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.

     

Comparison between imported versus domestic drug‐eluting stents in China: A large single‐center data

Background

In recent years, most drug‐eluting stents (DESs) were domestically produced in China, but how domestic DESs perform compared to imported DESs was still unknown.

Methods

A total of 9011 consecutive cases with DESs implantation in a single center throughout 2013 were prospectively collected. Two‐year clinical outcomes were evaluated between patients implanted with imported and domestic DESs.

Results

During 2‐year follow‐up, the rates of all‐cause death, cardiac death, myocardial infarction, stroke, and stent thrombosis were not significantly different between two groups. However, the rate of revascularization was significantly higher in domestic DES group, shown as higher rates of overall revascularization, target vessel revascularization (TVR), and target lesion revascularization (TLR) (9.7% vs 6.4%, P < 0.001; 5.6% vs 3.2%, P < 0.001; 4.5% vs 2.2%, P < 0.001, respectively). Accordingly, major adverse cardiac events (MACE) rate was significantly higher in domestic DES group (12.1% vs 8.5%, P < 0.001). Multivariable Cox regression analysis indicated that domestic DES was an independent risk factor of MACE (HR [95%CI]: 1.22 [1.05‐1.41]), overall revascularization (HR [95%CI]: 1.29 [1.09‐1.53]), TVR (HR [95%CI]: 1.54 [1.22‐1.94]), and TLR (HR [95%CI]: 1.85 [1.41‐2.42]). After propensity score matching, the rates of overall revascularization, TVR, and TLR were still significantly higher in domestic DES group, and domestic DES was still predictive of overall revascularization, TVR, and TLR in multivariate Cox regression analysis.

Conclusions

Domestic DESs showed the same safety as imported DESs in this real‐world cohort. But, patients implanted with domestic DESs had a higher risk of revascularization than imported DESs.

     

Use of the RenalGuard system to prevent contrast‐induced AKI: A meta‐analysis

Background

Contrast‐induced kidney injury (CI‐AKI) following cardiovascular interventions results in increased morbidity and mortality. RenalGuard (RG) is a novel, closed loop system which balances volume administration with forced diuresis to maintain a high urine output. We performed a meta‐analysis of the existing data comparing use of RG to conventional volume expansion.

Methods

Ten studies were found eligible, of which four were randomized controlled trials. Of an aggregate sample size (N) of 1585 patients, 698 were enrolled in the four RCTs and 887 belonged to the remaining registries included in this meta‐analysis. Primary outcomes included CI‐AKI incidence and relative risk. Mortality, dialysis, and major adverse cardiovascular events (MACCE) were secondary outcomes. A random effects model was used and data were evaluated for publication bias.

Results

RG was associated with significant risk reduction in CI‐AKI compared to control (RR: 0.30, 95%CI: 0.18‐0.50, P < 0.01). CI‐AKI in RG was found to be 7.7% versus 23.6% in the control group (P < 0.01). Use of RG was associated with decreased mortality (RR: 0.43, 95%CI: 0.18‐0.99, P = 0.05), dialysis (RR: 0.20, 95%CI: 0.06‐0.61, P = 0.01), and MACCE (RR: 0.42, 95%CI: 0.27‐0.65, P < 0.01) compared to control.

Conclusions

RG significantly reduces rates of CI‐AKI compared to standard volume expansion and is also associated with decreased rates of death, dialysis, and MACCE.

     

Head‐to‐head comparison of prasugrel versus ticagrelor in patients undergoing percutaneous coronary intervention: A meta‐analysis of randomized controlled trials

Objectives

We sought to compare the efficacy and safety of prasugrel and ticagrelor in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).

Background

Evidence from randomized head‐to‐head comparison between prasugrel and ticagrelor is rare regarding clinical endpoints.

Methods

PubMed, the Cochrane Library, and Web of Science were queried with the terms “prasugrel,” “ticagrelor,” and “randomized.” Relevant randomized controlled trials (RCTs) or the same terms were also surveyed using clinicaltrials.gov , escardio.org , pcronline.org , and tctmd.com . The clinical endpoints were death, myocardial infarction (MI), stroke, and stent thrombosis (ST) for efficacy, and any bleeding for safety.

