Angiographic and Clinical Outcomes after Implantation of Drug Eluting Stents in Bifurcation Lesions with Crush or Kissing Stent Technique

Background

Long‐term outcome after bifurcation stenting with drug‐eluting stents (DES) for obstructive coronary artery disease is poorly understood. In this study, we report 6–9‐month angiographic follow‐up and long‐term clinical outcomes after implantation of drug‐eluting stents by crush and kissing stent technique for coronary bifurcation lesions.

Methods

Consecutive patients undergoing bifurcation stenting with DES by crush or kissing stent technique were enrolled in a prospective registry. Angiographic follow‐up was obtained at 6–9 months and clinical follow‐up completed for a median of 38 months.

Results

A total of 86 patients participated in the study. Bifurcation stenting by crush technique was performed in 73 (85%) and by kissing stent in 13 (15%) patients. Stenting of left main bifurcation was applied in 24 (28%) patients. Angiographic follow‐up was completed in 75 (87%) patients and showed restenosis in the main for 8 (11%) and side branch for 20 (27%) patients. Clinical follow‐up was available for a median duration of 38 months. During follow‐up, 2 (2%) patients died, 4 (5%) experienced myocardial infarction (MI), and 11 (13%) underwent target vessel revascularization (TVR) with an overall major adverse cardiac event (MACE) rate of 16%. In left main cohort, angiographic restenosis occurred in 9 (37%) patients, and 3 (12%) patients required TVR. There were no deaths or stent thrombosis. A comparison of crush and kissing stent technique showed significantly higher angiographic restenosis with crush (26% vs 13% in kissing stent patients, P = 0.046) and 95% of restenosis in crush group involved ostium of the side branch. There was no difference in clinical outcomes between the crush and kissing stent groups. Final kissing balloon dilatation (FKB) was successful in 65 (89%) patients in the crush group and associated with a significant reduction in MACE (8% in FKB successful vs 37% in FKB unsuccessful, P = 0.04) during follow‐up.

Conclusion

Bifurcation stenting with crush or kissing stent technique is safe and associated with a low rate of TLR and MACE on long‐term follow‐up. Crush stenting is associated with a significantly higher rate of side branch restenosis compared to kissing stent technique. FKB is associated with significant reduction in MACE during follow‐up. (J Interven Cardiol 2013;26:145–152)

     

Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: Two‐year angiographic and three‐year clinical results from the SPIRIT II study

Background : Little is known about the impact of treatment with drug‐eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus‐eluting stent (EES) in patients with calcified or noncalcified culprit lesions. Methods : The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six‐month and 2‐year angiographic follow‐up and clinical follow‐up up to 3 years were completed. Results : The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6‐month in‐stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia‐driven target lesion revascularization (ID‐TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in‐stent ABR (7.4% vs. 0%, P = 0.08) and ID‐TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID‐TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12). Conclusions: The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley‐Liss, Inc.     

Angiographic outcomes with biodegradable polymer and permanent polymer drug‐eluting stents

Background : In the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus‐Eluting Stents (ISAR‐TEST‐4) trial, we demonstrated the noninferiority of biodegradable polymer (BP) sirolimus‐eluting stent to permanent polymer (PP) sirolimus/everolimus‐eluting stent (Cypher/Xience‐V) on the basis of clinical outcomes. In this study, we compare the antirestenotic efficacy of these stents in ISAR‐TEST‐4 patients with paired angiographic studies. Methods : Patients with de novo coronary lesions in native vessels (excluding left main lesions) were randomly assigned to receive a BP stent or a PP stent. Endpoints of interest of this study were in‐stent late lumen loss, in‐segment binary restenosis, and restenosis morphology at 6–8‐month follow‐up angiogram. Results : Of the 2,603 patients (3,372 lesions) enrolled in ISAR TEST‐4 trial, 2,016 patients (2,637 lesions) underwent repeat angiographic examination 6–8 months after randomization: 1,006 patients (1,323 lesions) treated with BP stents and 1,010 patients (1,314 lesions) treated with PP stents. No difference was observed between BP and PP stents in in‐stent late lumen loss (0.24 ± 0.6 vs. 0.26 ± 0.5 mm, respectively, P = 0.49) or in in‐segment binary restenosis (11.6% [153 lesions] vs. 11.8% [155 lesions], P = 0.85). Focal pattern of restenosis was observed in the majority of patients receiving either BP or PP stents. The diffuse pattern of restenosis was observed in 26.8% of patients treated with BP stent and 26.5% of patients treated with PP stent (P = 0.79). Conclusion : Angiographic characteristics of restenosis after BP‐based limus‐eluting stents are similar to those of PP‐based limus‐eluting stents. © 2011 Wiley‐Liss, Inc.     

