Ambulatory transradial percutaneous coronary intervention: A safe,effective, and cost‐saving strategy

Objectives : The aim of this prospective, multicenter study was to assess the safety, feasibility, acceptance, and cost of ambulatory transradial percutaneous coronary intervention (PCI) under the conditions of everyday practice. Background : Major advances in PCI techniques have considerably reduced the incidence of post‐procedure complications. However, overnight admission still constitutes the standard of care in most interventional cardiology centers. Methods : Eligibility for ambulatory management was assessed in 370 patients with stable angina referred to three high‐volume angioplasty centers. On the basis of pre‐specified clinical and PCI‐linked criteria, 220 patients were selected for ambulatory PCI. Results : The study population included a substantial proportion of patients with complex procedures: 115 (52.3%) patients with multivessel coronary artery disease, 50 (22.7%) patients with multilesion procedures, and 60 (21.5%) bifurcation lesions. After 4‐6 hr observation period, 213 of the 220 patients (96.8%) were cleared for discharge. The remaining seven (3.2%) patients were kept overnight for unstable angina (n = 1), atypical chest discomfort (n = 2), puncture site hematoma (n = 1), or non‐cardiovascular reasons (n = 3). Within 24 hr after discharge, no patients experienced readmission, stent occlusion, recurrent ischemia, or local complications. Furthermore, 99% of patients were satisfied with ambulatory management and 85% reported no anxiety. The average non‐procedural cost was lower for ambulatory PCI than conventional PCI (1,230 ± 98 Euros vs. 2,304 ± 1814 Euros, P < 10^?6). Conclusions : Ambulatory PCI in patients with stable coronary artery disease is safe, effective, and well accepted by the patients. It may both significantly reduce costs and optimize hospital resource utilization. © 2012 Wiley Periodicals, Inc.     

Percutaneous Coronary Intervention of Complex Calcific Coronary Lesions Utilizing Orbital Atherectomy Prior to Transcatheter Aortic Valve Replacement

BackgroundCoronary artery disease (CAD), often with severe calcification, is present in up to 75% of patients with severe aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR). Management of CAD in such patients is challenging. Orbital atherectomy (OA) is an effective treatment of severely calcified coronary lesions prior to stent implantation. However, there is limited data on the use of OA for percutaneous coronary intervention (PCI) to treat calcific CAD patients prior to TAVR (OA PCI + TAVR).MethodsRetrospective analysis of patients with moderate/severe calcific CAD and moderate/severe AS who underwent staged OA PCI + TAVR at one high-volume institution. Data were analyzed to assess the 1-year major adverse cardiac events after index OA PCI [MACE: death, target lesion revascularization (TLR), and myocardial infarction (MI)].ResultsThere were 18 patients (mean age of 82) treated with staged OA PCI + TAVR, and of those, 10 (56%) were male, 7 (39%) Caucasian, and 11 (61%) Hispanic/Latino. The average left ventricular ejection fraction was 49% and congestive heart failure was present in 12 patients (67%). There were no angiographic complications (0%), stent thrombosis (0%), or stroke events (0%). The 30-day and 1-year MACE rates were 5.6% (0% death, 0% TLR, 5.6% MI) and 17% (0% death, 11% TLR, and 17% MI [all non-Q-wave MI]), respectively.ConclusionsIn this single-center observational cohort series, patients with heavily calcified coronary lesions treated with OA prior to TAVR had low rates of MACE at 30 days and 1 year. The results demonstrate the feasibility and safety of OA for the treatment of complex calcific coronary lesions prior to TAVR. An up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD is also provided.Table of contents summaryThere is limited data on the use of orbital atherectomy (OA) for percutaneous coronary intervention (PCI) to treat calcific coronary artery disease (CAD) patients prior to transcatheter aortic valve replacement (TAVR). Our primary aim was to evaluate the feasibility, safety, and 1-year outcome of OA PCI pre-TAVR in patients with complex CAD and severe aortic stenosis (AS). We also aimed to provide a brief up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD. This retrospective cohort study found that OA is feasible and safe for the treatment of severely calcified coronary lesions before TAVR, resulting in acceptable 30-day and 1-year outcomes.     

