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Background: The long-term impact of drug-coated balloon (DCB) angioplasty for the treatment of patients with de novo coronary artery lesions remains uncertain. We aimed to assess the non-inferiority of DCB angioplasty with rescue stenting to intended drug-eluting stent (DES) deployment for patients with de novo, non-complex coronary artery lesions., Methods: REC-CAGEFREE I was an open-label, randomised, non-inferiority trial conducted at 43 sites in China. After successful lesion pre-dilatation, patients aged 18 years or older with de novo, non-complex coronary artery disease (irrespective of target vessel diameter) and an indication for percutaneous coronary intervention were randomly assigned (1:1), via a web-based centralised system with block randomisation (block size of two, four, or six) and stratified by site, to paclitaxel-coated balloon angioplasty with the option of rescue stenting due to an unsatisfactory result (DCB group) or intended deployment of second-generation thin-strut sirolimus-eluting stents (DES group). The primary outcome was the device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularisation) assessed at 24 months in the intention-to-treat (ITT) population (ie, all participants randomly assigned to treatment). Non-inferiority was established if the upper limit of the one-sided 95% CI for the absolute risk difference was smaller than 2·68%. Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT04561739. It is closed to accrual and extended follow-up is ongoing., Findings: Between Feb 5, 2021, and May 1, 2022, 2272 patients were randomly assigned to the DCB group (1133 [50%]) or the DES group (1139 [50%]). Median age at the time of randomisation was 62 years (IQR 54-69), 1574 (69·3%) of 2272 were male, 698 (30·7%) were female, and all patients were of Chinese ethnicity. 106 (9·4%) of 1133 patients in the DCB group received rescue DES after unsatisfactory DCB angioplasty. As of data cutoff (May 1, 2024), median follow-up was 734 days (IQR 731-739). At 24 months, the DoCE occurred in 72 (6·4%) of 1133 patients in the DCB group and 38 (3·4%) of 1139 in the DES group, with a risk difference of 3·04% in the cumulative event rate (upper boundary of the one-sided 95% CI 4·52; p non-inferiority =0·65; two-sided 95% CI 1·27-4·81; p=0·0008); the criterion for non-inferiority was not met. During intervention, no acute vessel closures occurred in the DCB group and one (0·1%) of 1139 patients in the DES group had acute vessel closure. Periprocedural myocardial infarction occurred in ten (0·9%) of 1133 patients in the DCB group and nine (0·8%) in the DES group., Interpretation: In patients with de novo, non-complex coronary artery disease, irrespective of vessel diameter, a strategy of DCB angioplasty with rescue stenting did not achieve non-inferiority compared with the intended DES implantation in terms of the DoCE at 2 years, which indicates that DES should remain the preferred treatment for this patient population., Funding: Xijing Hospital and Shenqi Medical., Translation: For the Chinese translation of the abstract see Supplementary Materials section., Competing Interests: Declaration of interests PWS reports consulting fees from Sahajanand Medical Technologies, Novartis, Merillife, Xeltis, and Philips/Volcano. DC reports honoraria from Terumo, Sanofi Aventis, and Medtronic; and participation on the advisory board of Abbott Vascular. ZJia is the founder of Beijing KeyTech Statistical Consulting and has stock in the company. R-JvG reports an unrestricted research grant to Radboud UMC from AstraZeneca. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Background: There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations., Methods: All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [<3 mm] versus long overlap), strategy (provisional versus 2-stent), routine versus bail-out FKI, and the use of imaging and proximal optimization technique., Results: Two thousand seven hundred forty-two patients were included. At 16 months (8-20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; P =0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; P =0.030) and target lesion revascularization (7.3% versus 15.2%; P =0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; P =0.034), while long overlap was not (6.8% versus 5.4%; P =0.567)., Conclusions: In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03544294.

Few data are available about the impact on outcomes of procedural strategies for percutaneous coronary intervention with thin-struts stents on unprotected left main (ULM): 792 patients with an ULM stenosis treated with percutaneous coronary intervention with thin-strut stents were enrolled in the present multicenter registry. Target lesion revascularization (TLR) was the primary end point. MACE (a composite of all-cause death, myocardial infarction, TLR, and stent thrombosis) and its single components, along with target vessel revascularization were the secondary end points. Subgroup analyses were performed according to complex versus noncomplex bifurcation lesions. After 16 months, 5.5% of patients experienced a TLR. At multivariate analysis, provisional stenting (odds ratio [OR] 0.46: 0.85 to 0.23, p = 0.006), use of imaging (OR 0.45: 0.23 to 0.98, p = 0.003) and final kissing balloon (FKB) (OR 0.41: 0.83 to 0.21, p = 0.001) reduced risk of TLR. FKB reduced risk of overall TLR only for 2 stents-strategy (6.2% vs 32.4%, p <0.05), but not for provisional strategy (3.8% vs 3.7%, p = 0.67). Intracoronary imaging reduced risk of overall TLR both for provisional (2.2% vs 5.4%) and for 2-stents strategy (7.3% vs 14.1% p <0.05 for both, all confidence interval 95%). In conclusion, TLR for ULM patients treated with thin-strut stents is infrequent. Provisional stenting was noninferior compared with 2-stents apart from complex lesions. Benefit from intracoronary imaging is consistent for different strategies, whereas that from FKB persists only for 2-stents., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: To evaluate pattern of in-BVS-restenosis after bioresorbable vascular scaffold (BVS) implantation., Background: In-stent restenosis morphology impacts target lesion revascularization (TLR) rates and clinical outcomes. Although several trials report on outcomes after BVS implantation, information about in-BVS restenosis pattern is still lacking., Methods: Between November 2011 and January 2014, in 7 of 10 European centers participating in the GHOST-EU registry, 668 patients underwent BVS implantation. Of them 164 patients (200 lesions) underwent an additional angiogram 3 to 12 months after index PCI., Results: Binary in-BVS restenosis (IBR) (in-segment diameter stenosis ≥50%) was observed in 12.7% (21 of 164) of patients (30 lesions), with a TLR rate of 16.5%. The IBR morphology was classified as focal margin in 50.0%, focal body in 26.7%, multifocal in 10.0%, and diffuse in 13.3% of these cases. Treatment of small vessels (OR 5.49, 95% CI 1.6-18.8, P < 0.01) was identified as independent predictor of IBR. Performing predilatation (OR 0.13, 95% CI 0.02-1.04, P = 0.06), high-pressure postdilatation (OR 3.16, 95% CI 0.90-11.18, P = 0.07) as well as treatment of acute coronary syndrome (OR 0.18, 95% CI 0.03-1.12, P = 0.07) seem to strongly influence this risk., Conclusions: The IBR morphology is mostly focal involving particularly the BVS margins suggesting association with procedural aspects in this early experience with BVS. Treatment of small vessels is the strongest predictor of higher IBR risk., (© 2017 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to evaluate midterm outcomes of bioresorbable vascular scaffolds (BVS) implanted in bifurcation lesions., Background: BVS have emerged as an alternative to conventional metallic drug-eluting stents for the treatment of coronary complex lesions., Methods: Between November 2011 and January 2014, 1189 patients underwent percutaneous coronary intervention with BVS at 10 European centers (GHOST EU registry). Of these, 289 consecutive patients (302 bifurcation lesions) treated with either single-stenting (n = 260) or double-stenting (n = 42) were evaluated., Results: True bifurcations were treated in 44.7%. Intravascular ultrasound and optical coherence tomography were utilized only in 22.2% and 21.2%, respectively. Predilation was performed in 95.4%, while postdilation of the main branch was performed in 61.3%. Final kissing inflation with no or minimal protrusion of a side-branch balloon into main branch was performed in 18.9%. Median follow-up period was 356 (IQR 191-419) days. The Kaplan-Meier estimated rates of target lesion failure and scaffold thrombosis (ST) were 6.4% and 2.5% at 360 days, respectively. Independent predictors for TLF were ACS and diabetes mellitus (HR 4.67; 95% CI: 1.78-12.3; P = 0.002 and HR 3.37; 95% CI: 1.38-8.26; P = 0.008, respectively)., Conclusions: BVS use for coronary bifurcation lesions in an "all-comer" population was associated with acceptable TLF rates up to midterm follow-up. However, ST rates were higher than seen with contemporary metallic stents possibly due to the low incidence of intravascular guidance and postdilation resulting in a higher likelihood of scaffold underexpansion and malapposition, further supporting the importance of meticulous implantation technique. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Background: Studies in patients with acute coronary syndrome (ACS) undergoing invasive management showed conflicting conclusions regarding the effect of access site on outcomes., Purpose: To summarize evidence from recent, high-quality trials that compared clinical outcomes occurring with radial versus femoral access in invasively managed adults with ACS., Data Sources: English-language publications in MEDLINE, EMBASE, and Cochrane databases between January 1990 and August 2015., Study Selection: Randomized trials of radial versus femoral access in invasively managed patients with ACS., Data Extraction: Two investigators independently extracted the study data and rated the risk of bias., Data Synthesis: Of 17 identified randomized trials, 4 were high-quality multicenter trials that involved a total of 17 133 patients. Pooled data from the 4 trials showed that radial access reduced death (relative risk [RR], 0.73 [95% CI, 0.59 to 0.90]; P = 0.003), major adverse cardiovascular events (RR, 0.86 [CI, 0.75 to 0.98]; P = 0.025), and major bleeding (RR, 0.57 [CI, 0.37 to 0.88]; P = 0.011). Radial procedures lasted slightly longer (standardized mean difference, 0.11 minutes) and had higher risk for access-site crossover (6.3% vs. 1.7%) than did femoral procedures., Limitation: Heterogeneity in outcomes definitions and potential treatment modifiers across studies, including operator experience in radial procedures and concurrent anticoagulant regimens., Conclusion: Compared with femoral access, radial access reduces mortality, major adverse cardiovascular events, and major bleeding in patients with ACS undergoing invasive management., Primary Funding Source: None. (PROSPERO registration number: CRD42015022031).

