Outcomes of Drug-Eluting Balloons for In-Stent Restenosis: Large Cohort Analysis and Single-Center Clinical Experience.

BACKGROUND: The use of drug-eluting balloons (DEBs) remains clinically relevant in the contemporary era of drug-eluting stent percutaneous coronary interventions (DES-PCI), especially in the setting of in-stent restenosis (ISR). Our goal was to assess the outcomes of ISR patients in a large prospective registry. METHODS: A total of 2329 consecutive patients with ISR-PCI (675 using DEB and 1654 with DES) were treated in our medical centre from 2010 to 2021. Clinical end points included mortality and major adverse cardiac events (MACE) at 1 year. Clinical outcomes were adjusted for multiple confounders. RESULTS: Mean ages (65.9 ± 11.0 vs 66.1 ± 10.5; P = 0.73) and percentages of female patients (16.6% vs 18.2%; P = 0.353) were similar between both ISR groups. Patients treated with DEB for ISR suffered more from diabetes, hypertension, and previous myocardial infarction (P < 0.01 for all) and presented more frequently with acute coronary syndrome (40.0% vs 34.4%; P = 0.01) compared with patients treated with DES for ISR. One-year MACE was significantly higher in the DEB ISR-PCI group (23.4% vs 19.6%; P = 0.002) compared to the DES ISR-PCI group, but no significant differences in mortality were observed at 1 year between the groups. After adjustment for multiple confounders, DEB ISR-PCI was not associated with increased MACE at 1 year (P = 0.55). CONCLUSIONS: In our large experience, patients treated with DEB for ISR-PCI have higher baseline risk and sustained increased MACE rates compared with DES ISR-PCI patients. After adjustment for confounding variables, clinical outcomes are similar between the groups at 1 year after PCI.

The Impact of Sex on Cardiogenic Shock Outcomes Following ST Elevation Myocardial Infarction.

BACKGROUND: Cardiogenic shock (CS) remains the leading cause of ST elevation myocardial infarction (STEMI)-related mortality. Contemporary studies have shown no sex-related differences in mortality. METHODS: STEMI-CS patients undergoing primary percutaneous coronary intervention (PPCI) were included based on a dedicated prospective STEMI database. We compared sex-specific differences in CS characteristics at baseline, during hospitalization, and in subsequent clinical outcomes. Endpoints included all-cause mortality and major adverse cardiac events (MACE). RESULTS: Of 3202 consecutive STEMI patients, 210 (6.5%) had CS, of which 63 (30.0%) were women. Women were older than men (73.2 vs. 65.5% y, p < 0.01), and more had hypertension (68.3 vs. 52.8%, p = 0.019) and diabetes (38.7 vs. 24.8%, p = 0.047). Fewer were smokers (13.3 vs. 41.2%, p < 0.01), had previous PCI (9.1 vs. 22.3% p = 0.016), or required IABP (35.3 vs. 51.1% p = 0.027). Women had higher rates of mortality (53.2 vs. 35.3% in-hospital, p = 0.01; 61.3 vs. 41.9% at 1 month, p = 0.01; and 73.8 vs. 52.6% at 3 years, p = 0.05) and MACE (60.6 vs. 41.6% in-hospital, p = 0.032; 66.1 vs. 45.6% at 1 month, p = 0.007; and 62.9 vs. 80.3% at 3 years, p = 0.015). After multivariate adjustment, female sex remained an independent factor for death (HR-2.42 [95% CI 1.014-5.033], p = 0.042) and MACE (HR-1.91 [95% CI 1.217-3.031], p = 0.01). CONCLUSIONS: CS complicating STEMI is associated with greater short- and long-term mortality and MACE in women. Sex-focused measures to improve diagnosis and treatment are mandatory for CS patients.

Temporal Trends in Complex Percutaneous Coronary Interventions.

