Contrast-enhanced excimer laser stepwise approach during PCI for resistant coronary lesions.

BACKGROUND: The treatment of resistant coronary lesions (RCL) is a great challenge for interventional cardiologists. The excimer laser coronary atherectomy (ELCA) is a plaque modification tool based on a main mechanism of photomechanical effect leading to mechanical disruption of the plaque. Contrast dye injection during laser delivery has demonstrated to enhance its power. AIM: To evaluate the effectiveness and safety of the contrast-enhanced ELCA by a stepwise approach in the treatment of RCLs. METHODS: We retrospectively examined consecutive patients undergoing contrast-enhanced ELCA-assisted PCI between 2018 and 2021 at two Italian sites. RCLs were defined as novo or in-stent undilatable/uncrossable with conventional balloons (SC/NC balloon). The primary endpoint was ELCA technical success defined as the laser catheter crossing the entire length of the target lesion established by angiographic evidence of the catheter tip in the artery distal to the stenosis. RESULTS: We enrolled 114 patients who underwent contrast-enhanced ELCA-assisted PCI: 58% of the patients had acute coronary syndrome while the left anterior descending artery was the target vessel in 42.1% of cases. The target lesion was most commonly in-stent (56.2%). The 0.9 mm ELCA catheter tip was employed in 89.5% of cases. The most used frequency/fluency profile was 70/70 (39.5%). The use of contrast-enhanced ELCA was associated with high technical, procedural, and clinical success rates (97.4%, 93.7%, and 90.1%, respectively). CONCLUSIONS: The contrast-enhanced ELCA seems to be a safe and effective treatment option for the management of both de novo and in-stent-resistant coronary lesions.

Treatment of coronary lesions with a novel crystalline sirolimus-coated balloon.

Background: There is mounting data supporting the use of drug-coated balloons (DCB) not only for treatment of in-stent restenosis (ISR), but also in native coronary artery disease. So far, paclitaxel-coated balloons represented the mainstay DCBs. The SeQuent® crystalline sirolimus-coated balloon (SCB) (B.Braun Medical Inc, Germany) represents a novel DCB, which allows a sustained release of the limus-drug. We evaluated its performance in an all-comer cohort, including complex coronary lesions. Methods: Consecutive patients treated with the SeQuent® SCB were analyzed from the prospective SIROOP registry (NCT04988685). We assessed clinical outcomes, including major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiovascular death. Angiograms and outcomes were independently adjudicated. Results: From March 2021 to March 2023, we enrolled 126 patients and lesions, of which 100 (79%) treated using a "DCB-only" strategy and 26 (21%) with a hybrid approach (DES + DCB). The mean age was 68 ± 10 years, 48 (38%) patients had an acute coronary syndrome. Regarding lesion characteristics, ISR was treated in 27 (21%), 11 (9%) underwent CTO-PCI and 59 (47%) of the vessels were moderate to severe calcified. Procedural success rate was 100%. At a median follow-up time of 12.7 (IQR 12; 14.2) months, MACE occurred in 5 patients (4.3%). No acute vessel closure was observed. Conclusions: Our data indicates promising outcomes following treatment with this novel crystalline SCB in an all-comer cohort with complex coronary lesions. These results require further investigation with randomized trials.

Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon.

BACKGROUND: Limus-eluting stents have become the mainstay for percutaneous coronary intervention (PCI). However, even with the latest generation drug-eluting stent, in-stent restenosis and very late stent thrombosis remain a concern. The Selution SLR™ drug-coated balloon (DCB) is a novel sirolimus-coated balloon that provides a controlled release of the antiproliferative drug. Herein we evaluated its performance in a real-world patient cohort with complex coronary artery lesions. METHODS: Patients undergoing PCI using the Selution SLR™ DCB were analyzed from the prospective SIROOP registry. We evaluated procedural success and clinical outcomes, including major adverse cardiovascular event (MACE), cardiac death, target vessel myocardial infarction and target lesion revascularization. RESULTS: From September 2020 to April 2021, we enrolled 78 patients (87 lesions) treated using a "DCB only" strategy. The mean age was 66.7 ± 10.4 years and 28 (36%) presented with an acute coronary syndrome. Almost all lesions were type B2/C 86 (99%) and 49 (63%) had moderate to severe calcifications. Procedural success was 100%. After a median follow-up of 11.2 months (interquartile range: 10.0-12.6), MACE occurred in 5 (6.8%) patients. No acute vessel closure was observed. CONCLUSIONS: In complex coronary lesions, a "DCB only" strategy using the Selution SLR™ DCB is not just safe and feasible, but also seems to be associated with a low rate of MACE at 1-year follow-up. Our promising results warrant further evaluation in a dedicated comparative trial.

