Multiple overlapping drug-eluting stents to treat diffuse disease of the left anterior descending coronary artery.

OBJECTIVES: We sought to determine the safety and efficacy of using multiple overlapping drug-eluting stents (DES) in patients with diffuse left anterior descending coronary artery (LAD) disease. BACKGROUND: Diffuse LAD disease represents a therapeutic challenge. Results after coronary artery bypass surgery are suboptimal, whereas the use of bare metal stents is limited by high rates of restenosis. The introduction of DES prompted treatment of long diffuse disease with multiple overlapping stents. METHODS: All consecutive patients with de novo diffuse LAD disease treated with more than 60-mm long DES from April 2002 to March 2004 were analyzed. RESULTS: The study population consisted of 66 patients. Thirty-nine patients were treated with sirolimus-eluting stents (SES), average length 84 +/- 22 mm, and 27 patients with paclitaxel-eluting stents (PES), average length 74 +/- 14 mm. The number of stents implanted per patient was 2.8 +/- 0.7, whereas the mean total stent length for the LAD treatment was 80 +/- 20 mm. Angiographic as well as procedural success was achieved in 95% of cases. Eleven (16.6%) patients had in-hospital non-Q-wave myocardial infarction (five SES and six PES), and one patient developed intraprocedural stent thrombosis. All patients had clinical follow-up, and 52 patients (79%) had an angiographic follow-up at six months. Hierarchical major adverse cardiac event rate was 15% (7.5% for SES and 7.5% for PES). No patients died, one patient had non-Q-wave myocardial infarction (non-index vessel), and 10 patients (15%) underwent target vessel revascularization. CONCLUSIONS: The implantation of multiple overlapping DES in patients with a diffusely diseased LAD is relatively safe and associated with good midterm clinical outcomes.

Is sirolimus better than paclitaxel? A review of the comparative data on drug-eluting stents.

Drug-eluting stents have been unequivocally demonstrated to reduce in-stent restenosis when compared to bare metal stents, with resultant lower rates of repeat revascularization. Comparative data are now emerging which compare the performance of sirolimus- and paclitaxel-eluting stents to each other rather than to bare metal stents. In this article, we review these data with the aim of placing the studies in context thereby providing an overall view of this rapidly developing field as it stands at present.

Clinical outcome following aleatory implantation of paclitaxel-eluting or sirolimus-eluting stents in complex coronary lesions.

We compared the clinical efficacy of paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs) in a contemporary cohort of patients who had complex lesions. We collected data on 9-month outcomes in 529 patients (281 in the PES group and 248 in the SES group) whose de novo lesions were treated with drug-eluting stents. The end point was per-patient in-hospital and follow-up major adverse cardiac events, which were defined as a composite of death, myocardial infarction, and target vessel revascularization, including target lesion revascularization. There were no in-hospital deaths or repeat revascularizations; however, 5.7% of the PES group and 2% of the SES group developed a myocardial infarction (p = 0.04). At a median follow-up of 10.6 months, the rate of major adverse cardiac events was similar between groups (18.1% vs 21%, adjusted hazard ratio 0.85, 95% confidence interval 0.57 to 1.25), without any difference in the occurrence of death or myocardial infarction. Diabetes and total stent length were independent predictors of major adverse cardiac events. Propensity analysis confirmed the similarity between devices (hazard ratio 0.87, 95% confidence interval 0.62 to 1.25). Most restenoses were focal and only 2 patients required surgical revascularization. In conclusion, implantation of drug-eluting stents in complex lesions was associated with favorable results and most patients remained free from surgical revascularization at follow-up. Overall, the 2 available stent platforms had similar performance characteristics.

Validation of predictors of intraprocedural stent thrombosis in the drug-eluting stent era.