Clinical and angiographic follow-up after balloon angioplasty with provisional stenting for coronary in-stent restenosis.

The objective of this study was to assess the angiographic and clinical outcome of patients with coronary in-stent restenosis treated with balloon angioplasty with provisional stenting. The study included 375 consecutive patients with in-stent restenosis managed with balloon angioplasty alone or combined with stenting. Clinical events were recorded during a 1-year follow-up period and quantitative analysis was performed on 6-month angiographic data. Of the 373 patients (451 lesions) with a successful procedure, 273 were treated with angioplasty alone and 100 with additional stenting. Target lesion revascularization was required in 23.7% of the patients: 20.7% in patients with angioplasty and 31.0% in patients with stenting. Angiographic restenosis rate was 38.9%: 35.8% in the angioplasty group and 47.7% in the stent group. Stenting in small vessels was associated with a much higher restenosis rate than in larger vessels (65.6% vs. 37.5%, respectively; P = 0.01). Thus, repeat balloon angioplasty with provisional stenting for in-stent restenosis is a safe treatment strategy associated with a relatively favorable long-term outcome. However, the long-term results might be improved if additional stenting is avoided especially in small vessels. Cathet. Cardiovasc. Intervent. 48:151-156, 1999.     

The Acute Changes of Fractional Flow Reserve in DK (Double Kissing), Crush,and 1‐Stent Technique for True Bifurcation Lesions

Background: While many studies confirmed the importance of fractional flow reserve (FFR) in guiding complex percutaneous coronary interventions (PCI), data regarding the significance of FFR for bifurcation lesions are still lacking. Methods: Between October 2008 and October 2009, 51 patients with true bifurcation lesions were consecutively enrolled and randomized into double kissing (DK) crush (n = 25), and provisional 1‐stent (n = 26) groups. FFR measurements at baseline and hyperemia were measured at pre‐PCI, post‐PCI, and at 8‐month follow‐up. Results: Clinical follow‐ups were available in 100% of patients while only 33% of patients underwent angiographic follow‐up. Baseline clinical and angiographic characteristics were matched between the 2 groups. Pre‐PCI FFR of the main branch (MB) in the DK group was 0.76 ± 0.15, which was significantly lower than in the provisional 1‐stent group (0.83 ± 0.10, P = 0.029). This difference disappeared after the PCI procedure (0.92 ± 0.04 vs. 0.92 ± 0.05, P = 0.58). There were no significant differences in terms of baseline, angiographic, procedural indexes, and FFR of side branch (SB) between the 2 treatment arms. However, immediately after PCI, the patient with DK crush had higher FFR in the SB as compared to the provisional 1‐stent group (0.94 ± 0.03 vs. 0.90 ± 0.08, P = 0.028, respectively) and also they had lower diameter stenosis (8.59 ± 6.41% vs. 15.62 ± 11.69%, P = 0.015, respectively). Conclusion: In the acute phase, immediately after PCI for bifurcation lesion, DK crush stenting was associated with higher FFR and lower residual diameter stenosis in the SB, as compared with the provisional 1‐stent group. (J Interven Cardiol 2010;23:341–345)     

Serial intravascular ultrasound analysis comparing double kissing and classical crush stenting for coronary bifurcation lesions

