Thrombus aspiration in late presenters with ST‐elevation myocardial infarction: A single‐center randomized trial

Objectives

To examine whether routine thrombus aspiration (TA) is associated with improved myocardial salvage in patients with ST‐elevation myocardial infarction (STEMI) presenting ≥12 h after onset of symptoms.

Background

TA is a recognized treatment option in patients with STEMI undergoing primary percutaneous coronary intervention (PPCI) especially in the setting of heavy thrombus burden. However, data on the role of TA in STEMI patients presenting late after onset of symptoms are limited.

Methods

In this single‐center prospective randomized study, patients with subacute STEMI presenting ≥12 and ≤48 h after symptom onset were randomized to primary PCI with or without manual TA in a 1:1 ratio. The primary endpoint was the myocardial salvage index assessed with Single Photon Emission Computed Tomography (SPECT) on admission and 4 days later.

Results

A total of 60 patients underwent randomization. Baseline characteristics were comparable between groups. TA was associated with improved myocardial salvage index compared with control group (60.1 ± 11.1% vs 28.1 ± 21.3%; P = <0.001). Furthermore, TA was associated with improved post‐procedural TIMI flow (2.9 ± 0.3 vs 2.5 ± 0.6; P = 0.003), myocardial blush grade (2.9 ± 0.3 vs 2.2 ± 0.8, P = <0.001), and reduction in left ventricular end‐diastolic dimensions (50.4 ± 4.3 mm vs 54.4 ± 5.8 mm, P = 0.004) compared with the control group. Clinical outcomes at 30 days and 6 months were similar between both groups.

Conclusions

TA might be associated with improved reperfusion and myocardial salvage especially in STEMI patients presenting after 12 h from symptom onset who are likely to have a heavy thrombus burden.

     

Low‐Dose Heparin for Elective Percutaneous Coronary Intervention

Objectives

We evaluated the safety and efficacy of low‐dose heparin (40 IU/kg) for elective percutaneous coronary intervention (PCI).

Background

Current guidelines recommend a 70–100 IU/kg bolus of heparin for elective PCI, but this dose may be associated with increased bleeding risk. Low‐dose heparin may have an advantage in this regard, but has not been well studied.

Methods

From January 2008 to October 2012, 300 patients underwent elective transfemoral PCI and were treated with an initial bolus of 40 IU/kg of heparin at the UCLA Medical Center. Dual antiplatelet therapy with clopidogrel and aspirin was administered prior to or just after diagnostic coronary angiography. The primary end‐point was the composite of cardiac death, myocardial infarction, urgent target vessel revascularization for ischemia, or major bleeding within 30 days after PCI.

Results

The mean activating clotting time was 233 ± 28 seconds. The primary end‐point occurred in 2.3%. The cardiac death rate was 0.3% but was not related to the PCI. The myocardial infarction rate was 1.3%. Urgent target vessel revascularization occurred in 1 patient (0.3%). The major bleeding rate was 0.3%. No stent thrombosis occurred.

Conclusion

Using a lower dose of heparin with dual antiplatelet therapy is safe and is associated with a low bleeding risk after transfemoral PCI while providing suppression of ischemic events. This may also represent a cost savings compared with other antithrombotic strategies. A randomized clinical trial comparing low‐dose heparin with bivalirudin in patients is required to determine the optimal anticoagulation strategy. (J Interven Cardiol 2014;27:58–62)

     

Comparison of three treatment strategies for patients with triple‐vessel coronary disease and left ventricular dysfunction

Introduction

Current guidelines recommend coronary artery bypass grafting (CABG) for patients with multivessel coronary disease and left ventricular (LV) dysfunction. However, some patients undergo percutaneous coronary intervention (PCI) or solely medical therapy (MT) in actual practice. The comparison of long‐term outcomes of these three treatment strategies in real world is unclear.

Methods

A total of 699 consecutive patients in a single centre from 2004 to 2011 who had TVD and LV ejection fraction ≤40%, no prior PCI or CABG and had completed a median 6.2‐year follow‐up were evaluated. The primary endpoint was all‐cause death. The secondary endpoints included cardiac death, major adverse cardiovascular and cerebrovascular events (MACCE; composite of all‐cause death, myocardial infarction, repeat revascularization, or stroke), and the individual components of the composite endpoint.

