Diagnostic accuracy of Murray law-based quantitative flow ratio in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

BACKGROUND: Murray law-based quantitative flow ratio (µQFR) is a novel computational method that enables accurate estimation of fractional flow reserve (FFR) using a single angiographic projection. However, its diagnostic value in patients with severe aortic stenosis (AS) remains unclear. METHOD: We included 25 consecutive patients who underwent transcatheter aortic valve replacement (TAVR) for severe AS with intermediate or greater (30-90%) coronary artery disease (CAD). Pre- and post-TAVR µQFR, QFR, instantaneous flow reserve (iFR), and post-TAVR invasive FFR values were measured. We evaluated the diagnostic performance of pre-TAVR µQFR, QFR, and iFR using post-TAVR FFR ≤ 0.80 as a reference standard of ischemia. RESULT: Pre-TAVR µQFR was significantly correlated with post-TAVR FFR (r = 0.73, p < 0.0001). The area under the curve of pre-TAVR µQFR on post-TAVR FFR ≤ 0.8 was 0.91 (95% confidence interval [CI] 0.77-0.98), comparable to that of pre-TAVR iFR (0.86 [95% CI 0.71-0.98], p = 0.97). The accuracy, sensitivity, specificity, and positive and negative predictive values of pre-TAVR µQFR on post-TAVR FFR ≤ 0.8 were 84.2% (95% CI 68.7-93.4), 61.6% (95% CI 31.6-86.1), 96.0% (95% CI 79.6-99.9), 88.9% (95% CI 52.9-98.3), and 82.8% (95% CI 70.6-90.6), respectively. For pre-TAVR iFR, these values were 76.5% (95% CI 58.8-89.3), 90.9% (95% CI 58.7-99.8), 69.6% (95% CI 47.1-86.8), 58.8% (95% CI 42.8-73.1), and 94.1% (95% CI 70.8-99.1), respectively. CONCLUSION: µQFR could be useful for the physiological evaluation of patients with severe AS with concomitant CAD.

Diagnostic Accuracy of Pre-Transcatheter Aortic Valve Replacement Nitroglycerin-Free Fractional Flow Reserve-Computed Tomography-Based Physiological Assessment in Patients With Severe Aortic Stenosis for Predicting Post-Transcatheter Aortic Valve Replacement Ischemia.

BACKGROUND: Fractional flow reserve-computed tomography (FFRCT) has not been validated in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) for coronary artery disease due to theoretical difficulties in using nitroglycerin for such patients.Methods and Results: In this single-center study, we prospectively enrolled 21 patients (34 vessels) and performed pre-TAVR FFRCTwithout nitroglycerin, pre-TAVR invasive instantaneous wave-free ratio (iFR) measurements, and post-TAVR FFR measurements using a pressure wire. The diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of pre-TAVR FFRCT≤0.80 to predict post-TAVR invasive FFR ≤0.80 were 82%, 83%, 82%, 71%, and 90%, respectively. A receiver operating characteristic analysis demonstrated an optimal cutoff of 0.78 for pre-TAVR FFRCTto indicate post-TAVR FFR ≤0.80, with an area under the curve (AUC) of 0.84, and the counterpart cutoff of pre-TAVR iFR was 0.89 with an AUC of 0.86. CONCLUSIONS: FFRCTwithout nitroglycerin could be a useful non-invasive imaging modality for assessing the severity of coronary artery lesions in patients with severe AS.

Frailty and Bleeding After Percutaneous Coronary Intervention.

