Target Vessel Failure Research Articles

A glimpse into the future of the percutaneous treatment of coronary chronic total occlusions.

Percutaneous coronary intervention (PCI) of coronary chronic total occlusion (CTO PCI) is one of the most challenging but rewarding procedures in the portfolio of interventional cardiologists. Several challenges, however, still must be overcome and many questions need to be answered. After coronary artery bypass graft (CABG), disease of the conduits and concomitant progression of atherosclerotic disease to CTO of the subtended native coronary vessels are common and associated with onset of new anginal symptoms and worsening of the prognosis. Which is the best strategy for these post-CABG CTOs? Furthermore, what is the role of physiology in the setting of CTO PCI? In the last decades, many researchers tried to demystify the complex maze but technical limitations and the demanding procedure itself, for both the patient and the operator, do not allow extensive investigation of its impact on clinical practice. Can we enhance periprocedural planning of CTO PCI with a more tailored and multidimensional evaluation? Analysis of coronary computed tomography angiography (CCTA) scans is getting more and more incorporated into the clinical routine and training of interventional cardiologists but mainly focuses on structural valvular disease. Nevertheless, with the appropriate expertise, a lot of information can be derived for coronary intervention to improve procedural planning and potentially outcomes. Finally, in the era of drug-eluting stent, is there a place for strategies that minimize metal implantation in the coronaries to further reduce late-onset adverse events in CTO PCI? This approach could be attractive in CTOs due to the higher risk of target vessel failure and revascularization shown in literature but, at the same time, more challenging due to the histological and anatomical complexity of the disease. In this review, we aim to tackle these questions and concomitantly provide a vision of potential future application of new techniques and technology in CTO PCI that could allow further advancement in this field.

Long-term prognostic implications of hemodynamic and plaque assessment using coronary CT angiography

Background and aimsHemodynamic and plaque characteristics can be analyzed using coronary CT angiography (CTA). We aimed to explore long-term prognostic implications of hemodynamic and plaque characteristics using coronary CT angiography (CTA). MethodsInvasive fractional flow reserve (FFR) and CTA-derived FFR (FFRCT) were undertaken for 136 lesions in 78 vessels and followed-up to 10 years until December 2020. FFRCT, wall shear stress (WSS), change in FFRCT across the lesion (ΔFFRCT), total plaque volume (TPV), percent atheroma volume (PAV), and low-attenuation plaque volume (LAPV) for target lesions [L] and vessels [V] were obtained by independent core laboratories. Their collective influence was evaluated for the clinical endpoints of target vessel failure (TVF) and target lesion failure (TLF). ResultsDuring a median follow-up of 10.1 years, PAV[V] (per 10% increase, HR 2.32 [95% CI 1.11–4.86], p = 0.025), and FFRCT[V] (per 0.1 increase, HR 0.56 [95% CI 0.37–0.84], p = 0.006) were independent predictors of TVF for the per-vessel analysis, and WSS[L] (per 100 dyne/cm2 increase, HR 1.43 [1.09–1.88], p = 0.010), LAPV[L] (per 10 mm3 increase, HR 3.81 [1.16–12.5], p = 0.028), and ΔFFRCT[L] (per 0.1 increase, HR 1.39 [1.02–1.90], p = 0.040) were independent predictors of TLF for the per-lesion analysis after adjustment for clinical and lesion characteristics. The addition of both plaque and hemodynamic predictors improved the predictability for 10-year TVF and TLF of clinical and lesion characteristics (all p < 0.05). ConclusionsVessel- and lesion-level hemodynamic characteristics, and vessel-level plaque quantity, and lesion-level plaque compositional characteristics assessed by CTA offer independent and additive long-term prognostic value.

Clinical Implications of Fractional Flow Reserve Measured Immediately After Percutaneous Coronary Intervention.