Background: Accumulated experience combined with technological advancements in percutaneous coronary interventions (PCI) over the past four decades, has led to a gradual increase in PCI utilization and complexity. We aimed to investigate the temporal trends in PCI complexity and the outcomes of complex PCI (C-PCI) in our institution. Methods: We analyzed 20,301 consecutive PCI procedures performed over a 12-year period. C-PCI was defined as a procedure involving at least one of the following: Chronic total occlusion (CTO), left main (LM), bifurcation or saphenous vein graft (SVG) PCI. Four periods of 3-year time intervals were defined (2008-10, 2011-2013, 2014-2016, 2017-2019), and temporal trends in the rate and outcomes of C-PCI within these intervals were studied. Endpoints included mortality and major adverse cardiac events [MACE: death, acute myocardial infarction (MI), and target vessel revascularization (TVR)] at 1 year. Results: A total of 5,647 (27.8%) C-PCI procedures were performed. The rate of C-PCI has risen significantly since 2,017 (31.2%, p < 0.01), driven mainly by bifurcation and LM interventions (p < 0.01). At 1-year, rates of death, acute MI, TVR and MACE, were all significantly higher in the C-PCI group (8.8 vs. 5.1%, 5.6 vs. 4.5%, 5.5 vs. 4.0%, 17.2 vs. 12.2%, p < 0.001 for all, respectively), as compared to the non-complex group. C-PCI preformed in the latter half of the study period (2014-2019) were associated with improved 1-year TVR (4.4% and 4.8% vs. 6.7% and 7.1%, p = 0.01, respectively) and MACE (13.8% and 13.5% vs. 17.3% and 18.2%, p = 0.001, respectively) rates compared to the earlier period (2007-2013). Death rate had not significantly declined with time. Conclusion: In the current cohort, we have detected a temporal increase in PCI complexity coupled with improved 1-year clinical outcomes in C-PCI.

Biodegradable polymer drug-eluting stents versus durable polymer drug-eluting stents for percutaneous coronary intervention: a contemporary registry-based analysis.

AIMS: We aimed to compare the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) with biodegradable polymer drug-eluting stents (BP-DES) versus durable polymer drug-eluting stents (DP-DES). METHODS AND RESULTS: Among 11 517 PCIs with second-generation DES performed in our institution between 2007 and 2019, we identified 8042 procedures performed using DP-DES and 3475 using BP-DES. The primary outcome was target lesion failure, the composite target lesion revascularization (TLR), target vessel myocardial infarction and death. Propensity score matching was used to create a well-balanced cohort. Mean follow-up was 4.8 years. Of the 3413 matched pairs, 21% were females, and the mean age was 66 years. At 1 year, the primary outcome occurred in 8.3% patients versus 7.1% (P = 0.07), and TLR rate was 3% versus 2% (P = 0.006) in patients with DP-DES and BP-DES respectively. Within 5 years, the primary outcome occurred in 23.1% versus 23.4% (P = 0.44), and the rate of TLR was 7.2% versus 6.5% (P = 0.07) in patients with DP-DES and BP-DES, respectively. CONCLUSION: Similar rates of the composite outcome were observed throughout the entire follow-up. Target lesion revascularization rates were lower in the BP-DES group at 1-year but equalized within 5 years.

Trends in ST-elevation myocardial infarction.

AIMS: Despite recent progress in coronary artery disease treatment, ST-segment elevation myocardial infarction (STEMI) remains a very high-risk medical condition. Whether recent patients' outcomes, following implementation of the 2012 European Society of Cardiology (ESC) STEMI guidelines have improved, is yet unclear. METHODS AND RESULTS: The study was based on a prospective detailed registry of 2004 consecutive patients with STEMI treated with primary percutaneous coronary intervention (pPCI). We compared trends during two different time periods (2006-2012 vs. 2012-2018). Endpoints included mortality and major adverse cardiac events (MACE: death, repeat myocardial infarction, target vessel revascularization and coronary artery bypass surgery) at 1 month, 1 and 2 years. Rates of transradial interventions have risen significantly (67.3 vs. 42.0%; P < 0.01), as have rates of prasugrel administration (69.8 vs. 4.5%; P < 0.01) and use of drug eluting stents (75.5 vs. 56.5%; P < 0.01). Both at 1 and at 2 years, MACE was significantly lower in the later period (11.6 vs. 20.9%; P < 0.01 and 18.9 vs. 25.4%; P < 0.01 respectively), whereas mortality was only significantly lower after 1 year (5.8 vs. 8.6%; P = 0.02). Cox regression identified the later period (2012-2018) to independently and favorably impact MACE (hazard ratio, -0.69; 95% CI, 0.56-0.85; P < 0.01) but not mortality (hazard ratio, -0.76; 95% CI, 0.54-1.05; P = 0.09). CONCLUSION: Among patients treated with pPCI for STEMI, adoption of the contemporary evidence-based treatments is associated with better MACE derived outcomes, following the inception of the 2012 ESC guidelines. Nonetheless, the long-term mortality was marginally (but not significantly) lower, which indicates an unmet need for further improvement.