Results

A total number of 2068 patients in 12 RCTs, whose longest follow‐up period was 6 months, was included in this study. The risks of death (odds ratio [OR]: 0.86, 95% confidence interval [CI]: 0.46‐1.62, P = 0.647), MI (OR: 1.61, 95%CI: 0.71‐3.62, P = 0.252), stroke (OR: 1.45, 95%CI: 0.25‐8.36, P = 0.680), and ST (OR: 0.76, 95%CI: 0.20‐2.81, P = 0.677) were similar between prasugrel and ticagrelor, respectively. While the incidence of bleeding according to the Bleeding Academic Research Consortium definitions was also comparable (OR: 0.83, 95%CI: 0.45‐1.52, P = 0.539), that according to the Thrombolysis in Myocardial Infarction criteria was lower in prasugrel than ticagrelor (OR: 0.49, 95%CI: 0.24‐0.97, P = 0.042).

Conclusions

Although the efficacy was similar between prasugrel and ticagrelor, prasugrel may be associated with a lower risk of bleeding compared with ticagrelor during short‐ to mid‐term follow‐up period after PCI. Further studies are warranted in a larger patient population during longer‐term follow up to validate these findings.

     

Aspiration Thrombectomy in Patients Undergoing Primary Angioplasty for ST Elevation Myocardial Infarction: An Updated Meta‐Analysis

Background

The Trial of Routine Aspiration Thrombectomy with PCI versus PCI alone in patients with STEMI (TOTAL trial) refuted the salutary effect of routine aspiration thrombectomy (AT) in PPCI for patients with ST‐elevation myocardial infarction (STEMI).

Objectives

We performed an updated meta‐analysis to assess clinical outcomes with AT prior to PPCI compared with conventional PPCI alone including the additional trial data.

Methods and Results

Clinical trials (n = 20) that randomized patients (n = 21,281) with STEMI between Routine AT (n = 10,619) and PPCI (n = 10,662) were pooled. There was no difference in all‐cause mortality between the 2 groups (RR: 0.89, 95%CI: 0.78–1.01, P = 0.08). Stratifying by follow up at 1‐month (RR: 0.87, 95%CI: 0.69–1.10, P = 0.25), up to 6 months (RR: 0.91, 95%CI: 0.74–1.13, P = 0.39 and beyond 6 months (RR: 0.88, 95%CI: 0.74–1.05, P = 0.16) yielded similar results. There was a statistically significant increase risk of stoke rate in the AT arm (RR: 1.51, 95%CI: 1.01–2.25, P = 0.04). The 2 groups were similar with regards to target vessel revascularization (0.94, 95%CI: 0.83–1.06, P = 0.28) recurrent MI (RR: 0.96, 95%CI: 0.80–1.16, P = 0.68, MACE events (RR: 0.91 95%CI: 0.81–1.02, P = 0.11), early (0.59, 95%CI: 0.23–1.50, P = 0.27) and late (RR: 0.91, 95%CI: 0.69–1.18, P = 0.47) stent thrombosis and net clinical benefit (RR 0.99, 95%CI: 0.91–1.07, P = 0.76).

Conclusion

Routine AT prior to PPCI in STEMI is associated with higher risk of stroke. There is no statistical difference in clinical outcome parameters of mortality, major adverse cardiac events, target vessel revascularization, stent thrombosis, and net clinical benefit between AT and PCI alone. (J Interven Cardiol 2015;28:503–513)

     

Second‐Generation Everolimus‐Eluting Stents Compared to First‐Generation Drug‐Eluting Stents in Patients Treated for Multivessel Disease

Objective

This study aimed to compare the safety and efficacy of everolimus‐eluting stents (EES) to first‐generation drug‐eluting stents (DES) in multivessel disease (MVD).

Background

Second‐generation EES have demonstrated superiority over first‐generation DES for single‐vessel disease, although the merits of EES in MVD are less established.

Methods

A cohort of 1,285 patients (3,124 lesions) with ≥2 diseased vessels were treated with either first‐generation DES (n = 1,002) or EES (n = 283). The rates of death, myocardial infarction, target lesion revascularization, target vessel revascularization, definite stent thrombosis, and major adverse cardiac events (MACE), defined as the combined incidence of target vessel revascularization, death, and non‐fatal myocardial infarction, were compared at 1 year.

Results

Baseline characteristics were similar except for a lower left ventricular ejection fraction and a lower incidence of stable angina pectoris in the first‐generation DES group (P = 0.001 and 0.013, respectively). At 1 year, the MACE rate was lower in the EES group (9.5P% vs. 15.7%; P = 0.01). Multivariable analysis demonstrated that EES use predicted a higher chance of freedom from MACE at 1 year (hazard ratio 0.58 [0.38–0.87]; P = 0.009; 95% confidence interval).