The purpose of the present study was to find the independent predictors of Fractional Flow Reserve (FFR) measured immediately after percutaneous coronary intervention with drug-eluting stent implantation (post-PCI FFR) and investigate if applying vessel-specific post-PCI FFR cut-off values to predict target vessel failure (TVF), a composite of cardiac death (CD), non-fatal myocardial infarction (MI) and target vessel revascularization (TVR), or a composite of CD and MI ameliorated its predictive power. Consecutive patients with post-PCI FFR measurement at our center between 2009 and 2021 were included in this analysis. A total of 434 patients with 500 vessels were included. Median pre-PCI FFR was 0.72 with no difference between LAD and non-LAD vessels. Median post-PCI FFR was 0.87. LAD location, male gender, smaller stent diameter, and lower pre-PCI FFR proved to be significant predictors of a lower post-PCI FFR. On a vessel-level, post-PCI FFR, stent length, and diabetes mellitus proved to be significant predictors of TVF and the composite of CD and MI. The best post-PCI FFR cut-off to predict TVF or a composite of CD and MI was 0.83 in the LAD and 0.91 in non-LAD vessels. LAD location is a predictor of a lower post-PCI FFR. Post-PCI FFR is an independent predictor of TVF as well as of the composite of CD and MI. No uniform target post-PCI FFR value exists; different cut-off values may have to be applied in LAD as opposed to non-LAD vessels.

Clinical Outcome of FFR-Guided Revascularization Strategy of Coronary Lesions: The HALE-BOPP Study.

Recently, questions around the efficacy and effectiveness of Fractional Flow Reserve (FFR) have arisen in various clinical settings. The Clinical Outcome of FFR-guided Revascularization Strategy of Coronary Lesions (HALE-BOPP) study is an investigator-initiated, multicentre, international prospective study enrolling patients who underwent FFR measurement on at least one vessel. In accordance with the decision-making workflow and treatment, the vessels were classified in three subgroups: (i) angio-revascularized, (ii) FFR-revascularized, (iii) FFR-deferred. The primary endpoint was the occurrence of target vessel failure (TVF, cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization). The analysis was carried out at vessel- and patient-level. 1305 patients with 2422 diseased vessels fulfilled the criteria for the present analysis. Wire-related pitfalls and transient adenosine-related side effects occurred in 0.8% (95% CI: 0.4%-1.4%) and 3.3% (95% CI: 2.5%-4.3%) of cases, respectively. In FFR-deferred vessels, the overall incidence rate of TVF was 0.024 (95% CI: 0.019-0.031) lesion/year. After a median follow-up of 3.6 years, the occurrence of TVF was 6%, 7% and 11.7% in FFR-deferred, FFR-revascularized and angio-revascularized vessels, respectively. Compared to angio-revascularized vessels, FFR-guided vessels (both FFR-revascularized and FFR-deferred vessels) showed a lower TVF incidence rate lesion/year (0.029, 95% CI: 0.024-0.034 vs. 0.049, 95% CI: 0.040-0.061 respectively, p = 0.0001). The result was consistent after correction for confounding factors and across subgroups of clinical interest. The patient-level analysis confirmed the lower occurrence of TVF in negative-FFR vs. positive-FFR subgroups. In a large prospective observational study, an FFR-based strategy for the deferral of coronary lesions is a reliable and safe tool, associated with good outcomes. NCT03079739.

Impact of Endothelial Dysfunction on Long-Term Clinical Outcomes in Patients With Chronic Coronary Syndromes Treated With Second Generation Drug-Eluting Stent Implantation

BackgroundStudies investigating clinical outcomes of patients with or without endothelial disfunction (ED) treated with percutaneous coronary intervention (PCI) for stable coronary artery disease (CAD) using second generation drug eluting stents (DES) are lacking. MethodsWe prospectively collected data from 109 patients undergoing PCI with second generation DES due to stable CAD between December 2014 and September 2016. ED was evaluated evaluating the flow mediated dilation (FMD) at the brachial artery level and defined by an FMD < 7 %. Primary outcome were major adverse cardiovascular events (MACE), secondary outcomes were target vessel failure (TVR), myocardial infarction (MI) and all-cause death. ResultsFive-year follow-up was available in all patients. Median FMD didn't significantly differ between patients who experienced the outcome and those who didn't [no TVR vs. TVR: p = 0.358; no MI vs. MI: p = 0.157; no death vs. death: p = 0.355; no MACE vs. MACE: p = 0.805]. No association between ED and an increased risk for the primary outcome as well as for the secondary ones was evident [MACE: 17.0 % vs. 14.3 %, HR 0.87 (0.33–2.26), log rank p = 0.780; TVR: 9.4 % vs. 5.4 %, HR 0.53 (0.12–2.24), log rank p = 0.384; MI: 3.7 % vs. 8.9 %, HR 2.46 (0.47–12.76), log rank p = 0.265; death: 7.5 % vs. 3.6 %, HR 0.53 (0.09–2.90), log rank p = 0.458]. These findings were confirmed using a lower threshold of FMD to define ED and at one-year landmark analysis. ConclusionsED is not associated with an increased risk of adverse events at long-term follow-up in a contemporary cohort of patients undergoing PCI with second generation DES.

