Percutaneous Coronary Intervention in Men, Women, and Minorities With a Previous Coronary Artery Bypass Graft Surgery (from the Pooled PLATINUM Diversity and PROMUS Element Plus Registries).

There is limited data on new-generation stent outcomes in patients with previous coronary artery bypass graft (CABG) and the associated risk of gender and race/ethnicity is unclear. We investigated 1-year outcomes after platinum chromium everolimus-eluting stent implantation in a diverse population of men, women, and minorities with previous CABG pooled from the PLATINUM Diversity (NCT02240810) and PROMUS Element Plus (NCT01589978) registries. Our primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR) at 1-year post percutaneous coronary intervention (PCI). Secondary end points included all-cause death, MI, TVR, target vessel failure, and stent thrombosis. A total of 4,175 patients were included in the analysis, including 1,858 women (44.5%), 1,057 minorities (25.3%), and 662 (15.9%) with previous CABG. Patients with previous CABG were older, included more men and White patients, and had more co-morbidities compared with patients without previous CABG. At 1 year, patients with previous CABG had a higher risk of MACE (12.6% vs 7.5%, hazard ratio 1.70, 95% confidence interval 1.32 to 2.19, p <0.001) and end points, including death/MI, TVR, and target vessel failure. After multivariate adjustment, no differences were observed in MACE (adjusted hazard ratio 1.11, 95% confidence interval 0.82 to 1.49, p = 0.506) or any secondary end points. No interaction was observed between previous CABG and gender or minority status. In conclusion, in a contemporary PCI population, patients with previous CABG remain at high risk for PCI because of their elevated risk profile. Previous CABG status was however not independently associated with worse outcomes after adjustment, nor was any interaction observed with gender or race/ethnicity.

Small-vessel PCI outcomes in men, women, and minorities following platinum chromium everolimus-eluting stents: Insights from the pooled PLATINUM Diversity and PROMUS Element Plus Post-Approval studies.

OBJECTIVE: We evaluated 1-year outcomes after platinum chromium everolimus-eluting stents (PtCr-EES) in small versus non-small coronary arteries within a large, diverse sample of men, women, and minorities. BACKGROUND: There exists limited outcomes data on the use of second-generation drug-eluting stent to treat small diameter coronary arteries. METHODS: We pooled patients from the PLATINUM Diversity and PROMUS Element Plus stent registries. Small-vessel percutaneous coronary intervention (SV-PCI) was defined as ≥1 target lesion with reference vessel diameter (RVD) ≤2.5 mm. Endpoints included major adverse cardiac event (MACE; death, myocardial infarction [MI] or target vessel revascularization [TVR]), target vessel failure (TVF; death related to the target vessel, target vessel MI or TVR) and definite/probable stent thrombosis (ST). Multivariable Cox regression was used to risk-adjust outcomes. RESULTS: We included 4,155/4,182 (99%) patients with available RVD, of which 1,607 (39%) underwent small-vessel PCI. SV-PCI was not associated with increased MACE (adjHR 1.02; 95%CI 0.81-1.30) or TVF (adjHR 1.07; 95%CI 0.82-1.39). MI risk was lower in white men compared to women and minorities, both in the setting of SV-PCI (adjHR 0.41; 95%CI 0.23-0.74 and adjHR 0.39; 95%CI 0.20-0.75, respectively) and for non-SV-PCI (adjHR 0.61; 95%CI 0.38-0.99 and adjHR 0.45; 95%CI 0.27-0.74, respectively). There was no significant interaction between RVD and sex or minority status for any endpoint. CONCLUSION: In a large diverse contemporary PCI outcomes database, SV-PCI with PtCr-EES was not associated with increased MACE or TVR and did not account for the increased MI risk noted in women and minorities compared to white men.

Clinical Outcomes and Cost Comparisons of Stent and Non-Stent Interventions in Infrainguinal Peripheral Artery Disease: Insights From the Excellence in Peripheral Artery Disease (XLPAD) Registry.

