Angiographic success and procedural complications in patients undergoing retrograde percutaneous coronary chronic total occlusion interventions: a weighted meta-analysis of 3,482 patients from 26 studies.

BACKGROUND: The efficacy and safety profile of retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We sought to perform a weighted meta-analysis of the success and complication rates of retrograde CTO PCI. METHODS: We conducted a meta-analysis of 26 studies published between 2006 and April 2013 reporting in-hospital outcomes of retrograde CTO PCI. Data on procedural success, frequency of death, emergent coronary artery bypass graft surgery (CABG), stroke, myocardial infarction (MI), perforation, tamponade, stent thrombosis, major vascular or bleeding events, contrast nephropathy, and radiation skin injury were collected. RESULTS: A total of 26 studies with 3482 patients and 3493 target CTO lesions were included. Primary retrograde CTO PCI was attempted in 52.4%. Pooled estimates of outcomes were as follows: procedural success 83.3% [95% confidence interval (CI): 79.0% to 87.7%]; death 0.7% (95% CI: 0.5% to 1.2%); urgent CABG 0.7% (95% CI: 0.4% to 1.2%); tamponade 1.4% (95% CI: 1.0% to 2.2%); collateral perforation 6.9% (95% CI: 4.6% to 10.4%); coronary perforation 4.3% (95% CI: 1.2% to 15.4%); donor vessel dissection 2% (95% CI: 0.9% to 4.5%); stroke 0.5% (95% CI: 0.2% to 1.0%); MI 3.1% (95% CI: 0.2% to 5.0%); Q wave MI 0.6% (95% CI: 0.4% to 1.1%); vascular access complications 2% (95% CI: 0.9% to 4.5%); contrast nephropathy 1.8% (95% CI: 0.8% to 3.7%); and wire fracture and equipment entrapment 1.2% (95% CI: 0.6% to 2.5%). CONCLUSIONS: Retrograde CTO PCI is associated with high procedural success rate and acceptable risk for procedural complications.

Prevalence and outcomes of intermediate saphenous vein graft lesions: findings from the stenting of saphenous vein grafts randomized-controlled trial.

BACKGROUND: We sought to examine the prevalence and progression rate of intermediate saphenous vein graft (SVG) lesions in the Stenting Of Saphenous vein grafts (SOS) trial. METHODS: The baseline and follow-up angiograms of 80 patients participating in the SOS trial were analyzed to determine the prevalence of intermediate (30-60% angiographic diameter stenosis) SVG lesions and their progression rate. RESULTS: At least one intermediate SVG lesion was present in 31 of 143 (22%) SVGs in 27 of 80 (34%) patients. Most intermediate lesions were present in the SOS stented SVGs (20 grafts in 19 patients). During a median follow-up of 35 months, angiographic follow-up was available for 28 grafts in 25 patients. Progression (defined as percent diameter stenosis ≥ 70% but <100% at follow-up angiography) was seen in 11 of 28 SVGs (39%) in 11 of 25 patients (44%). Progression rate at 12, 24 and 36 months was 28% and 47% and 84%, respectively. Seven of 11 patients (64%) with intermediate SVG lesion progression presented with an acute coronary syndrome and 8 (73%) underwent PCI. Four of the 28 grafts with intermediate lesions at baseline were 100% occluded at follow-up; all of those SVGs had received a stent in another location in the SVG as part of the SOS trial. CONCLUSIONS: Intermediate SVG lesions are common in patients undergoing SVG stenting, have high rates of progression and frequently present with an acute coronary syndrome. Further study of pharmacologic and mechanical treatments to prevent progression of these lesions is needed.

Paclitaxel-eluting stents reduce neointimal hyperplasia compared to bare metal stents in saphenous vein grafts: intravascular ultrasonography analysis of the SOS (Stenting of Saphenous Vein Grafts) trial.