Background : Compared with the classical crush, double kissing (DK) crush improved outcomes in patients with coronary bifurcation lesions. However, there is no serial intravascular ultrasound (IVUS) comparisons between these two techniques. Objectives : This study aimed to analyze the mechanisms of the two crush stenting techniques using serial IVUS imaging. Methods : A total of 54 patients with IVUS images at baseline, post‐stenting and eight‐month follow‐up were classified into classical (n = 16) and DK (n = 38) groups. All patients underwent final kissing balloon inflation (FKBI). Unsatisfactory kissing (KUS) was defined as the presence of wrist or >20% stenosis during FKBI at the side branch (SB) ostium. The vessels at bifurcation lesions were divided into the proximal main vessel (MV) stent, the crushed segment, the distal MV stent, the SB ostium and the SB stent body. Results : KUS and incomplete crushing were commonly observed in the classical group (62.5%, 81.3%), compared with DK group (18.0%, 39.5%, P < 0.001 and P = 0.004). The post‐stenting stent symmetry in the classical group was 71.85 ± 7.69% relative to 85.93 ± 6.09% in DK group (P = 0.022), resulting in significant differences in neointimal hyperplasia (NIH, 1.60 ± 0.21 mm² vs. 0.85 ± 0.23 mm², P = 0.005), late lumen loss (1.31 ± 0.81 mm² vs. 0.55 ± 0.70 mm², P = 0.013), and minimal lumen area (MLA, 3.57 ± 1.52 mm² vs. 4.52 ± 1.40 mm^2, P = 0.042) at the SB ostium between two groups. KUS was positively correlated with the incomplete crush and was the only predictor of in‐stent‐restenosis (ISR) at the SB ostium. Conclusion : DK crush was associated with improved quality of the FKBI and larger MLA. KUS predicted the occurrence of ISR. © 2011 Wiley Periodicals, Inc.     

Evaluation of the effects of everolimus‐eluting and paclitaxel‐eluting stents on target lesions with jailed side branches: 2‐year results from the SPIRIT III randomized trial

Objective: To evaluate whether an everolimus‐eluting stent (EES) with thinner stent struts and polymer results in less periprocedural myonecrosis and adverse outcomes. Background: Higher periprocedural myocardial infarction (MI) rates have been reported with the TAXUS® EXPRESS² paclitaxel‐eluting stent (PES) compared to the bare metal EXPRESS²® stent due to more frequent side branch compromise, presumably attributable to the thickness of the stent/polymer on the PES. Methods: In the SPIRIT III trial, we identified 113 patients in the XIENCE V® EES group and 63 patients in the TAXUS EXPRESS² PES group who met the criteria of having a lesion with a jailed side branch (<2 mm diameter, and <50% stenosis). Two‐year clinical outcomes were evaluated. Results: A periprocedural increase in Creatine Kinase‐MB >1× upper normal level occurred in 9.0% of EES compared to 29.7% of PES patients with jailed side branches, P = 0.01. Through 2 years, major adverse cardiac events (MACE; cardiac death, MI, or target lesion revascularization [TLR]) occurred in 6.8% of EES and 19.0% of PES jailed side branch patients (P = 0.03), with numerically lower rates of MI (2.9% vs. 10.3%, P = 0.07) and TLR (3.9% vs. 10.3%, P = 0.17) in the EES group, with comparable rates of cardiac death (1.9% vs. 1.7%, P = 1.00). Conclusions: In this post‐hoc analysis of the SPIRIT III RCT, patients undergoing stenting of target lesions with jailed side branches with the thin strut and polymer XIENCE V EES compared to the thicker strut TAXUS PES had lower rates of MACE through 2 years due to fewer MIs and TLRs. © 2010 Wiley‐Liss, Inc.     

Long-term outcomes of sirolimus-eluting stents vs. paclitaxel-eluting stents in unprotected left main coronary artery bifurcation lesions

Background:

The treatment of unprotected left main coronary artery (uLMCA) bifurcation lesions remains challenging.

Hypothesis:

We hypothesized that the type of drug‐eluting stent would correlate with clinical outcomes for the treatment of uLMCA bifurcation lesions.

Methods:

One hundred fifteen patients who underwent stent implantation using a provisional T‐stenting technique with sirolimus‐eluting stents (SES) or paclitaxel‐eluting stents (PES) for uLMCA bifurcation lesions were enrolled. A major adverse cardiac event (MACE) was defined as a composite of cardiac death, myocardial infarction, or target lesion revascularization.

