rate 14.8%) and one non-fatal reinfarction (1.5%). The cumulative rate of recurrent ischemia was 6% at 3 months and 15% at 6 months, without any further increment at one-year follow-up. A new angioplasty was performed in 7 patients and three patients underwent surgical revascularization. Thus 80% of patients after discharge were free of events. The angiographic control showed only one reocclusion of the infarct related artery and a restenosis rate of 27%. CONCLUSIONS: These results show that primary stenting is an effective procedure in treating non-selected patients with acute myocardial infarction with a low long-term incidence of adverse events and a low restenosis rate.     

Chronic total occlusion due to diffuse in‐stent restenosis: is brachytherapy the solution?

Percutaneous coronary intervention of chronic total occlusions (CTO) is associated with a significantly higher incidence of reocclusion and restenosis compared with non‐total occlusions. Randomized and observational trials have demonstrated the effectiveness of intracoronary brachytherapy (ICBT) for the prevention of recurrent in‐stent restenosis. However, limited data are available on the effectiveness of ICBT in patients with totally occluded in‐stent restenosis. The authors assessed the long‐term outcome of patients treated with intracoronary gamma radiation for totally occluded in‐stent restenotic lesions.

?Percutaneous coronary intervention and subsequent catheter‐based irradiation with iridium‐192 was performed in 100 patients (103 vessels) with diffuse in‐stent restenosis. At baseline, CTO of the target vessel at the site of the stent was present in 15 vessels (14.5%). Follow‐up data were collected during follow‐up visits and from telephone interviews. Repeat coronary angiography was performed in symptomatic patients with clinical restenosis. Clinical and angiographic characteristics were similar between the two groups, although there was a trend towards more unstable angina at the index procedure in CTO patients (66.7% versus 41.4%; p?=?0.12) compared with patients without non‐total occlusions. A higher percentage of patients (53.3%) with CTO required longer radiation sources (14 seeds, covering a length of 55?mm), compared with 23.9% of patients with non‐total occlusion (p?=?0.04). With a mean follow‐up period of 47.5?±?24.0 months, major adverse cardiac events (MACE) were observed in 10 of 15 patients (66.7%) with CTO compared with 25 out of 88 patients (28.4%) without CTO (p?= 0.009). According to multivariate analysis, total occlusion of the target vessel at baseline was the single independent predictor of MACE at one‐year follow‐up (relative risk 16.2, 95% confidence interval 4.2–62.9; p?<?0.0001).

?This study shows that the use of gamma radiation for the prevention of recurrence of in‐stent restenosis in patients with CTO does not seem to be as effective as in patients with non‐total occlusions. Furthermore, CTO was an independent predictor of worse outcome at long‐term follow‐up in this study. (Int J Cardiovasc Intervent 2004; 1:?33–38)     

Prospects in the treatment of stenosis of the coronary arteries

Treatment of stenosis of coronary arteries has progressed considerably since the introduction of angioplasty by Grüntzig. There are three problems associated with angioplasty: reocclusion, restenosis and extension of indications. To solve these problems, a good many techniques designed to flatten or destroy the plaque have been developed. Hemoperfusion balloons can be used to treat reocclusion by prolonged inflation and may reduce the rate of restenosis. Methods for assisting blood circulation (CPS or hemopump) extend the indications for angioplasty to inoperable patients. Stents hold the vessel open and hence prevent reocclusion. They can be useful for stenosis of shunts but in general are thrombogenic and have not proved efficacious in preventing restenosis. Laser-heated metal probes (hot tips) generate spasm and thrombosis. Lasers are now used to heat balloons which allow reattachment of grafts and reduction of restenosis. The excimer appears more promising. Atheroma is currently the subject of some interest and atherectomy has proved feasible, but the indications are as yet undefined. Although new techniques have introduced the possibility of treating certain reocclusions, none has proved effective in prevention of restenosis. The multiplicity of instruments currently available allows gradual extension of the indications for angioplasty.     

Intracoronary beta-brachytherapy in chronic total occlusions: a subgroup analysis from the RENO registry.