AIMS: To compare the intravascular ultrasonography (IVUS) findings between saphenous vein grafts (SVG) treated with paclitaxel-eluting stents (PES) vs. bare metal stents (BMS) in the Stenting Of Saphenous Vein Grafts (SOS) trial. METHODS AND RESULTS: Of the 80 SOS trial patients, 38 had both baseline and follow-up IVUS examination and were included in this substudy: 17 patients received 28 BMS in 26 lesions and 21 patients received 30 PES in 28 lesions. Quantitative IVUS analysis was performed to determine the volume of in-stent neointimal hyperplasia (NIH) - defined as the difference between stent volume and lumen volume in the stented segments. Baseline characteristics were similar between patients who did and did not undergo baseline and follow-up IVUS. Patients receiving BMS and PES had similar stent and lumen volumes immediately after stenting. At 12-month follow-up, compared to BMS, PES-treated lesions had significantly less NIH volume (3.4 vs. 21.9 mm³, p<0.001) and neointima hyperplasia progression (1.6 vs. 17.1 mm³, p<0.001). No significant differences were seen in the 5 mm segment proximal and distal to the stent. CONCLUSIONS: Compared to BMS, use of PES in SVG lesions is associated with significantly lower NIH formation, which may help explain the improved clinical outcomes with PES in these lesions.

Recurrent cardiovascular events with paclitaxel-eluting versus bare-metal stents in saphenous vein graft lesions: insights from the SOS (Stenting of Saphenous Vein Grafts) trial.

UNLABELLED: The Stenting of Saphenous Vein Grafts (SOS) trial demonstrated a reduction in clinical and angiographic adverse events with paclitaxel-eluting stents (PES) compared to bare-metal stents (BMS) in saphenous vein graft (SVG) lesions, but the rate of recurrent adverse events has not been described. METHODS: We performed a post hoc, landmark analysis to evaluate the risk of event recurrence following a non-fatal initial event among the SOS trial patients (pts). RESULTS: During a median follow-up of 35 months, the 80 pts enrolled in SOS experienced a total of 78 major cardiovascular events (MACE): 51 in the BMS group and 27 in PES group. No MACE were found in 28 pts (35%) while 52 pts (65%) had at least one event. The initial event was death in 13 pts (16%). Among the 39 pts whose initial event was not fatal, 12 (31%) had one or more subsequent MACE (50% of which were definitely related to the study SVG). The mean and median number of MACE per patient was significantly higher in patients receiving BMS versus PES (1.3 ± 1.2 and 1 ± 1.26 versus 0.6 ± 0.7 and 1 ± 0.825, p = 0.005 and p = 0.008, respectively). The rate of a second MACE following an initial event was 17% in the PES group and 37% in the BMS group (p = 0.24). Ten of 12 pts with recurrent events had received a BMS (83%). CONCLUSION: Pts undergoing SVG stenting had a high rate of recurrent events after an initial non-fatal event. These events were often related to the target vessel and most occurred in pts who had received a BMS, further supporting the benefit of PES over BMS in SVG lesions.

Continued benefit from paclitaxel-eluting compared with bare-metal stent implantation in saphenous vein graft lesions during long-term follow-up of the SOS (Stenting of Saphenous Vein Grafts) trial.

OBJECTIVES: This study sought to report the long-term outcomes after drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions in the SOS (Stenting of Saphenous Vein Grafts) trial. BACKGROUND: The long-term outcomes after DES implantation in SVGs are poorly studied. Apart from the SOS trial, the only other randomized trial comparing DES with bare-metal stents (BMS) in SVGs reported higher mortality in the DES group at 32 months. METHODS: In the SOS trial, 80 patients with 112 lesions in 88 SVGs were randomized to a BMS or paclitaxel-eluting stent (PES) and demonstrated improved short-term angiographic and clinical outcomes with PES. Extended clinical follow-up was subsequently obtained. RESULTS: Mean age was 67 ± 9 years, and all patients were men. The indications for stenting included acute coronary syndrome in 60% and stable angina in 31% of patients. The mean SVG age was 12 ± 6 years. The baseline characteristics of the patients in the 2 study groups were similar. Procedural success was achieved in 77 patients (96%). During a median follow-up of 35 months, compared with patients randomized to BMS, those receiving PES had a lower incidence of myocardial infarction (hazard ratio [HR]: 0.32, p = 0.01), target lesion revascularization (HR: 0.20, p = 0.004), target vessel revascularization (HR: 0.41, p = 0.03), and target vessel failure (HR: 0.34, p = 0.001) as well as a trend toward less definite or probable stent thrombosis (HR: 0.15, p = 0.08). All-cause mortality (HR: 2.04, p = 0.19) and cardiac mortality (HR: 0.62, p = 0.51) did not differ between groups. CONCLUSIONS: During long-term follow-up, use of PES was associated with significantly better clinical outcomes than BMS in SVG lesions. (Stenting of Saphenous Vein Grafts Trial [SOS]; NCT00247208).