The aim of this study was to evaluate the predictive ability of frailty for bleeding after percutaneous coronary intervention (PCI). In 2439 patients who underwent their PCI, frailty was prospectively assessed according to the Canadian Study of Health and Aging clinical frailty scale (CFS). Patients were divided into three groups according to the CFS: low (CFS levels 1 to 3; 1748 patients, 71.7%), intermediate (CFS levels 4 to 6; 519 patients, 21.3%), and high CFS groups (CFS levels 7 to 9; 172 patients, 7.1%). Academic Research Consortium High Bleeding Risk (ARC-HBR) was present in 47.3% in the low CFS group, in 83.2% in the intermediate CFS group and in 89.0% in the high CFS group (p <0.001). Patients in the intermediate and high CFS groups were associated with higher 1-year major bleeding risk after PCI in the overall cohort (HR 3.82, 95% CI 2.65 to 5.51, p <0.001, and HR 7.81, 95% CI 5.07 to 12.0, p <0.001, respectively). Patients in the high CFS group were also associated with higher 1-year major bleeding risk regardless of having the high bleeding risk (HBR) according to ARC-HBR. In conclusion, the association of frailty with 1-year major bleeding was consistently observed in patients with and without HBR, indicating that frailty per se might be a predictor for major bleeding after PCI on top of HBR criteria.

Clinical Outcomes After Percutaneous Coronary Intervention in Patients With Cancer.

BACKGROUND: The aim of this study is to evaluate clinical outcomes after percutaneous coronary intervention (PCI) in patients with cancer.Methods and Results:Cancer screening was recommended before PCI in consecutive 1,303 patients who underwent their first PCI. By using cancer screening, cancer was diagnosed in 29 patients (2.2%). In total, 185 patients had present or a history of cancer. Patients with cancer more often suffered from non-cardiac death than those without (4.4% vs. 1.5%, P=0.006), and patients with cancer requiring ongoing therapy (n=18) more often suffered from major bleeding compared with those with recently (≤12 months) diagnosed cancer who do not have ongoing therapy (n=59) (16.7% vs. 3.4%, P=0.049). During the 1-year follow up, 25 patients (2.0%) were diagnosed as having cancer, in which 48.0% of bleeding events led to a cancer diagnosis. Patients with high bleeding risk according to the Academic Research Consortium for high bleeding risk (ARC-HBR) were associated with a greater 1-year major bleeding risk than those without high bleeding risk in patients with (7.9% vs. 0.0%, P=0.02) and without cancer (7.1% vs. 2.5%, P<0.001), respectively. CONCLUSIONS: Cancer was diagnosed in 2.2% of 1,303 unselected patients before PCI by cancer screening and in 2.0% within 1-year after PCI. Cancer was associated with a greater risk of non-cardiac death, whereas ongoing active cancer was associated with greater risk of major bleeding. ARC-HBR criteria successfully identified high-bleeding risk patients, irrespective of the presence or absence of cancer.

Five-Year Clinical Outcomes After Drug-Eluting Stent Implantation Following Rotational Atherectomy for Heavily Calcified Lesions.

BACKGROUND: Percutaneous coronary intervention for heavily calcified lesions requires rotational atherectomy (RA). Long-term clinical outcomes after drug-eluting stent (DES) implantation following (RA) for heavily calcified lesions remain unclear. We assessed 5-year clinical outcomes after DES implantation following RA.Methods and Results:Between March 2006 and September 2011, 219 consecutive patients with 219 lesions treated with DES following RA, were retrospectively enrolled. The cumulative 5-year incidence of target-lesion revascularization (TLR) and definite stent thrombosis (ST) were assessed. The cumulative incidence of TLR within (≤) the first year was 18.6%. Late TLR beyond (>) 1 year continued to occur at 1.9% per year without a decrease in the rate (5-year incidence, 26.0%). The cumulative incidence of definite ST at 30 days, 1 and 5 years was 0.9%, 2.3% and 2.9%, respectively. The annual rate of definite ST beyond 1 year was 0.15%. On multivariate analysis, the significant predictor of TLR within 1 year was use of first-generation DES (hazard ratio [HR], 2.09; 95% CI: 1.10-4.03, P=0.02) and that of TLR beyond 1 year was hemodialysis (HR, 3.29; 95% CI: 1.06-10.55, P=0.04). CONCLUSIONS: Late TLR beyond 1 year continued to occur up to 5 years at a constant annual incidence, whereas very late ST was rare. Careful long-term clinical follow-up is continually needed in patients who have already received DES following RA for heavily calcified lesions.

Incidence and Long-Term Clinical Impact of Late-Acquired Stent Fracture After Sirolimus-Eluting Stent Implantation in Narrowed Coronary Arteries.

