Serial Optical Coherence Tomography Assessment of Coronary Atherosclerosis and Long-Term Clinical Outcomes.

BACKGROUND: The impact of high-risk coronary artery plaques identified using optical coherence tomography on late luminal narrowing and clinical events remains poorly understood. METHODS AND RESULTS: This multicenter prospective study included 176 patients who underwent percutaneous coronary intervention and serial optical coherence tomography at baseline and 1-year follow-up to investigate nontarget regions with angiographically intermediate stenosis. At 1 year after percutaneous coronary intervention, the coronary artery lumen area decreased significantly from 6.06 (95% CI, 5.60-6.53) mm2 to 5.88 (95% CI, 5.41-6.35) mm2 (difference, -0.18; 95% CI, -0.22 to -0.14 mm2; P<0.001), particularly in thin-cap fibroatheromas, thick-cap fibroatheromas, mixed plaques, and fibrous plaques. The prevalence of fibroatheroma decreased from 38% to 36% (P<0.001), whereas calcified plaque increased from 31% to 34% (P<0.001), accompanied by a significant increase in calcium thickness and angle. Diabetes and current smoking habits were independently associated with increasing calcium prevalence. Patients with thin-cap fibroatheroma had a significantly higher 3-year risk of ischemia-driven nontarget vessel revascularization (hazard ratio, 2.42 [95% CI, 1.03-5.71]; P=0.04), primarily due to revascularization in the imaged region. No significant association was observed between coronary artery calcium prevalence and clinical outcomes within 3 years. CONCLUSIONS: The coronary artery lumen area significantly decreased over a 1-year interval, particularly in thin-cap fibroatheromas, thick-cap fibroatheromas, mixed plaques, and fibrous plaques. Although thin-cap fibroatheroma prevalence was associated with higher risk of ischemia-driven nontarget vessel revascularization, no significant association was noted between coronary artery calcium prevalence and clinical outcomes within 3 years. The interaction between calcium progression and long-term clinical events necessitates further investigation. REGISTRATION: URL: https://www.umin.ac.jp/ctr/; Unique Identifier: UMIN000031937.

Association between cancer history and second-generation drug-eluting stent thrombosis: insights from the REAL-ST registry.

BACKGROUND: Cancer-associated thrombosis is a frequent complication of cancer; however, little evidence is available regarding the association between cancer history and coronary artery stent thrombosis (ST). We aimed to investigate the relationship between cancer history and second-generation drug-eluting stent thrombosis (G2-ST). METHODS: From the REAL-ST (Retrospective Multicenter Registry of ST After First- and Second-Generation Drug-Eluting Stent Implantation) registry, this study evaluated 1265 patients (G2- ST cases, n = 253; controls, n = 1012) with cancer-related information available. RESULTS: The prevalence of patients with cancer history was higher (12.3% vs. 8.5%, p = 0.065), and that of currently diagnosed and currently treated cancer was significantly higher in ST cases than controls (3.6% vs. 1.4%, p = 0.021; 3.2% vs. 1.3%, p = 0.037, respectively). Multivariable logistic regression analysis revealed that cancer history was associated with late ST (odds ratio [OR]: 2.80, 95% confidence intervals [CI]: 0.92-8.55, p = 0.071) and very late ST (OR: 2.40, 95% CI: 1.02-5.65, p = 0.046), but not with early ST (OR: 1.01, 95% CI: 0.51-2.00, p = 0.97). During the median follow-up period of 872 days after the index ST events, patients with cancer history showed a higher mortality than those without, among both ST cases (hazard ratio [HR]: 1.93, 95% CI: 1.06-3.51, p = 0.031) and controls (HR: 1.93, 95% CI: 1.09-3.40, p = 0.023). CONCLUSION: A post hoc analysis of REAL-ST registry revealed that patients with G2-ST had a higher prevalence of currently diagnosed and currently treated cancer. Notably, cancer history was associated with the occurrence of late and very late ST, but not with early ST.

