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.     

Unprotected left main disease managed with drug‐eluting stents: Long‐term outcome of 100 patients with increased surgical risk

Objectives : The purpose of this study was to determine long‐term clinical outcomes in high surgical risk patients (pts) with unprotected left main (ULM) disease who were managed with drug‐eluting stents (DES). Background : The long‐term efficacy of unprotected left main (ULM) stenting with DES remains uncertain. Methods : From June 2003 to December 2005, 100 pts with increased surgical risk underwent ULM stenting with DES. Patient risk was estimated by EuroSCORE. Disease was confined to the ostium/main stem in Group A (31 pts) and involved the bifurcation in Group B (69 pts). Study endpoints were MI, TVR, and death. Results : Mean age was 68 ± 1 years, EF 52 ± 1%. Mean EuroSCORE was 5.2 ± 0.4, and 41% pts had a EuroSCORE of >6. In Group A, 87% of lesions were directly stented. In Group B, 61% of pts received one stent and 39% received two stents. Primary success was 95%. Follow‐up data (mean 28 ± 1 months) were obtained in all patients. Restenosis occurred at the proximal stent margin in 5/9 pts. There were 12 cardiac deaths (88% cardiac survival) and 9 noncardiac deaths (79% total survival). In Group B, 5 pts died suddenly: 3 within the first week and 2 additional pts after 1 year. Sudden death did not occur in Group A. All cause event‐free survival was 65% in Group A and 67% in Group B. Conclusion : A substantial number of late adverse events occurred in both ostial and bifurcation groups with equal frequency. Until definitive data from randomized trials are available, ULM stenting should be performed only in patients with prohibitive surgical risk. © 2008 Wiley‐Liss, Inc.     

Unprotected left main coronary artery stenting with zotarolimus (Endeavor) drug‐eluting stents

Objectives: To report the safety and efficacy of zotarolimus eluting stents for treatment of unprotected left main coronary artery disease. Background: Percutaneous stent insertion is an increasingly popular alternative to bypass surgery for the management of left main (LM) coronary artery disease. While data support the use of sirolimus‐ and paclitaxel‐coated stents in the LM coronary artery, there are no published series reporting results with Endeavor (zotarolimus) stents, particularly in the context of unprotected left main (ULM) lesions. Methods: We retrospectively identified 40 consecutive patients who had ULM disease treated with Endeavor stents (ZES) and who had follow‐up angiography. The primary endpoint was the prevalence of major adverse cardiac events (MACE), including cardiac/unexplained death, nonfatal myocardial infarction (MI), and in‐stent restenosis (ISR)/target lesion revascularization (TLR). Results: Angiographic and procedural success was achieved in all cases. Follow‐up angiography occurred on average 5.6 ± 0.9 months after the index procedure. There were three incidences of ISR requiring TLR and another patient who had a NSTEMI in the follow‐up period. At late follow‐up (12.4 ± 1.8 months) three patients underwent CABG (one for RCA stenosis) and four patients died without knowledge of the status of the ULM stent (two cardiovascular and two deaths related to cancer progression). Conclusions: In conclusion, our experience with Endeavor stents for the treatment of ULM disease demonstrates excellent angiographic and clinical outcomes, with a 7.5% ISR/TLR rate and a 15% MACE rate, respectively, at an average clinical follow‐up of 12.4 months. © 2011 Wiley Periodicals, Inc.     

Reduced antiplatelet therapy after drug‐eluting stenting: Multicenter janus flex carbostent implantation with short dual antiplatelet treatment for 2 or 6 months—matrix study