Although predictors of acute intraprocedural stent thrombosis (IPST) in the drug-eluting stent era have been proposed, external validation is lacking. We thus analyzed the occurrence of IPST in the RECIPE study and found that, among 1,320 patients who underwent drug-eluting stent implantation, IPST occurred in 6 (0.5%), with in-hospital major adverse events in 4 (67%). IPST was predicted by number and total length of implanted stents, baseline minimal lumen diameter, and, in a pooled analysis that incorporated values from the present study and a previous study, use of elective glycoprotein IIb/IIIa inhibitors. Such results may provide useful information to guide prevention of this complication.

Huge coronary perforation during percutaneous intervention sealed by injection of polyvinyl alcohol microspheres.

During percutaneous coronary intervention, coronary perforation is one of the most feared life-threatening complications, as it may cause cardiac tamponade or acute myocardial infarction. The incidence of this serious complication in recent years has increased from 0.2 to 0.6%, most likely due to the increase of complex procedures. However, the management of coronary perforation has not been established yet. We report the first case of coronary perforation successfully managed with intracoronary injection of hydrogel microspheres.

Thin strut chrome-cobalt stent implantation for treatment of de-novo lesions in small coronary vessels: results of the RISICO Italian Registry (Registro Italiano Mini VISION nei piccolo Vasi) utilizing the Mini VISION coronary stent platform.

OBJECTIVES: The Registro Italiano Mini VISION nei piccoli Vasi registry is a prospective, multicenter, observational study, aimed at assessing immediate and long-term angiographic and clinical outcomes of a small-vessel cobalt-chrome super alloy-dedicated stent (Multi-Link RX VISION) in de-novo and long lesions. BACKGROUND: Small artery size is an important determinant of poor outcomes in percutaneous coronary interventions. METHODS: Patients with ischemic heart disease were included. The primary end point was procedural success. Secondary end points included clinical restenosis (need for target lesion revascularization ), incidence of major adverse cardiac events at 6 months, and cost-effectiveness analysis. RESULTS: Between September 2004 and October 2005, 143 patients (mean age 67 +/- 11 years; 22% diabetes) were enrolled; 6-month follow-up was completed in May 2006. Average lesion length, mean stent length and diameter were 16.8 +/- 7.1, 17.01 +/- 3.9 and 2.41 +/- 0.14 mm, respectively. Procedural success was 96%. At 6-month follow-up, the hierarchical major adverse cardiac event rate was 11.6%, 2.9% deaths, 2.9% myocardial infarction and 5.8% target lesion revascularization. Cost-effectiveness analysis will be reported in a further publication. CONCLUSION: Small-vessel disease treatment with Mini VISION stents permits an elevated procedural success rate with low incidence of clinical restenosis and major adverse cardiac events at mid-term follow-up. Such results require confirmation by means of a randomized controlled study against drug-eluting stents.

Clinical and angiographic follow-up of small vessel lesions treated with paclitaxel-eluting stents (from the TRUE Registry).

Several randomized trials have shown that sirolimus-eluting stents and paclitaxel-eluting stents (PES) are effective in reducing restenosis in respect to bare-metal stents, including the subset of small vessels. The objective of this study was to evaluate "real world" angiographic and clinical outcomes of a large series of patients enrolled in the TRUE registry and treated with PES for both small vessel and very small vessel lesions. A consecutive series of 675 patients (926 lesions) with reference vessel diameter <2.75 mm measured by quantitative coronary angiography analysis were analyzed. The primary end point was the rate of angiographic in-stent restenosis and 1-year major adverse cardiac events. In this study 390 lesions were identified as small vessel (reference vessel diameter >or=2.25 and <2.75 mm) and 536 lesions as very small vessel (reference vessel diameter <2.25 mm). Overall in-stent restenosis was 15.5% (n = 96). Compared with small vessel, the very small vessel lesions had more in-stent restenosis (21.7% vs 11.4%, p <0.001) and in-segment restenosis (29.3% vs 22.5%, p = 0.055). The majority of the restenotic lesions (n = 125) were focal (57%, n = 71). At 1 year, cardiac death was 1.6% (n = 11), acute myocardial infarction 0.5% (n = 4.), and the target lesion revascularization 12.8% (n = 86). Cumulative major adverse cardiac events rate was 17.3% (n = 119). The rate of definite and probable stent thrombosis was 0.9% (n = 8). In conclusion, in comparison with historical bare-metal stent controls, this large series of small vessel lesions treated with PES confirms previous results reporting the efficacy of PES in small vessels. The rate of subacute and late stent thrombosis was low in this subgroup of patients.