Long-term outcomes of balloon-expandable transcatheter aortic valve replacement in Japanese patients.

BACKGROUND: Data on long-term outcomes of transcatheter aortic valve replacement (TAVR) in Japanese patients beyond 5 years are limited. METHODS: Between June 2010 and December 2014, 55 consecutive inoperable or high surgical risk patients underwent TAVR with SAPIEN XT valves (Edwards Lifesciences, Irvine, CA, USA) for severe aortic stenosis at our institution. Among them, 2 patients were excluded from the analysis because one was converted to open surgery during the TAVR procedure and the other could not undergo TAVR due to device delivery failure. We retrospectively analyzed long-term clinical outcomes of these 53 patients (mean age: 84.1 years; mean STS score: 8.4) who had at least a 7-year follow-up after TAVR. RESULTS: The rates of freedom from all-cause and cardiovascular deaths at 7 years were 35.8 % and 79.3 %, respectively. The moderate or severe structural valve deterioration (SVD) rate at 5 and 7 years was 7.2 % and 11.4 %, respectively. The rate of bioprosthetic valve failure (BVF) at 7 years was 6.2 %. CONCLUSIONS: The 7-year mortality rate of inoperable or high surgical risk patients treated with SAPIEN XT was high, while the cardiovascular mortality rate was acceptable. Although the poor survival rate limited the long-term assessment of SAPIEN XT valve durability, the incidence of SVD and BVF was not rare.

Three-dimensional optical coherence tomography versus intravascular ultrasound in percutaneous coronary intervention for the left main coronary artery.

We aimed to compare the intravascular imaging findings, and clinical outcomes between three-dimensional optical coherence tomography (OCT)- and intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) for the left main coronary artery (LMCA). We enrolled 331 patients underwent OCT- or IVUS-guide single crossover stenting across the side branch (SB) and subsequent kissing balloon inflation (KBT) for LMCA bifurcation. Primary endpoint was defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization. Of 331 patients, 58 patients (17.5%) underwent OCT-guide PCI. OCT-guide PCI associated with higher frequency of proximal optimization technique (POT) (98.3% vs 85.3%, P = 0.013) and smaller balloon size of POT (4.29 ± 0.44 mm vs 4.43 ± 0.42, P = 0.02) than IVUS-guide PCI. Although maximal stent area at LMCA and minimal stent area at main vessel were significantly smaller in OCT-guide PCI in intravascular imaging (P = 0.01, and P = 0.002, respectively), the restenosis rate at follow-up angiography was comparable in both groups (15.2% vs. 9.4%, P = 0.387). Cumulative rate of primary endpoint was not significantly different between 2 groups both before and after propensity score adjustment (7.0% vs. 7.4%, P = 0.98 and 2.6% vs. 7.3%, P = 0.18). In conclusion, the clinical outcomes at 1 year were comparable, suggesting OCT- and IVUS-guided PCI for LMCA were similarly feasible. The balloon size of POT in OCT-guide PCI might be influenced by the limited visibility in the proximal LMCA.

Clinical Outcomes and Angiographic Results of Bailout Stenting for Guide Catheter-Induced Iatrogenic Coronary Artery Dissection　- Impact of Stent Type.