Impact of sex on outcomes of bifurcation lesion percutaneous coronary intervention: results from a single-centre prospective registry.

BACKGROUND: Coronary bifurcation lesions are technically and clinically more challenging compared to nonbifurcation lesions. Sex-related differences in diagnostic and invasive therapeutic coronary procedures have been described in the literature. Our objective was to assess the impact of sex on outcomes of bifurcation lesion percutaneous coronary intervention (PCI). METHODS: Our data were taken from a prospective registry of consecutive patients undergoing PCI for bifurcation lesions at our medical centre between 2004 and 2019. We compared rates of death and major adverse cardiac events (MACE) between men and women at 1 year and 3 years. MACE comprised cardiac death, myocardial infarction, target vessel revascularization or stroke. RESULTS: A total of 1209 patients were included, 948 (78.4%) were male and 261 (21.6%) were female. Women were older (mean age 69.7 ± 11 years vs. 63.1 ± 11 years, P < 0.01), and had more comorbidities than men. Female patients had more angiographically calcified (38.1% vs. 30.1%, P = 0.017) lesions. At 1-year follow up, there was no significant difference of MACE (18.8 vs. 15.2%, P = 0.183) or all-cause mortality (5.7% vs. 3.9%, P = 0.242) between sexes. At 3-year follow up, there was a significantly higher rate of MACE in women (29.1% vs. 22.5%, P = 0.026), this was driven by a significantly higher all-cause mortality (13.8% vs. 6.5%, P < 0.01). CONCLUSION: Women undergoing bifurcation PCI are older and have more comorbidities than their male counterparts. Intermediate term follow-up outcomes are similar between sexes. Poorer long-term outcomes of women are likely due to baseline higher risk profile.

Timing of Nonculprit Percutaneous Coronary Intervention after ST-Elevation Myocardial Infarction.

INTRODUCTION: Complete revascularization of ST-elevation myocardial infarction (STEMI) patients with multivessel disease (MVD) has recently shown to reduce risk of adverse cardiovascular events, including cardiovascular death. Optimal timing of revascularization of nonculprit lesions remains controversial. We aimed to measure cardiac outcomes related to duration between primary percutaneous coronary intervention (pPCI) of the culprit lesion and staged PCI (sPCI) of nonculprit lesions. METHODS: From a prospectively collected consecutive registry of 3,002 patients treated for STEMI by pPCI, 1,555 patients with MVD requiring sPCI were identified. Patients were placed into quartiles of duration to sPCI: 0-7 days (Q1), 7-22 days (Q2), 22-42 days (Q3), >42 days (Q4), excluding those who had complete revascularization at the index event. Major adverse cardiac events (MACEs) included all-cause mortality, myocardial infarction, target vessel revascularization, and coronary artery bypass surgery. Cox regression and propensity score matching were performed correcting for confounding factors. RESULTS: The average age at presentation was 65.7 ± 11.5 years. 333 were female (21.4%). Mean time between pPCI and sPCI was 28.3 days (±24.8). Rates of MACE were Q1 - 16.5%, Q2 - 21.2%, Q3 - 25.8%, and Q4 - 30.1% (log-rank <0.001). Following regression analysis, sPCI remained an independent risk factor for MACE (hazard ratio [HR] = 1.226 [95% confidence interval {CI}: 1.129-1.331, p < 0.001]). There was no association between the time interval up to sPCI with all-cause death (HR = 1.022 [95% CI: 0.925-1.129, p = 0.671]). CONCLUSIONS: Patients with MVD are at increased risk of experiencing MACE after revascularization of nonculprit vessels with increasing time delay between pPCI and sPCI.

Elderly Suffering from ST-Segment Elevation Myocardial Infarction-Results from a Database Analysis from Two Mediterranean Medical Centers.

Background: Little is known regarding primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI) in the elderly. Methods: Data on 319 octogenarians, 641 septuagenarians, and 2451 younger patients was collected from an ongoing prospective registry of patients treated with pPCI for STEMI at two Mediterranean-area medical centers in 2009-2017. Results: More octogenarian patients were female (40.8 vs. 31.9 septuagenarians and 26.5% under 70 y, p < 0.01), had hypertension (79.5 vs. 69.5 and 45.9%, p < 0.01), renal failure (32.5 vs. 20.1 and 5.2%, p < 0.01), and a lower left-ventricular ejection fraction (42.0 vs. 44.9 and 47.6%, p = 0.012). At 1 month and 3 years after intervention, mortality was higher in the octogenarian patients (12.2 vs. 7.9%, p = 0.01; and 36.7 vs. 23.1%, p < 0.01, respectively), with no significant differences in the rates of recurrent myocardial infarction, target vessel revascularization, coronary artery bypass surgery, and cardiovascular death. Following adjustment for confounders, 3-year mortality was significantly higher in the octogenarians (HR 3.89 vs. 3.19 for septuagenarians, p < 0.01), but rates of major adverse cardiac events or cardiovascular death were not. Conclusions: Despite suffering from higher all-cause mortality, octogenarian patients treated with pPCI for STEMI do not suffer an increased risk of ischemic cardiac events relative to younger patients.