Predictors of restenosis after treatment of bifurcational lesions with paclitaxel eluting stents: a multicenter prospective registry of 150 consecutive patients.

OBJECTIVES: The aim of the study was the assessment of the clinical, angiographic and procedural characteristics correlated with freedom from adverse events at 1 year in a real life setting of consecutive bifurcation lesions. BACKGROUND: Even if stent implantation has shown to be superior to conventional balloon angioplasty in most coronary lesions, bifurcation treatment with stent implantation both in main and in side branch (SB) still raises controversy. METHODS: We reviewed the results obtained in a prospective multicenter registry of 150 patients with 158 bifurcation lesions involving a SB of sufficient diameter to be treated, if necessary, with a polymer based paclitaxel eluting stent (PES, TAXUS). Two stents were used in 118 lesions (74.7%). Final kissing balloon inflation was performed in 87/118 lesions (73.7%) and in 30/40 lesions (75.0%) of the 2 and 1 stent group respectively. RESULTS: At 1-year clinical follow-up we observed 4 stent thromboses, all involving the SBs of the 2 stents group (2.7%). Unlike previous reports, revascularization involved the main vessel in the majority of patients (21/150, 14.0%). After an exploratory multivariable analysis the only parameter predictive of target lesion revascularization (TLR) (HR 0.52; CI 95% 0.11-0.86; p = 0.02) and target vessel revascularization (TVR) (HR 0.47; CI 95% 0.14-0.90; p = 0.03) was postprocedural main branch minimal lumen diameter (MB-MLD). CONCLUSIONS: In a real life setting of consecutive bifurcation lesions, thrombosis rate, concentrated in the SB and the 2-stents group, and need for target lesion revascularization remain higher than in less complex lesion subgroups treated with PES. No differences in immediate success and TLR were observed between 2 stents and 1 stent groups. The frequently observed suboptimal stent expansion and final MB-MLD predict 1 year revascularization.

Treating chronic total occlusions using subintimal tracking and reentry: the STAR technique.

Successful recanalization of coronary total occlusions (CTOs) remains an area where improvements are needed. We propose an approach similar to the one utilized in treating some peripheral artery occlusions and aimed to create a subintimal dissection with distal reentry. A 0.014' hydrophilic wire with a J-configuration is utilized for this purpose. We applied this technique to CTO of native coronaries in 31 patients where previous attempts failed in 21 of them (67%). The right coronary artery (RCA) was the index vessel in 87% of patients. Recanalization of the vessel and of most of distal branches was achieved in 21 patients; patency of at least one major distal branch was achieved in 9 patients. Drug-eluting stents (DESs) were implanted in 53% of patients. Three patients had intraprocedural vessel perforation without consequences. Five patients (16%) had in-hospital non-Q-wave myocardial infarction. No other adverse events occurred at a mean follow-up of 5.1 +/- 3.7 months except for one noncardiac death. Angiographic follow-up was performed in 21 (67%) patients and 53% of them developed restenosis. Reintervention on the target vessel was performed in 11 patients (52%). Complete success with the procedure was originally obtained in 8 of the 10 patients who did not develop restenosis and in 8 of them DESs were originally implanted. This technique appears a promising approach to recanalize difficult total occlusions, particularly the ones localize on the RCA, which has the most important side branches located distally.