Conclusions

The use of EES in patients with MVD is safe with signals for improved effectiveness compared to first‐generation DES. Randomized trials comparing new‐generation DES to coronary artery bypass grafting surgery are warranted.

     

Drug eluting stents are superior to bare metal stents to reduce clinical outcome and stent‐related complications in CKD patients,a systematic review,meta‐analysis and network meta‐analysis

Aims

To compare clinical outcome in Chronic kidney disease (CKD) patients receiving coronary stents according to stent type BMS versus DES and 1st generation versus 2nd generation DES.

Methods and Results

PubMed, Cinhal, Cochrane, Embase, and Web of Science were searched for studies including CKD patients. CKD was defined as eGFR < 60 mL/min. We selected n = 35 articles leading to 376 169 patients, of which 76 557 CKD patients receiving BMS n = 35,807, 1st generation DES n = 37,650, or 2nd generation DES n = 3100. Patient receiving DES, compared to BMS, had a 18% lower all‐cause mortality (RR 0.82, 95%CI 0.71‐0.94). The composite of death or myocardial infarction (MI) was lower in DES patients (RR 0.78, 95%CI 0.67‐0.91), as was stent thrombosis (ST) (RR 0.57, 95%CI 0.34‐0.95), target vessel/lesion revascularization (TVR/TLR) (RR 0.69, 95%CI 0.57‐0.84) and death for cardiovascular cause (RR 0.43, 95%CI 0.25‐0.74). We also found a gradient between 1st and 2nd generation DES, through BMS. Second, compared to 1st generation DES, were associated with further relative risk (RR) reduction of ?18% in of all‐cause death, and lower incidence of stent‐related clinical events: ?39% RR of ST risk; ?27 RR of TVR/TLR risk.

Conclusions

DES in CKD patients undergoing PCI were superior to BMS in reducing major adverse clinical events. This was possibly explained, by a lower risk of stent‐related events as ST and TVR or TLR. Second, compared to 1st generation DES may furtherly reduce clinical events.

     

Direct Stenting Versus Pre‐Dilation in ST‐Elevation Myocardial Infarction: A Systematic Review and Meta‐Analysis

Objectives

This study aimed at comparing direct stenting (DS) versus stenting with pre‐dilation (SP) in patients with ST‐elevation myocardial infarction (STEMI), using a systematic review and meta‐analysis of published evidence.

Background

There is conflicting evidence whether stenting strategy impacts clinical outcomes in patients with STEMI.

Methods

We searched EMBASE, MEDLINE, and CENTRAL, from inception to December 2014. The primary endpoint was mortality. Secondary endpoints included major adverse cardiac events (MACEs), ST‐segment resolution, and angiographic outcomes.

Results

A total of 9,331 patients enrolled in 12 studies (3 randomized controlled trials, RCTs; 9 non‐randomized studies, NRSs) were included. DS was associated with lower mortality (OR 0.55; 95%CI: 0.33–0.94; P = 0.03) in NRSs, and overall (OR 0.56; 95%CI: 0.37–0.86; P = 0.008). Mortality was non‐significantly reduced in RCTs (OR 0.56; 95%CI: 0.26–1.23; P = 0.15). DS was also associated with lower MACE rate (OR 0.71; 95%CI 0.60–0.84; P < 0.0001) in NRSs, but not in RCTs (OR 0.99; 95%CI: 0.61–1.60; P = 0.96). ST‐segment resolution, no reflow, final thrombolysis in myocardial infarction (TIMI) flow and final TIMI myocardial perfusion or blush grade were significantly better with DS in NRSs, and non‐significantly better in RCTs.

Conclusions

The available evidence suggests that DS in STEMI might be associated with better clinical and procedural outcomes, as compared with SP. However, the fact that RCTs account for the minority of available data and that most of the available studies poorly reflect current clinical practice, as well as the existence of publication bias, preclude drawing definitive conclusions.

     

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.

     

Long‐term outcomes post chronic total occlusion intervention—implications of completeness of revascularization

Background

Long term clinical outcomes post chronic total occlusion (CTO) intervention may depend not only on CTO success/failure alone but also on Completeness of revascularization.

Objectives

To determine long term outcomes post CTO intervention and relate them to both success versus failure and Complete Revascularization (CR) versus Incomplete Revascularization (IR).