Temporal trends in short and long-term outcomes after percutaneous coronary interventions among cancer patients.

While mortality of acute coronary syndrome (ACS) is known to have steadily decline over the last decades, data are lacking regarding the complex sub-population of patients with both coronary artery disease and cancer. A large single-center percutaneous coronary intervention (PCI) registry was used to retrieve patients who had a known diagnosis of malignancy during PCI. Patients were divided into two groups according to the period in which PCI was performed (period 1: 2006-2011, period 2: 2012-2017). Cox regression hazard models were implemented to compare primary endpoint, defined as the composite outcomes of major adverse cardiac events (MACE) (which include cardiovascular death, myocardial infarction or target vessel revascularization) and secondary endpoint of all-cause mortality, between the two time periods. A total of 3286 patients were included, 1819 (55%) had undergone PCI in period 1, and 1467 (45%) in period 2. Both short- and long-term MACE and overall mortality were significantly lower in patients who underwent PCI at the latter period (2.3% vs. 4.3%, p < 0.001 and 1.1% vs. 3.2%, p < 0.001 after 30 days and 24% vs. 30%, p < 0.001 and 12% vs. 22%, p < 0.001 after 2 years, respectively). However, in a multivariate analysis, going through PCI in the latter period was still associated with lower rates of overall mortality (HR 0.708, 95% confidence interval [CI] 0.53-0.93, p = 0.014) but there was no significant difference in MACE (HR 0.83, 95% CI 0.75-1.42, p = 0.16). Patients with cancer undergoing PCI during our most contemporary period had an improved overall survival, but no significant differences were observed in the composite cardiovascular endpoints, compared to an earlier PCI period. The management of coronary patients with cancer disease remains challenging.

Trends in Ischemic Mitral Regurgitation Following ST-Elevation Myocardial Infarction Over a 20-Year Period.

Background: Ischemic mitral regurgitation (IMR) is a common complication of acute ST-elevation myocardial infarction (STEMI). Little is known regarding the impact of IMR over a long period of follow up. Methods: Of 3,208 consecutive STEMI patients from a prospective registry, full echocardiographic information was available for 2,985 patients between the years 2000 and 2020. We compared the two decades- 2001 to 2010 and 2011 to 2020, and assessed for the presence of IMR at baseline, 3 (range 2-6) months and 12 (range 10-14) months after the index event. Results: One thousand six hundred and sixty six patients were included in the first decade, 1,319 in the second. Mean patient age was 61.3 ± 12.3 years, 21.1% female patients in the first decade vs. 60.9 ± 12.0 years and 22.2% female in the second (p = 0.40 and p = 0.212, respectively). Rates of moderate IMR or above during the index admission were 17.2% in the first period and 9.3% in the second one (p < 0.001). After 3 months, the rate of IMR was 48.5% for those who suffered from IMR at baseline, vs. 9.5% for those without IMR at baseline (HR- 4.2, p < 0.001). Death rates for those with moderate IMR or above were 14.7% and 17.8% after 1 and 2 years, respectively, vs. 7.3 and 9.6% for those without (p < 0.001 for both). IMR was associated with 1 year mortality in multivariate analysis (HR-1.37; 1.09-2.20, p = 0.009), as well as in propensity score matched analysis (HR 1.29; CI: 1.07-1.91; p < 0.001). Conclusions: IMR is a common complication following acute STEMI, impacting prognosis. Rates of IMR have declined significantly over the years.

Independent Impact of Peripheral Artery Disease on Percutaneous Coronary Intervention.