Guidezilla™ guide extension catheter I for transradial coronary intervention.

Background: Percutaneous coronary intervention (PCI) is the preferred treatment method for coronary artery diseases (CAD). This study aimed to evaluate the effectiveness and complications of the Guidezilla™ guide extension catheter I (GGEC I) in transradial coronary intervention (TRI). Methods: This case series study included patients with CAD who underwent TRI using the GGEC I between August 2016 and January 2019 at the First Affiliated Hospital of Xi'an Jiaotong University. Results: A total of 221 patients aged 65.1 ± 9.26 years were included. Coronary angiography results indicated that most patients (77.8%) had triple-vessel lesions, including 47.5% with chronic total occlusion (CTO). A total of 237 target lesions were treated, most being type C lesions (95.8%). The most common indication for GGEC I use was heavy calcification (67%), followed by extreme tortuosity (12.2%), extreme tortuosity and heavy calcification (10.9%), distally located lesion (4.5%), picking up the retrograde wire (3.2%), anomalous vessel origin (1.8%), and releasing the burr incarceration (0.4%). The mean operation time was 58 min, and the overall success rate was 94.1%. Four patients received a drug-coated balloon. No significant differences were found in operation time and success rate among the low (<23), intermediate (23-32), and severe (>32) CAD groups based on SYNTAX score stratification (P > 0.05). Two subacute thrombosis cases each were reported perioperatively, during hospitalization, and at the 1-month follow-up. Conclusion: The GGEC I might have advantages for TRI and is unaffected by SYNTAX score stratification.

DCBs as an adjuvant tool to DES for very complex coronary lesions.

Drug eluting stents (DES) have revolutionised interventional cardiology and currently represent the standard for percutaneous coronary interventions (PCI). However, due to several limitations, new strategies are required, especially in very complex lesions. Drug-coated balloons (DCB) offer an attractive therapeutic alternative, and have already obtained a Class I recommendation for the treatment of in stent restenosis (ISR) with Level A of evidence. Moreover, the role of DCB has been tested in several other settings, such as de novo large vessel disease, multivessel disease or very complex lesions, with promising results regarding safety and effectiveness. In this context, a hybrid strategy consisting in the use of a DES and DCB with the aim of reducing the amount of metal implanted and minimising the risk of ISR and stent thrombosis could become the solution for very complex lesions. Several important studies already demonstrated very good angiographic results in terms of late lumen loss and restenosis for this approach in bifurcation lesions. Moreover, for long diffuse coronary disease similar rates of MACE, TVR, and TLR at 2-year follow-up in comparison to a DES-alone strategy were found. What is more, the use of this strategy in high-bleeding risk patients could safely permit the practitioners to reduce the DAPT duration, as data is suggesting. As our daily practice already strongly incorporated this strategy and with more data expected from important trials, it is our strong believe that the hybrid approach can become a standard treatment choice in the near future.

Back to the future: DCB use instead of DES for the treatment of complex, native coronary artery disease.

The increasing complexity of coronary artery lesions in patients with significant co-morbidities and the need for revascularization, but with the ineligibility for surgical approach, has turned the percutaneous coronary intervention a challenging task, especially in a setting in which short- and long-term complications after drug-eluting stent implantation are high. Drug-coated balloons (DCBs) have become an important tool to replace stent placement in specific situations such as small coronary artery disease and in-stent restenosis. Although preliminary data of DCB use in complex lesions is promising, the available data are still limited. Therefore, in this article, we review the most recent and relevant literature about the use of DCB in native vessel disease and in complex anatomies/patients, and pretend to justify the necessity to develop well design trials about the use of this therapy in such settings, also thinking at DCBs as a complementary tool to drug-eluting stents.

Coronary lesion complexity in patients with heterozygous familial hypercholesterolemia hospitalized for acute myocardial infarction: data from the RICO survey.

