Sex Differences in 5-Year Outcomes After Deferral of Revascularization Following Physiological Coronary Assessment.

Background: The relationship between sex differences and long-term outcomes after fractional flow reserve (FFR)- and instantaneous wave-free ratio (iFR)-guided deferral of revascularization has yet to be elucidated. Methods and Results: From the J-CONFIRM registry (long-term outcomes of Japanese patients with deferral of coronary intervention based on FFR in a multicenter registry), this study included 432 lesions from 385 patients (men, 323 lesions in 286 patients; women, 109 lesions in 99 patients) with paired data of FFR and iFR. The primary endpoint was the cumulative 5-year incidence of target vessel failure (TVF), including cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. The median FFR value was lower in men than in women (0.85 [0.81, 0.88] vs. 0.87 [0.83, 0.91], P=0.002), but the iFR value was comparable between men and women (0.94 [0.90, 0.98] vs. 0.93 [0.89, 0.98], P=0.26). The frequency of discordance between FFR and iFR was comparable between men and women (19.5% vs. 23.9%, P=0.34), although with different discordance patterns (P=0.036). The cumulative incidence of 5-year TVF did not differ between men and women after adjustment for baseline characteristics (13.9% vs. 6.9%, adjusted hazard ratio 1.82 [95% confidence interval: 0.44-7.56]; P=0.41). Conclusions: Despite sex differences in the results for physiological indexes, the 5-year TVF in deferred lesions did not differ between men and women after adjustment for baseline characteristics.

Thrombotic Risk and Cardiovascular Events in Patients With Revascularization Deferral After Fractional Flow Reserve Assessment.

OBJECTIVES: The aim of this study was to evaluate the impact of thrombotic risk on the occurrence of cardiovascular events in patients with coronary artery disease with deferred revascularization after fractional flow reserve (FFR) measurements. BACKGROUND: Deferral of revascularization on the basis of FFR is generally considered to be safe, but after deferral, some patients have cardiovascular events over time. METHODS: From J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), 1,263 patients with deferral of revascularization on the basis of FFR were evaluated. The association between thrombotic risk as assessed by CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) thrombotic score and 5-year target vessel failure (TVF) and major adverse cardiac and cerebrovascular events (MACCE) was investigated. RESULTS: FFR and high thrombotic risk (HTR) were associated with increased risk for 5-year TVF (FFR per 0.01-unit decrease: HR: 1.08; 95% CI: 1.05-1.11; P < 0.001; HTR: HR: 2.16; 95% CI: 1.37-3.39; P < 0.001) and MACCE (FFR per 0.01-unit decrease: HR: 1.05; 95% CI: 1.02-1.06; P < 0.001; HTR: HR: 2.11; 95% CI: 1.56-2.84; P = 0.001). Patients with HTR had higher risk for 5-year TVF (HR: 2.30; 95% CI: 1.45-3.66; P < 0.001) and MACCE (HR: 2.34; 95% CI: 1.75-3.13; P < 0.001) than those without HTR, even when they had negative FFR. CONCLUSIONS: Assessment of thrombotic risk provides additional prognostic value to FFR in predicting 5-year TVF and MACCE in patients with deferral of revascularization after FFR measurements. (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry; UMIN000014473).

Consensus document on the standard of coronary angioscopy examination and assessment from the Japanese Association of Cardiovascular Intervention and Therapeutics.

Coronary angioscopy (CAS) is a unique diagnostic device that allows direct visualization of the vascular luminal surface in living patients. CAS contributes to elucidate the pathology of coronary artery disease. This consensus document provides a standard for CAS examination and assessment.

Safety, efficacy, and cost-performance of a simplified cryoballoon ablation procedure for paroxysmal atrial fibrillation.

BACKGROUND: The search for a less invasive and lower cost cryoballoon-based strategy for atrial fibrillation (AF) ablation has resulted in a simplified procedure that may be suitable for cryoballoon ablation (CBA). Here, we compared procedural characteristics and outcomes between conventional CBA and simple CBA. METHODS: We enrolled 628 consecutive patients who underwent initial CBA for AF (age, 69 ± 12 years; female, 263 (42%); paroxysmal AF, 576 (92%); CHA2DS2-VASc score, 2.7 ± 1.6 points). Simple CBA was characterized by the minimal procedure required to isolate pulmonary veins, including the following: (1) CBA was performed without guidance from a 3-D mapping system; (2) a coronary sinus electrode and esophageal temperature probe were not used; (3) a waiting period after pulmonary vein isolation was not set; and AF induction by isoproterenol and atrial burst stimuli were not performed. RESULTS: Simple CBA was performed in 240 (38%) patients. Procedural time (49 ± 18 versus 85 ± 27 min, p < 0.01) was shorter, and total procedural costs (20,699 ± 8,091 versus 30,350 ± 11,647 US dollars, p < 0.01) were lower with simple CBA than conventional CBA. Freedom from AF recurrence during the 12-month study period (79.8% versus 78.4%, p = 0.52) and complication rate (8.8% versus 13.1%, p = 0.09) were similar between the two groups. CONCLUSION: Compared with conventional CBA, simple CBA reduced procedural time and procedural costs while providing comparable outcomes.

