JACC. Cardiovascular interventions最新文献

Background: Drug-coated balloons (DCBs) are attractive for treating de novo coronary lesions, especially when involving bifurcations; however, their efficacy compared with drug-eluting stents (DES) remains uncertain.

Objectives: The aim of this study was to assess the prognosis of DCBs vs DES in patients with noncomplex bifurcation and nonbifurcation lesions.

Methods: This was a prespecified subgroup analysis of the REC-CAGEFREE I (Paclitaxel-Coated Balloon for Treatment of De-Novo Non-Complex Coronary Artery Lesions) trial, which was an investigator-initiated, noninferiority trial conducted at 43 sites in China that randomized 2,272 participants to paclitaxel-coated balloons (the DCB group) or sirolimus-eluting stents (the DES group) for the treatment of de novo lesions, regardless of vessel diameter. The primary outcome was a device-oriented composite endpoint (DoCE) at 24 months. Participants were stratified according to the presence vs absence of bifurcation, and inverse probability of treatment weighting (IPTW) was performed to adjust for between-group imbalances.

Results: A total of 2,257 of 2,272 participants (99.3%) with available angiographic results were included. At 24 months, the DoCE had occurred in 46 of 773 patients in the bifurcation group (6.0%) and 64 of 1,484 patients in the nonbifurcation group (4.3%) (HR_IPTW: 1.39; 95% CI: 0.87-2.21; P = 0.164). Seven hundred nineteen of 798 of the bifurcation lesions (90.1%) had DCB or DES treatment in the main vessel. A significant interaction for the DoCE was observed between bifurcation or nonbifurcation and assigned treatment (P_interaction = 0.031). In the nonbifurcation group, the DoCE occurred in 46 of 735 patients with DCBs (6.3%) and 18 of 749 (2.4%) with DES (HR_IPTW: 2.67; 95% CI: 1.64-4.33; P < 0.001); the in bifurcation group, the DoCE occurred in 26 of 394 patients with DCBs (6.7%) and 20 of 379 (5.3%) with DES (HR_IPTW: 1.03; 95% CI: 0.53-2.01; P = 0.934).

Conclusions: DCBs were associated with a numerically comparable risk for DoCE compared with DES in noncomplex bifurcations at 2 years. However, these findings should be interpreted as hypothesis generating only. (Paclitaxel-Coated Balloon for Treatment of De-Novo Non-Complex Coronary Artery Lesions; NCT04561739).

Background: Mitral regurgitation (MR) is a globally endemic heart disease burden with significant morbidity and mortality. Mitral transcatheter edge-to-edge repair (M-TEER) has emerged as a minimally invasive treatment with established safety and intermediate-term efficacy.

Objectives: The aim of this study was to determine M-TEER durability and the incidence, risk factors, and treatment strategies of M-TEER failure.

Methods: A comprehensive literature review was performed, identifying 457 records, from which 33 full-text papers were included. Definitions of MR recurrence, reintervention, and M-TEER durability and failure were provided. On the basis of these definitions, weighted means with 95% CIs were calculated for the rates of MR recurrence, reintervention, and their composite for both the overall population and the primary and secondary MR subgroups.

Results: The pooled weighted means of MR recurrence and reintervention ranged between 5% and 10% in the first months after the index procedure, remained relatively stable for the first 3 years, and increased at 5 years to 17% and 9%, respectively. MR recurrence and reintervention weighted means were numerically higher in primary than secondary MR, and 41% of primary MR patients experienced MR recurrence or reintervention at 5 years. Redo transcatheter edge-to-edge repair for M-TEER failure seemed safer than surgery but was associated with 1-year MR recurrence rates between 20% and 40%. Mitral valve replacement was the most common surgical technique for M-TEER failure.

Conclusions: The incidence of M-TEER failure after a successful index procedure increases after 3 years and is more pronounced with primary than secondary MR. More systematic, longer term follow-up data after M-TEER are required to better define M-TEER durability.

Background: Current guidelines and quality metrics after percutaneous coronary intervention (PCI) often assign equal weight to nonfatal adverse events, including heart failure hospitalization (HFH), acute coronary syndrome (ACS), and major bleeding, within composite endpoints.

Objectives: The aim of this study was to quantify and compare the associations of HFH, ACS, and major bleeding with subsequent mortality following PCI.

Methods: A Japanese multicenter prospective PCI registry (2008-2021) with 2-year postprocedural outcomes was analyzed. The primary outcome was all-cause mortality, with HFH, ACS, and major bleeding as time-varying exposures. Cumulative incidence was estimated with death as a competing risk. Cox proportional hazards models and population attributable fractions were used to assess associations between time-varying events and mortality, adjusting for conventional risk factors.

Results: Among 10,482 patients (mean age 69 years, 77.5% men) followed for a median of 730 days (Q1-Q3: 730-730 days), 1,021 (9.7%; 95% CI: 9.2%-10.3%) experienced adverse events. Two-year cumulative incidence rates were 4.7% (95% CI: 4.2%-5.1%) for HFH, 3.4% (95% CI: 3.0%-3.7%) for ACS, and 2.5% (95% CI: 2.2%-2.8%) for major bleeding. Cox analysis showed that HFH was associated with mortality (adjusted HR [aHR]: 6.11; 95% CI: 4.76-7.85), followed by ACS (aHR: 3.22; 95% CI: 2.14-4.84) and major bleeding (aHR: 2.62; 95% CI: 1.71-4.02). Population attributable fraction analysis demonstrated that HFH accounted for 20.1% (95% CI: 19.0%-21.0%) of mortality burden, higher than ACS (4.3%; 95% CI: 3.3%-4.9%) and major bleeding (2.9%; 95% CI: 1.9%-3.5%).

Conclusions: HFH shows stronger associations with mortality than ACS or major bleeding following PCI, suggesting that adverse events should not be weighted equally and underscoring the need to reconsider prioritization in clinical decision-making and endpoint definitions.