Methods

Consecutive patients taken up for CTO intervention with at‐least one CTO vessel between Jan 2006 to Dec 2015 were included. Clinical, procedural and follow up details were recorded in a pre‐specified custom made software. Primary endpoint of the study was survival free of major adverse event individual, death, myocardial infarction (MI), repeat revascularisation (percutaneous coronary intervention [PCI], or coronary artery bypass grafting (CABG) and recurrent or continued angina. Each individual adverse event was considered as a secondary end point.

Results

A total of 632 patients were enrolled in study with follow up data available in 549 (86%) constituting the study group with 490 (89.3%) success and 59 (11.7%) failure. Complete revascularization (CR) was obtained in 410 (74.7%). Follow up was median 2.9 years with inter‐quartile range 1.1‐4.8 years. Kaplan Meier survival analysis showed a better EFS with both CTO success versus failure (P = 0.03)and CR versus IR (P = 0.017). Individual adverse outcomes however were not significantly different in CTO success versus failure group but significantly better when analyzed with respect to CR versus IR including death (P = 0.049) and recurrent angina (P = 0.024). Repeat intervention and MI were not different by either analysis.

Conclusions

Successful CTO PCI results in a better long term event free survival but the difference between the groups is more if analyzed with respect to completeness of revascularization rather than CTO success/failure alone.

     

Bivalirudin versus heparin in patients undergoing percutaneous transcatheter aortic valve interventions: A systematic review and meta‐analysis

Background

Bivalirudin may be an effective anticoagulation alternative to heparin as anticoagulant agent in percutaneous transcatheter aortic valve interventions (PAVI). We aimed to compare safety and efficacy of bivalirudin versus heparin as the procedural anticoagulant agent in patients undergoing PAVI.

Methods

We conducted an electronic database search of all published data. The primary efficacy endpoints were all‐cause mortality, cardiovascular mortality, myocardial infarction, and stroke. Safety endpoints include major and life‐threatening bleed according to VARC and BARC bleeding, blood transfusion, vascular complications, and acute kidney injury. Odds ratios (OR) and 95% confidence intervals (CI) computed using the Mantel‐Haenszel method.

Results

Three studies (n = 1690 patients) were included, one randomized trial and two observational studies. There was a significant difference favoring bivalirudin over heparin for myocardial infarction (OR 0.41, 95%CI 0.20‐0.87). There was no significant difference in all‐cause mortality at 30 days (OR 0.97, 95%CI 0.62‐1.52), cardiovascular mortality (OR 1.03, 95%CI 0.52‐2.05), stroke (OR 1.23, 95%CI 0.62‐2.46), vascular complications (OR 0.96, 95%CI 0.70‐1.32), acute kidney injury (OR 1.03, 95%CI 0.53‐2.00), blood transfusion (OR 0.67, 95% CI 0.45‐1.01), major and life‐threatening bleed (OR 0.74, 95%CI 0.37‐1.49), and BARC bleeding (OR 0.52, 95%CI 0.23‐1.18).

Conclusions

In patient undergoing aortic valve interventions, no difference was seen between the use of bivalirudin and heparin as the procedural anticoagulant agent, except for a significant lower myocardial infarction events when bivalirudin was used. Further large randomized trials are needed to confirm current results.

     

A Meta‐Analysis of Sex‐Related Differences in Outcomes After Primary Percutaneous Intervention for ST‐Segment Elevation Myocardial Infarction

Introduction

The increasing use of primary percutaneous coronary intervention (pPCI) has improved clinical outcome in ST‐segment elevation myocardial infarction (STEMI) patients, but the impact of sex on early and mid‐term outcomes remains to be defined.

Methods

Medline, Cochrane Library, Biomed Central, and Google Scholar were searched for articles describing differences in baseline, periprocedural, and midterm outcomes after pPCI, by sex. The primary end point was all‐cause mortality at early and mid‐term follow‐up. Secondary endpoints included in‐hospital bleeding and stroke.

Results

Sixteen studies were included. Women were older, had more frequent hypertension, diabetes mellitus, and hypercholesterolemia, as well as longer ischemia time and more shock at presentation. Men were more likely to have had a previous myocardial infarction. Female sex emerged as independently associated to early mortality (OR 1.1; 95%CI, 1.02–1.18) but not to mid‐term mortality (OR, 1.01; 95%CI, 0.99–1.03). The pooled analysis showed a significantly higher risk of in hospital stroke (OR, 1.69; 95%CI, 1.11–2.56) and major bleeding (OR, 2.04; 95%CI, 1.51–2.77) in women.