Aims: The aim of the current study was to investigate the frequency and mechanisms of sequential incomplete stent apposition (ISA) changes such as persistent, resolved or newly acquired ISA during the first three days after primary PCI (pPCI) in a matched segment-level analysis, with the comparison between self-expanding and balloon-expandable stents assessed by optical coherence tomography (OCT)., Methods and Results: The current analysis is a substudy of the APPOSITION II study that included 69 patients (self-expanding: 35, balloon-expandable: 34) using serial optical coherence tomography (OCT) post procedure and three days after pPCI. In order to evaluate a temporal change in ISA, stented regions were segmented using fiduciary landmarks. In a total of 228 corresponding segments, persistent and newly acquired ISA were less frequently observed in self-expanding stents than in balloon-expandable stents (11.5% vs. 33.9%, p<0.01, 2.7% vs. 14.8%, p<0.01, respectively). New appearances of ISA were caused by tissue resorption, vasorelaxation and "early" recoil in balloon-expandable stents, and only tissue resorption in self-expanding stents., Conclusions: Three days after pPCI, tissue resorption and vasorelaxation were biological factors associated with new appearance of ISA while "early" recoil of balloon-expandable stents was a mechanical factor. Both persistent ISA and newly acquired ISA occurred less frequently in self-expanding stents, resulting in a low number of ISA segments compared to balloon-expandable stents. Clinical Trials Registration Information: Randomised Comparison Between the STENTYS Self-expanding Coronary Stent and a Balloon-expandable Stent in Acute Myocardial Infarction (APPOSITION II). ClinicalTrials.gov Identifier: NCT01008085

A 50-year-old man underwent coronary angiography for stable angina with evidence of chronic total occlusion of the right coronary artery. Chronic total occlusion recanalization was performed with implantation of 4 overlapping bioresorbable vascular scaffolds. At 12 months, elective follow-up coronary angiography documented an asymptomatic 90% in-scaffold restenosis of the right coronary artery located in the mid portion of a newly late-acquired aneurysm. To address the challenging issue introduced by the varying reference vessel diameters, a self-expandable stent was implanted., (Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Incomplete stent apposition (ISA) is characterized by the lack of contact of at least 1 stent strut with the vessel wall in a segment not overlying a side branch; it is more commonly found in drug-eluting stents than bare-metal stents. The accurate diagnosis of ISA, initially only possible with intravascular ultrasound, can currently be performed with higher accuracy by optical coherence tomography, which also enables strut-level assessment due to its higher axial resolution. Different circumstances related both to the index procedure and to vascular healing might influence ISA occurrence. Although several histopathology and clinical studies linked ISA to stent thrombosis, potential selection bias precluded definitive conclusions. Initial studies usually performed single time point assessments comparing overall ISA percentage and magnitude in different groups (i.e., stent type), thus hampering a comprehensive understanding of its relationship with vascular healing. Serial intravascular imaging studies that evaluated vascular response heterogeneity recently helped fill this gap. Some particular clinical scenarios such as acute coronary syndromes, bifurcations, tapered vessels, overlapping stents, and chronic total occlusions might predispose to ISA. Interventional cardiologists should be committed to optimal stent choices and techniques of implantation and use intravascular imaging guidance when appropriate to aim at minimizing acute ISA. In addition, the active search for new stent platforms that could accommodate vessel remodeling over time (i.e., self-expandable stents) and for new polymers and/or eluting drugs that could induce less inflammation (hence, less positive remodeling) could ultimately reduce the occurrence of ISA and its potentially harmful consequences., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The persistence of thrombus inside stent struts is a frequent event in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI), and this phenomenon might be associated with an increased risk of stent thrombosis. We sought to quantify by means of optical coherence tomography (OCT) the presence of in-stent thrombus after achievement of an optimal angiographic result in patients with ACS undergoing PCI. In addition, we evaluated the feasibility and safety of an OCT-guided strategy of in-stent thrombus removal. Eighty consecutive patients with ACS undergoing PCI were treated with two different strategies equally divided into two groups: angio-guided PCI, and OCT-guided PCI, in which additional OCT-driven in-stent balloon dilatation was adopted to reduce thrombus encroachment of the lumen. Overall in-stent thrombus area was 4.3 % with a maximal thrombus encroachment of 16.7 %. In the OCT-guided group, use of high pressure intra-stent dilatation led to a significant increase in stented area (9.6 ± 2.4 vs. 9.1 ± 2.49 mm(2), p = 0.002) and lumen area (9.2 ± 2.4 vs. 8.7 ± 2.3 mm(2), p < 0.001) and also significantly decreased in-stent thrombus area in absolute (0.35 ± 0.29 vs. 0.42 ± 0.30 mm(2), p = 0.001) and relative terms (3.58 ± 3.25 vs. 4.53 ± 3.01 %, p = 0.001). Values of TIMI flow, frame count and blush grade, as well as clinical outcomes were not detrimentally affected by such additional dilatations. The use of additional OCT-driven in-stent balloon dilatations is feasible, safe and might be effective in the treatment of in-stent thrombus for patients with ACS.