BACKGROUND: Guide catheter-induced iatrogenic coronary artery dissection is a rare but feared complication. When it occurs, bailout stenting is widely performed; however, its prognosis and the impact of stent type remains unclear.Methods and Results:The study population consisted of 77,257 consecutive patients (coronary angiography, 55,864; percutaneous coronary intervention, 21,393) between 2000 and 2015. We investigated the incidence, clinical outcomes, and angiographic results after bailout stenting and compared by stent type: bare-metal stent (BMS) and drug-eluting stent (DES). Iatrogenic coronary artery dissection occurred in 105 patients (incidence rate, 0.14%). All cases of iatrogenic coronary artery dissection that were recognized as requiring bailout procedure could be managed by stent implantation, and no patients died during bailout procedure. The 5-year cumulative incidences of cardiac death, target lesion revascularization, and major adverse cardiac events were 11.3%, 10.3%, and 21.0%, respectively. The binary restenosis rate was 10.4%, and it was not significantly different between BMS and DES implantation. In lesions with preprocedural stenosis, however, it was significantly lower in the DES group than in the BMS group. On the other hand, coronary artery dissection recurred in 8 patients, which was observed only after DES implantation. CONCLUSIONS: The immediate and long-term outcomes of bailout stenting for iatrogenic coronary artery dissection were acceptable. Although DES may be favorable for stenotic lesions, coronary artery dissection can recur after DES implantation.

Long-term outcomes of three-vessel coronary artery disease after coronary revascularization by percutaneous coronary intervention using second-generation drug-eluting stents versus coronary artery bypass graft surgery.

Studies on the outcomes of de novo three-vessel coronary artery disease (3VD) are limited. This study evaluated the outcomes after coronary revascularization in patients with 3VD treated by percutaneous coronary intervention (PCI) using second-generation drug-eluting stents (2ndDES) in comparison with coronary artery bypass grafting (CABG). We analyzed 853 patients undergoing either PCI or CABG for 3VD between 2010 and 2014. Of them, this study included 298 undergoing PCI with 2ndDES alone (PCI group) and 171 undergoing CABG (CABG group). The primary outcome measure was a composite of all-cause death, non-fatal myocardial infarction (MI), or stroke. The secondary outcome measures were cardiac death, MI, stroke, and target vessel revascularization (TVR). Propensity matching was used to adjust a cohort of patients with similar baseline characteristics. Between the PCI and CABG groups, no significant differences were found in the 3-year cumulative incidence of the primary outcome measure (14.9% vs. 12.9%, p = 0.60). After propensity score matching, no significant differences were found in the incidences of primary outcome measure (13.0% vs. 12.8%, p = 0.95), cardiac death, MI, and stroke (3.5% vs. 2.7%, p = 0.72; 1.2% vs. 0.0%, p = 0.31; and 4.9% vs. 3.1%, p = 0.35), whereas that of TVR was significantly higher in the PCI group (24.5 vs. 7.1%, p < 0.01). Compared with CABG, PCI with second-generation DES was not associated with higher risk of clinical outcomes, but was associated with a higher risk of TVR in the treatment of 3VD.

Delayed Valsalva obstruction after transcatheter self-expandable aortic valve implantation: a case report.

BACKGROUND: Delayed coronary obstruction after transcatheter aortic valve implantation has been reported to occur more commonly after self-expandable aortic valve implantation than balloon-expandable valve. CASE SUMMARY: An 86-year-old woman treated by transcatheter self-expandable aortic valve implantation had acute coronary syndrome 3 months after the procedure. Emergent coronary angiography showed decreased blood flow in the left coronary artery. Balloon angioplasty between the valve frame and the left coronary cusp was performed, and her ischaemia resolved. Contrast-enhanced computed tomography showed a commissural post of the supra-annular valve overlying the left coronary cusp, and serial computed tomography showed the valve frame expanding over time. She received coronary bypass grafting using saphenous vein grafts for the left anterior descending and left circumflex arteries. Four months after surgery for the left anterior descending artery, the patient had recurrent chest pain, and computed tomography showed a graft occlusion in the left anterior descending artery. Shortly afterwards, she died of sudden cardiac arrest. DISCUSSION: In this report, we describe delayed Valsalva obstruction after transcatheter self-expandable aortic valve implantation, which can be detectable by serial computed tomography. The sealing of a coronary cusp by a commissural post of the valve may be one of the causes of delayed coronary ischaemia after transcatheter self-expandable aortic valve implantation.

Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial.