Early- and Middle-Phase Angioscopic Assessment of Arterial Healing Following Current Drug-Eluting Stent Implantation in Patients With Acute Coronary Syndrome.

Background: Drug-eluting stents (DESs) have been widely used for the treatment of acute coronary syndrome (ACS). However, there are few reports on early- and middle-phase arterial repair after DES implantation in ACS patients. Methods and Results: Coronary angioscopy (CAS) findings covering the early and middle phases (mean [±SD] 4±1 and 10±2 months, respectively) of arterial healing after second- and later-generation DES placement between May 2009 and January 2020 were extracted from the Kansai Rosai Hospital Cardiovascular Center database. Neointimal coverage (NIC), yellow color intensity, and the incidence of thrombus adhesion were compared between ACS and chronic coronary syndrome (CCS) in the early (54 stents of 47 lesions, 38 ACS patients; 86 stents of 70 lesions, 52 CCS patients) and middle (179 stents of 154 lesions from 136 ACS patients; 459 stents of 374 lesions from 287 CCS patients) phases. In the early phase, NIC, the incidence of thrombus adhesion (ACS, 39.1%; CCS, 38.0%), and maximum yellow color grade were similar between the 2 groups. In the middle phase, although the maximum yellow color grade was significantly higher in the ACS group (P=0.013), NIC and the incidence of thrombus adhesion (ACS, 24.6%; CCS, 23.4%) were similar in the 2 groups. Conclusions: Arterial healing assessment with CAS showed that NIC and the incidence of thrombus adhesion after DES implantation were similar between ACS and CCS patients.

Potential mechanisms of in-stent occlusion in the femoropopliteal artery: an angioscopic assessment.

Although stent implantation has become widespread for the treatment of patients with peripheral artery disease with femoropopliteal (FP) lesions, in-stent restenosis, especially in-stent occlusion (ISO), remains as a major concern for refractory recurrence. Furthermore, the mechanisms of ISO in FP lesions have not been well elucidated. We performed angioscopy for 6 lesions (bare-metal stent: 3, drug-eluting stent: 3) from 5 patients (mean age 74 ± 10 years, male 40 %) with ISO in the FP artery immediately after wire-passing or thrombus aspiration. The presence of thrombus as well as the presence and location of organic stenosis were evaluated. Median duration from stent implantation to angioscopic evaluation was 1099.5 (514.5-2272.5) days, while the duration from recurrence of symptoms to angioscopic evaluation was 45 (5.75-60) days. Mixed thrombi were observed in all stents. Organic stenosis was detected at the proximal edge of the stents in 5 lesions. Organic stenosis was observed at the overlapping segment of the stent in one lesion. The distal edge of the stents could be evaluated in 3 lesions, and all of them showed organic stenosis at the site. Mixed thrombi and organic stenosis were observed in all stents. Partial development of organic stenosis in a stent followed by thrombus formation may be the potential mechanism of the development of ISO in the FP artery though the sample size of this study was small and it had no serial angioscopic data so that we should consider it as preliminary one at best.

Impact of Calcification on Clinical Outcomes After Endovascular Therapy for Superficial Femoral Artery Disease: Assessment Using the Peripheral Artery Calcification Scoring System.

PURPOSE: To investigate whether the severity of lesion calcification assessed by the novel peripheral artery calcification scoring system (PACSS) was associated with clinical outcomes after endovascular therapy (EVT) for superficial femoral artery (SFA) lesions. METHODS: A retrospective analysis was conducted of 394 consecutive patients (mean age 72±8 years; 290 men) with intermittent claudication [223 (57%) with diabetes, 81 (21%) on hemodialysis] who underwent successful EVT for de novo SFA lesions [length 152.1±95.7 mm; 199 (50%) TransAtlantic Inter-Society Consensus II class C/D] between January 2010 and December 2013. The patients were retrospectively categorized using the PACSS classification (grades 0-4: no visible calcification of the target lesion, unilateral wall calcification <5 cm, unilateral calcification ≥5 cm, bilateral wall calcification <5 cm, and bilateral calcification ≥5 cm, respectively). The main outcome was primary patency, while the secondary outcome measures were mortality and major adverse limb events [MALE: any intervention (repeat EVT or surgical revision) or major (above ankle) amputation]. Cox proportional hazards analysis was used to explore whether the PACSS classification was an independent predictor of clinical outcomes. Results are presented as the hazard ratio (HR) and 95% confidence interval (CI). RESULTS: The distribution of PACSS grades was 0 in 54%, grade 1 in 16%, grade 2 in 12%, grade 3 in 9%, and grade 4 in 9%. The 2-year primary patency rates in these grades, respectively, were 70.0%, 66.6%, 72.1%, 55.6%, and 36.3% (p<0.001). After multivariate analysis, PACSS grade 4 (HR 2.74, 95% CI 1.56 to 4.83, p<0.001), diabetes (HR 1.52, 95% CI 1.06 to 2.20, p=0.022), lesion length (HR 1.04, 95% CI 1.01 to 1.07, p=0.006), and vessel diameter (HR 0.80, 85% CI 0.65 to 0.98, p=0.038) were associated with loss of primary patency. PACSS grade 4 was also associated with MALE and mortality (p=0.048 and 0.011, respectively). Bare metal stent use (HR 0.47, 95% CI 0.30 to 0.73, p<0.001) was positively associated with primary patency. CONCLUSION: PACSS grade 4 calcification was independently associated with clinical outcomes after EVT for de novo SFA lesions.

