Ischemia-driven Target Vessel Revascularization Research Articles

Impact of Relative Improvement in Quantitative Flow Ratio on Clinical Outcomes After Percutaneous Coronary Intervention - A Subanalysis of the PANDA III Trial.

The clinical impact of relative improvements in coronary physiology in patients receiving percutaneous coronary intervention (PCI) for coronary artery disease (CAD) remains undetermined.Methods and Results: The quantitative flow ratio (QFR) recovery ratio (QRR) was calculated in 1,424 vessels in the PANDA III trial as (post-PCI QFR-pre-PCI QFR)/(1-pre-PCI QFR). The primary endpoint was the 2-year vessel-oriented composite endpoint (VOCE; a composite of vessel-related cardiac death, vessel-related non-procedural myocardial infarction, and ischemia-driven target vessel revascularization). Study vessels were dichotomously stratified according to the optimal QRR cut-off value. During the 2-year follow-up, 41 (2.9%) VOCEs occurred. Low (<0.86) QRR was associated with significantly higher rates of 2-year VOCEs than high (≥0.86) QRR (6.6% vs. 1.4%; adjusted hazard ratio [aHR] 5.05; 95% confidence interval [CI] 2.53-10.08; P<0.001). Notably, among vessels with satisfactory post-procedural physiological results (post-PCI QFR >0.89), low QRR also conferred an increased risk of 2-year VOCEs (3.7% vs. 1.4%; aHR 3.01; 95% CI 1.30-6.94; P=0.010). Significantly better discriminant and reclassification performance was observed after integrating risk stratification by QRR and post-PCI QFR to clinical risk factors (area under the curve 0.80 vs. 0.71 [P=0.010]; integrated discrimination improvement 0.05 [P<0.001]; net reclassification index 0.64 [P<0.001]). Relative improvement of coronary physiology assessed by QRR showed applicability in prognostication. Categorical classification of coronary physiology could provide information for risk stratification of CAD patients.

A simple angio-based coronary flow assessment of culprit vessels in primary percutaneous coronary intervention is associated with long-term prognosis after ST-segment-elevation myocardial infarction

BackgroundDespite prompt reperfusion, the risk of adverse clinical outcomes following ST-segment-elevation myocardial infarction (STEMI) remains pronounced, owing partly to suboptimal reperfusion. However, coronary functional evaluation is seldom feasible during primary percutaneous coronary intervention (PPCI). We aimed to examine the clinical implication of a simple coronary assessment based on single-angiographic view (μQFR) during PPCI in discriminating impaired coronary flow and adverse outcomes for STEMI. MethodsSTEMI Patients undergoing successful PPCI were enrolled and followed up prospectively from 4 medical centers in China. Post-PPCI μQFR of culprit vessels were analyzed. The primary outcome was major adverse cardiovascular events (MACE), defined as a composite of cardiac death, non-fatal MI, ischemia-driven target-vessel revascularization and readmission for heart failure. ResultsA total of 570 patients with STEMI were enrolled, and post-PCI μQFR was analyzable in 557 (97.7%) patients, with a median of 0.94. Patients with low post-PCI μQFR showed higher incidence of adverse outcomes than those with high μQFR, showing a 2.5-fold increase in the risk for MACE (hazard ratio: 2.51, 95% confidence intervals: 1.33 to 4.72; P = 0.004). Moreover, post-PCI μQFR significantly increased discriminant ability for the occurrence of MACE when added to traditional GRACE risk score for STEMI (integrated discrimination improvement: 0.029; net reclassification index: 0.229; P < 0.05). ConclusionsA low μQFR of culprit vessel in PPCI is independently associated with worse clinical outcomes in patients with STEMI. The single-angiographic-view-based coronary evaluation is a feasible tool for discriminating poor prognosis and could serve as a valuable complement in risk stratification for STEMI.

OCT-Guided vs Angiography-Guided Coronary Stent Implantation in Complex Lesions: An ILUMIEN IV Substudy

BackgroundILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided vs angiography-guided stent implantation in patients with high-risk clinical characteristics and/or complex angiographic lesions. ObjectivesThe authors aimed to specifically examine outcomes in the complex angiographic lesions subgroup. MethodsFrom the original trial population (N = 2,487), high-risk patients without complex angiographic lesions were excluded (n = 514). Complex angiographic lesion characteristics included: 1) long or multiple lesions with intended total stent length ≥28 mm; 2) bifurcation lesion with intended 2-stent strategy; 3) severely calcified lesion; 4) chronic total occlusion; or 5) in-stent restenosis. The study endpoints were: 1) final minimal stent area (MSA); 2) 2-year composite of serious major adverse cardiovascular events (MACEs) (cardiac death, target-vessel myocardial infarction [MI], or stent thrombosis); and 3) 2-year effectiveness, defined as target-vessel failure (TVF), a composite of cardiac death, target-vessel MI, or ischemia-driven target-vessel revascularization. ResultsThe postpercutaneous coronary intervention (PCI) MSA was larger in the OCT-guided (n = 992) vs angiography-guided (n = 981) group (5.56 ± 1.95 mm2 vs 5.26 ± 1.81 mm2; difference, 0.30; 95% CI: 0.14-0.47; P < 0.001). Compared with angiography-guided PCI, OCT-guided PCI resulted in a lower risk of serious MACE (3.1% vs 4.9%; HR: 0.63; 95% CI: 0.40-0.99; P = 0.04). TVF was not significantly different between groups (7.3% vs 8.8%; HR: 0.82; 95% CI: 0.59-1.12; P = 0.20). ConclusionsIn complex angiographic lesions, OCT-guided PCI led to a larger MSA and reduced the serious MACE, the composite of cardiac death, target-vessel MI, or stent thrombosis, compared with angiography-guided PCI at 2 years, but did not significantly improve TVF. (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in PCI; NCT03507777)

SYNERGY—Everolimus-Eluting Stent With a Bioabsorbable Polymer in ST-Elevation Myocardial Infarction: CLEAR SYNERGY OASIS-9 Registry

Our objective was to evaluate the clinical effectiveness of the SYNERGY stent in patients with ST elevation myocardial infarction (STEMI). The only drug eluting stent approved for treatment of STEMI by the FDA is the Taxus stent which is no longer commercially available, so further data are needed. The CLEAR SYNERGY stent registry was embedded into a larger randomized trial of patients with STEMI (N=7000), comparing colchicine vs. placebo and spironolactone vs. placebo. The primary outcome for the SYNERGY stent registry is major adverse cardiac events (MACE) as defined by cardiovascular death, recurrent MI, or unplanned ischemia driven target vessel revascularization (TVR) within 12 months. We estimated a MACE rate of 6.3% at 12 months after primary percutaneous coronary intervention (PPCI) for STEMI based on the TOTAL trial. Success was defined as upper bound of confidence interval (CI) to be less than the performance goal of 9.45%.Overall, 733 patients were enrolled from 8 countries with a mean age 60.2 years, 19% diabetes, 41.3% anterior MI and median door to balloon time of 72 minutes. The MACE rate was 4.8% (95% CI 3.2-6.3%) at 12 months which met the success criteria against performance goal of 9.45%. The rates of cardiovascular death, recurrent MI or TVR were 2.7%, 1.9%, 1.0% respectively. The rates of acute definite stent thrombosis were 0.3%, subacute 0.4%, late 0.4% and cumulative stent thrombosis of 1.1% at 12 months. In conclusion, the SYNERGY stent in STEMI performed well and was successful compared to the performance goal based on prior trials.Trial Registration: ClinicalTrials.gov Identifier: NCT03048825

Vessel-oriented cardiovascular events in patients with diabetes undergoing intracoronary physiology-guided revascularization

Abstract Background The safety of intracoronary physiology guided coronary revascularization in patients with diabetes mellitus is not well established. Purpose The aim of this work is to assess the risk of vessel oriented cardiovascular events (VOCE) in patients with and without diabetes mellitus (DM) who underwent physiology-guided coronary revascularization. Moreover, we sought to identify clinical features associated with increased risk of adverse outcomes among patients with DM particularly when coronary intervention was deferred based on intracoronary functional assessment. Methods This is a retrospective analysis of a multicenter registry of patients evaluated with fractional flow reserve and/or non-hyperaemic pressure ratio. The primary endpoint was a composite of VOCE including cardiac death, vessel-related myocardial infarction (MI), and ischemia-driven target vessel revascularization (TVR). Results A large cohort of 2828 patients and 3353 coronary lesions with and without DM was analysed to assess the risk of VOCE at long-term follow up (23, interquartile range 14-36 months). The primary endpoint occurred in 222 (6.6%) coronary lesions without difference between patients with and without DM (7.8% vs. 6.1%, P=0.078). Diabetes was not associated with the primary endpoint (adjusted hazard ratio, aHR, 1.20, 95% CI 0.89-1.61, P=0.226) or with its individual components. Conversely, insulin-dependent diabetes mellitus (IDDM) demonstrated an increased risk of VOCE (aHR 1.76, 95% CI 1.07-2.91, P=0.027). In particular, IDDM was independently associated with ischemia-driven TVR (aHR 2.13, 95% CI 1.22-3.72, P=0.008) but not with vessel-oriented MI and cardiac death. Myocardial revascularization was deferred in 2316 (69%) coronary lesions without difference between patients with and without DM (68.8% vs. 69.2%, P=0.820). In multivariable analysis, lesion localization in the proximal segment of the coronary artery (aHR 2.20, 95% CI 1.33-3.63, P=0.002), abnormal coronary physiology (aHR 5.95, 95% CI 2.27-15.59, P&amp;lt;0.0001) and IDDM (aHR 2.77, 95% CI 1.11-6.93, P=0.029) were independently associated with the risk of VOCE in the shared frailty Cox regression model. Conversely, overall DM was not associated with the primary endpoint (HR 1.39, 95% CI 0.98-1.98, P=0.069). Moreover, in patients with DM and deferred coronary lesions, lesion localization on the left anterior descending artery (aHR 3.13, 95%CI 1.31-7.51, P=0.010) and IDDM (aHR 2.47 95% CI 1.29-4.73, p=0.006) were associated with increased risk of VOCE after adjustment for clinical confounders. Conclusion Patients with non-IDDM and coronary lesions assessed with coronary physiology demonstrated low risk of VOCE at long-term follow up, similar to the risk of patients without DM. Conversely, IDDM represents a subgroup at high-risk of vessel-related adverse events and require close monitoring at follow up, even in presence of non-ischemic findings at coronary functional assessment.Overall cohortDeferred cohort