Objectives: The aim of this study was to compare, in a large all-comers registry, major adverse cardiac and cerebrovascular events (MACCE) after percutaneous coronary intervention (PCI) with first-generation drug-eluting stents (DES) versus coronary artery bypass grafting (CABG) in unprotected left main coronary artery (ULMCA) stenosis., Background: Percutaneous coronary intervention with DES implantation in ULMCA has been shown to be a feasible and safe approach at midterm clinical follow-up., Methods: All consecutive patients with ULMCA stenosis treated by PCI with DES versus CABG were analyzed in this multinational registry. A propensity score analysis was performed to adjust for baseline differences in the overall cohort., Results: In total 2,775 patients were included: 1,874 were treated with PCI versus 901 with CABG. At 1,295 (interquartile range: 928 to 1,713) days, there were no differences, at the adjusted analysis, in the primary composite endpoint of death, cerebrovascular accidents, and myocardial infarction (MI) (adjusted hazard ratio [HR]: 1.11; 95% confidence interval [CI]: 0.85 to 1.42; p = 0.47), mortality (adjusted HR: 1.16; 95% CI: 0.87 to 1.55; p = 0.32), or composite endpoint of death and MI (adjusted HR: 1.25; 95% CI: 0.95 to 1.64; p = 0.11). An advantage of CABG over PCI was observed in the composite secondary endpoint of MACCE (adjusted HR: 1.64; 95% CI: 1.33 to 2.03; p < 0.0001), driven exclusively by the higher incidence of target vessel revascularization with PCI., Conclusions: In our multinational all-comers registry, no difference was observed in the occurrence of death, cerebrovascular accidents, and MI between PCI and CABG. An advantage of CABG over PCI was observed in the incidence of MACCE, driven by the higher incidence of target vessel revascularization with PCI., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The pivotal ATLANTA first-in-man study showed the promising safety and efficacy profile of the novel Catania™ stent in a population with ~20% American College of Cardiology/American Heart Association (ACC/AHA) type C coronary lesions. The ATLANTA 2 registry was designed to evaluate the 12-month safety and efficacy of the Catania stent in a broader real world scenario., Methods and Results: The ATLANTA 2 registry was a prospective, non-randomised, single-arm study of patients with symptomatic ischaemic heart disease and de novo lesions of native coronary arteries. A total of 300 patients (396 lesions) were recruited and 482 Catania stents were implanted. At 12 months, major adverse cardiac events were 8.8%, mainly driven by target lesion revascularisation (6.5%). Cardiac death and non-fatal myocardial infarction occurred in 2.5% and 0.7% of patients, respectively. Subacute definite or probable stent thrombosis was 0.7%. No late stent thrombosis was recorded. Compared with patients treated with drug-eluting stents or bare metal stents in the study period, those treated with Catania stents experienced similar outcomes at one year., Conclusions: The 12-month results of the ATLANTA 2 registry confirmed the positive results of the ATLANTA first-in-man trial in a more complex population. A randomised trial is needed to assess the comparative value of the Catania stent over currently-used drug-eluting stents or bare metal stents.

Background: Coronary bifurcations remain a challenging lesion subset for percutaneous coronary intervention (PCI). It is unclear whether intravascular ultrasound (IVUS) guidance can improve PCI results in bifurcations. We aimed to compare IVUS-guided PCI versus standard PCI in a large registry of patients undergoing PCI for bifurcations in the drug-eluting stent era., Methods: A multicenter, retrospective study was conducted enrolling consecutive patients undergoing bifurcation PCI between January 2002 and December 2006 at 22 centers. The primary end-point was the long term rate of major adverse cardiac events [MACE, i.e. death, myocardial infarction or target lesion revascularization (TLR)]., Results: A total of 4,314 patients were included, 226 (5.2%) undergoing IVUS-guided PCI, and 4,088 (94.8%) standard PCI. Early (30-day) outcomes were similar in the two groups, with MACE in 1.3 versus 2.1%, respectively, death in 0.9 versus 1.0%, and stent thrombosis in 0 versus 0.6% (all p > 0.05). After 24 ± 15 months, unadjusted rates of MACE were 17.7 versus 16.4%, with death in 2.7 versus 4.9%, myocardial infarction in 4.4 versus 3.7%, TLR in 15.0 versus 12.3%, and stent thrombosis in 3.1 versus 2.7% (all p > 0.05). Even at multivariable Cox proportional hazard analysis with propensity score adjustment, IVUS was not associated with any statistically significant impact on the risk of MACE, death, myocardial infarction, TLR (neither on the main branch nor on the side branch), or stent thrombosis (all p > 0.05)., Conclusions: Despite a sound rationale to choose stent size, optimize stent expansion and guide kissing inflation, IVUS usage during PCI for coronary bifurcation lesions was not associated with significant clinical benefits in this large retrospective study.

Objectives: The purpose of this study was to determine the safety and efficacy of percutaneous coronary intervention (PCI) compared with coronary artery bypass graft (CABG) in patients with left main coronary artery (LMCA) disease., Background: Previous meta-analyses of PCI versus CABG in LMCA disease mainly included nonprospective, observational studies. Several new randomized trials have recently been reported., Methods: We identified 1,611 patients from 4 randomized clinical trials for the present meta-analysis. The primary endpoint was the 1-year incidence of major adverse cardiac and cerebrovascular events (MACCE), defined as death, myocardial infarction (MI), target vessel revascularization (TVR), or stroke., Results: PCI was associated with a nonsignificantly higher 1-year rate of MACCE compared with CABG (14.5% vs. 11.8%; odds ratio [OR]: 1.28; 95% confidence interval [CI]: 0.95 to 1.72; p = 0.11), driven by increased TVR (11.4% vs. 5.4%; OR: 2.25; 95% CI: 1.54 to 3.29; p < 0.001). Conversely, stroke occurred less frequently with PCI (0.1% vs. 1.7%; OR: 0.15; 95% CI: 0.03 to 0.67; p = 0.013). There were no significant differences in death (3.0% vs. 4.1%; OR: 0.74; 95% CI: 0.43 to 1.29; p = 0.29) or MI (2.8% vs. 2.9%; OR: 0.98; 95% CI: 0.54 to 1.78; p = 0.95)., Conclusions: In patients with LMCA disease, PCI was associated with nonsignificantly different 1-year rates of MACCE, death, and MI, a lower risk of stroke, and a higher risk of TVR compared with CABG., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Uncertainty surrounds the optimal revascularization strategy for patients with left main coronary artery disease presenting with acute coronary syndromes (ACSs), and adequately sized specific comparisons of percutaneous and surgical revascularization in this scenario are lacking. The aim of this study was to evaluate the incidence of 1-year major adverse cardiac events (MACEs) in patients with left main coronary artery disease and ACS treated with percutaneous coronary intervention (PCI) and drug-eluting stent implantation or coronary artery bypass grafting (CABG). A total of 583 patients were included. At 1 year, MACEs were significantly higher in patients treated with PCI (n = 222) compared to those treated with CABG (n = 361, 14.4% vs 5.3%, p <0.001), driven by a higher rate of target lesion revascularization (8.1% vs 1.7%, p = 0.001). This finding was consistent after statistical adjustment for MACEs (adjusted hazard ratio [HR] 2.7, 95% confidence interval [CI] 1.2 to 5.9, p = 0.01) and target lesion revascularization (adjusted HR 8.0, 95% CI 2.2 to 28.7, p = 0.001). No statistically significant differences between PCI and CABG were noted for death (adjusted HR 1.1, 95% CI 0.4 to 3.0, p = 0.81) and myocardial infarction (adjusted HR 4.8, 95% CI 0.3 to 68.6, p = 0.25). No interaction between clinical presentation (ST-segment elevation myocardial infarction or unstable angina/non-ST-segment elevation myocardial infarction) and treatment (PCI or CABG) was observed (p for interaction = 0.68). In conclusion, in patients with left main coronary artery disease and ACS, PCI is associated with similar safety compared to CABG but higher risk of MACEs driven by increased risk of repeat revascularization., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study is to verify the study hypothesis of the EXCEL trial by comparing percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) in an EXCEL-like population of patients., Background: The upcoming EXCEL trial will test the hypothesis that left main patients with SYNTAX score ≤ 32 experience similar rates of 3-year death, myocardial infarction (MI), or cerebrovascular accidents (CVA) following revascularization by PCI or CABG., Methods: We compared the 3-year rates of death/MI/CVA and death/MI/CVA/target vessel revascularization (MACCE) in 556 patients with left main disease and SYNTAX score ≤ 32 undergoing PCI (n = 285) or CABG (n = 271). To account for confounders, outcome parameters underwent extensive statistical adjustment., Results: The unadjusted incidence of death/MI/CVA was similar between PCI and CABG (12.7% vs. 8.4%, P = 0.892), while MACCE were higher in the PCI group compared to the CABG group (27.0% vs. 11.8%, P < 0.001). After propensity score matching, PCI was not associated with a significant increase in the rate of death/MI/CVA (11.8% vs. 10.7%, P = 0.948), while MACCE were more frequently noted among patients treated with PCI (28.8% vs. 14.1%, P = 0.002). Adjustment by means of SYNTAX score and EUROSCORE, covariates with and without propensity score, and propensity score alone did not change significantly these findings., Conclusions: In an EXCEL-like cohort of patients with left main disease, there seems to be a clinical equipoise between PCI and CABG in terms of death/MI/CVA. However, even in patients with SYNTAX score ≤ 32, CABG is superior to PCI when target vessel revascularization is included in the combined endpoint., (Copyright © 2011 Wiley-Liss, Inc.)