Long term outcomes of saphaneous vein graft intervention in elderly patients with prior coronary artery bypass graft

Objectives To investigate the procedure characteristics and long term follow-up ofpercutaneous coronary intervention （PCI） for sa phaneous vein graft （SVG） lesions in the elderly patients. Methods From December 2005 to December 201 l, 84 graft lesions were treated percumneously. Seventeen were located at proximal anastomosis, 48 were located at SVG body, 19 were located at distal anastomosis. Pri mary endpoint was defined as major adverse cardiovascular events （MACE, composite of cardiac death, target vessel revascularization, acute myocardial infarction）. Results The graft age was 6.7 i 4.0 years. Most anastomosis lesions （80.0%） presented within one year post coro-nary artery bypass grafting （CABG）. Proximal anastomosis lesion had the lowest successful rate for PCI compared with graft body and distal anastomosis lesions （70.6% vs. 91.7%, 79.0%, P 〈 0.05）. The distal embolic protection device was used in 19.1% of patients, most frequently used in body graft PCI （29.2%, P 〈 0.01）. The diameter of the stent was smallest in distal anastomosis group （2.9 ±0.4 mm, P 〈 0.05）. The highest post dilatation pressure was required in the proximal anastomosis （17.8 ± 2.7 atm, P 〈 0.05）. The patients were followed up for 24.3 ±16.9 months. MACE occurred in 18.57% of patients. Incidence of MACE was highest among proximal anastomosis PCI （47.1% vs. body graft PCI 16.7%, distal anastomosis PCI 21.1%; P 〈 0.05）. Old myocardial infarction was the predictive factor for the poor clinical outcomes （P〈 0.04）. Conclusions PCI of SVG lesions is feasible with lower success rate. PCI of ostial graft anastomosis lesions had the lowest procedure success rate and highest MACE rate compared with graft body and distal anastomosis lesions. Old myocardial infarction was a predictive factor of poor outcomes.     

Prognostic implications of percutaneous coronary interventions performed according to the appropriate use criteria for coronary revascularization

ObjectivesTo assess the prognostic implication of the ACCF/AHA/SCAI appropriate use criteria (AUC) for coronary revascularization in a cohort of non-acute coronary syndrome patients.BackgroundThe AUC for coronary revascularization were developed in order to deliver high-quality care; however, the prognostic impact of these criteria remains undefined.MethodsConsecutive patients (n = 3817) undergoing elective percutaneous coronary intervention (PCI) at MedStar Washington Hospital Center since the 2009 AUC publication were retrospectively grouped according to AUC as an “Appropriate,” “Inappropriate,” or “Undetermined” indication for PCI. Outcomes to 1 year were compared.ResultsPCI was categorized as “Appropriate” in 47%, “Inappropriate” in 1.8% and as “Uncertain” in 51% of patients. “Appropriate” PCI patients had a higher prevalence of hypertension and diabetes but a lower prevalence of smoking. “Inappropriate” PCI involved the treatment of more complicated lesions, with lower rates of drug-eluting stent utilization. While there were no differences in procedural complications among the 3 groups, in-hospital major complications and outcomes were worse for “Inappropriate” PCI patients. The 30-day (3.2% vs. 7% vs. 4.1%, p = 0.32) and 1-year (13.1% vs. 11.8% vs. 15.3%, p = 0.43) major adverse cardiac event rates of the “Appropriate,” “Inappropriate,” and “Uncertain” PCI patients, respectively, were comparable. In multivariable analysis, the procedural appropriateness was not associated with either in-hospital or 1-year outcome.ConclusionsAt large, physicians practicing in tertiary centers adhere to the AUC when subjecting patients with non-acute coronary syndrome to revascularization. The present analysis did not demonstrate association between long-term outcome and procedure appropriateness according to the AUC.     

Implementation of Robotic-Assisted Percutaneous Coronary Intervention Into a High-Risk PCI Program