Results

One hundred forty‐two patients (20.3%) underwent PCI, 201 (28.8%) underwent CABG while 356 (50.9%) received MT alone. MT alone was associated with the worst survival (P < 0.001). Compared with PCI, CABG was associated with a similar risk of all‐cause death (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.52‐1.41; P = 0.54) but lower risks of cardiac death (HR, 0.47; 95%CI, 0.25‐0.91; P = 0.03), repeat revascularization (HR, 0.29; 95%CI, 0.10‐0.85; P = 0.02), and MACCE (HR, 0.63; 95%CI, 0.43‐0.93; P = 0.02).

Conclusions

For patients with TVD and LV dysfunction, both CABG and PCI were associated with a lower risk of mortality compared with MT alone. Compared with PCI, CABG has a lower risk of cardiac death, repeat revascularization, and MACCE.

     

Sex‐based differences in bleeding and long‐term adverse events after percutaneous coronary intervention in older patients with coronary artery disease

Objectives

Differences in outcomes for women and men after percutaneous coronary intervention (PCI) in older patients remain controversial. Herein, we compared 2‐year outcomes by sex in Chinese older patients undergoing PCI.

Methods

A total of 4926 consecutive patients (33.6% women, age ≥60 years, mean age 67.4 ± 5.7 years) who underwent PCI at a single center in China from January 2013 to December 2013 were included in this study. The primary endpoint was 2‐year risk of bleeding according to the Bleeding Academic Research Consortium definitions. The secondary endpoints included 2‐year risk of major adverse cardiovascular and cerebrovascular events (MACCE). Hazard ratios were generated using multivariable Cox regression.

Results

Compared with men, women had significantly higher rates of in‐hospital all‐cause mortality (0.8% vs 0.2%, P = 0.001), cardiac death (0.5% vs 0.1%, P = 0.006), MACCE (2.4% vs 1.5%, P = 0.017), and bleeding (0.4% vs 0.1%, P = 0.015). At 2‐year follow up, there were no differences between men and women for all‐cause mortality (1.9% vs 1.8%, P = 0.839) and 2‐year MACCE (13.1% vs 11.8%, P = 0.216). However, women had a higher risk of 2‐year bleeding (9.2% vs 6.2%, P < 0.001), which persisted after adjusting for baseline differences and treatment characteristics (hazard ratio 1.35, 95% confidence interval 1.06‐1.71; P = 0.014).

Conclusion

We found that older women undergoing PCI were at increased risk of 2‐year bleeding compared with men. Further dedicated studies are needed to confirm these findings.

     

Long‐Term Outcome of Patients with Severe Biventricular Heart Failure and Severe Mitral Regurgitation After Percutaneous Edge‐to‐Edge Mitral Valve Repair

Objective

To assess long‐term outcome and parameters associated with poor and favorable outcome in patients with a left ventricular ejection fraction (LV‐EF) ≤25% and severe mitral regurgitation (MR) after percutaneous edge‐to‐edge mitral valve repair (pMVR).

Background

There is no data on long‐term outcome in this cohort of patients.

Methods

We analyzed all 34 patients with a LV‐EF ≤25% and severe MR treated with pMVR in 2 university hospitals from 2009 to 2012.

Results

Mitral regurgitation could be successfully reduced to grade ≤2 in 30 patients (88%). Long‐term follow‐up (up to 5 years) revealed a steep decline of the survival curve reaching 50% already 8 month after pMVR. In contrast, estimated survival of the remaining patients showed a favorable long‐term outcome. Patients deceased during the first year presented with higher right ventricular tricuspid pressure gradient (RVTG) (44.5 ± 8.4 mmHg vs. 35.2 ± 15.4 mmHg, P = 0.035) and worse RV‐function (P = 0.014) prior to the procedure. One‐year mortality of patients with pulmonary hypertension and depressed RV‐function (n = 22) was very high (77%) compared to the remaining patients (n = 12, mortality rate of 0%, P = 0.0001).

