BACKGROUND:Graft failure after coronary artery bypass grafting is a common clinical problem associated with adverse cardiovascular outcomes. Although percutaneous coronary intervention (PCI) for bypass graft lesions is frequently performed, the optimal device strategy remains debated. Recently, drug-coated balloon (DCB) has emerged as a stentless alternative. OBJECTIVES:This study aimed to compare 1-year clinical outcomes between drug-eluting stent (DES) and DCB-only strategies in patients undergoing PCI for bypass graft lesions. METHODS:We analyzed data from the J-PCI OUTCOME (Japanese Percutaneous Coronary Intervention Outcome Registry), a nationwide registry in Japan. Patients who underwent PCI with DES or stentless PCI with DCB for bypass graft lesions between 2017 and 2020 were included. The primary endpoint was major adverse cardiovascular events (MACEs), defined as a composite of all-cause death, acute coronary syndrome, and stroke within 1 year after PCI. Secondary endpoints included individual components of MACE, major bleeding, and planned repeat revascularization. RESULTS:Of the 610 PCIs for bypass graft lesions, 184 (30.2%) were stentless PCIs with DCB. One-year MACE rates did not differ significantly between the DES and DCB-only strategies (10.3% vs 8.6%; P = 0.69). No statistically significant differences were observed in the secondary endpoints. After multivariable adjustment, the DCB-only strategy was not associated with a significant difference in MACE risk after PCI compared with the DES-based strategy (adjusted HR: 1.01; 95% CI: 0.58-1.76; P = 0.96). CONCLUSIONS:Stentless PCI with DCB was frequently used in patients undergoing PCI for bypass graft lesions in Japan and was not associated with a significant difference in 1-year clinical outcomes compared with contemporary DES-based PCI strategies.
BACKGROUND:Self-expanding valves appear to have superior hemodynamics compared with balloon-expandable valves for valve-in-valve transcatheter aortic valve replacement (ViV-TAVR). OBJECTIVES:This study aimed to compare echocardiographic and clinical outcome data between supra-annular self-expanding valves (SASEVs) and intra-annular self-expanding valves (IASEVs), which in the past has remained limited, raising the need for further evaluation. METHODS:We analyzed ViV-TAVR procedures in the ACOR (Australian Cardiovascular Outcomes Registry). Patients receiving SASEV or IASEV were included. Baseline clinical and echocardiographic characteristics and postprocedure and 12-month outcomes were assessed. Echocardiographic parameters included gradients and left ventricular ejection fraction. Clinical outcomes included major adverse cardiac and cerebrovascular events, defined according to Valve Academic Research Consortium criteria. RESULTS:A total of 683 patients underwent ViV-TAVR: 566 (82.9%) with SASEV and 117 (17.1%) with IASEV. Baseline demographics were similar, although IASEV had higher rates of heart failure and a higher rate of baseline bioprosthetic valve regurgitation. Postprocedure echocardiographic findings were similar in both groups, with comparable mean gradients (14.9 mm Hg vs 13.3 mm Hg; P = 0.070), peak atrioventricular velocities (2.5 m/s vs 2.4 m/s; P = 0.073) and Dimensionless Performance Index (SASEV 0.4 vs IASEV 0.5; P < 0.001). At 12 months, although not statistically significant, there was a numerical trend toward higher major adverse cardiac and cerebrovascular events (11.9% vs 7.1%; P = 0.129) and stroke rates (5.4% vs 1.7%; P = 0.058) in the IASEV group. No significant differences were observed in mortality or bleeding. Findings were consistent after propensity score adjustment and multivariable logistic regression. CONCLUSIONS:Both SASEV and IASEV provide favorable and similar hemodynamic and clinical outcomes following ViV-TAVR.
BACKGROUND:A myocardial bridge (MB) is frequently observed after recanalization of a left anterior descending coronary artery (LAD) chronic total occlusion (CTO); however, the long-term prognostic impact of MBs in this specific setting remains controversial. OBJECTIVES:The aim of this study was to determine the impact of MBs on long-term outcomes in patients undergoing percutaneous coronary intervention of LAD CTOs. METHODS:Consecutive patients with LAD CTOs who underwent intravascular ultrasound-guided percutaneous coronary intervention from January 2019 to December 2021 were retrospectively analyzed. The primary endpoint was the 5-year rate of major adverse cardiac events (MACE), a composite of cardiac death, spontaneous myocardial infarction, and ischemia-driven revascularization. RESULTS:Among 685 patients analyzed, MBs were identified in 393 (57.4%) on intravascular ultrasound; stent extension into the bridged segment occurred in 44.3% of these cases (174 of 393). After a median 5-year follow-up, patients with MBs had a higher incidence of MACE compared with those without MBs (16.1% vs 8.9%; P = 0.006), driven primarily by more ischemia-driven revascularization in the MB group (15.1% vs 7.9%; P = 0.004). Stent extension into the MB was associated with a higher rate of MACE compared with sparing the MB (21.4% vs 11.9%; P = 0.0017). MACE rates did not differ between patients with MBs spared from stenting and those without MBs (11.9% vs 8.9%; P = 0.25). CONCLUSIONS:MBs are prevalent after LAD CTO recanalization. Although their presence is associated with adverse outcomes, the risk is driven mainly by stent extension into the bridged segment.
