Treatment Of Complex Coronary Lesions Research Articles

TCT-345 DYNAMX Bioadaptor Stent Implantation for the Treatment of Complex Coronary Lesions: Insights From the DYNAMITE Study

TCT-345 DYNAMX Bioadaptor Stent Implantation for the Treatment of Complex Coronary Lesions: Insights From the DYNAMITE Study

Randomized non-inferiority TrIal comParing reverse T And Protrusion versus double-kissing and crush Stenting for the treatment of complex left main bifurcation lesions

BackgroundThe treatment of left main bifurcation stenoses remains challenging.AimsWe compare the “Reverse T and Protrusion” (reverse-TAP) technique to Double-Kissing and crush (DK-crush).MethodsThe study was designed as non-inferiority trial, the primary endpoint was percentage stent expansion in the ostial side branch at optical coherence tomography.Results52 consecutive patients (13 females, 17 diabetics, Syntax score 25 [22–29]) with complex coronary bifurcation lesions of the left main were randomized in a 1:1 ratio to Reverse-TAP or DK-crush stenting. The intervention was performed according to protocol in all patients in both randomization groups. Side branch stent expansion was 75 [67–90]% in the DK-crush group and 86 [75–95]% in the reverse-TAP group (one-sided 97.5% lower parametric confidence interval: − 0.28%; P < 0.01 for non-inferiority; P = 0.037 for superiority). Side branch balloon pressure during final kissing was higher in the DK-crush group (14 [12–16] vs. reverse-TAP: 13 [12–14]; P = 0.043). Procedural time was shorter with reverse-TAP (DK-crush: 32 [24–44] min vs reverse–TAP: 25 [22–33] min; P = 0.044). Other procedural parameters were not different between groups. There was no difference in any of the safety endpoints up to 1 month.ConclusionsA reverse-TAP strategy for the interventional treatment of complex coronary lesions was non-inferior and superior to DK-crush for the primary endpoint side branch expansion while requiring less time. A larger study testing long-term clinical outcomes is warranted.Trail RegistrationNCT: NCT03714750.Graphical abstract

Safety and Efficacy of Guidezilla Extension Catheter for the Percutaneous Treatment of Complex Coronary Lesions.

The GuidezillaTM support extension catheter is designed to provide extra back-up support and efficient device delivery during complex percutaneous coronary interventions (PCIs), such as in treatment of severe calcification, tortuous chronic total occlusions (CTOs), and coronary anomalies. The aim of this study was to describe our initial experience with the GuidezillaTM extension catheter in the treatment of complex coronary artery lesions. This study retrospectively analyzed data from 165 PCI cases that used the GuidezillaTM guide extension catheter between March 2015 and August 2017. We collected patient clinical characteristics, target lesion characteristics, and procedural details. Eighty-six percent of patients had complex Type C lesions, and 13.9% had Type B lesions. Lesion length ranged from 8 mm to 130 mm (≤ 20 mm, 15.4%; 20-40 mm, 35.8%; > 40 mm, 49.1%). The right coronary artery (59.2%) was the most common intervention vessel followed by the left ascending artery (30.6%) and the left circumflex artery (10.2%). CTO accounted for 38% of all lesions, followed by distortions (28%), heavy calcification (24%), proximal stent thrombosis (9%), and coronary artery origin anomalies (1%). A total of 142 patients underwent successful PCI using the GuidezillaTM extension catheter. The success rate was 86%. The GuidezillaTM guide extension catheter was an effective and safe technique in the transradial treatment of complex coronary lesions. Use of the GuidezillaTM guide extension catheter can shorten the procedure time and ensure overall procedural success with a reduced complication rate in cases where adequate progress using angioplasty devices has not been achieved.

P6526Short and long-term outcomes of coronary perforation managed by coil embolization: a single-center experience

