Background The EMPIRE I study assessed the early (30 days) safety and efficacy of a new fully repositionable delivery system (IMPERIA) for the commercially available ALLEGRA transcatheter aortic valve in patients with either severe native aortic stenosis or a degenerated surgical bioprosthesis.Aim To report the final 1-year results of the EMPIRE I study.Methods EMPIRE I is a pre-market, prospective, multi-center, single-arm study conducted at 11 centers in 3 European countries. There were independent data safety and clinical events committees and an independent echocardiographic core laboratory. In this analysis, VARC-3 definitions of all clinical endpoints and echocardiographic parameters were employed.Results The study recruited 121 patients with severe native aortic stenosis and 16 with degenerated surgical bioprosthesis. At 1 year, the incidence of bioprosthetic valve dysfunction in the native population was 5.9%. No patients developed structural valve deterioration or endocarditis, and there were no patients with haemodynamic valve deterioration or bioprosthetic valve failure. In the valve-in-valve sub-group, 2/14 (14.3%) patients had moderate patient prosthesis mismatch at 30 days with no evidence of new bioprosthetic valve dysfunction at 1 year. In the native population, new permanent pacemaker implantation was 14.3% at 30 days and remained unchanged at 1 year. Cardiovascular mortality was 6.8% in the native population and 0% in the valve-in-valve patients. At 1-year, all-cause mortality was 10.8% (95% CI 6.4%-17.8%) in the native aortic stenosis population and 0% in the valve-in-valve patients.Conclusion After 1 year of follow-up, the results of the EMPIRE 1 study show excellent haemodynamic performance, a low rate of bioprosthetic valve dysfunction, and no bioprosthetic valve failure in patients treated with the ALLEGRATM trans-catheter aortic valve implanted using the new IMPERIATM fully repositionable delivery system.

BACKGROUND:In the REFORM trial, treatment of coronary in-stent restenosis with a Biolimus A9™ drug-coated balloon (BCB) was found to be inferior with respect to in-segment percentage stenosis at 6-months in comparison to treatment with a standard paclitaxel coated paclitaxel-coated balloon (PCB). AIMS:In this manuscript, the final prespecified 2-year clinical follow up follow-up of the REFORM trial is reported. METHODS:The Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the Biolimus A9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis: First-in-Man Trial (REFORM) was a multicenter, single blind, non-inferiority, randomized controlled trial comparing the BCB and PCB in the treatment of coronary in-stent restenosis (ISR). The primary angiographic endpoint of the trial was in-segment % diameter stenosis (%DS) at 6 months, which has previously been reported. A total clinical follow-up duration of 2 years was planned. Prespecified clinical outcomes at 2 years were: target lesion failure (TLF), target vessel failure (TVF), and their individual components. RESULTS:At 24 months, complete follow-up data was available for 93% (n = 188) of the intention to treat (ITT) population. The mean age was 68.7 years, and patients were predominantly male (80.2%). Comorbidities were well balanced between the 2 groups, including diabetes mellitus, which was present in 31% of the BCB group and 29.2% of the PCB group. ISR lesions were predominantly DES-ISR in both groups (BCB 80.7% vs. PCB 85.1%). Through to 2 year follow up, target lesion failure (TLF) occurred in 36 of 135 patients (27.8%) of patients in the BCB group and in 15 of 67 patients (23.5%) in the PCB group (HR: 1.25; 95% CI: 0.69-2.29). Clinically driven target lesion revascularization (CD-TLR) occurred in 31 of 135 patients (24.2%) in the BCB group versus 13 of 67 patients (20.4%) in the PCB group (HR: 1.26; 95% CI: 0.66-2.40). Target vessel myocardial infarction and cardiac death were comparable in both groups. CONCLUSION:In patients with coronary ISR, the final 2-year results from the REFORM study show that TLF rates were 27.8% in the biolimus-coated balloon BCB group and 23.5% in the paclitaxel-coated balloon PCB group. However, given the limited sample size and wide confidence intervals, the present analysis does not permit reliable inference regarding comparative event rates between treatment strategies. The results should be interpreted against the background of demonstrated inferior angiographic performance of the biolimus DCB at 6 months. TRIAL REGISTRATION:The trial was registered prospectively at www. CLINICALTRIALS:gov (identifier: NCT04079192).