BACKGROUND: The contemporary limb outcomes and costs of stent-based vs non-stent based strategies in endovascular revascularization of femoropopliteal (FP) peripheral artery disease (PAD) are not well understood. METHODS AND RESULTS: We present data from the ongoing United States multicenter Excellence in Peripheral Artery Disease Registry between 2006-2016 to compare stent vs non-stent treatment outcomes and associated costs in FP interventions. A total of 2910 FP interventions were performed in 2162 patients (mean age, 66 years), comprising 1339 stent based (superficial femoral artery, 93%) in 1007 patients and 1571 non-stent interventions (superficial femoral artery, 85%) in 1155 patients. A growing trend for non-stent based interventions and a declining trend in repeat revascularization rate at 1 year were observed across years of registry enrollment. Stent implantation was the prevailing strategy in treating longer FP lesions (mean length, 152 mm vs 105 mm; P<.001) and chronic total occlusions (65% vs 40%; P<.001), while stent implantation was employed less frequently when treating in-stent restenotic lesions (14% vs 20%; P<.001). Stent and non-stent interventions had similar 1-year limb outcomes in all-cause death, target-limb revascularization, target-vessel revascularization, and major or minor amputation. The average procedure costs for the stent group were significantly higher than the non-stent group ($6215 vs $4790; P<.001). CONCLUSION: There is a growing trend for non-stent FP artery interventions, with a significant decline in 1-year target-limb revascularization rates over time. One-year limb outcomes in stent-based compared to non-stent interventions are similar; however, at a significantly higher procedural cost.

Comparative Effectiveness Study of Drug-Eluting and Bare-Metal Peripheral Artery Stents in Endovascular Femoropopliteal Artery Revascularization.

OBJECTIVES: Paclitaxel drug-eluting stents (DESs) have been shown to improve primary patency of femoropopliteal lesions compared to plain balloon angioplasty with provisional bare-metal stents (BMSs) in randomized controlled studies. However, data are lacking on patency outcomes of real-world DES use relative to BMS use. This study compared clinically driven target-lesion revascularization (TLR), target-vessel revascularization (TVR), and target-limb revascularization outcomes at 1 year between DES and BMS treatments in a real-world setting. METHODS: The study identified 174 DES (Zilver PTX; Cook Medical) and 784 BMS femoropopliteal interventions from the available 969 Excellence in Peripheral Artery Disease (XLPAD) registry patients between October 2013 and December 2016. We analyzed both unmatched (174 DES and 784 BMS) and propensity score (PS)-matched datasets (174 for each). RESULTS: This study found that patients who underwent DES femoropopliteal endovascular revascularization had significantly lower TLR rates in both unmatched (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.35-0.91; P=.02) and matched data (HR, 0.50 95% CI, 0.27-0.91; P=.02). The DES group had a 43% lower TVR risk than the BMS group in the PS matched cohort (HR, 0.57; 95% CI, 0.33-0.98; P=.04). Mortality rate in the DES group (5%) was significantly higher than the BMS group in both unmatched (2%; P=.04) and matched groups (1%; P=.046) at 1 year. CONCLUSIONS: Patients treated with DES had higher lesion and vessel patency than BMS after adjusting for confounding, which included complexity of lesion characteristics and operators' clinical decision-making regarding selection of treatment modalities, in femoropopliteal endovascular interventions in a real-world registry.

The State of the Absorb Bioresorbable Scaffold: Consensus From an Expert Panel.

Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late. This is not too dissimilar to the challenges seen with first-generation DES in which refinement of deployment technique, prolongation of dual antiplatelet therapy, and technical iteration mitigated excess risk of very late stent thrombosis, making DES the treatment of choice for coronary artery disease. This white paper discusses the factors potentially implicated in the excess risks, including the scaffold consideration and deployment technique, and outlines patient and lesion selection, implantation technique, and dual antiplatelet therapy considerations to potentially mitigate this excess risk with the first-generation thick strut Absorb scaffold (Abbott Vascular, Abbott Park, Illinois). It remains to be seen whether these considerations together with technical iterations will ultimately close the gap between scaffolds and metal stents for short-term events while at the same time preserving options for future revascularization once the scaffold bioresorbs.