Angioscopic assessment of peri-stent contrast staining following drug-eluting stent implantation.

BACKGROUND: Peri-stent contrast staining (PSS) has been recognized as a predictor of late stent thrombosis following drug-eluting stent (DES) implantation. However, the intravascular conditions at PSS sites remain unclear. METHODS AND RESULTS: We evaluated 10 patients (median age 72 years, 80% male) with stable angina pectoris by coronary angioscopy. The patients had a total of 11 DES implantations (5 sirolimus-eluting stents; 4 paclitaxel-eluting stents; 2 everolimus-eluting stents) that showed PSS. Neointimal coverage (NIC), presence of thrombus, and yellow plaques underneath the stent were compared between PSS and non-PSS sites for each stent. NIC was graded as: grade 0, struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts embedded by neointima, but translucent; grade 3, struts fully embedded and invisible. Mean follow-up was 394±206 days (median: 289). NIC grade was lower at PSS sites (P=0.021) with 8 out of 11 stents (73%) having grade 0. Angioscopy detected a thrombus more frequently at PSS sites than at non-PSS sites (64% vs. 9%, P=0.012). Yellow plaques tended to be more significant at PSS sites than at non-PSS sites (82% vs. 45%, P=0.091). CONCLUSIONS: The angioscopic findings suggest high thrombogenicity at PSS sites.

Angioscopic assessment of early phase arterial repair after paclitaxel-coated nitinol drug-eluting stent implantation in the superficial femoral artery.

BACKGROUND: Although durable clinical outcomes have been reported, arterial repair after paclitaxel-coated nitinol drug-eluting stent (Zilver PTX) implantation in the superficial femoral artery (SFA) remains unclear. METHODS AND RESULTS: Angioscopic evaluation was performed in SFA intra-stent surfaces 80±29 (range, 49-135) days or 84±18 (range, 52-112) days following Zilver PTX (20 stents in 10 patients; mean age, 72±8 years; 40% men) or bare metal stent (BMS; 14 stents in 9 patients; mean age, 70±7 years; 67% men) implantation, respectively. Neointimal coverage (NIC) was graded as 0, stent struts exposed; grade 1, struts bulging into the lumen, but still transparently visible although covered; grade 2, struts embedded in the neointima, but translucent; grade 3, struts fully embedded and invisible. NIC was defined as heterogeneous when the NIC grade variation was ≥1. Presence of yellow plaque and thrombus were investigated. Dominant NIC was significantly different between Zilver PTX (grade 0, 35%; grade 1, 20%; grade 2, 25%; grade 3, 20%) and BMS (grade 0, 7%; grade 1, 0%; grade 2, 14%; grade 3, 79%; P=0.001). NIC heterogeneity was less frequently observed in Zilver PTX (40% vs. 86%, P=0.009). Prevalence of yellow plaque or thrombus (75% vs. 79%, P=0.57) or thrombus (75% vs. 79%, P=0.57) were similar between Zilver PTX and BMS. CONCLUSIONS: Early phase arterial repair was different between Zilver PTX and BMS.

Angioscopic assessment of arterial repair following biodegradable polymer-coated biolimus A9-eluting stent implantation. - Comparison with durable polymer-coated sirolimus-eluting stent-.

BACKGROUND: Second-generation drug-eluting stents (DES) are expected to show better arterial repair than older DES. We angioscopically compared the biodegradable polymer-coated biolimus A9-eluting stent (BES) and durable polymer-coated sirolimus-eluting stent (SES) to explore differences in arterial repair. METHODS AND RESULTS: Angioscopy was performed 9 ± 1 months after 15 BES and 16 SES were implanted initially in the native coronary artery. Heterogeneity of neointimal coverage (NIC) as well as the dominant NIC grade was examined. NIC was defined as: grade 0 = fully visible struts; grade 1 = struts bulging into the lumen, but covered; grade 2 = embedded, but translucent struts; grade 3 = invisible struts. Heterogeneity was judged when the NIC grade varied ≥ 1. In-stent late loss (0.06 ± 0.23 vs. 0.07 ± 0.18 mm, P = 0.80), and dominant NIC grade (1.5 ± 0.8 vs. 1.3 ± 0.7, P = 0.45) were similar for BES and SES. Within the stents, NIC was more heterogeneous in SES than in BES (P = 0.035). 80% of BES showed homogeneous NIC, while 56% of SES had heterogeneous NIC. CONCLUSIONS: BES showed limited late loss similar to that for SES. Nonetheless, the NIC with BES was more homogeneous than that with SES. Biodegradable polymer-coated BES may have an advantage in homogeneous NIC.