Aims: In the drug-eluting stent (DES) era, diabetes mellitus is still associated with poor clinical and angiographic outcome after PCI. Whether this phenomenon is exacerbated in the setting of acute coronary syndromes (ACS) is unclear. We investigated the long-term interaction of diabetes mellitus and clinical presentation in patients treated with percutaneous coronary intervention (PCI)., Methods: Consecutive patients undergoing PCI and DES implantation were retrospectively analyzed. The 3-year composite of death, non-fatal myocardial infarction (MI) or target vessel revascularization (TVR) was assessed., Results: Four subgroups of patients were identified: diabetes mellitus and ACS (n = 302); diabetes mellitus and no-ACS (n = 191); no-diabetes mellitus and ACS (n = 573); no-diabetes mellitus and no-ACS (n = 396). Compared to non-diabetes mellitus, diabetes mellitus patients experienced higher 3-year rates of death, non-fatal MI or TVR (32.3 vs. 21.9%, P < 0.001). Diabetes mellitus was significantly associated with the composite of death, non-fatal MI or TVR in the no-ACS group [adjusted hazard ratio (AHR) 1.307, 95% confidence interval (CI) 1.090-1.566, P = 0.004] and, albeit to a lesser extent, in the ACS group (AHR 1.177, 95% CI 1.006-1.377, P = 0.041). No statistically significant interaction was observed between diabetes mellitus and clinical presentation (P for interaction = 0.802)., Conclusions: No significant interaction between diabetes mellitus and clinical presentation was noted in this study. The high rates of cardiac events observed in diabetes mellitus patients despite recent advances in interventional techniques outline the need for a multidisciplinary approach in the management of diabetes mellitus patients, including optimization of glycemic control, aggressive medical therapy and more complete coronary revascularization.

Background: Previous studies have reported that the indeterminable aging and long-duration occlusion are associated with procedural failure and adverse long-term outcome. We aimed to investigate the clinical impact of occlusion duration in a consecutive series of patients who underwent percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) lesions., Methods and Results: From October 2005 to June 2009, a total of 303 patients with 328 CTO lesions were consecutively treated achieving a success rate of 86.3%. The average of occlusion duration estimated in 62.5% of cases (known occlusion duration [KOD] patients, n = 188) was 29.8 ± 41.3 months. In the remaining 37.5% of cases, the occlusion duration was indeterminate (indetermination of occlusion duration [IOD] patients, n = 115). No influence of duration in procedural outcome was observed. Moreover, no differences of 1-year major adverse cardiac events (MACE) were observed between KOD and IOD patients. The multivariate COX regression analysis identified diabetes mellitus and multivessel coronary disease as independent predictors of 12-month MACE (HR 5.023; 95% CI 0.164-9.653; P = 0.025 and HR 0.801; 95% CI 0.109-0.909, P = 0.033). The analysis did not show any influence of IOD and long occlusion duration in the occurrence of MACE. Predictors of angiographic failure recognized with multivariate binary logistic were vessel diameter <2.5 mm (OR 5.3; 95% CI 1.19-8.91; P = 0.02), CTO length >20 mm (OR 6.3; 95% CI 1.22-9.54; P = 0.02), and severe calcification (OR 3.2; 95% CI 1.62-5.51; P = 0.03)., Conclusion: IOD and long duration of CTO do not affect procedural and clinical outcome of patients who underwent CTO PCI. This marks the importance of considering PCI treatment, a reliable strategy in cases of IOD or long occlusion duration., (©2011, Wiley Periodicals, Inc.)

Background: Despite the well-known prognostic impact of systolic dysfunction in unselected patients undergoing percutaneous coronary intervention (PCI), limited data are available on its current predictive role after PCI for unprotected left main disease (ULM). We thus appraised the prognostic role of left ventricular ejection fraction (LVEF) in patients undergoing PCI for ULM with drug-eluting stents (DES)., Methods: Consecutive eligible subjects were retrospectively enrolled in a national registry. Patients were divided into three groups: LVEF < 30%, LVEF 30-45%, and LVEF > 45%. Relevant baseline and outcome data were compared with bivariate and multivariable tests., Results: A total of 975 subjects was included (LVEF < 30%: 46, LVEF 30-45%: 208, LVEF > 45%: 721). Patients with LVEF < 30% had several other unfavorable clinical features, including older age and higher EuroSCORE. Adverse event rates were different already at 7 days (p = 0.012 for all-cause death and p = 0.015 for major adverse cardiac events [MACE]), with even more significant trends up to 30 days and at long-term (p < 0.001 for death, and p < 0.001 for MACE). After a median of 18 months, risk of death totaled 39 versus 13 versus 8% (p < 0.001) and risk of MACE 44 versus 24 versus 22% (p = 0.003). Multivariable analyses showed however that reduced LVEF was not an independent predictor of adverse events at any time-point., Conclusions: Whereas reduced LVEF is apparently a significant predictor of adverse events after PCI with DES for ULM, its prognostic impact is mostly due to clustering with other adverse features.