Background The ALLEGRA (Biosensors International) transcatheter heart valve is a self-expanding supra-annular bovine pericardial aortic valve. A new delivery system (IMPERIA™, Biosensors International) has been designed which allows the valve to be fully resheathed and repositioned in situ. The aim of this premarket study was to assess the safety and efficacy of transcatheter aortic valve implantation using the combination of the CE (Conformite Europeenne) marked ALLEGRA valve and the new IMPERIA delivery system. Methods One hundred thirty-seven patients were enrolled in 11 centers from January to November 2023. There were 30 roll-in patients, 91 in the intention-to-treat (ITT) population and 16 with degenerated surgical aortic bioprostheses. The primary outcome was device success according to the Valve Academic Research Consortium-2 from discharge up to 7 days in the ITT cohort. Results Implantation of the ALLEGRA valve was successful in 136 patients (99.3%). There were no device embolizations and no patient required a second valve. Device success was achieved in 91.9% of the ITT cohort. At 30 days, all-cause mortality was 2.2% in the native aortic stenosis (AS) cohort and 0% in the valve-in-valve cohort. New pacemaker implantation was required in 12.4% (17/137). There was no patient prosthesis mismatch (PPM) in the 121 patients with native AS and moderate PPM in 2/16 valve-in-valve patients. Conclusions This study confirms the safety and efficacy of transcatheter aortic valve implantation using the IMPERIA delivery system to implant the CE marked ALLEGRA transcatheter heart valve in patients with severe calcific native AS or a degenerated surgical aortic bioprostheses.

BACKGROUND:In recent years, drug-coated balloon (DCB) angioplasty has become an established treatment option for the treatment of coronary in-stent restenosis (ISR). OBJECTIVES:The aim of this study was to compare the angiographic and clinical performance of the Biolimus A9-coated balloon (BCB; Biosensors Europe) with that of the paclitaxel-coated balloon (PCB; SeQuent Please, Braun Melsungen). METHODS:REFORM (Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the Biolimus A9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis: First-in-Man Trial) was a multicenter, assessor-blinded, noninferiority, 2:1 randomized controlled trial comparing the BCB and the PCB for the treatment of coronary ISR. The primary endpoint was in-segment percentage diameter stenosis at 6 months. Secondary endpoints included target lesion failure. The trial was registered prospectively at ClinicalTrials.gov (NCT04079192). RESULTS:A total of 202 patients were randomized at 20 centers in 6 countries, with 135 in the BCB group and 67 in the PCB group. The mean patient age was 68.5 ± 10 years. At 6 months, in-segment percentage diameter stenosis was 43.3% ± 22.9% in the BCB group compared with 31.4% ± 17.7% in the PCB group (95% CI for the difference: 4.9%-18.8%; prespecified noninferiority margin 12%, noninferiority P = 0.48). At 1 year, target lesion failure was observed in 23.7% of patients in the BCB group vs 17.1% in the PCB group (HR: 1.44; 95% CI: 0.72-2.88; P = 0.28). CONCLUSIONS:In patients with ISR, the REFORM study failed to demonstrate noninferiority of the investigational biolimus DCB compared with the standard paclitaxel DCB.

BackgroundChronic total occlusion (CTO) remains the most complex anatomical subset of lesions in percutaneous coronary intervention (PCI), often requiring advanced techniques and technologies, including the use of microcatheters.MethodsThe BIOMICS study is a premarket first-in-human prospective, multicenter, open-label, single-arm trial investigating the safety and efficacy of a novel coronary microcatheter (BioMC, Biosensors International) in 100 patients with symptoms of ischemia undergoing elective CTO-PCI. The primary efficacy end point of the study was device success defined according to the CTO-ARC (Chronic Total Occlusion Academic Research Consortium) criteria namely the ability of the microcatheter to successfully facilitate placement of a guide wire beyond the occluded coronary segment. The primary safety end point was the incidence of in-hospital cardiac death or myocardial infarction at hospital discharge.ResultsHundred patients were recruited between March 2022 and January 2023. The primary efficacy end point was achieved in 75% of patients (95% CI, 65.3%-83.1%; P < .0001 for superiority compared to the prespecified performance goal of 54%). The primary safety end point of in-hospital cardiac death or myocardial infarction was observed in 2% of the patients. There were no study device-related coronary perforations or device failures.ConclusionsThe use of a novel coronary microcatheter during CTO-PCI was associated with a high device success and an excellent safety profile.

