Complex Coronary Artery Lesions Research Articles

Current and emerging catheter technologies for percutaneous transluminal coronary angioplasty

Current and emerging catheter technologies for percutaneous transluminal coronary angioplasty Ponangi Udaya Prashant CARE Hospitals, Banjara Hills, Hyderabad, India Abstract: Appropriate guide catheter selection is a paramount requirement for successful angioplasty of complex coronary artery lesions. When choosing an appropriate guide catheter, the diameter and shape of the guide are the most important factors to be considered, and depend on the anatomy of the coronary artery and backup support required to cross the obstructive lesion. In turn, backup support of the guide catheter depends on the size and terminal shape of the guide rather than the route of intervention chosen and can be expressed mathematically. Many radial route-specific guide catheters have been developed by introducing extratertiary curves and angles to previous existing femoral guides. Backup support can be enhanced by various maneuvers and innovations like the “mother-child” technique. Computer-aided aortogram analysis can help in choosing the right catheter for anomalous coronary arteries. Newer catheter designs like increased lumen diameter ratios, total occlusion crossing support catheters, sheathless guides, and balloon-tipped guides are helping to overcome the shortcomings of antecedent guide catheters. Keywords: guide catheters, backup support, radial angioplasty, anomalous coronary arteries, Ikari catheter&nbsp

The novel 4.5F CoKatte catheter for stent delivery facilitation in complex coronary artery lesions.

The mother and child technique with a deep-seated 4F Kiwami catheter has been reported to be effective for delivering stents to complex lesions. To assess the feasibility and efficacy of a novel 4.5F child catheter for deep insertion and stent deployment into the distal coronary artery for the treatment of complex lesions. We retrospectively evaluated 51 consecutive patients, who underwent percutaneous coronary intervention between January 2011 and December 2013, using a 4.5F CoKatte catheter after stent delivery failure using the conventional procedures. We evaluated the procedure success, need for an additional anchor balloon technique, and complications related to the deep insertion. Stent delivery to the intended lesion was successful in all cases. For advancement and subsequent deep intubation of the catheter, 42 lesions required the additional anchor balloon technique. No complications, including proximal dissection, air embolism, and severe ischemia, were observed in relation to the deep insertion of the catheter. Percutaneous coronary intervention with the novel 4.5F catheter is a safe and effective method, which can facilitate stent delivery to a complex coronary lesion.

ABSORB Biodegradable Stents Versus Second-Generation Metal Stents: A Comparison Study of 100 Complex Lesions Treated Under OCT Guidance

The aim of this study was to compare the acute performance of the PLLA ABSORB bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) with second-generation metal drug-eluting stents (DES) in complex coronary artery lesions. Thick polymer-based BVS have different mechanical properties than thin second-generation DES. Data on the acute performance of BVS are limited to simple coronary lesions treated in trials with strict inclusion criteria. Fifty complex coronary lesions (all type American College of Cardiology/American Heart Association B2-C) treated with a BVS undergoing a final optical coherence tomography (OCT) examination were compared with an equal number of matched lesions treated with second-generation DES. The following stent performance indexes were assessed with OCT: mean and minimal area, residual area stenosis (RAS), incomplete strut apposition (ISA), tissue prolapse, eccentricity index, symmetry index, strut fracture, and edge dissection. One hundred lesions from 73 patients were analyzed. A higher balloon diameter/reference vessel diameter ratio was used for predilation in the BVS group (p < 0.01). Most of the BVS and DESwere post-dilated with short noncompliant (NC) balloons of similar diameter. OCT showed in the BVSgroup a higher tissue prolapse area (p= 0.08) and greater incidence of ISA at the proximal edge (p=0.04) with no difference in the overall ISA. The RAS was 20.2% in the BVS group and 21.7% in the DES group (p= 0.32). There was no difference in the eccentricity index. The minimal and mean lumen areas were similar in the 2 groups. Two cases of strut fractures occurred after the BVS, whereas none was observed in the DES. Based on OCT, the BVS showed similar post-procedure area stenosis, minimal lumen area, and eccentricity index as second-generation DES. The different approach for lesion preparation and routine use of OCT guidance during BVS expansion may have contributed to these results.