Results:

Ninety‐four patients were treated with SES and 21 patients with PES. Baseline characteristics were similar between the 2 groups. Angiographic follow‐up was performed in 99 (86%) patients. Late loss in the LMCA to the left anterior descending coronary artery was significantly lower in the SES group than in the PES group (0.28 ± 0.54 mm vs 1.03 ± 0.45 mm, P<0.001). One case of stent thrombosis occurred in the SES group. During follow‐up with a median of 712 days, the SES group had a lower MACE compared with the PES group (10.6% vs 28.6%, P = 0.032). Cox proportional hazards models including age, sex, diabetes, acute coronary syndrome, true bifurcation, stenting strategy, and type of drug‐eluting stent used (SES vs PES) demonstrated that stent type was the only predictor of MACE (hazard ratio of PES vs SES: 3.88, 95% confidence interval: 1.29–11.67, P = 0.016).

Conclusions:

According to the results of the present study, SES may be associated with more favorable outcomes than PES for stenting of uLMCA bifurcation, which should be further studied by larger trials. © 2011 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose.     

Provisional stenting for multivessel PCI

Background: Bare stents reduce acute complications and repeat revascularization following percutaneous coronary intervention (PCI), but are costly and may lead to in‐stent restenosis. It remains unclear whether stents should be universally implanted or whether provisional stenting mainly to suboptimal balloon dilatation results is an acceptable approach for multivessel PCI. Objective: To compare the long‐term clinical restenosis and target lesion revascularization (TLR) of stented and non‐stented coronary artery lesions in patients who had multivessel PCI. Methods: We performed retrospective analysis of matched data from 129 consecutive patients who underwent multivessel PCI (at least optimal balloon angioplasty to one coronary artery segment and balloon angioplasty plus stenting to another coronary artery in the same patient, all lesions are de novo native coronary artery lesions with vessel diameter ?2.5?mm). The study endpoint was restenosis and repeat revascularization at one‐year follow‐up. Results: Baseline characteristics were similar in both groups. Low in‐hospital MACE (3.1%). Acute myocardial infarction, emergency revascularization via either PCI or CABG was detected and angiographic success was achieved in 99.3% of lesions in both groups. The rate of clinically driven angiographic restenosis and TLR at one‐year (follow‐up?100%) was similar (17.1% versus 18.6%, P?=?0.871, and 13.9% versus 16.3%, P?=?0.728, for optimal balloon angioplasty versus provisional stenting. Conclusions: The main findings from this study are that long‐term angiographic restenosis and TLR was comparable for optimal balloon angioplasty and provisional stenting, suggesting that provisional stenting is an acceptable approach for multivessel PCI.     

Comparison of zotarolimus‐ versus everolimus‐eluting stents in the treatment of coronary bifurcation lesions

Objectives : To compare zotarolimus‐eluting stent (Endeavor Sprint®; ZES‐S) and the everolimus‐eluting stent (Xience V®; EES) in the treatment of coronary bifurcation lesions Background : Both these stents have demonstrated good outcomes in the treatment of coronary lesions. However, the outcomes with respect to treatment of bifurcation lesions have yet to be conclusively demonstrated. Methods : In this single centered, nonrandomized, open label study, we treated, between August 2006 and December 2008, 110 bifurcations with ZES‐S and, in a second stage of the study, 129 bifurcations with EES. The primary end point was to compare the rate of major adverse cardiac events (MACE) (death, myocardial infarction, and new target lesion revascularization) in‐hospital and at 12 months of follow‐up. Provisional T stenting was the strategy used in the majority of cases. Angiographic follow‐up was performed only in patients who presented signs or symptoms suggestive of angina or ischemia. Results : There were no significant differences in in‐hospital MACE between the groups (ZES‐S: 8.1%; EES: 6.2%; P = 0.5). At 12 months, the ZES‐S group had significantly more MACE than the EES group (23.1% vs. 4.5%; P < 0.001) and an elevated index of new revascularization of the bifurcation (17.5% vs. 3.2%; P < 0.001). There were no significant differences in mortality (four patients in ZES‐S vs. one in EES; P = 0.14). Conclusion : The treatment of coronary bifurcation lesions using everolimus‐eluting stents results in better outcomes at 12 months of follow‐up than zotarolimus‐eluting stents. © 2011 Wiley Periodicals, Inc.     