Conventional interventional therapy has been less rewarding in chronic total occlusion (CTO). Brachytherapy by its antiproliferative and positive remodeling effect may be more efficacious. Forty-six centers registered 1,098 consecutive patients undergoing brachytherapy with the BetaCath system. Of these, 78 patients had 82 lesions (CTO) at presentation-the study population. With 67% in-stent CTO, 8% graft CTO, 4% recurrent CTO, long lesions (27.6 +/- 20.9 mm), and 31% diabetes, the cohort had high risk for recurrence. The in-hospital event rate was 1.3%. Six-month follow-up revealed 1.3% death, 5.1% myocardial infarction, 21.8% target vessel revascularization, 77.8% improved angina, 34.5% binary restenosis, 12.7% reocclusion, and 10.3% late thrombosis. The results were comparable to all other patients in the registry, although late thrombosis rate was higher in the CTO group (10.3% vs. 5.0%; P = 0.047). In the in-stent CTO subgroup (n = 52; 66.7%), there was no in-hospital event, no follow-up death or myocardial infarction, restenosis in 35.1%, and reocclusion in 10.8% of patients. In comparison, death or myocardial infarction was significantly higher in de novo CTO subgroup (P = 0.005). Compared to all other in-stent restenosis patients in the registry, the patients with in-stent CTO had similar clinical and angiographic event rate. Thus, beta-brachytherapy was safe, feasible, and effective in this broad population of high-risk patients with CTO presenting in day-to-day practice. It was particularly effective in in-stent CTO, where conventional interventional strategies are disappointing.     

Wiktor Stent for Treatment of Chronic Total Coronary Artery Occlusions: Short- and Long-Term Clinical and Angiographic Results From a Large Multicenter Experience

Objectives. This study reports the first multicenter experience with the Wiktor coil stent for treatment of chronic total coronary artery occlusions (CTOs).Background. Percutaneous transluminal coronary angioplasty (PTCA) of CTO is associated with very high restenosis and reocclusion rates. Coronary stenting has been proposed as a means of improving outcome. However, the Wiktor device for CTOs has never been tested in a large patient sample.Methods. From January 1993 to December 1996, 89 patients with 91 CTOs underwent Wiktor stent implantation after successful PTCA. The post-stenting regimen consisted of warfarin (Coumadin) plus aspirin in the initial 49 patients (55%) and aspirin plus ticlopidine in 40 patients (45%).Results. Stenting was successful in 87 patients (98%). At 1 month, 6% of patients had subacute stent thrombosis, 3% had a major bleeding event, and 1% had access-site complications. Subacute stent thrombosis showed univariate association with warfarin therapy (p = 0.009). Angiographic follow-up was obtained in 76 (93%) of 82 eligible patients. The restenosis rate was 32%, including 4% reocclusions. By multiple logistic regression analysis, restenosis was independently associated with multiple stents (adjusted odds ratio [OR] 27.67, 95% confidence interval [CI] 4.25 to 79.95, p = 0.0008) and increasing values of occlusion length (adjusted OR 1.23, 95% CI 1.09 to 1.39, p = 0.001). Freedom from death, myocardial infarction or stented vessel revascularization was 87% and 72% at 1 and 3 years, respectively.Conclusions. Short- and long-term clinical and angiographic outcomes are favorable in patients undergoing Wiktor stent implantation in CTO. Further technical improvement is needed to reduce the restenosis rate in patients with long lesions and multiple stents.     

Results of intracoronary stents for management of coronary dissection after balloon angioplasty

Dissections after coronary balloon angioplasty are risk factors for acute or subacute vessel closures. Intracoronary stenting was developed to avoid these complications by pressing the intimal and medial flaps against the vessel wall, thus reducing the risk of acute thrombosis. A total of 22 stents were implanted into the coronary arteries of 15 patients with dissections after balloon angioplasty causing angina pectoris or ischemic electrocardiographic changes. Stent delivery was successful in all cases. In 1 patient acute stent thrombosis was documented and treated successfully by thrombolytic therapy. Another patient underwent coronary artery bypass surgery 24 hours later because of persisting angina. Angiograms after 24 hours documented vessel patency in the remaining 14 patients. Late control angiograms after 4 to 6 months were obtained in 12 of 14 patients. Vessel patency without significant restenosis was observed in 8 patients, restenosis in 3 and reocclusion in 1 patient. All 3 patients with multiple stent implantation had restenosis (n = 2) or reocclusion (n = 1), compared with 1 patient with single stent implantation. Thus, intracoronary stenting appears to be a secure and effective method of handling bailout situations caused by dissection after balloon angioplasty, with good long-term results when only a single stent is implanted.     