Reply to Rubino et al.

We thank Rubino et al. for their interest in our recently published paper [1, 2]. We agree with them that the correct timing for discontinuing double antiplatelet therapy is still controversial. The Society of Thoracic Surgeons guidelines recommend withholding clopidogrel at least 5 days prior to surgery in elective cases and a few days in acute coronary syndromes, while maintaining aspirin up to surgery in both scenarios [3]. On the contrary, previous European guidelines suggest discontinuing clopidogrel 5–7 days before surgery even in patients who need urgent cardiac surgery. Aspirin should be stopped 2–10 days before surgery in elective patients but continued up to the day of surgery in patients with acute coronary syndrome [4]. Furthermore, the timing of discontinuing double antiplatelet treatment might be different in patients with previous stent implantation in less than one year. We strongly believe that the choice of withholding the double antiplatelet therapy should be tailored to the individual patient according to the risk of bleeding and thrombosis and possibly guided by a point-of-care testing. Currently, in the setting of an acute coronary syndrome, our policy is to continue aspirin and discontinue clopidogrel at least 2–3 days before surgery. In the presence of severe critical lesions, we prefer to administrate an intravenous short acting glycoprotein IIb/IIIa inhibitor. Our study confirms that patients receiving clopidogrel in combination with aspirin up to the time of surgery are at risk of increased blood loss, reoperation for bleeding and transfusions. Interestingly, these patients also had higher incidence of postoperative myocardial infarction, something previously reported in the literature and discussed in our paper. We recognize that in our study the three groups examined had a different risk profile and probably more complex coronary artery lesions; however, we reduced potential confounding factors using a multivariate analysis. The use of SYNTAX score might have been helpful in the risk stratification, but the SYNTAX trial data became available only in March 2009. Finally, we did not consider patients referred to surgery after failed PCI as our database did not account for this preoperative variable [5]. We agree that an accurate point-of-care test of platelet function in association with other clinical parameters may be better to identify high-risk patients for postoperative bleeding and reducing postoperative morbidity [6].

Proximal buddy in jail technique: A bail out technique to increase guide support.

During percutaneous coronary intervention, "buddy-in-jail" technique is often used to facilitate stent delivery in complex coronary artery lesions. However, the safety and efficacy of this tech-nique when used with different jailed wire and applied in different target vessel lesions remain elusive. The aim of this retrospective study was to analyze the effectiveness of "buddy-in-jail" technique in the tortuous and rigid lesions of both the common and neighboring coronary arteries. The effectiveness between hydrophilic-coated and non-hydrophilic-coated guide wire as jailed wires was also compared. The "buddy-in-jail" technique was applied in 15 patients after failed balloon or stent delivery into the target vessel lesion from June 2014 to December 2016. The safety and effectiveness of the "bud-dy-in-jail" technique was compared in the tortuous and rigid lesions of both the common and neighbor-ing coronary arteries and between hydrophilic-coated and non-hydrophilic-coated "jailed" wires. Stent delivery was successful in 13 (86.7%) patients with the use of "buddy-in-jail" technique. The success rate was similar to the group using the common artery (87.5%) as a "buddy" vessel and the group using a neighboring artery (85.7%) as a "buddy" vessel (p > 0.05), and between hydrophilic- -coated (100%) and non-hydrophilic-coated "jailed" wire (77.8%) group (p > 0.05). All wires were successfully extracted without complications. The "buddy-in-jail" technique offers a potential alternative approach for the distal stent delivery in both the common and neighboring coronary arteries. Also, both hydrophilic and non-hydro-philic-coated wire could be safely and effectively used as "jailed" wire.