Conclusions

Although pMVR lead to a successful reduction of MR in patients with a LV‐EF ≤25%, 1‐year mortality in this cohort was very high. However, a subgroup of patients showed a favorable long‐term outcome after pMVR. Especially the right ventricular parameters sustained RV‐function and absence of pulmonary hypertension—easily assessed with echocardiography—might be used to identify this subgroup and encourage pMVR in these patients.

     

Femoral Access PCI in a Default Radial Center Identifies High‐Risk Patients With Poor Outcomes

Background

Increasingly the trans‐radial route (TRR) is preferred over the trans‐femoral route (TFR) for PCI. However, even in high volume default TRR centers a cohort of patients undergo TFR PCI. We examined the demographics, procedural characteristics, and outcomes of patients undergoing PCI via the TF.

Methods

The patient demographics, procedural data, and outcomes of 5,379 consecutive patients undergoing PCI at a default radial center between 2009 and 2012 were examined. Major bleeding (MB) was classified by ACUITY and BARC definitions.

Results

A total of 559 (10.4%) patients underwent PCI via the TFR and 4,820 patients via the TRR (89.6%). Baseline variables associated with TFR were shock, previous CABG, chronic total occlusion intervention, rotablation/laser use, female sex, and renal failure. Sixty‐five patients of the TFR cohort (11.6%) experienced MB with 27 (41.5%) being access site related. MB was significantly more frequent than in the radial cohort. The variables independently associated with MB in the TFR cohort were renal failure, acute presentation, shock, and age. In the TFR, patients with MB mortality was high at 30 days (17.2% vs 2.6% for no MB, P < 0.0001) and at 1 year (37.6% vs 5.0%, P < 0.0001). Shock and MB were highly predictive of 30 day and 12 month mortality.

Conclusion

In a default radial PCI center 10% of patients undergo PCI via the femoral artery. These patients have high baseline bleeding risk and undergo complex interventions. As a result the incidence of major bleeding, transfusion and death are high. Alternative strategies are required to optimize outcomes in this select group. (J Interven Cardiol 2015;28:485–492)

     

Variability in Maximal Suggested Door‐in‐Door‐out Time for Hospitals Transferring Patients for Primary Angioplasty in STEMI

Objectives

We derived a formula for maximal suggested door‐in‐door‐out time (DIDO) for hospitals that do not perform primary percutaneous coronary intervention (PCI) for ST‐elevation myocardial infarction (STEMI).

Background

Efforts to minimize DIDO at non‐PCI hospitals can improve door‐to‐balloon time (D2B). Targeting a maximal suggested DIDO for a transferring hospital can influence reperfusion strategy.

Methods

We examined time to treatment intervals for 193 STEMI patients who underwent primary PCI at our hospital. D2B in transferred patients (D2B_T) was divided into 3 intervals: transferring hospital DIDO, inter‐hospital transport time, and interventional time. We defined maximal suggested DIDO as the maximum DIDO that would allow PCI with D2B_T ≤120 minutes.

Results

D2B was higher in transfer compared to on‐site patients (147 ± 52 vs. 75 ± 44 minutes, P < 0.0001). In transfer patients, treatment time intervals were: DIDO 80 ± 42 minutes, transport time 37 ± 18 minutes, interventional time 35 ± 16 minutes. The greatest variability in D2B_T was related to DIDO. We estimated that maximal suggested DIDO = [120 ? (transport time plus interventional time)]. Using a fixed interventional time of 40 minutes, we simplified this as: maximal DIDO = 80 ? transport time. Maximal suggested DIDO for 4 transferring hospitals in our network ranged from 1 to 65 minutes. DIDO under the hospital‐specific threshold was the strongest predictor of achieving D2B_T <120 minutes.

Conclusions

Transferring hospitals' maximal suggested DIDO is variable, and can be calculated from inter‐hospital transport time. Instead of a universal target DIDO (e.g., <30 minutes), maximal suggested DIDO can be calculated individually for each non‐PCI hospital within a STEMI network.