Patient-level outcomes of patients undergoing resorbable magnesium scaffold (RMS) implantation stratified according to different subgroups: a post-hoc analysis of SHERPA MAGIC study

Abstract Background The SHERPA-MAGIC is an investigator-driven, multicenter, prospective, single-arm study that enrolled patients undergoing resorbable magnesium scaffold (RMS) implantation in 18 Italian centers. The results from the first 543 patients supported the safety and long-term performance of RMS in a real-world population. Purpose The present post-hoc analysis aimed to assess differences in adverse events at patient-level (patient-oriented composite endpoints, POCE, defined as the composite of all-cause death, myocardial infarction -MI- and ischemia-driven coronary revascularization) at the longest follow-up between different subgroups of the final study population (n=543). Methods We identified the subgroups according to different variables: age, sex, cardiovascular risk factors, clinical presentation, left ventricle ejection fraction, multivessel disease, multivessel PCI, and antiplatelet therapy. If the analysis highlighted a subgroup of patients at higher risk of adverse events, to understand if this finding is related to RMS implantation or to the characteristic itself, a propensity score matched analysis was conducted comparing patients of the SHERPA-MAGIC study with a matched cohort of patients receiving second generation drug eluting stent. The endpoint for the comparison between the two matched cohorts was POCE. Results The mean age of the final study population was 56±9 years. 433 (78%) patients were men, and the most common clinical presentation was MI (n=402, 74%). At the median follow-up of 3.5 [2.6-4.3] years, the cumulative occurrence of the primary endpoint (vessel-oriented composite endpoints, VOCE, including cardiac death, target vessel MI, and ischemia-driven target vessel revascularization) was 37 (5.8%, 95%CI 4.1%-7.9%) and 54 (9.9%, 95% CI 7.5%-12.7%) patients met criteria for POCE. There was no significant difference among POCE in the subgroup analysis (Figure 1), with the exception of patients with MI as clinical presentation. As compared to patients admitted for chronic coronary syndrome, MI patients showed a significantly higher POCE rate (11.4 vs 5.6%, CI 8.5-14.9, p=0.04). Therefore, a propensity score matched analysis was conducted comparing MI patients of the SHERPA-MAGIC study with a matched cohort of MI patients from the Acute coRonary sYndrOmes proSpective regisTry Of Ferrara (ARYOSTO) study (NCT02438085) treated with second-generation DES. We did not find significant differences in the cumulative occurrence of POCE between SHERPA MAGIC and ARYOSTO (11.4% vs. 12.5% respectively, p=0.71) (Figure 2). Conclusions The present analysis confirmed the safety and effectiveness of RMS across several subgroups of patients stratified by clinical and procedural characteristics. We found that MI patients had an higher occurrence of POCE, but this was not related to RMS implantation. Indeed, a similar MI population treated with second generation DES showed the same long-term outcome.Fig 1POCE difference between subgroupsFig 2Propensity matched MI populations

Impact of Excessive Increase in Systolic Blood Pressure after Exercise on Clinical Outcomes in Patients with ST-Segment Elevation Myocardial Infarction.