Background Peripheral artery disease (PAD) is a known risk factor for adverse outcomes in patients undergoing percutaneous coronary intervention. However, in some studies PAD is not an independent risk factor. We sought to examine the independent impact of PAD on a large prospective percutaneous coronary intervention registry. Methods and Results From our single-center prospective percutaneous coronary intervention registry, we have retrospectively analyzed 25 690 patients (years 2004-2018). We examined the influence of PAD on short- and long-term outcomes using both regression and propensity-matched analyses. Patients with documented PAD (n=1610, 6.3% of total) were older (66.7±10.8 versus 65.4±12.1, P<0.01), had higher rates of diabetes mellitus (69.3% versus 46.3%, P<0.01), hypertension (92.1% versus 76.1%, P<0.01) and renal failure (38.3% versus 18.2%, P<0.01). There were no differences in the rates of stable versus acute presentations, but less were treated with Prasugrel and Ticagrelor (3.3% versus 8.0% and 7.9% versus 11.9%, respectively, P<0.001 for both). Both 30-day and 3-year rates of all-cause death and major adverse cardiac events were higher for patients with PAD versus control (4.9% versus 2.1% and 7.3% versus 3.3% death and major adverse cardiac events at 30 days, respectively; 43.4% versus 29.0% and 55.0% versus 37.8%, respectively at 3 years, P<0.001 for all). Following multivariate analysis, the presence of PAD was associated with a higher risk of both death (hazard ratio [HR], 1.66; CI 1.52-1.83; P<0.001) and major adverse cardiac events (HR, 1.51; CI, 1.40-1.64; P<0.001). Conclusions PAD constitutes an independent risk factor for adverse outcomes in patients undergoing percutaneous coronary intervention. Further studies are needed to ascertain which effective therapies may mitigate this risk.

A risk score based on simple angiographic characteristics to aid in choosing the optimal revascularization strategy for patients with multivessel disease presenting with ST-elevation myocardial infarction.

BACKGROUND: The optimal revascularization strategy is not clearly defined for patients with ST-elevation myocardial infarction with multivessel disease (MV-STEMI). We aimed to develop a simple angiographic risk score for identifying patients with MV-STEMI that might benefit from a multivessel percutaneous coronary intervention (MV-PCI), compared to a PCI for only the infarct-related artery (IRA-PCI). METHODS AND RESULTS: This retrospective study acquired data from a single-center STEMI registry on 841 consecutive patients with MV-STEMI (645 IRA-PCI and 196 MV-PCI). Patients were stratified according to high- and low-risk scores. We devised a score based on three characteristics of non-culprit lesions previously reported to predict overall mortality (proximal left anterior descending artery involvement, maximal % stenosis, and number of involved vessels). The primary endpoint was major adverse cardiac events (MACEs: a composite of death/MI/urgent repeat revascularization). After a median follow-up of 1909 days, MACE occurred in 205/841 (24.4%) patients. MACE risk was higher in the high-risk than in the low-risk group (HR 1.43, P < 0.001). In comparing the IRA-PCI and MV-PCI approaches within each risk group, we found that these revascularization strategies had differential effects on outcome. Compared to the MV-PCI, IRA-PCI was associated with less MACE in the low-risk group (HR 0.597, P = 0.033), and more MACE in the high-risk group (HR 3.14, P < 0.001). CONCLUSION: For patients with MV-STEMI that undergo primary PCI, a simple risk score based on three angiographic characteristics could identify patients at high risk of future adverse events. This score might facilitate choosing the optimal revascularization strategy.

Long-term outcomes of percutaneous coronary intervention for unprotected left main coronary artery according to the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) score.

BACKGROUND: Percutaneous coronary intervention (PCI) of unprotected left-main coronary artery (uLMCA) is increasingly performed. Although it is recommended to calculate the SYNTAX score, if uLMCA PCI is considered, data of outcomes by the SYNTAX score are scarce, particularly among patients with high score (SYNTAX ≥ 33). OBJECTIVE: To evaluate long-term outcomes of uLMCA PCI according to SYNTAX score in real-world practice. METHODS: Patients following PCI of uLMCA throughout 2006-2018, in a tertiary hospital, were included and classified into three groups according to the SYNTAX I score. The primary outcome was three-year major adverse cardiac event (MACE) comprising all-cause mortality, myocardial infarction (MI), target vessel revascularization (TVR), or coronary artery bypass surgery (CABG). RESULTS: Overall 632 patients were analyzed, mean age 72.8 ± 11.5, males: 69%, classified as following: SYNTAX <22 (n = 225); SYNTAX 22-32 (n = 250) and SYNTAX ≥33 (n = 157). Patients with greater SYNTAX score had higher prevalence of diabetes mellitus, renal failure, peripheral arterial disease and stroke. Additionally, they had lower ejection fraction, greater EuroScore, and number of vessels involved. Procedural success rates were very high (>95%) and did not depend on the SYNTAX score. The rates of MACE and its components were significantly higher in patients with higher SYNTAX score. Multivariate analysis showed that SYNTAX score is an independent predictor of three-year MACE following uLMCA PCI [HRSYNTAX22-32 = 3 (95% confidence interval [CI]: 1.2-11.5), HRSYNTAX≥33 = 3.4 (95% CI: 1.8-13.3]. CONCLUSIONS: Despite the high success rates of uLMCA PCI in real-world patients with high SYNTAX score, the latter was significantly associated with worse three-year outcomes.

