The angiography-guided spot versus entire stenting in patients with long coronary lesions trial: Study design and rationale for a randomized controlled trial protocol.

BACKGROUND: /Purpose: Long-stenting, even with a second-generation drug-eluting stent (DES), is an independent predictor of restenosis and stent thrombosis in patients with long coronary lesions. Spot-stenting, i.e., selective stenting of only the most severe stenotic segments of a long lesion, may be an alternative to a DES. The purpose of this study is to compare the one-year clinical outcomes of patients with spot versus entire stenting in long coronary lesions using a second-generation DES. METHOD: This study is a randomized, prospective, multi-center trial comparing long-term clinical outcomes of angiography-guided spot versus entire stenting in patients with long coronary lesions (≥25 mm in length). The primary endpoint is target vessel failure (TVF) at 12 months, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization (TVR). A total of 470 patients are enrolled for this study according to sample size calculations. This study will be conducted to evaluate the non-inferiority of spot stenting compared to entire stenting with zotarolimus-eluting stents (ZES). RESULTS: This study is designed to evaluate the clinical impact of spot-stenting with ZESs for TVF due to possible edge restenosis or non-target lesion revascularization. Theoretically, spot-stenting may decrease the risk of TVR and the extent of endothelial dysfunction. CONCLUSION: This SPOT trial will provide clinical insight into spot-stenting with a current second-generation DES as a new strategy for long coronary lesions.

Clinical experience with 12-month follow-up in patients after implantation of a novel long-tapered sirolimus drug-eluting stent.

INTRODUCTION: Long lesions contribute to a significant number of percutaneous coronary interventions. AIM: To assess the efficacy and safety of a novel long-tapered drug-eluting stent (DES) at a 12-month follow-up (FU) in patients with long coronary atherosclerotic lesions. MATERIAL AND METHODS: A prospective clinical cohort study was conducted in 32 patients who underwent percutaneous coronary intervention using a BioMime Morph tapered stent (Meril Life Sciences, India). The patients were followed for 3, 6, and 12 months. The safety endpoints were death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and MACE and/or major bleeding. RESULTS: Mean lesion length was 48 mm (range: 35-70 mm) measured via quantitative coronary analysis (QCA). In most cases, the target lesion was located in the LAD (68.75%). A GuideLiner catheter (Vascular Solutions Inc., MN, USA) was used in 12.5% of procedures; buddy-wire technique in 9.4% of cases. Bifurcation lesions were treated in 40.6% of cases. Additional stent implantation was needed in 56% of the procedures (25% of cases due to proximal or distal dissection, or due to insufficient stent length in 31% of cases). On 12-month FU we observed 1 TLR (3.1%), 1 TVR (3.1%), and 1 non-cardiovascular death. CONCLUSIONS: The long sirolimus-eluting stent with tapered structure was characterized by good deliverability in long coronary lesions, although in some cases "buddy wire" or extension microcatheter use was necessary. Follow-up at 3, 6, and 12 months showed no significant major adverse cardiovascular events related to the device.

Everolimus drug-eluting stent performance in patients with long coronary lesions: The multicenter Longprime registry.

OBJECTIVES: To assess the efficacy and safety of the Xience Prime everolimus-eluting stent (EES) in long coronary lesions in a real-world population. BACKGROUND: Long lesions are considered difficult technically and in terms of achieving successful clinical outcomes. With first generation DES, MACE can be as high as 10% at a short-medium term follow-up. There are a few data available in this subset regarding the use of second generation DES METHODS: A prospective, multicenter registry of consecutive patients (aged 64.8 ± 11.2 years, 77% men and 33% diabetics) in 29 tertiary hospitals with de novo > 24 mm lesions in vessels of 2.25-4 mm was performed. The primary and secondary endpoints were major adverse cardiac events (MACE; cardiac death, myocardial infarction, and target lesion revascularization) and stent thrombosis (ST) at 1, 12, and 24 months. Patients were on dual antiplatelet therapy during 12 months. RESULTS: A total of 610 patients with 705 long lesions were included (1.2 per patient). Lesion length was 34.59 ± 11.17 mm and vessel size 2.93 ± 0.41 mm. Stented length was 39.83 ± 14.08 mm (1.4 stents per lesion). Predilatation/postdiltatation was performed in 75 and 33% of the cases, intravascular ultrasound in 15%. The device success rate was 99.1%. MACE and ST rates at 1, 12, and 24-months follow-up were 0.3, 2.1, and 5.4% and 0.2, 0.7, and 1.5%, respectively. CONCLUSION: In this real-world population, the Xience Prime EES performs extremely well in long lesions, with a very low rate of both MACE and ST.