Outcomes in Women and Minorities Compared With White Men 1 Year After Everolimus-Eluting Stent Implantation: Insights and Results From the PLATINUM Diversity and PROMUS Element Plus Post-Approval Study Pooled Analysis.

Importance: There exist limited outcomes data for women and minorities after contemporary percutaneous coronary intervention (PCI). Objective: To examine 1-year outcomes in women and minorities vs white men after PCI with everolimus-eluting stents. Design, Settings, and Participants: The PLATINUM Diversity study was a single-arm study enrolling women and minorities. Patient-level pooling with the PROMUS Element Plus Post-Approval Study was prespecified. Data on social determinants of health and language were collected in the PLATINUM Diversity cohort, which included 1501 patients at 52 US sites. The PROMUS Element Plus Post-Approval study enrolled 2681 patients at 52 US sites with some site overlap and included an "all-comers" population. All patients were enrolled beginning in October 2014 and were followed for 12 months. Analyses began in August 2016. Interventions: Patients received 1 or more everolimus-eluting stent implantation. Main Outcomes and Measures: The primary end point was 1-year major adverse cardiac events (MACE), which included death/myocardial infarction (MI)/target vessel revascularization. Secondary ischemic end points were also evaluated. Results: The pooled study consisted of 4182 patients: 1635 white men (39.1%), 1863 women (white and minority) (44.5%), and 1059 minority patients (women and men) (25.3%). Women and minorities had a higher prevalence of diabetes, prior stroke, hypertension, renal disease, and congestive heart failure than white men but lower rates of multivessel disease, prior coronary artery bypass graft surgery, prior MI, and smoking. Unadjusted 1-year MACE rates (white men, 7.6%; women, 8.6%; minorities, 9.6%) were similar between groups with no significant differences after risk adjustment. The adjusted risk of death/MI was higher among women (odds ratio, 1.6; 95% CI, 1.1-2.4) and minorities (odds ratio, 1.9; 95% CI, 1.2-2.8) compared with white men and the adjusted risk of MI was higher in minorities (odds ratio, 2.6; 95% CI, 1.4-4.8). These differences were driven primarily by nonstent-related MIs. Within the PLATINUM Diversity cohort, the independent predictors of MACE were cardiogenic shock, renal disease, history of peripheral vascular disease, multivessel disease, widowhood, and lack of private insurance. Conclusions and Relevance: After contemporary everolimus-eluting stent implantation, women and minorities experience a similar risk of 1-year MACE but a higher adjusted risk of recurrent ischemic events primarily because of nonstent-related MIs. Both clinical and angiographic factors and social determinants of health, including widowhood and insurance status, contribute to 1-year MACE among women and minorities.

Comparative Assessment of Procedure Cost and Outcomes Between Guidewire and Crossing Device Strategies to Cross Peripheral Artery Chronic Total Occlusions.