Objectives : The Multicentre registry with Antiplatelet TReatment two–sIX months (MATRIX) evaluated safety and efficacy at 12‐month follow‐up of Janus Flex stenting with 2‐ or 6‐month dual antiplatelet therapy (DAT) period. Background : There are no data of Janus Flex stent (Carbostent and Implantable Devices—CID, Saluggia, Italy), a polymer‐free, tacrolimus‐eluting coronary stent, followed by short‐term DAT, in daily practice. Methods : Patients were prospectively enrolled at 12 high‐volume procedures centres. After stenting, four sites prescribed 2‐month DAT, eight sites 6‐month DAT. Major adverse cardiac events (MACE) and stent thrombosis (ST) rate was evaluated at 12‐month follow‐up, for entire population, as well as for 2‐ and 6‐month DAT groups, distinctly. MACE included cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Results : From March 2007 to June 2008, 572 patients (mean age 64.91 ± 11 years, 77.45% males) were enrolled. After successful stenting, 12‐month follow‐up showed a 12.74% MACE occurrence (cardiac death 0.98%; MI 3.13%; TLR 8.62%), with good Janus Flex safety profile confirmed by only two (0.39%) ST. After adjustment for potential confounding, no significant differences were noted at 12‐month follow‐up among 2‐ or 6‐month DAT groups (MACE—8.99% versus 12.47%, P = 0.16; cardiac death—0.54% versus 1.14%, P = 0.52; MI—2.38% versus 2.71%, P = 0.83; TLR—5.66% versus 10.60%, P = 0.20; ST—0% versus 0.55%, P = 0.99). At multivariable analysis, DAT time duration was not an independent risk factor for adverse events (adjusted HR 0.47, 95% confidence interval 0.16–1.35, P = 0.16). Conclusions : Janus Flex coronary stenting, followed by short DAT, is safe and feasible, without differences between 2‐ and 6‐month DAT groups. A randomized trial confirming these encouraging data is needed. © 2011 Wiley Periodicals, Inc.     

Percutaneous left main coronary disease treatment without on‐site surgery back‐up in patients with acute coronary syndromes

Background : Best revascularization strategy in patients with acute coronary syndromes (ACS) and unprotected left main (ULM) coronary disease is still debate reflecting lack of convincing data. Objectives : To assess clinical feasibility and efficacy of ULM percutaneous coronary intervention (PCI) in patients with ACS and describe the practice of a center without on‐site surgical back‐up over a 7‐year period. Methods : Data on high‐risk patients with ACSs undergoing percutaneous ULM treatment were prospectively collected in an independent registry. Primary end‐points of this study were immediate and long‐term outcomes expressed as target lesion failure (TLF, composite of cardiac death, myocardial infarction (MI), and target lesion revascularization). Results : Between January 2003 and January 2010, 200 consecutive patients were included in this study. Angiographic success was obtained in 95% of patients but procedural success was 87% primarily affected by an 11% of in‐hospital cardiac mortality. At median follow‐up of 26 months (IQ 10–47), the overall TLF rate was 28.5%, with 16.0% of cardiac death, 7.0% of MI, and 10.5% of clinically driven target lesion revascularization rates. Cumulative definite/probable stent thrombosis was 3.5%. Elevated EuroSCORE value and pre‐procedural hemodynamic instability were the strongest predictors of TLF. Temporal trend analysis showed progressive but not significant improvement for both immediate (P = 0.110) and long‐term (P = 0.073) outcomes over the study period. Conclusions : This single‐center study based on current clinical practice in patient with ULM disease and ACS confirmed PCI as feasible revascularization strategy in absence of on‐site cardio‐thoracic support. Nevertheless, the outcome of these high‐risk patients is still hampered by a sensible in‐hospital mortality rate. © 2011 Wiley Periodicals, Inc.     

Four‐year clinical outcome of sirolimus‐ and paclitaxel‐eluting stents compared to bare‐metal stents for the percutaneous treatment of stable coronary artery disease

Background : There are limited data on the long‐term safety and efficacy profile of coronary stent implantation in patients with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). Objective : We aimed to assess the 4‐year clinical outcome in patients who received a bare‐metal stent (BMS), sirolimus‐eluting stent (SES), or a paclitaxel‐eluting stent (PES) for the percutaneous treatment of stable angina in our center during 2000–2005. Methods : In the study period, a total of 2,449 consecutive patients (BMS = 1,005; SES = 373; and PES = 1071) underwent a PCI as part of three historical PCI‐cohorts for stable angina and were routinely followed for the occurrence of major adverse cardiac events (MACE). Results : At 4 years follow‐up, 264 BMS patients (26.8%) had a MACE, compared to 75 SES patients (20.9%) and 199 PES patients (23.9%). Multivariate analysis showed that SES and PES were superior to BMS with respect to MACE [hazard ratio (HR) = 0.62, 95% confidence interval (CI): 0.47–0.81; HR = 0.67, 95% CI: 0.55–0.82, respectively]. The occurrence of MACE was significantly lower in the SES and PES population, primarily due to less target‐vessel revascularization (TVR) procedures (HR = 0.53, 95% CI: 0.37–0.75; HR = 0.71, 95% CI: 0.62–0.81, respectively). The occurrence of early, late, and very late stent thrombosis was equally rare with each stent type. There were no significant differences between SES and PES on death, myocardial infarction, TVR, and MACE. Conclusion : These findings suggest that SES and PES result in decreased TVR procedures and MACE compared to BMS at 4 years follow‐up. SES or PES implantation should be the preferred choice over BMS for patients with stable CAD undergoing PCI. © 2010 Wiley‐Liss, Inc.     