HomeCirculationVol. 147, No. 12Highlights From the Circulation Family of Journals No AccessNewsRequest AccessFull TextAboutView Full TextView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toNo AccessNewsRequest AccessFull TextHighlights From the Circulation Family of Journals Originally published21 Mar 2023https://doi.org/10.1161/CIRCULATIONAHA.123.064167Circulation. 2023;147:977–981FootnotesCirculation is available at www.ahajournals.org/journal/circCorrespondence to: Katja Zeppenfeld, MD, PhD, Leiden University Medical Center, Department of Cardiology (C-05-P), PO Box 9600, 2300 RC Leiden, the Netherlands. Email k.zeppenfeld@lumc.nl eLetters(0)eLetters should relate to an article recently published in the journal and are not a forum for providing unpublished data. Comments are reviewed for appropriate use of tone and language. Comments are not peer-reviewed. Acceptable comments are posted to the journal website only. Comments are not published in an issue and are not indexed in PubMed. Comments should be no longer than 500 words and will only be posted online. References are limited to 10. Authors of the article cited in the comment will be invited to reply, as appropriate.Comments and feedback on AHA/ASA Scientific Statements and Guidelines should be directed to the AHA/ASA Manuscript Oversight Committee via its Correspondence page.Sign In to Submit a Response to This Article Previous Back to top Next FiguresReferencesRelatedDetails March 21, 2023Vol 147, Issue 12 Advertisement Article InformationMetrics © 2023 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.123.064167PMID: 36944038 Originally publishedMarch 21, 2023 PDF download Advertisement

Background:Percutaneous coronary intervention (PCI) is increasingly used as a treatment option for unprotected left main stem artery (unprotected left main stem percutaneous intervention) disease. However, whether patient outcomes have improved over time is uncertain. Methods:Using the United Kingdom national PCI database, we studied all patients undergoing unprotected left main stem percutaneous intervention between 2009 and 2017. We excluded patients who presented with ST-segment-elevation, cardiogenic shock, and with an emergency indication for PCI. Results:Between 2009 and 2017, in the study-indicated population, 14 522 unprotected left main stem percutaneous intervention procedures were performed. Significant temporal changes in baseline demographics were observed with increasing patient age and comorbid burden. Procedural complexity increased over time, with the number of vessels treated, bifurcation PCI, number of stents used, and use of intravascular imaging and rotational atherectomy increased significantly through the study period. After adjustment for baseline differences, there were significant temporal reductions in the occurrence of peri-procedural myocardial infarction (P<0.001 for trend), in-hospital major adverse cardiac or cerebrovascular events (P<0.001 for trend), and acute procedural complications (P<0.001 for trend). In multivariable analysis examining the associates of in-hospital major adverse cardiac or cerebrovascular events, while age per year (odds ratio, 1.02 [95% CIs, 1.01-1.03]), female sex (odds ratio, 1.47 [1.19-1.82]), 3 or more stents (odds ratio, 1.67 [05% [1.02-2.67]), and patient comorbidity were associated with higher rates of in-hospital major adverse cardiac or cerebrovascular events, by contrast use of intravascular imaging (odds ratio, 0.56 [0.45-0.70]), and year of PCI (odds ratio, 0.63 [0.46-0.87]) were associated with lower rates of in-hospital major adverse cardiac or cerebrovascular events. Conclusions:Despite trends for increased patient and procedural complexity, in-hospital patient outcomes have improved after unprotected left main stem percutaneous intervention over time.