Although the clinical outcomes for patients with ST-elevation myocardial infarction (STEMI) have improved significantly, some patients still experience poor clinical outcomes. The available risk classifications focus on the short-term outcomes, and it remains important to find high-risk features among patients with STEMI. In Japan, the 200 m walk electrocardiogram (ECG) test is widely performed before discharge. The purpose of this study was to investigate the association between the excessive increase in systolic blood pressure (SBP) following a 200 m walk and the long-term clinical outcomes in patients with STEMI. We included 680 patients with STEMI and divided those into an excessive increase in SBP group (n = 144) and a non-excessive increase in SBP group (n = 536) according to the SBP increase after a 200 m walk ECG test. We defined an excessive increase in SBP as SBP ≥ 20 mmHg either just after or 3 min after a 200 m walk ECG test. The primary endpoint consisted of major cardiovascular events (MACE), defined as the composite of all-cause death, non-fatal myocardial infarction, readmission for heart failure, and ischemia-driven target vessel revascularization. The median follow-up duration was 831 days. MACE was more frequently observed in the excessive increase in SBP group (24.3%) than in the non-excessive increase in SBP group (15.1%). Multivariate Cox hazard analysis revealed that the excessive increase in SBP was significantly associated with MACE (HR 1.509, 95% CI: 1.005-2.267, p = 0.047) after controlling for multiple confounding factors. An excessive increase in SBP after the 200 m walk ECG test was significantly associated with MACE in patients with STEMI. The 200 m walk ECG test is simple and low-cost, but may help to identify high-risk patients with STEMI.

Device-based antegrade dissection re-entry versus parallel wire techniques for the percutaneous revascularization of coronary chronic total occlusions.

Device-based antegrade dissection re-entry (ADR) and parallel wire technique (PWT) are two important techniques in the antegrade approach in percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). The study is aimed to compare the procedural and mid-term outcomes between device-based ADR using the CrossBoss/Stingray system and PWT in CTO PCI. Data was retrospectively collected from consecutive patients who underwent CTO PCI using device-based ADR or PWT. CTO due to in-stent restenosis were excluded. A total of 273 patients were included in the study (n = 55 in device-based ADR group, n = 218 in PWT group). Baseline characteristics were similar across groups except for higher prevalence of prior PCI and lower level of lipid profile in the ADR group. Moreover, although patients in the ADR group showed higher contrast volume (441.6 ± 162.4 mL vs. 361.5 ± 142.1 mL, p < 0.001), more intravascular ultrasound guidance (50.9% vs. 22.9%, p < 0.001), more guidewires used (4.6 ± 1.4 vs. 3.4 ± 1.2, p < 0.001) and higher troponin T level after PCI (0.167 vs. 0.087, p = 0.004), the technical success, procedural success and in-hospital complications were similar between the two groups. During a median follow-up of 1 year, the ADR group showed no difference in major adverse cardiac events (MACE, including all cause death, nonfatal myocardial infarction, and ischemia driven target vessel revascularization) (7.3% vs. 14.7%, p = 0.150) as compared with the PWT group. In the documented center, the use of device-based ADR for CTO PCI showed no difference in in-hospital complications and mid-term MACE as compared with PWT, despite higher procedure complexity in ADR group.

Guiding Intervention for Complex Coronary Lesions by Optical Coherence Tomography or Intravascular Ultrasound

BackgroundOptical coherence tomography (OCT) and intravascular ultrasound (IVUS) have shown comparable outcomes in guiding percutaneous coronary intervention (PCI). However, their comparative effectiveness in complex coronary artery lesions remains unclear. ObjectivesThis study compared the effectiveness and safety of OCT-guided vs IVUS-guided PCI for complex coronary artery lesions. MethodsThis was a prespecified, main subgroup analysis of complex coronary artery lesions in the OCTIVUS (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention) trial, which included unprotected left main disease, bifurcation disease, an aorto-ostial lesion, a chronic total occlusion, a severely calcified lesion, an in-stent restenotic lesion, a diffuse long lesion, or multivessel PCI. The primary endpoint was a composite of death from cardiac causes, target vessel–related myocardial infarction, or ischemia-driven target vessel revascularization. ResultsIn 2,008 randomized patients, 1,475 (73.5%) underwent imaging-guided PCI for complex coronary artery lesions; 719 (48.7%) received OCT-guided and 756 (51.3%) IVUS-guided PCI. At a median follow-up of 2.0 years, primary endpoint event had occurred in 47 patients (6.5%) in the OCT-guided group and in 56 patients (7.4%) in the IVUS-guided group (HR: 0.87; 95% CI: 0.59-1.29; P = 0.50). These findings were consistent in adjusted analyses. The incidence of contrast-induced nephropathy was similar between the 2 groups (1.9% vs 1.5%; P = 0.46). The incidence of major procedural complications was lower in the OCT-guided group than in the IVUS-guided group (1.7% vs 3.4%; P = 0.03). ConclusionsAmong patients with complex coronary artery lesions, OCT-guided PCI showed a similar risk of primary composite event of death from cardiac causes, target vessel–related myocardial infarction, or target vessel revascularization as compared with IVUS-guided PCI. (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention [OCTIVUS]; NCT03394079)

Optical Coherence Tomography-Guided or Intravascular Ultrasound-Guided Percutaneous Coronary Intervention: The OCTIVUS Randomized Clinical Trial.