Long‐term risk of clinical events from stenting side branches of coronary bifurcation lesions with drug‐eluting and bare‐metal stents: An observational meta‐analysis

Objectives : To compare the long‐term risks of coronary bifurcation lesions treated with side‐branch stenting using drug‐eluting versus bare‐metal stents. Background : Side‐branch stenting is an off‐label practice, but when needed, the incidence of late adverse events may differ between drug‐eluting and bare‐metal stents. Methods : We systematically searched PubMed, and the National Institutes of Health and Cochrane Registries for studies of coronary bifurcation stenting reporting clinical outcomes over at least 5 months. Data were extracted and cross checked independently by two investigators for inclusion in an observational meta‐analysis. Clinical outcomes included major adverse clinical events (MACE), death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. We used random‐effects models and meta‐regression in 6,825 subjects from 42 studies. Results : Most (79%) of the heterogeneity in MACE between treatment groups was explained by differences in stent type, side‐branch stenting, and length of follow‐up. Compared with drug‐eluting stents without side‐branch stenting, drug‐eluting stents with side‐branch stenting had a 3% higher incidence of myocardial infarction [95% confidence interval (CI) = 0.3%, 5%, P < 0.05], but no significant increase in MACE, death, TVR, or stent thrombosis. Bare‐metal stenting without side‐branch stenting had 10% (95% CI = 3%, 16%, P < 0.01) higher MACE, and 10% (95% CI = 4%, 17%, P < 0.01) higher TVR, whereas bare‐metal side‐branch stenting had 31% (95% CI = 23%, 39%, P < 0.001) higher MACE, and 19% (95% CI = 10%, 28%, P < 0.001) higher TVR. Conclusions : Side‐branch stenting has a much smaller impact on long‐term MACE with drug‐eluting stents compared with bare‐metal stents. Although this study does not support routine side‐branch stenting, when side‐branch stenting is required, drug‐eluting stents are associated with less adverse outcomes.© 2011 Wiley‐Liss, Inc.     

85岁及以上老年冠心病患者经皮冠状动脉支架治疗的临床观察

目的 探讨85～94岁冠心病患者经皮冠状动脉支架治疗的疗效和预后.方法 回顾性分析90例85岁以上冠心病患者经皮冠状动脉支架治疗的临床和造影特点、住院期间和长期疗效.结果 90例中,21例应用金属裸支架(BMS),69例应用药物洗脱支架(DES).三支病变41例,2支病变21例,单支病变28例.手术成功率为94.4%,术前与术后TIMI-3级血流比例分别为72.2%和94.4%.手术相关并发症为15.6%,主要为冠脉夹层(11.1%).住院期间主要心血管不良事件(MACE)为7.8%,其中DES组住院期间MACE为5.8%,BMS组为14.3%.DES组出现2例严重出血.86例患者随访1年时,总的MACE为4.6%,其中DES组为6.0%,BMS组没有任何MACE.DES组出现]例脑卒中和1例严重出血.47例患者随访2年时,总的MACE为14.9%,其中DES组MACE为19.4%,BMS组无任何MACE.DES组1例发生严重出血,BMS组1例发生脑卒中.多因素COX回归分析表明,肌酐水平和高血压是影响长期预后的重要因素.结论 85岁以上冠心病患者经皮冠状动脉支架治疗手术成功牢较高,住院期间和长期的MACE事件发生率较低,并存高血压和严重.肾功能不全的患者MACE的发生率相对较高.     