Background: Twenty percent to 40% of patients are affected by angina after percutaneous coronary intervention (PCI), which is associated with anxiety, depression, impaired physical function, and reduced quality of life. Understanding patient and procedural factors associated with post-PCI angina may inform alternative approaches to treatment. Methods: Two hundred thirty patients undergoing PCI completed the Seattle Angina Questionnaire (SAQ-7) and European quality of life–5 dimension–5 level (EQ-5D-5L) questionnaires at baseline and 3 months post-PCI. Patients received blinded intracoronary physiology assessments before and after stenting. A post hoc analysis was performed to compare clinical and procedural characteristics among patients with and without post-PCI angina (defined by follow-up SAQ-angina frequency score <100). Results: Eighty-eight of 230 patients (38.3%) reported angina 3 months post-PCI and had a higher incidence of active smoking, atrial fibrillation, and history of previous myocardial infarction or PCI. Compared with patients with no angina at follow-up, they had lower baseline SAQ summary scores (69.48±24.12 versus 50.20±22.59, P <0.001) and EQ-5D-5L health index scores (0.84±0.15 versus 0.69±0.22, P <0.001). Pre-PCI fractional flow reserve (FFR) was lower among patients who had no post-PCI angina (0.56±0.15 versus 0.62±0.13, P =0.003). Percentage change in FFR after PCI had a moderate correlation with angina frequency score at follow-up ( r =0.36, P <0.0001). Patients with post-PCI angina had less improvement in FFR (43.1±33.5% versus 67.0±50.7%, P <0.001). There were no between-group differences in post-PCI FFR, coronary flow reserve, or corrected index of microcirculatory resistance. Patients with post-PCI angina had lower SAQ-summary scores (64.01±22 versus 95.16±8.72, P ≤0.001) and EQ-5D-5L index scores (0.69±0.26 versus 0.91±0.17, P ≤0.001) at follow-up. Conclusions: Larger improvements in FFR following PCI were associated with less angina and better quality of life at follow-up. In patients with stable symptoms, intracoronary physiology assessment can inform expectations of angina relief and quality of life improvement after stenting and thereby help to determine the appropriateness of PCI. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03259815.

BACKGROUND:Drug-coated balloon (DCB) angioplasty with paclitaxel-eluting devices is an established treatment for coronary in-stent restenosis (ISR). Biolimus A9™ (BA9), a sirolimus analogue with enhanced lipophilicity, may facilitate enhanced local drug delivery into vascular tissue. A novel DCB coated with Biolimus A9™ represents an alternative to traditional paclitaxel- and sirolimus-coated devices. Hence, we sought to investigate the safety and efficacy of this novel DCB in the treatment of coronary ISR. METHODS AND DESIGN:REFORM (NCT04079192) is a prospective, multicenter, single blind, randomized controlled trial comparing the BA9-DCB (Biosensors Europe SA, Morges, Switzerland) to the paclitaxel-coated SeQuent® Please DCB (Braun Melsungen AG, Germany) in the treatment of coronary ISR. A total of 201 patients with coronary artery disease and an indication for interventional treatment of ISR in a bare-metal stent (BMS) or drug-eluting stent (DES) have been randomized 2:1 to receive treatment with the BA9- or the paclitaxel-DCB comparator. Patients were enrolled across 24 investigational centers in Europe and Asia. The primary endpoint is percent diameter stenosis (%DS) of the target segment as assessed by quantitative coronary angiography (QCA) at 6 months. Key secondary endpoints are in-stent late lumen loss, binary restenosis, target lesion failure, target vessel failure, myocardial infarction and death at 6 months. Subjects will be followed for 24 months from enrolment. IMPLICATIONS:The REFORM trial will seek to prove that the BA9-DCB is non-inferior to the standard paclitaxel-DCB comparator in the treatment of coronary ISR with respect to %DS at 6 months and has similar safety characteristics.