Intravascular imaging-guided percutaneous coronary intervention (PCI) with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) showed superior clinical outcomes compared with angiography-guided PCI. However, the comparative effectiveness of OCT-guided and IVUS-guided PCI regarding clinical outcomes is unknown. In this prospective, multicenter, open-label, pragmatic trial, we randomly assigned 2008 patients with significant coronary artery lesions undergoing PCI in a 1:1 ratio to undergo either an OCT-guided or IVUS-guided PCI. The primary end point was a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year, which was powered for noninferiority of the OCT group compared with the IVUS group. Safety outcomes were also assessed. At 1 year, primary end point events occurred in 25 of 1005 patients (Kaplan-Meier estimate, 2.5%) in the OCT group and in 31 of 1003 patients (Kaplan-Meier estimate, 3.1%) in the IVUS group (absolute difference, -0.6 percentage points; upper boundary of one-sided 97.5% CI, 0.97 percentage points; P<0.001 for noninferiority). The incidence of contrast-induced nephropathy was similar (14 patients [1.4%] in the OCT group versus 15 patients [1.5%] in the IVUS group; P=0.85). The incidence of major procedural complications was lower in the OCT group than in the IVUS group (22 [2.2%] versus 37 [3.7%]; P=0.047), although imaging procedure-related complications were not observed. In patients with significant coronary artery lesions, OCT-guided PCI was noninferior to IVUS-guided PCI with respect to the incidence of a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year. The selected study population and lower-than-expected event rates should be considered in interpreting the trial. URL: https://www. gov; Unique number: NCT03394079.

Optical Coherence Tomography–Guided versus Angiography-Guided PCI

BackgroundData regarding clinical outcomes after optical coherence tomography (OCT)–guided percutaneous coronary intervention (PCI) as compared with angiography-guided PCI are limited.MethodsIn this prospective, randomized, single-blind trial, we randomly assigned patients with medication-treated diabetes or complex coronary-artery lesions to undergo OCT-guided PCI or angiography-guided PCI. A final blinded OCT procedure was performed in patients in the angiography group. The two primary efficacy end points were the minimum stent area after PCI as assessed with OCT and target-vessel failure at 2 years, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Safety was also assessed.ResultsThe trial was conducted at 80 sites in 18 countries. A total of 2487 patients underwent randomization: 1233 patients were assigned to undergo OCT-guided PCI, and 1254 to undergo angiography-guided PCI. The minimum stent area after PCI was 5.72±2.04 mm2 in the OCT group and 5.36±1.87 mm2 in the angiography group (mean difference, 0.36 mm2; 95% confidence interval [CI], 0.21 to 0.51; P<0.001). Target-vessel failure within 2 years occurred in 88 patients in the OCT group and in 99 patients in the angiography group (Kaplan–Meier estimates, 7.4% and 8.2%, respectively; hazard ratio, 0.90; 95% CI, 0.67 to 1.19; P=0.45). OCT-related adverse events occurred in 1 patient in the OCT group and in 2 patients in the angiography group. Stent thrombosis within 2 years occurred in 6 patients (0.5%) in the OCT group and in 17 patients (1.4%) in the angiography group.ConclusionsAmong patients undergoing PCI, OCT guidance resulted in a larger minimum stent area than angiography guidance, but there was no apparent between-group difference in the percentage of patients with target-vessel failure at 2 years. (Funded by Abbott; ILUMIEN IV: OPTIMAL PCI ClinicalTrials.gov number, NCT03507777.)

A Randomized Controlled Trial Comparing BioMime Sirolimus-Eluting Stent With Everolimus-Eluting Stent: Two-Year Outcomes of the meriT-V Trial.

Drug-eluting stents (DESs) based on biodegradable polymers (BPs) have been introduced to reduce the risk for late and very late stent thrombosis (ST), which were frequently observed with earlier generations of DES designs based on durable polymers (DPs); however, randomized controlled trials on these DES designs are scarce. The meriT-V trial is a randomized, active-controlled, non-inferiority trial with a prospective, multicenter design that evaluated the 2-year efficacy of a novel third-generation, ultra-thin strut, BP-based BioMime sirolimus-eluting stent (SES) versus the DP-based XIENCE everolimus-eluting stent (EES) for the treatment of de novo lesions. The meriT-V is a randomized trial that enrolled 256 patients at 15 centers across Europe and Brazil. Here, we report the outcomes of the extended follow-up period of 2 years. The randomization of enrolled patients was in a 2:1 ratio; the enrolled patients received either the BioMime SES (n = 170) or the XIENCE EES (n = 86). The three-point major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization (ID-TVR), was considered as the composite safety and efficacy endpoint. Ischemia-driven target lesion revascularization (ID-TLR) was evaluated as well as the frequency of definite/probable ST, based on the first Academic Research Consortium definitions. The trial had a 2-year follow-up completion rate of 98.44% (n = 252/256 patients), and the clinical outcomes assessment showed a nonsignificant difference in the cumulative rate of three-point MACE between both arms (BioMime vs. XIENCE: 7.74% vs. 9.52%, P = 0.62). Even the MI incidences in the BioMime arm were insignificantly lower than those of the XIENCE arm (1.79% vs. 5.95%, P = 0.17). Late ST was observed in 1.19% cases of the XIENCE arm, while there were no such cases in the BioMime arm (P = 0.16). The objective comparisons between the novel BP-based BioMime SES and the well-established DP-based XIENCE EES in this randomized controlled trial show acceptable outcomes of both the devices in the cardiac deaths, MI, ID-TVR, and ST. Moreover, since there were no incidences of cardiac death in the entire study sample over the course of 2 years, we contend that the findings of the study are highly significant for both these DES designs. In this preliminary comparative trial, the device safety of BioMime SES can be affirmed to be acceptable, considering the lower three-point MACE rate and absence of late ST in the BioMime arm over the 2-year period.