An Update on Drug-Eluting Stents

Coronary artery disease remains one of the major causes of morbidity and mortality worldwide. Percutaneous coronary intervention has been shown to be an effective treatment for angina pectoris, although it does not provide any prognostic benefit in stable patients. Drug-eluting stents (DES) have revolutionised the practice of interventional cardiology by permitting the percutaneous treatment of increasingly complex coronary artery lesions, which historically would have only been treated with surgery. There have been concerns with their long-term safety; however, the most recent large meta-analysis appears to suggest that these concerns are no longer a pertinent issue with the newest generation of stents. Consequently, DES are being used in complex patients and lesion types, and clinical data and guideline recommendations support this. New stent designs are also continually being developed, with the aim to further improve the safety profile of these devices. It must, however, be kept in mind that complacency following the impressive result from initial DES studies lead to, amongst others things, sub-optimal and careless stent deployment, and inappropriate patient selection, which may have ultimately contributed to the prior safety concerns. It is vital, therefore, that this is not repeated in light of the reassuring data, or with newer devices. Finally, as stent design improves, it is becoming increasingly difficult to identify meaningful and clinically relevant differences in stent performance without the requirement of a very large, expensive, randomised trial.

Atherosclerosis burden and coronary artery lesion complexity in acute coronary syndrome patients

Syntax score (SS) is a prognostic marker in patients with acute coronary sydromes (ACS). Carotid intima media thickness (CIMT) and cardio ankle vascular index (CAVI) are well known surrogate marker of atherosclerosis burden. But association between atherosclerosis burden and coronary artery disease (CAD) complexity in ACS patients has not been investigated yet. Consecutive patients with first time diagnosis of ACS (n = 172) were enrolled. SS, a marker of CAD complexity, was assessed by dedicated computer software. CIMT was examined by B-mode ultrasound. CAVI was assessed by VaSera VS-1000 cavi instrument. SS for low, intermediate and high tertiles of CIMT value were 10.1 ± 8.2 vs 11.4 ± ± 7.9 and 15.2 ± 8.8; p = 0.02). SS for normal, borderline and abnormal CAVI values were 4 ± 3.7 vs 11.1 ± 7.2 and 14.1 ± 9.1, respectively p = 0.009). Also, there was independent association between SS and CIMT (95% coinfidence interval [CI] 2.1-19, p = 0.014) and CAVI (95% CI 15-29, p = 0.021]. Neither traditional cardiovascular risk factor nor thrombolysis in myocardial infarction (TIMI) risk score was independent determinant of SS. We have shown that patients with higher atherosclerosis burden have more complex coronary artery lesions. Also these patients may be identified early by using surrogate markers of atherosclerosis. Its clinical significance requires further research.

AS-148: Benefit of Statin therapy in Very Elderly Patients with Acute Myocardial Infarction

The elderly patients with acute coronary syndrome (ACS) usually have more presence of comorbidities such as diabetes mellitus, hypertension, more complex coronary artery lesions, and reduced cardiac and overall physiologic reserve, resulting higher mortality and serious complications. Statin therapy in ACS patients has been proved to improve clinical outcomes. However, little is known about the effect of statin therapy in the very elderly patients with acute myocardial infarction (AMI).

Aortic knob calcification and coronary artery lesion complexity in non-ST-segment elevation acute coronary syndrome patients

Coronary artery lesion complexity is important for risk stratification of acute coronary syndrome (ACS) patients undergoing cardiac catheterization. SYNTAX score is a pure angiographic measure of anatomic coronary complexity. Chest radiography is a routine examination for evaluating patients with chest pain. There have been no studies to date exploring the relation between aortic knob calcification (AKC) and coronary lesion complexity assessed by SYNTAX score. 135 consecutive patients with first time diagnosis of non-ST segment elevation ACS were enrolled. SYNTAX score was calculated by dedicated computer software. Aortic calcification was assessed visually. Patients with AKC had higher SYNTAX score compared to those without AKC (16±6 vs. 11±7, p=0.019). Also, patients with AKC had higher TIMI risk score and were more elderly. Linear regression analysis demonstrated AKC (95% confidence interval [CI] 1.7-6.9, p=0.002), diabetes (95% CI, 1.1-5.7, p=0.005), and smoking (95% CI, 1.2-13.5, p=0.004) as independent determinants of SYNTAX score. Aortic calcification detected on chest X-ray is an independent predictor of complex coronary artery lesions in patients with ACS.