Prognostic significance of the Medina classification in bifurcation lesion percutaneous coronary intervention with second-generation drug-eluting stents.

The Medina classification is the most widespread method to describe bifurcation lesions. However, little is known regarding its prognostic impact. Therefore, the aim of this study is to assess the prognostic significance of the Medina classification following percutaneous coronary intervention (PCI). From a prospective registry of 738 consecutive patients undergoing PCI for bifurcation lesions, 505 were treated with second-generation drug-eluting stents (DES). Of these, 407 (80.6%) presented with "true bifurcation" (TB) lesions (Medina class 1.0.1, 1.1.1, 0.1.1) and 98 (19.4%) in all other categories ("non-true bifurcation" = NTB). We compared rates of death and major adverse cardiac events (MACE: cardiac death, myocardial infarction, or target vessel revascularization) at 12 months and 3 years. Patients with TB had lower rates of previous bypass surgery (7.4% vs. 11.2%, p = 0.043). TB lesions were more likely to be calcified (33.9% vs. 28.6%, p = 0.003) and ulcerated (8.8% vs. 4.1%, p < 0.01). At 12 months, mortality was numerically higher for TB PCI (4.1% vs. 2.1%, p = 0.052) and MACE rates were higher (19.2% vs. 10.2%, p < 0.001). At 3 years, both all-cause death (10.1% vs. 5.1%, p = 0.002) and rates of MACE (37.2% vs. 17.6%, p < 0.001) were higher for TB PCI. After performing regression analysis, TB remained an independent predictor for poor outcomes (OR-2.28 at 12 months, CI 1.45-9.50, p = 0.007, OR-3.75 at 3 years, CI 1.52-6.77, p = 0.001 for MACE). In conclusion, TB lesions, according to the Medina classification, portend worse prognosis for patients undergoing bifurcation PCI. This may guide prognostication and decision-making in treatment.

Temporal trends in the practice of the transradial approach for percutaneous coronary intervention in a large tertiary center.

OBJECTIVE: The transradial approach (TRA) has increasingly been adopted for the use of percutaneous coronary interventions (PCI), with reported clinical benefits. Little is known regarding the change in outcomes over time. PATIENTS AND METHODS: From our large single-center PCI registry, we have analyzed 15 429 patients in two periods - 2008-2012 (period 1) and 2013-2017 (period 2). We examined the proportions of use of TRA, the influence on in-hospital outcomes, and adjusted long-term effects. RESULTS: The rate of TRA rose from 15.9% in period 1 to 69.1% in period 2, including in specific situations such as acute coronary syndrome, chronic total occlusion, bifurcation, calcified lesions, and unprotected left main PCI. In-hospital rates of bleeding were lower for TRA versus transfemoral artery (1.8 vs. 5.1%, overall, P < 0.001), as were rates of additional bleeding events in the following 12 months (1.3 vs. 2.4%, P < 0.001). Following multivariate analysis, use of TRA was associated with a lower 30-day and 4-year rate of the composite outcomes of death, myocardial infarction, target vessel revascularization, or coronary artery bypass surgery [at 4 years, hazard ratio (HR) = 0.86; 95% confidence interval (CI): 0.77-0.96; P = 0.007, during period 1 and HR = 0.62; 95% CI 0.55-0.7; P < 0.0001 during period 2]. Interaction analysis showed a stronger effect at the latter period (HR = 0.69, 95% CI: 0.59-0.81, P < 0.001). CONCLUSION: Over a decade of follow-up, TRA has gained acceptance for different PCI scenarios, including complex patients - a course which is associated with consistent short and long-term clinical benefits.

Outcomes of primary percutaneous cardiac intervention for ST elevation myocardial infarction with a saphenous vein graft culprit.