The incidence and long-term clinical impact of stent fracture (SF) occurred beyond 1 year after sirolimus-eluting stent (SES) implantation remains unclear. From April 2004 to March 2008, 985 consecutive patients with 1,307 lesions were treated only with SES. Of these, 868 patients (88.1%) with 1,140 lesions underwent follow-up angiography within 1 year after the index procedure, and 646 patients (65.6%) with 872 lesions underwent it both within and beyond 1 year after the index procedure. According to the diagnosed timing of SF, we divided the patients into the 2 groups: early SF (<1 year after the index procedure) and late-acquired SF (>1 year after the index procedure). Early- and late-acquired SFs were observed in 64 of 868 patients (7.4%) and 66 of 1,140 lesions (5.8%); 12 of 646 patients (1.9%) and 12 of 872 lesions (1.4%), respectively. Cumulative 10-year incidence of clinically driven target lesion revascularization and definite stent thrombosis were numerically higher in the early- and late-acquired SF groups than in the non-SF group (41.6% vs 45.5% vs 19.0%; 8.0% vs 8.3% vs 2.0%, respectively). In conclusion, late-acquired SF after SES implantation occurred in 1.4% of lesions, which was lower than that of early SF. However, both early- and late-acquired SFs appeared to be associated with clinically driven target lesion revascularization and stent thrombosis during the long-term follow-up.

Difference of Tissue Characteristics Between Early and Late Restenosis After Second-Generation Drug-Eluting Stents Implantation　- An Optical Coherence Tomography Study.

BACKGROUND: The mechanism and time course of in-stent restenosis (ISR) after implantation of second-generation DES have not yet been fully elucidated. We sought to evaluate the differences in tissue characteristics between the different phases of ISR after second-generation DES implantation using optical coherence tomography (OCT).Methods and Results:From June 2010 to December 2015, 324 consecutive patients with 337 ISR lesions underwent OCT. Of these, we analyzed 53 lesions in 53 patients who had their first ISR after second-generation DES implantation and underwent OCT before any procedures. According to the timing of ISR, the patients were divided into the early group (within 1 year: E-ISR, n=30) and late group (beyond 1 year: L-ISR, n=23). Quantitative parameters and qualitative characteristics of the neointima were evaluated. In the minimum lumen area site analysis, the E-ISR group had more frequently homogeneous intima than the L-ISR group (26.7% vs. 4.4%, P=0.02). The frequencies of neointima with lipid-laden, thin-cap fibroatheroma, neovascularization and macrophage infiltration were significantly higher in the L-ISR group than in the E-ISR group (30.0% vs. 69.6%, P<0.01; 0.0% vs. 26.1%, p <0.01; 6.7% vs. 26.1%, P=0.049; 3.3% vs. 26.1%, P=0.01, respectively). CONCLUSIONS: Neointimal tissue characteristics differed between E-ISR and L-ISR after second-generation DES implantation. E-ISR was mainly caused by neointimal hyperplasia, whereas neoatherosclerosis was the main mechanism of L-ISR.

Usefulness of rotational atherectomy with optical frequency domain imaging guidance for severe calcified coronary lesions after Kawasaki disease.

A 40-year-old man was referred to our hospital for the treatment of severe calcified coronary lesions of right coronary artery due to Kawasaki disease. He had a past history of early stent thrombosis after drug-eluting stent implantation for acute myocardial infarction at the left anterior descending artery, regardless of continued dual antiplatelet therapy and no stent malapposition and underexpansion. We performed rotational atherectomy and plain balloon angioplasty with optical frequency domain imaging guidance, and obtained an excellent initial result without stent implantation, which was maintained during the 1-year follow-up.

Impact of total stent length after cobalt chromium everolimus-eluting stent implantation on 3-year clinical outcomes.