BackgroundHow to implement robotic-assisted PCI safely and when to escalate to more complex cases has not been previously described. We sought to evaluate clinical outcomes in patients undergoing robotic-assisted PCI in the first year of a newly established robotic-assisted PCI program.MethodsAll patients who underwent robotic-assisted PCI in the first 12 months at a single academic center were included in the study. Lesion complexity was characterized as “PRECISE-like”, “CORA-PCI-like”, or “CORA-PCI excluded” based on established criteria. The primary outcome was clinical success, defined as <30% residual stenosis after stenting with a final TIMI flow grade 2–3 and no procedural complications. Secondary outcomes included robotic success, defined as clinical success with robotic completion, unintentional manual conversion rate, procedure time, and procedural complications.ResultsOf the 57 consecutive lesions treated, 12 (22.6%) had a PRECISE-like lesion complexity while 32 (56.1%) had a CORA- PCI-like, and 13 (22.8%) a CORA-PCI excluded lesion complexity. There was no significant difference in clinical success (100.0% vs. 96.7% vs. 100.0%, p = 1.00) among the groups but robotic success was numerically lower as complexity increased (100.0% vs. 80.0% vs. 72.7%, p = 0.15), with an increased frequency of manual conversion. There was no significant difference in procedural complication rates among the groups. The robotic completion rate improved during the study period.ConclusionRobotic-assisted PCI, can be safely implemented in a moderate-sized academic center, with a rapid escalation in patient and lesion complexity.     

Combined cutting balloon angioplasty and intracoronary beta radiation for treatment of in-stent restenosis: clinical outcomes and effect of pullback radiation for long lesions.

Intracoronary beta (beta) radiation decreases the incidence of target lesion revascularization after percutaneous intervention (PCI) for in-stent restenosis (ISR). Cutting balloon (CB) angioplasty may also be superior to other percutaneous techniques for the treatment of ISR. We sought to study the outcomes of patients with ISR who underwent both CB angioplasty and intracoronay beta radiation and compare them to patients with ISR who underwent other PCI techniques without concomitant radiation. We also sought to evaluate the safety and efficacy of pullback intracoronary beta radiation for the treatment of long ISR lesions. Between January 2001 and November 2001, 102 patients (mean age = 55 +/- 13 years) with ISR underwent both CB angioplasty and intracoronay beta radiation. beta radiation was delivered using the Beta Cath (Novoste) 30 mm system, and pullback radiation was performed in 41 patients. A comparison group included a total of 393 patients with ISR who underwent other PCI techniques without concomitant intracoronary radiation therapy. Follow-up was obtained in 99 patients (97%) in the CB angioplasty with intracoronary radiation group and 377 patients (96%) in the comparison group. At follow-up, both target vessel revascularization (TVR) and major adverse cardiovascular events (MACE) occurred significantly less in the CB angioplasty with intracoronary radiation group than in the comparison group (7% vs. 18% for TVR, and 14% vs. 24% for MACE; P < 0.05 for both). In the pullback radiation group, TVR was performed in five patients (12%), and MACE occurred in eight patients (20%). A combination of CB angioplasty and intracoronay beta radiation for ISR seems to yield low rates of subsequent target vessel revascularization and adverse cardiac events. In addition, pullback beta radiation using the Beta Cath (Novoste) 30 mm system is safe and can be used to treat long ISR lesions effectively. Further randomized trials are needed to confirm these findings.     

Trans-Stent FFR Gradient as a Modifiable Integrant in Predicting Long-Term Target Vessel Failure

BackgroundFractional flow reserve (FFR) after percutaneous coronary intervention (PCI) is associated with long-term outcomes. Data relating FFR-based trans-stent gradient (TSG) after PCI to long-term outcomes are sparse.ObjectivesThe aim of this study was to test whether TSG is associated with adverse events at follow-up after PCI.MethodsData were gathered from a prospective registry evaluating 501 vessels in 416 patients with median follow-up period of 596 days. Primary endpoints were: 1) target vessel failure (TVF), including target vessel revascularization, and target vessel myocardial infarction after discharge; and 2) major adverse cardiac events (MACE) including TVF, target vessel revascularization, nontarget vessel MI, cardiac death.ResultsAfter PCI, median post-PCI FFR was 0.86 and median TSG was 0.04. TSG >0.04 was associated with increased rates of TVF (8.7% vs 2.9%; P = 0.014) and MACE (17.8% vs 9.2%; P = 0.02). Post-PCI FFR < 0.86 was associated with increased rates of TVF (6.1% vs 2.2%; P = 0.03) and MACE (16.5% vs 10%; P = 0.036). The vessel subgroup with high TSG and low FFR had significantly higher rates of TVF (10.2%; P = 0.02) and MACE (20.1%; P = 0.049) than vessels with: 1) high TSG and high FFR (TVF, 2.9%; MACE, 9.7%); 2) low TSG and low FFR (TVF, 3.8%; MACE, 11.3%); and 3) low TSG high FFR (TVF, 2.2%; MACE, 7.5%). In multivariate analysis, TSG was independently predictive of TVF.ConclusionsHigher TSG was an independent predictor of adverse events, particularly TVF, and identified a subgroup of patients at higher risk for poor outcomes. The combination of high TSG and low FFR showed significantly worse outcomes compared with an “ideal result” (high FFR and low TSG). These data support a recommendation to use TSG during FFR evaluation to determine the functional success of PCI.     