Abstract Background Coronary perforation is a serious complication in percutaneous coronary intervention (PCI), as it can lead to pericardial effusion causing tamponade, often necessitating emergency pericardiocentesis and rarely, cardiac surgery. With increasing treatment of complex coronary lesions, such as chronic total occlusion (CTO), the incidence of coronary perforation is also increasing. Distal wire perforation and collateral vessel perforation can be managed by coil embolization during PCI, which prevented the need of cardiac surgery. Purpose To report the short and long-term outcomes of patients with coronary perforation as a complication of PCI managed by coil embolization in our center Methods We retrospectively analyzed 66 patients who had coronary perforation treated by coil embolization during PCI from 32007 PCI procedures performed in our center from Oct 2012 to June 2018. Results Of sixty-six cases of coronary perforation, twenty-six cases were distal coronary perforation, while 40 cases were collateral perforation. The average coil number used in distal coronary and collateral perforation lesion is 1.8±0.9 and 1.8±1.0, respectively. The maximum number of coil implanted in each patient is 4 in both groups. Two emergency cardiac surgery to seal the perforation was performed after coil embolization in distal coronary perforation and pericardiocentesis, including one distal left circumflex artery perforation and one distal left anterior descending artery perforation. In collateral perforation, one case of CABG was performed due to myocardial ischemia caused by CTO lesion. During a follow-up of 707±476 days, one patient in collateral perforation group had CABG one month later, while no death or myocardial infarction (MI) was detected. Fifty-four (81.2%) cases of perforations occurred while treating chronic total occlusion, and 74.0% of these perforations were located in collateral vessels, mostly epicardial vessels. Thirty-nine CTO cases (72.2%) were revascularized successfully with the aid of coil embolization. Conclusion Coil embolization is feasible and effective in treating distal coronary perforation and collateral perforation during PCI procedure. In CTO lesions, coil embolization facilitates the success of revascularization by PCI.

TCT-342 Excimer Laser Lesion Modification in-Stent Restenosis and Non-Optimal Dilated Stents. The ELM Registry

The treatment of complex coronary lesions, underexpanded stents and in-stent restenosis (IRS) seems to be a promising area for excimer laser coronary atherectomy (ELCA) use. The stent underexpansion is a risk factor for in stent restenosis and late thrombosis. The aim of this study was to examine

Angiographic Analysis of Trans-Radial Percutaneous Coronary Intervention Cases by the Backup Support of Guide Extension Catheter

Background:The guide extension catheter – Guidezilla (Boston Scientific, United States of America) is a useful adjunctive tool in percutaneous revascularization of complex coronary lesions, and provides an extension to the guide catheter with better coaxial alignment, support and stability.Objective: The objective of this study was to describe the usefulness and easy deliverability of stent by Guidezillain the trans-radial treatment of complex coronary lesions as our initial experience.Methods:This prospective observational study was conducted at the Department of Cardiology, Ibrahim Cardiac Hospital &amp; Research Institute (ICHRI), Dhaka from July 2016 to September 2017. The transradial approach was used in all cases. Clinical, angiographic and procedural data of percutaneous coronary interventions performed using Guidezilla, including indications for use of Guidezilla were collected and analyzed.Results:A total of 19 procedures (in 18 patients) were evaluated. 57.89% of cases were related to left circumflex coronary artery or obtuse marginal branch. The commonest challenge for use of Guidezillawas proximal angulation (63.15%) and calcification (47.4%). Commonest type of lesion was ACC/ AHA Type C lesion (63.2%). Successful stent deployment was achieved in 16 of the 19 procedures (84.2%). Among the unsuccessful cases, there was stent damage in one case and distal dissection after deployment of a stent in other. Stent deployment was not possible in two cases, due to diffuse lesion and heavy calcification.Conclusions:Guide extension catheter is a good trans-radial back-up support for calcified, complex and tortuous coronary anatomy, which otherwise may have been considered unsuitable for PCI. The use of such support can reduce the necessity for the more expensive alternative of deploying multiple small stents in order to traverse the lesions.Bangladesh Heart Journal 2018; 33(1) : 54-60

COMPLICATED FORMS OF CORONARY LESIONS AND THEIR IMPACT ON THE FORECAST

The extension of indications for endovascular treatment of complex coronary lesions, along with ensuring efficiency and safety, is the priority target of percutaneous coronary intervention (PCI) application for the coronary heart disease (CHD). Among the independent predictors of the adverse events of PCI, the diffuse coronary artery lesions is a separate object of interest. Substantial progress in treatment of this category of patients was achieved with the introduction of drug-eluting stents (DES). However, the method had a downside of late and very late stent thrombosis. In order to solve the problem stents with biodegradable polymer were developed. Efficacy and safety evaluation of new generation long DES in treatment of diffuse coronary artery lesions has become a promising research trend.