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.     

Coronary angiography after thrombolytic therapy for acute myocardial infarction

PURPOSE: To review the status of emergency, urgent, routine, and selective angiography after intravenous thrombolytic therapy. DATA SOURCES: Relevant English-language articles published from January 1985 to July 1990 were identified through MEDLINE. STUDY SELECTION: For emergency angiography, four major randomized studies were reviewed and data from nine studies that incorporated rescue coronary angioplasty were pooled for meta-analysis. For urgent angiography, two controlled trials were reviewed. Comparisons of routine and selective angiography were done using data from two dedicated, large-scale, controlled trials and the ancillary findings of four other studies of reperfusion that incorporated angiography. DATA EXTRACTION: The review emphasizes the findings from multicenter, randomized, controlled trials. DATA SYNTHESIS: Emergency coronary angiography is done primarily in preparation for primary or rescue angioplasty; the value of rescue angioplasty has yet to be assessed in a randomized trial, but technical success and reocclusion improve significantly after therapy with nonspecific plasminogen activators compared with relatively specific agents (success rate, 86% compared with 75%, respectively; P = 0.03; reocclusion rate, 10.9% compared with 26.8%, respectively; P less than 0.001). Urgent coronary angiography has value for treating recurrent ischemia, but patients who develop this complication after thrombolysis are likely to have a suboptimal outcome despite aggressive care. Studies support the use of either selective or routine angiography in uncomplicated patients after thrombolytic therapy; either approach is acceptable, but the former is more practical and may prove to be cost effective. CONCLUSIONS: Optimal follow-up for patients with evolving myocardial infarction who receive thrombolysis may incorporate coronary angiography at various stages. Although our ability to noninvasively detect reperfusion, reocclusion, or viable but ischemic myocardium is limited at present, available data may assist in selecting a catheterization strategy.     

Determinants of target vessel failure in chronic total coronary occlusions after stent implantation. The influence of collateral function and coronary hemodynamics

OBJECTIVES: The goal of this study was to assess the influence of collateral function, coronary hemodynamics, and the angiographic result on the risk of target vessel failure (TVF) after recanalization of a chronic total coronary occlusion (CTO). BACKGROUND: Collaterals may have an adverse effect on TVF. METHODS: In 111 consecutive patients, a CTO (duration >2 weeks) was successfully recanalized with stent implantation. Collateral function was assessed by intracoronary Doppler flow velocity and pressure recordings distal to the occlusion. Baseline collateral function was determined before the first balloon inflation, and recruitable collateral function after stenting during a balloon reocclusion. Finally, the coronary flow velocity reserve (CFVR) and the fractional flow reserve (FFR) were measured. RESULTS: Angiographic follow-up after 5 +/- 4 months in 106 patients showed a reocclusion in 17% and a restenosis in 36%. The major determinants of TVF were the stent length (p < 0.01) and number of implanted stents (p < 0.01). No difference was observed in baseline or recruitable collateral function between patients with and without TVF; 52% of patients had a CFVR >or= 2.0, and only 18% a CFVR >or=2.5 after percutaneous transluminal coronary angioplasty, but neither cutoff-value predicted TVF. A low FFR discriminated patients with reocclusion (0.81 +/- 07 vs. 0.86 +/- 08, p < 0.05) but not with restenosis (0.87 +/- 0.06). CONCLUSIONS: This study showed that there is no relation between a well-developed collateral supply and the risk of TVF in recanalized CTOs. This was rather determined by the stented segment length. There was also no adverse effect of the frequently observed impaired CFVR on TVF, whereas a low FFR was associated with a higher risk of reocclusion.     