OBJECTIVES: The aim of this study was to assess actual procedural costs and outcomes comparing wire-catheter and dedicated chronic total occlusion (CTO) device strategies to cross peripheral artery CTOs. BACKGROUND: Peripheral artery CTO interventions are frequently performed, but there are limited data on actual procedural costs and outcomes comparing wire-catheter and dedicated CTO devices. METHODS: The XLPAD (Excellence in Peripheral Artery Disease Intervention) registry (NCT01904851) was accessed to retrospectively compare cost and 30-day and 12-month outcomes of wire-catheter and crossing device strategies for treatment of infrainguinal peripheral artery CTO. RESULTS: Of all 3,234 treated lesions, 42% (n = 1,362) were CTOs in 1,006 unique patients. Wire-catheter approaches were used in 82% of CTOs, whereas dedicated CTO devices were used in 18% (p < 0.0001). CTO crossing device use was associated with significantly higher technical success (74% vs. 65%; p < 0.0001) and mean procedure cost ($7,800.09 vs. $4,973.24; p < 0.0001). Because 12-month repeat revascularization (11.3% vs. 17.2%; p = 0.02) and amputation rates (2.8% vs. 8.5%; p = 0.002) in the CTO crossing device arm were lower compared with the wire-catheter group, the net cost for an initial CTO crossing device strategy was $423.80 per procedure. CONCLUSIONS: An initial wire-catheter approach to cross a peripheral artery CTO is most frequently adopted. The use of dedicated CTO crossing devices provides significantly higher technical success and lower reintervention and amputation rates, at a net cost of $423.80 per procedure at 12 months.

Femoropopliteal Artery Stent Thrombosis: Report From the Excellence in Peripheral Artery Disease Registry.

BACKGROUND: There are limited data on femoropopliteal artery stent thrombosis (ST), which is a serious adverse outcome of peripheral artery interventions. METHODS AND RESULTS: Index procedures resulting in femoropopliteal ST were compared with stent procedures without subsequent ST in the Excellence in Peripheral Artery Disease registry. The study data had a total of 724 cases of stent procedures and 604 unique patients. Femoropopliteal ST occurred in 26 of 604 patients (4.3%) over a median follow-up of 6 months post procedure. ST was more likely to occur in men (96.3% versus 82.2%; P=0.026) and to have an initial intervention for chronic total occlusions (88.5% versus 64.0%; P=0.01). There was no significant difference in ST between drug-coated and bare-metal stents (4.4% versus 3.4%; P=0.55), but the rate of ST was significantly higher with self-expanding covered stent grafts compared with bare-metal stents (10.6% versus 3.4%; P=0.02). ST was significantly associated with an increased risk of 12-month major adverse limb events (hazard ratio, 4.99; 95% confidence interval, 2.31-10.77; P<0.001) compared with no ST. On multivariate analysis, treatment of chronic total occlusion lesions (odds ratio, 3.46; 95% confidence interval, 0.98-12.20; P=0.05) and in-stent restenosis lesions (odds ratio, 5.30; 95% confidence interval, 1.83-15.32; P=0.002) were independently associated with an increased risk of ST. CONCLUSIONS: In a multicenter peripheral interventional registry, femoropopliteal ST occurred in 4.3% of patients who underwent stent procedures, and it was associated with treatment of chronic total occlusions and in-stent restenosis lesions, and had higher 12-month major adverse limb events. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01904851.

Stent and Non-Stent Based Outcomes of Infrainguinal Peripheral Artery Interventions From the Multicenter XLPAD Registry.

BACKGROUND: There are limited data regarding contemporary use of stent and non-stent based treatment strategies of infrainguinal peripheral artery disease (PAD). METHODS: We analyzed data from the ongoing multicenter XLPAD registry between July 2005 and October 2013 to report on the use of non-stent (atherectomy ± balloon angioplasty) and stent-based treatment of superficial femoral artery (SFA), popliteal, and below-the-knee (BTK) vessels in contemporary clinical practice. RESULTS: A total of 584 interventions (SFA, 82.5%; popliteal, 7.2%; BTK, 9.9%) were performed in 372 patients (mean age, 63.2 years; diabetes mellitus, 57.7%; Rutherford category 1-3, 73.5%; Rutherford category 4-6, 20.1%). Stents were deployed in 389 lesions (66.6%; SFA, 90.5%; popliteal, 5.1%; BTK, 4.1%) and non-stent strategy (atherectomy, 49%) in 195 lesions (33.4%; SFA, 66.7%; popliteal, 11.3%; BTK, 21.5%). In the stent and non-stent groups, mean lesion lengths were 133.9 mm and 86.0 mm (P<.001), chronic total occlusions (CTOs) constituted 63.0% and 49.7% (P<.01), and restenotic lesions were 12.6% and 32.3% (P<.001), respectively. At a mean follow-up of 260 ± 130 days, in the stent and non-stent treated patients, all-cause mortality was 4.3% and 3.5% (P=.65), clinically indicated repeat revascularization was 17.5% and 14.9% (P=.42), and amputation was 4.6% and 9.2% (P<.01), respectively. SFA lesion location, long lesion length, and CTO were associated with the use of stents. Advanced Rutherford class was associated with a non-stent treatment strategy. CONCLUSION: The majority of endovascular peripheral arterial interventions are performed in the SFA; most include a CTO and in patients with diabetes mellitus. Operators use stents to primarily treat complex SFA lesions with overall similar outcomes, except for fewer amputations compared to a non-stent strategy.