Carotid artery intima-media thickness and plaque score can predict the SYNTAX score

There are few reports demonstrating a relationship between carotid artery ultrasound (carotid-US) findings and the complexity of coronary artery disease. We aimed to examine the relationship between carotid-US findings and the severity of the SYNTAX score (SXscore). Subjects were 501 consecutive patients who underwent carotid-US and first coronary angiography from December 2008 to January 2011. Carotid-US was used to determine the mean common carotid artery intima-media thickness (meanIMT) and the plaque score (PS). The prevalences of low (0-22), intermediate (23-32), and high (≥33) SXscore patients were 84.8, 7.4, and 7.8%, respectively. The SXscore was correlated with the meanIMT (Spearman's rank correlation coefficient; ρ = 0.442, P< 0.0001) and the PS (ρ = 0.544; P< 0.0001). The odds ratios associated with the meanIMT and the PS for prediction of an intermediate or the high SXscore were 1.24 and 1.31, respectively. The areas under the receiver-operating characteristic curves for the meanIMT and the PS to predict the intermediate or the high SXscore were 0.791 and 0.846, respectively. When we set the cut-off value of a meanIMT of 0.9 mm, the sensitivity was 92.1% for intermediate or the high SXscore. Similarly, a cut-off level of a PS of 5 presented a sensitivity of 96.1%. A meanIMT ≥0.9 mm and a PS ≥ 5 had negative predictive values of 97.3 and 98.6%, respectively, for intermediate or high SXscore. Carotid-US parameters have predictive value for the SXscore. In addition, the PS and the meanIMT showed excellent negative predictive value for the presence of complex coronary artery lesions.

Increased Carotid Intima–Media Thickness is Associated With Higher SYNTAX Score

The main purpose of this study was to investigate the relation between carotid intima-media thickness (CIMT) and coronary artery disease (CAD) complexity. Consecutive patients (n = 360) with CAD confirmed by coronary angiography were enrolled. Mean CIMT and the overall SYNTAX score (SXscore) were 0.87 ± 0.12 mm and 15 ± 9, respectively. In univariate analysis, there was a significant correlation between the overall SXscore and CIMT (r = .42, P < .001), age (r = .23, P < .001), hypertension (r = .27, P = 0.001), diabetes (r = 0.11, P = 0.02), smoking (r = .24, P = .01), dyslipidemia (r = .2, P = 0.03), and β-blocker use (r = .19, P < .001). In multivariate analysis, CIMT (β = .34, P < .001) and age (β = .11, P < .019) were independently associated with SXscore. We have demonstrated a significant relation between CIMT and SXscore. Although this study is correlative and no causative conclusions can be drawn, our findings suggest that increased CIMT could reflect complex coronary artery lesions.

The use of excimer laser for complex coronary artery lesions

Excimer laser coronary atherectomy (ELCA) has been used for coronary intervention for more than 20 years. Advances in delivery systems for laser energy using the xenon-chlorine pulsed laser catheter deliver higher energy density with lower heat production. The Spectranetics CVX-300 (Spectranetics, Colorado Springs, CO, USA) excimer laser catheter system has been used for the treatment of complex coronary lesions. We report our experience with the use of this advanced system for stenoses for which were unsuitable for standard percutaneous coronary intervention; for example, balloon-resistant lesions, chronic total occlusions, and for underexpanded stents in calcified lesions. ELCA may also be valuable for thrombus-containing lesion. We find ELCA to be indispensable in the catheterization laboratory for specific complex or calcified lesions. Its role should be explored in a large randomized trial of thrombus containing lesions and saphenous vein grafts.