Importance: Very short mandatory dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with a drug-eluting stent may be an attractive option. Objective: To test the hypothesis of noninferiority of 1 month of DAPT compared with standard 12 months of DAPT for a composite end point of cardiovascular and bleeding events. Design, Setting, and Participants: Multicenter, open-label, randomized clinical trial enrolling 3045 patients who underwent PCI at 90 hospitals in Japan from December 2015 through December 2017. Final 1-year clinical follow-up was completed in January 2019. Interventions: Patients were randomized either to 1 month of DAPT followed by clopidogrel monotherapy (n=1523) or to 12 months of DAPT with aspirin and clopidogrel (n=1522). Main Outcomes and Measures: The primary end point was a composite of cardiovascular death, myocardial infarction (MI), ischemic or hemorrhagic stroke, definite stent thrombosis, or major or minor bleeding at 12 months, with a relative noninferiority margin of 50%. The major secondary cardiovascular end point was a composite of cardiovascular death, MI, ischemic or hemorrhagic stroke, or definite stent thrombosis and the major secondary bleeding end point was major or minor bleeding. Results: Among 3045 patients randomized, 36 withdrew consent; of 3009 remaining, 2974 (99%) completed the trial. One-month DAPT was both noninferior and superior to 12-month DAPT for the primary end point, occurring in 2.36% with 1-month DAPT and 3.70% with 12-month DAPT (absolute difference, -1.34% [95% CI, -2.57% to -0.11%]; hazard ratio [HR], 0.64 [95% CI, 0.42-0.98]), meeting criteria for noninferiority (P < .001) and for superiority (P = .04). The major secondary cardiovascular end point occurred in 1.96% with 1-month DAPT and 2.51% with 12-month DAPT (absolute difference, -0.55% [95% CI, -1.62% to 0.52%]; HR, 0.79 [95% CI, 0.49-1.29]), meeting criteria for noninferiority (P = .005) but not for superiority (P = .34). The major secondary bleeding end point occurred in 0.41% with 1-month DAPT and 1.54% with 12-month DAPT (absolute difference, -1.13% [95% CI, -1.84% to -0.42%]; HR, 0.26 [95% CI, 0.11-0.64]; P = .004 for superiority). Conclusions and Relevance: Among patients undergoing PCI, 1 month of DAPT followed by clopidogrel monotherapy, compared with 12 months of DAPT with aspirin and clopidogrel, resulted in a significantly lower rate of a composite of cardiovascular and bleeding events, meeting criteria for both noninferiority and superiority. These findings suggest that a shorter duration of DAPT may provide benefit, although given study limitations, additional research is needed in other populations. Trial Registration: ClinicalTrials.gov Identifier: NCT02619760.

Risk Factors and Long-Term Clinical Outcomes of Second-Generation Drug-Eluting Stent Thrombosis.

Background The risk factors and long-term clinical outcomes of patients with definite stent thrombosis (ST) after second-generation drug-eluting stent (DES) implantation have not yet been adequately assessed. Methods and Results The REAL-ST (Retrospective Multicenter Registry of ST After First- and Second-Generation DES Implantation) included 313 definite ST of second-generation DES (early ST, n=179; late ST, n=66; very late ST, n=68). Four patients without definite ST of second-generation DES were identified as control patients for each ST case. Risk factors of definite ST were mostly different according to the timing of ST: ST-segment-elevation myocardial infarction, non-ST-segment-elevation myocardial infarction, and unstable angina at presentation, current smoking, left ventricular ejection fraction <40%, prior percutaneous coronary intervention, stent overlap, severely calcified lesion, left main coronary artery lesion, proximal left anterior descending lesion, postdiameter stenosis ≥20%, for early ST; age <70 years, ST-segment-elevation myocardial infarction at presentation, hemodialysis, left ventricular ejection fraction <40%, in-stent restenosis, and severely calcified lesion for late ST; and proximal left anterior descending lesion and in-stent restenosis for very late ST. Cumulative 4-year incidence of death after the index ST events was significantly higher in the ST patients than control patients (33.0% versus 12.3%, P<0.001 for early ST versus control; 30.6% versus 14.2%, P<0.001 for late ST versus control; and 28.0% versus 13.0%, P<0.001 for very late ST versus control, respectively). Conclusions Risk factors of definite ST after second-generation DES implantation were mostly different according to the timing of ST. Definite ST patients showed unfavorable long-term clinical outcomes compared with those without definite ST. Clinical Trial Registration URL: https://www.umin.ac.jp . Unique identifier: UMIN000025181.