     

The impact of successful revascularization of coronary chronic total occlusions on long‐term clinical outcomes in patients with non‐ST‐segment elevation myocardial infarction

Objectives

The purpose of this study was to assess the long‐term clinical impact of revascularization of coronary concomitant coronary chronic total occlusion (CTO) in patients with Non‐ST‐segment elevation myocardial infarction (NSTEMI).

Background

CTO is associated with poorer prognosis in patients with NSTEMI. The evidence of revascularization of CTO in patients with NSTEMI is still conflicting.

Methods

Consecutive patients with NSTEMI and CTO who underwent percutaneous coronary intervention (PCI) within 72 h of admission from 2006 to 2015 were retrospectively recruited and analyzed. A total of 967 patients underwent PCI for NSTEMI. Among them, 106 (11%) patients had concomitant CTO and were recruited for analysis. CTO lesions were revascularized successfully in 67 (63.2%) patients (successful CTO PCI group), while the CTO in the remaining 39 patients were either not attempted or failed (No/failed CTO PCI group).

Results

The 30‐day cardiac death and major adverse cardiac events (MACE) were significantly lower in the successful CTO PCI group (both cardiac death and MACE were 3% vs 30%, P < 0.001, respectively). A landmark analysis set at 30th day for 30‐day survivals was performed. After a mean of 2.5‐year follow‐up, the long‐term cardiac death was still significantly lower (16.9% vs 42.3%, P < 0.001), whereas the MACE showed a trend toward lower incidence (26.2% vs 40.7%, P = 0.051) in the successful CTO PCI group. In multivariate Cox regression analysis, successful revascularization of CTO is an independent protective predictor for long‐term cardiac death (HR 0.310, 95% CI, 0.109‐0.881, P = 0.028) in all population and in propensity‐score matched cohort (P = 0.007).

Conclusions

Successful revascularization of CTO was associated with reduced risk of long‐term cardiac death in patients with NSTEMI and concomitant CTO.

     

Percutaneous Closure of Post‐Infarction Ventricular Septal Defects—An Over Decade‐long Experience

Objectives

To report an over decade‐long experience with percutaneous post‐infarction ventricular septal defect (PIVSD) closure.

Background

PIVSDs remains a major clinical challenge with extremely high mortality. Data concerning interventional closure of PIVSD is scarce.

Methods

All percutaneous PIVSD closures performed between 2003 and 2016 in 8 participating centres were identified. Data concerning patients and procedures was acquired. Patients were divided into two groups, based on the time interval between VSD diagnosis and closure (≤14 days—acute phase, >14 days—non‐acute phase).

Results

Twenty‐one percutaneous PIVSD closures were performed on 20 patients (9 females, mean age: 70 years). Mean interval between the diagnosis and the procedure was 182.6 ± 500 days (range: 7–2228). Defects were mostly located in apical (55%) segments of the septum. In 7 cases (33%) the procedure was performed in the acute phase. The closure was technically successful in 17 cases (81%). Four patients died within 48 hours after the procedure. 30‐days survival rate of the entire cohort was 70%. Univariate analysis revealed impact of technical success of the procedure (HR 0.13, CI 0.03–0.68 P = 0.016) and white blood cell count (HR 1.36 per unit increase, CI 1.1–1.69, P = 0.005) on 30‐day mortality.

Conclusions

In a selected population of patients percutaneous PIVSD closure is feasible and provides satisfactory survival rate. Procedural success has a protective impact on survival. Timing of the closure remains controversial. Procedure in the non‐acute phase carries lower mortality, but at the same time introduces a selection bias. Larger registry‐based studies are required.

     

Everolimus‐Eluting Stents Versus Sirolimus‐ or Paclitaxel‐Eluting Stents: Two‐Year Results from the Guthrie Health Off‐Label Stent (GHOST) Registry

Objectives

We sought to compare the safety and effectiveness of everolimus‐eluting stents (EES) versus first generation drug‐eluting stents (FG‐DES; sirolimus‐eluting stent [SES] or paclitaxel‐eluting stent [PES]).