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.     

The EXTREME registry: Titanium‐nitride‐oxide coated stents in small coronary arteries

Objectives : We sought to explore the immediate results of Titan2^® stent implantation in small coronary arteries, as well as the incidence of major adverse cardiac events (MACE) at six months follow‐up. Background : The safety of Titan2^® stent has been confirmed in several studies in real‐life unselected populations. Methods : We enrolled 311 consecutive patients admitted for percutaneous intervention for at least one significant (50%) de novo lesion in a native small coronary artery (2.0–2.75 mm). All lesions were treated with Titan2^® stent implantation. Patients were prospectively followed up for at least six months. The primary endpoint was MACE at six months follow‐up [death, myocardial infarction (MI), or target vessel revascularization (TVR)]. Secondary endpoints included angiographic and clinical procedural success, in‐hospital MACE, target lesion revascularization (TLR) during follow‐up, and stent thrombosis. Results : The mean age was 67.3 ± 10.9 years (65.9% males). A total of 356 Titan2^® stents were implanted in 353 lesions. Angiographic and clinical procedural success was achieved in 344 (97.5%) patients. No case of in‐hospital MACE or acute stent thrombosis was reported. Clinical follow‐up was completed for an average of 8 ± 2 months. Two patients (0.7%) died, and 6 (2.1%) developed MI. TLR was performed in 12 (4.2%) and TVR in 16 (5.5%) patients, all were clinically driven. Cumulative MACE occurred in 20 (6.9%) patients. One patient suffered subacute stent thrombosis, but no late stent thrombosis. Conclusions : Titan2^® stent implantation in small coronary arteries achieves excellent immediate outcome, with a low incidence of MACE at mid‐term follow‐up. © 2010 Wiley‐Liss, Inc.     

Cardiac events after low osmolar ionic or isosmolar nonionic contrast media utilization in the current era of coronary angioplasty.

OBJECTIVES: Our study aimed to compare the isosmolar nonionic dimer iodixanol and the low osmolar ionic agent ioxaglate in the current era of percutaneous coronary intervention (PCI), using clopidogrel, enoxaparine, direct stenting, and drug eluting stent. BACKGROUND: Previous studies have suggested an association between thrombus-related events and type of contrast media. METHODS: Our prospective single-center study included 498 consecutive patients who were assigned to receive either iodixanol (n = 231) or ioxaglate (n = 267). The primary endpoint was the cumulative rate of in-hospital major adverse clinical events (MACE). A secondary endpoint was the rate of angiographic or procedural complications. RESULTS: Clinical and angiographic baseline characteristics and procedural data were similar in the 2 groups. A peak anti-Xa > 0.5 IU/ml was obtained in 97% in both groups. Glycoprotein IIb/IIIa inhibitors were used in 42% of patients. Coronary stenting was performed in 91% of patients, with direct stenting in 70%, and drug-eluting stent in 28% of patients. In-hospital MACE was more frequent in patients receiving iodixanol compared with those receiving ioxaglate (4.8% vs. 0.3%, P < 0.005). This difference was mainly related to the appearance of a large thrombus during PCI (6% with iodixanol vs. 0.3% with ioxaglate, P < 0.0001). In multivariate analysis, independent predictors of in-hospital MACE were use of iodixanol (P < 0.01), the higher number of stent used (P < 0.008), bifurcation/ostial lesion (P < 0.01), and balloon dilation before stenting (p < 0.001). CONCLUSIONS: In our study reflecting the current era of PCI, thrombus-related events are more frequent with the isosmolar nonionic dimer iodixanol than with the low osmolar ionic agent ioxaglate.     