Orbital Atherectomy for Treatment of Severely Calcified Coronary Artery Bifurcation Lesions: A Multicenter Analysis

ObjectiveThis study evaluated the safety and efficacy of orbital atherectomy (OA) for the treatment of severely calcified coronary artery bifurcation lesions.BackgroundPercutaneous coronary intervention (PCI) of severely calcified coronary artery lesions is associated with lower procedural success and higher rates of target lesion failure compared to non-calcified lesions. OA is an effective treatment for calcified coronary artery lesions prior to stent implantation. However, there is little data regarding the safety and efficacy of OA in patients with coronary artery bifurcation lesions.MethodsData were obtained from analysis of patients with severe coronary artery calcification who underwent OA and coronary stent implantation at ten high-volume institutions. Data were pooled and analyzed to assess peri-procedural outcomes and 30-day major adverse cardiac events (MACE).ResultsA total of 1156 patients were treated with OA and PCI. 363 lesions were at a coronary artery bifurcation. There were no statistically significant differences in baseline characteristics between the bifurcation and non-bifurcation groups. In the bifurcation group, treatment involved the left anterior descending artery and its branches more frequently and right coronary artery less frequently. After propensity score matching, the 30-day freedom from MACE was not statistically significant between the two groups.ConclusionIn this multicenter cohort analysis, patients with severely calcified coronary bifurcation lesions had low rates of MACE and target vessel revascularization at 30 days at rates comparable to non-bifurcation lesions. This analysis demonstrates that OA is safe and effective for complex coronary lesions at both bifurcation and non-bifurcation locations.     

Computerized gradual balloon inflation: a novel strategy of coronary angioplasty superior to a standard manual approach

BackgroundMechanical trauma caused by PCI is a primary reason for restenosis and subsequent target lesion revascularization (TLR). To minimize this trauma, we developed a computerized angioplasty pressure sensor and inflator device (CAPSID) for gradual inflation. The objective of this prospective randomized study was to examine whether use of CAPSID reduces early and late cardiac events in patients undergoing PCI.MethodsPatients undergoing PCI were eligible and randomized to CAPSID or standard balloon inflation (plain old balloon angioplasty). In the CAPSID group, a slow, gradual balloon inflation was performed by a personal computer. Stenting was used in both groups only for suboptimal results. Patients with total occlusions and vein grafts were excluded. Clinical follow-up for major adverse cardiac events (MACE) was performed at 6 and 12 months, with repeat coronary angiography performed for clinical symptoms or positive stress testing.ResultsA total of 234 patients completed the study. At 1-year follow-up, the CAPSID group had a significantly lower rate of MACE (21% vs. 37%, P<.005). In patients who underwent angiography, there was a significantly lower rate of restenosis in the CAPSID group (20.2% vs. 35.5%). The reduction in TLR was even more pronounced in the subgroup undergoing stenting (8% vs. 24%; P<.001).ConclusionsWe conclude that gradual computerized balloon inflation is more effective than standard manual balloon inflation in reducing adverse coronary events. The combination of CAPSID and subsequent stent deployment was especially effective in reducing TLR.     

Dedicated Tryton Side Branch Stents used in the treatment of coronary bifurcation lesions

IntroductionCoronary bifurcation lesions account for 15–20% of all percutaneous coronary interventions.Dedicated bifurcation stents have recently been introduced with the aim to simplify treatment and improve early and late outcomes following stenting of bifurcation lesions.The purpose of our study was to assess the safety and effectiveness of the Tryton dedicated side branch stent at a 6-month clinical and angiography follow-up.MethodsForty-two patients with bifurcation lesions were included in our study. The primary endpoint was a 6-month MACE and angiographic stent patency was also evaluated by MS-CT coronarography.ResultsTwenty-two patients (52.38%) were treated for acute coronary syndromes, 39 (92.85%) lesions were “true bifurcations”. The 6-month clinical follow-up was performed in all patients. The 6-month MACE rate (cardiac death, myocardial infarction and target lesion revascularization) was 9.52% (95% CI: 2.66–22.62%); of these one patient (2.38%; 95% CI: 0.06–12.57%) died due to cardiogenic shock caused by early stent thrombosis and three patients (7.14%; 95% CI: 1.50–19.48%) required repeated revascularization (TVR) due to in-stent restenosis, all of them in bare metal stents. Tryton stent implantation was successful in 100% lesions.6-Month MS-CT coronarography was performed in 39 (92.85%) patients. The implanted bifurcation Tryton stents were satisfactorily visualized in 97.43% of them and a satisfactory 6-month angiographic patency was demonstrated in 37 patients (88.1%).ConclusionThe usage of a dedicated bifurcation Tryton Side Branch Stent for PCI of the bifurcation lesions is technically feasible with satisfactory long-term results.     