Outcomes of Percutaneous Coronary Interventions for Long Diffuse Coronary Artery Disease with Extremely Small Diameter

The optimal percutaneous coronary intervention (PCI) strategy and clinical outcomes of long lesions with an extremely small residual lumen remain unclear. This study aimed to assess the efficacy of a modified stenting strategy for diffuse coronary artery disease (CAD) with an extremely small distal residual lumen. 736 Patients who received PCI using second-generation drug-eluting stents (DES) ≥38 mm long were retrospectively included and categorized into an extremely small distal vessel (ESDV) group (≤2.0 mm) and a non-ESDV group (>2.0 mm) according to the maximal luminal diameter of the distal vessel (dsDMax). A modified stenting technique was applied by landing an oversized DES in the distal segment with the largest luminal diameter and maintaining the distal stent edge partially expanded. The mean dsDMax and stent lengths were 1.7 ± 0.3 mm and 62.6 ± 18.1 mm in the ESDV group and 2.7 ± 0.5 mm and 59.1 ± 16.0 mm in non-ESDV groups, respectively. The acute procedural success rate was high in both the ESDV and non-ESDV groups (95.8% and 96.5%, p = 0.70) with rare distal dissection (0.3% and 0.5%, p = 1.00). The target vessel failure (TVF) rate was 16.3% in the ESDV group and 12.1% in the non-ESDV group at a median follow-up of 65 months without significant differences after propensity score matching. PCI using contemporary DES with this modified stenting technique is effective and safe for diffuse CAD with extremely small distal vessels.

The standard versus prolonged dual antiplatelet therapy after the XINSORB bioresorbable scaffold implantation (SPARTA) trial: study protocol for a randomized controlled trial

BackgroundDual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is the standard of care after coronary stenting, including coronary stenting involving bioresorbable scaffolds (BRSs). Current clinical guidelines recommend at least 12 months of DAPT after BRS implantation. However, the correlation between prolonged DAPT and net clinical benefits remains unknown.MethodsThe SPARTA trial is designed to be a prospective, randomized, parallel-group, clinical trial. It aims to compare the benefits and risks of DAPT applied for either 12 or 36 months after XINSORB BRS implantation. The primary endpoints are the incidence of the composite endpoint of major adverse cardiac events (MACEs), including all-cause death, any myocardial infarction (MI), and all revascularizations, as well as Bleeding Academic Research Consortium Definition (BARC) type 3 or 5 bleeding events. The secondary endpoints of the study include the device-oriented composite endpoint of target lesion failure (defined as cardiac death, target vessel-related MI, or ischemia-driven target lesion revascularization), target vessel failure (defined as cardiac death, MI, or ischemia-driven target vessel revascularization), scaffold thrombosis, and minor bleeding events. This trial will enroll 2106 subjects treated with the XINSORB BRS only. All subjects will receive DAPT after the index procedure for 12 (± 1) months. Subjects without MACEs or major bleeding will be randomized to receive either 24 additional months of DAPT or aspirin alone.DiscussionThis trial is designed to investigate the impact of extending the duration of DAPT up to 3 years after XINSORB BRS implantation by investigating the balance of risks and benefits in a broad population of treated patients.Trial registrationClinicalTrials.gov NCT04501900. Registered on 6 August 2020.

Abnormal physiological findings after FFR-based revascularisation deferral are associated with worse prognosis in women

The prognostic value of abnormal resting Pd/Pa and coronary flow reserve (CFR) after fractional flow reserve (FFR)-guided revascularisation deferral according to sex remains unknown. From the ILIAS Registry composed of 20 hospitals globally from 7 countries, patients with deferred lesions following FFR assessment (FFR > 0.8) were included. (NCT 04485234) The primary clinical endpoint was target vessel failure (TVF) at 2-years follow-up. We included 1392 patients with 1759 vessels (n = 564 women, 31.9%). Although resting Pd/Pa was similar between the sexes (p = 0.116), women had lower CFR than men (2.5 [2.0–3.2] vs. 2.7 [2.1–3.5]; p = 0.004). During a 2-year follow-up period, TVF events occurred in 56 vessels (3.2%). The risk of 2-year TVF was significantly higher in women with low versus high resting Pd/Pa (HR: 9.79; p < 0.001), whereas this trend was not seen in men. (Sex: P-value for interaction = 0.022) Furthermore, resting Pd/Pa provided an incremental prognostic value for 2-year TVF over CFR assessment only in women. After FFR-based revascularisation deferral, low resting Pd/Pa is associated with higher risk of TVF in women, but not in men. The predictive value of Pd/Pa increases when stratified according to CFR values, with significantly high TVF rates in women in whom both indices are concordantly abnormal.Clinical Trial Registration: Inclusive Invasive Physiological Assessment in Angina Syndromes Registry (ILIAS Registry), NCT04485234.

Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: Design and rationale of the SELUTION DeNovo Trial

Drug eluting stents (DES) are associated with a 2% to 4% annual rate of target lesion failure through 5-to-10-year follow-up. The presence of a metallic protheses is a trigger for neo-atherosclerosis and very late stent thrombosis. A "leave nothing behind" strategy using Drug Coated Balloons has been suggested; however, paclitaxel coated balloons are only recommended in selected indications. Recently a novel sirolimus eluting balloon, the SELUTION SLR TM 014 PTCA balloon (SEB) (M.A. MedAlliance SA, Nyon, Switzerland) has been developed. A strategy of percutaneous coronary intervention (PCI) with SEB and provisional DES is non-inferior to a strategy of systematic DES on target vessel failure (TVF) at one and five years. If non-inferiority is met at 5 years, superiority will be tested. SELUTION DeNovo is a multi-center international open-label randomized trial. Subjects meeting eligibility criteria are randomized 1:1 to treatment of all lesions with either SEB and provisional DES or systematic DES. Major inclusion criteria are PCI indicated for ≥1 lesion considered suitable for treatment by either SEB or DES and clinical presentation with chronic coronary syndrome, unstable angina or non-ST segment elevation myocardial infarction (NSTEMI). There is no limitation in the number of lesions to be treated. Target lesions diameters are between 2 and 5 mm. Major exclusion criteria are lesions in the left main artery, chronic total occlusions, ST segment elevation myocardial infarction and unstable non-ST segment elevation myocardial infarction. Three thousand three hundred twenty six patients will be included in 50 sites in Europe and Asia. TVF rates and their components will be determined at 30 days, 6 months and annually up to 5 years post-intervention. Among secondary endpoints, bleeding events, cost-effectiveness data and net clinical benefits will be assessed. SELUTION DeNovo trial is an open-label, multi-center international randomized trial comparing a strategy of PCI with SEB and provisional DES to a strategy of PCI with systematic DES on TVF at one and five years. Non-inferiority will be tested at one and five years. If non-inferiority is met at five years, superiority will be tested.

Impact of core laboratory assessment on treatment decisions and clinical outcomes using combined fractional flow reserve and coronary flow reserve measurements – DEFINE-FLOW core laboratory sub-study

ObjectiveThe role of combined FFR/CFR measurements in decision-making on coronary revascularization remains unclear. DEFINE-FLOW prospectively assessed the relationship of FFR/CFR agreement with 2-year major adverse cardiac event (MACE) and target vessel failure (TVF) rates, and uniquely included core-laboratory analysis of all pressure and flow tracings. We aimed to document the impact of core-laboratory analysis on lesion classification, and the relationship between core-laboratory fractional flow reserve (FFR) and coronary flow reserve (CFR) values with clinical outcomes and angina burden during follow-up. MethodsIn 398 vessels (348 patients) considered for intervention, ≥1 coronary pressure/flow tracing was approved by the core-laboratory. Revascularization was performed only when both FFR(≤0.80) and CFR(<2.0) were abnormal, all others were treated medically. ResultsMACE was lowest for concordant normal FFR/CFR, but was not significantly different compared with either discordant group (low FFR/normal CFR: HR:1.63; 95%CI:0.61–4.40; P = 0.33; normal FFR/low CFR: HR:1.81; 95%CI:0.66–4.98; P = 0.25). Moreover, MACE did not differ between discordant groups treated medically and the concordant abnormal group undergoing revascularization (normal FFR/low CFR: HR:0.63; 95%CI:0.23–1.73;P = 0.37; normal FFR/low CFR: HR:0.70; 95%CI:0.22–2.21;P = 0.54). Similar findings applied to TVF. ConclusionsPatients with concordantly normal FFR/CFR have very low 2-year MACE and TVF rates. Throughout follow-up, there were no differences in event rates between patients in whom revascularization was deferred due to preserved CFR despite reduced FFR, and those in whom PCI was performed due to concordantly low FFR and CFR. These findings question the need for routine revascularization in vessels showing low FFR but preserved CFR.Clinical trial registration: http://ClinicalTrials.govNCT02328820