Systemic rapamycin without loading dose for restenosis prevention after coronary bare metal stent implantation

Objectives : The aim of this study was to assess the role of short oral administration of rapamycin, without loading dose, in the reduction of restenosis rate after bare metal stent implantation. Background : Previous studies suggest that the administration of oral rapamycin reduces angiographic restenosis after bare metal stent implantation. Methods : This was prospective, open‐label study of 80 patients randomized to either oral rapamycin (2 mg/day for 30 days, starting within 24 hr of stent implantation) or no therapy after implantation of a coronary bare metal stent. The primary study end point was incidence of angiographic binary restenosis and late loss at six months. The secondary end points were target lesion revascularization (TLR), target vessel revascularization (TVR), and incidence of major adverse cardiovascular events (MACE) at 6 months. Results : Angiographic follow up was completed in 72/80 (90%) of patients. In the rapamycin group, the drug was well tolerated (22.5% minor side effects) and was maintained in 100% of patients. At six months, the in‐segment binary restenosis was 10.5% in rapamycin group vs. 51.4% in no‐therapy group, P < 0.001) and the in‐stent binary restenosis was 7.9% in rapamycin group vs. 48.7% in no‐therapy group, P < 0.001. The in‐segment late loss was also significantly reduced with oral therapy (0.29 ± 0.39 vs. 0.86 ± 0.64 mm, respectively, P < 0.001). Similarly, after six months, patients in the oral rapamycin group also showed a significantly lower incidence of TLR and TVR (7% vs. 22.7%, respectively, P = 0.039) and MACE (7% vs. 22.7%, respectively, P = 0.039). Conclusions : This study showed that the administration of oral rapamycin (2 mg/day, without loading dose) during 30 days after stent implantation significantly reduces angiographic and clinical parameters of restenosis. © 2009 Wiley‐Liss, Inc.     

Long‐term outcome of provisional side‐branch T‐stenting for the treatment of unprotected distal left main coronary artery disease

Percutaneous coronary intervention (PCI) on distal left main (LM) remains an independent predictor of poor outcome. The strategy of implanting one stent on the main branch (MB), with provisional stenting on the side‐branch (SB) only when required (provisional T‐stenting), has become the default approach to most bifurcation lesions. This prospective registry sought to investigate the long‐term safety and efficacy of provisional SB T‐stenting for the treatment of unprotected distal LM disease in patients undergoing PCI. From January 2006 to May 2009, 107 consecutive patients affected by unprotected distal LM disease underwent PCI at our center with the intent to use a provisional SB‐stenting technique. We evaluated the rate of major adverse cardiac events (MACE) at long‐term follow‐up (up to 12–41 months). Procedural success was obtained in 98% of patients. A final kissing balloon inflation was performed in 95% and intravascular ultrasound in 83% of patients. Additional stenting on the SB after provisional stenting on MB was required in 29% of lesions. Long‐term follow‐up (3.5 years; 25–75th percentile and 1.1–4.5 years) was completed in 97% of patients. The cumulative incidence of MACE was 32.7%: all‐cause death was 15.8%, nonfatal myocardial infarction 8.4%, and target vessel revascularization 21.5%. At multivariable analysis, age (hazard ratio, 2.08; 95% confidence interval: 2.01–3.32, P = 0.03), European System for Cardiac Operative Risk Evaluation (HR 1.20, 95% CI: 1.04–1.33, P = 0.02), and diabetes mellitus (HR 3.48, 95% CI: 1.12–6.87, P = 0.01) were identified as independent predictors of MACE. In patients with unprotected distal LM disease undergoing PCI, a provisional strategy of stenting the MB only is associated with good long‐term clinical outcomes. © 2011 Wiley‐Liss, Inc.     

The role of acute wall recoil and late restenosis: results of the OCBAS trial (Optimal Coronary Balloon Angioplasty with Provisional Stenting versus Primary Stent)

Early deterioration of minimal luminal diameter immediately after PTCA, has been associated with an increase of late restenosis. Lesions with no early loss after PTCA have a low restenosis rate. Coronary stents reduce restenosis in lesions exhibiting early wall recoil. The purpose of the OCBAS study was to compare two strategies during coronary interventions; provision vs. elective stenting. 116 patients with good PTCA results were randomized to stent ( n = 57) or to optimal PTCA ( n = 59). After randomization in PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting). Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had a follow-up angiographic study; 98.2% in the stent and 94.9% in the PTCA group. Immediate and follow-up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1.5 mm; P < 0.03). However, late loss was significantly higher in the stent than the PTCA groups (0.63 &#45 0.59 vs. 0.26 &#45 0.44, respectively; P = 0.01). Hence, net gain with both techniques was similar (1.32 &#45 0.3 vs. 1.24 &#45 0.29 mm for the stent and PTCA groups respectively; P = NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; P = NS) and TVR (17.5 in stent vs. 13.5% in PTCA; P = NS) were also similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group ( P = NS). Overall costs (hospital and follow-up) were US$591,740 in the stent versus US$398,480 in the PTCA group ( P < 0.02). The strategy of the PTCA with delay angiogram and provisional stent if early loss occurs, had similar restenosis rate and TVR than universal use of bare stents.     