Objectives: Strut coverage represents the most powerful morphometric predictor of stent thrombosis and the best surrogate indicator of endothelization. The aim of this study was to get new insights on temporal patterns of vessel healing after stenting with different types of stent., Methods: Optical coherence tomography (OCT) was used to investigate the early strut coverage of lesions treated with CATANIA (CAT) stent, drug-eluting stent (DES) or cobalt-chromium bare metal stent (BMS). Two cohorts of 10 and 24 patients underwent OCT follow-up at 7-10 and 28-32 days after stenting, respectively. In each cohort, patients were randomly assigned to receive a CAT stent in one lesion and a BMS or a DES in a separate lesion., Results: A total of 7975 and 8406 struts were analyzed for the comparisons of CAT stent vs. DES and CAT stent vs. BMS at 7-10 days, respectively. A total of 21 123 and 25 069 struts were analyzed for the comparisons of CAT stent vs. DES and CAT stent vs. BMS at 28-32 days, respectively. At 7-10 days, the CAT stent showed higher coverage rates compared with DES (90.0 vs. 85.9%, P < 0.0001) and BMS (90.2 vs. 83.6%, P < 0.0001). Similarly, at 28-32 days, the coverage rate was higher with CAT stent compared with DES (97.7 vs. 90.5%, P < 0.0001) and BMS (97.2 vs. 96.5%, P < 0.0001)., Conclusion: The CAT stent yields quicker and more complete strut coverage than DES and BMS in the early phases of vessel healing following stent implantation.

Introduction: Adjunctive pharmacotherapy is of key importance in determining the outcomes of percutaneous coronary intervention (PCI). In parallel, there has been an increasing body of evidence indicating that the aggressive management of coronary risk factors and changes in lifestyle behavior yield additional positive results in morbidity and mortality reductions. A stream of new data from randomized clinical trials has recently prompted the release of a focused update of the PCI guidelines, endorsing new recommendations on the use of antiplatelet drugs and parenteral anticoagulants., Areas Covered: The aim of this manuscript is to provide an up-to-date overview of the current evidence on the use of adjunctive pharmacological therapy in patients undergoing revascularization, with focus on results of recent trials and future directions., Expert Opinion: Given the availability of several pharmacological agents with different mechanisms of action, understanding whether a drug should or should not be prescribed, as well as individualizing the pharmacological formula to the patient's need and risk category, is pivotal to balance the safety and efficacy of adjunctive therapies for PCI. Studies on new antiplatelet agents and selective inhibitors of specific coagulation factors are likely to characterize the next years of research on interventional pharmacology., (© 2011 Informa UK, Ltd)

Objectives: The aim of this study was to investigate the ability to predict cardiac mortality of the Global Risk Classification (GRC) and the Clinical SYNTAX (Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) score (CSS) in left main (LM) patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)., Background: There is a renewed interest in combining clinical and angiographic information to define the risk of patients undergoing LM revascularization., Methods: The GRC and CSS were assessed in patients undergoing LM PCI (n = 400) or CABG (n = 549). Stand-alone clinical (ACEF [age, creatinine, ejection fraction]), EuroSCORE (European System for Cardiac Operative Risk Evaluation) and angiographic (SYNTAX score) risk scores were also investigated., Results: The GRC (Hosmer-Lemeshow statistic 0.357, p = 0.550; area under the curve 0.743) and the ACEF (Hosmer-Lemeshow 0.426, p = 0.514; area under the curve 0.741) showed the most balanced predictive characteristics in the PCI and CABG cohorts, respectively. In PCI patients, the CSS used fewer data to achieve similar discrimination but poorer calibration than the GRC. Propensity-adjusted outcomes were comparable between PCI and CABG patients with low, intermediate, or high EuroSCORE, ACEF, GRC, and CSS and those with low or intermediate SYNTAX score. Conversely, in the group with the highest SYNTAX score, the risk of cardiac mortality was significantly higher in PCI patients (hazard ratio: 2.323, 95% confidence interval: 1.091 to 4.945, p = 0.029)., Conclusions: In LM patients undergoing PCI, combined scores improve the discrimination accuracy of clinical or angiographic stand-alone tools. In LM patients undergoing CABG, the ACEF score has the best prognostic accuracy compared with other stand-alone or combined scores. The good predictive ability for PCI along with the poor predictive ability for CABG make the SYNTAX score the preferable decision-making tool in LM disease., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Several studies have produced estimates of the outcome of percutaneous coronary intervention (PCI) in the field of left main (LM) coronary artery disease, but no research has been found that surveyed the issue of a comprehensive knowledge of LM anatomy and assessed the impact of different anatomic phenotypes on the likelihood of developing complications after LM PCI. We sought to develop a specific investigation on the basis of the regional anatomy and quantitative analysis of a large series of angiograms performed in our institution. We reviewed the baseline selective digital coronary angiographic examinations of 1,000 patients who did not undergo LM PCI and 296 patients with significant LM stenosis who did undergo PCI. All patients in both groups underwent a comprehensive qualitative and quantitative assessment of LM anatomical features according to several parameters. Hierarchical cluster analysis (HCA) was used to identify different anatomic phenotypes of the LM coronary artery. Three different anatomical patterns were identified by HCA. The proportion of patients with LM disease increased across clusters (19% in cluster 1, 27% in cluster 2 and 44% in cluster 3, p < 0.001). No differences were observed in terms of 18-month major adverse cardiac event-free survival among patients with LM disease undergoing PCI stratified by clusters (log rank p = 0.77). In conclusion, LM phenotypes can be identified that are more likely to present with atherosclerotic disease and significant stenosis.

Risk stratification is key in optimizing care of patients undergoing percutaneous coronary intervention (PCI). Score algorithms, in particular, are useful prognostic tools to select the most appropriate strategy of treatment and help patients and their families to get a better understanding of issues relevant to treatment strategies and subsequent risks. Most scores tested in the setting of PCI focus on clinical variables. The SYNTAX score is a semiquantitative angiographic score developed to prospectively characterize the disease complexity of the coronary vasculature. This scoring system has recently been assessed in numerous cohorts of patients undergoing coronary revascularization by PCI or bypass surgery. When using the SYNTAX score, however, physicians are still challenged with a labor-intensive calculation and conflicting results from validation studies. Understanding how the SYNTAX score works, for which patients it works best, and whether it predicts accurately enough for its purpose is of paramount importance to get the maximum benefit from its application. The present article provides an overview of the background and the currently available evidences on the use of the SYNTAX score in patients undergoing coronary revascularization along with its limitations., (Copyright © 2011 Mosby, Inc. All rights reserved.)

Due to safety concerns in recent years, much effort has been devoted to improving the outcomes associated with drug-eluting stents (DESs). This review summarizes the current status of methodological and technical achievements reported in second-generation DES. Novel stents are described based on the component (the platform, the polymer, and the drug) that has undergone the most significant changes compared to earlier generation DES. An overview of the currently available evidence on the use of novel coronary devices in patients undergoing coronary revascularization is also reviewed.

Aims: Many operators are discouraged from attempting percutaneous coronary intervention (PCI) of the left main coronary artery in the presence of a right coronary artery (RCA) stenosis, due to the perceived increased risk of periprocedural complications and poor clinical outcome at follow-up. The aim of this study was to asses if the impact of PCI on the clinical outcome of left main patients differed significantly relative to the presence of RCA disease., Methods and Results: A total of 255 consecutive patients undergoing PCI of the left main coronary artery were analysed. Patients were subdivided into "RCA disease" (n=113) and "no RCA disease" (n=142) groups. In the RCA disease group, 33 (29.2%) patients had a chronic total occlusion (CTO). The primary endpoint was the incidence of cardiac death at 3-year follow-up. Patients with RCA disease showed a higher rate of cardiac death (17.7%) compared with those without (6.7%, p=0.056). Patients with a CTO in the RCA had a significantly higher cardiac mortality (30.0%) compared with patients without RCA disease (6.7%, p=0.015) and patients without RCA disease or a >50-99% RCA stenosis combined (8.8%, p=0.021). The presence of residual RCA disease significantly predicted the occurrence of cardiac death (HR 4.41, 95% CI 1.55-12.51, p=0.005)., Conclusions: Patients with unprotected left main disease treated with PCI have worse outcome in terms of cardiac mortality when the RCA is diseased, especially when a CTO is present.