BACKGROUND:The polymer-free biolimus coated stent (BioFreedom) was shown to be superior to bare metal stents in the LEADERS FREE randomized trial in high bleeding risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT). However, there is limited outcome data with this device in an all-comers' population.METHODS:We conducted a prospective single-arm study of patients undergoing percutaneous coronary intervention with the polymer-free biolimus coated stent in 25 centers in France with wide inclusion criteria including multivessel disease, complex lesions, and acute coronary syndromes. The primary endpoint was the incidence of target lesion failure (TLF), a composite of cardiac death or target-vessel myocardial infarction (MI) or clinically indicated target lesion revascularization (ci-TLR) at 1-year. The patient population was classified according to the presence (or not) of HBR criteria according to the recent ARC-HBR definition.RESULTS:Between April 2019 and April 2020, 1497 patients were enrolled. TLF occurred in 101 (6.9%) patients, including cardiac death in 35 (2.4%), target vessel MI in 20 (1.4%) and ci-TLR in 65 (4.5%) of them. There were 491 HBR patients (32.8%) and 1006 non-HBR patients. The median duration of DAPT was 74 days in the HBR group versus 348 days in the non-HBR group (p < 0.0001). TLF occurred in 44 (9.2%) of the HBR group and in 57 (5.8%) of the non-HBR group (relative risk 1.62 [95% confidence interval: 1.10-2.41], p = 0015). Compared to the non-HBR group, HBR patients had higher rates of cardiac death (4.4% vs. 1.4%, p = 0.0005) and target vessel MI (2.9% vs. 0.6%, p = 0.0003), but similar rates of ci-TLR. BARC 3-5 bleeding occurred in 6.2% of the HBR group versus 1.4% of the non-HBR group (p < 0.0001).CONCLUSION:In this multicenter all-comers study, HBR patients treated with a polymer-free biolimus coated stent had, compared to non-HBR patients, an increased risk of cardiac death and MI, and despite a shorter duration of DAPT, continued to have higher rates of BARC 3-5 bleeding.

In cardiogenic shock with severe left main coronary artery stenosis (LM), limited information exists on short and longer-term outcomes. We sought to determine the outcomes of unprotected LM PCI in cardiogenic shock.Excluding patients with previous CABG, consecutive patients undergoing PCI in cardiogenic shock from the Melbourne Intervention Group registry between 2005 and 2013 were analysed. Those post LM PCI were compared to those post non-LM PCI. Patient and procedural data were collected with 30-day and 12-month follow-up. Australian National Death Index linkage was performed for long-term mortality analysis.After excluding previous CABG, 18,069 procedures were performed during 1st January 2005 to 30th November 2013, 601 procedures in the setting of cardiogenic shock. Of these, 45 were performed to an isolated LM and 556 to a non-LM. Those with LM PCI were older and more likely to have a baseline left ventricular ejection fraction (LVEF) of <45%. The in-hospital, 30-day, 12-month and long-term mortality to 9 years in cardiogenic shock after LM PCI was 64.4%, 66.7%, 73.3% and 80.0% compared to 36.5%, 36.9%, 40.5% and 46.0%, after non-LM PCI (p < 0.001). On multivariate analysis, LM PCI was a significant independent predictor of long-term mortality (HR1.59, 95%CI 1.00–2.53, p = 0.048). Landmark analysis of survivors to discharge found the long-term mortality of LM PCI approaches 60% compared to 27% for those with non-LM PCI (p = 0.003).Long-term outcomes after PCI to LM in cardiogenic shock are poor, with much of the excess in mortality occurring early. However, reasonable long-term survival was found beyond the initial high-risk period.

Aims A fractional flow reserve (FFR) value >= 0.90 after percutaneous coronary intervention (PCI) is associated with a reduced risk of adverse cardiovascular events. TARGET-FFR is an investigator-initiated, single-centre, randomized controlled trial to determine the feasibility and efficacy of a post-PCI FFR-guided optimization strategy vs. standard coronary angiography in achieving final post-PCI FFR values >= 0.90. Methods and results After angiographically guided PCI, patients were randomized 1:1 to receive a physiology-guided incremental optimization strategy (PIOS) or a blinded coronary physiology assessment (control group). The primary outcome was the proportion of patients with a final post-PCI FFR >= 0.90. Final FFR <= 0.80 was a prioritized secondary outcome. A total of 260 patients were randomized (131 to PIOS, 129 to control) and 68.1% of patients had an initial post-PCI FFR <0.90. In the PIOS group, 30.5% underwent further intervention (stent post-dilation and/or additional stenting). There was no significant difference in the primary endpoint of the proportion of patients with final post-PCI FFR >= 0.90 between groups (PIOS minus control 10%, 95% confidence interval -1.84 to 21.91, P = 0.099). The proportion of patients with a final FFR <= 0.80 was significantly reduced when compared with the angiography-guided control group (-11.2%, 95% confidence interval -21.87 to -0.35], P = 0.045). Conclusion Over two-thirds of patients had a physiologically suboptimal result after angiography-guided PCI. An FFR-guided optimization strategy did not significantly increase the proportion of patients with a final FFR >= 0.90, but did reduce the proportion of patients with a final FFR <= 0.80.