Conclusions

As compared to men, women undergoing pPCI have more bleedings and strokes, and a worse early, but not mid‐term mortality. These findings may allow a better risk stratification of pPCI patients.

     

Role of deferred stenting in patients with ST elevation myocardial infarction treated with primary percutaneous coronary intervention: A systematic review and meta‐analysis

Objectives

We conducted a meta‐analysis of studies comparing deferred stenting strategy versus the conventional approach with immediate stenting in patients with ST elevation myocardial infarction.

Background

Deferring stent after mechanical flow restoration has been proposed as a strategy to reduce the risk of “no reflow” in patients with STEMI undergoing primary percutaneous coronary intervention (pPCI). Conflicting evidence is available currently, especially after the recent publication of three randomized clinical trials.

Methods

Searches in electronic databases were performed. Comparisons between the two strategies were performed for both hard clinical endpoints (all cause‐mortality, cardiovascular mortality, unplanned revascularization, myocardial infarction and readmission for heart failure) and surrogate angiographic endpoints (TIMI flow < 3 and myocardial blush grade (MBG) < 2).

Results

Eight studies (three randomized and five non‐randomized) were deemed eligible, accounting for a total of 2101 patients. No difference in terms of hard clinical endpoints was observed between deferred and immediate stenting (OR [95% CI]: 0.79 [0.54‐1.15], for all‐cause mortality; odds ratio (OR) [95% CI]: 0.79 [0.47‐1.31] for cardiovascular mortality; OR [95% CI]: 0.95 [0.64‐1.41] for myocardial infarction; OR [95% CI]: 1.37 [0.87‐2.16], for unplanned revascularization and OR [95% CI]: 0.50 [0.21‐1.17] for readmission for heart failure). Notably, the deferred stenting approach was associated with improved outcome of the surrogate angiographic endpoints (OR [95% CI]: 0.43 [0.18‐0.99] of TIMI flow < 3 and OR [95% CI]: 0.25 [0.11‐0.57] for MBG < 2.

Conclusions

A deferred stenting strategy could be a feasible alternative to the conventional approach with immediate stenting in “selected” STEMI patients undergoing pPCI.

     

Long‐Term Clinical Outcomes of a Biodegradable Polymer‐Based Biolimus‐Eluting Stent

Objectives

To investigate the long‐term clinical outcomes of biolimus‐eluting stents with biodegradable polymers in real‐world clinical practice.

Background

Long‐term clinical outcomes of biolimus‐eluting stents have not been clearly established.

Methods

A total of 824 all‐comer patients (971 lesions) treated with unrestricted implantation of a biolimus‐eluting stent with a biodegradable polymer were prospectively enrolled. Patients were divided into complex (413 patients) versus noncomplex (411 patients) groups according to the complexity of coronary lesions. Long‐term clinical outcomes for stent efficacy (target lesion revascularization) and safety (composite of cardiac death, target lesion‐related myocardial infarction, and definite or probable stent thrombosis) were compared between the two groups during 5 years of follow‐up.

Results

The complex group showed higher rates of decreased left ventricular ejection fraction, impaired renal function, previous history of myocardial infarction, and diabetes mellitus compared to the noncomplex group. In the overall population, the 5‐year cumulative rate of target lesion revascularization was 4.8% (8.3% in the complex group vs 1.6% in the noncomplex group, P < 0.001). For stent safety, the 5‐year cumulative rate for a composite of cardiac death, target lesion‐related myocardial infarction, and stent thrombosis was 2.5% overall (3.9% in the complex group vs 1.1% in the noncomplex group, P = 0.010). Overall 5‐year cumulative rate of stent thrombosis was 0.4% (0.5% in the complex vs 0.2% in the noncomplex group, P = 0.561) with no very late stent thrombosis (VLST).

Conclusions

Biodegradable polymer‐based biolimus‐eluting stents showed favorable efficacy and safety in all‐comer patients during 5 years of follow‐up. (J Interven Cardiol 2016;29:162–167)

     

Polymer‐free versus permanent polymer‐coated drug eluting stents for the treatment of coronary artery disease: A meta‐analysis of randomized trials

Background

Polymer‐free drug eluting stents (PF‐DES) were developed, in part, to overcome risk of late ischemic events observed with permanent polymer‐coated DES (PP‐DES). However, trial results are inconsistent with longer‐term safety and efficacy of PF‐DES remaining unknown. We performed a meta‐analysis of randomized trials assessing outcomes of patients receiving PF‐DES versus PP‐DES for treatment of coronary artery disease (CAD).