Background: Drug-eluting stents (DESs) introduction has somewhat renewed the issues of strategy and stenting technique for treatment of bifurcation lesions. In particular, concerns remain on extensive use of DESs, especially in the side branch, and on time of dual antiplatelet therapy (DAT) discontinuation, reflecting lack of pertinent long-term data. This study aimed to evaluate clinical safety and efficacy of different strategies for bifurcations treatment in a large observational real-world registry., Methods: A multicenter, retrospective Italian study of consecutive patients undergoing bifurcation percutaneous coronary intervention between January 2002 and December 2006 was performed. The primary end point was the long-term rate of major adverse cardiac events (MACEs). The role of DAT length on outcome was also analyzed., Results: A total of 4,314 patients (4,487 lesions) were enrolled at 22 independent centers. In-hospital procedural success rate was 98.7%. After median follow-up of 24 months, MACEs occurred in 17.7%, with cardiac death in 3.4%, myocardial infarction in 4.0%, target lesion revascularization in 13.2%, and stent thrombosis in 2.9%. Extensive multivariable analysis showed that MACEs were independently predicted by age, diabetes, renal failure, systolic dysfunction, multivessel disease, myocardial infarction at admission, restenotic lesion, bare-metal stent implantation, complex stenting strategy, and short duration of DAT., Conclusions: This large study based on current clinical practice in an unselected patient population presenting with bifurcation disease and submitted to percutaneous coronary intervention demonstrated favorable long-term clinical results in this challenging patient setting, especially when DESs, simple stenting strategy, and DAT for at least 6 months are used., (2010 Mosby, Inc. All rights reserved.)

Objectives: The aim of this study was to investigate the association between plaque distribution at left main (LM) bifurcation and target lesion revascularization (TLR) after stenting., Background: Despite favorable reported mid- and long-term results, stent implantation on LM bifurcation remains challenging. The role of atherosclerotic plaque distribution in affecting LM bifurcation stenting outcomes has not been explored., Methods: A total of 329 patients undergoing LM bifurcation stenting in 2 centers were included. A method based on different plaque locations within the bifurcation area was applied. The overall population was divided in 2 groups according to the presence of a specific pattern characterized by plaque occupying (n = 145) or not occupying (n = 184) the whole bifurcation (WB) area., Results: Baseline clinical, angiographic, and procedural characteristics were well-balanced between the 2 groups. The WB group showed a significantly higher risk of 3-year TLR compared with the non-WB group (24.9% vs. 8.3%; unadjusted hazard ratio: 3.12; 95% confidence interval: 1.59 to 6.11; p = 0.001; adjusted hazard ratio: 2.84; 95% confidence interval: 1.43 to 5.64; p = 0.003). The 3-year TLR rate was not significantly different between patients treated with 1-or 2-stent techniques either in the WB or non-WB groups. In the WB group, TLR was similar between patients with lesions classified as 1,1,1 and non-1,1,1 by the Medina classification (20.7% vs. 26.8%, p = 0.57, respectively)., Conclusions: The WB pattern is associated with enhanced TLR risk, regardless of stent technique and plaque severity. This could impact the treatment strategy of high-risk lesions involving the whole bifurcation area., (Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate the prognostic value of exercise myocardial scintigraphy in patients undergoing incomplete revascularization by means of percutaneous coronary intervention (PCI) with at least a residual chronic total occlusion (CTO) left untreated., Methods: Of 569 consecutive patients with multivessel disease undergoing myocardial scintigraphy after incomplete revascularization by PCI between March 1997 and December 2004, 126 (79% male, 64+/-10 years) with >or= 1 residual CTO fulfilled the eligibility criteria and entered in the study. Hard events defined as cardiac death and myocardial infarction, soft events defined as incidence of unstable angina and PCI procedures, and their composite were assessed at a median follow-up period of 44 months., Results: Hard events were observed in six patients (4.8%). All of them had severely abnormal perfusion defects detected by myocardial scintigraphy. Soft events occurred in 0 (0%), 10 (7.9%), and 15 (11.9%) patients with normal, mildly abnormal, and severely abnormal perfusion, respectively. In the Kaplan-Meier analysis, the log-rank test was statistically significant across patients stratified by summed stress score either in terms of hard, soft and hard, or soft events. Univariate and multivariate Cox proportional-hazards showed an incremental significant information when the scintigraphic variables were added to clinical, angiographic, left ventricular ejection fraction, and Duke treadmill score, for prediction of the composite of hard and soft cardiac events (P < 0.006)., Conclusions: Among patients with a residual CTO left untreated after PCI, myocardial perfusion imaging provides significant independent information concerning the subsequent risk of cardiac events.

Background: Conventional two-dimensional angiography lacks the ability to properly image the true bifurcation geometry, and its percutaneous coronary intervention-induced changes in the clinical setting., Methods and Results: A novel three-dimensional reconstruction system was investigated by retrospectively analyzing 39 lesions in 35 consecutive patients with coronary bifurcation disease treated with the mini-crush technique. At baseline, significant correlations were proved between two- and three-dimensional systems in terms of either reference vessel diameter (R(2)= 0.68 and 0.29 for main and side branches, respectively), minimum lumen diameter (R(2)= 0.73 and 0.36), stenosis diameter (R(2)= 0.69 and 0.29), and lesion length (R(2)= 0.48 and 0.58). These results were consistent with those observed after the procedure and at 8-month follow-up. Lesion length was significantly longer with the three-dimensional compared to the two-dimensional system for both main and side branches (P < 0.001, and P = 0.007, respectively)., Conclusions: The three-dimensional quantitative reconstruction system may provide accurate evaluation of the complex curvilinear structure of bifurcation lesions when using a double stent technique.

Background and Objective: Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of acute coronary syndromes (ACS) improves clinical outcomes through salvage of myocardial tissue. Although use of intracoronary glycoprotein IIb/IIIa inhibition with PCI can result in improved rates of normal epicardial flow and myocardial perfusion, several unmet needs remain. The purpose of this trial is to evaluate the efficacy and safety of an intracoronary bolus of abciximab delivered using the ClearWayRX Therapeutic Perfusion Catheter followed by a dosing regimen of intravenous abciximab infusion after PCI, compared with intracoronary abciximab infusion, via the guiding catheter, followed by a dosing regimen of intravenous abciximab infusion after PCI in patients with ACS., Study Design: Patients with ACS (either unstable angina/non-ST-elevation myocardial infarction or ST-elevation myocardial infarction with open infarct-related artery) and visible thrombus referred for PCI will be randomized to receive one of the two treatment regimens: local intracoronary infusion of abciximab through the ClearWayRX System or intracoronary infusion of abciximab via the guiding catheter. Both groups will receive intravenous infusion of abciximab during the 12-h period following the procedure. Optical coherence tomography assessment will be performed prior to abciximab administration and after the intracoronary infusions to document the change in the thrombus score. In addition, postintervention assessments of coronary microcirculatory function will be evaluated by means of the corrected thrombolysis in myocardial infarction frame count flow and the 'myocardial blush grade'., Implications: If local intracoronary infusion of abciximab through the ClearWayRX System significantly reduces thrombus burden, it will lend support to the use of this delivery system as a valuable tool in patients with ACS treated with PCI.