Two Years Follow-Up Outcome of Synergy™ Coronary Stent: Comparison between Case Control Study-Oriented Definition/Criterion and Real-World Results

Objectives: To clarify the 2 years outcome of Bioabsorbable Polymer Everolimus-Eluting Stent (BP-EES) using several criteria/definitions. Previous reports have showed worse outcomes in Real-World (RW) setting than case-Controlled Clinical trials (CC). Methods and Materials: We studied consecutive patients who received BP-EES implantation from October 2017 through January 2018. We adopted the parameters used in previous BP-EES associated CC (SYNERGY, EVOLVE), compared the CC inclusion criteria (on-label) with others (offlabel) at 2 years follow-up. Results: There were 678 BP-EESs inserted in 437 patients (283 male, mean age 72.3±11.2 years). Data from 4 patients lacked, and therefore the follow-up rate was 99.1%. There were 381 patients (87.2%) satisfying the CC criteria. Male gender, ejection fraction &lt;40%, smoker, multiple stenting, total stent length, target vessel failure and all death was higher in the off-label group (P&lt;0.05). Regarding revascularization- related parameters (all target lesion/non-target lesion revascularization), there was no difference between the 2 groups (TLR 6.1% vs 3.6%, non-TL TVR 5.6% vs 10.9%; CC vs off-label, p=ns, respectively). On the other hand, comparison of TLR using the CC definition (ischemia-oriented TLR) and real-world definition (any TLR) showed approximately 2-3 times higher frequency in the real-world basis (1.6% vs 5.8% per patient basis and 2.1%vs 5.8% per stent basis). Conclusions: Different definitions for repeat angioplasty among the reports may be a key cause of the discrepancy in revascularization frequency in dug-eluting stent studies, and it is the different inclusion criteria among studies that are associated with patient vulnerability.

Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice.

The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patient-oriented composite outcome (POCO) at 2 years. Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group. Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel. Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487-3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663-3.012, P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES. ClinicalTrials.gov Identifier: NCT02601404, NCT04265443.

29 PROGNOSTIC IMPACT OF TARGET VESSEL FAILURE AS FIRST EVENT AFTER ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: INSIGHT FORM 10-YEAR FOLLOW-UP OF THE EXAMINATION EXTEND TRIAL

Abstract Background Outcome after primary PCI for ST-segment elevation myocardial infarction may be very different. Either it may be free of events during years or it may be characterized by many recurrent events. It is unknown whether to have a target vessel failure (TVF) as first event may impact subsequent outcomes during follow-up. We aim to evaluate very long-term outcomes of STEMI patients according to the occurrence of TVF as the first event during follow-up. Methods EXAMINATION-EXTEND trial randomized STEMI patients to everolimus-eluting stent or bare-metal stent with 10-year follow-up. All the patients were stratified according to their first event (TVF-First vs. NonTVF-First). TVF was defined as the composite of TV cardiac death, TV myocardial infarction, or TV revascularization. The primary endpoint of this study was 10-year POCE, defined as the composite of all-cause death, any myocardial infarction, or any revascularization. Results Out of the 1498 enrolled patients, 161 (10.7%) had a TVF as first clinical event during follow-up. TVF-First patients had higher rates of previous MI or PCI, with less use of manual thrombectomy, and received more BMS with a longer total stent length. On multivariate analysis, manual thrombectomy and bare-metal stent implantation were independent predictors of TVF as first event. Ten-year adjusted POCE was statistically higher in TVF-First patients compared to the NonTVF-First group (31.1% vs 27.5%, adjHR: 1.82; 95%CI: 1.34 - 2.48; p &amp;lt; 0.001). Conclusions In our STEMI population TVF occurred in 10.7% as the first event during follow-up. At 10-year follow-up, patients who experienced a TVF as first event exhibited a high risk for subsequent POCE events as compared to patients who did not.