Combination thrombolytic therapy: a comparison of simultaneous and sequential regimens of tissue plasminogen activator and urokinase

Coronary angioplasty following unsuccessful tissue plasminogen activator (t-PA) therapy for acute myocardial infarction has been associated with a high incidence of subsequent reocclusion of the infarct-related artery, and a relatively high in-hospital mortality. In contrast, the combination of t-PA and urokinase, when given intravenously prior to coronary angiography, appears to be associated with a low incidence of post-rescue angioplasty reocclusion. In order to determine whether intraprocedural urokinase, given at the time of rescue coronary angioplasty for failed t-PA therapy, improves long-term patency of the infarct vessel to the same extent as preangiographic, combination t-PA/urokinase therapy, three thrombolytic treatment strategies were retrospectively compared. The first group included 86 patients undergoing rescue angioplasty after t-PA monotherapy (t-PA alone). The clinical and angiographic outcomes of these patients were compared with those of 24 patients who received intravenous or intracoronary urokinase during rescue angioplasty following unsuccessful t-PA therapy (sequential t-PA/urokinase therapy), and with those of 34 patients undergoing rescue coronary angioplasty following unsuccessful therapy with the combination of intravenous t-PA and urokinase (simultaneous therapy). There was no difference in postangioplasty patency rate of the infarct-related artery between the three groups. However, the sequential t-PA/urokinase regimen was associated with a subsequent reocclusion rate that was lower than the rate that occurred in the t-PA monotherapy group but higher than the rate in the simultaneous t-PA/urokinase group (13 versus 29 versus 2%, respectively; p = 0.003).(ABSTRACT TRUNCATED AT 250 WORDS)     

Re-angioplasty of in-stent restenosis versus balloon restenoses--a matched pair comparison

BACKGROUND: Despite different biological mechanisms involved in the restenotic process of in-stent restenosis and restenosis after balloon angioplasty alone, the occurrence of a second restenosis has been reported in the same range. There are no data available comparing the outcome after re-angioplasty of such lesions. We analyzed in a matched pair comparison the clinical outcome and angiographic long-term result of patients with balloon angioplasty of a first in-stent restenosis versus patients with balloon re-angioplasty of a first balloon restenosis. METHODS: Both groups consisted of 74 lesions matched by treated vessel, lesion location differentiated in proximal and non-proximal, and angiographic appearance of coronary artery disease differentiated in singular stenosis, diffuse or mixed pattern. Clinical follow-up was 100%. Angiographic follow-up was 78.4% after median 174 days. RESULTS: Angiographic restenosis rate in matched pairs of patients (n=46/74) was significantly higher in the balloon restenosis group (41.3%, n=19/46) compared to the in-stent restenosis group (21.7%, n=10/46, p<0.042). There was no death or myocardial infarction. After clinical follow-up, target lesion revascularization rate was significantly lower in the in-stent restenosis group compared to the balloon restenosis group (12.1%, n=9/74 versus 27.0%, n=20/74; difference between groups 14.9%, 95% confidence interval 2.0-27.3%, p<0.023). Multivariate logistic regression analysis revealed as predictors for a second restenosis unstable angina pectoris, non-proximal lesion, restenosis after balloon angioplasty and the occurrence of the first restenosis within 90 days after initial intervention. CONCLUSION: Clinical and angiographic outcome after balloon angioplasty of a first in-stent restenosis was significantly better compared with balloon re-angioplasty of a first balloon restenosis.     