Methods

Electronic searches were performed for randomized trials comparing outcomes between PF‐DES and PP‐DES. Trials reporting major adverse cardiovascular events (MACE), myocardial infarction (MI), stent thrombosis (ST), all‐cause death, target lesion/vessel revascularization (TLR/TVR), and late lumen loss (LLL) were included. Analyses were performed at longest follow‐up and landmarked beyond 1‐year.

Results

Twelve trials (6,943 patients) were included. There was no significant difference in MACE between PF‐DES and PP‐DES at longest follow‐up (Odds Ratio [OR] 0.96, 95%CI 0.85‐1.10, P = 0.59) or landmark analysis beyond 1‐year (OR 0.96, 95%CI 0.76‐1.20, P = 0.70). Although PF‐DES were associated with a significant reduction in all‐cause death (OR 0.85, 95%CI 0.72‐1.00, P < 0.05), this effect was not present on landmark analysis beyond 1‐year (OR 0.89, 95%CI 0.73‐1.10, P = 0.30). There were no differences observed for MI (OR 1.00, 95%CI 0.77‐1.28, P = 0.99) or ST (OR 0.95, 95%CI 0.54‐1.68, P = 0.86), with similar efficacy outcomes including TVR (OR 1.07, 95%CI 0.91‐1.26, P = 0.42), TLR (OR 1.03, 95%CI 0.88‐1.21, P = 0.68) and angiographic LLL (pooled mean difference 0.01 mm, 95%CI ?0.08 to 0.11, P = 0.76).

Conclusions

PF‐DES are as safe and efficacious as PP‐DES for the treatment of patients with CAD, but do not significantly reduce late ischemic complications.

     

Post‐dilation in transcatheter aortic valve replacement: A systematic review and meta‐analysis

Objectives

The aim of this study was to perform a meta‐analysis to compare the outcomes of patients undergoing TAVR with and without balloon post‐dilation (PD).

Background

PD is a commonly used technique in TAVR to minimize paravalvular regurgitation (PVR), albeit supported by little evidence.

Methods

Systematic review and meta‐analysis of 6 studies comparing 889 patients who had PD compared to 4118 patients without PD.

Results

Patients undergoing PD were more likely male (OR 1.92; 95% CI, 1.41‐2.61; P < 0.001) and to have coronary artery disease (OR 1.31; 95% CI, 1.03‐1.68; P = 0.03) than those patients not requiring PD. There were no significant differences in 30‐day mortality (OR 1.24; 95% CI, 0.88‐1.74; P = 0.22) and myocardial infarction (OR 0.93; 95% CI, 0.46‐1.90; P = 0.85). Patients undergoing TAVR did not have higher 1‐year mortality rates (OR 0.98; 95% CI, 0.61‐1.56; P = 0.92). The incidence of stroke was significantly greater in patients with PD (OR, 1.71; 95% CI, 1.10‐2.66). PD was able to reduce the incidence of moderate‐severe PVR by 15 fold (OR 15.0; 95% CI, 4.2‐54.5; P < 0.001), although rates of moderate‐severe PVR were still higher after PD than patients who did not require PD (OR 3.64; 95% CI, 1.96‐6.75; P < 0.001).

Conclusions

PD significantly improves rates of PVR, however careful patient selection is needed to minimize increased risk of strokes.

     

Long‐term clinical results of bioresorbable absorb scaffolds using the PSP‐technique in patients with and without diabetes

Objectives

We evaluated clinical results up to 36 months after implantation of Absorb BVS using PSP‐technique and compared the outcome of patients with and without diabetes mellitus.

Background

Absorb II demonstrated that interventional treatment of coronary artery disease with bioresorbable vascular scaffolds (BVS) without proper PSP‐technique (pre‐dilation, proper sizing, and post‐dilation) is associated with an increased thrombotic risk, even in simple lesions.