The SIRIUS-DIRECT trial: a multi-center study of direct stenting using the sirolimus-eluting stent in patients with de novo native coronary artery lesions.

OBJECTIVE: To assess the safety and efficacy of direct stenting using the sirolimus-eluting BX Velocitytrade mark stent in patients with coronary lesions. BACKGROUND: Although direct coronary stenting has become a widespread practice, there have been no systematic assessments of direct stenting with drug-eluting stents. METHODS: Total of 225 patients with identical inclusion and exclusion criteria as the original SIRIUS trial were enrolled in this prospective single-arm study. They were compared in a no-inferiority design with 412 similar patients from the SIRIUS trial who had sirolimus-eluting stents deployed after predilatation and were preassigned to angiographic follow-up evaluation. RESULTS: Direct stenting was successful in 85.8% of the patients. Compared with the predilatation group, direct stenting was associated with shorter median procedure duration (33 min vs. 45 min, P < 0.001). Angiographic follow-up at 8 months revealed similar late loss (in-stent-0.19 +/- 0.47 mm vs. 0.17 +/- 0.44 mm, and in-lesion-0.23 +/- 0.41 mm vs. 0.24 +/- 0.47 mm) and similar frequency of binary restenosis (in-stent-4.6% vs. 3.2% and in-lesion-6.1% vs. 8.9%) between the two treatment strategies. However, stent-edge restenosis was lower with direct stenting than in the predilatation control group (2.1% vs. 6.9%, P = 0.02). At 12-months, there were no significant differences in target lesion revascularization (3.7% vs. 5.1%, P = ns) or composite major adverse cardiac events (7.0% vs. 8.3%, P = ns). CONCLUSIONS: In patients similar to those treated in the SIRIUS trial, direct stenting using sirolimus-eluting stents achieves excellent short- and long-term clinical and angiographic results with shorter procedure time and less frequent stent edge restenosis compared with predilation stent implantation techniques.     

Incidence and Characteristics of Late Catch‐Up Phenomenon Between Sirolimus‐Eluting Stent and Everolimus‐Eluting Stent: A Propensity Matched Study

Objectives

We evaluated and compared the incidence and characteristics of late catch‐up phenomenon (LCU) between everolimus‐eluting stent (EES) and sirolimus‐eluting stent (SES) implantations.

Background

Late catch‐up phenomenon after everolimus‐eluting stent (EES) implantation has not yet been evaluated sufficiently.

Methods

Between April 2007 and May 2011, 1,234 patients with coronary artery disease were treated with SES and 502 patients with EES. Following propensity score matching, we evaluated 495 SES‐treated patients and 495 ESS‐treated patients. The incidences of LCU (i.e., late target lesion revascularization [TLR] [1–3 years]) were compared.

Results

The cumulative incidence of TLR at 3 years was 11.9% in the SES group and 6.1% in the EES group (P = 0.001). The incidence of late TLR was 7.5% in the SES group and 3.4% in the EES group (P = 0.004). Even though not statistically significant, intravascular ultrasound showed a higher tendency of stent fracture (SF) in late restenosis lesions in the SES group than in the EES group (37.0% vs 7.7%; P = 0.052). Moreover, the SF rate tended to increase in late restenosis compared with early restenosis (within 1 year) in the SES group compared with the EES group (SES: 37.0% vs 22.2%; P = 0.293, EES: 7.7% vs 10.0%; P = 0.846), although the increase was not significantly different.