Safety and feasibility of X-sizer-facilitated rescue percutaneous coronary intervention: a preliminary experience

Failed thrombolysis following ST-elevation myocardial infarction (STEMI) is associated with a poor prognosis. Rescue balloon angioplasty with or without stent implantation is an established treatment for failed thrombolysis. Recently, X-Sizer thrombectomy has been shown to be effective in removing intracoronary thrombi and improving coronary perfusion in patients with acute coronary syndrome. In this retrospective study, we sought to evaluate the safety and feasibility of X-Sizer-facilitated rescue percutaneous coronary intervention (PCI) for the treatment of STEMI after failed thrombolysis. Clinical data are from a retrospective review of 95 patients who underwent X-Sizer-facilitated primary PCI (n = 80) or rescue PCI (n = 15) during the period from November 2000 to February 2003. Baseline and procedural characteristics of the 2 groups were similar, except for a higher prevalence of hypercholesterolemia in the rescue PCI group. Angiographic success was achieved in 96% in the primary PCI group and 100% in the rescue PCI group. The 30-day mortality (7.5% vs. 13.3%), major acute coronary event (MACE; 7.5% vs. 13.3%), and MACE with angina (15% vs. 13.3%) rates were similar between the primary PCI and the rescue PCI groups. Similarly, the 6-month mortality (10% vs. 13.3%), MACE (16.3% vs. 13.3%) and MACE with angina (25% vs. 26.7%) rates were also comparable (p = NS for all comparison). In particular, there were no incidences of death, reinfarction or repeat revascularization between 30 days and 6 months in the rescue PCI group. In conclusion, X-Sizer-facilitated rescue PCI was safe and feasible. The outcomes of patients who underwent X-Sizer-facilitated rescue PCI were similar to those who underwent X-Sizer-facilitated primary PCI.     

Five-year experience with transradial coronary angioplasty in ST-segment-elevation myocardial infarction

Background and purposePercutaneous coronary intervention (PCI) via radial approach has been shown to be an alternative to femoral approach in emergency cases; however, its feasibility has been questioned. This single-center study was performed to compare the outcomes and complication rates between transradial (TR) and transfemoral (TF) PCI in ST-segment-elevation myocardial infarction (STEMI).Methods and materialsThe clinical and angiographic data of 582 consecutive STEMI patients treated with PCI between 2001 and 2006 were evaluated in a retrospective study. Forty-three patients were excluded from the present study due to cardiogenic shock or rescue PCI. Patients (n=539) were categorized into the TR group (n=167) or the TF group (n=372), and several parameters were evaluated to assess the advantages and drawbacks of TR access: access-site crossover, rate of access-site complications, procedure time, fluoroscopy time, X-ray area dose, major adverse cardiac events (MACE) at 1 month, and consumption of angioplasty equipment.ResultsIn the TR group, the crossover rate to femoral access was 5%, while in the TF group, it was 0.8% (P<.05). There was a significant difference, in both major and minor access-site complications, between the TR group and the TF group (0% vs. 5%, P<.05, and 4% vs. 9%, P<.05, respectively). Consumption of angioplasty equipment proved to be the same for the two groups. The MACE rate was 4% in the TR group and 11% in the TF group (P<.05).ConclusionsOur results suggest that the TR approach is a safe and effective way to treat STEMI; furthermore, site-related complications are less common with this approach.     