1140 CLINICAL OUTCOME OF FRACTIONAL FLOW RESERVE GUIDED REVASCULARIZATION STRATEGY OF CORONARY LESIONS: THE HALE-BOPP STUDY

Abstract Background There are currently some doubts about the efficacy of fractional flow reserve (FFR)-guided revascularization in different clinical settings. Aim To evaluate the long-term outcome of an FFR-deferred strategy in daily practice. Methods The Clinical Outcome of FFR-guided Revascularization Strategy of Coronary Lesions (HALE-BOPP) is an investigator-initiated, multicenter, international prospective study consecutively enrolling patients who underwent FFR measurement on at least one vessel. According to decision-making workflow and treatment, vessels were classified in three subgroups: i) angio-revascularized, ii) FFR-revascularized, iii) FFR-deferred. The primary endpoint was the occurrence of target vessel failure (TVF, cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization). The analysis is carried out at vessel- and patient-level. Results Overall, 1305 patients with 2422 diseased vessels fulfilled criteria for the present analysis. Wire-related pitfalls and transient adenosine-related side effects occurred in 0.8% (95%CI 0.4%-0.1%) and 3.3% (95% 2.5%-4.3%) of cases, respectively. In FFR-deferred vessels the overall incidence rate of TVF was 0.024% (95%CI 0.019-0.031) lesion/year. After a median follow-up of 3.5 years, the occurrence of TVF was 6%, 7% and 11.7% in FFR-deferred, FFR-revascularized and angio-revascularized vessels, respectively. As compared to angio-revascularized vessels, FFR-guided vessels (both FFR-revascularized and FFR-deferred vessels) showed a lower TVF incidence rate lesion/year (0.029, 95%CI 0.024-0.034 vs. 0.049, 95%CI 0.040-0.061 respectively, p= 0.0001). This was consistent after correction for confounding factors and across subgroups of clinical interest. Patient-level analysis confirmed the lower occurrence of TVF in negative-FFR vs. positive-FFR subgroups. Conclusions In a large prospective observational study, FFR-based strategy for the deferral of coronary lesions is reliable and safe and associated with good long-term outcome.

Intravascular Ultrasound Guidance Is Associated with a Favorable One-Year Target Vessel Failure Rate and No Residual Myocardial Ischemia after the Percutaneous Treatment of Very Long Coronary Artery Lesions.

Background: Studies have shown that percutaneous coronary intervention (PCI) in long coronary artery lesions (≥30 mm) is associated with more frequent target vessel failure (TVF), and a significant proportion of patients have lesions that continue to induce ischemia after PCI (FFR ≤ 0.8). We investigated the impact of intravascular ultrasound (IVUS) on the functional PCI result and one-year TVF rate after the percutaneous treatment of long coronary artery lesions. Methods: A total of 80 patients underwent IVUS-guided PCI in long coronary artery lesions. The PCI results were validated with IVUS and FFR. Procedural outcomes were the proportion of patients with: (1) optimal physiology result (post PCI FFR value ≥ 0.9); (2) optimal anatomy result (all IVUS PCI optimization criteria met); and (3) optimal physiology and anatomy result. The clinical outcome was TVF during a one-year follow-up (target vessel (TV)-related death, TV myocardial infarction, ischemia-driven TV revascularization). Results: The mean stented segment length was 62 mm. The target vessel (TV) was the left anterior descending artery in 82.5% of cases. There were no patients with residual ischemia (FFR ≤ 0.8) after PCI. Optimal coronary flow (FFR ≥ 0.9) was achieved in 37.5%; optimal anatomy, as assessed by IVUS, was achieved in 68.4%; and both optimal flow and anatomy were achieved in 25% of patients. Target vessel failure during the 12-month follow-up was 2.5%. Conclusions: In the percutaneous treatment of very long coronary artery lesions, the use of IVUS guidance is associated with a low TVF rate during a one-year follow-up and no residual myocardial ischemia, as assessed by FFR.