Impact of retrograde approach on long-term clinical outcomes of patients undergoing coronary chronic total occlusion interventions.

AIMS: The aim of the study was to assess the long-term outcomes of coronary chronic total occlusion (CTO) lesions after retrograde percutaneous coronary intervention (PCI) in comparison with those after antegrade PCI alone. METHODS AND RESULTS: A total of 842 consecutive patients (928 CTO lesions) undergoing PCI and subsequent follow-up were classified into two groups: retrograde PCI for at least one CTO (n=302, retrograde group) and antegrade PCI alone (n=540, antegrade group). The total procedural success rate was 89.7%. The retrograde group had significantly higher incidences of periprocedural myocardial infarction and coronary perforation (7.3% vs. 3.7%, p=0.01; 7.9% vs. 4.4%, p=0.04, respectively). Median follow-up duration was 7.7 (interquartile range 5.6-8.7) years. Seven-year relative risk comparing the retrograde and antegrade groups was neutral in all-cause death (adjusted HR [aHR] 1.06, 95% CI: 0.75-1.49; p=0.745), cardiac death (aHR 0.85, 95% CI: 0.47-1.55; p=0.598), coronary artery bypass grafting (aHR 1.62, 95% CI: 0.74-3.54; p=0.229), and non-target vessel revascularisation (aHR 0.96, 95% CI: 0.78-1.17; p=0.663). CONCLUSIONS: Retrograde CTO PCI did not lead to worse long-term outcomes despite increased risk in periprocedural myocardial infarction and coronary perforation.

Severe Aortic Stenosis in Dialysis Patients.

BACKGROUND: Characteristics and prognosis of hemodialysis patients with severe aortic stenosis have not yet been well defined. METHODS AND RESULTS: The CURRENT AS (contemporary outcomes after surgery and medical treatment in patients with severe aortic stenosis) registry, a Japanese multicenter registry, enrolled 3815 consecutive patients with severe aortic stenosis. There were 405 hemodialysis patients (initial aortic valve replacement [AVR] group: N=135 [33.3%], and conservative group: N=270) and 3410 nonhemodialysis patients (initial AVR group: N=1062 [31.1%], and conservative group: N=2348). The median follow-up duration after the index echocardiography was 1361 days, with 90% follow-up rate at 2 years. The cumulative 5-year incidence of all-cause death was significantly higher in hemodialysis patients than in nonhemodialysis patients in both the entire cohort (71% versus 40%, P<0.001) and in the initial AVR group (63.2% versus 17.9%, P<0.001). Among hemodialysis patients, the initial AVR group as compared with the conservative group was associated with significantly lower cumulative 5-year incidences of all-cause death (60.6% versus 75.5%, P<0.001) and sudden death (10.2% versus 31.7%, P<0.001). Nevertheless, the rate of aortic valve procedure-related death, which predominantly occurred within 6 months of the AVR procedure, was markedly higher in the hemodialysis patients than in the nonhemodialysis patients (21.2% and 2.3%, P<0.001). CONCLUSIONS: Among hemodialysis patients with severe aortic stenosis, the initial AVR strategy as compared with the conservative strategy was associated with significantly lower long-term mortality risk, particularly the risk for sudden death, although the effect size for the survival benefit of the initial AVR strategy was smaller than that in the nonhemodialysis patients.