Radial vs Femoral Access in ACS Patients Undergoing Complex PCI Is Associated With Consistent Bleeding Benefit and No Excess of Risks

BackgroundThe comparative effectiveness of transradial (TRA) compared with transfemoral (TFA) access in acute coronary syndrome (ACS) patients undergoing complex percutaneous coronary intervention (PCI) remains unclear.MethodsAmong 8404 ACS patients in the Minimising Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX (MATRIX)—Access trial, 5233 underwent noncomplex (TRA: n = 2590; TFA: n = 2643) and 1491 complex (TRA: n = 777; TFA: n = 714) PCI. Co-primary outcomes were major adverse cardiovascular events (MACE, the composite of all-cause mortality, myocardial infarction, or stroke) and the composite of MACE and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding (net adverse cardiovascular events [NACE]) at 30 days.ResultsRates of 30-day MACE (HR 0.94, 95% CI 0.72-1.22) or NACE (HR 0.89, 95% CI 0.69-1.14) did not significantly differ between groups in the complex PCI group, whereas both primary end points were lower (HR 0.84, 95% CI 0.70-1.00; HR 0.83, 95% CI 0.70-0.98; respectively) with TRA among noncomplex PCI patients, with negative interaction testing (P_int = 0.473 and 0.666, respectively). Access-site BARC type 3 or 5 bleeding was lower with TRA, consistently among complex (HR 0.18, 95% CI 0.05-0.63) and noncomplex (HR 0.41, 95% CI 0.20-0.85) PCI patients, whereas the former group had a greater absolute risk reduction of 1.7% (number needed to treat: 59) owing to their higher absolute risk.ConclusionsAmong ACS patients, PCI complexity did not affect the comparative efficacy and safety of TRA vs TFA, whereas the absolute risk reduction of access-site major bleeding was greater with TRA compared with TFA in complex as opposed to noncomplex PCI.     

Transradial Versus Transfemoral Access for Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery Stenosis: A Systematic Review and Meta-Analysis

IntroductionPCI of ULMS is frequently performed through TFA because of technical complexity and safety concern. Studies have shown comparable efficacy and safety of TRA versus TFA, however, these studies are few in number. We intended to compare the clinical outcomes between transradial access (TRA) and transfemoral access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for unprotected left main coronary artery stenosis (ULMS) by performing a meta-analysis.MethodA systematic search of database, including, PubMed, Web of Science, Google scholar and Cochrane Database were performed by two independent reviewers. Studies were included comparing “TRA” versus “TFA” in patients undergoing PCI in ULMS. The primary outcome was a procedural success rate. Secondary outcomes were major bleeding, access site complications, in-hospital and long term: major adverse cardiac events (MACE), myocardial infarction (MI) and cardiovascular mortality.ResultsEight studies were included in the analysis. The procedural success rate was 97.3% and there was no statistically significant difference between TRA and TFA groups (OR, 1.41 [CI 0.64, 3.12], I² = 26%). The rates of access site complications (OR, 0.17 [CI 0.07, 0.41], I² = 16%), major bleeding (OR, 0.39 [CI 0.17, 0.86], I² = 0%) and all-cause mortality (OR, 0.28 [CI 0.12, 0.64], I² = 0%) were lower in the TRA group. There were no significant differences in in-hospital and long term cardiovascular mortality, MI and MACE between the two groups.ConclusionIn contrast to TFA, TRA is associated with reduced bleeding and access site complications, with similar procedural success rate in patients undergoing PCI of ULMS.     

Impact of unknown diabetes and prediabetes on clinical outcomes in “nondiabetic” Chinese patients after a primary coronary intervention

Background and aimTo explore the prevalence of unknown diabetes (DM) or prediabetes (pre-DM) in “nondiabetic” patients and its association with 2-year clinical outcomes after primary percutaneous coronary intervention (PCI).Methods and results5202 consecutive “nondiabetic” patients who underwent primary PCI at Fuwai Hospital from January to December 2013 were prospectively enrolled. The patients were grouped according to their glycemia status: unknown DM (HbA1c ≥ 47 mmol/L; FPG≥ 7.0 mmol/L), pre-DM (HbA1c 39–47 mmol/L; FPG: 5.6–6.9 mmol/L) and normoglycemia (NG, HbA1c < 39 mmol/L; FPG < 5.6 mmol/L). The main endpoint was 2-year major adverse cardiovascular events (MACE), including cardiac death, myocardial infarction, and target vessel revascularization. A total of 905 patients had unknown DM, and 3407 patients had pre-DM. Unknown DM and pre-DM were associated with aging (p < 0.001); a greater proportion of hypertension (p < 0.001), previous myocardial infarction (p < 0.001), and chronic kidney disease (p = 0.004). During the 2-year follow-up, the rate of MACE was significantly higher in the unknown DM and pre-DM groups than in the NG group (8.1% vs. 5.8% vs. 4.1%, respectively, p = 0.001). Multivariate analyses demonstrated that unknown DM was associated with a 1.9-fold higher event risk compared to NG (95% CI: 1.2–2.8).ConclusionsThe prevalence of abnormal glucose metabolism was high in “nondiabetic” Chinese PCI patients. Patients with unknown DM and pre-DM had higher event risks than those with NG. In “nondiabetes” patients requiring PCI, routine assessment of HbA1c and FPG appears to be of value to identify patients with an increased event risk.     