Bioresorbable coronary stent for the treatment of complex coronary lesions: Data from an all-comer registry

BackgroundThe study aimed to report the results from an all-comers registry of patients undergoing coronary angioplasty and treated with bioresorbable vascular scaffold (BVS). MethodsFifty-five consecutive patients with type B/C coronary lesions according to the AHA classification and treated with BVS were enrolled in the study. The clinical and procedural characteristics of enrolled patients were recorded. Fifty-five consecutive subjects with coronary lesions type B/C treated with everolimus eluting stent (EES) were used as control group. ResultsThe incidence of adverse events was not statistically significant comparing subjects treated with BVS with those treated with EES. Non significant differences were also found in the follow-up considering the presence of diabetes, multivessel disease, use of more than one stent at the same time, diagnosis (STEMI vs UA/NSTEMI), use of coronary stents in overlapping.The differences were significant considering the type of lesion (Log-Rank p<0.05), stenoses treated in correspondence of a coronary bifurcation (p<0.05), the SYNTAX score (cut off 22) (p<0.001); after multivariable correction for age and gender, however, differences remained significant only for SYNTAX score. ConclusionsThe use of BVS in an all-comers registry of patients undergoing coronary angioplasty on complex coronary lesions is associated with a safety profile comparable to that obtained with EES; the use of BVS in particular conditions, such as very high SYNTAX score, should be further assessed.

Twelve-month follow-up of complex patients treated with the Xience VTM everolimus drug-eluting stents in daily practice – results of the BRAVO Brazilian Registry

BackgroundThe Xience VTM everolimus-eluting stent is a new generation drug-eluting stent (DES) that incorporates a low profile cobalt-chromium platform (81μm) and a highly biocompatible polymer (fluoropolymer), which carries and controls the release of everolimus. Recent studies have demonstrated sustained safety and efficacy of the Xience VTM in the treatment of real-world populations. Our aim was to report the clinical results of 12 months of the BRAVO Brazilian protocol. MethodsThe BRAVO Registry was a prospective, non-randomized, single-arm, multicenter (25 centers) study that evaluated the late clinical results of 535 minimally selected patients treated with the drug- eluting stent Xience VTM in Brazilian daily practice. ResultsOverall, 40% of patients had diabetes, 25% prior myocardial infarction, and 42% presented with acute coronary artery syndrome. The majority of lesions (69%) was highly complex (ACC/AHA type B2 or C). The mean length and the nominal stent diameter were 19.9 ± 5.3mm and 3.0 ± 0.4mm, respectively. The angiographic and procedural successes were 99.7 and 98%, respectively. At 12 months, the cumulative rate of major adverse cardiac events, available in 100% of patients, was 5.6% (cardiac death: 1.3%; acute myocardial infarction: 3.0%; revascularization of the target lesion: 2.2%). Stent thrombosis occurred in 5 patients (0,9%), and only 1 case was reported between 6 and 12 months. ConclusionsThe drug-eluting stent Xience VTM demonstrated sustained safety and efficacy up to 12 months in the treatment of complex coronary lesions in patients from daily practice.

Seguimento de 12 meses de pacientes complexos tratados com stents farmacológicos liberadores de everolimus XIENCE V® na prática diária – resultados do registro brasileiro BRAVO

BackgroundThe Xience VTM everolimus‐eluting stents is a new generation drug‐eluting stent (DES) that incorporates a low profile cobalt‐chromium platform (81μm) and a highly biocompatible polymer (fluoropolymer), which carries and controls the release of everolimus. Recent studies have demonstrated sustained safety and efficacy of the Xience VTM in the treatment of real‐world populations. Our aim was to report the clinical results of 12 months of the BRAVO Brazilian protocol. MethodsThe BRAVO Registry was a prospective, non‐randomized, single‐arm, multicenter (25 centers) study that evaluated the late clinical results of 535 minimally selected patients treated with the drugeluting stent Xience VTM in Brazilian daily practice. ResultsOverall, 40% of patients had diabetes, 25% prior myocardial infarction, and 42% presented with acute coronary artery syndrome. The majority of lesions (69%) was highly complex (ACC/AHA type B2 or C). The mean length and the nominal stent diameter were 19.9 ± 5.3mm and 3.0 ± 0.4mm, respectively. The angiographic and procedural successes were 99.7 and 98%, respectively. At 12 months, the cumulative rate of major adverse cardiac events, available in 100% of patients, was 5.6% (cardiac death: 1.3%; acute myocardial infarction: 3.0%; revascularization of the target lesion: 2.2%). Stent thrombosis occurred in 5 patients (0,9%), and only 1 case was reported between 6 and 12 months. ConclusionsThe drug‐eluting stent Xience V™ demonstrated sustained safety and efficacy up to 12 months in the treatment of complex coronary lesions in patients from daily practice.