Introduction The impact of a vascular complication (VC) in the setting of intraaortic balloon pump (IABP) supported PCI on clinical outcomes is unclear. Methods Using data from the BCIS National PCI Database, multivariate logistic regression was used to identify independent predictors of a VC. Propensity scoring was used to quantify the association between a VC and outcomes. Results Between 2007 and 2014, 9,970 PCIs in England and Wales were supported by IABP (1.6% of total PCI), with 224 femoral VCs (2.3%). Annualized rates of a VC reduced as the use of radial access for PCI increased. The independent predictors of a VC included a procedural complication (odds ratio [OR] 2.9, p < .001), female sex (OR 2.3, p < .001), PCI for stable angina (OR 3.47, p = .028), and use of a glycoprotein inhibitor (OR 1.46 [1.1:2.5], p = .04), with a lower likelihood of a VC when radial access was used for PCI (OR 0.48, p = .008). A VC was associated with a higher likelihood of transfusion (OR 5.7 [3.5:9.2], p < .0001), acute kidney injury (OR 2.6 [1.2:6.1], p = .027), and periprocedural MI (OR 3.2 [1.5:6.7], p = .002) but not with adjusted mortality at discharge (OR 1.2 [0.8:1.7], p = .394) or 12-months (OR 1.1 [0.76:1.56], p = .639). In sensitivity analyses, there was a trend towards higher mortality in patients experiencing a VC who underwent PCI for stable angina (OR 4.1 [1.0:16.4], p value for interaction .069). Discussion and Conclusions Although in-hospital morbidity was observed to be adversely affected by occurrence of a VC during IABP-supported PCI, in-hospital and 1-year survival were similar between groups.

The aims of this study were to use a national percutaneous coronary intervention (PCI) registry to study temporal changes in procedure volumes of PCI using rotational atherectomy (ROTA-PCI), the patient and procedural factors associated with differing quartiles of operator ROTA-PCI volume, and the relationship between operator ROTA-PCI volumes and in-hospital patient outcomes.Whether higher operator volume is associated with improved outcomes after ROTA-PCI is poorly defined.Data from the British Cardiovascular Intervention Society national PCI database were analyzed for all ROTA-PCI procedures performed in the United Kingdom between 2013 and 2016. Individual logistic regressions were performed to quantify the independent association between annual operator ROTA-PCI volume and in-hospital outcomes.In total, 7,740 ROTA-PCI procedures were performed, with a negatively skewed distribution and an annualized operator volume median of 2.5 procedures/year (range 0.25 to 55.25). Higher volume operators undertook more complex procedures in patients with greater comorbid burdens than lower volume operators. A significant inverse association was observed between operator ROTA-PCI volume and in-hospital mortality (odds ratio [OR]: 0.986/case; 95% confidence interval [CI]: 0.975 to 0.996; p = 0.007) and major adverse cardiac and cerebral events (OR: 0.983/case; 95% CI: 0.975 to 0.993; p < 0.001). Additionally, lower rates of emergency cardiac surgery (OR: 0.964/case; 95% CI: 0.939 to 0.991; p = 0.008), arterial complications (OR: 0.975/case; 95% CI: 0.975 to 0.982; p < 0.001) and in-hospital major bleeding (OR: 0.985/case; 95% CI: 0.977 to 0.993; p < 0.001) were associated with higher ROTA-PCI operator volume. Sensitivity analyses in several subgroups demonstrated a consistency of improved outcomes as annual ROTA-PCI volume increased. An annual volume of <4 ROTA-PCI procedures/year was observed to be associated with increased major adverse cardiac and cerebral events, with 239 of 432 operators (55%) not exceeding this threshold.In-hospital adverse outcomes occurred less frequently as ROTA-PCI operator volume increased. These data suggest that operator volume is an important factor determining outcome after ROTA-PCI.