Methods

In 2,126 patients undergoing percutaneous coronary intervention (PCI), we compared the 2‐year incidence of stent thrombosis (ST) and target vessel revascularization (TVR) between the EES versus FG‐DES groups. Secondary end‐points included all‐cause death, myocardial infarction (MI), death or MI, and major adverse cardiovascular events (MACE, including death, MI, ST, or TVR). Further, we evaluated these end‐points in 2 propensity‐matched subgroups: EES versus SES; EES versus PES.

Results

Complete 2‐year follow‐up was available in 1,911 (90%) patients. Compared to FG‐DES, implantation of EES was associated with trends towards lower ST (0.9% vs. 2.8%, P = 0.068) and TVR (3.8% vs. 7.2%, P = 0.052), which persisted after adjustment for baseline differences (for ST, adjusted hazard ratio, HR 0.32; 95% confidence interval, 95% CI 0.10–1.02, P = 0.053; for TVR, HR 0.40; 95% CI 0.22–0.75, P = 0.004). Compared to SES, EES implantation was associated with lower TVR and a trend towards lower ST. Compared to PES, EES implantation was associated with less ST and TVR and trends towards lower death/MI and MACE. In the EES group, no ST was seen after the first 3 months.

Conclusions

The use of EES compared to FG‐DES appears to be associated with reductions in ST and TVR at 2‐year follow‐up. Improved outcomes with EES are observed in comparison with SES as well as PES. (J Interven Cardiol 2013;26:153–162)

     

Predictors for long‐term survival after transcatheter edge‐to‐edge mitral valve repair

Objectives

To determine predictors for long‐term outcome in high‐risk patients undergoing transcatheter edge‐to‐edge mitral valve repair (TMVR) for severe mitral regurgitation (MR).

Background

There is no data on predictors of long‐term outcome in high‐risk real‐world patients.

Methods

From August 2009 to April 2011, 126 high‐risk patients deemed inoperable were treated with TMVR in two high‐volume university centers.

Results

MR could be successfully reduced to grade ≤2 in 92.1% of patients (116/126 patients). Long‐term clinical follow‐up up to 5 years (95.2% follow‐up rate) revealed a mortality rate of 35.7% (45/126 patients). Repeat mitral valve treatment (surgery or intervention) was needed in 19 patients (15.1%). Long‐term clinical improvement was demonstrated with 69% of patients being in NYHA class ≤II. In a multivariable Cox regression analysis, the post‐procedural grade of MR (hazard ratio [HR] 1.55 per grade, P = 0.035), the left ventricular ejection fraction (HR 0.58 for difference between 75th and 25th percentile, P = 0.031) and the glomerular filtration rate (HR 0.33 for 75th vs 25th percentile, P < 0.001) were independent predictors for long‐term mortality. Patients with primary MR and a post‐procedural MR grade ≤1 had the most favorable long‐term outcome.

Conclusions

This study determines predictors of long‐term clinical outcome after TMVR and demonstrates that the grade of residual MR determines long‐term survival. Our data suggest that it might be of benefit reducing residual MR to the lowest possible MR grade using TMVR—especially in selected high‐risk patients with primary MR who are not considered as candidates for surgical MVR.

     

Renal Protection Using Remote Ischemic Peri‐Conditioning During Inter‐Facility Helicopter Transport of Patients With ST‐Segment Elevation Myocardial Infarction: A Retrospective Study

Objective

To assess the impact of remote ischemic peri‐conditioning (RIPC) during inter‐facility air medical transport of ST‐segment elevation myocardial infarction (STEMI) patients on the incidence of acute kidney injury (AKI) following primary percutaneous coronary intervention (pPCI).

Background

STEMI patients who receive pPCI have an increased risk of AKI for which there is no well‐defined prophylactic therapy in the setting of emergent pPCI.

Methods

Using the ACTION Registry‐GWTG, we evaluated the impact of RIPC applied during inter‐facility helicopter transport of STEMI patients from non‐PCI capable hospitals to 2 PCI‐hospitals in the United States between March, 2013 and September, 2015 on the incidence of AKI following pPCI. AKI was defined as ≥0.3 mg/dL increase in creatinine within 48–72 hours after pPCI.