Methods

In this prospective study 319 patients with 420 lesions were enrolled and treated with the Absorb BVS. Pre‐dilation was mandatory and post‐dilation with a high‐pressure balloon was performed in patients with a scaffold length >12 mm. Patients were clinically followed up to 3 years. Primary outcome measure was the device‐oriented endpoint (DoCE) defined as cardiac death, myocardial infarction not clearly related to a non‐target vessel and target lesion revascularization.

Results

DoCE was 5.0%, 7.1%, and 10.0% after 12, 24, and 36 months for the total population. Rate of scaffold thrombosis was 0.5%, 0.8%, and 1.4% after 12, 24, and 36 months. Rate of DoCE was higher in the diabetic subgroup with 9.1%, 12.6%, and 12.9% after 12, 24, and 36 months compared with 4.0% (P = 0.13), 5.6% (P = 0.05), and 9.9% (P = 0.20) in patients without diabetes mellitus.

Conclusions

Patients treated with the Absorb BVS using the PSP‐technique show good results up to 3 years with a low rate of scaffold thrombosis. Patients suffering from diabetes mellitus have an increased rate of DoCE compared with non‐diabetic patients.

Clinical Trial Registration

clinicaltrials.gov_NCT02162056 .

     

Outcomes of Overlapping Heterogeneous Drug‐Eluting Stents Versus Homogeneous Drug‐Eluting Stents for Diffuse Lesions in Small Coronary Arteries

Objective

To investigate the outcomes of overlapping drug‐eluting stenting (DES) in small and diffuse lesions.

Background

Clinical outcomes of overlapping heterogeneous versus homogeneous DES of diffuse lesions (requiring ≥30 mm of length) in small coronary arteries (requiring ≤2.75 mm of diameter) are unknown.

Methods

From January 2005 to December 2009, there were 99 patients with diffuse lesions in small coronary arteries receiving overlapping heterogeneous DES, and 558 patients receiving overlapping homogeneous DES at our institution. The clinical end‐point of the study included in‐hospital and 12‐month major adverse cardiac events (death, nonfatal myocardial infarction, and target vessel revascularization (TVR).

Results

There were no statistically significant differences between overlapping heterogeneous and homogeneous DES groups in‐hospital (2.0% vs. 1.4%, respectively; P = 0.66) and 12‐month (9.1% vs. 9.3%, respectively; P = 0.94) major adverse cardiac events. After adjustment, no significant differences for major adverse cardiac events were noted, but the rate of nonfatal myocardial infarction was lower in overlapping homogeneous DES group (odds ratio: 4.20, P = 0.03).

Conclusion

In this analysis, there were no significant differences in major adverse cardiac events between the 2 types of overlapping DES for diffuse lesions in small coronary arteries, except for higher nonfatal myocardial infarction in overlapping heterogeneous DES. (J Interven Cardiol 2013;26:264–270)

     

Recurrent Myocardial Infarction After Primary Percutaneous Coronary Intervention in Multivessel Coronary Disease Is Primarily Related to Stent Failure

Objectives

Our aim was to investigate the risk of events related to non‐culprit lesions after primary percutaneous coronary intervention (PCI) in patients with multivessel coronary disease (MVD).

Background

In patients undergoing primary PCI for ST‐elevation myocardial infarction (STEMI) who are diagnosed with MVD, the optimal treatment strategy is currently under debate. Although observational data exposed an increased risk of multivessel PCI in the acute phase of STEMI, 2 recently published randomized controlled trials showed a reduction of death or recurrent myocardial infarction (MI) after preventive PCI of non‐culprit lesions when compared with culprit‐lesion PCI only.

Methods

We performed a post‐hoc analysis of 279 patients with MVD included in the Paclitaxel‐Eluting Stent versus Conventional Stent in Myocardial Infarction with ST‐Segment Elevation (PASSION) trial. We analyzed the incidence and cause of recurrent MI. Recurrent MI due to stent failure was assumed in the event of definite or probable stent thrombosis.

Results

After 5 years, 14 patients (5.7%) with MVD had a recurrent MI versus 17 (5.4%) patients with 1‐vessel disease (HR 1.06, 95%CI 0.52–2.15, P = 0.87). The majority of events was attributable to stent failure, while of the remaining 6 events, only 1 was proven to originate from a lesion that was judged significant at enrolment.

Conclusions

In this post‐hoc analysis of the PASSION trial, recurrent MI in patients with MVD was mainly related to stent failure rather than a new event originating from a significant stenosis in a non‐culprit coronary artery. (J Interven Cardiol 2015;28:523–530)

     

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.