Results of percutaneous drug‐eluting stent implantation for unprotected left main coronary disease according to left ventricular systolic function

Objectives: We aimed to appraise the early and long‐term outcome after percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) in patients with unprotected left main disease (ULM) and left ventricular systolic dysfunction (LVD). Background: PCI with DES has being performed with increasing frequency in subjects with ULM and LVD, but few specific data are available. Setting and Patients: We identified patients undergoing PCI with DES for ULM at our Center and distinguished those with ejection fraction (EF) >50% from those with 40% <EF ≤50% and those with EF ≤40%. The primary end‐point was the rate of major adverse cerebro‐cardiovascular events (MACCE, ie death, myocardial infarction [MI], stroke, repeat PCI or bypass surgery). Results: A total of 197 patients were included, 57.4% with EF >50%, 32.0% with 40% <EF ≤50%, and 10.6% with EF ≤40%. In‐hospital mortality was significantly higher in those with EF ≤40% (9.5% vs. 0 and 3.2%, P < 0.001). A total of 96% patients were followed for 23 ± 14 months, yielding a MACCE rate of 44.2% (41.6% in those with EF >50%, 41.6% in those with 40% <EF ≤50%, and 61.9% in those with EF ≤40%, P = 0.4). Specifically, death occurred in 2.7%, 7.9%, and 28.6% (P < 0.001), cardiac death in 1.8%, 4.8%, and 23.8% (P = 0.001), MI in 8.0%, 7.9% and 0 (P = 0.4), and TVR in 15.9%, 11.1% and 33.3% (P = 0.6). Conclusion: Systolic ventricular dysfunction is highly correlated with in‐hospital and long term death rates in patients undergoing PCI with DES for ULM disease. However it does not confer an increased risk of nonfatal adverse events or stent thrombosis. © 2009 Wiley‐Liss, Inc.     

Clinical and procedural outcomes of percutaneous coronary intervention for de novo lesions involving the ostial left circumflex coronary artery

Background

Percutaneous treatment for ostial left circumflex artery (LCx) lesions is known to be associated with suboptimal results.

Aims

The present study aims to assess the procedural and long-term clinical outcomes of percutaneous coronary intervention (PCI) for de novo ostial LCx lesions overall and according to the coronary revascularization strategy.

Methods

Consecutive patients undergoing PCI with second generation drug eluting stents or drug coated balloons for de novo ostial LCx lesions in three high-volume Italian centers between 2012 and 2021 were retrospectively evaluated. The primary endpoint was target-vessel revascularization (TVR) at 2 years. Secondary endpoints included major adverse cardiovascular and cerebrovascular events (MACCE), target lesion revascularization, myocardial infarction, stroke, all-cause death, and repeat revascularization.

Results

A total of 366 patients were included in the analysis with a median follow-up of 901 (IQR: 450−1728) days. 79.5% of the patients were male, 33.6% were diabetic, 49.7% had a previous PCI, and 23.1% a prior surgical revascularization. Very ostial LCx stenting was performed in 34.1%, crossover from left main to LCx in 17.3%, and a two-stent strategy in 48.6% of cases, respectively. In the overall population, the incidence of TVR at 2 years was 19.0% while MACCE rate was 25.7%. No major differences in clinical outcomes were found according to the stenting strategy. Use of intracoronary imaging was associated with fewer MACCE (HR: 0.47, 95% CI: 0.25−1.13, p = 0.01), while the diameter of the stent implanted in the ostial LCx was associated with less TVR (HR: 0.43, 95% CI: 0.25−0.75, p = 0.002).

Conclusions

Percutaneous revascularization of the ostial LCx is associated with a high rate of TVR, regardless of the stenting strategy. Intracoronary imaging and proper stent sizing may reduce the failure rates.     

Long‐term clinical outcomes after drug‐eluting stent implantation in unprotected left main coronary artery disease