Results

Patients who received RIPC (n = 127), compared to those who did not (n = 92), were less likely to have AKI (11 of 127 patients [8.7%] vs. 17 of 92 patients [18.5%]; adjusted odds ratio = 0.32, 95% CI 0.12–0.85, P = 0.023) and all‐cause in‐hospital mortality (2 of 127 patients [1.6%] vs. 7 of 92 patients [7.6%]; adjusted odds ratio = 0.14, 95% CI 0.02–0.86, P = 0.034) after adjusting for socio‐demographic and clinical characteristics. There was no difference in hospital length of stay (3 days [interquartile range, 2–4] vs. 3 days [interquartile range, 2–5], P = 0.357) between the 2 groups.

Conclusion

RIPC applied during inter‐facility helicopter transport of STEMI patients for pPCI is associated with lower incidence of AKI and in‐hospital mortality. The use of RIPC for renal protection in STEMI patients warrants further in depth investigation.

     

Underutilization of Percutaneous Coronary Intervention for ST‐Elevation Myocardial Infarction in Medicaid Patients Relative to Private Insurance Patients

Objective

To determine whether disparities in access to invasive cardiac procedures still exist for Medicaid patients, given how old earlier studies are and given changes in the interim in appropriateness guidelines.

Patients and Methods

A total of 5,022 Medicaid and private insurance patients in New York from January 1, 2008 through December 31, 2009 under age 65 with ST‐elevation myocardial infarction (STEMI) were compared with regard to their access to percutaneous coronary interventions (PCI) before and after controlling for numerous patient characteristics and other important factors.

Results

Medicaid patients were significantly less likely to be admitted initially to a hospital certified to perform PCI (90.4% vs. 94.3%, P < 0.001). Also, Medicaid patients were found to be significantly less likely to undergo PCI than other patients (adjusted odds ratio [AOR] = 0.81, 95% CI 0.66, 0.98, P = 0.03). When the probability of each hospital performing PCI for STEMI patients was controlled for, Medicaid patients were still less likely to undergo PCI after controlling for other risk factors (AOR = 0.80, 95% CI 0.65, 0.99, P = 0.04).

Conclusions

Medicaid STEMI patients are significantly less likely to undergo PCI within the same day of admission as private pay patients even after adjusting for patient characteristics related to receiving PCI, and the strength of this relationship is not diminished when controlling for whether the admitting hospital has approval to perform PCI or controlling for the tendency of the admitting hospital to treat STEMI with PCI. (J Interven Cardiol 2013;26:470‐481)

     

Complete versus incomplete revascularization with drug‐eluting stents for multi‐vessel disease in stable,unstable angina or non‐ST‐segment elevation myocardial infarction: A meta‐analysis

Objectives

To determine whether drug‐eluting stent (DES) coronary complete revascularization (CR) confers clinical benefit over incomplete revascularization (IR) in patients with multivessel coronary artery disease (MVD).

Background

Clinical benefit of CR over IR in patients with MVD with angina (both stable and unstable) and non‐ST‐segment elevation myocardial infarction (NSTEMI) in DES has not been well studied.

Methods

We conducted a systematic online literature search of PUBMED and EMBASE. Literatures that compared the clinical outcomes between CR and IR with exclusively or majority (>80%) using DES in patients without or included only small portion (<20%) of ST‐segment elevation myocardial infarction or single‐vessel coronary artery disease were included. Hazards ratio (HR) with 95% confidence interval (CI) was calculated with random‐effects model.

Results

No randomized clinical trials were identified. A total of 14 observational studies with total of 41 687 patients (CR 39.6% and IR 60.4%) were included in this meta‐analysis. CR was associated with lower incident of all‐cause mortality (HR 0.71, P = 0.001), major adverse events (HR 0.75, P < 0.001), cardiovascular mortality (HR 0.39, P < 0.001). Meta‐regression analysis showed that CR significantly reduced the risk of all‐cause mortality in advanced age, triple vessel disease and male sub‐groups.

Conclusions

CR with DES conferred favorable outcomes compared to IR in MVD patients with stable, unstable angina or NTEMI. Further research to achieve higher CR in MVD patients may lead to improvement in prognosis in these cohorts.

