Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion.

BACKGROUND: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. METHODS: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. RESULTS: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P=0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P=0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. CONCLUSIONS: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.

Preventive strategies of renal insufficiency in patients with diabetes undergoing intervention or arteriography (the PREVENT Trial).

Few studies have compared the ability of sodium bicarbonate plus N-acetylcysteine (NAC) and sodium chloride plus NAC to prevent contrast-induced nephropathy (CIN) in diabetic patients with impaired renal function undergoing coronary or endovascular angiography or intervention. Diabetic patients (n = 382) with renal disease (serum creatinine ≥1.1 mg/dl and estimated glomerular filtration rate <60 ml/min/1.73 m(2)) were randomly assigned to receive prophylactic sodium chloride (saline group, n = 189) or sodium bicarbonate (bicarbonate group, n = 193) before elective coronary or endovascular angiography or intervention. All patients received oral NAC 1,200 mg 2 times/day for 2 days. The primary end point was CIN, defined as an increase in serum creatinine >25% or an absolute increase in serum creatinine ≥0.5 mg/dl within 48 hours after contrast exposure. There were no significant between-group differences in baseline characteristics. The primary end point was met in 10 patients (5.3%) in the saline group and 17 (9.0%) in the bicarbonate group (p = 0.17), with 2 (1.1%) and 4 (2.1%), respectively, requiring hemodialysis (p = 0.69). Rates of death, myocardial infarction, and stroke did not differ significantly at 1 month and 6 months after contrast exposure. In conclusion, hydration with sodium bicarbonate is not superior to hydration with sodium chloride in preventing CIN in patients with diabetic nephropathy undergoing coronary or endovascular angiography or intervention.

Comparison of the effectiveness of sirolimus- and paclitaxel-eluting stents for small coronary artery lesions.

BACKGROUND: The sirolimus-eluting stent (SES) and the paclitaxel-eluting stent (PES) reduce restenosis in small coronary artery lesions. However, it is not clear which of these stents is superior in terms of clinical outcomes. METHODS: The authors retrospectively examined 197 patients with 245 de novo small coronary artery lesions (

Late stent malapposition after drug-eluting stent implantation: an intravascular ultrasound analysis with long-term follow-up.

BACKGROUND: Late stent malapposition (LSM) after drug-eluting stent (DES) implantation has not been evaluated sufficiently in real-world practice. METHODS AND RESULTS: We evaluated the incidence, mechanisms, predictors, and long-term prognosis of LSM after DES implantation in 557 patients (705 native lesions; sirolimus-eluting stent in 538 lesions and paclitaxel-eluting stent in 167 lesions) in whom intravascular ultrasound was performed at index and 6-month follow-up. LSM occurred in 82 patients with 85 lesions (12.1% overall, 95% CI 9.7% to 14.5%, 71 lesions (13.2%) in sirolimus-eluting stents and 14 lesions [8.4%] in paclitaxel-eluting stents, P=0.12]; the incidence was 25.0% (4/16) after directional coronary atherectomy before stenting, 27.5% (14/51) in chronic total occlusion lesions, and 31.8% (7/22) after primary stenting in acute myocardial infarction (P=0.13, P<0.001, and P=0.001, respectively, versus elective stenting with conventional balloon predilation, 9.7% [60/616]). There was an increase of external elastic membrane area (from 17.1+/-3.6 to 21.4+/-4.8 mm2, P<0.001) that was greater than the increase in plaque area (from 9.3+/-2.5 to 10.5+/-2.7 mm2, P<0.001). Independent predictors of LSM were total stent length, primary stenting in acute myocardial infarction, and chronic total occlusion lesions. Except for 1 death in the non-LSM group, there were no major adverse cardiac events in either LSM or non-LSM patients during a mean 10-month follow-up after detection of LSM. CONCLUSIONS: LSM occurs in 12% of cases after DES implantation. The predictors of LSM are total stent length, primary stenting in acute myocardial infarction, and chronic total occlusion lesions. LSM after DES implantation was not associated with any major adverse cardiac events during a subsequent 10-month (mean) follow-up.

Impact of diabetes mellitus on angiographic and clinical outcomes in the drug-eluting stents era.

The effect of diabetes mellitus (DM) on angiographic restenosis and clinical outcomes after implantation of drug-eluting stents (DESs) has not been investigated in real-world practice. This study consisted of 226 patients who had DM and 560 patients who did not who underwent DES implantation between February 2003 and December 2003. We retrospectively compared the incidence of 6-month angiographic restenosis and 9-month major adverse cardiac events (MACEs), defined as cardiac death, myocardial infarction, and target lesion revascularization, between patients with and without DM. The 6-month angiographic restenotic rate (10.1% vs 8.2%, p = 0.41) and late loss (0.41 +/- 0.63 vs 0.36 +/- 0.65, p = 0.31) were similar between patients with and without DM. In addition, incidences of MACEs (4.9% vs 4.8%, p = 1.00) and target lesion revascularization (4.4% vs 4.1%, p = 0.84) were similar. Patients who had insulin-dependent DM manifested higher prevalences of restenosis (25.0% vs 8.5%, p = 0.04) and MACEs (17.2% vs 3.1%, p = 0.01) compared with patients who had non-insulin-dependent DM. In conclusion, in this study of real-world patients who underwent DES implantation, patients who had DM had restenotic rates and clinical outcomes that were similar to those in patients who did not have DM.