Safety of Same-Day Discharge after Percutaneous Coronary Intervention with Orbital Atherectomy

BackgroundSeverely calcified lesions present many challenges to percutaneous coronary intervention (PCI). Orbital atherectomy (OA) aids vessel preparation and treatment of severely calcified coronary lesions. Same-day discharge (SDD) after PCI has numerous advantages including cost savings and improved patient satisfaction. The aim of this study is to evaluate the safety of SDD among patients treated with OA in a real-world setting.MethodsThis was a single-center retrospective analysis of patients undergoing OA. In-hospital and 30-day outcomes were assessed for major adverse cardiac events (MACE), device-related events and hospital readmissions.ResultsThere were 309 patients treated with OA of whom 94 had SDD (30.4%). Among SDD patients, there were no acute procedural complications and all patients were safely discharged on the day of the procedure. MACE at 30 days occurred in 1 patient (1.06%) due to major bleeding in the setting of a gastric arteriovenous malformation. There were 8 patients with unplanned 30-day readmissions (8.5%).ConclusionSDD after OA in patients with heavily calcified lesions appears to be safe, with low rates of adverse events and readmissions in select patients. In patients with SDD treated with OA, unplanned readmission occurred at a similar rate to the statewide average 30-day PCI readmission rate. Larger studies are needed to confirm the safety of this treatment paradigm and the potential cost savings.     

Safety and Feasibility of Same Day Discharge Strategy for Primary Percutaneous Coronary Intervention

Background:The strategy for early discharge after primary percutaneous coronary intervention (PCI) could have substantial financial benefits, especially in low-middle income countries. However, there is a lack of local evidence on feasibility and safety of the strategy for early discharge. Therefore, the aim of this study was to assess the safety of early discharge after primary PCI in selected low-risk patients in the population of Karachi, Pakistan.Methods:In this study 600 consecutive low-risk patients who were discharged within 48 hours of primary PCI were put under observation for major adverse cardiac events (MACE) after 7 and 30 days of discharge respectively. Patients were further stratified into discharge groups of very early (≤ 24 hours) and early (24 to 48 hours).Results:The sample consisted of 81.8% (491) male patients with mean age of 54.89 ± 11.08 years. Killip class was I in 90% (540) of the patients. The majority of patients (84%) were discharged within 24 hours of the procedure. Loss to follow-up after rate at 7 and 30 days was 4% (24) and 4.3% (26) respectively. Cumulative MACE rate after 7 and 30 days was observed in 3.5% and 4.9%, all-cause mortality in 1.4% and 2.3%, cerebrovascular events in 0.9% and 1.4%, unplanned revascularization in 0.9% and 1.2%, re-infarction in 0.3% and 0.5%, unplanned re-hospitalization in 0.5% and 0.5%, and bleeding events in 0.5% and 0.5% of the patients respectively.Conclusion:It was observed that very early (≤ 24 hours) discharge after primary PCI for low-risk patients is a safe strategy subjected to careful pre-discharge risk assessment with minimal rate of MACE after 7-days as well as 30-days.     

Distal embolic protection during percutaneous coronary intervention in patients with acute coronary syndromes: The RUBY study