Angiographic Coronary Calcification: A Simple Predictor of Long-Term Clinical Outcomes in Patients with Acute Myocardial Infarction.

Coronary calcification detected by coronary angiography is a simple risk marker for long-term clinical outcomes in stable coronary artery disease. However, the significance of angiographic coronary calcification in the culprit lesion of acute myocardial infarction (AMI) has not been fully discussed. The purpose of this retrospective study was to assess the usefulness of angiographic coronary calcification as a risk marker for long-term clinical outcomes following percutaneous coronary intervention to the culprit lesions of AMI. We included 1209 patients with AMI and divided them into the none-mild calcification group (n=923) and the moderate-severe calcification group (n=286) according to angiographic coronary calcification in the culprit lesion of AMI. The primary endpoint was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of all-cause death, nonfatal MI, readmission for heart failure, and ischemia-driven target vessel revascularization. The median follow-up duration was 542 (Q1: 182, Q3: 990) days. A total of 345 MACE were observed during the study period. The occurrence of MACE was significantly greater in the moderate-severe calcification group than in the none-mild calcification group (43.4% vs. 23.9%, p＜0.001). In the multivariate Cox hazard model, moderate-severe calcification was significantly associated with MACE (hazard ratio 1.302, 95% confidence interval 1.011-1.677, p=0.041) after controlling multiple confounding factors. Angiographically moderate to severe calcification in AMI culprit lesion was associated with long-term worse clinical outcomes. Angiographic coronary calcification can be a simple risk marker in patients after AMI.

A prospective double-blinded randomized study on drug-eluting stent implantation into nitrate-induced maximally dilated vessels in patients with coronary artery disease

BackgroundPercutaneous coronary intervention (PCI) has been developed using drug-eluting stents (DES); however, stent implantation is associated with concerns of stent thrombosis and target vessel revascularization (TVR). The stent diameter is a critical factor in TVR and clinical events. The nitrate administration in coronary angiography can dilate the reference vessel diameter, enabling accurate vessel size measurement and optimal stent implantation support. This study was designed to evaluate the effect of stent implantation in the maximally dilated coronary artery in patients with coronary artery disease (CAD).MethodsThis prospective double-blinded randomized (1:1) study is designed to compare the efficacy and safety between DES implantation into the nitrate-induced maximally dilated vessels and conventional DES implantation in patients with CAD. A total of 400 patients who underwent PCI with a sirolimus-eluting stent will be enrolled. The primary endpoint is the mean diameter of the deployed stents. Secondary endpoints include cardiac death, myocardial infarction, stent thrombosis, or ischemia-driven TVR 1 year after the procedure.DiscussionThis study will be the first randomized controlled trial to evaluate the effect of DES implantation on nitrate-induced maximally dilated vessels in patients with CAD.Trial registrationThe trial was registered on 18 June 2021 as Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels (ClinicalTrials.gov Identifier: NCT04931784).

Cardiovascular events in patients with deferred lesions and chronic kidney disease.

No study has reported the association between the worsening of chronic kidney disease (CKD) and cardiovascular events in patients with deferred coronary artery lesions. We included patients with deferred lesions, defined as a fractional flow reserve (FFR) value > 0.80 treated with conservative medical therapy. Patients were divided into three groups: group 1, CKD stages 1-2; group 2, CKD stages 3-5; and group 3, CKD stage 5D (hemodialysis), with the clinical outcomes compared. The primary endpoint was the first occurrence of target vessel myocardial infarction, ischemia-driven target-vessel revascularization, or all-cause death. The primary endpoint was noted in 17, 25, and 36 patients in groups 1, 2, and 3, respectively. Within the three groups, the incidence rate of deferred lesions was 7.0%, 10.4%, and 32.4%, respectively. No difference was observed in the incidence of the primary endpoint between groups 1 and 2 (log-rank p = 0.16). However, the patients in group 3 had a significantly higher risk for the primary endpoint than those in groups 1 and 2 (log-rank p < 0.0001). In the multivariate Cox proportional hazards model, the patients in group 3 exhibited a higher incidence of the primary endpoint than those in group 1 (HR: 2.14; 95% CI 1.02-4.49; p < 0.01). Careful management is needed in patients undergoing hemodialysis, even if coronary artery stenosis is considered a deferred lesion.