Percutaneous coronary intervention of native coronary artery versus saphenous vein graft in patients with prior coronary artery bypass graft surgery: Rationale and design of the multicenter, randomized PROCTOR trial

Patients with prior coronary artery bypass grafting (CABG) frequently require repeat percutaneous revascularization due to advanced age, progressive coronary artery disease and bypass graft failure. Percutaneous coronary intervention (PCI) of either the bypass graft or the native coronary artery may be performed. Randomized trials comparing native vessel PCI with bypass graft PCI are lacking and long-term outcomes have not been reported. PROCTOR (NCT03805048) is a prospective, multicenter, randomized controlled trial, that will include 584 patients presenting with saphenous vein graft (SVG) failure and a clinical indication for revascularization, as determined by the local Heart Team. The trial is designed to compare the clinical and angiographic outcomes in patients randomly allocated in a 1:1 fashion to either a strategy of native vessel PCI or SVG PCI. The primary study endpoint is a 3-year composite of major adverse cardiac events (MACE: all-cause mortality, non-fatal target coronary territory myocardial infarction [MI], or clinically driven target coronary territory revascularization). At 3-years, after evaluation of the primary endpoint, follow-up invasive coronary angiography will be performed. Secondary endpoints comprise individual components of MACE at 1, 3 and 5 years follow-up, PCI-related MI, MI >48 hours after index PCI, target vessel failure, target lesion revascularization, renal failure requiring renal-replacement therapy, angiographic outcomes at 3-years and quality of life (delta Seattle Angina Questionnaire, Canadian Cardiovascular Society Grading Scale and Rose Dyspnea Scale). PROCTOR is the first randomized trial comparing an invasive strategy of native coronary artery PCI with SVG PCI in post-CABG patients presenting with SVG failure.

Combined use of hyperemic and non-hyperemic pressure ratios for revascularization decision-making: From the ILIAS registry

ObjectiveThe aim of this study is to evaluate the diagnostic and prognostic value of non-hyperaemic Pd/Pa and to determine its additional value when combined with the gold standard hyperaemic pressure ratio (FFR) to guide revascularization. MethodsIn a large, multi-center, retrospective registry, we included a total of 2141 patients with a clinical indication for coronary angiography providing physiological data in 2726 vessels. A classification was made based on the FFR (cut-off value: 0.80) and non-hyperaemic Pd/Pa (cut-off value: 0.92) values and the primary outcome was target-vessel failure (TVF) at 5-year follow-up. ResultsMean age was 63 ± 10.0 and 75% of the study population were men. Regression analysis showed an overall good correlation between FFR and non-hyperaemic Pd/Pa (r = 0.73, p < 0.005) and discordance was present in 17% of the vessels. Resting Pd/Pa was independently associated with TVF at 5-year follow-up (HR 0.08, 95%CI: 0.02–0.27; p < 0.005). The risk for TVF was the lowest in vessles with concordant normal pressure ratio's, with the highest risk in vessels with any abnormal pressure ratio in which revascularization was deferred. In these vessels, there was no difference in risk for TVF between the discordant and concordant abnormal values. ConclusionAbnormal pressure ratios in both non-hyperemic and hyperemic conditions portend important prognostic value. Combined application of FFR and non-hyperemic Pd/Pa efficiently identifies those vessels with concordant normal resting and hyperemic pressure ratios of which long-term clinical outcomes are excellent. These data lead to hypothesize that the decision to defer revascularization should potentially be based on combined non-hyperemic and hyperemic pressure ratios. Clinical trial registrationInclusive Invasive Physiological Assessment in Angina Syndromes Registry (ILIAS Registry), NCT04485234

Impact of Sex on Clinical Outcomes in Patients undergoing Complex Percutaneous Coronary Angioplasty (from the e-ULTIMASTER Study)

Female gender has been shown to be associated with worse clinical outcomes after percutaneous coronary intervention (PCI). However, the impact of gender on the clinical outcomes of complex PCI is still poorly understood. This study examined the differences in patient and coronary lesion characteristics and longer-term clinical outcomes in male and female patients who underwent complex PCI. This was a sub-analysis of the e-ULTIMASTER study, which was a large, multicontinental, prospective, observational study enrolling 37,198 patients who underwent PCI with the Ultimaster stent. Patients who underwent complex PCI were stratified by gender. The primary outcome was target lesion failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target lesion revascularization at 12 months. A total of 13,623 patients underwent complex procedures, of which 35.7% were women. Women were twice as likely as men to be aged ≥80 years (17.6% vs 9%, p <0.0001) and had a higher prevalence of cardiovascular risk factors. Women had fewer lesions treated than men (1.5 ± 0.8 vs 1.6 ± 0.8, p <0.0001) and fewer stents implanted (2.0 ± 1.1 vs 2.1 ± 1.1, p <0.0001). There was no statistically significant difference in clinical outcomes at 12 months between women and men. Event rates were comparable in women and men for target lesion failure (4.7% vs 4.3%, p=0.30), target vessel failure (5.1% vs 4.9%, p=0.73), and cardiac death (1.8% vs 1.7%, p=0.80).In conclusion, our findings suggest no significant differences in clinical outcomes between women and men who underwent complex PCI.