     

Short‐term Effect of Upstream Administration in Comparison to Deferred Injection of Tirofiban on Patients with Acute ST‐Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Background

High bolus dose tirofiban has been demonstrated to provide greater inhibition of platelet aggregation, but the most appropriate timing of its administration remains unknown.

Objectives

To evaluate the efficacy of upstream vs. deferred administration of tirofiban in patients with acute ST‐segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI) on clinical outcomes.

Methods

The 660 patients with acute ST‐segment elevation myocardial infarction undergoing primary percutaneous coronary intervention were divided into upstream (n = 330, administration of tirofiban to all patients in emergency room) and deferred groups (n = 330, treatment of patients with large thrombus burden or no‐reflow phenomenon in cardiac catheterization laboratory during PCI). The primary end‐points were death, nonfatal myocardial infarction (MI), stent thrombosis (ST), revascularization of targeted vessels (TVR) or major adverse cardiac events (MACE) at 1 month and 6 months following PCI, with safety end‐point at 7 days.

Results

Compared with that of the deferred group, there was a significant increase of left ventricular ejection fraction (LVEF) in the upstream group within 7 days (55.5 ± 6.6% vs. 54.6 ± 7.9%, P = 0.011). The rates of 7‐day and 1‐month MACE in the upstream group were lower than those in the deferred group (1.5% vs. 4.2%, 3.3% vs. 7.0%, P = 0.037 and 0.034, respectively). However, there were higher tendencies for major and minor bleedings in the upstream group (1.8% vs. 0.9%, 2.7% vs. 1.5%, P = 0.315 and 0.280, respectively).

Conclusion

To the Chinese patients with acute myocardial infarction undergoing primary PCI, upstream administration of tirofiban was slightly superior to deferred injection for short‐term clinical outcomes.

     

Percutaneous Coronary Intervention of Complex Calcified Lesions With Drug‐Coated Balloon After Rotational Atherectomy

Objectives

We investigated the safety and efficacy of PCI using drug‐coated balloon (DCB) after rotational atherectomy (rotablation) in a retrospective single center study in patients with calcified de novo coronary lesions. The majority of patients had an increased risk for bleeding.

Background

DCB has been effective in the treatment of in‐stent restenosis, small vessels, and bifurcations. DCB enables short one month dual antiplatelet treatment. No published data exist on the use of DCB after rotablation.

Methods

82 PCIs were performed in 65 patients (mean age 72 ± 10 years) using rotablation followed by DCB treatment. The median follow‐up time was 17 months. 82% of the patients had at least one risk factor for bleeding such as oral anticoagulation. 32% had an acute coronary syndrome. Median duration of dual antiplatelet treatment was 1 month.

Results

MACE (the composite of cardiovascular death, ischemia‐driven target‐lesion revascularization [TLR] or non‐fatal myocardial infarction) occurred in 14% and 20% of the patients at 12 and 24 months, respectively. The rate of ischemia‐driven TLR was 1.5% at 12 months and 3.0% at 24 months. No acute closure of the treated vessel occurred. Bailout stenting was needed in 10% of the PCIs. The incidence of significant bleeding was 9% at 12 months.

Conclusions

This is the first study to show that PCI using DCB after preparation of calcified lesions with rotablation is safe and effective. This novel strategy may be considered especially in patients with a bleeding risk such as those using an oral anticoagulant.

     

Impact of Coronary Artery Disease Burden on 12‐Month Mortality of Patients After Transcatheter Aortic Valve Implantation

Objectives

The aim of the study was to compare 12‐month mortality rate of patients with and without complete coronary revascularization before transcatheter aortic valve implantation (TAVI).

Background

There are limited data on the impact of coronary artery disease burden in patients with severe aortic stenosis undergoing TAVI.

Methods

One hundred and one consecutive patients undergoing TAVI were enrolled. Of them 16 (15.8%) had an incomplete coronary revascularization. The primary endpoint was 12‐month all‐cause mortality.