Intracoronary physiology-guided percutaneous coronary intervention in patients with diabetes

ObjectiveThe risk of vessel-oriented cardiac adverse events (VOCE) in patients with diabetes mellitus (DM) undergoing intracoronary physiology-guided coronary revascularization is poorly defined. The purpose of this work is to evaluate the risk of VOCE in patients with and without DM in whom percutaneous coronary intervention (PCI) was performed or deferred based on pressure-wire functional assessment.MethodsThis is a retrospective analysis of a multicenter registry of patients evaluated with fractional flow reserve (FFR) and/or non-hyperaemic pressure ratio (NHPR). Primary endpoint was a composite of VOCE including cardiac death, vessel-related myocardial infarction (MI), and ischemia-driven target vessel revascularization (TVR).ResultsA large cohort of 2828 patients with 3353 coronary lesions was analysed to assess the risk of VOCE at long-term follow-up (23 [14–36] months). Non-insulin-dependent-DM (NIDDM) was not associated with the primary endpoint in the overall cohort (adjusted Hazard Ratio [aHR] 1.18, 95% CI 0.87–1.59, P = 0.276) or in patients with coronary lesions treated with PCI (aHR = 1.30, 95% CI 0.78–2.16, P = 0.314). Conversely, insulin-dependent diabetes mellitus (IDDM) demonstrated an increased risk of VOCE in the overall cohort (aHR 1.76, 95% CI 1.07–2.91, P = 0.027), but not in coronary lesions undergoing PCI (aHR 1.26, 95% CI 0.50–3.16, P = 0.621). Importantly, in coronary lesions deferred after functional assessment IDDM (aHR 2.77, 95% CI 1.11–6.93, P = 0.029) but not NIDDM (aHR = 0.94, 95% CI 0.61–1.44, P = 0.776) was significantly associated with the risk of VOCE. IDDM caused a significant effect modification of FFR-based risk stratification (P for interaction < 0.001).ConclusionOverall, DM was not associated with an increased risk of VOCE in patients undergoing physiology-guided coronary revascularization. However, IDDM represents a phenotype at high risk of VOCE.Graphical abstract

Rivaroxaban in patients with abdominal aortic aneurysm and high-sensitivity C-reactive protein elevation (BANBOO): study protocol for a randomized, controlled trial

BackgroundAbdominal aortic aneurysm (AAA) is a fatal disease due to the tendency to rupture. The drug treatment for small AAA without surgical indications has been controversial. Previous studies showed that high-sensitivity C-reactive protein (hs-CRP) had become a potential biomarker of the disease, and the anti-inflammatory effect of rivaroxaban for AAA had been well established. Thus, we hypothesized that rivaroxaban could control the progression of AAA in patients with hs-CRP elevation.MethodsThe study is a prospective, open-label, randomized, controlled clinical trial. Sixty subjects are recruited from the General Hospital of Northern Theatre Command of China. Subjects are randomly assigned (1:1) to the intervention arm (rivaroxaban) or control arm (aspirin). The primary efficacy outcome is the level of serum hs-CRP at 6 months. The secondary outcomes include imaging examination (the maximal diameter of AAA, the maximal thickness of mural thrombus, and the length of aneurysm), major adverse cardiovascular and cerebrovascular events (MACCE, including AAA transformation, non-fatal myocardial infarction, acute congestive heart failure, stent thrombosis, ischemia-driven target vessel revascularization, vascular amputation, stroke, cardiovascular death, and all-cause death), and other laboratory tests (troponin T, interleukin 6, D-dimer, and coagulation function).DiscussionThe BANBOO trial tested the effect of rivaroxaban on the progression of AAA in patients with elevated Hs-CRP for the first time.Trial registrationChiCTR2100051990, ClinicalTrials.gov, registered on 12 October 2021.