Five-Year Outcomes After Paclitaxel-Coated Balloon Angioplasty for Drug-Eluting Stent Restenosis.

The long-term outcomes of patients who underwent paclitaxel-coated balloon (PCB) angioplasty for drug-eluting stent restenosis (DES-ISR) remain unclear. We investigated the 5-year safety and efficacy outcomes of PCB angioplasty for DES-ISR. The study included 185 patients with 216 DES-ISR lesions who underwent PCB angioplasty from September 2008 to December 2010. Two serial angiographic follow-ups were routinely scheduled at 6 and 18 months after the index procedure. Five-year clinical outcomes were investigated. The mean duration of follow-up was 2,052 ± 352.5 days, and 94.1% of the patients completed the 5-year follow-up. Recurrent restenosis was observed in 48 lesions (22.2%) at the 6-month follow-up and late restenosis was observed in 22 lesions (14.3%) at the 18-month follow-up. Very late restenosis was observed in 6 lesions (6.8%), and target lesion revascularization (TLR) was performed for 8 lesions (13.6%) beyond 24 months after the procedure. The cumulative rates of TLR at 1, 2, and 5 years were 16.4%, 28.9%, and 34.1%, respectively. In patients who underwent TLR, 87% (52 of 60 patients) underwent TLR within the first 2 years after the index procedure. Multivariable analysis revealed that in-stent occlusion lesion (odds ratio [OR] 2.21; 95% confidence interval [CI] 1.09 to 4.47; p = 0.03), postprocedural percent diameter stenosis >35% (OR 3.19; 95% CI 1.54 to 6.68; p = 0.001), and right coronary artery ostial lesions (OR 5.56; 95% CI 1.40 to 24.9; p = 0.01) were independent predictors of recurrent restenosis. In conclusion, our results suggest that long-term outcomes after PCB angioplasty are acceptable; however, close follow-up during the first 2 years following this procedure may be necessary.

Late Restenosis After Paclitaxel-Coated Balloon Angioplasty Occurs in Patients With Drug-Eluting Stent Restenosis.

BACKGROUND: There are currently inadequate data on whether "late restenosis" occurs after paclitaxel-coated balloon (PCB) angioplasty for in-stent restenosis (ISR) lesions. OBJECTIVES: To evaluate the long-term safety and efficacy of PCB angioplasty, we investigated serial clinical and angiographic outcomes after PCB angioplasty for ISR lesions. METHODS: Between September 2008 and December 2012, PCB angioplasty was performed in 468 patients with 550 ISR lesions (bare-metal stent restenosis [BMS-ISR]: 114 lesions, drug-eluting stent restenosis [DES-ISR]: 436 lesions). Two serial angiographic follow-ups were routinely planned for the patients (at 6 and 18 months after the procedure). RESULTS: Early follow-up (6 months) angiography was performed for 488 lesions (89%), and recurrent restenosis occurred in 13 lesions (13.0%) in the BMS-ISR group and in 82 lesions (21.1%) in the DES-ISR group. Target lesion revascularization was performed for 7 lesions (7.0%) in the BMS-ISR group and 54 lesions (13.9%) in the DES-ISR group. Late follow-up (18 months) angiography was performed for 377 (88%) of the remaining 427 lesions (excluding target lesion revascularization lesions), and late restenosis was found in 2 lesions (2.5%) in the BMS-ISR group and 50 lesions (16.8%) in the DES-ISR group. Delayed late lumen loss was significantly larger in the DES-ISR group. Previous stent size ≤2.5 mm, percentage diameter stenosis after the procedure, and in-stent occlusion lesion were independent predictors of early restenosis. DES-ISR, percentage diameter stenosis at early follow-up, and hemodialysis were independent predictors of late restenosis. CONCLUSIONS: Late restenosis occurs after PCB angioplasty for DES-ISR lesions.