BACKGROUND: Patients treated with primary percutaneous coronary intervention (pPCI) for ST elevation myocardial infarction (STEMI) who have a history of coronary artery bypass grafting (CABG) are at high risk of adverse cardiovascular outcomes. Data on the risk of a saphenous vein graft (SVG)-infarct-related artery (IRA) compared to other culprit vessels are sparse. METHODS: The study was based on a prospectively collected registry of 2,405 consecutive patients with STEMI attending a tertiary medical center in 2001-2017. Patients with an SVG-IRA (n = 172) were compared with patients with native vessel disease (n = 2,333) for mortality and major adverse cardiac events (MACE), which included death, myocardial infarction (MI), target vessel revascularization (TVR), and coronary artery bypass surgery (CABG) at 1 month and 3 years. RESULTS: The SVG-IRA group was significantly older than the native vessel group (p = .05), with no between-group differences in rates of male patients (76 vs. 82%, p = .59), diabetes (24.2 vs. 26.2%, p = .73), and renal failure (18.8 vs. 9.2%, p = .25). Mortality was higher in the SVG-IRA group at 1 month (13.9 vs. 2.5%, p < .01) and 3 years (23.9 vs. 7.4%, p < .01). At 3 years, SVG-IRA was associated with the highest rates of MACE (55.6%), compared with native vessel disease. After correction for confounders, SVG-IRA remained an independent risk factor for MACE both at 1 month (HR-2.08, 95%CI 1.72-3.11, p < .01) and 3 years (HR-2.01, 95%CI 1.28-3.09, p < .01). CONCLUSION: Among patients treated with pPCI for STEMI, outcomes are worse when the culprit is an SVG.

Prediction of mortality in hospital survivors of STEMI: External validation of a novel acute myocardial infarction prognostic score.

INTRODUCTION & OBJECTIVE: Recently we developed and internally-validated the Soroka Acute Myocardial Infarction (SAMI) Score for prediction of all-cause long-term mortality (c-statistic 0.83-0.94) among hospital-survivors of AMI. We aimed to perform an external-validation of the SAMI score for long-term risk-stratification of STEMI patients undergoing PCI. METHODS & SETTINGS: A prospective registry of 1273 STEMI patients treated using primary PCI and discharged alive from Rabin Medical Center in Israel between 2004 and 2014 (age 60.8 ±â€¯12.5 years, 83% males) was utilized for the validation. Chi-square test and logistic regression were used for calibration, and c-statistic (ROC procedure) for discrimination assessment of the SAMI score. RESULTS: All-cause mortality following one- and 5-years post-discharge was 3.8% and 8.1%, respectively. SAMI score values ranged between (-5) and (+15) points (median 2-points). In a univariate analysis the SAMI score variables were significantly associated with 1- and 5-years mortality. Higher SAMI score was associated with increased risk for dying: a one-point increase was associated with OR of 1.33 (95%CI: 1.24-1.42, p < 0.001) and 1.37 (95%CI: 1.29-1.44, p < 0.001) for 1- and 5-years mortality respectively. No statistically significant difference was found in the currently observed mortality rates by groups of SAMI score and the expected mortality rates as per the SAMI score index. The c-statistics were 0.82 and 0.83 for 1- and 5-year mortality, respectively. CONCLUSIONS: The SAMI score is a simple, robust and now also externally-validated prognostic tool for prediction of long-term all-cause mortality in hospital survivors of STEMI.

Accuracy of Fractional Flow Reserve Derived From Coronary Angiography.

BACKGROUND: Measuring fractional flow reserve (FFR) with a pressure wire remains underutilized because of the invasiveness of guide wire placement or the need for a hyperemic stimulus. FFR derived from routine coronary angiography (FFRangio) eliminates both of these requirements and displays FFR values of the entire coronary tree. The FFRangio Accuracy versus Standard FFR (FAST-FFR) study is a prospective, multicenter, international trial with the primary goal of determining the accuracy of FFRangio. METHODS: Coronary angiography was performed in a routine fashion in patients with suspected coronary artery disease. FFR was measured in vessels with coronary lesions of varying severity using a coronary pressure wire and hyperemic stimulus. Based on angiograms of the respective arteries acquired in ≥2 different projections, on-site operators blinded to FFR then calculated FFRangio using proprietary software. Coprimary end points were the sensitivity and specificity of the dichotomously scored FFRangio for predicting pressure wire-derived FFR using a cutoff value of 0.80. The study was powered to meet prespecified performance goals for sensitivity and specificity. RESULTS: Ten centers in the United States, Europe, and Israel enrolled a total of 301 subjects and 319 vessels meeting inclusion/exclusion criteria which were included in the final analysis. The mean FFR was 0.81 and 43% of vessels had an FFR≤0.80. The per-vessel sensitivity and specificity were 94% (95% CI, 88% to 97%) and 91% (86% to 95%), respectively, both of which exceeded the prespecified performance goals. The diagnostic accuracy of FFRangio was 92% overall and remained high when only considering FFR values between 0.75 to 0.85 (87%). FFRangio values correlated well with FFR measurements ( r=0.80, P<0.001) and the Bland-Altman 95% confidence limits were between -0.14 and 0.12. The device success rate for FFRangio was 99%. CONCLUSIONS: FFRangio measured from the coronary angiogram alone has a high sensitivity, specificity, and accuracy compared with pressure wire-derived FFR. FFRangio has the promise to substantially increase physiological coronary lesion assessment in the catheterization laboratory, thereby potentially leading to improved patient outcomes. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique Identifier: NCT03226262.