Background: Whether SYNTAX score should be used as a stand-alone tool or whether its performance may be improved by the parallel use of clinical scores focusing on comorbidities, such as EuroSCORE, is a matter of debate., Methods: A combined risk model including both clinical and angiographic information was developed, and its performance tested on a contemporary population of 255 patients with left main disease undergoing percutaneous coronary intervention (PCI). A global risk classification (GRC) system was created by combination of SYNTAX score and EuroSCORE strata, and new classes of risk were defined., Results: When EuroSCORE was fitted into the SYNTAX score model, c-statistic increased from 0.681 to 0.732 for the prediction of cardiac mortality. The likelihood ratio test for the significance of adding the EuroSCORE term to the model was chi(2) = 4.109 (P = .043) with a net reclassification improvement of 26% (P = .002). GRC showed the best prediction and discriminative ability in terms of two-year cardiac mortality (HR 3.40, 95% CI 1.79-6.43, P < .001; c-statistic 0.756) as compared with SYNTAX score (HR 2.87, 95% CI 1.35-6.10, P = .006; c-statistic 0.747) and EuroSCORE (HR 3.04, 95% CI 1.41-6.57, P = .005; c-statistic 0.708) alone., Conclusions: We found a significant improvement in the prediction of cardiac mortality with the inclusion of EuroSCORE in a SYNTAX score-based model. The degree of reclassification between treatment threshold categories indicates that clinical and angiographic information are both important for assessing individual risk of patients undergoing left main PCI., (Copyright 2010 Mosby, Inc. All rights reserved.)

Background: Novel approaches to modify stents have been developed to address the limitations of bare-metal stents (BMS) and drug-eluting stent (DES), aiming for ideal features, such as decreased restenosis rates with decreased thrombogenicity and without the need for long-term dual antiplatelet therapy., Rationale: The Assessment of The LAtest Non-Thrombogenic Angioplasty Stent (ATLANTA) trial was the first-in-man study to show the safety and efficacy of the Polyzene-F coated CATANIA stent (CeloNova BioSciences, Newnan, Georgia, USA) as an alternative to both BMS and DES. The stent was found to be associated with a good clinical outcome with no vessel thrombosis and a modest growth of late neointima. A subgroup undergoing optical coherence tomography late assessment showed almost complete stent strut coverage at 6 months. However, whether the CATANIA stent is superior in promoting a greater stent strut coverage rate both at 7 and 30 days with respect to DES and BMS is unknown., Methods: The Rapid Evaluation of Vessel HEaling After AngiopLasty (REVEAL) trial will be a prospective, randomized study providing new evidence on early vessel healing and thrombus development after stenting with different stent types. Optical coherence tomography examination at 7-10 days or 28-32 days after implantation will evaluate strut coverage and vessel healing. The primary endpoint will be a comparison of the percentage of 'healed stent struts' at 28-32 days, identified by the presence of an evenly apposed rim of tissue on stent struts, and without apposition of thrombotic material, on the total amount of analyzed struts for the stent groups.

No-reflow is defined as a failure to restore antegrade normal coronary flow, despite appropriate treatment of coronary obstruction. This phenomenon occurs in 5% to 50% of patients undergoing percutaneous coronary intervention, depending on the methods used to assess it and the clinical scenario. This article reviews recent advances in understanding the aspects of no-reflow and provides details on the current knowledge and future developments in diagnosis, prevention and treatment of this complication.

Aims: At present there exists no direct comparative data for the detection of in-stent tissue coverage as assessed by intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in clinical settings. To explore this subject, we investigated the correlation between the IVUS and OCT measurements derived from a contemporary population., Methods and Results: The present study includes 20 patients who had stents imaged at a six months follow-up with both IVUS and OCT, acquired with an automated pull-back. Off-line analyses were done by an independent validated Core-Lab (RHR, Rome, Italy). Measurements of stent length obtained by IVUS and OCT were 16.3+/-3.0 mm and 16.2+/-3.8 mm respectively (p=0.82) and were similar to nominal length (16.3+/-3.3 mm). Luminal area in the OCT image set was lower than that obtained in the corresponding IVUS image set (3.83+/-1.60 mm2 vs 4.05+/-1.44 mm2, p<0.001), while stent area was significantly higher when measured by OCT (6.61+/-1.39 mm2 vs 6.17+/-1.07 mm2, p<0.001). The percentage of tissue coverage measured by IVUS was lower than that measured in the corresponding OCT image sets (35.5+/-16.4% vs 43.4+/-16.1%, p<0.001). Correlation coefficients were high for repeated OCT measurements by two different observers (r=0.99)., Conclusions: OCT can quantify in-stent coverage and detect strut healing with high reproducibility. IVUS tends to underestimate the percentage of in-stent tissue coverage as compared to OCT.

Background: The potential for the CATANIA (CAT) stent to be an alternative to both bare-metal stents (BMS) and drug-eluting stents (DES) has been recently demonstrated in the Assessment of The LAtest Non-Thrombogenic Angioplasty stent (ATLANTA) first-in-human study. The aim of the present study was to compare short-term outcomes of patients treated with the CAT stent with those treated with BMS., Methods: Based on an internal registry, the 30-day and 6-month risk-adjusted outcomes for patients who received the CAT stent (n=254) were compared against outcomes of a historical cohort of patients who received BMS (n=552) between January 2001 and December 2001., Results: At 30 days, use of BMS vs. the CAT stent resulted in borderline significant differences with respect to major adverse cardiac and cerebrovascular events (MACCE) and cardiac death or myocardial infarction. At 6 months, BMS showed a statistically significant higher adjusted risk of MACCE (HR 2.79, 95% CIs 1.20-6.48, P=.017) and no differences with respect to the subcomponent end points. The cumulative incidence of definite stent thrombosis (Academic Research Consortium defined) at 6 months was 0.39% for the CAT stent and 2.35% for the BMS., Conclusions: This study confirms the favorable early and mid-term safety profile and the high-level efficacy of the CAT stent in the treatment of de novo coronary lesions seen in the ATLANTA trial. The use of stents with a nanothin Polyzene-F surface treatment provided improved results with respect to BMS and lower risk of acute and subacute stent thrombosis.

Background: The SYNTAX score (SXscore) has been proposed recently as a valuable tool to characterize the coronary vasculature prospectively with respect to the number of lesions and their functional impact, location, and complexity. However, the prognostic value of SXscores in patients undergoing percutaneous coronary intervention of the left main artery has not been validated., Methods and Results: We applied the SXscore in 255 consecutive patients who underwent percutaneous coronary intervention for left main disease and explored its performance with respect to their clinical outcome. Univariate and multivariate Cox proportional hazard regression analyses were performed to evaluate the relation between the SXscore and the incidence of cardiac mortality, the primary end point of the study, and major adverse cardiac events (MACE). At 1 year, the SXscore significantly predicted the risk of cardiac death (hazard ratio, 1.12/unit increase; 95% CI, 1.06 to 1.18; P<0.001) and MACE (hazard ratio, 1.59/unit increase; 95% CI, 1.02 to 2.48; P=0.043). After adjustment for potential confounders, a higher SXscore remained significantly associated with cardiac mortality (adjusted hazard ratio, 1.15; 95% CI, 1.05 to 1.26; P=0.003) and MACE (adjusted hazard ratio, 1.06; 95% CI, 1.02 to 1.10; P=0.005). C-indexes for SXscores in terms of cardiac death and MACE were 0.83 and 0.64, respectively. Using classification tree analysis, discrimination levels of 34 and 37 were identified as the optimal cutoff to distinguish between patients at low and high risk of cardiac death and MACE, respectively., Conclusions: The SXscore is a useful tool to predict cardiac mortality and MACE in patients undergoing percutaneous revascularization of the left main coronary artery.