Contemporary use of embolic protection devices in saphenous vein graft interventions: Insights from the stenting of saphenous vein grafts trial.

BACKGROUND: We sought to evaluate the contemporary use of embolic protection devices (EPDs) in saphenous vein graft (SVG) interventions. METHODS: We examined EPD use in the stenting of saphenous vein grafts (SOS) trial, in which 80 patients with 112 lesions in 88 SVGs were randomized to a bare metal stent (39 patients, 43 grafts, and 55 lesions) or paclitaxel-eluting stent (41 patients, 45 grafts, and 57 lesions). RESULTS: An EPD was used in 60 of 112 lesions (54%). A Filterwire (Boston Scientific) was used in 70% of EPD-treated lesions, Spider (ev3, Plymouth, Minnesota) in 12%, Proxis (St. Jude, Minneapolis, Minnesota) in 12%, and Guardwire (Medtronic, Santa Rosa, California) in 7%. Of the remaining 52 lesions, an EPD was not utilized in 13 lesions (25%) because the lesion was near the distal anastomosis, in 14 lesions (27%) because of an ostial location, in one lesion (2%) because of small SVG size, in two in-stent restenosis lesions (4%) because of low distal embolization risk, and in 22 lesions (42%) because of operator's preference even though use of an EPD was feasible. Procedural success was achieved in 77 patients (96%); in one patient a Filterwire was entrapped requiring emergency coronary bypass graft surgery and two patients had acute stent thrombosis. CONCLUSION: In spite of their proven efficacy, EPDs were utilized in approximately half of SVG interventions in the SOS trial. Availability of a proximal protection device could allow protection of approximately 25% of unprotected lesions, yet operator discretion appears to be the major determinant of EPD use.

Clinical presentation and angiographic characteristics of saphenous vein graft failure after stenting: insights from the SOS (stenting of saphenous vein grafts) trial.

OBJECTIVES: We sought to compare the clinical presentation and angiographic patterns of saphenous vein graft (SVG) failure after stenting with a paclitaxel-eluting stent (PES) versus a similar bare-metal stent (BMS). BACKGROUND: The mode of SVG failure after stenting has been poorly characterized. METHODS: The SOS (Stenting Of Saphenous Vein Grafts) trial enrolled 80 patients with 112 lesions in 88 SVGs who were randomized to a BMS or PES. Angiographic follow-up at 12 months was available in 83% of the patients. RESULTS: Binary angiographic restenosis occurred in 51% (24 of 47) of BMS-treated lesions versus 9% (4 of 43) of PES-treated lesions (p < 0.0001). Graft occlusion occurred in 9 of the 21 SVGs (43%) that failed in the BMS group and in 2 of 4 SVGs (50%) that failed in the PES group. SVG failure after stenting presented as an acute coronary syndrome in 10 of the 24 patients (42%) (7 of those 10 patients presented with non-ST-segment elevation acute myocardial infarction), stable angina in 9 (37%) patients, and without symptoms in 5 (21%) patients. Of the 19 patients (with 20 grafts) who developed symptomatic graft failure, repeat SVG revascularization was successfully performed in all 13 (100%) subtotally obstructed SVGs but was attempted (and successful) in only 1 of 7 (14%) occluded SVGs. Revascularization of a native coronary artery was performed in an additional 4 of 7 (57%) symptomatic patients with an occluded SVG. CONCLUSIONS: SVG failure after stenting often presents as acute myocardial infarction and with SVG occlusion. Compared with BMS, PES reduce SVG failure.

A randomized controlled trial of a paclitaxel-eluting stent versus a similar bare-metal stent in saphenous vein graft lesions the SOS (Stenting of Saphenous Vein Grafts) trial.