TCT-171: Utility of Magnetic Navigation for the Percutaneous Treatment of Complex Coronary Artery Lesions: Outcomes and Learning Curve

TCT-171: Utility of Magnetic Navigation for the Percutaneous Treatment of Complex Coronary Artery Lesions: Outcomes and Learning Curve

The CID Chrono™ cobalt–chromium alloy carbofilm-coated coronary stent system

BackgroundIn an attempt to improve the stent's safety, development of bare metal stents (BMS) continues, with new materials and geometry. Chrono™ (CID, Italy) is a thin strut cobalt–chromium (Co–Cr) stent combining the clinical benefits of the bio- and haemo-compatible Carbofilm™ coating. MethodsWe assessed the safety and efficacy of percutaneous coronary interventions (PCI) using the new Co–Cr Chrono™ stent in patients undergoing elective PCI for de novo lesions in native coronary vessels. The patients were followed for 12months for the occurrence of major cardiac events (MACE, defined as death, myocardial infarction, repeat PCI and bypass surgery). Patients with complex (B2/C) lesions were compared to those with non-complex lesions (A/B1). ResultsA total of 340 consecutive patients were analysed: 155 patients with complex lesions (Complex group) and 185 patients with non-complex lesions (Non-complex group). Dual antiplatelet therapy was maintained >1month in 21% of patients in both Complex and Non-complex group. Stent length was longer in the Complex group (25±10mm versus 17±6mm; p<0.001). Stent diameter <3.0mm was most frequent in the Complex group (35.5% versus 27.5%; p<0.05). During the 12-month follow-up period MACE occurred in 10.6% of the global population (12.3% in the Complex group and 9.2% in the Non-complex group; p=0.43). Repeat PCI was most frequent in the Complex group (9.7% versus 3.8%; p=0.044). The incidence of definite and probable stent thrombosis (ARC criteria) was 1.29% in the Complex group and 1.08% in the Non-complex group (p=1.0). ConclusionsImplantation of the Co–Cr Chrono™ stent results in a good safety and efficacy for both complex and non-complex de-novo coronary artery lesions.

Percutaneous coronary intervention of patients with complex small coronary artery lesion unsuitable for coronary artery bypass graft

To investigate the safety and efficacy of percutaneous coronary intervention (PCI) in patients with low left ventricular ejection fraction (LVEF) and complex small coronary artery lesions. Complete or partial post-PCI revascularization of coronary artery was employed in 16 patients with a low LVEF and complex small coronary artery lesions who were unsuitable for CABG (coronary artery bypass grafting). All cases were observed with regards to immediate success rate of operation, complication, hospitalization duration, improvement of cardiac function and LVEF and major adverse cardiac events (including cardiac death, myocardial infarction and target lesion revascularization) at 12 months post-operation. All cases were successfully treated without death and severe complications while the hospitalization duration was (11 +/- 5) days. The follow-up survey at 12 months post-operation showed that no major adverse cardiac event occurred, the post-operative improvement of cardiac function was from III - IV grade to I - II grade, the improvement of LVEF was from 25% - 45% [(29 +/- 8)%] to 32% - 48% [(37 +/- 7)%], left ventricular end diastolic diameter (LVDd) was shortened from 52 - 79 (66 +/- 11) mm to 49 - 68 (58 +/- 8) mm. The reexamination of 14 cases by coronary angiography at 12 months post-operation showed that there was no intra-stent thrombosis while 20% - 40% intra-stent restenosis occurred in 2 cases. For patients with a low LVEF and complex small coronary artery lesions, PCI is a safe and effective method to lower the mortality rate of CHD patients with heart failure and improve the long-term patient prognosis.