Conclusions

EES was superior to SES in terms of LCU. SF may be associated with LCU after SES implantation. (J Interven Cardiol 2015;28:551–562)

     

Contradictory Shear Stress Distribution Prevents Restenosis after Provisional Stenting for Bifurcation Lesions

Background: Endothelial shear stress is one of the local hemodynamic factors suspected in the development of coronary atherosclerosis in bifurcation lesions. In patients with provisional stenting, the endothelial shear stress (SS) distribution is unknown. Objective: The aim of this study was to investigate the magnitude and distribution of the SS of coronary bifurcation lesions stenting by the provisional approach. Methods: Ten consecutive patients were included in this study. Quantitative coronary analysis, flow study, and three‐dimensional computational analysis with the aid of the commercial software CD STAR‐CCM+ were done before and after the provisional stenting procedure and also 8 months later. Results: Clinical and angiographic follow‐up were available in all patients. No patient had a side branch (SB) stent. At the 8‐month follow‐up, no major adverse cardiac event (MACE) occurred. There was also no clinical and angiographic restenosis. Before PCI, the distal main vessel (MV)‐lateral, and the SB‐lateral subsegments had relative nonsignificant lower SS value (4.08 ± 2.78 Pa and 4.35 ± 5.04 Pa, respectively) when compared to other segments. After 8‐month follow‐up, sustained decreased SS value was shown in the distal MV‐lateral segment (4.08 ± 2.78–1.68 ± 1.65 Pa), when compared with significantly increased SS value in the SB‐lateral subsegment 4.35 ± 5.04–16.50 ± 40.45 Pa). The explanation is that after stenting in the MV, the flow was redistributed immediately after percutaneous coronary intervention (PCI) and reversed back to its original 8 months later. However, the growth of the fibrous tissue causing in‐stent restenosis (ISR) is prohibited by sirolimus on the stent struts. In contrast, in a branch opened up by plain old balloon angioplasty (POBA), the flow did not change much, the flow could even be worse because it is shifted to the MV after the cross‐sectional area of the MV improved by stenting. However, thanks to POBA, there is increased fibrous tissue formation, enough to increase the SS and prevent further accumulation of cell and cholesterol needed for more restenosis. Conclusion: In the provisional approach, low endothelial SS correlated with no restenosis for patients who underwent stenting of the MV, while a contradictory combination of high SS and no restenosis was seen in the SB after only POBA. The mechanism of prevention of restenosis in the SB is by increasing the SS while in the MV, the mechanism of prevention of ISR is secondary to sirolimus on the stents struts. (J Interven Cardiol 2010;23:319–329)     

Four‐year clinical follow‐up of the XIENCE V everolimus‐eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: The SPIRIT II trial

This report describes the 4‐year clinical outcomes of the SPIRIT II study, which randomized 300 patients to treatment with the XIENCE V everolimus‐eluting stent (EES), or the TAXUS paclitaxel‐eluting stent. At 4‐year clinical follow‐up, which was available in 256 (85.3%) patients, treatment with EES lead to a trend for lower rates of ischemia‐driven major adverse cardiovascular events, a composite of cardiac death, myocardial infarction, and ischemia‐driven target lesion revascularization (EES 7.7% vs. paclitaxel‐eluting stent 16.4%, P = 0.056). Treatment with EES also resulted in a trend toward lower rates of cardiac death and numerically lower rates of myocardial infarction, ischemia‐driven target lesion revascularization, and stent thrombosis. Overall, this study reports numerically fewer clinical events in patients treated with EES at 4‐year follow‐up, which is consistent with results from earlier follow‐up. © 2010 Wiley‐Liss, Inc.     

A comparison of the clinical and angiographic evolution of diabetic and nondiabetic patients treated by conventional angioplasty versus stent implantation in native coronary arteries