Results

Twelve‐month all‐cause mortality was higher in patients with incomplete coronary revascularization than in patients with complete coronary revascularization or without significant lesions (75.0% vs 7.1%; P < 0.001). Importantly, incomplete coronary revascularization was an independent predictor of higher mortality rate after 12 months (hazard ratio (HR) for incomplete coronary revascularization 10.86, 95% CI 3.72–31.73; P < 0.001; HR for a history of stroke/TIA 3.93, 95% confidence interval (CI) 1.39–11.07; P < 0.001; HR for blood transfusion 2.84 95% CI (1.06–7.63); P = 0.039). In 9 of 16 (56.3%) patients, incomplete revascularization was related to the presence of chronic total occlusions (CTO). Patients with CTO had an increased mortality rate after 12 months (55.6% vs 14.1%; P = 0.008) as compared to patients without the CTO.

Conclusions

Incomplete coronary revascularization and a history of stroke or TIA may be independent predictors of all‐cause mortality in patients undergoing TAVI. However, further studies are recommended to confirm the results, especially in terms of the impact of CTO presence on long‐term mortality after TAVI.

     

9‐month results of polymer‐free sirolimus eluting stents in young patients compared to a septuagenarian and octogenarian all‐comer population

Objectives

To evaluate the 9‐month safety and efficacy of polymer‐free sirolimus eluting drug eluting stents in septuagenarians and octogenarians.

Methods

An all‐comer, worldwide single armed trial ( ClinicalTrials.gov Identifier NCT02629575) was conducted to demonstrate the safety and efficacy of an ultra‐thin strut, polymer‐free sirolimus eluting stent (PF‐SES). The primary endpoint was the 9‐month target revascularization rate (TLR). Secondary endpoints included the rates of major adverse cardiac events (MACE), stent thrombosis (ST) and bleeding (BARC) in septuagenarians (≥70 years, <80 years), and in octogenarians (≥80 years) to be compared to the younger patient group (<70 years).

Results

A total of 1607 patients were treated with PF‐SES in the sub‐70‐year‐old age group, 694 in septuagenarians, and 371 in the octogenarian patient group. At 9 months, the MACE rates were 7.2% in octogenarians, 5.3% in septuagenarians, and 3.0% in the younger patient group (P = 0.001). These were mostly driven by all‐cause mortality (4.4% vs 1.9% vs 0.6%, P < 0.001) while the TLR rates were only numerically lower in the younger age group (P = 0.080). BARC 1‐5 bleeding events were more frequent in the older age group (1.9% vs 2.7% vs 4.6%, P = 0.012) whereas the rates for ST were not different (0.7% vs 0.6% vs 0.6%, P = 0.970).

Conclusions

In octogenarians treated with PF‐SES, the rates for MACE, overall mortality, and bleeding are higher as compared to the younger age groups. However, the rates for TLR and ST were not significantly different across the investigated age groups. PF‐SES are safe and effective in octogenarians.

     

Short‐term and long‐term clinical outcomes of rotational atherectomy in resistant chronic total occlusion

Objectives

To evaluate the short‐ and long‐term clinical outcomes of RA in CTO coronary intervention.

Background

The application of rotational atherectomy (RA) may improve the success rate of percutaneous recanalization of chronic total occlusion (CTO) with heavy calcification.

Methods

From January 2011 to September 2014, we enrolled 285 patients with CTO who underwent successful percutaneous coronary intervention (PCI). Resistant CTO lesions were defined as those with heavy calcifications as well as those that no devices are able to pass after guide wire crossing.

Results

All patients with resistant CTO lesions (n = 26) were successfully treated by RA without major complications, except 1 patient complicated with coronary perforation and treated by surgery successfully (success rate: RA group vs non‐RA group: 96.2%, vs 89.5%, P = 0.038). Compared to the non‐RA group, the patients in the RA group were older (P = 0.028), had higher J‐CTO scores (P = 0.001), and needed longer stents (P = 0.001). All patients were followed up for a mean period of 3.4 ± 2.3 years, and the 1‐year and long‐term clinical outcomes of the RA group were excellent and comparable with those not receiving RA in multivariate analysis adjusted for multiple variables.

Conclusion

The treatment of RA is safe and feasible for resistant CTO lesions with heavy calcification. The short‐ and long‐term clinical outcomes of the treatment of RA were excellent and comparable with those not needing RA for CTO PCI.