Standards in interventional therapy of coronary artery disease

This review provides an overview of current percutaneous coronary interventional techniques (PCI) in patients with acute and chronic coronary artery disease. The indications for PCI have expanded during the past two decades, and no absolute contraindications remain. The chief limitations to event free survival following balloon angioplasty have been abrupt vessel closure in the short term and restenosis in the long term. The therapeutic effect of arterial vessel enlargement through PCI is accompanied by various degrees of arterial injury with exposure of thrombogenic components. Depending on the degree of activation of the coagulation cascade, as well as platelet adhesion and aggregation, this may result in intracoronary thrombus formation and subsequent ischemic sequelae. Therefore, inhibition of platelets and the coagulation system has always been central to interventional investigations. Restenosis has been the most important long-term limitation of PCI. Coronary artery stents have become an important adjunct to conventional balloon angioplasty owing to their dual function of reducing acute complications and the long term risk of restenosis. Although coronary artery stents serve as antirestenosis devices and reduce target vessel revascularisation requirements compared with balloon angioplasty, they themselves become a source of restenosis. In-stent restenosis is a major challenge for the interventionalist. None of the available interventional modalities provides optimal acute results, and long-term results are even poorer. This is especially true for diffuse in-stent restenosis lesions which have high recurrence rates. Thus, mechanical treatment modalities for evolved in-stent restenosis can only be one step in a comprehensive strategy for prevention and treatment. Brachytherapy as an adjunct seems to be especially promising, but late thrombosis, delayed restenosis and the potential for very late fibrosis are matters of concern. As attention has turned towards the prevention of in-stent restenosis new techniques such as drug delivering stents and gene therapy to inhibit the biological reaction of the vessel wall are likely to obtain greater importance.     

Stenting of Nonacute Total Coronary Occlusions: Predictors of Late Angiographic Outcome

Objectives. This study was designed to determine and assess factors predictive of the intermediate-term outcome of stenting of nonacute total coronary occlusions.Background. Balloon angioplasty of recanalized coronary occlusions is associated with a combined restenosis/reocclusion rate of up to 65%. Adjunctive stenting holds the potential to reduce this rate significantly. However, variables affecting the late angiographic outcome of coronary stenting in the setting of a total occlusion have not been elucidated sufficiently.Methods. Coronary stenting was performed in 143 consecutive patients with a nonacute total occlusion; 120 of these patients (84%), with a total of 121 occlusions, underwent repeat angiography within 6 months and comprised the study group. High pressure stent implantation aimed to cover the site of the occlusion as well as adjacent diameter stenoses ≥70% and all possibly induced dissections. Pertinent angiographic and procedural variables obtained at the time of the intervention were entered into a multivariate logistic regression analysis model to assess their influence on the angiographic outcome at follow-up.Results. Mean preinterventional reference lumen diameter for the 121 vessels was 2.99 ± 0.53 mm (mean ± SD); occlusion length ranged from 4 to 44 mm (median of 7.7). After balloon angioplasty, dissections were found in 80% of patients. Lesions were covered with stents a median of 16 mm in length (range 8 to 53). The minimal lumen diameter (MLD) achieved after stenting was 2.89 ± 0.48 mm. After a median follow-up period of 4.5 months, mean MLD was assessed at 1.91 ± 0.90 mm, corresponding to a loss index of 0.34 ± 0.31. There were 27 vessels with a nonocclusive restenosis ≥50% and 8 with a reocclusion, for a combined restenosis/reocclusion rate of 29%. Factors found to adversely influence angiographic outcome were a post-stenting MLD ≤2.54 mm, a stented vessel segment length >16 mm, a balloon/vessel diameter ratio for final stent expansion ≤1.00 and the presence of a dissection after balloon angioplasty.Conclusions. Compared with previous reports on stand-alone balloon angioplasty, stenting of nonacute total coronary occlusions lowers the 6-month restenosis/reocclusion rate to ∼30%. The late procedural outcome is independently and statistically significantly influenced by the MLD after stenting, the length of the stented vessel segment, the balloon/vessel diameter ratio for final stent expansion and the incidence of dissections after balloon angioplasty.     