BACKGROUND: Although patients with familial heterozygous hypercholesterolemia (FH) have a high risk of early myocardial infarction (MI), the coronary artery disease (CAD) burden in FH patients with acute MI remains to be investigated. METHODS: The data for all consecutive patients hospitalized in 2012-2019 for an acute MI and who underwent coronary angiography were collected from a multicenter database (RICO database). FH (n = 120) was diagnosed using Dutch Lipid Clinic Network criteria (score ≥ 6). We compared the angiographic features of MI patients with and without FH (score 0-2) (n = 234) after matching for age, sex, and diabetes (1:2). RESULTS: Although LDL-cholesterol was high (208 [174-239] mg/dl), less than half of FH patients had chronic statin treatment. When compared with non-FH patients, FH increased the extent of CAD (as assessed by SYNTAX score; P = 0.005), and was associated with more frequent multivessel disease (P = 0.004), multiple complex lesions (P = 0.022) and significant stenosis location on left circumflex and right coronary arteries. Moreover, FH patients had more multiple lesions, with an increased rate of bifurcation lesions or calcifications (P = 0.021 and P = 0.036, respectively). In multivariate analysis, LDL-cholesterol levels (OR 1.948; 95% CI 1.090-3.480, P = 0.024) remained an independent estimator of anatomical complexity of coronary lesions, in addition to age (OR 1.035; 95% CI 1.014-1.057, P = 0.001). CONCLUSIONS: FH patients with acute MI had more severe CAD, characterized by complex anatomical features that are mainly dependent on the LDL-cholesterol burden. Our findings reinforce the need for more aggressive preventive strategies in these high-risk patients, and for intensive lipid-lowering therapy as secondary prevention.

The role of intravascular ultrasound in percutaneous coronary intervention of complex coronary lesions.

Intravascular ultrasound (IVUS) is a catheter-based coronary imaging technique. It utilises the emission & subsequent detection of reflected high frequency (30-60 MHz) sound waves to create high resolution, cross-sectional images of the coronary artery. IVUS has been the cornerstone of intracoronary imaging for more than two decades. When compared to the invasive coronary angiogram which studies only the silhouette of the contrast-filled artery lumen, IVUS also crucially images the vessel wall. Because of this capability, IVUS has greatly facilitated understanding of the coronary atherosclerosis process. Such insights from IVUS reveal how commonly and extensively plain angiography underestimates the true extent of coronary plaque, the characteristics of plaques prone to rupture and cause acute coronary syndromes (lipid rich, thin cap atheroma), and a realisation of the widespread occurrence of vessel remodelling in response to atherosclerosis. Similarly, IVUS has historically provided salutary mechanistic insights that have guided many of the incremental advances in the techniques of percutaneous coronary intervention (PCI). Examples include mechanisms of in-stent restenosis, and the importance of high-pressure post-dilatation of stents to ensure adequate stent apposition and thereby reduce the occurrence of stent thrombosis. IVUS also greatly facilitates the choice of correct diameter and length of stent to implant. Overall, a compelling body of evidence indicates that use of intravascular ultrasound in PCI helps to achieve optimal technical results and to mitigate the risk of adverse cardiac events. In this review, the role of intravascular ultrasound as an adjunct to PCI in complex coronary lesions is explored. The complex coronary situations discussed are the left main stem, ostial stenoses, bifurcation stenoses, thrombotic lesions, the chronically occluded coronary artery, and calcified coronary artery disease. By thorough review of the available evidence, we establish that the advantages of IVUS guidance are particularly evident in each of these complex CAD subsets. In particular, some consider the use of IVUS to be almost mandatory in left main PCI. A comparison with other intracoronary imaging techniques is also explored.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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%. CONCLUSION: 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.

Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV.

Background: It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation. Methods: The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates. Results: A total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment. Conclusion: In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years. Trial registration number: NCT01496638.

Treatment of complex coronary lesions by excimer laser coronary atherectomy: the experiences of single center / 中国实用内科杂志

OBJECTIVE: The aim of this study was to introduce the experience in treatment of acute ST segment elevation myocardial infarction(STEMI), saphenous vein graft(SVG), Chronic total occlusion(CTO),In-stent restenosis(ISR)and diffuse calcification lesions by excimer laser coronary atherectomy(ELCA). METHODS: Twenty-two patients were enrolled through our center from November 2016 to May 2017 and ELCA was performed on 22 lesions.The clinical and procedure endpoints were recorded. RESULTS: All the lesions were successfully crossed with laser catheterand and finally were performed by ELCA. Five cases(22.7%)with STEMI, ten cases(45.5%) with SVG lesions,five cases with ISR and other cases were CTO(4.5%) and Calcification(4.5%) lesions.Seventeen patients underwent balloon dilatation and successful implantation of drug-eluting stents(DES) and one patients was treated with drug-eluting balloon(DEB).the procedual and clinical success rates were 100%. At 6.6±2.7 months follow-up, there were no major adverse cardiac events(MACEs) and ELCA relatedcomplications recorded. Conclution This limited evdiences showed that treatment of complex coronary lesions by excimer laser coronary atherectomy may be a Safe and effective choice.It can be further popularized in complex coronary artery disease.