Online Angiography Image-Based FFR Assessment During Coronary Catheterization: A Single-Center Study.

OBJECTIVES: To assess the diagnostic performance of angiography-derived fractional flow reserve (FFRangio) measurements in patients with stable coronary artery disease when used online in the catheterization laboratory during routine coronary angiography. BACKGROUND: FFR, an index of the hemodynamic severity of coronary stenosis, is derived from invasive measurements using a pressure-monitoring guidewire and hyperemic stimulus. While FFR is the gold standard, it remains under-utilized. FFRangio may have several advantages owing to the reduced operator time, no wire-related or procedural complications, and no need for administration of vasodilators. METHODS: FFRangio is a novel technology that uses a patient's hemodynamic data and routine angiograms to generate FFR values at each point along the coronary tree. We present the online application of the system where FFRangio was successfully used in the catheterization laboratory during routine coronary angiography and compared to invasive FFR. Fifty-three patients (79% men) and 60 coronary lesions were analyzed. RESULTS: Values derived using FFRangio ranged from 0.58-0.96 and correlated closely (Pearson's correlation coefficient, r=0.91; P<.001) with the invasive FFR measurements (range, 0.52-0.97). The 95% limits of agreement between invasive and non-invasive FFR ranged from -0.065 to 0.07 using Bland-Altman analysis. For an FFR cut-off value of 0.80, the sensitivity, specificity, and diagnostic accuracy of FFRangio were 86%, 100%, and 95%, respectively. CONCLUSIONS: This is the first report of using the online application of the FFRangio system. In this single-center experience, FFRangio values showed high correlation rates to invasive FFR.

Temporal trends in percutaneous coronary interventions thru the drug eluting stent era: Insights from 18,641 procedures performed over 12-year period.

BACKGROUND: The last decade, regarded as the DES era in PCI, has witnessed significant advances in the management of coronary disease. We aimed to assess temporal trends in the practice and outcome of percutaneous coronary intervention (PCI) during the drug eluting stent (DES) era. METHODS: We analyzed 18,641 consecutive PCI's performed between January 2004 and December 2016, distinguished by procedural date (Q1 : 2004-2006, n = 4,865; Q2 : 2007-2009, n = 4,977; Q3 : 2010-2012, n = 4,230; Q4 : 2013-2016, n = 4,569). RESULTS: At presentation, mean patients age was 65 (±11) years and 22.8% were females. Over time, there was a rise in the relative number of octogenarians (Q1 : 10.7% vs Q4 : 15.5%, P < 0.001) and an increase in the burden of most comorbidities (e.g., left ventricular dysfunction ≥ moderate and chronic kidney disease, P < 0.001 for both). Despite a 2-fold increase in the rate of complex interventions, and a 3-fold increase in the rate of unprotected left-main angioplasty (P < 0.001 for both), the radial approach was increasingly adopted (Q1 : 2% to Q4 : 63.5%, P < 0.001). DES implantation increased from 43% to 83% at the expense of bare metal stent (BMS) application, and accompanied by drug coated balloon sprout to 1.8%, P < 0.001. Kaplan-Meier survival curves revealed a time-based enhanced outcome, with a decreased rate of death, MI, target vessel revascularization and CABG over the years. CONCLUSIONS: In the last decade, PCI has evolved to offer better outcome to more elderly, sicker patient population, with more complex coronary disease interventions. The shift to second generation DES and to enhanced PCI techniques may explain part of this progress.