Long-term outcomes of patients treated with sirolimus-eluting resorbable magnesium scaffolds: Insights from the SHERPA-MAGIC study

BackgroundThe resorbable magnesium scaffold (RMS) is a second-generation bioresorbable scaffold (BRS) that has shown conflicting results in previous studies. These findings suggest that patient selection and implantation technique may have an impact on clinical outcomes. This study aimed to investigate the safety and long-term effectiveness of RMS in a narrowly selected population. MethodsSHERPA-MAGIC is an investigator-driven, multicenter, prospective, single-arm study that enrolled patients undergoing BRS coronary implantation in 18 Italian centers. The present analysis considered the first 543 enrolled patients treated with RMS, with a minimum follow-up of 1 year. The study protocol included strict criteria for patient selection and standardization of RMS implantation. The primary outcome was the occurrence of the vessel-oriented composite endpoints (VOCE), including cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. ResultsOverall, 635 vessels were treated. The 1-year cumulative occurrence of VOCE was 22 (3.5%, 95% CI 2.2%–5.2%), which was significantly lower than the prespecified estimation (from 5.5% to 8.5%). At the median follow-up of 3.5 [2.6–4.3] years, there were 3 (0.5%) cardiac deaths, 12 (1.9%) target vessel myocardial infarctions, and 33 (5.2%) ischemia-driven target vessel revascularizations. A total of 37 (5.8%, 95%CI 4.1%–7.9%) VOCEs were detected. Scaffold thrombosis occurred in 4 (0.6%, 95%CI 0.1%–1.6%) cases. Patient-level analysis confirmed the findings of the vessel-level analysis. ConclusionsThese results confirm the safety and performance of RMS technology. If confirmed in randomized controlled trials, they may rekindle interest in the use of scaffolds in daily practice.

Prognostic value of post-procedural μQFR for drug-coated balloons in the treatment of in-stent restenosis.

Investigating the prognostic value of the Murray law-based quantitative flow ratio (μQFR) on the clinical outcome after treatment of in-stent restenosis (ISR) with a drug-coated balloon (DCB). Patients participating in a previous randomized clinical trial for DCB-ISR were post-hoc analyzed. The primary endpoint was vessel-oriented composite endpoint (VOCE), defined as cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. μQFRs at baseline and after DCB angioplasty was calculated, and its prognostic value as a predictor of VOCE was explored in Cox regression. A total of 169 lesions in 169 patients were analyzed. At 1-year follow-up, 20 VOCEs occurred in 20 patients. Receiver-operating characteristic curve analysis identified a post-procedural μQFR of ≤ 0.89 as the best cut-off to predict VOCE (area under curve [AUC]: 0.74; 95% confidence interval [CI]: 0.67-0.80; p < 0.001), superior to post-procedural in-stent percent diameter stenosis, which reported an AUC of 0.61 (95% CI: 0.53-0.68; p = 0.18). Post-procedural μQFR was significantly lower in patients with VOCE compared with those without (0.88 [interquartile range: 0.79-0.94] vs. 0.96 [interquartile range: 0.91-0.98], respectively; p < 0.001). After correction for potential confounders, post-procedural μQFR ≤ 0.89 was associated with a 6-fold higher risk of VOCE than lesions with μQFR > 0.89 (hazard ratio: 5.94; 95% CI: 2.33-15.09; p < 0.001). Post-procedural μQFR may become a promising predictor of clinical outcome after treatment of DES-ISR lesions by DCB angioplasty.

Efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with coronary atherosclerotic heart disease and gastrointestinal disease undergoing percutaneous coronary intervention: study protocol for a non-inferiority randomized controlled trial

BackgroundDual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is recommended for patients with coronary heart disease (CHD) undergoing percutaneous coronary intervention (PCI) to antithrombosis, meanwhile, increasing the risks of gastrointestinal bleeding. Rivaroxaban, a novel oral anticoagulant, combined with a P2Y12 receptor inhibitor reduces adverse events in patients with CHD and atrial fibrillation who underwent PCI. The effect of rivaroxaban plus P2Y12 inhibitor on reducing bleeding events in patients with CHD and gastrointestinal disease (GID) undergoing PCI remains unclear.MethodThe study is a prospective, single-center, randomized controlled trial. A total of 1020 patients with CHD and GID undergoing PCI will be enrolled. Patients are randomized (1:1) to receive either rivaroxaban 10 mg plus clopidogrel 75 mg daily or aspirin 100 mg plus clopidogrel 75 mg daily; both treatments will last 6 months. The primary endpoint is Bleeding Academic Research Consortium (BARC) type 2–5 bleeding requiring medical intervention. The secondary endpoint is a composite of major adverse cardiovascular and cerebrovascular events (MACCE), including all-cause death, cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization, and stroke.DiscussionThe objective of this study is to evaluate the efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with CHD and GID undergoing PCI. We aim to explore an optimized antithrombotic strategy, which achieves the same anti-ischemic effect as standard DAPT without increasing the risk of GIB, for patients with CHD and GID undergoing PCI.Trial registrationThis protocol is registered at the Chinese Clinical Trial Registry under the number ChiCTR2100044319. And this publication is based on version 1.4 of the trial protocol dated Sep 6, 2021.