Protective Effect of Remote Ischemic Preconditioning on Myocardial Damage After Percutaneous Coronary Intervention in Stable Angina Patients With Complex Coronary Lesions　- Subanalysis of a Randomized Controlled Trial.

BACKGROUND: The effect of remote ischemic preconditioning (RIPC) on periprocedural myocardial damage (pMD) in patients undergoing percutaneous coronary intervention (PCI) is controversial. The aim of this study was to investigate the effect of RIPC or intravenous nicorandil on pMD following elective PCI in a subgroup of patients with complex coronary lesions from a multicenter randomized controlled trial.Methods and Results:Patients with stable angina who underwent elective PCI were assigned to 3 groups: control, upper-limb RIPC or intravenous nicorandil. The major outcome was pMD incidence following PCI, with pMD defined as an elevated level of high-sensitivity cardiac troponin T or creatine kinase myocardial band at 12 or 24 h after PCI. A total of 171 patients with complex coronary lesions (ACC-AHA coronary classification type B2 or C) were analyzed. The incidence of pMD following PCI was significantly lower in the RIPC group than in the control group (44.4% vs. 66.1%; P=0.023). The adjusted odds ratio (95% confidence interval) for pMD in the RIPC vs. the controls was 0.41 (0.18-0.94). The incidence of pMD in the nicorandil group was not significantly reduced compared with the control groups. CONCLUSIONS: This substudy suggested that RIPC prior to PCI prevented pMD in patients with complex coronary lesions. Further investigation in a multicenter prospective study is needed to confirm these results.

Bioresorbable Everolimus-Eluting Vascular Scaffold for Long Coronary Lesions: A Subanalysis of the International, Multicenter GHOST-EU Registry.

OBJECTIVES: The authors sought to investigate 1-year outcomes in patients treated with bioresorbable everolimus-eluting vascular scaffolds (BVS) for "long coronary lesions." BACKGROUND: The present substudy derived from the GHOST-EU registry included 1,722 lesions in 1,468 consecutive patients, enrolled between November 2011 and September 2014 at 11 European centers. METHODS: The lesions were divided into 3 groups according to continuous BVS length: 1) shorter than 30 mm; 2) between 30 and 60 mm; and 3) longer than 60 mm. Primary device-oriented endpoint (target lesion failure [TLF]) was defined as a combination of cardiovascular death, target vessel myocardial infarction, or clinically driven target lesion revascularization. RESULTS: Patients with lesions ≥60 mm had more comorbidities and more complex lesion characteristics, including chronic total occlusions (37%), bifurcation lesions (40.3%), higher Syntax score (16.4 ± 7.8), and higher number of scaffolds implanted per lesion (3.3 ± 0.9 mm). The main target vessel was the left anterior coronary artery in all groups. Median follow-up was 384 (interquartile range: 359 to 459) days. One-year follow-up was completed in 70.3% of patients. TLF at 1 year was significantly higher in group C (group A 4.8%, group B 4.5%, group C 14.3%; overall p = 0.001), whereas there were no significant differences between groups A and B. Finally, a numerically higher (but not statistically significant) number of scaffold thromboses were observed in group C when compared with shorter lesions (group A 2.1%, group B 1.1%, group C 3.8%; overall p = 0.29). CONCLUSIONS: In a real-world setting, treatment of long coronary lesions with BVS ≥60 mm was associated with a higher TLF rate, driven by myocardial infarction and clinically driven target lesion revascularization.

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

BACKGROUND: The study aimed to report the results from an all-comers registry of patients undergoing coronary angioplasty and treated with bioresorbable vascular scaffold (BVS). METHODS: Fifty-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. RESULTS: The 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. CONCLUSIONS: The 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.

Low-dose adjunctive cilostazol in patients with complex lesions undergoing percutaneous coronary intervention.