Objective: To assess the safety and feasibility of the GuardWire^TM system as an embolic protection device during percutaneous coronary intervention (PCI) in acute coronary syndromes (ACS). Background: Distal embolization occurs in approximately 15% of patients after primary angioplasty and is associated with reduced myocardial reperfusion, more extensive myocardial damage and a poor prognosis. Distal embolic protection could reduce the rate of embolic complications and improve outcome. Methods: 329 patients (mean age 60±12 years) were included: 278 (84.5%) with ST‐elevation myocardial infarction (STEMI), 50 (15.2%) with unstable angina/non‐STEMI and 1 (0.3%) with post‐infarction angina. Primary endpoint was the incidence of major adverse cardiac events (MACE) at 30 days. Secondary endpoints were the magnitude of ST‐segment resolution at 90 and 180?min post‐procedure, myocardial blush grade, and angiographically visible distal emboli. Results: The GuardWire^TM system was successfully positioned in 99% of patients. Complete ST‐elevation resolution (>70%) was observed in 28.5% immediately post‐procedure, and in 35.4% and 41.6% at 90 and 180?min post‐procedure. TIMI‐3 flow grade was achieved by 89.8% of patients after intervention and mean corrected TIMI frame count was 20.2±13.2. Grade‐3 myocardial blush was seen in 47.7% of patients and distal emboli were angiographically visible in 7.4%. Incidence of MACE at 30 days was 3.3% (death 1.2%; Q‐wave MI 0.3%; non‐Q‐wave MI 0.3%; coronary artery bypass graft 0.6%; repeat PCI 0.9%). Conclusion: The GuardWire^TM system was successfully positioned in nearly all patients without complications. The use of this embolic protection device in ACS patients undergoing PCI was associated with low rates of distal embolization and 30‐day MACE.     

Direct Stenting in Patients Treated with Orbital Atherectomy: An ORBIT II Subanalysis

BackgroundDirect stenting offers many potential advantages in appropriately selected lesions. Coronary artery calcification increases the complexity and risk of adverse events associated with percutaneous coronary intervention. This study aimed to examine the feasibility of direct stenting after treatment with orbital atherectomy (OA).MethodsORBIT II was a single-arm trial enrolling 443 subjects with de novo severely calcified coronary lesions treated with OA; direct stenting was utilized in 59.0% of cases. Procedural outcomes and 3-year major adverse cardiac event (MACE) rates were compared in subjects treated with pre-stent balloon dilatation versus direct stenting after OA.ResultsProcedural success (84.2% vs. 93.3%; p = 0.004) was significantly higher in the direct stenting cohort. 3-year MACE occurred less frequently in the direct stenting cohort (29.9% vs. 19.1%; p = 0.006), driven by lower rates of myocardial infarction and target lesion revascularization. In a propensity matched analysis, procedural success and 3-year MACE rates were similar in the pre-stent balloon dilatation and direct stenting groups (85.0% vs. 91.8%; p = 0.122 and 28.2% vs. 19.6%; p = 0.078, respectively).ConclusionsOrbital atherectomy facilitates direct stenting and is associated with high procedural success and favorable 3-year outcomes in carefully selected patients. Randomized studies are needed to assess the optimal strategy after lesion preparation with OA.     

Effect of Paclitaxel-Coated Balloon Angioplasty on Side Branch Lesion and Cardiovascular Outcomes in Patients with De Novo True Coronary Bifurcation Lesions Undergoing Percutaneous Coronary Intervention

Purpose

To compare the effects of paclitaxal-coated balloon (PCB) versus conventional balloon (CB) on side branch (SB) lesion and cardiovascular outcomes in patients with de novo true bifurcation lesions.

Methods

In total, 219 patients with de novo true bifurcation lesions were enrolled and divided into PCB group (102 cases) and CB group (117 cases) according to angioplasty strategy in SB. Drug-eluting stent (DES) was implanted in main vessel (MV) for each subject. All subjects underwent a 12-month follow-up for late lumen loss (LLL), restenosis, and major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI). MACEs included cardiac death, nonfatal myocardial infarction, and unstable angina requiring admission.

Results

There were no differences in diameter, minimum lumen diameter (MLD), and stenosis for bifurcation lesions between the two groups before and immediately after PCI (P?>?0.05). After 12-month follow-up, no differences occurred in MV-MLD and MV-LLL between the two groups (P?>?0.05); SB-MLD in PCB group was higher than that in CB group (1.97?±?0.36 mm vs. 1.80?±?0.43 mm, P?=?0.007); SB-LLL in PCB group was lower than that in CB group (0.11?±?0.18 mm vs. 0.19?±?0.25 mm, P?=?0.024). Multivariate COX analyses indicated that PCB group had lower MACE risk than CB group (HR?=?0.480, 95%CI 0.244–0.941, P?=?0.033).

Conclusion

PCB could decrease SB-LLL and MACE risk in patients with de novo true coronary bifurcation lesion 12 months after single-DES intervention.