Objective: To investigate long‐term outcomes of unprotected left main coronary artery (ULMCA) disease treatment using drug‐eluting stents (DES). Background: In several studies, DES implantation in ULMCA appeared safe and effective at mid‐term; however, to date, there is limited long‐term data. Methods : All consecutive patients undergoing sirolimus‐ or paclitaxel‐eluting stent implantation in ULMCA disease at a single institution were evaluated. The primary endpoint was long‐term major adverse cardiac events (MACE) defined as cardiac death, nonfatal myocardial infarction, or target lesion revascularization (TLR). Stent thrombosis (ST), according to Academic Research Consortium definitions, was also evaluated. Results: A total of 210 patients were assessed. In‐hospital MACE rate was 1%. During a mean follow‐up of 28.0 ± 14.5 months, MACE occurred in 26 patients (12.5%): cardiac death in nine patients (4.3%) and TLR in 17 patients (8.2%). The cumulative MACE‐free survival rate was 89.0, 87.4, and 85.4% at 1, 2, and 3 years, respectively. ST occurred in three patients (1.4%): one case was definite and the other two were probable/possible ST; there were no cases of very late ST. Binary restenosis occurred in 8.3%. The EuroScore >6 was the only independent predictor of MACE [hazard ratio (HR) 2.24, 95% confidence interval (CI) 1.05–4.77, P = 0.04]. There was a trend toward an increased risk of MACE associated with distal ULMCA location (HR 2.14, 95% CI 0.87–5.29, P = 0.10). Conclusions: Our study showed DES implantation in ULMCA to be feasible, safe, and effective at long term. Randomized trials comparing percutaneous versus surgical revascularization are warranted to define the treatment of choice for ULMCA disease. © 2009 Wiley‐Liss, Inc.     

Five‐year long‐term 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 FIRST trial

Background : Drug‐eluting stents have shown to be superior over bare metal stents in clinical and angiographic outcomes after percutaneous treatment of coronary artery stenosis. However, long‐term follow‐up data are scarce and only available for sirolimus‐ and paclitaxel‐eluting stents. Aim : To assess the feasibility and performance of the XIENCE V everolimus‐eluting stent (EES) versus an identical bare metal stent after a 5‐year follow‐up period. Methods : SPIRIT FIRST was a First in Man, multicentre, prospective, single‐blind, clinical trial, randomizing 60 patients with a single de novo coronary artery lesion in a ratio of 1:1 to either an everolimus eluting or a bare metal control stent. Results : At 5‐year clinical follow‐up, data were available in 89% and 86% of patients in the everolimus and control arm, respectively. In the everolimus arm, no additional death, myocardial infarction, clinically driven target lesion revascularization (TLR), or clinically driven target vessel revascularization (TVR) events were observed between 1‐ and 5‐year follow‐up. The 5‐year hierarchical major adverse cardiac events (MACE) and target vessel failure (TVF) rates for the everolimus arm were 16.7% (4/24) for both endpoints. In the control group, no additional cardiac death, myocardial infarction, or clinically driven TLR events were observed between 2‐ and 5‐year follow‐up. No additional clinically driven TVR events were observed between 3‐ and 5‐year follow‐up. The 5‐year hierarchical MACE and TVF rates for the control arm were 28.0% (7/25) and 36.0% (9/25), respectively. No stent thromboses were observed in either the everolimus arm or the control arm up to 5 years. Conclusion : The favorable 5‐year long term clinical outcome of the EES is consistent with the results from other studies of the EES with shorter follow‐up. © 2010 Wiley‐Liss, Inc.     

Best practices for treating coronary ostial lesions

• Percutaneous coronary intervention of ostial lesions can be fraught with multiple challenges.
• Intravascular ultrasound detects imperfect stenting results (stent underexpansion and incomplete ostial coverage) in approximately half of imaged ostial lesions.
• Corrective actions based on intravascular ultrasound imaging can improve the long‐term outcomes of patients undergoing ostial lesion stenting.

     

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)

     

Three‐year outcome of drug‐eluting stent implantation for coronary artery bifurcation lesions

Objectives: To compare the very long‐term clinical outcomes of bifurcation lesions using the crush and the simultaneous kissing stent (SKS) techniques. Background: A variety of two‐stent techniques have been used to treat coronary artery bifurcation lesions in the drug‐eluting stent era, but the long‐term clinical outcome of these approaches is not known. Methods: A total of 74 consecutive patients underwent bifurcation stenting using either the crush or SKS techniques. Mean patient age was 66.91 ± 11.3 years; 26% were diabetic, and the left anterior descending/diagonal bifurcation was the most frequently treated lesion (68%). Results: In‐hospital outcomes were not significantly different between groups. Over a median follow‐up of 3.3 years, 1 patient in the SKS group and 3 patients in the crush group died (P = ns). Probable stent thrombosis leading to death according to the Academic Research Consortium definition occurred in 1 patient in the crush group. Mortality in the remaining 3 patients was noncardiac. Target lesion revascularization (TLR) occurred in 14 patients (40%) in the SKS group and 5 patients (12.8%) in the crush group (P = 0.015). Survival free from major adverse cardiac events (MACE) was significantly less in the SKS group and predominantly driven by TLR (60 vs. 88%, P = 0.001). Conclusions: In conclusion, over a median of 3.3 years of follow‐up, TLR and MACE are significantly lower in bifurcation lesions treated with the crush technique when compared with the SKS technique. Definite or probable stent thrombosis is rare with either technique. © 2009 Wiley‐Liss, Inc.     