BACKGROUND:Drug-coated balloons improve outcomes after femoropopliteal angioplasty, but concerns regarding the long-term safety of paclitaxel-coated devices have prompted interest in alternative antiproliferative strategies. OBJECTIVES:This study sought to evaluate the 2-year patient-centered and clinical outcomes of sirolimus-coated balloon (SCB) versus paclitaxel-coated balloon (PCB) angioplasty. METHODS:SIRONA was a prospective, multicenter, randomized, controlled, noninferiority trial comparing SCB with PCB angioplasty in patients with femoropopliteal artery disease (96.5% intermittent claudication). The present analysis reports prespecified outcomes at 2 years. Effectiveness endpoints included patient-reported outcomes (VascuQol, clinical improvement, and EQ-5D-3L), primary patency, and freedom from clinically driven target lesion revascularization. Safety endpoints included major amputation and all-cause mortality. Longer-term follow-up is ongoing to assess durability and safety up to 5 years. RESULTS:A total of 482 patients was randomized (SCB: n = 238; PCB: n = 244). Improvements in vascular quality of life were sustained through 2 years and were similar between groups (between-group difference: 0.05, 95% CI: -0.15 to 0.24; P = 0.63). Clinical improvement (≥1 Rutherford category) occurred in 88% of the SCB group and 89% of the PCB group (P = 0.89). Kaplan-Meier estimates of primary patency were 64.6% for SCB and 67.2% for PCB (log-rank P = 0.34). Freedom from clinically driven target lesion revascularization was 91.2% for SCB and 88.1% for PCB (log-rank P = 0.42). Major amputation was rare (0.4% in both groups). All-cause mortality occurred in 6.3% and 3.7%, respectively (P = 0.21), with no device- or procedure-related deaths. CONCLUSIONS:SCB angioplasty resulted in sustained patient-reported and clinical outcomes comparable to PCB angioplasty through 2 years, with similar patency, revascularization, and safety.
BACKGROUND:Incomplete microvascular reperfusion during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) remains a major challenge. OBJECTIVES:This study sought to determine whether the pressure optimization protocol (POP) improves reperfusion outcomes compared with conventional rapid inflation-deflation stenting in patients undergoing primary PCI for STEMI. METHODS:In this multicenter randomized trial with blinded endpoint assessment, patients undergoing primary PCI were assigned 1:1 to POP (stent inflation to ≥14 atm maintained until pressure stability, defined as no pressure drop ≥0.3 atm over 30 seconds) or conventional rapid inflation-deflation stenting. The primary endpoint was hierarchical reperfusion success, analyzed using the Finkelstein-Schoenfeld unmatched WIN ratio: ST-segment resolution ≥70% at 90 minutes, final TIMI grade 3, and absence of slow-flow/no-reflow. RESULTS:Between September 30, 2024, and November 11, 2025, 607 patients underwent randomization (POP arm, n = 307; conventional arm, n = 300). POP improved the primary hierarchical reperfusion endpoint (WIN ratio: 1.42; 95% CI: 1.11-1.79; P = 0.004). The net WIN difference was +12.64% (95% CI: 3.69-20.98), driven mainly by the first 2 hierarchical components, ST-segment resolution ≥70% (+5.70%; 95% CI: -1.89 to 12.56) and final TIMI grade 3 flow (+5.95%; 95% CI: 1.80-10.00). Postdilation was less frequent with POP (213 of 326 stents [65.3%] vs 294 of 323 [91.0%]; P < 0.001). At median follow-up of 30 days (IQR: 29-32), major adverse cardiovascular events (death, myocardial infarction, stent thrombosis, or stroke) occurred in 6 of 307 vs 12 of 300 patients; Kaplan-Meier estimated event rates were 2.0% (95% CI: 0.4-3.5) and 4.1% (95% CI: 1.8-6.3), respectively (HR: 0.49; 95% CI: 0.18-1.31; P = 0.15). CONCLUSIONS:Among patients with STEMI undergoing primary PCI, pressure-optimized stent inflation resulted in significantly higher rates of successful reperfusion than conventional stenting and reduced need for post dilation. A trend toward fewer 30-day major adverse cardiovascular events was observed. Larger trials are warranted to assess effects on longer-term clinical outcomes. (RAPID-POP: A Randomized Controlled Trial; NCT06430892).