Optimal use of left ventriculography at the time of cardiac catheterization: a consensus statement from the Society for Cardiovascular Angiography and Interventions.

The rationale to perform left ventriculography at the time of cardiac catheterization has been little studied. The technique and frequency of use of left ventriculography vary by geographic regions, institutions, and individuals. Despite the recent publication of guidelines and appropriate use criteria for coronary angiography, revascularization, and noninvasive imaging, to date there have been no specific guidelines on the performance of left ventriculography. When left ventriculography is performed, proper technique must be used to generate high quality data which can direct patient management. The decision to perform left ventriculography in place of, or in addition to, other forms of ventricular assessment should be made taking into account the clinical context and the type of information each study provides. This paper attempts to show the role of left ventriculography at the time of coronary angiography or left heart catheterization. The recommendations in this document are not formal guidelines but are based on the consensus of this writing group. These recommendations should be tested through clinical research studies. Until such studies are performed, the writing group believes that adoption of these recommendations will lead to a more standardized application of ventriculography and improve the quality of care provided to cardiac patients. © 2014 Wiley Periodicals, Inc.

Crossing of infrainguinal peripheral arterial chronic total occlusion with a blunt microdissection catheter.

PURPOSE: Crossing of lower-extremity arterial chronic total occlusion (CTO) can be challenging. Use of the Viance peripheral CTO crossing device (Covidien) in the superficial femoral (SFA), popliteal, and below-the knee (BTK) arterial locations has received limited study. METHODS: Fifty-eight patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) were treated between April 2010 and November 2013 with the Viance device. The procedural and 30-day clinical outcomes were collected. RESULTS: Mean age was 65.5 ± 8.7 years and 55.1% had diabetes mellitus. Most lesions (n = 58) were TASC classification type C (n = 16; 27.6%) and D (n = 16; 27.6%), with mean lesion length 140.0 ± 71.0 mm; 93.1% of lesions were de novo and 81.0% were severely calcified. Technical success (crossing without the use of a reentry device) was achieved in 87.9% of cases and procedural success was obtained in 86.2%; 51.7% of lesions received stents, with the remaining treated with balloon angioplasty and/or atherectomy. Average fluoroscopy time was 39.1 ± 21.2 min, with 187.8 ± 72.0 mL of contrast and 210.0 ± 212.0 Gy cm² radiation dose-area product. There was 1 periprocedural complication (access-site hematoma treated conservatively without blood transfusion). At 30 days post procedure, there was significant improvement in ankle-brachial index (0.72 ± 0.30 to 0.84 ± 0.16; P=.01) and Rutherford class (3.33 ± 0.81 to 1.54 ± 1.47; P<.001). Clinically-indicated target vessel revascularization, surgical intervention or amputation at 30 days was 5.2%. CONCLUSION: Use of Viance to cross infrainguinal arterial CTO was associated with high success, low complication rates, and significant symptom improvement.

SCAI expert consensus statement for aorto-iliac arterial intervention appropriate use.