Usefulness and Safety of a Guide Catheter Extension System for the Percutaneous Treatment of Complex Coronary Lesions by a Transradial Approach

Objective: The aim of this study was to describe our initial experience with the GuideLiner® catheter (Vascular Solutions Inc.) in the transradial treatment of complex lesions. Materials and Methods: The clinical, angiographic and procedural data of percutaneous coronary interventions where GuideLiner was used during 2013 were collected. The transradial approach was used in all cases. The indication for its use, efficacy and periprocedural complications were determined. Sixteen consecutive procedures (in 15 patients; 12 males and 3 females) were evaluated. The indication for the use of GuideLiner was a difficulty to advance and properly position a stent through a tortuous and/or calcified artery despite using high-support guide catheters or other useful techniques. Results: Of the 16 angiographic procedures, 14 (87.5%) were successful (stent deployment in 13 cases and a drug-eluting balloon in 1 case). Unsuccessful cases were a chronic total occlusion and a diffusely diseased left anterior descendant artery. A type B dissection of a proximal left circumflex artery was the only periprocedural complication. Conclusion: Use of the GuideLiner was an effective and safe technique for the percutaneous treatment of complex coronary lesions in which the adequate progress of angioplasty devices had failed. GuideLiner was particularly helpful when using the transradial approach. Only one minor complication was recorded.

GW24-e1373 Effect and security with triple antiplatelet therapy in patients undergoing drug-eluting stents for the treatment of complex coronary lesions

ObjectivesTo evaluate the efficacy and safety of triple antiplatelet therapy (cilostazol combined with clopidogrel and aspirin) in patients undergoing multiple drug-eluting stents (DES) implantation of complex coronary lesions.MethodsTotally 128 senile...

Differential Impact of Cilostazol on Restenosis According to Implanted Stent Type (from a Pooled Analysis of Three DECLARE Randomized Trials)

Even in the drug-eluting stent era, restenosis has remained an unresolved issue, particularly in the treatment of complex coronary lesions. In this study, patient-level data from 3 randomized trials (Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Diabetes Mellitus [DECLARE-DIABETES] and Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Long Native Coronary Lesions [DECLARE-LONG] I and II) were pooled to estimate the differential antirestenotic efficacy of add-on cilostazol according to the implanted drug-eluting stent in patients at high risk for restenosis. A total of 1,399 patients underwent sirolimus-eluting stent (SES; n = 450), paclitaxel-eluting stent (n = 450), and zotarolimus-eluting stent (n = 499) implantation and received triple-antiplatelet therapy (TAT; aspirin, clopidogrel, and cilostazol, n = 700) and dual-antiplatelet therapy (aspirin and clopidogrel, n = 699). Randomization of antiplatelet regimen was stratified by stent type. In-stent late loss after TAT was significantly lower than that after dual-antiplatelet therapy, regardless of implanted stent type. However, the incidence of in-segment restenosis after TAT was significantly lower with SES (0.5% vs 6.7%, p = 0.014) and zotarolimus-eluting stent (12.2% vs 20.0%, p = 0.028) implantation but not paclitaxel-eluting stent implantation (14.4% vs 20.0%, p = 0.244). A significant interaction was present between stent type and antiplatelet regimen for the risk for in-segment restenosis (p = 0.004). Post hoc analysis using bootstrap resampling methods showed that the relative risk reduction for in-segment restenosis after TAT was most prominent with SES implantation. In conclusion, add-on cilostazol effectively reduced restenosis in patients at high risk for restenosis, particularly in those receiving SES, suggesting the sustainable utility of add-on cilostazol therapy in newer generation drug-eluting stents with comparable efficacy with that of SES.

The state of the excimer laser for coronary intervention in the drug-eluting stent era

This study aims to determine how excimer laser coronary atherectomy (ELCA) performs in the drug-eluting stent (DES) era. For more than 20 years, ELCA has been used for coronary intervention. With developments in the coronary intervention field, the role of ELCA is in question. The study includes 119 patients with 124 lesions who underwent percutaneous coronary intervention (PCI) with ELCA in our institution from January 2004 to May 2011. The main indications for ELCA use were saphenous vein graft (SVG) (45 lesions), acute myocardial infarction (AMI) (7 lesions), chronic total occlusion (CTO) (32 lesions), in-stent restenosis (ISR) (15 lesions), and calcified de-novo lesions (25 lesions). High success rates were recorded for the SVG, AMI, CTO, ISR, and calcified lesion indications (91.1%, 85.7%, 93.8%, 86.7%, and 80%; respectively). ELCA related complications were reported in 10 patients (8%); four dissections, three no-reflow phenomena, two perforations, and one thrombus formation. ELCA is an alternative solution with acceptable performance in the treatment of complex coronary lesions not ideally suitable for balloon angioplasty.