Trans-Stent FFR Gradient as a Modifiable Integrant in Predicting Long-Term Target Vessel Failure

BackgroundFractional flow reserve (FFR) after percutaneous coronary intervention (PCI) is associated with long-term outcomes. Data relating FFR-based trans-stent gradient (TSG) after PCI to long-term outcomes are sparse. ObjectivesThe aim of this study was to test whether TSG is associated with adverse events at follow-up after PCI. MethodsData were gathered from a prospective registry evaluating 501 vessels in 416 patients with median follow-up period of 596 days. Primary endpoints were: 1) target vessel failure (TVF), including target vessel revascularization, and target vessel myocardial infarction after discharge; and 2) major adverse cardiac events (MACE) including TVF, target vessel revascularization, nontarget vessel MI, cardiac death. ResultsAfter PCI, median post-PCI FFR was 0.86 and median TSG was 0.04. TSG >0.04 was associated with increased rates of TVF (8.7% vs 2.9%; P = 0.014) and MACE (17.8% vs 9.2%; P = 0.02). Post-PCI FFR < 0.86 was associated with increased rates of TVF (6.1% vs 2.2%; P = 0.03) and MACE (16.5% vs 10%; P = 0.036). The vessel subgroup with high TSG and low FFR had significantly higher rates of TVF (10.2%; P = 0.02) and MACE (20.1%; P = 0.049) than vessels with: 1) high TSG and high FFR (TVF, 2.9%; MACE, 9.7%); 2) low TSG and low FFR (TVF, 3.8%; MACE, 11.3%); and 3) low TSG high FFR (TVF, 2.2%; MACE, 7.5%). In multivariate analysis, TSG was independently predictive of TVF. ConclusionsHigher TSG was an independent predictor of adverse events, particularly TVF, and identified a subgroup of patients at higher risk for poor outcomes. The combination of high TSG and low FFR showed significantly worse outcomes compared with an “ideal result” (high FFR and low TSG). These data support a recommendation to use TSG during FFR evaluation to determine the functional success of PCI.

Clinical Relevance of Impaired Physiological Assessment After Percutaneous Coronary Intervention: A Meta-analysis.

Despite the optimal angiographic result of percutaneous coronary intervention (PCI), residual disease at the site of the culprit lesion can lead to major adverse cardiac events. Post-PCI physiological assessment can identify residual stenosis. This meta-analysis aims to investigate data of studies examining post-PCI physiological assessment in relation to long-term outcomes. Studies were included in the meta-analysis after performing a systematic literature search on July 1, 2022. The primary end point was the incidence of major adverse cardiac events, vessel-orientated cardiac events, or target vessel failure. Low post-PCI fractional flow reserve, reported in 7 studies with fractional flow reserve cutoff values between 0.84 and 0.90, including 4017 patients, was associated with an increased rate of the primary end point (hazard ratio [HR], 2.06; 95% CI, 1.37-3.08). One study reported about impaired post-PCI instantaneous wave-free ratio with instantaneous wave-free ratio cutoff value of 0.95 in relation to major adverse cardiac events, showing a significant association (HR, 3.38; 95% CI, 0.99-11.6; P = .04). Low post-PCI quantitative flow ratio, reported in 3 studies with quantitative flow ratio cutoff value between 0.89 and 0.91, including 1181 patients, was associated with an increased rate of vessel-orientated cardiac events (HR, 3.01; 95% CI, 2.10-4.32). Combining data of all modalities, impaired physiological assessment showed an increased rate of the primary end point (HR, 2.32; 95% CI, 1.71-3.16) and secondary end points, including death (HR, 1.41; 95% CI, 1.04-1.89), myocardial infarction (HR, 2.70; 95% CI, 1.34-5.42) and target vessel revascularization (HR, 2.88; 95% CI, 1.91-4.35). Impaired post-PCI physiological assessment is associated with increased adverse cardiac events and individual end points, including death, myocardial infarction, and target vessel revascularization. Therefore, prospective studies are awaited on whether physiology-based optimization of PCI results in better clinical outcomes.