Patients with complex coronary lesions undergoing percutaneous coronary intervention (PCI) have more major adverse cardiac events (MACE) than do those with simpler cases. Therefore, intensive antiplatelet therapy might be needed in these patients. A total of 127 patients with complex lesions undergoing PCI in the Second Hospital of Tianjin Medical University from October 2012 to April 2014 were randomized to receive either dual (aspirin plus clopidogrel, DAPT, n = 66), or triple antiplatelet therapy (aspirin plus clopidogrel plus cilostazol; TAPT, n = 61). Patients in the TAPT group received low-dose cilostazol (100 mg loading, followed with 50 mg twice per day) for 3-6 months. The primary endpoint was composite MACE. The complex coronary target lesions were defined as at least one of the following: left main disease; severe 3-vessel disease; chronic total occlusion lesions; true bifurcation lesion; ostial lesions; severe calcified lesions; and highly thrombotic lesions. The two groups had similar baseline clinical and angiographic characteristics. One-year clinical outcomes showed that the TAPT group had significantly lower incidences of myocardial infarction (1.6% vs 13.6%, P = 0.018) and MACE (1.6% vs 16.7%, P = 0.004) than DAPT group. The DAPT group had two cases of stent thrombosis, while the TAPT group did not. Furthermore, adjunctive low-dose cilostazol didn't significantly increase the incidence of bleeding events (26.2% vs 19.7%, P = 0.381) regardless of major (4.9% vs 4.5%, P = 0.921) or minor (21.3% vs 15.2%, P = 0.368) bleeding events. In conclusion, low-dose adjunctive cilostazol seems superior to dual antiplatelet therapy in reducing recurrent ischemic events in patients with complex coronary lesions and the two test groups have a similar incidence of bleeding events.

Treatment of complex coronary lesions by excimer laser coronary atherectomy:the initial experiences in China / 中国介入心脏病学杂志

Objective Excimer laser coronary atherecomy ( ELCA) has been recently used for the treatment of complex coronary lesions including calcified stenosis , chronic total occlusions and in-stent restenosis. Such complex lesions are difficult to adequately treat with balloon angioplasty and /or intracoronary stenting.The aim of this study was to introduce our early experiences in using ELCA in China . Methods Fifteen patients were enrolled through our center from March 2015 to April 2016 , and excimer laser coronary angioplasty was performed on 15 lesions.Eleven patients were previously failed cases either from uncrossable balloon ( 9 lesions ) or expandable balloon ( 6 lesions ) . The procedure and clinical endpoints were recorded .Results Laser catheter with 0.9 mm diameters were used in all 15 coronary lesions.All the lesions were successfully crossed with laser catheter and finally dilated with balloon .The procedural success rate was 100%.Drug eluting stents ( DES ) were implanted in 86.7% lesions and 2 cases were treated with drug eluting balloon .Clinical success was obtained in all patients (100%).There was no dissection , major side branch occlusion , spasm, no-reflow phenomenon nor acute vessel closure . Conclusions This study shows that laser-facilitated coronary angioplasty is a simple , safe and effective device for the management of complex coronary lesions .

Early outcome of high energy Laser (Excimer) facilitated coronary angioplasty ON hARD and complex calcified and balloOn-resistant coronary lesions: LEONARDO Study.

AIM: An innovative xenon-chlorine (excimer) pulsed laser catheter (ELCA X80) has been recently used for the treatment of complex coronary lesions, as calcified stenosis, chronic total occlusions and non-compliant plaques. Such complex lesions are difficult to adequately treat with balloon angioplasty and/or intracoronary stenting. The aim of this study was to examine the acute outcome of this approach on a cohort of patients with coronary lesions. METHODS AND RESULTS: Eighty patients with 100 lesions were enrolled through four centers, and excimer laser coronary angioplasty was performed on 96 lesions (96%). Safety and effectiveness data were compared between patients treated with standard laser therapy and those treated with increased laser therapy. Laser success was obtained in 90 lesions (93.7%), procedural success was reached in 88 lesions (91.7%), and clinical success in was obtained in 87 lesions (90.6%). There was no perforation, major side branch occlusion, spasm, no-reflow phenomenon, dissection nor acute vessel closure. Increased laser parameters were used successfully for 49 resistant lesions without complications. CONCLUSIONS: This study suggests that laser-facilitated coronary angioplasty is a simple, safe and effective device for the management of complex coronary lesions. Furthermore, higher laser energy levels delivered by this catheter improved the device performance without increasing complications.