Objectives: The purpose of our study was to investigate the utility of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score in aiding patient selection for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in a large contemporary registry of patients undergoing revascularization of left main coronary artery., Background: The SYNTAX score has been developed as a combination of several validated angiographic classifications aiming to grade the coronary lesions with respect to their functional impact, location, and complexity., Methods: Between March 2002 and December 2008, 819 patients with left main coronary artery disease underwent revascularization in 2 Italian centers. We compared clinical outcomes of PCI versus CABG in patients with SYNTAX score < or =34 and patients with SYNTAX score >34., Results: The rates of 2-year mortality were similar between CABG and PCI in the group of patients with SYNTAX score < or =34 (6.2% vs. 8.1%, p = 0.461). Among patients with SYNTAX score >34, those treated with CABG had lower rates of mortality (8.5% vs. 32.7%, p < 0.001) than those treated with PCI. After statistical adjustment, revascularization by PCI resulted in a similar risk of death compared with CABG in patients with SYNTAX score < or =34 (hazard ratio: 0.81, 95% confidence interval: 0.33 to 1.99, p = 0.64) and in a significantly higher risk in patients with SYNTAX score >34 (hazard ratio: 2.54, 95% confidence interval: 1.09 to 5.92, p = 0.031)., Conclusions: A SYNTAX score threshold of 34 may usefully identify a cohort of patients with left main disease who benefit most from surgical revascularization in terms of mortality.

Recent studies of drug-eluting stents (DES) use in routine clinical practice have led to concern regarding their long-term safety and to questions about the adequacy of current antiplatelet therapy guidelines. This study sought to derivate a risk score for predicting stent thrombosis after drug-eluting stenting. The large single center DES Real-world Incremental Value in the erA of percutaneous revascularizaTION (DERIVATION) database, collecting data about 1,377 patients of any age undergoing PCI with DES as treatment for symptomatic coronary artery disease, was use for this purpose. Logistic regression and bootstrap procedure were used to select correlates of stent thrombosis that were subsequently weighted and integrated into an integer scoring system. Five variables selected from the initial multivariate model were weighted proportionally to their respective odds ratio for stent thrombosis [baseline left ventricular ejection fraction <50% (4 points), angioplasty in the setting of acute coronary syndromes (3 points), bifurcation lesion (2 points), left anterior descending as target vessel (2 points), multiple stenting (2 points)]. Three strata of risk were defined (low risk, 0-2; intermediate risk, 3-6; high risk >or=7) with good prognostic accuracy for early, late and very late thrombosis (c statistic = 0.75, 0.65 and 0.73, respectively) in the derivation set. In conclusion, the DERIVATION score may be used as a simple clinical tool for the identification of a sizable cohort in whom close monitoring and aggressive therapy may be beneficial.

Background: With the aim of reducing restenosis after percutaneous coronary intervention with bare-metal stents (BMSs) for the treatment of ischemic heart disease, drug-eluting stents (DESs) were introduced in the field of percutaneous coronary intervention in 2002. However, the higher cost of DES in comparison with BMS made it necessary to determine whether their use brings a real economic advantage., Methods: In order to verify the clinical and economic benefit of DES in comparison with BMS and surgical treatment with coronary artery bypass graft (CABG), the Sicily Regional Government arranged for the creation of a directory where patients receiving at least one DES (with sirolimus or with paclitaxel) were enrolled from June 2004 to February 2005. The cost-effectiveness analysis for DES was carried out by means of two decisional models: one referring to patients treated with DES who, without such a device, would have undergone CABG, and the second one referring to patients treated with DES who, without such device, would have received BMS. Cost analysis was carried out from the point of view of the SSR (Servizio Sanitario Regionale, Regional Health Service)., Results: The use of DES on patients destined to CABG generated average unitary differential savings of euro9003, after 9 months of follow-up, and average total differential savings of euro4 438 479. The use of DES on patients destined to BMS gave average unitary differential savings of euro1075, after 9 months of follow-up, and average total differential savings of euro1 052 425. The use of DES instead of BMS and CABG allowed SSR to make average differential savings of euro3760 per successful case. The refund threshold value of DES, setting to zero the SSR average differential savings for patients treated with DES who would otherwise have been treated with BMS, was euro2489., Conclusion: The medium-term results of the proposed models, tested with sensitivity analysis, demonstrate the use of DES to be justified; moreover, these results could positively influence the attitude of the SSR toward these new therapeutic strategies, which are an improvement on standard therapies, both from a clinical and a financial standpoint.

Objectives: We sought to evaluate clinical and angiographic outcomes of percutaneous coronary intervention (PCI) in patients receiving both bare-metal stents (BMS) and drug-eluting stents (DES)., Background: Few data are available about the safety and efficacy of the practice namely called "hybrid PCI"., Methods: One hundred and eighty-six patients, 502 de novo lesions, received during PCI both BMS (n = 266) and DES (316), with a mean of 3.1 +/- 1.2 stents/patient. Cumulative major adverse cardiac events were analyzed at 24 +/- 22 months., Results: Clinical follow up was carried out in 100% of eligible patients. Angiographic follow up at 8.6 +/- 4.4 months was achieved in 70.4% of patients, 71.6% of stents and 72.5% of lesions. Binary restenosis was 12.9% vs. 20.6% (p = 0.034) in DES vs. BMS, respectively; late loss was significantly higher in BMS than in DES (0.67 +/- 0.73 vs. 0.35 +/- 0.71 mm; p < 0.001). DES showed less lumen loss and binary restenosis rates than BMS in B2/C lesions (p < 0.001 and 0.007, respectively), while any significant difference was detected in A/B1 lesions (p = 0.27 and 0.76, respectively)., Conclusions: The simultaneous use of DES and BMS is safe and provides similar results for the 2 stents only in simple lesions. In complex lesions, BMS offer restenosis and a target lesion revascularization rates significantly higher than with DES.

Objectives: This study sought to assess safety and efficacy of implantation of the Catania Coronary Stent System with Nanothin Polyzene-F (CeloNova BioSciences, Newnan, Georgia) in human coronary arteries with clinical data and comprehensive intracoronary imaging., Background: Novel approaches to modify stents (e.g., bioactive agents, coatings) have been developed to address the limitations of bare-metal and drug-eluting stents (e.g., restenosis, target lesion revascularization [TLR], late thrombosis)., Methods: This first-in-man study using the Catania stent is a prospective, single center, nonrandomized, single-arm study of 55 patients with symptomatic ischemic heart disease with de novo, obstructive lesions of native coronary arteries., Results: Acute angiographic success was 100%. A core laboratory analyzed quantitative coronary angiography and intravascular ultrasound data immediately after stenting and at 6-month follow-up. Late lumen loss was 0.60 +/- 0.48 mm and the percent neointimal hyperplasia volume was 27.9 +/- 16.1%. In 15 of 55 randomly selected patients, 1,904 cross-sections (19,028 struts) were analyzed at 6 months by optical coherence tomography. Overall, 99.5% of struts were covered. Only 29 of 19,028 struts (0.15%) were malapposed. Binary angiographic restenosis was 6.8%. No death, myocardial infarction, or Academic Research Consortium-defined stent thrombosis was observed at 12 months. The incidence of TLR at 12 months was clinically driven TLR 3.6% (2 of 55) and nonclinically driven TLR 7.3% (4 of 55)., Conclusions: This first-in-man showed an excellent early and mid-term safety profile and high-level efficacy of the new Catania stent in the treatment of de novo coronary lesions in a fairly complex population. Polyzene-F coated stents may be an alternative to both bare-metal and drug-eluting stents with reduced late loss, restenosis, and the TLR without long-term dual antiplatelet therapy.