OBJECTIVES: The objective was to assess whether total stent length (TSL) after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation was associated with long-term clinical outcomes. BACKGROUND: The impact of TSL after CoCr-EES implantation on long-term clinical outcomes remained unclear. METHODS: A total of 1,007 consecutive patients with 1,382 lesions treated only with CoCr-EES were analyzed. Patients and lesions were divided into tertile group: TSL per patient (TSL-P) (PA [8-23 mm], n = 382; PB [23-46 mm], n = 312; and PC [46-204 mm], n = 313), and TSL per lesion (TSL-L) (LA [8-18 mm], n = 486; LB [18-28 mm], n = 475; and LC [28-140 mm], n = 421). The cumulative 3-year incidence of clinically driven target-lesion revascularization (CD-TLR) and definite stent thrombosis (ST) based on TSL-P and TSL-L groupings were accessed. RESULTS: After inverse probability of weighted adjustment, the cumulative 3-year incidence of CD-TLR for the TSL-P and TSL-L were higher in the PC and LC groups than in the other groups (hazard ratio [HR] 2.92, 95% confidence intervals [CI] 1.66-5.15, P < 0.001 vs. PA; HR 2.49, 95% CI 1.47-4.20, P < 0.001 vs. PB; HR 1.94, 95% CI 1.15-3.28, P = 0.01 vs. LA; HR 2.80, 95% CI 1.73-4.54, P < 0.001 vs. LB, respectively). No significant differences in the cumulative 3-year incidence of definite ST were observed in both TSL-P and TSL-L groups. CONCLUSIONS: TSL after CoCr-EES implantation has significantly impact on CD-TLR rate through 3 years, but it is not associated with an increased incidence of definite ST. © 2016 Wiley Periodicals, Inc.

Two-year clinical outcomes of the NOBORI biolimus-eluting stents versus XIENCE/PROMUS everolimus-eluting stents in small vessel disease.

BACKGROUND: Biolimus-eluting stents (BES) have similar efficacy and safety compared with cobalt chromium everolimus-eluting stents (CoCr-EES), whereas it is unclear whether the same applies to small vessel disease. We sought compare clinical outcomes between BES and CoCr-EES in patients with small vessel disease. METHODS AND RESULTS: A total of 1,132 patients treated only with BES (612 patients) or EES (520 patients) in small vessel disease (stent size 2.5-mm) were retrospectively analyzed. We assessed the cumulative 2-year incidence of major adverse cardiovascular events (MACE), defined as a composite of cardiac death, myocardial infarction (MI), definite stent thrombosis (ST), and clinically driven target lesion revascularization (CD-TLR). The cumulative 2-year incidence of MACE was similar between the two groups (12.1% vs. 11.8%, P = 0.77). The cumulative incidence of cardiac death, CD-TLR, and definite ST were also not significantly different between both groups (3.2% vs. 3.6%, P = 0.78; 8.3% vs. 8.4%, P = 1.00; 0.33% vs. 0.21%, P = 0.66, respectively). After multivariate adjusting, the adjusted risk of BES group relative to CoCr-EES group for MACE was not significantly different (hazard ratio [HR]: 0.78, 95% confidential interval [CI]: 0.53-1.15, P = 0.20). Similarly, no significant difference in the adjusted risks for cardiac death and CD-TLR were observed between the two groups (HR: 0.62, 95% CI: 0.28-1.37, P = 0.24; HR: 0.81, 95% CI: 0.51-1.29, P = 0.38). CONCLUSIONS: Two-year clinical outcomes of BES are similar to those of CoCr-EES in patients with small vessel disease. The use of BES is acceptable for small coronary artery disease. © 2015 Wiley Periodicals, Inc.

Incidence and Clinical Impact of Stent Fracture After PROMUS Element Platinum Chromium Everolimus-Eluting Stent Implantation.