Drug-Eluting Stents in Animals and Patients

Four legs good, two legs better. — —George Orwell, Animal Farm, 1945 Since the earliest use of coronary stents for treating symptomatic coronary stenosis, maintaining patent arteries after treatment has remained an elusive goal. Although the first bare metal stents opened stenotic arteries, they injured the arterial wall. The buildup of intimal scar tissue caused restenosis, a frustrating problem for prevention or treatment. After a dozen years of research, however, drug-eluting stents were developed; armed with polymer coating and paclitaxel or sirolimus, they prevented restenosis and were hailed as a major therapeutic breakthrough. Article see p 141 Not long afterward, however, questions about the safety and efficacy of drug-eluting stents surfaced as reports of late stent thrombosis began to appear.1,2 Cardiologists wondered if prevention of restenosis was always a good thing. If no protective cellular layer formed over the struts of the drug-eluting stent—even months or years after implantation—would thrombus develop on the exposed metal scaffolding or other damaged or inflamed areas on the blood vessel wall? Over months or years, would progressive inflammation or late “catchup” tissue growth cause drug-eluting stents to lose their early advantage over bare metal stents? The pendulum in this debate has swung back and forth as clinical trials first raised concern about increased thrombosis and then later quelled our fears as our understanding of how drug-eluting stents work in real life has matured. An important issue has been the increased use of stents in patients with more complex coronary and other disorders, raising the question of whether the established standards of safety and efficacy still apply. Answers for these challenging questions have come from 2 worlds: clinical studies of patients with stents …

TAXUS VI final 5-year results: a multicentre, randomised trial comparing polymer-based moderate-release paclitaxel-eluting stent with a bare metal stent for treatment of long, complex coronary artery lesions

To assess the long-term safety and efficacy of the paclitaxel-eluting TAXUS moderate-release (MR) investigation-only stent for the treatment of long, complex coronary artery lesions. TAXUS VI was a prospective, double-blind, multicentre trial wherein 446 patients were randomised between a TAXUS Express MR stent and an uncoated Express Control stent. At 5-years, the overall rate of major adverse cardiac events (MACE) was similar in the two groups at 27.8% in control and 31.3% in TAXUS (P = 0.61), including similar rates for stent thrombosis. The target vessel revascularisation (TVR) rate was 23.7% in control and 22.2% in TAXUS (P = 0.45) with a non-target lesion revascularisation (non-TLR) rate of 5.1% in control and 10.9% in TAXUS (P = 0.0274) and a TLR rate of 21.4% in control and 14.6% in TAXUS (relative reduction, 32%; P = 0.0325). Furthermore, subgroup analysis revealed that the TLR benefit of TAXUS was preserved among study groups including small vessels, long lesions and patients receiving multiple overlapping stents. Treatment of complex coronary lesions with the TAXUS MR stent demonstrated similar MACE, similar TVR, and reduced TLR rates compared with control through five years. Based on these positive results, the aetiology of increased non-TLR TVR rate in TAXUS remains unclear.

Long-Term Outcome in Patients Treated With Sirolimus-Eluting Stents in Complex Coronary Artery Lesions: 3-Year Results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) Trial

Our purpose was to evaluate the long-term use of sirolimus-eluting stents (SES) and bare-metal stents (BMS) in patients with complex coronary artery lesions. Although the use of SES has proved to be effective in patients with simple coronary artery lesions, there are limited data of the long-term outcome of patients with complex coronary artery lesions. We randomly assigned 322 patients with total coronary occlusions or lesions located in bifurcations, ostial, or angulated segments of the coronary arteries to have SES or BMS implanted. At 3 years, major adverse cardiac events had occurred in 20 patients (12%) in the SES group and in 59 patients (38%) in the BMS group (p < 0.001). Four versus 2 patients suffered a cardiac death (p = NS), and 5 versus 1 died of a noncardiac disease (p = NS) in the SES versus the BMS group. Six patients in the SES group versus 15 patients in the BMS group suffered a myocardial infarction (p < 0.05) during the 3-year observation period, and target lesion revascularization was performed in 8 patients (4.9%) versus 53 patients (33.8%), respectively (p < 0.001); of these, 4 in the SES versus 7 in the BMS group were performed between 1 and 3 years after the index treatment (p = NS). According to revised definitions, stent thrombosis occurred in 5 patients (3.1%) in the SES group and in 7 patients (4.4%) in the BMS group (p = NS); very late stent thrombosis was observed in 4 versus 1 patient. A continued benefit was observed up to 3 years after implantation of SES in patients with complex coronary artery lesions. The rate of late adverse events was similar in the 2 groups, and stent thromboses occurred rarely after 1 year. (Sirolimus Eluting Stents in Complex Coronary Lesions [SCANDSTENT]; NCT00151658)