OBJECTIVES: The aim of this study was to compare the frequency of angiographic restenosis and clinical events between a paclitaxel-eluting stent (PES) and a similar bare-metal stent (BMS) in saphenous vein graft (SVG) lesions. BACKGROUND: There are conflicting and mostly retrospective data on outcomes after drug-eluting stent implantation in SVGs. METHODS: Patients requiring SVG lesion stenting were randomized to BMS or PES. The primary study end point was binary in-segment restenosis at 12-month follow-up quantitative coronary angiography. Secondary end points included death, myocardial infarction, ischemia-driven target vessel and lesion revascularization, and target vessel failure. RESULTS: Eighty patients with 112 lesions in 88 SVGs were randomized to a BMS (39 patients, 43 grafts, 55 lesions) or PES (41 patients, 45 grafts, 57 lesions). Binary angiographic restenosis occurred in 51% of the BMS-treated lesions versus 9% of the PES-treated lesions (relative risk: 0.18; 95% confidence interval [CI]: 0.07 to 0.48, p < 0.0001). During a median follow-up of 1.5 years the PES patients had less target lesion revascularization (28% vs. 5%, hazard ratio: 0.38; 95% CI: 0.15 to 0.74, p = 0.003) and target vessel failure (46% vs. 22%, hazard ratio: 0.65; 95% CI: 0.42 to 0.96, p = 0.03), a trend toward less target vessel revascularization (31% vs. 15%, hazard ratio: 0.66; 95% CI: 0.39 to 1.05, p = 0.08) and myocardial infarction (31% vs. 15%, hazard ratio: 0.67; 95% CI: 0.40 to 1.08, p = 0.10), and similar mortality (5% vs. 12%, hazard ratio: 1.56; 95% CI: 0.72 to 4.11, p = 0.27). CONCLUSIONS: In SVG lesions, PES are associated with lower rates of angiographic restenosis and target vessel failure than BMS.

Carotid artery stenting will replace carotid endarterectomy.

Stroke is the third leading cause of death in the United States. Carotid artery stenosis represents one of the most common etiologies of stroke. The current treatment modalities available for the treatment of carotid artery stenosis are carotid endarterectomy (CEA) and carotid artery stenting (CAS). Several clinical trials comparing CEA with medical management showed superiority of the surgical arm; however, the applicability of these results to the general population is limited by the fact that the patients and surgeons enrolled in these trials were carefully selected, and the optimal medical therapy used does not meet the current treatment standards. Carotid artery stenting has emerged as a treatment alternative to CEA, as shown in randomized trials comparing the 2 treatment modalities. Recent data from large-volume CAS registries indicate that percutaneous treatment of carotid artery stenosis compares favorably to CEA. Furthermore, the CAS trial designs make these results more applicable to the community standards. These data suggest that CAS will become the treatment of choice in patients with carotid artery stenosis.

Coronary-subclavian steal: presentation and management: two case reports.

Subclavian stenosis is a highly prevalent and underrecognized clinical entity. In patients with a history of coronary artery bypass grafting utilizing a left internal mammary artery, subclavian artery stenosis can cause coronary-subclavian steal, leading to myocardial ischemia. Traditionally, this has been treated surgically with a vascular bypass operation. Two cases of coronary-subclavian steal syndrome are presented, 1 treated percutaneously with angioplasty and stent, and 1 treated with a combined endovascular-surgical procedure.

Outcome of patients undergoing balloon angioplasty in the two months prior to noncardiac surgery.

We report on the incidence of adverse cardiac events in 350 patients who underwent noncardiac surgery within 2 months of successful balloon angioplasty (BA) at our institution between 1988 and 2001. Three patients died perioperatively (n = 1) or had myocardial infarction (n = 2) (0.9%, 95% confidence interval [CI] 0.2% to 2.5%), which is a lower incidence than that reported for patients undergoing noncardiac surgery after stenting (3.9% to 32%). One patient died, and 2 had a nonfatal myocardial infarction. All 3 (1.6%, 95% CI 0.3% to 4.6%) were among the 188 patients who underwent surgery within 2 weeks of BA. Repeat target vessel revascularization was performed in 10 patients (2.9%, 95% CI 1.4% to 5.2%): in 3 (1.6%, 95% CI 0.3% to 4.6%) of 188 patients who underwent surgery within 2 weeks of BA and in 7 (5.1%, 95% CI 2.1% to 10.2%) of 138 patients who underwent surgery within 3 to 7 weeks of BA. Therefore, in patients in whom percutaneous coronary revascularization is required before noncardiac surgery, BA appears to be safe, especially in patients who need to undergo surgery early after percutaneous coronary intervention.