OBJECTIVES: This study sought to assess the incidence and clinical impact of stent fracture (SF) after the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES). BACKGROUND: SF remains an unresolved, clinically relevant issue, even in the newer-generation drug-eluting stent era. METHODS: From March 2012 to August 2013, 816 patients with 1,094 lesions were treated only with PtCr-EES and 700 patients (85.7%) with 898 lesions undergoing follow-up angiography within 9 months after the index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by plain fluoroscopy, intravascular ultrasound, or optical coherence tomography during the follow-up. We assessed the rate of SF and the cumulative incidence of clinically driven target lesion revascularization and definite stent thrombosis within 9 months after the index procedure. RESULTS: SF was observed in 16 of 898 lesions (1.7%) and 16 of 700 patients (2.2%). Lesions with in-stent restenosis at baseline (odds ratio [OR]: 14.2, 95% confidence intervals [CI]: 5.09 to 39.7; p < 0.001) or hinge motion (OR: 4.31, 95% CI: 1.12 to 16.5; p = 0.03), and total stent length (per 10-mm increase; OR: 1.32, 95% CI: 1.12 to 1.57; p = 0.001) were predictors of SF. Cumulative incidence of clinically driven target lesion revascularization within 9-months was numerically higher in the SF group than that in the non-SF group (18.7% vs. 2.3%). Cumulative incidence of definite stent thrombosis within 9 months after the index procedure was similar between the SF and non-SF groups (0.0% vs. 0.23%). CONCLUSIONS: SF after PtCr-EES occurs in 1.7% of lesions and appears to be associated with clinically driven target lesion revascularization.

Two-Year Clinical Outcomes of Newer-Generation Drug-Eluting Stent Implantation Following Rotational Atherectomy for Heavily Calcified Lesions.

BACKGROUND: Clinical outcomes of implantation of the newer-generation drug-eluting stent (DES) following rotational atherectomy for heavily calcified lesions remain unclear in the real-world setting. METHODS AND RESULTS: We enrolled 252 consecutive patients (273 lesions) treated with newer-generation DES following rotational atherectomy. The primary endpoint was the cumulative 2-year incidence of major adverse cardiovascular events (MACE), defined as cardiac death, myocardial infarction, clinically-driven target lesion revascularization, and definite stent thrombosis. Complete clinical follow-up information at 2-year was obtained for all patients. The mean age was 73.2±9.0 years and 155 patients (61.5%) were male. Cumulative 2-year incidence of MACE (cardiac death, myocardial infarction, clinically-driven target lesion revascularization and definite stent thrombosis) was 20.3% (7.0%, 2.1%, 18.1% and 2.1%, respectively). Predictors of MACE were presenting with acute coronary syndrome (hazard ratio [HR]: 3.80, 95% confidence interval [CI]: 1.29-11.2, P=0.02), hemodialysis (HR: 1.93, 95% CI: 1.04-3.56, P=0.04) and previous coronary artery bypass graft (HR: 2.26, 95% CI: 1.02-5.00, P=0.045). CONCLUSIONS: PCI for calcified lesions requiring rotational atherectomy is still challenging even in the era of newer-generation DES.

Incidence and clinical impact of stent fracture after the Nobori biolimus-eluting stent implantation.

BACKGROUND: Stent fracture (SF) after drug-eluting stent implantation has become an important concern. The aim of this study was to assess the incidence, predictors, and clinical impact of SF after biolimus-eluting stent. METHODS AND RESULTS: A total of 1026 patients with 1407 lesions undergoing the Nobori biolimus-eluting stent implantation and follow-up angiography within 9 months after index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by using plain fluoroscopy, intravascular ultrasound, or optical coherence tomography during the follow-up. We assessed the rate of SF and the cumulative incidence of clinically driven target lesion revascularization and definite stent thrombosis within 9 months. SF was observed in 58 (4.1%) of 1407 lesions and 57 (5.5%) of 1026 patients. Lesions with hinge motion (OR 8.90, 95% CI 3.84 to 20.6, P<0.001), tortuosity (OR 4.16, 95% CI 1.75 to 9.88, P=0.001), and overlapping stents (OR 2.41, 95% CI 0.95 to 6.10, P=0.06) were predictors of SF. Cumulative incidence of clinically driven target lesion revascularization within 9 months was numerically higher in the SF group than that in the non-SF group (12.0% versus 1.0%). Cumulative incidence of definite stent thrombosis within 9 months tended to be higher in the SF group than that in the non-SF group (1.7% versus 0.5%). CONCLUSIONS: SF after biolimus-eluting stent occurs in 4.1% of lesions and appears to be associated with clinically driven target lesion revascularization.