One-year clinical outcome of percutaneous coronary intervention with very long (≥ 40mm) drug-eluting stent.

OBJECTIVES: The aim of this study was to assess the clinical outcome of patients with diffuse coronary lesions treated with very long drug-eluting coronary stents (DES) (≥ 40mm) over a period of one year. METHODS: This single-center prospective study enrolled a total of 343 consecutive patients (376 long stents) who underwent percutaneous coronary stent implantation with very long DES. One year clinical outcomes were analyzed. A subgroup analysis of diabetic patients was also performed. RESULTS: One year follow up data was available for 314 patients (91.5%). All-cause mortality was 5 (1.6%). Eleven (3.5%) patients had non-ST-elevation myocardial infarction. Definite / probable stent thrombosis was reported in 7 (2.2%) patients. Over one year, 3 (1%) patients underwent target lesion revascularization (TLR). The total number of target lesion failure was 9 (2.9%). The rate of target lesion failure at one year was 2.6% using one vessel per patient analysis. Two patients had ischemic stroke. Any major adverse cardiac event (MACE) was observed in 19 (6%) patients. The event rates between sirolimus and everolimus stent groups were compared - cardiac death (1.7% vs 1.5%; p=0.911), stent thrombosis (2.5% vs 1.7%; p=0.612), TLR (1% vs 0.8%; p=0.878), any MACE (7% vs 4.1%; p=0.284). Exertional dyspnea was reported by 47 (15%) patients at the end of one year. Dual antiplatelet adherence rate was 96% (n=301 of 314). CONCLUSION: Use of very long stents (≥40mm) for diffuse coronary lesions is safe and effective with acceptably low event rates. No significant differences in event rates were observed between the types of DES used in this study (Sirolimus Vs. everolimus).

Clinical outcomes after PCI treatment of very long lesions with the XIENCE V everolimus eluting stent; Pooled analysis from the SPIRIT and XIENCE V USA prospective multicenter trials.

BACKGROUND: Lesion length has been an important factor in predicting a worse outcome after percutaneous coronary interventions (PCI); however, the safety and efficacy of second-generation drug eluting stents in very long coronary lesions has not been validated in large scale randomized controlled trials. METHODS: We performed a patient level pooled analysis of 13,266 patients undergoing planned overlapping stent treatment of very long coronary lesions with the XIENCE V everolimus eluting coronary stent system from 6 trials evaluating the XIENCE V stent (Spirit II, III, IV, V, Spirit Small Vessel and XIENCE V USA). Patients were divided into two cohorts, a very long lesion (VLL) group (lesions ≥35 mm) and a control group (lesions >24 to <35 mm). The primary outcome measures were Target Lesion Failure (TLF), Major Adverse Cardiac Events (MACE), and Academic Research Consortium (ARC) defined definite and probable stent thrombosis at 1 year. RESULTS: A total of 13,266 patients were included in the pooled analysis of which 2.4% (323 patients with 328 total lesions) had a mean lesion length of 47.1 ± 13.7 mm in the VLL group which were compared to controls comprised of 3.6% of the cohort (482 patients with 500 total lesions) with mean lesion length of 28.1 ± 2.4 mm.There was no significant difference in the rates of TLF between the VVL and control groups (8.9 vs. 10%, P = 0.63), MACE (9.2 vs. 10%, P = 0.74) or stent thrombosis (1.6 vs. 1.5%, P = 0.92) at 1 year. CONCLUSIONS: In the treatment of very long coronary lesions, the XIENCE V stent appears as safe and effective as percutaneous coronary interventions for long lesions. © 2016 Wiley Periodicals, Inc.