Monitoring of antiplatelet therapy with the PFA-100® in peripheral angioplasty patients

Background: In patients suffering from peripheral arterial occlusive disease (PAOD) the risk of restenosis after percutaneous transluminal angioplasty (PTA) might be influenced by platelet mediated factors. Objective: To look for a correlation between the effect of antiplatelet therapy and recurrence of disease after PTA by monitoring platelet function in 3-month intervals by the platelet function analyzer system, PFA-100®, over a period of 1 year. Patients and methods: A group of 98 patients (43 females, 55 males) with PAOD, treated with aspirin ( n = 52), thienopyridine ( n = 34) or combination therapy of both ( n = 12) were followed over a period of 12 months after elective PTA of the lower extremities with regard to occurrence of restenosis or reocclusion at the site of angioplasty, to demonstrate inhibitory effects on platelets, induced by antiplatelet therapy. Results: PFA-100 proved suitable to identify 'non-responders' to antiplatelet therapy, in a 12-month follow-up period. In 'non-responders' to clopidogrel therapy, a higher incidence of restenosis or reocclusion after PTA of the lower limbs was detected compared with 'responders'. Conclusion: PFA-100, upon stimulation with ADP, might predict patients under clopidogrel therapy with elevated risk for the development of complications following PTA of the lower limbs. This could offer the chance to switch to an alternative therapy or adapt the dose.     

Short- and long-term clinical effects of primary directional coronary atherectomy for acute myocardial infarction

We performed primary directional coronary atherectomy (DCA) without antecedent thrombolytic therapy in 21 of 67 patients with acute myocardial infarction within 24 hr of onset between June 1993–March 1994. Reperfusion with primary DCA was successful in 18 patients (85.7%, group D). Results were compared with those of primary balloon angioplasty patients treated between June 1992–May 1993 (group P). Minimum lumen diameter (MLD) values both immediately after reperfusion and in predischarge angiograms were significantly larger in group D than in group P, but were similar in late follow-up angiograms. Although a larger MLD in group D than in group P contributed to the prevention of reocclusion of the coronary artery before discharge in DCA patients, a high rate of restenosis at late follow-up canceled the beneficial effects of primary DCA. © 1996 Wiley-Liss, Inc.     

A Clinical Trial Comparing Primary Stenting of the Infarct-Related Artery With Optimal Primary Angioplasty for Acute Myocardial Infarction: Results From the Florence Randomized Elective Stenting in Acute Coronary Occlusions (FRESCO) Trial

Objectives. This study sought to compare stenting of the primary infarct-related artery (IRA) with optimal primary percutaneous transluminal coronary angioplasty (PTCA) with respect to clinical and angiographic outcomes of patients with an acute myocardial infarction.Background. Early and late restenosis or reocclusion of the IRA after successful primary PTCA significantly contributes to increased patient morbidity and mortality. Coronary stenting results in a lower rate of angiographic and clinical restenosis than standard PTCA in patients with angina and with previously untreated, noncomplex lesions.Methods. After successful primary PTCA, 150 patients were randomly assigned to elective stenting or no further intervention. The primary end point of the trial was a composite end point, defined as death, reinfarction or repeat target vessel revascularization as a consequence of recurrent ischemia within 6 months of randomization. The secondary end point was angiographic evidence of restenosis or reocclusion at 6 months after randomization.Results. Stenting of the IRA was successful in all patients randomized to stent treatment. At 6 months, the incidence of the primary end point was 9% in the stent group and 28% in the PTCA group (p = 0.003); the incidence of restenosis or reocclusion was 17% in the stent group and 43% in the PTCA group (p = 0.001).Conclusions. Primary stenting of the IRA, compared with optimal primary angioplasty, results in a lower rate of major adverse events related to recurrent ischemia and a lower rate of angiographically detected restenosis or reocclusion of the IRA.     

Long-term outcome of angioplasty for multivessel coronary disease: importance and price of complete revascularization.