Aorto-iliac arterial occlusive disease is common and may cause a spectrum of chronic symptoms from intermittent claudication to critical limb ischemia. Treatment is indicated for symptoms that have failed lifestyle and medical therapies or occasionally to facilitate other interventional procedures such as TAVR and/or placement of hemodynamic assist devices. It is widely accepted that TASC A, B, and C lesions are best managed with endovascular intervention. In experienced hands, most TASC D lesions may be treated by endovascular methods, and with the development of chronic total occlusion devices, many aorto-iliac occlusions may be recanalized safely by endovascular means. Interventional cardiologists should be well versed in the anatomy, as well as the treatment of aorto-iliac disease, given their need to traverse these vessels during transfemoral procedures. Overall, aorto-iliac occlusive disease is more commonly being treated with an endovascular-first approach, using open surgery as a secondary option. This document was developed to guide physicians in the clinical decision-making related to the contemporary application of endovascular intervention among patients with aorto-iliac arterial disease.

Ad hoc percutaneous coronary intervention: a consensus statement from the Society for Cardiovascular Angiography and Interventions.

Percutaneous coronary interventions (PCI) may be performed during the same session as diagnostic catheterization (ad hoc PCI) or at a later session (delayed PCI). Randomized trials comparing these strategies have not been performed; cohort studies have not identified consistent differences in safety or efficacy between the two strategies. Ad hoc PCI has increased in prevalence over the past decade and is the default strategy for treating acute coronary syndromes. However, questions about its appropriateness for some patients with stable symptoms have been raised by the results of recent large trials comparing PCI to medical therapy or bypass surgery. Ad hoc PCI for stable ischemic heart disease requires preprocedural planning, and reassessment after diagnostic angiography must be performed to ensure its appropriateness. Patients may prefer ad hoc PCI because it is convenient. Payers may prefer ad hoc PCI because it is cost-efficient. The majority of data confirm equivalent outcomes in ad hoc versus delayed PCI. However, there are some situations in which delayed PCI may be safer or yield better outcomes. This document reviews patient subsets and clinical situations in which one strategy is preferable over the other.

Renal artery stenosis: an update on diagnosis and management.

Reno-vascular disease, along with diabetes mellitus, is the leading cause of dialysis in the elderly population, accounting for 50-66% of cases in patients above 65 years of age. Reno-vascular disease is a broad term, which includes renal artery stenosis, ischemic nephropathy, such as atherosclerotic obstruction, thrombo-embolic phenomenon, nephrosclerosis secondary to hypertension and acute occlusion of renal arteries (either bilateral or unilateral in singlekidney patients). Renal artery stenosis, defined as a 50% or greater occlusion of a renal artery (unilateral or bilateral), is an important cause of secondary hypertension. It often presents as drug refractory hypertension or renal insufficiency. Atherosclerotic renal artery stenosis accounts for 90% of such cases, the remaining 10% being caused by fibro-muscular dysplasia. The incidence of atherosclerotic renal artery stenosis is increasing among the aging population, who are at an increased risk due to cardiovascular complications. This is a review of the emerging trends in the diagnosis and management of renal artery stenosis.

Synergistic use of sirolimus-eluting stents and intravascular ultrasound for the treatment of unprotected left main and vein graft disease.

Treating unprotected left main disease and degenerated saphenous vein grafts by percutaneous intervention remains one of the more challenging situations facing interventional cardiologists. We present two cases showing how the use of sirolimus-eluting stents in combination with other novel techniques might alter treatment paradigms in the future.

Hemodynamic complications of ventricular septal rupture after acute myocardial infarction.

Ventricular septal rupture (VSR) is a rare but serious complication following acute myocardial infarction (MI). Patients may present with a new murmur associated with a thrill. Right heart catheterization will demonstrate elevated right atrial and pulmonary artery pressures as well as an oxygen step-up at the right ventricular level. Patients with a right ventricular infarction or cardiogenic shock and a ventricular septal rupture have high in-hospital mortality rates. Prompt diagnosis followed by surgical repair is essential for patients with VSR following MI.