Background. While thinner struts are associated with improved clinical outcomes in bare-metal stents (BMS), reducing strut thickness may affect drug delivery from drug-eluting stents (DES) and there are limited data comparing otherwise similar thin and thick strut DES. We assessed 2-year outcomes of patients treated with a thin strut (84–88um) cobalt-chromium, biodegradable polymer, Biolimus A9-eluting stent (CoCr-BP-BES) and compared these to patients treated with a stainless steel, biodegradable polymer, Biolimus A9-eluting stent (SS-BP-BES). Methods. In total, 1257 patients were studied: 400 patients from 12 centres receiving ≥1 CoCr-BP-BES in the prospective Biomatrix Alpha registry underwent prespecified comparison with 857 patients who received ≥1 Biomatrix Flex SS-BP-BES in the LEADERS study (historical control). The primary outcome was major adverse cardiac events (MACE)—cardiac death, myocardial infarction (MI), or clinically driven target vessel revascularization (cd-TVR). Propensity analysis was used to adjust for differences in baseline variables and a landmark analysis at day-3 to account for differences in periprocedural MI definitions. Results. MACE at 2 years occurred in 6.65% CoCr-BP-BES versus 13.23% SS-BP-BES groups (unadjusted HR 0.48 [0.31–0.73]; P=0.0005). Following propensity analysis, 2-year adjusted MACE rates were 7.4% versus 13.3% (HR 0.53 [0.35–0.79]; P=0.004). Definite or probable stent thrombosis, adjudicated using identical criteria in both studies, occurred less frequently with CoCr-BP-BES (1.12% vs. 3.22%; adjusted HR 0.32 [0.11–0.9]; P=0.034). In day-3 landmark analysis, the difference in 2-year MACE was no longer significant but there was a lower patient-orientated composite endpoint (11.7% vs. 18.4%; HR 0.6 [0.43–0.83]; P=0.006) and a trend to lower target vessel failure (5.8% vs. 9.1%; HR 0.63 [0.4–1.00]; P=0.078). Conclusion. At 2-year follow-up, propensity-adjusted analysis showed the thin strut (84–88um) Biomatrix Alpha CoCr-BP-BES was associated with improved clinical outcomes compared with the thicker strut (114–120um) Biomatrix Flex SS-BP-BES.

The authors used the British Cardiovascular Intervention Society (BCIS) national percutaneous coronary intervention (PCI) database to explore temporal changes in the use of intravascular imaging for unprotected left main stem PCI (uLMS PCI), defined the associates of imaging use, and correlate clinical outcomes including survival with imaging use. Limited registry data support the use of intravascular imaging during uLMS PCI to improve outcomes. Data were analyzed from 11,264 uLMS PCI procedures performed in England and Wales between 2007 and 2014. Multivariate logistic regression was used to identify associates of imaging use. Propensity matching created 5,056 pairs of subjects with and without imaging and logistic regression was performed to quantify the association between imaging and outcomes. Multivariate logistic regression to identify the independent predictors of 12-month mortality was performed. Imaging use increased from 30.2% in 2007 to 50.2% in 2014 (p for trend < 0.001). The factors associated with imaging use included stable angina presentation (odds ratio [OR]: 1.200; 95% confidence interval [CI]: 1.147 to 1.246; p < 0.001), bifurcation LMS disease (OR: 1.220; 95% CI: 1.140 to 1.300; p < 0.001), previous PCI (OR: 1.320; 95% CI: 1.200 to 1.440; p < 0.001), and radial access (OR: 1.266; 95% CI: 1.217 to 1.317; p < 0.001). A lower rate of coronary complications, lower in-hospital major adverse cardiac events (OR: 0.470; 95% CI: 0.37 to 0.590; p < 0.001), and improved 30-day (OR: 0.540; 95% CI: 0.430 to 0.680; p < 0.001) and 12-month (OR: 0.660; 95% CI: 0.570 to 0.770; p < 0.001) mortality were observed with imaging use compared with no imaging use. Greater mortality reductions were observed with higher operator LMS PCI volume. In logistic regression modeling, imaging use was associated with improved 12-month survival. The observed lower mortality with use of intravascular imaging to guide uLMS PCI justifies the undertaking of a large-scale randomized trial.