BACKGROUND: Complete revascularization of multivessel coronary artery disease (MVD) by coronary artery bypass surgery has been shown to improve outcome, but there is a lack of similar data for patients treated by angioplasty. METHODS: Therefore, a consecutive series of 250 patients with MVD was separated into two groups, those with complete revascularization (n=101) and those with incomplete revascularization (n=149). Six-month 'clinical restenosis' rate assessed by stress myocardial perfusion scintigraphy or symptom-driven angiography and long-term 32 months outcome were compared with an equally sized group of single vessel disease (SVD) patients. RESULTS: MVD patients with complete revascularization had a higher 'clinical restenosis' rate than patients with SVD (35 vs. 22%, P<0.02), although restenosis rate per treated vessel was similar (23%, 18%, P NS). If this higher early restenosis rate were accepted as 'price' for complete MVD angioplasty, long-term event-free survival was no longer different from that of SVD patients (86 vs. 93%, P NS). In contrast, patients with incomplete multivessel angioplasty had a significantly worse long-term outcome (22% events), especially if initially untreated, non-occluded vessels remained untreated (25% events). CONCLUSION: MVD angioplasty with complete revascularization has a long-term event-free survival similar to that of SVD angioplasty but at the price of a higher rate of 6-month restenosis and repeat interventions.     

Fate of patients with acute myocardial infarction with patency of the infarct-related vessel achieved with successful thrombolysis versus rescue angioplasty.

Patients with failure of infarct-related artery recanalization after thrombolytic therapy have a poor clinical outcome. These patients have been considered for rescue angioplasty 90 min after thrombolytic therapy at the time of emergency catheterization in the course of five Thrombolysis and Angioplasty in Myocardial Infarction (TAMI) trials. The outcome of 776 patients with patent infarct-related vessels after emergency catheterization was analyzed--607 with thrombolysis-mediated patency of the infarct-related vessel and 169 with patency achieved by angioplasty. Baseline characteristics of the thrombolysis and angioplasty patency groups were similar except for a higher acute left ventricular ejection fraction (51.3% versus 48.2%) in the thrombolysis group (p = 0.003). Seven to 10 day left ventricular ejection fraction was higher (52.3% versus 48.1%), infarct zone functional recovery was greater (0.44 versus 0.21 standard deviation/chord, or 18% versus 7%, p = 0.001) and reocclusion was less (11% versus 21%) in the thrombolysis compared with the angioplasty group. Despite these differences, angioplasty patency was associated with the same low in-hospital mortality rate (5.9% versus 4.6%) and long-term mortality rate (3% versus 2%) as thrombolysis patency. Reocclusion adversely affected the mortality rate and ventricular functional recovery. Technical failure of rescue angioplasty was associated with a much higher mortality rate than was technical success (39.1% versus 5.9%). Thrombolysis patency was preferable to angioplasty patency after thrombolytic therapy in acute myocardial infarction, but both were associated with the same low in-hospital and long-term mortality rates, suggesting that rescue angioplasty is beneficial in some patients with failure of infarct-related artery recanalization after thrombolytic therapy.     

Comparison of stent versus balloon angioplasty for pulmonary vein stenosis complicating pulmonary vein isolation

Introduction: Pulmonary vein stenosis (PVS) is a rare but significant complication of pulmonary vein isolation (PVI). Dilation and stent angioplasty have been described but not compared.
Methods and Results: All percutaneous interventions for PVS complicating PVI between December 2000 and March 2007 were reviewed. Acute success, defined as post-intervention stenosis ≤30%, and long-term outcome of dilation versus stent angioplasty were compared. Freedom from restenosis was defined as freedom from repeat intervention. Overall outcome for all interventions was examined. We studied 34 patients with 55 stenotic veins followed for a mean of 25 months. Dilation was performed in 39 veins and stenting in 40 veins (16 primarily, 24 after dilation restenosis). Acute success and restenosis rates were 42% and 72% for dilation versus 95% (P < 0.001) and 33% for stenting. Time to restenosis was greater for stent angioplasty (P = 0.003). Stents ≥10 mm in diameter had lower restenosis than smaller stents. Risk factors for restenosis included small reference vessel diameter and longer time from PVI to intervention for PVS. All but two patients experienced improvement (n = 10) or resolution of symptoms (n = 22). The mean percent stenosis decreased from 82% to 21% for the entire cohort and mean flow to the lung quadrant increased from 10% to 17%.
Conclusion: Stent angioplasty results in less restenosis than dilation, particularly for stents ≥10 mm. Early referral may improve long-term patency by minimizing reference vessel atrophy. Most patients with PVS post-PVI can be improved symptomatically with catheter intervention.