INTRODUCTION AND OBJECTIVES: Diabetic patients have a high restenosis risk after balloon coronary angioplasty. Stent implantation in these patients appears to be a potential beneficial therapeutic option. The aim of this study was to compare the clinical and angiographic outcome of diabetic patients vs non-diabetic patients, treated with conventional angioplasty vs stent implantation in lesions located in native coronary arteries. MATERIAL AND METHODS: A total of 302 patients (58 diabetics and 244 non-diabetics) underwent a coronary angioplasty of one vessel in native coronary arteries with initial success and after at least six months clinical and angiographic follow-up were included in the study. Of the total number of patients, 100 were treated with conventional balloon angioplasty and 202 with stent implantation. Major adverse clinical events and angiographic restenosis rate were evaluated at follow-up. RESULTS: Mean age of patients was 65 years and 74% were male. Angiographic restenosis rate was similar in diabetic vs non-diabetic patients with stent implantation (24% vs 23% respectively). Nevertheless, diabetic patients treated with balloon angioplasty compared to diabetic patients treated with stenting, evolved with a higher restenosis rate (64% vs 24%; p < 0.05), and at the end of follow-up diabetics had need a higher rate of target vessel revascularization (40% vs 24%; p < 0.05), a lower major event free survival (56% vs 70%; p < 0.05) and worse symptomatic status (72% vs 36%; p < 0.05). CONCLUSIONS: Diabetic patients treated with conventional one vessel coronary balloon angioplasty evolved with a high restenosis rate and a bad mid-term clinical outcome. Stent implantation was able reduce to the restenosis rate and improve the mid-term clinical outcome, in a comparable population of diabetic patients.     

Two‐year outcomes after deployment of XIENCE V everolimus‐eluting stents in patients undergoing percutaneous coronary intervention of bifurcation lesions: A report from the SPIRIT V single arm study

The aim of this analysis was to analyze outcomes of patients undergoing Xience V EES treatment of bifurcation lesions, a subset in which treatment is particularly challenging. The SPIRIT V Study provided an evaluation of the Xience V everolimus eluting stent (EES) performance in complex patient and lesion population. The SPIRIT V Single Arm Study enrolled 2700 patients with de novo coronary artery lesions suitable to be optimally treated with a maximum of four planned Xience V EES. Lesion evaluation was by visual assessment. The outcomes of the 492 patients undergoing Xience V EES stenting of ≥1 bifurcation lesion were compared to those with no bifurcation lesion treated. Compared to those without bifurcation treatment, patients with bifurcation treatment were more likely to have multi‐vessel disease (49% vs 40%), left main treatment (3.1% vs 0.9%), more lesions treated (1.5 vs 1.3), calcification (36.4% vs 27.5%), and ostial (17.1% vs 8.2%) and angulated lesions (29.3% vs 21.1%), all P < 0.001. The 30‐day composite rate of death, myocardial infarction (MI), target vessel revascularization (TVR) was 4.3% in patients with bifurcation PCI and 2.2% in those with non‐bifurcation PCI (P = 0.017). At 2 years, this composite event rate was 11.3% and 10.0% in these two groups, respectively (P = 0.403). Rates of cardiac death, MI, target lesion revascularization (TLR), TVR, and ARC defined definite or probable stent thrombosis (0.4% vs 0.9%, P = 0.402) were not significantly different between the two groups. Despite greater patient and lesion complexity, treatment of patients with bifurcation lesions using the Xience V EES in the SPIRIT V prospective Single Arm Study was safe and effective, with low overall event rates that were similar to those without bifurcation lesion treatment. © 2013 Wiley Periodicals, Inc.     

Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): Immediate and long-term follow-up results

Objective. This study sought to compare two strategies of revascularization in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. A good immediate angiographic result with provisional stenting was considered to occur only if early loss in minimal luminal diameter (MLD) was documented at 30 min post-PTCA angiography.Background. Coronary stenting reduces restenosis in lesions exhibiting early deterioration (>0.3 mm) in MLD within the first 24 hours (early loss) after successful PTCA. Lesions with no early loss after PTCA have a low restenosis rate.Methods. To compare angiographic restenosis and target vessel revascularization (TVR) of lesions treated with coronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n = 57) or to optimal PTCA (n = 59). After randomization in the PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting).Results. Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had a follow-up angiographic study: 98.2% in the stent and 94.9% in the PTCA group. Immediate and follow-up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1.5 mm; p < 0.03). However, late loss was significantly higher in the stent than the PTCA group (0.63 ± 0.59 vs. 0.26 ± 0.44, respectively; p = 0.01). Hence, net gain with both techniques was similar (1.32 ± 0.3 vs. 1.24 ± 0.29 mm for the stent and the PTCA groups, respectively; p = NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; p = NS) and TVR (17.5% in stent vs. 13.5% in PTCA; p = NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group (p = NS). Overall costs (hospital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTCA group (p < 0.02).Conclusions. The strategy of PTCA with delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.