Pseudoperforation during kissing balloon angioplasty.

We describe a case of apparent perforation during kissing balloon angioplasty of a bifurcation lesion. There was no evidence of perforation on follow-up angiography or via intravascular ultrasound. Possible etiologies include minimal perforation that immediately sealed postdeflation or forced contrast into the microvascular bed via a proximal side branch.

Routine intravascular ultrasound scanning guidance of coronary stenting is not associated with improved clinical outcomes.

PURPOSE: The purpose of the current study was to determine whether there is any incremental benefit to routine intravascular ultrasound (IVUS) guidance of percutaneous coronary intervention. METHODS AND RESULTS: We compared the outcome of 796 patients who underwent an IVUS study (IVUS group) during the index stent procedure with 8274 patients who did not have an IVUS study (angiography group). The primary end point was the composite end point of death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 months of the index stent procedure. There were statistically significant differences in multiple procedural characteristics. Most importantly, those patients who underwent an IVUS study had a larger postprocedural minimal lumen diameter and smaller postprocedural percent diameter stenosis. However, there was no significant difference between the IVUS group and the angiography group with respect to the primary end point (RR 1.10, 95% CI 0.91, 1.32) or any of the individual clinical end points. Adjustment for multiple clinical and procedural characteristics did not significantly alter these findings. CONCLUSIONS: These data suggest that the routine performance of IVUS during stent placement influences the performance of the procedure, as judged by differences in procedural characteristics, but does not improve clinical outcome at 9 months.

Cutting balloon angioplasty vs. conventional balloon angioplasty in patients receiving intracoronary brachytherapy for the treatment of in-stent restenosis.

The objective of this study was to evaluate the safety and efficacy of cutting balloon angioplasty (CBA) for the treatment of in-stent restenosis prior to intracoronary brachytherapy (ICB). Cutting balloon angioplasty may reduce the incidence of uncontrolled dissection requiring adjunctive stenting and may limit "melon seeding" and geographic miss in patients with in-stent restenosis who are subsequently treated with ICB. We performed a retrospective case-control analysis of 134 consecutive patients with in-stent restenosis who were treated with ICB preceded by either CBA or conventional balloon angioplasty. We identified 44 patients who underwent CBA and ICB, and 90 control patients who underwent conventional percutaneous transluminal coronary angioplasty (PTCA) and ICB for the treatment of in-stent restenosis. Adjunctive coronary stenting was performed in 13 patients (29.5%) in the CBA/ICB group and 41 patients (45.6%; P < 0.001) in the PTCA/ICB group. There was no difference in the injury length or active treatment (ICB) length. The procedural and angiographic success rates were similar in both groups. There were no statistically significant differences in the incidence of death, myocardial infarction, recurrent angina pectoris, subsequent target lumen revascularization, or the composite endpoint of all four clinical outcomes (P > 0.05). Despite sound theoretical reasons why CBA may be better than conventional balloon angioplasty for treatment of in-stent restenosis with ICB, and despite a reduction in the need for adjunctive coronary stenting, we were unable to identify differences in clinical outcome.

Safety and efficacy of aspirin, clopidogrel, and warfarin after coronary stent placement in patients with an indication for anticoagulation.

BACKGROUND: Dual antiplatelet therapy with aspirin and clopidogrel has replaced aspirin and systemic anticoagulation with warfarin as the preferred antithrombotic therapy after percutaneous coronary intervention (PCI) with stent placement. However, a number of patients have indications for all 3 drugs. We sought to determine the frequency and type of hemorrhagic complications in patients who undergo systemic anticoagulation with warfarin while receiving aspirin and clopidogrel after a PCI with stent placement. METHODS: We performed a retrospective analysis of the Mayo Clinic PCI database and identified 66 consecutive patients who were discharged from hospital after PCI between January 2000 and August 2002 (inclusive) receiving a combination of dual antiplatelet therapy (aspirin and clopidogrel) and systemic anticoagulation (warfarin) to determine the incidence of bleeding and other clinical events during the treatment period. RESULTS: Six patients (9.2%; 95% CI, 3.5-19.0) reported a bleeding event; 2 patients required a blood transfusion. No patient died or sustained a myocardial infarction or stent thrombosis. CONCLUSIONS: The risk of bleeding may be increased in patients treated with aspirin, a thienopyridine, and warfarin early after PCI with stent placement.