Selective drug‐eluting stent implantation for high‐risk patients with acute ST‐elevation myocardial infarction: Rationale and safety

Background : A selective policy of drug‐eluting stent (DES) implantation in ST‐elevation myocardial infarction (STEMI) patients at high risk of restenosis may maximize the benefit from restenosis reduction and minimize risk from late stent thrombosis (LaST). Objectives : We sought to prospectively determine the safety of selective DES implantation for long lesions (>20 mm), small vessels (<2.5 mm) and diabetic patients in patients with STEMI using a prospective single‐center registry. Methods : A total of 252 patients who underwent primary PCI between January 2005 and December 2006 were included: 126 consecutive patients receiving DES were compared with 126 age‐, sex‐, and vessel‐matched controls with STEMI who received bare‐metal stents. Composite major adverse cardiovascular events (MACE) (death, AMI, and target vessel revascularization) were used as the primary outcome measure. Results : Baseline clinical and angiographic characteristics and outcomes were similar between groups except for the prespecified diabetes, lesion length, and maximum stent diameter. Long‐term outcomes at a median follow up of 34 ± 6 months showed significant reductions in reinfarction (2% vs. 11%, P = 0.03), target vessel revascularization (TVR) (10% vs. 24%, P = 0.02), and composite MACE (18% vs. 31%, P = 0.03) with DES, with no excess of death (9% vs. 7%, P = NS) or LaST (2% vs. 1%, P = NS). In a Cox multivariate model, clopidogrel cessation at long‐term follow‐up was the most powerful predictor of hierarchical MACE (HR: 5.165; 95%CI: 2.019–13.150, P = 0.001). Conclusions : Selective DES implantation in patients with high‐risk STEMI appears safe, and exposes fewer patients to the risk of LaST. A randomized comparison of selective versus routine DES use in patients with STEMI should be considered. © 2010 Wiley‐Liss, Inc.     

Drug eluting stenting in bifurcation coronary lesions long-term results applying a systematic treatment strategy

Objectives : To explore the long‐term results following implantation of drug‐eluting stents (DES) in bifurcation lesions according to contemporary “real world” practice. Background : Limited information is available on the long‐term outcomes of patients with bifurcation lesions who are treated using DES. A systematic approach for bifurcation lesion management was applied, using either a “provisional” single stent technique or a dedicated two stents strategy according to the side‐branch diameter and severity of its ostial stenosis. Methods : Four hundred one consecutive patients underwent bifurcation percutaneous coronary intervention (PCI) using DES and were included in our prospective registry. All adverse events were recorded up to 2 years and distinguished according to the planned PCI strategy (e.g., one versus two stents technique). Results : A planned two stents strategy was used in 141 patients (35% of patients). In 260 patients (65%), the planned treatment involved stenting of the main branch only with “provisional” stenting of the side‐branch according to procedural course. Thus, 24 patients (9.2%) needed additional stenting at the side‐branch to complete the PCI. Cumulative major adverse cardiac event rate at 1 and 2 years was similar for both groups (11.4% vs. 14.8% at 1 year and 19.4% vs. 25.7% at 2 years for the single vs. two stents groups, accordingly, P = NS for both). Likewise, there was no difference in mortality, cardiac mortality, myocardial infarction, need for target lesions or target vessel revascularization, or definite stent thrombosis rate between the two groups at 6, 12, and 2 years follow‐up. The rate of angiographically confirmed (i.e., definite) stent thrombosis did not differ between the two groups during follow‐up. Conclusions : Our study revealed favorable long‐term clinical results following DES implantation using a systematic, rather simplified approach towards bifurcation stenting and using either a single or double stenting technique. © 2011 Wiley Periodicals, Inc.