Efficiency and safety of the sirolimus eluting stent in complex coronary artery lesions after cessation of dual antiplatelet therapy: fifteen months clinical outcome of the randomised Stenting Coronary Arteries in Non-stress/benestent Disease (SCANDSTENT) trial

The randomised Stenting Coronary Arteries in Non-stress/benestent Disease (SCANDSTENT) trial reported considerably less angiographic restenosis after implantation of sirolimus-eluting stents (SES) vs bare metal stents (BMS) in patients with complex coronary lesions. The purpose of this study was to evaluate the clinical outcome after a majority of the SCANDSTENT patients had stopped the dual antiplatelet therapy. The SCANDSTENT trial randomly assigned 322 patients with symptomatic complex coronary artery disease (occlusions, bifurcations, ostial or angulated lesions) to receive SES or BMS. At 15 months after stent implantation, when 80% of the patients had stopped taking clopidogrel, six patients in the SES group and 10 in the BMS group had died or suffered a myocardial infarction (non significant [NS]). Compared with BMS, SES reduced the rate of target vessel revascularisation (TVR) from 33.1% to 5.6% (P<0.001) and the frequency of major adverse cardiac events from 35.7% to 8.6% (p<0.001). Definite stent thrombosis was observed in five patients in the BMS group, and two cases of probable and possible stent thrombosis were observed in the SES group (NS). One case of possible SES thrombosis occurred more than one year after stent implantation. Compared with BMS, SES markedly reduced the frequency of TVR and MACE within 15 months in SCANDSTENT patients with complex coronary artery lesions without development of delayed restenosis.

Abstract 2151: Long-Term Outcome in Patients Treated with Sirolimus Eluting Stents in Complex Coronary Artery Lesions. Analysis of 3-year Results of the Randomized SCANDSTENT Trial

Background - The long-term outcome of patients with complex coronary artery lesions treated with drug-eluting stents is unknown. This study evaluated the 3-year clinical outcome of patients randomized in the SCANDSTENT study to have sirolimus-eluting stents (SES) or bare metal stents (BMS) implanted in their complex lesions. Methods and Results - We randomly assigned 322 patients with symptomatic coronary artery disease and either a total coronary occlusion, a lesion located in a bifurcation, in an ostial or in an angulated segment of the coronary artery to have SES or BMS implanted. At 3 years, major adverse cardiac events had occurred in 24 patients (15%) in the SES group and in 59 patients (37%) in the BMS group ( P &lt;0.001). Four versus 2 patients suffered a cardiac death (NS), and 5 versus 1 died of a non-cardiac disease (NS). Six patients in the SES group versus 15 patients in the BMS group suffered a myocardial infarction ( P &lt;0.05), and target lesion revascularization was performed in 8 patients (4.9%) versus 53 patients (33.8%), respectively ( P &lt;0.001); of these 4 in the SES versus 7 in the BMS group was performed between 1 and 3 years after the index treatment (NS). According to revised definitions, stent thrombosis occurred in 5 patients (3.1%) in the SES group and in 7 patients (4.4%) in the BMS group (NS); very late stent thromboses were observed in 4 versus 1 patient. Conclusions - A continued benefit was observed out to 3 years after implantation of SES in patients with complex coronary artery lesions. Late adverse events occurred less frequently in the SES group, and stent thromboses occurred rarely after 1 year.