Incidence, correlates, management, and clinical outcome of coronary perforation: analysis of 16,298 procedures.

BACKGROUND: Coronary perforation is a serious but uncommon complication of percutaneous coronary intervention (PCI) and is associated with significant morbidity and mortality. METHODS: We performed an analysis of the Mayo Clinic PCI database. Clinical records, procedural reports, and angiographic studies were reviewed. Multiple logistic regression analysis was performed to identify clinical, procedural, anatomic, and angiographic correlates of coronary perforation. RESULTS: A total of 16,298 PCI procedures were performed between January 1990 and December 2001. We identified 95 coronary perforations (0.58%; 95% CI, 0.47-0.71). The incidence of coronary perforation varied with time. Correlates of coronary perforation included the use of an atheroablative device and female sex. Twelve patients (12.6%) sustained an acute myocardial infarction, and cardiac tamponade developed in 11 patients (11.6%). Management strategies included reversal of heparin, pericardiocentesis, placement of a covered stent, and surgical repair. Seven patients died (7.4%). CONCLUSIONS: Coronary perforation during PCI is rare, but is associated with significant morbidity and mortality. The variable frequency of perforation may be explained by temporal variations in the use of atheroablative devices.

Clinical safety of magnetic resonance imaging early after coronary artery stent placement.

OBJECTIVES: Our aim was to examine the rate of adverse cardiac events in patients undergoing magnetic resonance imaging (MRI) <8 weeks after coronary stent placement. BACKGROUND: The risk of coronary stent thrombosis from dislodgement due to MRI early after stent placement is not well defined. Manufacturers recommend postponing MRI studies until eight weeks after coronary stent placement. METHODS: We analyzed the Mayo Clinic Rochester Percutaneous Coronary Intervention Database and examined records of 111 patients who underwent MRI <8 weeks after coronary stent placement treated with aspirin and a thienopyridine. Occurrence of death, myocardial infarction (MI), and repeat revascularization within 30 days of MRI were recorded. RESULTS: Magnetic resonance imaging (1.5 tesla) was performed within a median of 18 days (range, 0 to 54 days) after coronary stent placement. Four noncardiac deaths occurred, and three patients had repeat revascularization procedures. Stent thrombosis did not occur (95% confidence interval, 0% to 3.3%). CONCLUSIONS: Magnetic resonance imaging <8 weeks after coronary stent placement appears to be safe, and the risk of cardiac death or MI due to stent thrombosis is low. Postponing MRI does not appear to be necessary.

Clinical outcome of patients undergoing non-cardiac surgery in the two months following coronary stenting.

OBJECTIVES: We sought to determine the frequency and timing of complications at our institution when surgery was performed within two months of coronary stent placement. BACKGROUND: The optimal delay following coronary stent placement prior to non-cardiac surgery is unknown. METHODS: We analyzed the Mayo Clinic Percutaneous Coronary Intervention and Surgical databases between 1990 and 2000 and identified 207 patients who underwent surgery in the two months following successful coronary stent placement. RESULTS: Eight patients (4.0%) died or suffered a myocardial infarction or stent thrombosis. All 8 patients were among the 168 patients (4.8%, 95% confidence interval [CI] 2.1 to 9.2) undergoing surgery six weeks after stent placement; the frequency of these events ranged from 3.8% to 7.1% per week during each of the six weeks. No events occurred in the 39 patients undergoing surgery seven to nine weeks after stent placement (0%, 95% CI 0.0 to 9.0). CONCLUSIONS: These data suggest that, whenever possible, non-cardiac surgery should be delayed six weeks after stent placement, by which time stents are generally endothelialized, and a course of antiplatelet therapy to prevent stent thrombosis has been completed.