Drug-eluting Balloons in Coronary Artery Disease – Current and Future Perspectives

Percutaneous treatment of complex coronary lesions, such as small-vessel disease, diabetes and long diffuse disease, remain hampered by suboptimal results, even with the use of drug-eluting stents (DES). The paclitaxel drug-eluting balloon (DEB) is an interesting emerging device that optimises clinical outcomes in these specific lesions. The DEB may become a viable alternative treatment option for the inhibition of coronary restenosis and subsequent revascularisation, as it allows local release of a high-concentration antirestenotic drug, paclitaxel, into the coronary vessel without using a metal scaffold or durable polymers. Several studies have already shown promising and consistent results in the treatment of in-stent restenosis. The DEB has demonstrated its added value compared with certain DES. Inspired by these results, an increasing number of studies have been started in different coronary lesion subsets to explore the value of the DEB in a broader range of lesions. It will be interesting to see whether the DEB will find more indications beyond in-stent restenosis treatment. Moreover, will all DEBs offer the same added value, or will there be differences in efficacy among the DEBs produced by the various manufacturers? As was the case in the development of DES, now the puzzle pieces have to be put together for DEB.

329 First experience with the guideliner mother in child catheter for the treatment of complex coronary lesions

329 First experience with the guideliner mother in child catheter for the treatment of complex coronary lesions

Drug-eluting Balloons in Coronary Artery Disease – Current and Future Perspectives

Percutaneous treatment of complex coronary lesions, such as small-vessel disease, diabetes and long diffuse disease, remain hampered by suboptimal results, even with the use of drug-eluting stents (DES). The paclitaxel drug-eluting balloon (DEB) is an interesting emerging device that optimises clinical outcomes in these specific lesions. The DEB may become a viable alternative treatment option for the inhibition of coronary restenosis and subsequent revascularisation, as it allows local release of a high-concentration antirestenotic drug, paclitaxel, into the coronary vessel without using a metal scaffold or durable polymers. Several studies have already shown promising and consistent results in the treatment of in-stent restenosis. The DEB has demonstrated its added value compared with certain DES. Inspired by these results, an increasing number of studies have been started in different coronary lesion subsets to explore the value of the DEB in a broader range of lesions. It will be interesting to see whether the DEB will find more indications beyond in-stent restenosis treatment. Moreover, will all DEBs offer the same added value, or will there be differences in efficacy among the DEBs produced by the various manufacturers? As was the case in the development of DES, now the puzzle pieces have to be put together for DEB.

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.

AS-235: 6-Month Outcomes of the Paclitaxel-Eluting Balloon for the Treatment of Complex Coronary Lesions: Insights from the Dior Spanish Multicenter Registry

In the drug-eluting stent (DES) era, some situations continue to be associated with a high risk of restenosis or stent thrombosis. We sought to assess the efficacy and safety of a new paclitaxel-coated, drug-eluting balloon (DEB) in such cases.

TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions

Drug-eluting stents (DESs) have shown to be effective in reducing in-stent restenosis, although data relating to long-term experience in treating more complex lesion subsets are limited. In order to assess the long-term safety and clinical efficacy of the polymer-based moderate release (MR) paclitaxel-eluting TAXUS MR stent in treatment of complex lesion subsets, we evaluated the 2-year follow-up of TAXUS VI. TAXUS VI was a randomized multi-centre study enrolling 446 patients with complex lesions, including small vessels in 28% of patients and a mean lesion length of 20.6 mm. At 9-month follow-up, the use of the TAXUS MR stent was highly effective, resulting in a significant 53% reduction of the target vessel revascularization (TVR) rate (primary endpoint) from 19.4% in the control group to 9.1% in the TAXUS group (P = 0.0027). Clinical follow-up at 2 years post-stenting was available in 98.6% of the TAXUS group and 95.6% of the control group. The incidence of major adverse cardiac event at 1- and 2-year follow-up was 16.4% and 21.3% in the TAXUS group when compared with 22.5 and 25.1% in the control group, respectively. A significant difference in TVR was maintained at 2-year follow-up (TAXUS 13.9%; control 21.9%; P = 0.0335). The cumulative 1- and 2-year survival rates free from TVR were, respectively, 91.7 and 90.3% in the TAXUS group vs. 80.0 and 79.0% in the control group (log-rank P < 0.001). The number of patients required to be treated with a TAXUS stent to prevent one re-percutaneous coronary intervention at 2 years was 12.5. Treatment of complex coronary lesions with the polymer-based MR paclitaxel-eluting TAXUS MR stent is associated with a sustained clinical benefit and low rates of TVR up to 2 years after device implantation.