Immediate and follow-up results after long stent implantaton in diffuse long coronary lesions / 대한내과학회지

BACKGROUND: The results and restenosis after long stent implantation for diffuse long coronary lesion has not been fully evaluated. We evaluated immediate and follow-up results of single long coronary stenting for long coronary disease. METHODS: This study report on the use of follow-up examination is possible 48 patients with 50 lesions after stenting in total 70 patients with 72 lesions with long lesion. Diffuse long coronary lesion was defined as a lesion length longer than 20mm. Mean follow-up duration was 8.7+/-2.9 months and mean patients age was 58+/-10 years. Total patients was infused 8000-10000IU heparin and added bolus 3000-5000IU heparin for activating clotting time(ACT) was over 250 seconds during procedure. Restenosis was defined over 50% diameter stenosis in 6 months follow-up angiographic study. RESULTS: Angiographic success was achieved 68/70 patients(97.1%) in this study. Mean reference diameter was 3.14+/-0.1mm and baseline, final, follow-up minimal luminal diameter(MLD) was 0.6+/-0.4mm, 3.0+/-0.4mm, 1.6+/-0.3mm on each occasion and each % diameter stenosis(% DS) was 78.7+/-0.4%, 4.9+/-0.4%, 47.4%+/-0.5% present. The overall significantly increased in diabetics patients(7/21 vs 3/29 p=0.04) and in long lesion length patients(33.9+/-4mm vs 30.4+/-0.4mm p=0.02) but, clinical diagnosis and indication of stenting, lesional location, stent length, stent size, reference diameter size were not associated with restenosis rate. CONCLUSION: Single long stent implantation for diffuse long coronary lesion shown excellent success rate but high restenosis rate present. The restenosis rate was significantly associated with diabetics and lesion length Some further study for improving restenosis rate is needed.

Early Outcome of Long Coronary Stent Implantation

BACKGROUND: Percutaneous transluminal coronary angioplasty(PTCA) for long coronary lesion is known to be associated with low success rate,suboptimal outcome,high complication and restenosis rates. Here we report the early clinical and angiographic results of long coronary stent implantations for long coronary lesions. METHOD: We analyzed the clinical,angiographic features and early results after stent implantations in 46 patients who were implanted long coronary stent(> or =20mm in length)among 174 stented patients at Chonnam University Hospital from Jan.through Nov.1996. RESULT: 1) Age was 59+/-7(35-78) years,and sex ratio was 2.5:1(33 male:13 female). clinical diagnosis was as follows; 24 patients with unstable angina, 21 with acute myocardial infarction, 1 with stable angina and 6 with old myocardial infarction. Left ventricular ejection fraction by left venriculogram was 58+/-10(27-87)%. 2) Involved numbers of vessel were single in 27 patients, two in 14 patients, and three in 5 patients. Target stented coronary arteries were 28 left anterior descending arteries, 17 rigtt coronory arteries, and 1 left circumflex artery. Morphologic types of target lesions were type C in 26 patients, type B2 in 20, and diameter stenosis(DS) was 76+/-13%, minimal luminal diameter(MLD) 1.0+/-0.3mm, length 21+/-6(10-38)mm. Indications for stent were 28 denovo lesions, 10 restenoses, 5 suboptimal PTCAs and 3 bailout procedures. Twenty six Microstents 2, 15 Wallstents, 4 Freedom stents, and 1 Wictor stent were used. Stent diameter was 3.2+/-0.3(2.5-5.0)mm and length 30+/-3(20-49)mm, stent diameter/reference diameter(RD) ratio 1.0+/-0.1, and stent minus lesion length 9.0+/-3.7mm. 3) Stents were deployed successfully in all 46 patients. No procedure-related death, myocardial infarction, emergency bypass surgery, and laboratory evidences of acute or subacute stent thrombosis were observed. 4) DS was decreased to 3.5+/-7.5%, MLD was increased to 3.2+/-0.3mm(p<0.0001, respectively). Acute gain was 2.2+/-0.4mm(71.8+/-15.6%,p<0.0001). CONCLUSION: We observed high success rate without major complications in long stent implantations for long coronary arterial lesions. Long-term follow-up should be required to prove long coronary stent as a better treatment modality to reduce acute complications and late restenosis.